Pfizer

Psychological symptom reports

Male, 40 - 59 years

Age Reported Symptoms Notes
40 2021-01-04 sleep disorder, restlessness COVID vaccine Tuesday. Some soreness at the site that resolved over 2 days. Over the past 24 hours... Read more
COVID vaccine Tuesday. Some soreness at the site that resolved over 2 days. Over the past 24 hours, developed some mild parasthesias [nonspecific]. Aren't painful, but tingling is annoying, contributed to restless night last night. Response 12/26: Acetaminophen, Start B-complex with Fe, report if not already done Chart 12/26: Reported. A bit better this am but will start vitamins Chart 12/29 [excerpt] Still having same symptoms of parasthesias. Started multivitamin as well as acetaminophen. I've noticed it affects only the right side of my body, and that it's purely sensory, no motor changes. Still mild, but not been sleeping well Responded, scheduled appt.   Vaccinated in L deltoid. Describes R side of body feels 'Cold' [dysesthesia] on R side of body and extremities. No weakness, no change in ROM. No joint swelling. No rash. Sensation feels less on R but still sense of touch. Thinks this is about the same- notices more when lies down in bed than in daytime. Symptoms persist 1/5/2021: Referred to Neurology at his request
40 2021-01-06 feeling abnormal, anxiety Employee returned to vaccination area at 13:45, reported mild intermittent tingling in hands and fee... Read more
Employee returned to vaccination area at 13:45, reported mild intermittent tingling in hands and feet bilat; primarily feet and primarily when he sat down. Also reported mild brief blotchiness to bilat lower forearms. Narrative: Mildly anxious, mild reactions to which he was unsure if he should return to vaccination site or not. Denied dizziness, light-headedness, palpitations. Reported mild feeling of a 'rush' "kind of feeling, like, stimulated". VS: at 13:46: BP 14977. O2 99%, P 79, T 36.3. Reported he had been continuing doing his duties without difficulty but didn't know if he should be concerned. Noted blotchiness on forearms under different lighting when he went to restroom. Blotchiness mild to moderate and mostly resolved before he left. VS at 14:02: BP 136/69, O2 99%, P 80, T 36.7. Reported tingling mostly resolved if he stretches his legs out some. Reported anxiety over "the whole thing. It's just weird and I've been excited about the vaccine". Reviewed S/S to be aware of, when to seek medical attention and that he was feeling completely stable and comfortable before he left. Positively reactive to increased information and seeing improvement in blotchiness. Left at 14:08.
40 2021-01-08 confusional state Symptoms began on 1/2/21 Self isolating Start of symptoms similar to a cold with mild discombobulati... Read more
Symptoms began on 1/2/21 Self isolating Start of symptoms similar to a cold with mild discombobulation Symptoms are mild with a loss of taste and smell continuing
40 2021-01-12 impaired work ability Significant chills for 5 hours, fever, body aches, headache significant enough to impair my ability ... Read more
Significant chills for 5 hours, fever, body aches, headache significant enough to impair my ability to work the following day. No reaction occurred after first dose. Reaction began with several hours of chills.
40 2021-01-13 impaired work ability Per reporter: "I received the COVID vaccine on 12/29/2020 (first dose). The first couple days I had ... Read more
Per reporter: "I received the COVID vaccine on 12/29/2020 (first dose). The first couple days I had a really sore left arm, but didn?t feel any ?side effects? until about Wednesday, 1/6 (about a week later). I remember waking up to a sore left side of my upper body. The left side of my neck, chest, arm, and lymph node (under my left arm) felt weird. It was until about Saturday night, 1/9, that I felt my left under arm lymph node noticeably swollen. I had a bad headache and loss of energy, and overall feeling unwell. No fever or night sweats to report. I was absent from work on 1/11 and 1/12, as a result. 1/13 was my first day back and feel better. The swollen left lymph node is no longer present, but still slightly tired. I did not seek Medical Care for my symptoms.
40 2021-01-18 loss of personal independence in daily activities Experienced severe shaking chills, necessitating I leave work. Also experienced mild myalgias, heada... Read more
Experienced severe shaking chills, necessitating I leave work. Also experienced mild myalgias, headache. Treated with acetaminophen 1000mg and ibuprofen 400mg.
40 2021-01-20 loss of personal independence in daily activities general ache/pains, headache woke me up ~3:30am. movement hurt, pain progressed, headaches got worse... Read more
general ache/pains, headache woke me up ~3:30am. movement hurt, pain progressed, headaches got worse, never went away. nausea, fever throughout the day, general tiredness and increased join point all day. swollen glands in arm pits. headache pain completely impaired daily activity. Tylenol in the afternoon for fever, dramamine for nausea Effects lasted 24 hours... headaches persisted 5+days
40 2021-01-25 feeling abnormal Body ache, chills diarrhea, fatigue, mild fever, muscle pain, brain foggy
40 2021-02-01 confusional state About 2 to 3 minutes after receiving the injection I felt light headed and passed out. My wife said ... Read more
About 2 to 3 minutes after receiving the injection I felt light headed and passed out. My wife said my eyes were open but glazed over. I also started shaking. When I woke up I was confused and felt nauseated. A few minutes after I woke up the EMTs ran my vitals. My heart rate was in the 40s and my blood pressure was in the 90s. I have never had a reaction like this to any other shot/vaccines.
40 2021-02-01 confusional state Systemic: Other- Patient said he suffered from confusion, fatigue, and had a hypertensive emergency ... Read more
Systemic: Other- Patient said he suffered from confusion, fatigue, and had a hypertensive emergency in which he had to increase his amount of blood pressure medication. Highest reading was 198/116.-Severe; symptoms lasted 2 days
40 2021-02-04 anxiety Headache, "Feels like I need to run." pain in back of shoulder blades, anxious
40 2021-02-05 anger Rage for no apparent reason. It subsided a day later.
40 2021-02-12 sleep disorder Violent tremors or chills in the middle of the night for half an hour, followed by a burning electri... Read more
Violent tremors or chills in the middle of the night for half an hour, followed by a burning electric feeling in my muscles. Not able to sleep afterwards. Woke up and muscles in body are very tight and tense.
40 2021-02-28 anxiety fainted with preceding anxiety after getting the vaccine
40 2021-03-02 disorientation After waiting 15 minutes I was released and felt fine. About 3-5 minutes after leaving the site my t... Read more
After waiting 15 minutes I was released and felt fine. About 3-5 minutes after leaving the site my tongue became numb and felt s=slightly swollen, throat became extremely dry, pulse rate increased from low 50 BPM to 100 BPM. Drove to a nearby store and stopped, felt a bit disoriented when trying to call my wife. Drank water and waited at a store for approximately 15 minutes until I felt better. This was about 40 minutes after the vaccine was administered. When driving home still some discomfort/numbing of the tongue and throat. Ate at 1:30 and symptoms had stopped.
40 2021-03-02 mental impairment Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with fatigue, chest tightness, back pain, myalgias, headaches, right arm soreness, and decreased concentration. Patient states had COVID-19 illness in October 2020 and current symptoms are similar. Patient denies facial/throat swelling, palpitations, rash, or lesions and reports some symptom improvement with acetaminophen. Vitals within normal ranges except blood pressure 141/84 attributed to white coat syndrome. Advised to continue acetaminophen and discharged to home stable.
40 2021-03-08 sleep disorder began with dehydration - frequent urination, low fever - up all night due to stomach issues very tir... Read more
began with dehydration - frequent urination, low fever - up all night due to stomach issues very tired all of the time, drinking unreal amounts of water developed dangerously high blood sugar over the next week - diagnosed with diabetes on March 1
40 2021-03-09 depression Following 1 week of the normal symptoms, 2 weeks of weakness, muscle pain and mild depression.
40 2021-03-11 nervousness patient waited his 15 minutes for observation. he walked out of the vaccination clinic about 12:23 ... Read more
patient waited his 15 minutes for observation. he walked out of the vaccination clinic about 12:23 & returned at 12:25 due to feeling like his tongue was numb. he also felt shaky & dizzy
40 2021-03-15 disturbance in attention Starting 3/15/21 and continuing today, 3/16/21 (the time this was authored), I have noticed that I c... Read more
Starting 3/15/21 and continuing today, 3/16/21 (the time this was authored), I have noticed that I continue to have brain-fog after the second COVID vaccine. Not sure if this is normal or will go away.
40 2021-03-19 disturbance in attention I had difficulty concentrating and focusing on Wednesday evening, a little over a day after getting ... Read more
I had difficulty concentrating and focusing on Wednesday evening, a little over a day after getting my first shot. The focusing/concentration issues went away by the next morning when I woke up, however I have been feeling very tired physically since then. I'm yawning all day and have very little energy or interest in doing things I need to be doing. I'm not certain that this is vaccine related, and I'm not super concerned about it yet as I'm on Spring break from school, but I start virtual classes again on Monday and will be concerned if I'm still super tired. If it doesn't go away by next weekend, I will likely resubmit/add on to this report if that is an option. It is not a serious concern yet so I haven't contacted medical professionals yet, but I thought it might be a good idea to at least report that this has been going on to VAERS
40 2021-03-22 anxiety Anxiety
40 2021-03-24 loss of personal independence in daily activities, disorientation Starting at 8pm on vaccination day I got loopy and disoriented, and had a hard time speaking intelli... Read more
Starting at 8pm on vaccination day I got loopy and disoriented, and had a hard time speaking intelligibly. I also had trouble with balance and fine motor skills. Had some personality changes too: became very moody with erratic mood swings. The next day I slept all day because of exhaustion and aches. When I woke up on Wednesday (36hrs later) I was literally screaming in pain because of how bad my arm and shoulder hurt. It hurt to move it, and hurt not to move it. It was excruciating and ibuprofen didn't seem to help at all. Throughout Wednesday I could hardly move my left arm. Getting dressed or washing my hair was very difficult and very painful. I was also still very uncoordinated. My left armpits lymph nodes were so swollen that (1) it filled in my entire armpit so there was no more pit, just a very soft bulge, and (2) the fluid extended all the way to my chest and it looked like I had one breast and one pec.
40 2021-03-26 incoherent, loss of personal independence in daily activities, disorientation 8 hours after shot extreme nausea. In one instant, extreme feeling of an instant blow to the head, ... Read more
8 hours after shot extreme nausea. In one instant, extreme feeling of an instant blow to the head, extreme ringing in ears, unable to hear, disoriented, unable to speak, incoherent, rapid fever that quickly reduced. Symptoms disappeared quickly and were gone within an hour. Afterwards mild headache, fatigue, nausea persisted for 2-3 days.
40 2021-03-27 loss of personal independence in daily activities Pfizer-BioNTech COVID-19 Vaccine EUA Got vaccinated on 8/24/21, starting 8/26/21 I have severe pain ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Got vaccinated on 8/24/21, starting 8/26/21 I have severe pain and decreased movement in my right shoulder. I cannot perform daily tasks or use my right arm.
40 2021-03-30 confusional state Client got lightheaded when changing position from sitting to standing. SN noted client kneeled on a... Read more
Client got lightheaded when changing position from sitting to standing. SN noted client kneeled on all fours and laid on floor. He become confused and verbally non responsive. His breathing was irregular on our assessment. On arousal patient started to respond after 30-40 seconds. His speech was garbled and delayed and patient was aware that he had fainted. He admits to a history of fainting in the past at work. He was able to walk to observation bay to lay down for approximately an hour. Paramedics were called at the beginning of episode. Bp 129/78, Pulse 78 Resp16, O2 sat 98% temp 32 C temporal He rested in bay about a hour and was transported home via car by wife after refusing transfer to hospital by paramedics
40 2021-04-01 insomnia Body ache and difficulty sleeping beginning overnight after shot, increasingly unpleasant body aches... Read more
Body ache and difficulty sleeping beginning overnight after shot, increasingly unpleasant body aches, weakness, tiredness throughout following day.
40 2021-04-07 disturbance in attention, confusional state Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of co... Read more
Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of control of lower right arm. Extreme fatigue unable to get up and move at times. Very light headed and on the verge of blacking out.. possibly Loss of consciousness. Extreme tightness in chest. Increase work of breathing. Confusion. Unable to keep eyes open and maintain alertness. Extremely tired Symptoms have gotten a little better throughout the day of april 8th with lots of rest and very little physical activity. I still have slight tightness in chest. Increase work of breathing. Still have tingling throughout body and am lightheaded. When doing any physical activity I become fatigued and lightheaded very fast and must stop after 5-10 minutes. Tongue is still tingling and metallic taste in moutg
40 2021-04-09 feeling abnormal patient stated he was feeling cold and a tingling in his throat and started to have tunnel vision w... Read more
patient stated he was feeling cold and a tingling in his throat and started to have tunnel vision with a weird feeling. patient was assessed for vitals times 3 every 10minutes patient later after third set of vitals stated he was feeling back to normal patient was escorted back out to the exit of the building with his son also accompany him. patient was encouraged to encourage fluids, and to make sure to rest. patient vitals were as follows 9:19a b/p 135/92 p 93 r 18 o2 99% 9:25a b/p 134/84 p 83 r 18 o2 99% 9:30ab/p121/87 p86 r18 o2 98% patient was released and escorted to the car.
40 2021-04-10 feeling abnormal, impaired work ability 4 days of fever, headache, body aches, fatigue, "brain zaps", brain fog. Most symptoms have resolve... Read more
4 days of fever, headache, body aches, fatigue, "brain zaps", brain fog. Most symptoms have resolved but fever and brain fog persist as of day 6. Sleeping 14+ hours per day, unable to work due to symptoms.
40 2021-04-13 disturbance in attention I had already completed my menstrual cycle before the vaccine. I started a extremely heavy menstrual... Read more
I had already completed my menstrual cycle before the vaccine. I started a extremely heavy menstrual flow the day after vaccination and it went on for 8 days. I had body aches on my left side only. Was not able to stay awake an entire hour. Slept 3/4 of the day away for the first 4 days. It was hard to focus or read any information.
40 2021-04-17 feeling abnormal, confusional state, abnormal dreams, panic attack Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a ... Read more
Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a feeling that i would pass out or die and tingling and shakimg; tingling and shaking throughout his body; tingling and shaking throughout his body; As he remained in a confused mental state; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; nocturnal panic attack with unknown trigger; Occasinally elevated blood pressure; slight markings of dehydration; hangover; This is a spontaneous report from a Contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer), second dose via an unspecified route of administration, administered in arm left on 24Mar2021 11:30 at age of 40-year-old (Lot Number: ER8733) at single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at Facility of Doctor's office/urgent care. Medical history included gout, anxiety, gastrooesophageal reflux disease, 'espoghutis'. The patient did not have allergies to medications, food, or other products. Concomitant medication within 2 weeks of vaccination included omeprazole; allopurinol; escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in arm left on 10Mar2021 11:30 at age of 40-year-old (Lot Number: En6206) at single dose for COVID-19 immunization. On 02Apr2021, the patient had vivid/lucid dreaming with bright lights and unusual feelings as he initially fell asleep. He was able to wake himself up but remained in between sleep and awake. This was accompanied by light headiness a feeling that he would pass out or die and tingling and shaking throughout his body as he remained in a confused mental state while his wife called an ambulance. In 2021, his vitals were fine with occasionally elevated blood pressure and slight markings of dehydration ( during the day following his second dose he felt like he had a bad hangover). The ER doctor thought the most likely explanation is sometime of nocturnal panic attack with unknown trigger. He had not previously sufferer anything like it. The events were reported as non-serious. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the adverse events which included: drugs to calm, fluids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events light headiness, tingling and shaking throughout his body, confused mental state, nocturnal panic attack with unknown trigger, vivid/lucid dreaming with bright lights, elevated blood pressure, slight markings of dehydration, hangover were resolving. Information on lot/batch number obtained. Further information is expected.
40 2021-04-18 disorientation Shortness of breath. Disorientation, Dizziness, Gastrointestinal issues, urinary tract discomfort, b... Read more
Shortness of breath. Disorientation, Dizziness, Gastrointestinal issues, urinary tract discomfort, blurred vision for extended periods of time during multiple days.
40 2021-04-18 disturbance in attention Bruising on upper back and left arm. Blurred Vision. Gastrointestinal issues. Shortness of Breath. ... Read more
Bruising on upper back and left arm. Blurred Vision. Gastrointestinal issues. Shortness of Breath. Dizziness. Eyes being extremely sore. Fatigue. Difficulty concentrating.
40 2021-04-20 depression, anxiety I believed vaccine caused anxiety attacks and depression. I could not leave the house without fear. ... Read more
I believed vaccine caused anxiety attacks and depression. I could not leave the house without fear. I needed multiple therapy sessions and multiple medications to help overcome illness.
40 2021-04-23 feeling abnormal Fatigue, body aches, brain fog, loss of muscle tone and headache.
40 2021-04-24 anxiety Fever - Unverified by Medical Treatment Facility Dizziness Sitting & Standing Vomiting Psychosis - I... Read more
Fever - Unverified by Medical Treatment Facility Dizziness Sitting & Standing Vomiting Psychosis - Inability to Communicate Properly Major Anxiety Allergic Reaction - Unverified by Hospital CT - Scan Not Performed Psychological Evaluation Not Performed
40 2021-04-24 irritability Irritable; was fatigued; Patient has tenderness at the injection site; This is a spontaneous report ... Read more
Irritable; was fatigued; Patient has tenderness at the injection site; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received BNT162B2 first dose on 30Mar2021 17:15 (Age at vaccination was 40 Years old) on left arm at single dose for COVID-19 immunization. Medical history included Pencillin Allergy. Concomitant medications in two weeks included SSRI. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has tenderness at the injection site, and was fatigued and irritable beginning approximately 24 hours after vaccination (31Mar202105:00 PM). Symptoms lasted for approximately 12 hours. At the end of that 12 hour period all symptoms ceased. The outcome of the events was recovered in 2021. No treatment for the events. No covid tested post vaccination. No follow up attempts are possible. Information on lot/batch number cannot be obtained.
40 2021-04-26 confusional state Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Un... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium
40 2021-04-26 nervousness Patient DOB: 11/18/1980. Received his first dose Pfizer (LOT#: EW0179 EXP: 8/2021) at 1108 on 4/27/2... Read more
Patient DOB: 11/18/1980. Received his first dose Pfizer (LOT#: EW0179 EXP: 8/2021) at 1108 on 4/27/21. Patient alerted EMT. Patient stated that she was sweating a lot and felt like his vision went blurry/dark for about 3 minutes. Patient stated that he also felt nervous. EMT alerted PHN. PHN suggested to move patient to zero gravity chair. Patient walked with assistance from EMT to gravity chair. Patient walked over and sat down safely on gravity chair. EMT took patients vital signs. BP: 118/60, pulse: 65, O2: 97%. Patient was given water. PHN recommended that patient stay an extra 30 minutes. Patient agreed. EMT re-assessed patient. Patient stated that he was feeling a lot better and that his vision was completely fine now. Patient left vaccination site unassisted and with a steady gait at 1150.
40 2021-04-28 feeling abnormal Brain fog; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 40-year-... Read more
Brain fog; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 05Apr2021 (10:30) as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), allopurinol, omeprazole (PRILOSEC) and lorazepam. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 15Mar2021 (when the patient was 40 years old) for COVID-19 immunization. On 05Apr2021 (14:00), the patient had brain fog and dizziness. The events had resulted into doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care, and were reported to be serious (causing disability or permanent damage). The patient did not receive any treatment for the reported events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
40 2021-05-01 feeling abnormal Nausea Foggy brain Fatigue
40 2021-05-03 insomnia, nervousness Since shot last Thursday April 29 at 930 am I cannot sleep at all and have a hard time breathing. Bo... Read more
Since shot last Thursday April 29 at 930 am I cannot sleep at all and have a hard time breathing. Body will not let me fall asleep. I get a rush of nervous or anxious energy and hot flashes
40 2021-05-06 confusional state, feeling abnormal, abnormal dreams Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Se... Read more
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: vivid dreams-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: general feeling of increased inflammation of joint pain
40 2021-05-07 sleep disorder I developed sudden-onset, severe, crushing pain in my left shoulder, radiating down my left arm. Th... Read more
I developed sudden-onset, severe, crushing pain in my left shoulder, radiating down my left arm. This is the location where I received my vaccine one month prior. The pain was 8/10 and lasted approximately 7 hours. It woke me from sleep. I also experienced nausea. I tried Tylenol 1000mg, ice, and heat. Nothing helped. I went to the Urgent Care. They did multiple EKGs and lab tests. They ruled out a heart attack and pulmonary embolism. There was no injury. They were unable to find any cause for the pain. They administered aspirin, protonix, and nitroglycerin. The pain resolved after the third dose of nitroglycerin. (I was told by the cardiology PA that this was probably a coincidence.)
40 2021-05-09 confusional state Chills, dizziness, vax fog (confusion, disorientation), fatigue, headaches. Took a 3 hour nap and wo... Read more
Chills, dizziness, vax fog (confusion, disorientation), fatigue, headaches. Took a 3 hour nap and woke up with just a headache, which went away in the evening.
40 2021-05-09 disturbance in attention Fatigue, nausea, dizzyness, headache, difficulty concentrating, generally feeling like I have a conc... Read more
Fatigue, nausea, dizzyness, headache, difficulty concentrating, generally feeling like I have a concussion
40 2021-05-11 insomnia, feeling abnormal Body aches, severe chills/shaking, mild to moderate headache, sleeplessness. I took Advil and put o... Read more
Body aches, severe chills/shaking, mild to moderate headache, sleeplessness. I took Advil and put on pants, a sweatshirt, a a beanie and got underneath 3 blankets (for the chills). I fell asleep about 2 hours later. Now, it is 11:23 am on 5/12/2021 and I still feel moderate to severe fatigue, mild chills and my headache is gone. My head does feel a bit foggy though. I took Advil again at 6:45 am. At noon, I'm going to take Aspirin.
40 2021-05-12 nightmare Bad dreams.
40 2021-05-17 feeling abnormal, disorientation, confusional state 40 Y/O M 15 mins post vaccine- A/Ox0, presented disoriented with a confused daze followed by complai... Read more
40 Y/O M 15 mins post vaccine- A/Ox0, presented disoriented with a confused daze followed by complaint of dizziness and general feeling of "not right". v/s within normal limits. PT given emesis bag for episode of nausea. PT A/Ox3 w/in 2 minutes post-episode. W/in 10 minutes still feels "cloudy". EMS called for evaluation.
40 2021-05-17 panic attack Started 5/11 in the morning with headache and dizziness. Left arm started feeling heavy and numb als... Read more
Started 5/11 in the morning with headache and dizziness. Left arm started feeling heavy and numb also finger tips got tingling. Started to get sharp chest pains near my heart then started to feel fatigue. Then my tongue started to get swollen/numb and I couldn't really talk. Went to urgent care and due to my condition they called the ambulance and went to hospital. They did an EKG/chest x-rays and blood work. Couple hours later they send me home with no diagnosis just to see primary doctor. Symptoms were mild for 2 days then again on 5/14 symptoms came back and went back to urgent care. They did an EKG/Covid test/ only and doctor just said it was a panic attack. I disagree I still don't feel completely right.
40 2021-05-18 anxiety After about 5 minutes of vaccine administration, patient complained of "feeling of passing out", swe... Read more
After about 5 minutes of vaccine administration, patient complained of "feeling of passing out", sweating hands and face, racing heart rate. Called 911. After EMT arrived, and checked patient for any issues. From EMT, patient had known history of "fear of needles" and had anxiety attack after the vaccine. After about 20 minutes, patient was stabled and got release by EMT.
40 2021-05-19 sleep disorder Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: ... Read more
Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Nausea-Severe, Systemic: Unable to Sleep-Severe, Additional Details: He was covered in red spots, terrible itching. Couldn't sleep or eat for 3-4 weeks. He has taken mostly steroids to treat. Finally cleared on about May 14th. He said the itching was intense, could not eat or sleep. Ready to jump out of his skin. Just wanted to call someone to let them know and document.
40 2021-05-21 thinking abnormal Shortly after I received the shot, I had minor soreness in the spot of the injection. This was the o... Read more
Shortly after I received the shot, I had minor soreness in the spot of the injection. This was the only symptom for about 12 hours. At the twelve hour mark, about, I almost immediately started shivering uncontrollably. I was very cold ad sweating. I wasnt able to think clearly. My wife said I had a fever. Also, I had a headache. This occurred for about 6 hours. I was still cold and sweating, with a headache, for about another 4 hours, but it wasn't as extreme. I was still unable to think well. I had a desire to drink gatorade, not water, at this time. This was unusual. I drank about 2L of gatorade. I began to not feel cold, and only had a minor fever. Not sure how correlated these are. Over the next 10hrs or so, I slowly improved and was able to carryon daily activities.
40 2021-05-26 loss of personal independence in daily activities 50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after... Read more
50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after vaccine 2nd dose (April 27, 2021).; Strong pressure in head; loss of ability to support body in RL; Slurred speech; Difficulty in breathing; Cognitive difficulties; Extreme headache; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL7533) via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number EL8727) in the Left arm on 29Mar2021 16:00 at the age of 40 years for covid-19 immunisation. No known allergies. No vaccines were received within 4 weeks prior to the COVID vaccine. Healthy and no prior adverse event history. The patient experienced transient ischemic attack 1 week after vaccine 2nd dose, strong pressure in head, loss of ability to support body in RL, slurred speech, difficulty breathing, cognitive difficulties, extreme headache on 27Apr2021 16:30; visited emergency department. 2nd incident 02May2021- 50% loss of vision, tingling on one side of body, slurred speech, cognitive difficulties, extreme headache. The adverse events resulted in emergency room and healthcare professional office visit. Patient was treated with headache medications. It was reported that patient was recovered from events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.
40 2021-05-28 confusional state, feeling abnormal, amnesia Walking to the observation room approximately 2 minutes post shot I felt extreme dizziness. Felt li... Read more
Walking to the observation room approximately 2 minutes post shot I felt extreme dizziness. Felt like I could potentially pass out so I waited 30 minutes in the observation room before leaving. After I was fairly confident I would not pass out I left the facility. When I made it outside it felt like the right side of my brain was "not there," like a portion of my brain was dead. While driving home approximately 45 minutes post shot I felt numbness and tingling on the right side of my face. Mental confusion also started. I don't recall the numbness and tingling in my face continuing at this time. Proceeded home, laid down on the couch to relax and about 3 hours post shot felt my heart racing. Checked heart rate with pulse oximeter and heart rate was 120 w/98 oxygen. 5 minutes later the heart rate went down to around 90 but blood oxygen went to 90. I sat up, drank water and pulse/oxygen returned to normal. The next day the mental confusion continued. Approx. 24 hours post shot tingling and numbness felt on right side of face. Couldn't move lips properly, communicate to my facial muscles. This lasted around an hour or two. 30 hrs post shot short term memory loss caused confusion when typing texts, following conversation, etc. Symptoms improved greatly over the next couple of days. Tiredness/general unwell feeling approximately 48hrs post shot but unremarkable. By the time I went to a GP 84hours post shot I felt 95%. Went to a neurologist 108hrs post shot who performed standard tests and all was well. 1 week post shot got into an argument and felt tingling and numbness on right side which lasted approximately 10 seconds.
40 2021-05-29 depression, anger From the patient I participated in phase 3 randomized, Double-Blind, placebo controlled Center stud... Read more
From the patient I participated in phase 3 randomized, Double-Blind, placebo controlled Center study for Clinical Research back in December of 2020 to determine the safety and efficacy of AstraZenecas, a combination of 2 of their monoclonal antibodies (AZD8895 and AZD1061) to preexposure prophylaxis in COVID-19 I was told to wait at 90 days before I got my vaccine and I think I should have waited much longer. Not long after I received the monoclonal antibody treatment I started to have really bad depression issues and anger problems that seemed to last up to around mid April of 2021. I also had my hepatitis viral load go from 180,000 to 580,000 in just a few months so a massive jump in hep c viral load. I reported all of this to them and they assured me that I was fine and the promised I?d be ok. I recently got the Pfizer vaccine with my second dose being on May the 7th 2021. My first dose on April the 16th was felt within minutes and I thought I was going to have to ask a staff worker with help getting out to the car. I was very sick for a day or so and it made me very frightened to get the second one. So much that I contacted The council about it. Everyone was extremely polite and very helpful. I got my second dose and it was not as bad to go through but now I have a constant fungal infection that I can not get rid of and if I eat sweets it gets really bad. My concern is not for anyone getting just the vaccine but for the people who have had the monoclonal antibodies and then getting the vaccine within 3 months. The second dose seemed to make me angry but it did not last as long. I?m worried about the effects other people may have had by combining the 2 or maybe not waiting longer before getting the actual vaccine. I don?t know but I can?t get rid of this fungus and I?m not sure else who to report it to. I?ve obviously shown it to my doctor. He gave me anti fungal creams but it turns out I have an allergy to fungal creams. I did let the drug trial site know what happened as well. I do not think it?s a Pfizer thing but a combination of it with the AstraZeneca monoclonal antibodies and the vaccine.
40 2021-06-06 disorientation Within about 5 minutes of patient of patient receiving the vaccine, he had a seizure in the lobby of... Read more
Within about 5 minutes of patient of patient receiving the vaccine, he had a seizure in the lobby of the pharmacy. The seizure was not witnessed by any employee, but by his companion and a customer. I immediately had a technician call 911 and ran out with our emergency kit when I heard the patient's companion screaming for help. When I got to the patient he was in a seated position in a chair in the lobby and was coming to. He was disoriented and looking around. I asked if he knew his name and what day it was, he did know. I asked if he knew where he was and he responded correctly. He said he felt week and hot, he appeared sweaty. I checked his blood pressure (100/58) and pulse (50 bpm). His temperature was 97.1. His companion stated he had never had a seizure before when asked. I gave him some water and sat with him until EMS arrived. He remained seated the entire time and said he felt week. A few minutes after EMS arrived, the patient left via stretcher by ambulance, but remained conscience.
40 2021-06-07 panic attack Vision loss, hearing loss, muscle control loss and fell over. Thought I was dying. Feel better now a... Read more
Vision loss, hearing loss, muscle control loss and fell over. Thought I was dying. Feel better now after breathing and trying to call myself down as it panicked me. Cuts and scrapes on hand and knee and elbow from falling. Scary as luckily I made it home driving ok.
40 2021-06-10 insomnia Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable co... Read more
Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable consumer. A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on 03May2021 (at the age of 40 years) and second dose of BNT162B2 on 26May2021, as a single dose for COVID-19 immunization. The patient medical history included Ventricular tachycardia and concomitant medications included Amiodarone used for Ventricular tachycardia on an unknown date. Reporter stated that he took the highest dose in that medicine, yes the highest, I do not know what the highest is that he is taking I know it is the highest since they said they cannot give him anything now". Reporter stated, "My son might be having a reaction to the Pfizer vaccine and he has a test in the morning, but he already been into the emergency room and all these and I need to ask or talk to somebody that can medically give me some advice before his test specifically we do not know he can actually have this test now. Reporter added, "Now do you need to know his side effects that he is having from the vaccine that came from the vaccine. Okay the side effects he is having started right after his first vaccine on 03May2021 he started getting the sleep apnea well not sleep apnea sorry about that he started getting insomnia and he cannot sleep and he ended up getting a cough so when he went back to his second vaccine his insomnia started getting worse, he is like he cannot sleep at all and when he does fall asleep its only for 2 hours and he gets so tried, his body start jerking and makes him wake up. Report-er stated, "They are worsening". The patient underwent laboratory test and procedures which included chest X-ray, Nuclear test on Friday and have not got results for that test. Outcome of events was reported as unknown. Reporter seriousness for Insomnia, Cough, his body start jerking was unspecified.
40 2021-06-15 loss of personal independence in daily activities, anxiety, fear 2 days post vaccination onset of acute arthritic symptoms symmetrically along body beginning in the ... Read more
2 days post vaccination onset of acute arthritic symptoms symmetrically along body beginning in the hips, and escalating to back, neck, shoulders, wrists, hands, and knees, in that order. Right side is now becoming more severe for pain and stiffness, but still roughly symmetrical. Symptoms are more severe upon waking and some mobility is restored by regular movement within an hour, but it is becoming harder and more painful each day. Was taking ex str. Tylenol at 500mg 8 x3 times a day for pain management, have since switched to aspirin 500mg 4-5 x2 times per day but that too is becoming less effective. Severe mobility impact, cannot get groceries, walk dog, open bags, jars, cans, and am starting to develop anxiety around the worsening symptoms. No health coverage. No primary care physician. Sporadicly I have days that the symptoms are almost completely non-existent, but these ?relief days? are never consecutive and the next day will always have the symptoms worsen again. I have always generally been in pretty good health, and I?ve never taken anything regularly, but this has me terrified.
40 2021-06-20 feeling abnormal Following the vaccination on 2/23/21, Pt had fever, chills, fatigue the first two days. On the third... Read more
Following the vaccination on 2/23/21, Pt had fever, chills, fatigue the first two days. On the third and fourth days, he added diarrhea and headache to those symptoms. He felt awful over the weekend and spoke to his doctor on Monday, 3/1. The doctor began him on steroids and ivermectin. Over the next 24 hours his breathing began to worsen. He entered the hospital on Tuesday, 3/2, for supplemental oxygen. Things continued to get worse. He was intubated and put on a ventilator on 3/6/21 and ultimately spent 13 days in a coma. He was extubated on 3/19/21 but then had seizures on 3/20/21 and had to be reintubated to secure his airway. Pt was taken back off the ventilator on 3/24/21. He suffered vocal cord paralysis and ultimately wound up with both a PEG tube and tracheotomy. He was discharged from the hospital after 43 days and then spent 10 days in an inpatient rehab center. He continues to deal with vocal cord issues, tracheal stenosis, nerve damage in his neck and shoulder, muscle atrophy, and damaged lungs.
40 2021-06-21 impaired work ability A day later general flu like symptoms had to take a day off from work and then the following day my ... Read more
A day later general flu like symptoms had to take a day off from work and then the following day my symptoms decreased but i still felt tired and headaches.
40 2021-06-22 sleep disorder Chest pain that was much more severe when sitting or sleeping. Sleep was disrupted nightly and I was... Read more
Chest pain that was much more severe when sitting or sleeping. Sleep was disrupted nightly and I was not able to sleep on my left side. The chest pain lasted about 6 weeks and occurred most severely 3-4 times per day. I visited my PCP and he said that he heard a loud murmur or wooshing sound. He checked for a fib but heart ECG was normal. We scheduled an echo but the echo was not performed until 2 months post onset of the symptoms. Symptoms seem to point to subacute pericarditis. Increase of Petechiae on the torso. One spontaneously bled. Seems to be fading after three months.
40 2021-06-24 confusional state Chest pains, left rib area won't stop hurting, a few days after shot felt like my abs were having a ... Read more
Chest pains, left rib area won't stop hurting, a few days after shot felt like my abs were having a charley horse. Back pain, nausea dizziness and confusion on a daily basis. Doctors have no idea what's wrong with me suggesting upset stomach, ulcer, heartburn, spinal issues., anxiety, depression. They are just guessing.
40 2021-06-24 disorientation 6/25/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation... Read more
6/25/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: loss of consciousness. Assessment : Time of assessment 0831am. Pallor, Clammy and disoriented. Actions taken: Vitals sign taken EMS called at 0831. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 856am. Patient refuses EMS transport. Water given 0835- BP- 67/44, P- 39, O2- 100 %, recheck- at 0839- BP- 105/66 , 0915- bp 012/82, P- 44, O2- 100% Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. EMS accessed patient, patient refuses transport. Wife with patient. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 6/25/2021 8:27 AM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8736 NDC: 59267-1000-2
40 2021-06-24 feeling abnormal, thinking abnormal Extremely High Fever, Chills, Urination burning, Nausea, Headache, Sore Throat, Extreme Fatigue, Men... Read more
Extremely High Fever, Chills, Urination burning, Nausea, Headache, Sore Throat, Extreme Fatigue, Mental fog and unusual thoughts.
40 2021-06-27 feeling abnormal Heart Palpitations, heart stopping, chest pain, chest irriation, heavy breathing
40 2021-06-29 feeling abnormal I got the vaccine shot on a Thursday, and woke up the next Friday morning feeling strong tingles on ... Read more
I got the vaccine shot on a Thursday, and woke up the next Friday morning feeling strong tingles on my face, weird sensations, & some swelling of lymph nodes had started. i thought i might be having a minor reaction, or it felt like i might. Saturday morning i woke up w' some bumps & inflammation w' a painful red sore on my nose bridge next to my right eye. i almost went to urgent care Saturday night but talked myself out of it, then Sunday woke up & had more inflammation & swelling, tenderness, & pain & discomfort. i went to my doctor on Monday as it felt intolerable & was getting worse, i told him about getting the vaccine, reporting it felt like my immune system was confused or something, he said there were some vaccine reactions, that it was possible for it to affect people differently, that it was rare, that he didn't know, but he said it looked like shingles was attacking me & referred me to the Eye Institute to see Dr, who tested me even as my eye was swelling shut. There was a danger it could get in the eye. Prescribed Acyclovir antiviral. My condition kept worsening but i kept taking the antivirals & eventually responded well to them. It hurt everywhere, & the pain was indescribable, at almost every level. It was excruciating. i was fighting off the attack by the 3rd week & could open my eye, but was still in a lot of pain, had to rest almost all the time, could barely eat & speak for weeks, or go outside in the sun for more than a couple minutes, because of the brightness etc. & was overall incapacitated for about 5 weeks. It was completely disabling. The doctors were very impressed w' how intense the condition was, & showed me to all the students at the Eye Institute. They were pleased w' how well i have been healing up. My immune system feels strong too. It was just brutal but i am recovering now, thankfully. i still feel prolonged effects though, w' even some pain at times during the day, or if i am active then i feel like i have to rest. i am just really thankful it doesn't hurt like that now. There is probably gonna be some permanent scarring because of the damage to my face from the nervous system inflammation, as my face is heavily scarred now because of the attack, i could maybeget plastic surgery for the scarring on the right side of my face.
40 2021-06-30 anxiety, impaired work ability Pt became severely sick with flu-like symptoms and could not work on April 20-22. He worked on Apri... Read more
Pt became severely sick with flu-like symptoms and could not work on April 20-22. He worked on April 23. He told people he was sick again on April 24. He was very anxious and committed suicide some time between April 27-28.
40 2021-06-30 depression Severe, acute depression that started a few days after the first dose and then mostly resolved befor... Read more
Severe, acute depression that started a few days after the first dose and then mostly resolved before the second dose. After the second dose, severe, acute depression occurred again, even more intense than that occurring after the first dose. This was the worst I've ever felt in my life mentally. No treatment. Resolved on its own after two to three weeks.
40 2021-07-01 insomnia insomnia started getting worse; he gets so tried; his body start 'jerking'; feels like he is suffoca... Read more
insomnia started getting worse; he gets so tried; his body start 'jerking'; feels like he is suffocating; it's like somebody is choking him/choking sensation/feels like somebody has his thumb in the middle of his adam's apple and his throat; light headed; This is a spontaneous report from a contactable consumer (patient's mother). A 40-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 26May2021 as the 2ND dose, single for COVID-19 immunization. Medical history included ongoing ventricular tachycardia. Concomitant medication included amiodarone (manufacturer unknown) taken for ventricular tachycardia, start and stop date were not reported, taking the highest dose (as reported). The patient previously received the first dose of bnt162b2 (lot number and expiry date unknown) on 03May2021 for COVID-19 immunization and right after the patient experienced insomnia and cough. When the patient went back to his second vaccine, his insomnia started getting worse. He can't sleep at all and when he does fall asleep it is only for 2 hours and he gets so tired, his body starts 'jerking' and it makes him wake up. Since the second vaccine, the patient said it's like somebody is choking him, he said it feels like he is suffocating and he said it feels like somebody has his thumb in the middle of his adam's apple and his throat and so they send him to the emergency room and they told him to go home and just take sleeping pills. However the reporter stated that the patient can't take the sleeping pills because of his ventricular tachycardia and the medicine that he is on. They were getting the patient setup for his test the following morning from the day of the report and when he woke the morning of the day of the report he experienced the choking sensation and all that kind of stuff but he is light headed and they don't know if he should be taken to that test the following morning but yes the test is really important because of his heart and they don't know if he can take the medication that they are going to give a 'nuclear' medication with having all these side effects like these if it is from the Pfizer vaccine so that was why the patient's mother was reaching out for somebody with medical knowledge about the vaccine and the side effects and if someone could tell them if the patient could continue with his test. They wanted to know how long the side effects will last and if the side effects need treatment. The patient had a lab test (unspecified) and a chest x-ray both on unspecified dates but they did not have the results at the time of the report. The outcome of the events was unknown. Information on lot number/batch number was requested.
40 2021-07-08 insomnia, feeling abnormal Increased yawn reflex to find air.; Chills immediately after/ cold body; Sweaty hands; Tight throat ... Read more
Increased yawn reflex to find air.; Chills immediately after/ cold body; Sweaty hands; Tight throat muscles; Sore upper left arm; Weird feeling in the body; Very slight difficulty breathing; Very slight difficulty articulating some words; Nausea; Difficulty sleeping; Loss of appetite; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK8727) via an unspecified route of administration in the left arm on 24Mar2021 at 16:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had known allergies to penicillin and amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) 20mg once a day for unknown indication and from an unknown date. On 24Mar2021 at 16:45, the patient experienced increased yawn reflex to find air, chills immediately after / cold body, sweaty hands, fatigue, tight throat muscles, sore upper left arm, weird feeling in the body, very slight difficulty breathing (but SPO2 ok at 98%), very slight difficulty articulating some words, nausea, difficulty sleeping and loss of appetite. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests which included oxygen saturation test on an unknown date and the result was SPO2 at 98%. The clinical outcome of events increased yawn reflex to find air, chills immediately after / cold body, sweaty hands, fatigue, tight throat muscles, sore upper left arm, weird feeling in the body, very slight difficulty breathing, very slight difficulty articulating some words, nausea, difficulty sleeping and loss of appetite was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-11 disturbance in attention Tinnitus - ringing in the ears. I was working from home that week while my family was out of town a... Read more
Tinnitus - ringing in the ears. I was working from home that week while my family was out of town and noticed the intensity of ringing ramp up over the course of the week. I received my shot on Monday afternoon and by the following Sunday morning, the intensity was so great that it was difficult to concentrate/comprehend what was said during a church service. I saw my ENT doctor the following week and got a hearing test, which picked up some slight hearing loss. Since then, intensity has fluctuated day to day and in different environments. The left ear is worse than the right ear. At the time of this report, I've experienced several days of consecutive ringing that has been about the most intense that I've experienced. I've been told there is no effective treatment for the condition, but I've utilized lipo-flavonoid with mixed results. Ringing seems to be less intense after nights where I've slept well, but that is increasingly challenging.
40 2021-07-11 loss of personal independence in daily activities, impaired work ability Following my second Pfizer dose on on 4/2/21 I began having a strong burning pain in my right forear... Read more
Following my second Pfizer dose on on 4/2/21 I began having a strong burning pain in my right forearm and wrist area. I perceived this initially to be carpal tunnel and it started on 4/5/21. I self treated with ibuprofen for a few days with no improvement, then saw my PCP on 4/9. My PCP thought this to be tenosynivitis, and prescribed Methylprednislone. The steroid treatment helped for the first few days but then the pain quickly spread to my right leg in the thigh area. Same type of pain, burning and intense. I was able to walk, but with a slight limp. I saw my PCP again on 4/15 to discuss the new symptoms. He began researching possible conditions and also ordered some blood tests for common auto-immune diseases (Uric Acid, C-Reactive Protein, CMP, ANA). Everything returned normal except for C-Reactive (value- 50+). To be sure it wasn?t a case of septic arthritis, I was placed on an antibiotic on 4/17 (Keflex) for 7 days. The Keflex did not help and actually gave me a slight fever (100.1) and I missed work on 4/19,20,21. I started to improve on 4/16 but the symptoms were still present. As a followup, my PCP ordered a more comprehensive blood panel to be reviewed at my next appointment on 4/30. The following blood tests were ordered: TSH 3rd Gen Blood, CBC, CMP (BAMP, TP ALB TBIL,ALK, AST, ALT), and LIPID Panel. On PCP appointment on 4/30, my symptoms continued to present in legs and right arm. All values from blood tests were normal. He ordered a lower back xray, which was scheduled for 5/11. At this point, my PCP referred me to a rheumetologist as he had exhausted his options. Unfortunately, the earliest rheumatology available was 5/18. On 5/18 appointment with rheumatology resulted in more tests: Parvovirus B19, Rheumatoid Factor, Serum Protein Electrophoresis, Urine PRotein/Creatinine Ratio, Immunoglobulin Assay-Blood, Immunofixation Procedure Blood, ASO- Blood, CPK Blood, Cyclic Citrullinated Peptide Antb, Hep B Surface AG, Hep C AB- Blood, Microalbumin urine random. All tests read as negative or normal except ASO. Rheumetologist referred me to Infectious Disease for further testing on 5/26, which resulted in the following blood tests: Ehrlichia Chaffeensis AB IGG, DNASE B Antibody, HLA Typing A B C Single - Blood, Legionnella -Blood, Prostate Specific Antigen, Unrinanalysis with Microscopic, Chlamydia and GC RNA AMP, Upper respiratory throat culture. He also ordered an ECG, a chest XRAY (PA and Lateral), CT scan of the pelvis. On 6/4 at a followup appointment, he ordered Crypto AG and C-Reactive Protein. At this point, CRP value was 180.74. I worked my last day of work on 5/14 as the pain became too intense to manage. As the week progressed, I slowly lost my ability to walk and care for myself. I could walk only 10-15 feet at a time, and doing so would cause a severe flare-up of pain in my legs. I was mostly bedridden for 2 weeks starting on 5/20 and was only getting up very minimally. I needed a wheelchair for transport to my appointments on 5/25, 5/26, 6/2, 6/3. By 6/4, I was barely able to walk to that appointment, but the office is very small so I was able to make a short distance. My rheumetologist, having reviewed all my normal test results ordered an EMG on my legs and right arm and also an MRI on my lumbar and cervical. EMG conducted on 6/24 and revealed some nerve damage and signs of neuropathy in my legs; and also carpal tunnel in the right wrist. MRI Lumbar (6/25) revealed some common lower back issues, but nothing affecting the nerves that may be the cause of my symptoms. MRI Cervical (7/12) completed but yet to be analyzed. As of today, July 12, I?m feeling much improved over how I felt in early June. I can walk a short distance of ? mile without needing a break. I have lost muscle tone and need to work on getting my strength back. My right arm has minimal pain but will flareup with heavy computer usage. However, for the past 2 weeks, my left arm (which has been symptom free since April) now has a similar burning pain that starts at the funnybone of the elbow and runs up to my wrist. The pain comes and goes but is sometimes very intense and can be debilitating. It is hard for me to open some doors with this hand or even hold a heavy cup of water. As a previously healthy person, and having done exhaustive testing, myself and my PCP believe I had a rare and negative reaction to the vaccine.
40 2021-07-15 hallucination, loss of personal independence in daily activities, disorientation, anxiety Patient came into pharmacy on 7/ 14/21 and described the following: Severe body pain in areas where ... Read more
Patient came into pharmacy on 7/ 14/21 and described the following: Severe body pain in areas where he has "recent" injuries (vasectomy, back issues). No control over bowel movements. Disoriented/ motor skills severely lacking; couldn't walk down steps or down the hallway. had to call for help to family to do normal tasks. mild hallucinations. mental anguish; things were true in his head but not true in reality; mental dysphoria. Thinking this was the end; was able to recognize it but also very concerning. 3:30 am saturday this started; not all gone yet (7/14). Tension headaches (not prior). Extremely cold, clammy, sweaty; had to change clothes based on the amount of sweat. Not drug user, not alcohol, active military, not 48 hrs prior till recent. no pre workout. no medications. ibuprofen later saturday morning. First vaccine he just had local pain at shot site, some pain to the older issue sites and tiredness but nothing more than 24 hours. No mental illness dx at this time; possible ptsd but never diagnosed, not something he suffers from on a daily basis.
40 2021-07-16 amnesia, hallucination I was hospitalized on 6/2/2021 due to viral Meningoencephalitis. Althought this was 6 weeks after 2... Read more
I was hospitalized on 6/2/2021 due to viral Meningoencephalitis. Althought this was 6 weeks after 2nd shot, was told I should still report it since it was caused by a virus that the hospital was unable to determine after negative tests for other viruses. Had high fever, which led to loss of consciousness and possible seizure. Experienced hallucinations and loss of self-awareness (forgot who I was). Taken to hospital, entered into ICU for 5 days. Spinal tap revealed viral infection. Throat culture revealed strep throat. Given antibiotics and IV fluids for several days. Restored self-awareness and fever disappeared after a few days. Intense headaches persisted for days. Was discharged from hospital on June 7, 2021 after 7 days. Experienced possible repeat seizure 5 days later in public, loss of sensation in legs, slurred speech. Was re-administered into different hospital on June 13, 2021. Spent ~5 days in that hospital, received EEG which showed brain damage on right temporal lobe. Received another spinal tap which showed infection was improving. Discharged on June 16, 2021.
40 2021-07-17 insomnia He experienced some leg shaking; Can not sleep; His legs started shaking and Friday it got worse; he... Read more
He experienced some leg shaking; Can not sleep; His legs started shaking and Friday it got worse; he went from 180 to, when he was at the doctor, they said 175; Nausea; After getting both doses he experienced Chills; Vomiting; Arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, NDC number, Expiry Date of Pfizer Covid-19 Vaccine: Unknown), via an unspecified route of administration on 15Jun2021 at 10:00 AM (vaccinated at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes and reported as patient has had since he was 22 he thinks. He went with his ex-wife on vacation and came back, so probably 22, Caller clarifies that he thinks he is a type 1 diabetic but he is not sure, he takes insulin. Ongoing smoker and reported as I smoke and occasionally drink on the weekend maybe but nothing crazy. He has been smoking since he was 17 he guesses. Ketoacidosis and reported as caller adds that he did have ketoacidosis last year and they did do everything, CAT scans and all the blood work and everything. This was this past year. Caller does not know additional information but states it was prior to receiving the vaccine. The patient doctor a year ago gave some heart medication because patient had high blood pressure. The time before he saw him, he said it was too low and stop taking it. Family medical history reported as nobody has diabetes in his family, and he is the first. His dad had cancer and passed away when he was 58. Concomitant medications included insulin human injection, isophane (NOVOLIN N) and insulin human (NOVOLIN R) both were taken since he was 23 years for diabetes from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown) on 25May2021 for Covid-19 immunization and he got sick, it made him throw up, experienced chills. The first dose appointment was at 9:30 am. The patient states he got the second shot last Wednesday. Then, he went to work on Thursday. Friday on 18Jun2021, his legs started shaking and Friday it got worse. Saturday it got worse. Sunday, they felt a little better. Monday, or actually yesterday, he went to the doctor and the doctor said he has to go see a neurologist because the doctor kept him there for 3 hours looking at his legs and feeling them. They were moving out of control. Caller added as, considering his job, he walks 20-30,000 steps a day and he has never had trouble with his legs but he was diabetic. Caller adds that right now he kind of walks, like his girlfriend and son explained it, like a gimp and when he walks his legs pop. The patient cannot sleep. He slept maybe 6 or 7 hours since last Friday 18Jun2021. On an unspecified date the patient went from 180 to, when he was at the doctor, they said 175. Caller confirms this was new since receiving the vaccine. He has been 180 my whole life. He has not been able to work in a couple of day because he cannot walk. He guesses the weight loss is because of the vaccines. But, he is diabetic too, and was in pretty good health before this. Caller adds he has to pay for doctor appointments, his doctor kept him there for close to 4 hours and he looked at his legs for 45 minutes. He did not understand what was going on, and he sees him all the time for his diabetes. The doctor said that he has to see a neurologist, but none of these symptoms happened in his life until he got the shot. The patient arm of course was a little sore like when you get a shot and it hurts. Caller went to work and was fine, went to work the next day and was fine. This past Friday, his legs started shaking and he does not know. He could not sleep, they would not stop moving. He can control them if he uses muscle and really tries to control them. caller adds this is not going on still, he just thinks the pharmacist who gave the shot gave it rough. Also, his job is to walk a lot and lift stuff so that could be contributing to that part. Legs shaking, The patient spoke as per attached document in terms of nausea and vomiting. Treatment; cannot not sleep: caller adds he has a pool and when he goes swimming it feels better. If he walks around too much, how can he explain it, it gest worse but he can control it. If he flexes his muscles he can stop it, like flexing his legs that is how he stops it. If he does not, they just shake. He cannot not sleep because they shake so much they wake him up. The patient was diabetic and uses insulin and the same medication he has taken for years. The patient has been fine. His doctor a year ago gave him some heart medication because he had high blood pressure. The time before he saw him he said it was too low and stop taking it. The patient walks a lot and exercises or swims and uses insulins. One was long and one was short acting. Investigations were none, the patient saw a doctor yesterday who was trying to get him into a neurologist. He thinks it has to do with his nerves. He is trying everything he can. Adverse events do not require a visit to emergency room, but the doctor said if he cannot get him in to a neurologist in the next day or two, that he wants him to go to the emergency room. Needs visit to physician office. The patient doctor did not know what to do and just referred him to a neurologist. Caller just wanted to report this because none of these symptoms occurred until the second shot, or, well, it was the first shot that made him throw up and the other things with the second shot. his doctor did not know what to do and just referred him to a neurologist. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. Adverse events following prior vaccinations was none, he has not had a vaccine since he was a kid or teenager he guesses. The patient underwent lab tests and procedures which included weight loss: went from 180 to 175 lbs on an unknown date and reported as He went from 180 pounds to 175 pounds. Outcome of the event cannot sleep and his legs started shaking and Friday it got worse were not resolved and event arm was a little sore was resolved on an unspecified date, and remaining events were unknown. Information about lot/batch number has been requested.
40 2021-07-19 insomnia, disorientation Blood pressure went up to 160; My heart rate went up to 130/Rapid heart rate; disorienting; unable t... Read more
Blood pressure went up to 160; My heart rate went up to 130/Rapid heart rate; disorienting; unable to eat; post-nasal drip 'dripping' into my lungs; Occasional shortness of breath; Dizzy; Unable to eat and actually zero desire to eat; Sweating/ sleep sweat; sleeping off and on; Was just physically ill/ malaise; Chills; Fever; Extremely tired/ general fatigue; I throw up the water I have been drinking all day; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 13Apr2021 at 08:00 (at the age of 40-years-old) as single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). The patient stated that it was just a standard rescue inhaler 100 mcg. The patient was vaccinated on 13Apr2021 at 08:00 and within 5 minutes his blood pressure went up to 160 and heart rate went up to 130, so they called paramedics over, who were already on site and did pulse check and blood pressure check until they knew what heart rate, blood pressure and oxygenated blood was. They did not allow him to leave for an hour because it was so highly elevated, he felt so dizzy and very disorienting. His friend dropped him home because he could not drive, there was no way he could drive. After an hour the blood pressure got back down to 140 and heart rate was still about 120, it was lower, so he went home and immediately lay down and rest the entire day. He was just physically ill and experienced chills, fever, sleep sweat, extremely tired, strangely no arm soreness at all. He got every other possible side effect and that lasted until 01:30 in the morning, after he throw up, he was finally able to get some sleep. He took rest the entire day, sleeping off and on, unable to eat and actually zero desire to eat, rapid heart rate, sweating, and occasional shortness of breath. He used the rescue inhaler as treatment, that was probably because he laid on his back for so long and also probably just post-nasal drip into lungs. At 01:30 in the morning, he throw up the water he had drank all day and felt a bit better. It was probably because he did not eat all day. He slept until noon and didn't went to work because he felt malaise, general fatigue, his arm didn't hurt. He didn't feel great on the day of reporting, but it was not like the previous day. He had to go to the emergency room, as his mom kept pushing him to go and he was like not going. He had not eaten anything on the day of reporting, so he was looking for something to (incomplete sentence). The patient took 1 gm of Tylenol (over the course of maybe 14 hours) on 13Apr2021 and was advised not to take Advil for whatever reason. The patient underwent blood volume the previous month which was normal and no STDs. He was negative for COVID. That's why he felt okay with vaccine and then before that he did a PCR test which was also negative. The patient have been in 11 countries in the previous year and might have undergone 20 PCR test. He was kind of scared taking the second shot. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-07-21 confusional state Heart Rate for no reason would jump up to 180-200 beats per minute, confusion, high blood pressure. ... Read more
Heart Rate for no reason would jump up to 180-200 beats per minute, confusion, high blood pressure. Called 911 because I thought I was having a heart attack. I did not go to the hospital during that event. I told them I had a cup of coffee with breakfast and that I had my vaccine two days prior and they said it was probably from that. I had 20 other events the following months sometimes at night, same symptoms. The worst was on 6/13/21 I was helping my friend move and my heart rate jumped up and blood pressure went up as well. I called my wife to pick me up and I could not communicate my location, I was standing under a street sign in a neighborhood I am familiar with. I though I was going to lose consciousness. I called 911 and decided to go to the hospital and see what was happening to me. I have had several EKG and came back clean. The doctor said for some reason I am having episodes of SVT and that I need to wear a holter monitor to figure out what is happening to me. After that day I removed any and all alcohol and caffeine from my diet. Beers on the weekend and I would have one to two cups of coffee a day from our coffee machine at home. 6 weeks later the monitor has been approved and I am wearing it now. I set up a doctor because I did not one and had an EKG and explained my sysptoms and he said he has seen this happen to a lot of men specifically and it usually takes several months and it "should" go away. I meet with a Cardiologist on July 29th. Since removing alcohol and caffeine the episodes decreased and went away within a week and I have not had any episodes for the past 4 weeks.
40 2021-07-21 disorientation, hallucination Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and una... Read more
Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and unable to speak or hear for several minutes. Transported to emergency room. Still have hearing issues and headache a week later.
40 2021-07-21 insomnia, thinking abnormal Have songs playing in my head; Unwanted thoughts; Sleeplessness; Swollen glands; This is a spontaneo... Read more
Have songs playing in my head; Unwanted thoughts; Sleeplessness; Swollen glands; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 at 22:30 (at the age of 40-year-old ) as a single dose for COVID-19 immunisation. Medical history included epilepsy. Concomitant medication included lamotrigine (LAMICTAL) taken from an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 10Mar2021 at 23:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 22:45, the patient experienced sleeplessness, unwanted thoughts, swollen glands and had songs playing in his head (thinking abnormal). The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event sleeplessness, unwanted thoughts, swollen glands and thinking abnormal were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
41 2021-01-10 depression Patient received first vaccine 12/29/2020. While in waiting period post-vaccination, he developed ti... Read more
Patient received first vaccine 12/29/2020. While in waiting period post-vaccination, he developed tinnitus and was hot, flushed, and diaphoretic. He felt very cold and "wobbly" after other symptoms subsided. He had sharp pains in the joints on the side of injection which continued through 1/1/21 later that day. He was tired and had a minor headache 12/29/2020-12/31/2020. Patient had a bout of severe depression and "not caring about anything" beginning 12/29/2020 and lasting about 16 hours. He has no history of depression. He awoke 1/1/2021 and the depression was gone. Patient states all these symptoms disappeared when his arm pain resolved. He developed a "strained" throat on 1/1/2021 which is the only symptom that has continued to the day of this report.
41 2021-01-10 feeling abnormal 1. Lethargy 2. Intense Migraine 3. Joint pain 4. Foggy Brain 5. Heavy Chest 6. Chills
41 2021-01-11 feeling abnormal Lethargic not hungry Headache Weak Cloudy head
41 2021-01-12 confusional state High Fever 101.6 F, lethargy, Confusion, Muscle/Joint aches and pains, headache, Tiredness, Chills a... Read more
High Fever 101.6 F, lethargy, Confusion, Muscle/Joint aches and pains, headache, Tiredness, Chills all started about 17 hours after the shot(vaccine) Fever finally broke after taking 1000mg Tylenol. About 40 hours after the vaccine I felt normal again with just a mild aches and pains in joints.
41 2021-01-12 insomnia, impaired work ability Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fal... Read more
Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fall off; Couldn't sleep; joint pain; had to miss work; fever reaching 104 degrees; chills; muscle ache; headache; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). This 41-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on at arm left 05Jan2021 at single dose (lot number: EK9231) for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received flu vaccine and felt a little tired and sore with Flu vaccine. The patient got his first dose and then worked all day on 05Jan2021. Around 18:00-19:00 on 05Jan2021, he had fever, chills, muscle aches, headaches, joint pain, tiredness, and weakness. Fever was up to 104. The patient was referring to the Pfizer COVID-19 Vaccine first felt short of breath on 05Jan2021. He was wearing a mask and felt like he couldn't breathe. He did not feel really ok on 05Jan2021 like with a flu shot. He was working and felt a little itchy. He came home around 18:00-19:00 and had chills, headache, muscle soreness like arms would fall off. He couldn't sleep. He had fever and chills through the night. He had fever up to 104 on 05Jan2021 and had to miss work. The patient stated his nose was stuffy on an unspecified date. No additional vaccines administered on same date of pfizer suspect. No prior vaccinations within 4 weeks. Outcome of all events was unknown.
41 2021-01-12 nightmare, hallucination Sweating, Chills, Extreme Body Aches, Wheezing(never in life before), Dryness of Mouth, 99.8 Fever b... Read more
Sweating, Chills, Extreme Body Aches, Wheezing(never in life before), Dryness of Mouth, 99.8 Fever but fealth much worse, Heart burn, felt like my inside of body was swelled up, slight Gas, Hallusinations, Nightmare, Extreme Back pain not able to stay still, but I had slight back pain before this was 1000 times worse. I thought its coming to an end. This is exactly what happened to me when I had peak of COVID except the wheezing, I though I had COVID all over again. I took Vitamin C, Vitamin D, Zinx, Tums, Ibuprofen and fell asleep around 2 AM. I woke up at 7 AM in a pool of sweat had to remove the blankets to washer. I had no fever and nothing else it seemed like a switch is turned off and everything went away. Injection site was hurting allot during this time, but when I woke up nothing even injection site was not hurting either. It was a horrible night but seemed that nothing happened in AM.
41 2021-01-13 feeling abnormal 99 degrees; felt really bad/feels like a 3 or 4 out of 10; muscle aches and pains; tired and fatigue... Read more
99 degrees; felt really bad/feels like a 3 or 4 out of 10; muscle aches and pains; tired and fatigue; felt like he was going to throw up; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PFI302), via an unspecified route of administration in left arm on 05Jan2021 11:00 at single dose for ''front line worker''. Medical history included Crohn's disease from 2012. Concomitant medications included adalimumab (HUMIRA, injection, Lot: R22-03-A-01, Expiry: Feb2021) from Feb2019 and ongoing at 40 ml twice monthly for Crohn's disease (When providing weight he adds that he has had some weight gain due to medication side effects with Humira), ibuprofen (He took Ibuprofen on Tuesday night and 1 last night. He has not taken any today). Caller received the Pfizer covid-19 vaccine two days ago (05Jan2021). He has mild side effects to report. He is a Clinic Social Worker. Following the vaccine he experienced muscle aches and pains on 05Jan2021. He was tired and fatigued on 05Jan2021. His temperature was 97.5 yesterday (06Jan2021). It now 99 degrees (07Jan2021). His temperature went up 1.5 degrees. He felt like he was going to throw up in Jan2021. He received the vaccine at 11:00 am. At 05Jan2021 4:00 pm he felt really bad. He feels like a 3 or 4 out of 10. He is scheduled to get his second dose on 26Jan2021. The outcome of the events muscle aches and pains and tired and fatigue was recovering. The outcome of other events was unknown.
41 2021-01-15 impaired work ability The day after had myalgias and fatigue and arm pain. But on 1/10/21 began developing mild 2/10 head... Read more
The day after had myalgias and fatigue and arm pain. But on 1/10/21 began developing mild 2/10 headaches. On 1/11/21 the headache worsened to 4/10 and was associated with myalgias and neck stiffness. After a jog, I was in the shower and noticed a rash all over my body that had been pruritic. I went to the ER that night where I tested negative for flu A/B and also tested negative for covid (Antigen then PCR). Got a CMP, CBC, and coags to rule out ITP. everything was normal. The symptoms were so bad I stayed home from work on 1/12/21. Over the next few days the rash improved and the headache slowly went away
41 2021-01-19 insomnia Chills, stiff joints, insomnia, excessive sweating while sleeping, pain to injection site
41 2021-01-20 insomnia After 1st Pfizer shot I experienced the worst headache of my life 4-6 hours after the shot with loca... Read more
After 1st Pfizer shot I experienced the worst headache of my life 4-6 hours after the shot with localized pulsation in my right temporal region prior to the headache. The headache persisted through the night and I could not sleep and did not decrease with over the counter medication, my pain was rated 9/10 to 10/10 in the same area the pulsation happened. This headache continued for 4-6 hours at a severe level than for another 6-8 hours at a moderate to severe level. I ended up checking in at the Emergency department that I worked at after my shift and got labs and CT scan, this was after my symptoms resolved. I thought that I might have had a head bleed and wish I would have gotten my CT earlier when experiencing the symptoms. I was not provided a vaccine disclosure sheet or any information on what to do if experience severe symptoms or what symptoms to expect. I am upset that I was not provided guidance about what to expect and how to manage post vaccine symptoms, I would have gone into ED sooner with this information and feel I may have missed possible diagnosis due to lack of disclosure and guidance.
41 2021-01-25 impaired work ability About 4 hours after receiving the vaccine, began with headache and nausea/upset stomach. Symptoms pr... Read more
About 4 hours after receiving the vaccine, began with headache and nausea/upset stomach. Symptoms progressively worsened to create low grade temperature body / joint achiness. Notable extreme fatigue. Prevented from going to work.
41 2021-01-26 loss of personal independence in daily activities Feeling weak; Muscle pain; Chills; Not been able to work for last 3-4 days; Please specify other loc... Read more
Feeling weak; Muscle pain; Chills; Not been able to work for last 3-4 days; Please specify other location: Right shoulder; Shortness of breath; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231, Expiry Date: 30Apr2021) via an unspecified route of administration in right shoulder on 30Dec2020 20:30 at single dose for COVID-19 immunisation. The medical history was not reported. There were no concomitant medications. The patient previously took influenza vaccine on 2020 for immunization 2-3 months before this BNT162B2 vaccine, previously took flu shot in the past for immunization and got sick from it. That was about 3 years ago (2018). The patient went and got the Pfizer BioNTech about 2 weeks ago. Wants to know if side effects can start then after the vaccine. He has had chills, muscle pain, shortness of breath, and dizziness. Got this at hospital and has not been able to go to work on Jan2021 that last 3-4 days due to feeling weak. Received the vaccine on 30Dec2020 and the dizziness and shortness of breath kind of started days after that on Dec2020. The chills started a couple of days ago, about 3 days ago (Jan2021) and has been off and on. The muscle pains started today (13Jan2021). Just got a text message about getting the second dose next Wednesday. He did not get any other vaccines that day or 4 weeks prior. He got the shot to protect himself from the virus, but feels like he has the virus or something. The events did not require a visit to emergency room, but may go to be seen tomorrow. Events outcome of chills, muscle pain, shortness of breath, dizziness, and not been able to go to work that last 3-4 days due to feeling weak was not recovered.
41 2021-02-07 restlessness Roughly 12 hours after receiving the second dose of the vaccination, I began to be restless, especia... Read more
Roughly 12 hours after receiving the second dose of the vaccination, I began to be restless, especially when trying to sleep. I noticed that my resting heart rate was way above normal (normal = 76-80 bpm). My heart rate after about 10pm rose to about 115-120 bpm and stayed at that level for about 12 hours.
41 2021-02-09 impaired work ability low grade fever, chills, muscle aches in shoulders/neck, headache, light headed. Symptoms started b... Read more
low grade fever, chills, muscle aches in shoulders/neck, headache, light headed. Symptoms started becoming persistent during commute to work beginning at approximately 0630. Symptoms were significant enough to hinder productive work by 1100, went home early. Napped from 1200-1500. Symptoms subsided by 1800.
41 2021-02-10 sleep disorder, feeling abnormal Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was ve... Read more
Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was very hot similar to being in a sauna. Removing for changing the blanket to a thinner one resulted in extreme chills within one minute. Covering with blanket resulted in extreme hot within 10 minutes. Repeated this cycle for several hours until fall asleep. High discomfort throughout body. Woke up at 10:00 a.m. with mild grade fever of 99.5° (average resting temperature is 96.5). Felt extreme cold and chills shivering body aches headache until 6:00 p.m. felt hungry and okay enough to eat. Main concern is the extreme hot to extreme cold cycle in early morning. It felt as though the body was not in sync. During fever throughout day/afternoon body's reaction was normal - fever meant chills and shivering, putting on a blanket meant comfortable warmth (after long periods of time). But in early morning no no fever yet body burning hot almost suffocating sauna heat insider body, and removing the blanket a immediate and severe chills with uncontrollable shaking, instead of relief from heat... Concerned if vaccine affects body's heart regulation system (hypothalamus, thyroid, etc). General malaise during this period is an understatement... It was not a single spot or feeling pain it was the whole body wanting to twist itself and feeling 'deprssed' and very 'ill' all over all at once.
41 2021-02-14 feeling abnormal, insomnia Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep;... Read more
Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep; Ringing in the ears; Nausea; Flu like symptoms; Bad sore arm; Muscle aches; Joint pain; This is a spontaneous report from a contactable consumer (mother of the patient). The same consumer reported information for 3 patients. This is the first of 3 reports. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunisation at the age of 41-year-old. Medical history and concomitant medications were unknown. On 25Jan2021, the patient experienced Flu like symptoms, He had a bad sore arm, barely able to move his arm, Nausea, Muscle ache, Joint pain; no fever. On unknown date, the patient experienced not feeling well/ feels horrible, chills, body ache. Patient stayed home from work one day. On 27Jan2021, the patient felt a little better, but he still would have the symptoms. On 28Jan2021, the patient had ringing in the ears, he has muscle aches, he could not sleep. Patient reportedly as very well young man and he has no medical problems. The patient was recovering from the events. Information about lot/batch number has been requested.
41 2021-02-21 confusional state, feeling abnormal Patients spouse reports he started to feel "funny" 5 mins post vaccination administration. Patients ... Read more
Patients spouse reports he started to feel "funny" 5 mins post vaccination administration. Patients spouse called for assist when he he became unconscious at 7:25pm. He was found unconscious and failed to respond to a sternal rub. EMS called. Initial assessment: HR-weak pulse-not palpable, agonal, shallow breathing, and unresponsive. VS- BP 160/100 HR- 100 Wife used smelling salt to arouse the patient. He was confused after regaining consciousness. 7:37pm- EMS arrived and assumed care, transferring patient to a higher level of care.
41 2021-02-23 insomnia, feeling abnormal, sleep disorder Dose 2 of Covid vaccine given 2/18/2021, on 2/19/2021 felt bad, stayed in bed all day and that eveni... Read more
Dose 2 of Covid vaccine given 2/18/2021, on 2/19/2021 felt bad, stayed in bed all day and that evening had a sharp pain in chest. chest pain continued intermittent next day and then 2/22/2021 0200 it was a sharp crudhing pain that radiate down his L arm, same arm had the vaccine in, awoke him from sleep
41 2021-02-24 irritability, confusional state 95.4 body temp, grogginess, confusion, fatigue, headaches, confusion, irritation, lack of appetite, ... Read more
95.4 body temp, grogginess, confusion, fatigue, headaches, confusion, irritation, lack of appetite, lethargic
41 2021-03-03 feeling abnormal, insomnia cough; runny nose; fuzzy headed/scatter brained; not sleeping good; This is a spontaneous report fro... Read more
cough; runny nose; fuzzy headed/scatter brained; not sleeping good; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: WEN5318), via an unspecified route of administration on left arm on 28Jan2021 (at the age of 41years) at single dose for covid-19 immunization. Medical history included scratchy throat the day before the vaccine (27Jan2021). The patient had no concomitant medications and no investigation assessment. The patient got first dose of vaccine 28Jan2021 and was debating whether to get Covid test because of symptoms. The patient had a cough and runny nose on 29Jan2021 and fuzzy headed, scatter brained and not sleeping good in 2021. The patient considered the events as non-serious. Asked if these symptoms were from the vaccine and if getting the vaccine cause a false positive on the Covid test. Stated Friday had cough and runny nose. He stated that it felt like he had a pretty bad head cold and would not think about getting tested but since Covid was around. Wanted to know if these were common side effects of the vaccine or if he needed to get tested. The patient just moved houses and it was a stressful process. Sometimes when one gets stressed that one gets sick and may have contributed to his condition. Later clarified that this was for the Pfizer Covid 19 vaccine. The patient stated that the cough and runny nose worsened over the weekend and was a little better now and took alpha lipoic acid;minerals nos;quercetrin;vitamins nos (EMERGEN-C). The outcome of the events cough and rhinorrhea was recovering while unknown for the remaining events.
41 2021-03-15 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: LEFT ARM TREMERS-Mil... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: LEFT ARM TREMERS-Mild, Systemic: Nausea-Mild
41 2021-03-17 confusional state Second Pfizer COVID vaccine given 2/12/2021. Developed symptoms one day after 2nd Pfizer vaccination... Read more
Second Pfizer COVID vaccine given 2/12/2021. Developed symptoms one day after 2nd Pfizer vaccination with headache, body aches, chills, followed by abdominal pain, vomiting and diarrhea over the next 3 days, then became confused per wife so he came to ED for evaluation on 3/16/2021 and evaluated by me. Also had black stools and vomiting blood. Diagnoses: Septic shock, Gastrointestinal Bleeding with severe blood loss, Hepatitis with Hepatic Encephalopathy, Liver cirrhosis. Admitted to hospital 2/16/2021-discharged 2/21/2021. Since symptoms developed day after vaccination, I am compelled to report.
41 2021-03-19 sleep disorder Muscle stiffness in Right arm (opposite of injection arm), neck stiffness (can not look up), could n... Read more
Muscle stiffness in Right arm (opposite of injection arm), neck stiffness (can not look up), could not sleep. This has been happening and slowly getting worse over the past 18 hours.
41 2021-03-22 insomnia Headache, nausea, fever, chills, soreness in right arm, and insomnia. No treatment provided. Symptom... Read more
Headache, nausea, fever, chills, soreness in right arm, and insomnia. No treatment provided. Symptoms ongoing as of 9:45am 03/23/2021
41 2021-03-23 insomnia woke up warm/sweaty; mild general body aches/stiffness; Mild arm soreness; trouble sleeping; This is... Read more
woke up warm/sweaty; mild general body aches/stiffness; Mild arm soreness; trouble sleeping; This is a spontaneous report from a contactable healthcare professional (patient). This 41-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route on 18Feb2021 at 09:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included psoriasis for which he received guselkumab (TREMFYA) injections every 2 months. The patient had not received any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient did not receive any concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient previously received dose 1 of BNT162B2 on 27Jan2021 at 01:30 as a single dose in the right arm for COVID-19. On 19Feb2021 at 00:00 after dose 2 of BNT162B2 the patient experienced mild arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of mid arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness were recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
41 2021-03-24 anxiety felt heart was racing, comes and goes. clammy hands, anxious. HR 92 BP 136/82
41 2021-03-24 suicidal thoughts, depression suicidal thoughts; Site pain; chills; body aches; tinnitus; depression; This is a spontaneous report... Read more
suicidal thoughts; Site pain; chills; body aches; tinnitus; depression; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old (reported as 42-years-old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the right arm, on 05Mar2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included pericarditis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included emtricitabine, tenofovir disoproxil fumarate (TRUVADA), omeprazole (PRILOSEC), cetirizine hydrochloride (ZYRTEC), and fluticasone propionate (FLONASE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced suicidal thoughts, site pain, chills, body aches, tinnitus, and depression on 06Mar2021 at 04:00. The patient underwent lab tests and procedures which included nasal swab: negative on 01Jul2020. The clinical outcome of suicidal thoughts, site pain, chills, body aches, tinnitus, and depression was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
41 2021-03-29 feeling abnormal I felt fine at first for the 15 minutes they held me for observation. But as I walked out to my car ... Read more
I felt fine at first for the 15 minutes they held me for observation. But as I walked out to my car I quickly got heavy and tired and started to ache and have a headache. I had to rest in my car for a while before driving home. Once home I crashed immediately for around 4 hours in the middle of the day which is not like me. I had an important dinner meeting i had to attend for my livelihood. I thought I was feeling better but half way through Dinner I started feeling bad again. Got to the point that I stopped eating and excused myself to get home and rest. Symptoms progressed rapidly. Unfortunately I was pulled over for a minor traffic stop and tried to explain that I was having a bad reaction to the vaccine and needed to get home. They wouldn?t believe me and torturously treated me like an OVI. I?m hoping that I can get some kind of documentation and or assistance. I have court on the 1st and it will be devastating if I am convicted. I was not intoxicated and was not warned about the dangers of driving after the vaccine. Please call me. I need help
41 2021-04-01 impaired work ability 3/30-Adverse events experienced and are they still occurring now: Caller c/o fatigue & generalized ... Read more
3/30-Adverse events experienced and are they still occurring now: Caller c/o fatigue & generalized "feeling sick" since receiving 2nd vaccine on 3/25/2021. C/o shortness of breath beginning on Sunday 3/28/2021, called out of work yesterday and today, stayed in bed both days due to "feeling exhausted", no distress while on phone. Reports taking tylenol/ibuprofen as needed as well as using rescue inhaler for asthma as needed. Advised to follow up with PCP or Urgent Care due to SOB and asthma history. 4/1-Follow up call by Patient feeling better than yesterday, no longer feeling shortness of breath. Recommended to follow up with physician if symptoms worsen.
41 2021-04-01 sleep disorder Within 5 mins of the shot, I got dizzy but I sat down and that feeling went over. After dinner the s... Read more
Within 5 mins of the shot, I got dizzy but I sat down and that feeling went over. After dinner the same day, I had vertigo and had to vomit. Since then there has been nausea and headache, and I have trouble sleeping in. I feel some more discomfort after eating food. I have intermittent fever also. It has been about 10 days today since I got my COVID Pfizer shot and I still don't feel physically well. I just wanted to report this, as the impression from documentation I read is that symptoms should go away in 3-4 days.
41 2021-04-07 feeling abnormal started to sweat and felt "not right" post injection a few minutes, states has happened several time... Read more
started to sweat and felt "not right" post injection a few minutes, states has happened several times in past when getting injections. staff assisted to floor and states did lose consciousness for a moment. felt better once in obs, 1517 bp 119/68 hr 83 rr 20 sats 98% on ra. 1530 bp 138/72 hr 67 rr 17 sats 98% on ra. states s/s resolved, stood up with no issues, escorted to personal vehicle with no issues.
41 2021-04-07 irritability, disturbance in attention Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of fee... Read more
Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of feeling in tips of fingers / thumb Tinnitus Lower back pain Lack of focus / irritable Overall random shots of pain through body Diarrhea legs and feet turned purple Constant frontal headache Lack of appetite/ nausea Some foods taste metallic
41 2021-04-09 anxiety Patient reported feeling clammy, lightheaded, short of breath, anxious, and nauseated after vaccinat... Read more
Patient reported feeling clammy, lightheaded, short of breath, anxious, and nauseated after vaccination Patient seen by medical team and vitals improved after patient drank Gatorade Patient reported not having anything to eat in the morning Patient has history of anxiety Patient refused medical transport and signed medical form, patient stated symptoms improved Patient will have a family member pick him and his daughter up to drive home
41 2021-04-15 panic attack Panic attack, resolved with time.
41 2021-04-16 anxiety 4/17/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation... Read more
4/17/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: dizziness. Assessment : Time of assessment 0903am. Alert and oriented, Anxious and dizziness. Actions taken: Vitals sign taken VAERS form obtained and completed by juice and water given. by RN 0903am- BP_ 140/87, P- 78, O2- 98%, 0910 , - BP- 143/94, P- 78, O2- 99% Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/17/2021 8:36 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8730
41 2021-04-17 feeling drunk, feeling abnormal Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic v... Read more
Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic violation." He was told "to get out of the car and had a field sobriety test, and I looked intoxicated."; Felt heavy and tired/Run down; Had a headache; Upset stomach; sleep for a few minutes, I didn't pass out but it was similar/crashed for 4-5 hours in the middle of the day which I never do; aching; Over all weakness; Started feeling sick again at dinner; Woke up feeling really bad; Bad diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergic to sulfa, PCN and amoxicillin. The patients concomitant medications were not reported. On an unspecified date the patient experienced sleep for a few minutes, I didnt pass out but it was similar, was pulled over for minor traffic violation. He was told to get out of the car and had a field sobriety test, and I looked intoxicated, felt heavy and tired/run down, had a headache, bad diarrhea, upset stomach, sleep for a few minutes, I didnt pass out but it was similar, crashed for 4 to 5 hours in the middle of the day which I never do, aching, overall weakness, started feeling sick again at dinner, he went to the bathroom a few times, woke up feeling really bad. The patient was worried because everything was coming to a head right now. The caller got the first shot, he waited for 15 minutes and felt fine. As the caller walked to his car he began feeling heavy, had severe diarrhea, headache, aching, it was almost like he passed out, it felt like he went to sleep. The patient got home and crashed 4 to 5 hours in the middle of the day and woke up feeling really bad. The patient went to a very important dinner meeting that night. While the patient was at the meeting he went to the bathroom a few times and then excused himself because he felt so bad. The patient did not even finish one cocktail with dinner. The caller got pulled over for a minor traffic stop, cutting the corner and crossing the line or something small. The officers believed the caller was driving under the influence and started making him do a sobriety test with 40 degree wind gusts, the patient was miserable. The caller told the officers that he needed to seek medical attention but they ignored him. The officers forced the caller to do the urine test. It has been 5 days since his vaccination and he is just now feeling better. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
41 2021-04-18 anxiety Metal taste in mouth within 30 minutes of injection., similar to injection 1. I otherwise felt fin... Read more
Metal taste in mouth within 30 minutes of injection., similar to injection 1. I otherwise felt fine and had a normal day of moderate physical activity. I awoke in the middle of the night with chills and body aches and a strong feeling of anxiety. I was able to fall back asleep and woke up as normal a few hours later. I had a very strong head ache centered behind my sinuses, body aches in my pelvis and legs, and hot flashes mixed with chills. Aches were manageable with Tylenol. As the day progressed those continued and I was very fatigued. I went to bed earlier than normal and after a full night's sleep symptoms subsided.
41 2021-04-18 sleep disorder Ankle pain started and got continually worse throughout the day Friday with no acute injury. Could n... Read more
Ankle pain started and got continually worse throughout the day Friday with no acute injury. Could not sleep due to intensity of pain and went to Urgent Care Saturday morning. Prescribed diclofenac potassium and told to go to orthopedic doctor in 3-4 weeks if not improved. X-rays taken and negative for bone breaks. Constant and severe pain has continued.
41 2021-04-20 feeling abnormal lost hearing in right ear; everything sounds muffled; constant buzzing; felt foggy, like brain fog; ... Read more
lost hearing in right ear; everything sounds muffled; constant buzzing; felt foggy, like brain fog; tired, really tired; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 41-years, at single dose in left upper arm on 16Mar2021 at 12:00 (Lot Number: EP6955) for covid-19 immunisation. The patient medical history was none. Weight was 99.79 kg and Height was 191 cm. There were no concomitant medications. The patient previously received tetanus vaccine for immunisation when he was a kid. The patient reported that he had his first shot and was scheduled to take second shot today (on 06Apr2021). He stated that two days after the first shot, on 18Mar2021, he didn't have any arm pain, nausea, vomiting, or headaches. He lost hearing out of right ear. He already went to the physician about it. He was scheduled to go to Ear Nose and Throat doctor on 12Apr2021. He stated they checked his ear and everything. The hearing loss was not related to any kind of ear wax or anything. He went to urgent care, so they were limited to what they can do, and he was referred out to Ear Nose and Throat. He said everything sounded muffled and liked a constant buzzing in that ear. He had never had this problem. That doctor was going to check his ears and would do a hearing test on 12Apr2021. He confirmed that the hearing loss started on 18Mar2021. He also confirmed that the hearing loss was still ongoing and it was about the same, or persisting. The patient also reported that after the first one he didn't have the side effects that they claim to have. He hadn't died from it. He was just tired really tired, two to three hours after the shot, he got the shot at 12 noon, so about 2 to 3 o'clock. He laid down to rest and went to sleep. He woke up the next morning, went to work and was fine. He stated that other than that no headache, no arm pain, no diarrhea, no vomiting. He just felt foggy like brain fog the following morning after the vaccine till about mid-day and it went away. It only lasted four or five hours. He confirmed that was on 17Mar2021, as well as, that he had recovered completely. The patient received treatment and included that prescription medication for ear: Ofloxacin 0.3%. Instill five drops in the right ear two times a day for seven days. There was no additional vaccine administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event outcome for Hearing loss, Muffled hearing in both ears and Ear buzzing was not recovered, while for Tiredness and Foggy feeling in head was recovered on 17Mar2021.
41 2021-04-22 feeling abnormal Day 1 after vaccination: Fever, chills, aches, headache, nausea; all day Day 2 after vaccination: No... Read more
Day 1 after vaccination: Fever, chills, aches, headache, nausea; all day Day 2 after vaccination: None Day 3 after vaccination: Woke up in the middle of the night with dizziness, or head "swimming" sensation, and body aches. Managed to get back to sleep after about an hour, but woke up at normal time still feeling a "swimming" sensation in the head where it's not dizzy, but similar, and still minor body aches. Submitting this report while I'm still in Day 3
41 2021-04-24 confusional state collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneou... Read more
collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneous report from a contactable physician. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration on 04Apr2021 at a single dose for covid-19 immunization. Medical history included G72.3 periodic paralysis. Concomitant medication included diclofenamide (KEVEYIS) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The physician stated that the patient received the Pfizer vaccine on Sunday 04Apr2021. The patient collapsed about an hour and half later and, has felt very weak and was experiencing muscle pain since then - all experienced on 04Apr2021. The patient has also been experiencing weakness, confusion, fatigue, and shortness of breath all since Sunday 04Apr2021. The physician reported that there were two different kinds of potassium in the vaccine which he felt was contributing to this. It was informed that the patient has been currently resting and will follow-up if his symptoms don't improve. The outcome of the adverse events was unknown. It was unknown if treatment was received for the adverse events. It was unknown if the patient was tested for covid post-vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-04-24 feeling abnormal Ive been diagnosed with ADEM by findings from a MRI inflammation of cervical spine and brain , symp... Read more
Ive been diagnosed with ADEM by findings from a MRI inflammation of cervical spine and brain , symptoms began around a week after 2nd shot and got worse for about a month , pain in neck ,tingling though body , headaches, sunburn feeling in torso , fatigue , bilateral numbness in hands, loss of bladder pressure, erectile dysfunction
41 2021-04-26 feeling abnormal Shortness of breath, chest pain that feels like a heart attack, rapid heart rate, headache, muscle f... Read more
Shortness of breath, chest pain that feels like a heart attack, rapid heart rate, headache, muscle fatigue and extreme tiredness
41 2021-04-27 sleep disorder, euphoric mood, panic attack, feeling abnormal, impaired work ability 3/26 @ 3:15pm ? Got the first dose of Pfizer COVID-19 vaccine for the 1:10pm appointment. However ac... Read more
3/26 @ 3:15pm ? Got the first dose of Pfizer COVID-19 vaccine for the 1:10pm appointment. However actual time received was around 3:15pm. No vaccine reaction was observed and drove back home. However did not eat or drink much from morning till 4:30pm due to the long line at the vaccination center 4/4 @ 9:00pm ? Experienced first sign of near-syncope at the dinner table upon picking up a glass of milk 4/6 @ 8:45am ? Experienced brain fog, to be exact head felt like it was filled with cotton candy, at the back and top of the head. Felt this way the entire day. Went to work as usual. Logged out at around 5:30pm 4/7 @ 9:00am ? dizziness started getting worse. Started feeling imbalance and started losing depth perception which climbing down staircase 4/8 @ 10:00am ? started to get easily startled by any unexpected trigger. Whole body would ?twitch? or ?startle? upon slightest unexpected event. For e.g., sound, touch, taste (hot/cold) 4/10 @ 12:00pm ? Went to ER. ER ordered series of book tests, EKG, chest x-ray. Everything came out normal. ER doctor said to wait it out and after a week symptom may go away. ER doctor felt body?s immune response was over-working due to the vaccine immune response and possibly pollen allergy I may have experienced right after getting the vaccine. No prescription meds give. Advised to take Meclizine 25mg and Zyrtec. Below are the symptoms experienced on 4/10: ? Lightheadedness/Sudden Jerking body movements when triggered/passing out momentarily for a second when taking strain/not in my elements ? Feeling extremely fatigued. Did not sleep well at night on 4/8 and 4/9 ? Head feels Intoxicated, foggy, lightheaded, as if stuffed with cotton candy. Startled when unexpected things happen like a sudden jerking movement along with momentary passing out while anything unexpected happens. E.g., when I am pushing myself on the sofa to re-position, I feel my whole body is turning off for a second. Simply does not feel normal ? Rubbery legs ? Worsens after shower. I feel like I need to lay down as the foggy feeling worsens after shower ? Lightheadedness. Losing control sometimes. ? I am easily startled when climbing down the stairs - no Depth perception. ? Don?t have the strength to blow nose or cough. Feels like momentary fainting when doing these activities ? Dis-equilibrium. Whole body is twitching when something unexpected happens to my senses. ? Unable to control while laughing feels like momentary faint. I have felt like this when I was down with a fever. Tickled easily ? Difficulty pulling myself out of bed. Felt like muscle was giving away ? Tingling feeling in the right abdomen area ? Difficulty staying alert or focused and random rather unpleasant thoughts constantly coming to mind. Felt a bit of panic attack. 4/11 ? Went to PCP. Body weakness and fatigue got worse. PCP did blood sugar test and flushed out the left ear. Ordered Brain MRI to see if structurally anything was wrong. Brain MRI came out OK as well however noticed minor sinusitis. Prescribed Amoxicillin antibiotics and nasal spray. Referred me to Neurologist and Head and Neck Specialist. 4/11 ? 4/15 - Above symptoms progressively got worse. Especially weakness in the arms and shoulders. Arms quivered every time trying to stand up and felt like fainting. Hand-eye coordination progressively got worse. For e.g., could not pick up water bottle, hands were quivering badly 4/15 ? Neurologist conducted certain diagnostic tests and concluded that there are no neurological issues. Said with rest and plenty of fluids it should get better. Spinal tap was not recommended and said if symptoms got worse a spinal tap can be done during the next visit. Follow up visit with neurologist scheduled on 4/27 4/15 ? 4/27 ? Weakness in arms got better. Arm strength and coordination has improved however it?s still not back to normal. Brain fog and dizziness still persists with no improvement. Left limb and arms are stronger than the left. Difficulty climbing up and down stairs. Dizziness worsens after shower. Not feeling myself. In addition, not able to multitask - getting startled and need to be deliberate about having to do everyday chores need to just focus on one task 100% completely and if something else comes up then my body just goes into a momentary shock. Mostly I can feel my head feeling heavy and my eyelids shutting down when something shocking happens ? a feeling like body is ?turning off?, almost a fainting or passing out feeling. Sometimes when I turn to one side and sleep, I can feel a flickering sensation in the ear. Still always feeling woozy and as if there is something in my head ? a medicated or intoxicated feeling in the head 4/27 ? Neurologist said she sees a lot of improvement and reiterated again that I don?t have any neurological issues. She said I can go back to work starting 5/1. She said I may have Conversion Disorder / Disequilibrium. It?s hard for me to fathom why she would diagnose me with Conversion Disorder when so many people are reporting very similar symptoms that I am facing on the below forum: https://www.drugdiscoverytrends.com/dizziness-among-common-covid-19-vaccine-side-effects/ 4/30 ? Next appointment with Head and Neck / Audiology
41 2021-04-29 excessive sleepiness, feeling abnormal Felt extremely tired around 7:30pm. Went to bed. Woke up at 6:00am to get kids ready for school, fel... Read more
Felt extremely tired around 7:30pm. Went to bed. Woke up at 6:00am to get kids ready for school, felt intense headache joint pain, and intense cold feeling to the point of shaking. Went to bed again around 7:45 am. Slept most of the day with headache getting worse. Next day symptoms lessened slightly still bad headache and brain fog which I still have as of today but getting better.
41 2021-05-02 impaired work ability, irritability, confusional state fatigue, loss of appetite starting around 12:30 PM 5/2 napped from 2:00PM until 3:30 PM, no more fat... Read more
fatigue, loss of appetite starting around 12:30 PM 5/2 napped from 2:00PM until 3:30 PM, no more fatigue fatigue, irritability, confusion, body aches set in around 6:00 PM around 8:00 PM started alternating between feeling hot and chills, and presumabliy a fever (did not take temperature) went to sleep for the night around 1:30 AM on 5/3. Sometime between then and 7:00 AM woke up in a sweat, so fever presumably broke awoke for the day around 8:20 AM but was still too fatiuged to go to work as of now still feel some fatigue and headache
41 2021-05-02 loss of personal independence in daily activities Joint pains in knees elbows and shoulders for about 4 weeks pain in the left knee to the point where... Read more
Joint pains in knees elbows and shoulders for about 4 weeks pain in the left knee to the point where I could barely walk. Started taking glucosamine and chondroitin and MSM. One day after taking vitamins. started feeling much better all symptoms cleared up one to two weeks after second shot of covid-19 Pfizer. Feeling good now able to go to the gym and start working out again.
41 2021-05-04 excessive sleepiness Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home... Read more
Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home with a meeting at 0900 and knew by 0920 that I had to take the day off. Spent the entire rest of the day and night in bed. Fever peaked at 101.1F , nausea, constant headache, shaking chills and then sweats, extreme fatigue and full body severe muscle soreness. Light headed and very weak. I slept all day until almost 1500. When I woke up my fever was gone. I'm left tonight feeling hungry again along with some residual sore muscles and aches. The fever responded well to Ibuprofen. I hydrated with water and Gatorade. It pretty much felt like influenza for just under 48 hours. I feel like I'm past the worst of it now, but I'm not fully recovered.
41 2021-05-04 insomnia Severe pain in neck and bilateral arms radiating all the way down to hands. Pins and needles feelin... Read more
Severe pain in neck and bilateral arms radiating all the way down to hands. Pins and needles feeling in bilateral arms with numbness and tingling. Feels like Nerve pain unbeliever by Tylenol and motion. Unable to sleep in either sidelying position since numbess, tingling and pain develops in corresponding arms and then quickly moves to hands. Unable to make a fist with right hand where vaccine was administered. Fine motor and gross motor strength decrease.
41 2021-05-09 impaired work ability On April 18 and 19, following my 2nd injection, I had very bad chills and could not get warm. I was ... Read more
On April 18 and 19, following my 2nd injection, I had very bad chills and could not get warm. I was nauseous although I did not vomit. On April 22, I began having severe sharp stabbing pains just to the right of my belly button. It felt like I was being stabbed with a very hot knife, and after about 15-90 seconds, it would go away. Anytime I reached for something, bent over, twisted, turned or tried to hug someone, I would get this same pain and it would double me over in pain. On Monday April 26 at 7pm, I finally checked into the Emergency Room at the direction of my Primary Doctor. They did a bunch of blood work on me and sent me for a CT Scan of my abdomen. All of the blood work came back in normal ranges, and the CT Scan showed my appendix was "borderline" according to the surgeon. They consulted with Dr and decided to admit me for a surgical consult and further examination. They gave me fluids and morphine through an IV for the first 24 - 36 hrs, and then switched to Norco by mouth. I continued having pain throughout my stay. On Thursday, April 29, they took me to surgery for "exploratory surgery" with the intention of removing my appendix and looking around to see if anything else stood out to them that would cause me this pain. They stated my appendix had scar tissue on it and they removed it, but said they did not know if this would stop the pain I was having. On Friday April 30, I was released from the hospital at approximately 6pm. By 9pm on Friday, I began having those same sharp, stabbing, burning pains in my abdomen again, now to the right of my belly button again and further towards my right side. I also had sharp burning pain in the inside of my upper right arm, between my bicep and tricep muscles. This pain continued on through the weekend occurring more frequently and more severe. On Monday morning at about 1:30am, I woke up with severe abdominal pains all over and went into the bathroom. I had diarrhea and nausea and felt like I was going to vomit. Between 1:30am and 7:30am, I went to the bathroom 6 times. I went to work on Monday and continued having abdominal pains and diarrhea all day and night. On Tuesday, I went to the bathroom a total of 17 times. On Wednesday, I saw my primary Dr., who examined my abdomen and pains. He suggested I take immodium for the diarrhea and a supplement for muscle pain, as he felt this was the cause of my pain. On Wednesday, I went to the bathroom 21 times and was very nauseaus. I started the Imodium and it had no effect on me whatsoever. On Thursday, I had to call off work because I couldn't stop using the bathroom. By 4pm, I had been to the bathroom 18 times. I returned to the ER. They took a stool sample and did an ultrasound in the ER. They decided to admit me again for surgical consult and pain management. On Friday, Dr ordered another ultrasound of my abdomen, specifically my gallbladder, kidney, and liver. He also sent me for a CT Scan with contrast. They completed a total lab workup of my blood. All of these results came back normal, and nothing on the images showed anything wrong with my organs. On Saturday May 8, Dr came to the hospital to examine me. He stated everything related to my GI was fine. He asked if I have back pain, which I told him I do. At this time, I was in extreme pain and I couldn't even touch my skin. Dr attempted to examine my abdomen, and just by placing his hand on my stomach, I screamed in pain. He then put his hand behind my back and pushed a little, and it cause extreme pain in my abdomen. At this time, Dr suggested that maybe the pain is caused by something going on in my back. Maybe a pinched nerve or something. He ordered an X-ray of my upper and lower spine. Later that day, the results of the X-ray came back and showed there was nothing wrong with my spine. With these results, Dr then ordered an MRI of my lumbar and thoracic spine. On Sunday May 9 at 1030am, I was taken to radiology for an MRI. The initial report shows that I do not have any pinched nerves and nothing notable that would cause this type of pain in my body. As of now, no diagnosis or explanation for the pain I am experiencing. The pain is gradually getting worse and at times I am unable to move at all without extreme severe pain in my body. At times, my right groin hurts and I am unable to stand on my feet, as it feels as if I have pulled a groin muscle. The pain in my abdomen takes my breath away and feels like I am being set on fire in that area of my body. The pain no longer goes away and is constant, but moves throughout my right side from my groin to my shoulder only. I am not able to put my right arm behind my back because I get this pain in the back of my shoulder area. This pain is only on my right side at this time. So far, there is no explanation for this pain. I never had anything like this until I got the vaccine.
41 2021-05-10 poor quality sleep Ache and today he was feeling "more achy"; Burning sensation, discomfort, and aching in his arm "rig... Read more
Ache and today he was feeling "more achy"; Burning sensation, discomfort, and aching in his arm "right where he got the shot"; Burning sensation, discomfort, and aching in his arm "right where he got the shot"; Did not sleep well/ did not sleep good; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm on 14Apr2021 (at the age of 41-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He reports that on Monday 19Apr2021 he experienced a burning sensation, discomfort, and aching in his arm "right where he got the shot" and reports that it feels like he just received the vaccine. He tells me that right after he got the vaccine he worked out and that night (Wednesday night on 14Apr2021) he did not sleep well. He states on Thursday night he slept okay, Friday and Saturday night did not sleep good, Sunday "so so", and then states yesterday (22Apr2021) he started to ache and today he was feeling "more achy." Caller would like to know if it was normal to have a reaction this late to the vaccine. He was concerned about whether he should take the second dose of the vaccine because of this, and states his next dose was due 5May2021. Response: Spoke from the prescribing information PFIZER-BIONTECH COVID-19 VACCINE to let caller know that side effects were reported over a 7-day period following each dose of the vaccine and also let caller know that "the mean duration of pain at the injection site after dose 2 was 2.5 days (range 1 to 36 days)." Spoke from the attached documents regarding contraindications to receiving a dose of the vaccine and what signs of a severe allergic reaction could include. Referred caller to healthcare professional (HCP) for further guidance. Caller would like to know if it was okay to take a medication such as Advil to treat his symptoms that he was experiencing after receiving the Pfizer BioNTech COVID-19 vaccine. Response: Spoke from the attached document regarding the use of medications such as Tylenol and Ibuprofen after vaccination to treat symptoms. Referred caller to HCP for any further guidance on medication recommendations. The outcome of the events was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
41 2021-05-10 restlessness, insomnia Nausea: 1hr Palpitations: 24hr Restlessness: 8hr Insomnia: 8hr Fatigue: 36hr Pain at injection site:... Read more
Nausea: 1hr Palpitations: 24hr Restlessness: 8hr Insomnia: 8hr Fatigue: 36hr Pain at injection site: 5hr Headache: 12hr
41 2021-05-11 anxiety Tinnitus with onset the next day after first injection. Hissing sound in both ears. Has lasted 5 1... Read more
Tinnitus with onset the next day after first injection. Hissing sound in both ears. Has lasted 5 1/2 weeks so far. Some days it is barely noticeable and other days it is very distracting and causes anxiety.
41 2021-05-15 agitation, anxiety, restlessness, insomnia Late night insomnia, agitation, restlessness, anxiety (awake between 3-6AM with racing thoughts); Ab... Read more
Late night insomnia, agitation, restlessness, anxiety (awake between 3-6AM with racing thoughts); Able to fall asleep at normal bedtime; THC, CBD, melatonin 6mg ineffective; Benadryl partially effective.
41 2021-05-19 anxiety Patient was given vaccine and while waiting the 15 minute monitoring period he fainted. He was respo... Read more
Patient was given vaccine and while waiting the 15 minute monitoring period he fainted. He was responsive right away and needed to throw up. We attended to him and called EMS. He said he had anxiety from the seeing the needle and is probably why he fainted.
41 2021-05-19 sleep disorder Arm soreness started on May 18 @ 3:30pm. Went to sleep with same arm soreness at 11pm. Woke up at ... Read more
Arm soreness started on May 18 @ 3:30pm. Went to sleep with same arm soreness at 11pm. Woke up at 1:15am on May 19, walked approximately 12 feet started experiencing cold chills. At 1:20am, while standing and holding cellphone in right hand, started experience of convulsive seizure to the point of cellphone health stats saying i walked 103 steps while standing still convulsing. After calming down enough to sit, i sat on couch to sleep. Heart rate was still registering in 200 bpms for next couple hours. May 20, 2021 started experiencing sore throat at 5:30am. As day progresses am experiencing flu type symptoms.
41 2021-05-21 confusional state Shortness of breath weakness tired chills achey heart palpitations headache dizzy confused lasted 2 ... Read more
Shortness of breath weakness tired chills achey heart palpitations headache dizzy confused lasted 2 weeks
41 2021-05-23 depression, irritability Recurrent tinnitus, ringing in the ears, which worsened about 2-3 days after second shot and made me... Read more
Recurrent tinnitus, ringing in the ears, which worsened about 2-3 days after second shot and made me question whether to get the second dose; Severe headache 30 hours after first dose, then sporadically especially if fatigued, need to rule out whether they are migraines which I have never been diagnosed with before, continued and worsened after second dose. Malaise; Night sweat about 36 hours after first dose; Chills all night one night after the second dose. Soreness at injection site for first 30 hours after first dose, not as much after second dose. Fatigue, depression and irritability in the weeks after the first dose. After the second dose it is too soon to tell.
41 2021-05-27 anxiety He got his first dose of Pfizer. I believe he was suffering from anxiety attack. He told me that is ... Read more
He got his first dose of Pfizer. I believe he was suffering from anxiety attack. He told me that is how he often feels seeing needles. His blood pressure and heart rate were all normal. EMS services were called and the patient was checked out and ok.
41 2021-05-27 impaired work ability, feeling abnormal Short-term (24-36 hours after both shots): Extreme fatigue, muscle pain/soreness, headache, fever, n... Read more
Short-term (24-36 hours after both shots): Extreme fatigue, muscle pain/soreness, headache, fever, nausea. Worst I've ever felt in my adult life, like my whole body was rebelling against me. Long-term (for roughly 10 days after both shots): Serious shortness of breath, irregular and very high heartbeat, extreme fatigue. Couldn't do any physical activity without immediately becoming out of breath (normally very healthy and active). Heart would race unpredictably, reaching 120 bpm (normal resting for me is 60-70). General malaise. Felt more like 80 years old than 40. Was unable to do normal physical activity and work for weeks. Feeling better overall, but still sometimes feel like I get tired unusually easily and heart behaves strangely now and then.
41 2021-05-28 excessive sleepiness had diarrhea; a fever of 103*F; He was shivering due to lack of energy; He was shivering due to lack... Read more
had diarrhea; a fever of 103*F; He was shivering due to lack of energy; He was shivering due to lack of energy; lost his voice; threw up; sleeping for 48 hours; terrible pain in his stomach which made him scream to the point where he lost his voice; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 23Apr2021 14:15 (Batch/Lot Number: EW0171, not sure if the 0 is a O or a 0) as single dose at the age of 41-year-old for covid-19 immunisation, administered not at a military facility. Medical history included ongoing Hashimoto's disease diagnosed about 10 years ago, ongoing vitamin D deficiency diagnosed about 8 years ago, ongoing vitamin b12 deficiency diagnosed about 8 years ago, lung neoplasm malignant. Family history included: dad had lung cancer, mother had thyroid issues and Alzheimer's. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. The patient experienced terrible pain in his stomach which made him scream to the point where he lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, metallic taste in the mouth on 23Apr2021 with outcome of recovered on 24Apr2021, had diarrhea on 24Apr2021 with outcome of recovered on 26Apr2021, a fever of 103°F on 24Apr2021 with outcome of recovered on 26Apr2021, he was shivering due to lack of energy on 24Apr2021 with outcome of recovered on 27Apr2021, lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, threw up on 24Apr2021 with outcome of recovered on 27Apr2021, sleeping for 48 hours on 24Apr2021 with outcome of recovered on 27Apr2021. The patient underwent lab tests and procedures which included body mass index: 37 on an unknown date, body temperature: 103 Fahrenheit on 24Apr2021. Therapeutic measures were taken as a result of terrible pain in his stomach which made him scream to the point where he lost his voice, had diarrhea, threw up. The course of events was as follows: Within the 1st 24 hours, he mentioned that he was fine and easy but had a metallic taste in the mouth for 24 hours. He mentioned that the next 72 hours were really bad for him. On 24Apr2021, that night, he started to feel terrible pain in his stomach which made him scream to the point where he lost his voice. It was like knives cutting his stomach. He threw up everything he ate, had diarrhea for 2 days along with a fever of 103 degree F for 2 days. He would try to go to the bathroom and he was shivering due to lack of energy that he could not go to the bathroom. He slept for 48 hours after the 1st 24 hours after vaccination due to the side effects. By Monday afternoon, 26Apr2021, he noticed that his side effects were subsiding and by Tuesday, 27Apr2021, he was a different person and was like nothing happened, he was able to resume a normal life and go back to work. The events did not require a visit to Emergency Room or physician Office. He did not go he was taking orange juice and ibuprofen to treat himself. No relevant tests. He asked if this was contraindicated with him to get the 2nd dose. He has not spoken to his doctor yet. He queried if he should get the second dose or is it contraindicated. Patient mentioned he is very large at 6'6" and 320 lbs. He is wondering if he should have a different dose because he is so big. This report is not related to a study or program. Information on Lot/Batch number was available. No further information is expected.
41 2021-05-31 amnesia, thinking abnormal pt reported have amnesia and not clear thoughts 24 hours after receiving 2nd Pfizer dose
41 2021-06-01 feeling abnormal I felt completely fine for the first 5 minutes. I left the store. After 5 more minutes I started f... Read more
I felt completely fine for the first 5 minutes. I left the store. After 5 more minutes I started feeling bad (I was seated). My whole body was sweating and my vision was affected (everything was bright). I was able to return to the store but was close to passing out. I sat down for about 10-15 minutes while the symptoms persisted and I was not able to see well. After that time the sweating stopped and my sight was no longer affected. This was not anxiety and I have no history of fainting with shots. This was a reaction to the shot. After about an hour I felt fine except for muscle soreness at the injection sight. If the reaction was any worse I would have passed out or asked for help. I am hesitant to get a second dose out of concern that the reaction could be worse.
41 2021-06-02 loss of personal independence in daily activities Muscular pain in both upper arms well after initial vaccine reaction had subsided, normal movement o... Read more
Muscular pain in both upper arms well after initial vaccine reaction had subsided, normal movement of arm up and/or back and rapid movements in other axes cause intense muscle pain followed by severe minutes of pain fading to dull ache. The pain issue has only worsened since it's onset. The pain in each arm is proportionate to the initial vaccine reaction, meaning the arm that got the second dose experiences more sever pain than the one that got the first. The pain in both is preventing normal activities and affecting quality of life.
41 2021-06-07 sleep disorder Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4/15/21 and 5/6/21. Patient presented to ED on 5/9/21 with complaints of acute onset substernal chest pain that woke him from sleep. Patient also endorses left arm pain, diaphoresis and nausea. No significant past medical history or family history of heart disease. ECG demonstrated inferior ST elevations. Patient was taken to cath lab and found to have no angiographic evidence of CAD. Patient discharged on aspirin 81 mg QD, Clopidogrel 75 mg QD, Metoprolol 12.5 mg BID, Rosuvastatin 5 mg QD.
41 2021-06-08 feeling abnormal He has had a lot of symptoms since second COVID-19 vaccine 5 weeks ago-Pfizer vaccine. Notes tinglin... Read more
He has had a lot of symptoms since second COVID-19 vaccine 5 weeks ago-Pfizer vaccine. Notes tingling and numbness in his left arm, dizzy, nausea, "brain fog" and "loosing motor skills". Headaches are tapering off. He is on Amantadine from Neurology. His symptoms came on immediately after the 2nd shot. Severe symptoms- headache , brain fog. Had been in ED- had CT head. Saw neurology and then sent to Headache clinic. He has several people he knows with similar symptoms and had gone thru long term
41 2021-06-14 anxiety 3 hours after vaccine, he experienced acute symptoms - dizziness, lightheadedness (described as room... Read more
3 hours after vaccine, he experienced acute symptoms - dizziness, lightheadedness (described as room spinning around), anxiety (not problematic before), profuse sweating, feeling of doom, nausea/wretching, pronounced shaking. called 911, taken by ambulance to ER, prior symptoms continued in varying intensity for the next 3 - 4 hours. He was given IV fluids, antibiotics, then admitted to the hospital. He had loss of balance, continued lightheadedness, loss of appetite. Hospitalized for 3 days. Went home with a walker (not used before). He gradually improved over a two week period.
41 2021-06-21 insomnia headache, itchy/burning eyes, muscle aches, bone pain, cold chills/hot flashes, insomnia, diarrhea, ... Read more
headache, itchy/burning eyes, muscle aches, bone pain, cold chills/hot flashes, insomnia, diarrhea, pain in testicals, and nausea
41 2021-06-23 feeling abnormal I have had NONSTOP ringing in my left ear since April 19th. I have sporadically experienced ringing ... Read more
I have had NONSTOP ringing in my left ear since April 19th. I have sporadically experienced ringing in my Right ear as well but not nearly to the extent I have in my left ear. I also experienced frequent, daily headaches for about the first month or so after the shot. I also experienced neck/right shoulder stiffness for about 3 weeks following the shot. I continue to wake up on a daily basis with a feeling in my head and ears like I've been listening to loud music or been in a loud sporting event for several hours (on top of the still nonstop/constant ringing in my left ear that will not go away). I have also experienced swelling in my feet and ankles anytime i'm active for an extended period of time
41 2021-06-23 nervousness, anxiety within 1 hour of taking the dose, I started feeling tingling on my face. I also got nervous and anxi... Read more
within 1 hour of taking the dose, I started feeling tingling on my face. I also got nervous and anxious. Tingling stayed for a couple of hours.also there was some pain in the right arm but at night...there was a lof of pain. I took Tylenol for pain. Next day pain disappeared. Although it was still sore.
41 2021-06-26 incoherent vaccine was administered and patient lost consciousness. he began to turn red and did not breathe fo... Read more
vaccine was administered and patient lost consciousness. he began to turn red and did not breathe for several seconds at which we were about to administer an EpiPen. He then took a breath and started to convulse. he regained consciousness and was not coherent at first. He was sweaty and pale. Pt became alert and oriented and stayed in the room while we waited for the emt to arrive. He declined to be taken to the hospital. He moved to the waiting room and was monitored for 30 minutes before leaving
41 2021-06-28 feeling abnormal Pt reports lymph node swelling to left side of neck began 5 days after initial dose of Pfizer vaccin... Read more
Pt reports lymph node swelling to left side of neck began 5 days after initial dose of Pfizer vaccine (3/25/2021); reports node was firm and "Pistachio size, swelling to a Pecan size." Pt reports muscle pain, and bilateral lower extremities "extremely hot and sweaty." "extreme fatigue and weakness." Pt was seen by his primary provider at local HCF and was prescribed "2 rounds of antibiotics, Zithromycin and steroid." Dr. also had an ultrasound at another HCF which he reports showed lymph note "reactive and inflamed." Pt continued to follow up with medical provider and waited 3 months to received Pfizer booster vaccine (6/23/2021), which he did receive and subsequently reports reaction is "worse." He reports left side of neck lymph node swelled to "Pecan size" and this time left under arm lymph node palpable "pea size" and he became "loopy;" "not fully present" described it as driving as in a fog "dissociated." Extreme fatigue and weakness continue. Pt reports he then again saw his primary medical provider and was prescribed more antibiotics (Rocefin I.M.) and steroids. He is being referred to an ENT MD and infectious disease MD for follow up. Pt reports he tested multiple times in the past for COVID-19 via rapid testing (No PCR confirmatory test done), he reports he never tested positive for COVID-19 but reports he had all the symptoms including loss of taste and smell back in July 2020.
41 2021-06-30 insomnia, anxiety RAPID HEART RATE - MULTIPLE VISITS TO ER WITH EKG AND BLOOD TESTS -RESULTS NEGETIVE LIGHT-HEADINESS ... Read more
RAPID HEART RATE - MULTIPLE VISITS TO ER WITH EKG AND BLOOD TESTS -RESULTS NEGETIVE LIGHT-HEADINESS SEVER HEADACHE'S TROUBLE SLEEPING ANXIETY
41 2021-07-12 sleep disorder Acute onset neck pain while sleeping began on date reported. Remained severe for ~5 days. Since th... Read more
Acute onset neck pain while sleeping began on date reported. Remained severe for ~5 days. Since then, waxing and waning pain. Significant improvement by June 2021 but not resolution.
41 2021-07-14 impaired work ability About two weeks after second dose. I started having pain in one leg, after a few days it was both le... Read more
About two weeks after second dose. I started having pain in one leg, after a few days it was both legs, then the numbness from waist down, tingling and burning sensation on both feet. Muscle spasms, nerve pain. Since then its been really hard to do my job. I completely stop working on May 18. Doctors orders. I been going to physical therapy, but not helping, My doctor recommended me to report , because, of all the testing and Xrays have got, nothing comes up. He referred me to see a Neurologist and Allergist to further make exams, to make sure its not Guillen Barre Symdrome. I have been in medication for pain , disinflamatory medication, but until now everything is the same.
41 2021-07-15 feeling abnormal Day 1-2 post injection: Severe body aches (whole body - hurt to even try to pick up cell phone), vi... Read more
Day 1-2 post injection: Severe body aches (whole body - hurt to even try to pick up cell phone), visibly swollen left armpit painful to touch and with arm movement, severe rigors, fever ~101, rapid temperature changes (burning up to freezing), sweating, headache, nauseousness, dizziness, exhaustion/low energy, no appetite, brain fog Day 3: above started to slowly subside Majority of symptoms have gone away. Still get nauseous and dizzy at some point every day. Low energy, lethargic still, no real appetite, still have brain fog.
41 2021-07-20 anxiety, restlessness Restlessness, anxiety, tinnitus, vertigo. Prior to the second dose of the vaccine I wasn't under a ... Read more
Restlessness, anxiety, tinnitus, vertigo. Prior to the second dose of the vaccine I wasn't under a doctor's care for any of those issues. One or more of the above issues have impacted me daily since 3/30. I visited the emergency room on 4/2 because my anxiety was so bad it felt like I was having a heart issue.
41 2021-07-23 sleep disorder, insomnia Started with shoulder and armpit aches (~15 hours after receiving the shot). Progressed into strong... Read more
Started with shoulder and armpit aches (~15 hours after receiving the shot). Progressed into strong pain in the shoulder and armpit. These symptoms kept me up all night. Then progressed into large golf-ball-size swelling in the left armpit which lasted several days. I took ibuprofen for the swelling, but didn't seem to do much. After a few days, the swelling started to reduce.
41 2021-07-26 anxiety Loss of equilibrium, aching muscles, soreness, shaking, symptoms of vertigo, anxiety, weakness, loss... Read more
Loss of equilibrium, aching muscles, soreness, shaking, symptoms of vertigo, anxiety, weakness, loss of balance, loss of dexterity, loss of muscle memory,
41 2021-07-28 feeling abnormal Chest pain; Headache; muscle fatigue; joint pain; muscle pain; muscle cramps; arm soreness; dizzines... Read more
Chest pain; Headache; muscle fatigue; joint pain; muscle pain; muscle cramps; arm soreness; dizziness; vertigo; blurry vision; tingly sensation in arm and leg; sharp toe pain; out of body experience; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 02May2021 at 14:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and acid reflux. The patient did not take any concomitant medications. The past drug history was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 18:45, the patient experienced chest pain, headache, muscle fatigue, joint pain, muscle pain and cramps, arm soreness, dizziness, vertigo, blurry vision, tingly sensation in arm and leg, sharp toe pain, out of body experience and brain fog. The clinical outcome of the events chest pain, headache, muscle fatigue, joint pain, muscle pain, muscle cramps, pain in arm, dizziness, vertigo, blurry vision, tingling sensation, pain in toe, out of body experience and foggy feeling in head were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
42 2021-01-08 sleep disorder Fever, uncontrolled rigors, extreme/uncomfortable aching of the feet and hands that awoke from sleep
42 2021-01-09 anxiety Dizziness, Diarrhea, HYPERtension & Tachycardia Narrative: Mild dizziness 5 minutes after vaccinatio... Read more
Dizziness, Diarrhea, HYPERtension & Tachycardia Narrative: Mild dizziness 5 minutes after vaccination. 167/110, heart rate 77 at 1408. 144/01, heart rate 68 at 1417. Reported mild anxiety. Observed 30 minutes. No e/o allergic reaction and anxiety resolved.
42 2021-01-09 disorientation Headache fatigue, disorientation, loss of interest Narrative:
42 2021-01-10 feeling abnormal Immediate weird taste in his mouth ("like licking a kitty litter box and made his snickers taste gro... Read more
Immediate weird taste in his mouth ("like licking a kitty litter box and made his snickers taste gross"), dizziness, and nausea after getting the vaccine. Brain fog, dizziness, and nausea continued for the rest of the shift. 5 hours after the vaccine (10pm) he was very fatigued. When he woke up the next morning his arm felt like it "was in a vice" and he is still hazy.
42 2021-01-12 nightmare, impaired work ability DEVELOPED DIZZINESS, EXTREME FATIGUE, CHILLS, WEAKNESS, NIGHTMARES AND ELEVATED BLOOD PRESSURES SINC... Read more
DEVELOPED DIZZINESS, EXTREME FATIGUE, CHILLS, WEAKNESS, NIGHTMARES AND ELEVATED BLOOD PRESSURES SINCE 1/12/2021 AT NIGHT. UNABLE TO GO TO WORK.
42 2021-01-13 impaired work ability In the afternoon - pain in right shoulder; within a couple of days: lost of taste, fever, chills, sh... Read more
In the afternoon - pain in right shoulder; within a couple of days: lost of taste, fever, chills, shortness of breath, diarrhea . Tested for Covid 27th of December and was positive. Was on steroids and antibiotics and vitamins; and still on steriods and breathing treatments and still haven't gone back to work.
42 2021-01-14 confusional state, loss of personal independence in daily activities, impaired work ability, feeling abnormal I was vaccinated on 1/2/2021 and developed oral parasthesias the day of the vaccination. On day 3 af... Read more
I was vaccinated on 1/2/2021 and developed oral parasthesias the day of the vaccination. On day 3 after the vaccine, I developed a severe headache with ?brain fog,? confusion, and hyperacusis. The headache has now persisted for 10 days and was severe enough that I missed several days of work this week as I was unable to carry out my clinical duties. I was seen in ED this past weekend and ultimately followed up with neurology after the headache had persisted for 7+ days. The working theory is that I may have developed aseptic meningitis as a side effect of the vaccine and I am currently on a steroid taper which has resulting in partial but significant improvement in my symptoms. I am back at work but still experiencing a mild headache and facial parasthesias. I did request a Covid test in ED 1 on 1/10/21 and tested negative.
42 2021-01-14 impaired work ability fever, headache, nausea. called in sick to work.
42 2021-01-19 euphoric mood Severe dizziness/ light headed "euphoric" feeling
42 2021-01-21 impaired work ability, confusional state, memory impairment About 3 minutes after receiving the shot, I became dizzy. After 15 minutes, I was still dizzy. I h... Read more
About 3 minutes after receiving the shot, I became dizzy. After 15 minutes, I was still dizzy. I had a little shortness of breath and it felt like my heart was beating faster but this only lasted a few minutes. They had me wait an additional 10 minutes and the dizziness was better but not gone completely. I drove myself home and tried to work from home but was feeling confused. I took the rest of the day off. The next day (yesterday) I woke up exhausted. I took a sick day and slept until noon, which was about 14 hours in total. When I woke up, I felt okay but had no appetite and did not get out of bed for 5 hours. When I finally got up, I still felt dizzy. I ate dinner, watched some TV and went to bed. I woke up this morning without the fatigue but started to feel dizzy in the shower to the point where I almost lost by balance twice. I'm trying to work from home today but feel very dizzy and confused. I couldn't remember my office's phone number. I'm sweating but my temperature is 97.5.
42 2021-01-24 sleep disorder About 72 hours after receiving the vaccination i was shivering uncontrollably on and off, breaking o... Read more
About 72 hours after receiving the vaccination i was shivering uncontrollably on and off, breaking out in sweats on and off. Once i would start to feel better after sleeping 4-6 hours. I get out of bed thinking I was better, then another hour or so later the symptoms were back, so I would go back to bed shivering uncontrollably off and on again, sweating and uncomfortable until falling back to sleep.. This lasted for about 48 hours, which started 72 after receiving my vaccination. No adverse symptoms the first 2 days following the vaccination. I got vaccinated on Tuesday, 1/19/21 - symptoms started Friday, 1/22/21 - Saturday, 1/23/21. Sunday, 1/24/21 I finally felt normal again.
42 2021-01-28 anxiety Tingling hands, Feeling weak and tired Patient alert and oriented noted with tingling sensation in b... Read more
Tingling hands, Feeling weak and tired Patient alert and oriented noted with tingling sensation in both hands at around 5:35 pm, 6 minutes after being vaccinated for 1st dose of PFizer CoviD 19 vaccine. Vitals signs taken BP 156/96, HR 115, RR 20, T 98, O2 sat 98% RA. Patient offered beverage and tolerated well. Patient was monitored, Vitals re checked as Follows: BP 129/80, HR 105, RR 18, O2 sat 99% RA. At around 6:05 PM Patient verbalized that tingling was gone, monitoring continues, pt. noted anxious at all times. Patient states that he is taking Citalopram 30 mg For 2 years. Vitals rechecked at 7 PM BP 148/88, P 134, RR 20 MD evaluated pt with recommendation to send pt to ER For Further (monitor) evaluation. EMS arrived at 7:22 pm and take over the pt. Patient left Ambulating with Wife and EMS.
42 2021-02-05 impaired work ability On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullne... Read more
On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullness or pressure in my left ear, mild sinus congestion, and chills. The congestion and chills ended after one day, but the feeling of fullness in the ear has persisted to this day. Then, on January 29, I had a bout of positional vertigo and vomiting that lasted two to three hours. I also experienced ringing or roaring in my left ear. Ever since, I have a bout of vertigo approximately every 24 hours, and the ringing and sense of fullness in the ear ebb and flow on 24 hours cycles as well. This experience has been debilitating and affected my ability to work. My doctor has diagnosed Meniere's disease and says he has been seeing similar symptoms apparently linked to the COVID vaccines. I started taking prednisone on doctor's orders yesterday (February 5), which has stopped the vertigo. Ringing and occasional fullness in the ears persist.
42 2021-02-09 impaired work ability fever. called in sick to work.
42 2021-02-09 thinking abnormal Pt sitting up in chair became pale, pasty, diaphoretic, states he isn't thinkin straight. Pt laid in... Read more
Pt sitting up in chair became pale, pasty, diaphoretic, states he isn't thinkin straight. Pt laid in floor, legs elevated. EMS activated, evaluated by paramedics, orthostatics negative, patient allowed to rest for until 1635. Patient color returned, states he felt better, ambulated out of clinic independently. Wife at side.
42 2021-02-17 feeling abnormal Day of the shot (in the afternoon) I felt began feeling ?off?. Day after the shot I had pretty se... Read more
Day of the shot (in the afternoon) I felt began feeling ?off?. Day after the shot I had pretty severe body aches and exhaustion that lasted for two full days and lingered for a third day although not as severe. It?s now a week since the last vaccination shot and I went for my first run since the vaccination. I regularly run about 5 miles 3x a week in the mornings. On this run,; which was at about 75% of my normal pace, my lungs felt very heavy with very labored breathing, having to stop and catch my breath periodically. I eventually had to stop at mile 3.
42 2021-02-18 sleep disorder 1. That night I had an elevated blood pressure (around 140/100) but it did return to normal levels (... Read more
1. That night I had an elevated blood pressure (around 140/100) but it did return to normal levels (typically 125/80) the next day. 2. Also that night, I had significant body aches (joints and muscle) that was strong enough to effect my sleep. 3. I developed a sore throat 3 days post vaccine that persisted approximately 2-3 days.
42 2021-02-21 insomnia Sleeplessness. Unable to stay asleep for more than 2 hours at a time since receiving first dose of t... Read more
Sleeplessness. Unable to stay asleep for more than 2 hours at a time since receiving first dose of the pfizer covid vaccine.
42 2021-03-03 feeling abnormal, depression, anxiety, panic attack On Monday I had the COVID vaccination. I noticed no side effects on Tuesday other than tenderness at... Read more
On Monday I had the COVID vaccination. I noticed no side effects on Tuesday other than tenderness at the injection site. On Wednesday, I noticed light bruising up and down my arms. Thursday morning around 10 AM, I started to have side effect - some so severe they must be documented. At 10 AM, I felt lightheaded and had brain fog. By noon my head was pounding with a headache followed by an upset stomach. At 2 PM things started getting bad and continued to worse. It was not the headache or stomach that need to be noted but a sudden and severe onset of depression and anxiety. - Depression like I have not felt in years when I was at my worst. Throughout the day the depression worsened and by 7 PM, I was unable to stop crying and was overwhelmed with anxiety and PTSD panic attacks. While I have the training to understand this is temporary, - I am very worried about what I?m feeling , because there was no warning or mention of this side effect. I have the resources needed for this but people that are more fragile need to prepare for the sudden o set of critical/ debilitating depression.
42 2021-03-03 thinking abnormal soreness at the point of administration of his left arm; Muscle soreness/muscle soreness at the poin... Read more
soreness at the point of administration of his left arm; Muscle soreness/muscle soreness at the point of injection spread to his whole body; it was like aches all over his body; Fatigue; Frequent urination; Cognitive fuzziness; This is a spontaneous report from a contactable consumer (patient) reported that a 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date 31May2021), intramuscular on the left arm on 28Jan2021 16:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), mentioned he was a patient facing drug addiction counselor in training, smoke cigarettes but he has cut down to a half a pack a day, at most. The patient previously received flu vaccine on an unspecified date for flu vaccination and experienced soreness at the point of administration of his left arm. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken from an unspecified date for ADHD. The patient received his first COVID-19 vaccine this past Thursday, 28Jan2021. The next morning (29Jan2021), he woke up with real soreness at the point of administration of his left arm, well beyond what he remembered for a flu vaccine. The second night (30Jan2021), the soreness progressed. It was hard to sleep on his left arm. It was like he had been punched. He had to sleep on his right side versus his left side. On 29Jan2021, the muscle soreness at the point of injection spread to his whole body, it was like aches all over his body. The soreness has gotten a little bit better day by day. He confirmed he got a rapid nasal molecular COVID swab test because he was just covering his bases and he tested negative for COVID-19 on 02Feb2021. He also experienced fatigue. The fatigue really started to set in on Friday evening (29Jan2021), it was like he got hit by a truck. He was typically a high energy person and its very out of the ordinary for him to feel this way. He normally has class on Saturday from 9-noon but he had to cancel going with the amount of fatigue he was experiencing. He also had some cognitive fuzziness on Jan2021. His fatigue was still there, but it has gotten a little better. He was normally very high energy, but he missed two classes and skipped his internship today. He doesn't feel like himself. He also has had frequent urination which he noticed probably Friday night (29Jan2021), all the way up until now. However, he has been drinking a lot of water. The patient received a test/report showing he has no chromosomal issues and no likelihood of issues on an unspecified date. The outcome of soreness at the point of administration of his left arm and Frequent urination was not recovered; Muscle soreness/muscle soreness at the point of injection spread to his whole body and fatigue was recovering; it was like aches all over his body and cognitive fuzziness was unknown.
42 2021-03-10 anxiety Pt, Very anxious, dizziness,chest tightness. Vital signs taken 150/90 p80 r 16 145/100 80 r 16 160/1... Read more
Pt, Very anxious, dizziness,chest tightness. Vital signs taken 150/90 p80 r 16 145/100 80 r 16 160/100 p 81 r16 157/90 p 78 r16
42 2021-03-10 anxiety 42 yo male without h/o reaction to prior vaccinations or medical problems here for first covid vacci... Read more
42 yo male without h/o reaction to prior vaccinations or medical problems here for first covid vaccination. approx 9 min after vaccination with dizziness but no headache, no syncope np altered mental status no shortness of breath no wheezing no palpitation no chest pain no stridor no dysphonia no globus no rash no flushing no hives no angioedema. sx resolved with hydration. pt admitted to poor intake and anxiety.. pt discharged home alert and oriented.
42 2021-03-11 excessive sleepiness, sleep disorder After about 12 hours, I was woken up from sleeping with extreme body aches/headache and starting get... Read more
After about 12 hours, I was woken up from sleeping with extreme body aches/headache and starting getting the chills and shaking. I lost all energy and struggled to get out of bed and walk. Laid in bed all day, took Tylenol, slept off and on. Didn't subside until 6:00pm the next evening when I broke out in a sweat and got some energy back.
42 2021-03-14 anxiety Received 1st dose at mass clinic. After a few minutes while sitting in observation area, pat observe... Read more
Received 1st dose at mass clinic. After a few minutes while sitting in observation area, pat observed by Dr and med student to be very pale, dyspneic, lightheaded and complaining of nausea. BP 148/94 O2 applied at 1.5 LPN N/C. Pt able to sit in chair without problems, remained responsive. States he was fine until he saw others getting their vaccine and that made him anxious. Observed for 30 minutes, pulse ox 95%. Oxygen removed and pt was able to walk out without difficulty and go home after condition much improved. Local EMS on site with pulse and O2.
42 2021-03-15 impaired work ability Severe joint pain in left shoulder with burning/ electrical pain radiating down tricep to my elbow. ... Read more
Severe joint pain in left shoulder with burning/ electrical pain radiating down tricep to my elbow. I?ve used ibuprofen, heat, ice, rest and it still hurts a week later. I?ve missed three days of work now.
42 2021-03-24 feeling abnormal, mental impairment Complained of feeling weird/ tingly. No sense of pain to pinch. Dulled responses. Acting without ... Read more
Complained of feeling weird/ tingly. No sense of pain to pinch. Dulled responses. Acting without inhibition- wanted to pour water all over self, sleep face down in the grass, fly a plane. Acting inebriated or drugged.
42 2021-03-26 sleep disorder Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes.... Read more
Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes. Upset stomach with vomiting and diarrhea. Body was shaking and didn?t have a fever. Skin felt like it was burning whole body felt swollen. Started around 2:30am with the cramping. It woke me up. Once I got up everything came so fast. Was rushed to hospital where I was admitted very quickly. I was blacking out on the drive there and blacked out while in their care. This was from one dose of Pfizer vaccine for Covid. I was put on a GI, Allergy, and steroid medications. I was hooked up to an IV and 3 drugs were injected. I passed out numerous times but was discharged at 5am.
42 2021-03-29 anxiety, feeling abnormal Very anxious before vaccine; BP at home 154/90. Felt like "punched in face"/foggy; lightheaded. BP ... Read more
Very anxious before vaccine; BP at home 154/90. Felt like "punched in face"/foggy; lightheaded. BP 148/98; pulse 88; p ox 98%; gave water. Continued monitoring; after about 30 minutes, then noted chest "heaviness"; "sore throat"--no tightness, no vision changes. Rapid response evaluated; Patient refused ED; continued monitoring for 10-15. VSS; chest heaviness resolved. Accompanied to hospital entrance; had ride home.
42 2021-03-30 abnormal behaviour, confusional state, disorientation Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing... Read more
Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing your doing something wrong and unable to correct it; Motor skills slowed; Fuzzy tongue; generally out of sorts feeling; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 42-years, via an unspecified route of administration in left arm at 12:15 AM on 16Mar2021 at single dose for COVID-19 immunisation, in Public Health Clinic. Medical history was reported as none. No other vaccine in four weeks. No COVID-19 prior vaccination. No known allergies. Concomitant medications were not reported. At 08:30 AM on 17Feb2021, the patient had periods of disorientation, confusion. Equatable to the description of Alzheimer's or dementia patients. Knowing you doing something wrong and unable to correct it. Motor skills slowed. Fuzzy tongue, and generally out of sorts feeling. Punctuated by periods of lucidity. No treatment received. Outcome of the events was recovering. No Covid-19 tested post vaccination.
42 2021-03-30 disorientation, feeling abnormal Felt a large amount of sensation in my injection arm 1-2 minutes after shot. Started to feel faint a... Read more
Felt a large amount of sensation in my injection arm 1-2 minutes after shot. Started to feel faint and light-headed 3-4 minutes after shot. Passed out about 5 minutes after shot. Felt sweaty, disoriented, spacey, and nauseated shortly after coming back to consciousness. Went to hospital in an ambulance and released a couple hours later.
42 2021-03-30 disturbance in attention Loss of hearing to last less than 5 min. followed by ringing ears through the following day. Uncon... Read more
Loss of hearing to last less than 5 min. followed by ringing ears through the following day. Uncontrolled palsy for head and neck intermittently through the injection day. I lost my voice and had spasms in my larynx. For several hours I had a hard time choosing my words and speaking which was the scariest. I could not focus enough to even wash my hands on injection day and had to be driven home from work. I got dehydrated because water tasted horrible. The next morning I am better on all fronts except the ringing in my ears wont stop
42 2021-03-30 sensation of foreign body 30-35 minutes after injection, while I was driving home, I felt some minor difficulty swallowing., b... Read more
30-35 minutes after injection, while I was driving home, I felt some minor difficulty swallowing., but no impediment to breathing or speaking. I rerouted to a plaza with a grocery store and urgent care clinic, and bought some Benadryl and took it at about 2:55PM. I waited 20 minutes in the parking lot before deciding I was safe to drive home. When I read about the possibility of a biphasic reaction, where my throat could close up again later, I went to a Clinic (5:40PM walk-in appointment with NP), and they could not treat me, and advised me to go to the Emergency Room. I initially decided to just go home, but went to the Emergency Room out of an abundance of caution at around 7PM. Dr. gave me a prescription for an epi pen and prednisone, just in case symptoms worsened. They did not, and I did not use either drug. The throat swelling started around 2:45PM and worsened for about half an hour. It remained steady (no airway constriction, no difficulty taking pills or drinking water) without getting worse, and started to subside around 5PM. By the time I woke up this morning (3/31), I don't think there is any lingering swelling. I can feel a very slight lump in my throat, but I can't tell if that is a very small amount of residual swelling or just hyper-vigilance based on yesterday's experience. Note: This swelling feeling is identical to my memory of what I felt when I was diagnosed as allergic to penicillin in 2000 or 2001. Back then, the only "treatment" was to immediately stop taking penicillin (and to never take it again), based on a phone call with my doctor's office. I did have a strong immune response after that (102° fever, chills, fatigue, muscle pain), but I don't consider that an adverse reaction. This report is focused on what appeared to be a mild anaphylactic reaction.
42 2021-03-30 sleep disorder Flu like symptoms next day. Vomiting and diarrhea. Body aches. Hot and cold sweats and chills. N... Read more
Flu like symptoms next day. Vomiting and diarrhea. Body aches. Hot and cold sweats and chills. Night cold sweats during brief sleeping periods. Third day was the same. Loss of appetite and dehydrated. Severe itching on my back. Today is the fourth day and I broke out with a rash on my back. Cortisone has relieved it thus far. My appetite is back. I did not vomit but still experiencing diarrhea.
42 2021-04-06 anxiety Paramedic called to observation for 42 YO male with dizziness, lightheaded, and anxiety. Upon arriv... Read more
Paramedic called to observation for 42 YO male with dizziness, lightheaded, and anxiety. Upon arrival PT found sitting in chair A&OX4, skins: pink/warm/dry, pupils: Equal and reactive. Pt speaks very little English and PT's wife translated for him. PT states that he started feeling symptoms 10 minutes after receiving his Pfizer vaccine. Upon assessment PT states he has 10/10 chest pain non radiating/dull in nature with increased pain on inspiration. Pt states that this has happed before a few months ago and was diagnosed with HTN but was not prescribed any medication by his primary care physician. PT does not take any medications and has no allergies. Pt status did not improve or decrease while in the care of the paramedic. Pt vitals then assessed and were as follows: 0943: BP 172/118, HR 71, RR 24, SPO2 99% RA, Lungs clear/equal bilaterally. 1002: BP 180/131, HR 80, RR22, SPO2 98% RA, Lungs clear/equal bilaterally. The paramedic made the decision to activate the EMS 911 system. Upon EMS arrival report given to responding paramedics and PT care transferred. EMS Paramedics began to treat patient for Chest Pain Protocol, and transported PT to Local ER.
42 2021-04-06 confusional state After Vaccine Administration pt pulled to observation lot to wait 15 minutes for observation of adv... Read more
After Vaccine Administration pt pulled to observation lot to wait 15 minutes for observation of adverse reaction. He lost consciousness after becoming confused for 1 minute. He was assessed by a guardsman and EMS staff regaining conciseness within a few minutes
42 2021-04-06 sensation of foreign body 1 minute after vaccine injection I experienced a tightening of my throat. It was very uncomfortable... Read more
1 minute after vaccine injection I experienced a tightening of my throat. It was very uncomfortable and made it difficult to swallow and felt like a "lump in my throat". I asked an onsite nurse if this was a common reaction, and she offered medical attention. I denied it because it was not getting worse. She gave me a bottle of water and it seemed to help it a bit while drinking. But, quickly returned after water was swallowed. I was monitored for 30 minutes as recommended. The tightness remained for 1 hour post vaccine injection and disappeared as quickly as it started. I fear the second dose may be worse.
42 2021-04-08 feeling abnormal I had a strange feeling in the left side of my face that I wasn't sure if it was a reaction or not. ... Read more
I had a strange feeling in the left side of my face that I wasn't sure if it was a reaction or not. It happened within the first 15 minutes but did not last more than 30 minutes. I did not experience anything else until the first evening when my arm was very sore. The next day my arm was more sore and I had a mild circular red mark around the injection site and the arm was much harder on that side. I also felt a little in my back and neck. By the second day in the evening the only thing I felt was pain in the arm which eventually traveled into my armpit by day 3. It wasn't until day 5 that all the pain was completely gone. I may have experienced fatigue the first two days also.
42 2021-04-10 feeling abnormal, restlessness, sleep disorder On 3/31/21 pt reports feeling "achy, like a wet blanket", headache, Restless and up every hour of th... Read more
On 3/31/21 pt reports feeling "achy, like a wet blanket", headache, Restless and up every hour of the night. "I felt like a freight train ran over me. " Treated for a sinus infection with Z-Pak. Notified he was covid (+) on 4/2/21. Fever, chills, dyspnea.
42 2021-04-14 sleep disorder Starting the night of the injection, my left arm gets numb from my elbow to my fingertips. Only my r... Read more
Starting the night of the injection, my left arm gets numb from my elbow to my fingertips. Only my ring and pinky finger are affected. The color and temp of the fingers are normal, but it feels like the circulation is cut off. If I get up and work it for about a half-hour it is completely normal (and stays so throughout the day). This wakes me up 3-4 times a night and continues to this day >3 weeks later. I started Zeposia medication a few days before this shot. I didn't have this effect with my 2nd shot in my other arm. I did use an ax to chop wood for 4 hours 2 days before the shot, and my arm was sore from that before the injection. It's possible this is unrelated to the shot altogether, and I did something to trigger some sort of carpal tunnel with the ax. I plan on discussing with my Dr at some point.
42 2021-04-15 sleep disorder Extreme soreness and discomfort at base of skull, sinus cavity?s below eyes felt inflamed and dried,... Read more
Extreme soreness and discomfort at base of skull, sinus cavity?s below eyes felt inflamed and dried, unable to sleep or get comfortable, alternated between feeling chills and feeling overheated, vomiting
42 2021-04-18 emotional distress Pt was found in severe distress in the bathroom by his wife. He couldn't walk or stand, complained ... Read more
Pt was found in severe distress in the bathroom by his wife. He couldn't walk or stand, complained of being dizzy with slurred speech and was throwing up a lot. 911 was immediately called. The EMTs during their assessment said his BP was normal but when he was asked his name, he started saying the alphabet"ABC... XYZ". He was transported by ambulance to ER. Cat scan showed he had a bleed on the brain. The doctors told us it was because he had very high blood pressure, however where the bleed was, they said he wouldn't need surgery and that the body would reabsorb it over time. He was admitted to the ICU and has been there ever since. Several days later, he started having difficulty breathing and they discovered several blood clots in his right leg that had broken off into his heart and lungs. He had emergency surgery to remove the clots in his heart (approximately 10) and was given heparin in small doses over an 8 hour period so that it wouldn't cause the bleed in his brain to increase. The doctor should fill in the rest.
42 2021-04-18 feeling abnormal Patient started 2 days after vaccine with shortness of breath and fever/chills. He says he was unabl... Read more
Patient started 2 days after vaccine with shortness of breath and fever/chills. He says he was unable to get out of bed for 24 hours. He said the rest of the week he didn't feel quite right. A week after the vaccine he started with red capillary veins popping up all over his legs. By Saturday his legs were purple and swollen. He has multiple tests run at the hospital. They doctor believes it is vasculitis that has resulted from patient getting the covid vaccine.
42 2021-04-18 feeling abnormal 3.5 hours after the vaccine shot my body shot full of adrenaline and my heart raced up to 150 beats ... Read more
3.5 hours after the vaccine shot my body shot full of adrenaline and my heart raced up to 150 beats per minute. I ended up checking myself into the emergency room 5 hours after the vaccine shot because my heart rate wouldn't slow down and my blood pressure increased. They found out my heart had gone into atrial fibrillation. I have had no known history of atrial fibrillation in the past and prior EKG's at physicals have been normal. I am an otherwise healthy individual.The doctor conducted an emergency Cardioversion to return the heart rhythm to normal.
42 2021-04-21 confusional state Flu-like symptoms. Weakness of muscles, soreness, tired. Missed work. Mental confusion. Sore left ar... Read more
Flu-like symptoms. Weakness of muscles, soreness, tired. Missed work. Mental confusion. Sore left arm where shot was received.
42 2021-04-22 feeling abnormal, insomnia Terrible loud ringing in ears and buzzing in head, hearing loss (high frequency ), fatigue, insomni... Read more
Terrible loud ringing in ears and buzzing in head, hearing loss (high frequency ), fatigue, insomnia, fever, chills, brain fog
42 2021-04-22 impaired work ability Bright, starry vision; could not use computer
42 2021-04-22 nervousness 42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. P... Read more
42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. Patient notified one of the observation nurses that he was not feeling well. The NP was assisting another patient but saw that the patient with his head back and pale. As soon as the NP was at the patient side, it was noted that the patient?s eyes were rolling back, his face was pale, and his lips were blue. The NP attempted a sternal rub with no response from patient. NP instructed police to please call Fire Rescue to transport patient to the ER. Patients left upper extremity was flexed at the elbow and stiff. At that time the patient was placed on the floor by several nurses and the paramedic and patient legs were elevated. Within 10-15 mins patient immediately sat up but was instructed to lay down. Patient was placed on 3L of O2 by nasal cannula and vitals were taken. Patient initial vitals 166/94 L Arm, 98% 3L O2, 84 Pulse and EKG was NSR. Patient no longer with pallor and lips were pink. Patient states that he isn?t feeling well and feels a nervousness throughout his body. Patient placed on stretcher in Trendelenburg. Vitals retaken, 137/97 BP, 98% 3L O2, 80 P. Patient pulses were thready and patient became diaphoretic. Fire Rescue arrive to site and transported patient to the ER. CNO and PM present during event and aware that patient transported to the ER for further evaluation
42 2021-04-23 feeling abnormal About six hours after receiving my shot, my arm became extremely sore, as to be expected. Circa 9pm... Read more
About six hours after receiving my shot, my arm became extremely sore, as to be expected. Circa 9pm I began to have significant trouble breathing, experienced acute pain in my abdomen, and began to hear ringing in my ears combined with feeling like I was going to pass out. I didn?t feel dizzy, rather I started getting tunnel vision that blocked out more of my field of view as the ringing increased. Circa 11pm, I lost consciousness while trying to move and collapsed on the floor. My wife called 911 while I was unresponsive, and I regained consciousness while being attended to by EMTs who checked my vitals. Around 12am I didn?t feel like I was going to lose consciousness again, and the EMTs recommended I be taken to the hospital. Since I was feeling better I politely declined. Today I am still feeling foggy and have joint pain (in addition to some bruising from falling after losing consciousness , but I no longer have the acute abdominal pain.
42 2021-04-28 feeling abnormal, insomnia Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and ting... Read more
Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and tingling, eye irritation, blurred vision, headaches, stomach discomfort.
42 2021-04-28 insomnia, sleep disorder initially began as what felt like jolts to my chest area from inside my chest over five days beginni... Read more
initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory. The X-ray and blood work came back negative per ER. Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour. 2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage. 3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs. 4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air. 6. Penis no longer has the same sensation and difficulty with erection.
42 2021-04-28 thinking abnormal, feeling abnormal, disturbance in attention, confusional state 3 hours after injection, felt like hands, arms, and legs were swelling (but they weren't), and had a... Read more
3 hours after injection, felt like hands, arms, and legs were swelling (but they weren't), and had a total brain fog, felt like I was either on drugs or had alzheimers. Paced around my house and backyard in a fog, confused, not clear of thought. Had a hard time spelling words in emails. Symptoms went away within 45-60 minutes and did not return. Since that time felt a little tired but nothing serious. Today I feel completely normal.
42 2021-04-30 memory impairment, insomnia Personality changes; headaches; extreme fatigue; Also, I was unaware on conversations that I had.; I... Read more
Personality changes; headaches; extreme fatigue; Also, I was unaware on conversations that I had.; I had high blood pressure and insomnia.; I had high blood pressure and insomnia.; It would seem that I had cerebritis from the shot; This is a spontaneous report from a contactable physician (patient). A 42-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL1284, expiry date not reported), via an unspecified route of administration, administered in right arm (at the age of 42 years old) on 08Jan2021 14:30 as a single dose for covid-19 immunisation. There were no medical history (reported as none) and no concomitant medications. The patient had no known allergies. The patient had no covid prior vaccination. The patient received the first dose of bnt162b2 (brand as Pfizer) for Covid-19 immunisation on 18Dec2020 (at the age of 42 years old) at 03:30 PM administered on the right arm. The vaccine was administered on a hospital. The patient had no other vaccine in four weeks and no other medications in two weeks. On 08Jan2021 11:00 PM, the patient experienced personality changes, headaches, and extreme fatigue, and also was unaware on conversations that he had. The symptoms lasted about 24 hours acutely, but for the 3 weeks afterwards, patient had high blood pressure and insomnia (2021). It would seem that patient had cerebritis from the shot since an unspecified date in 2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. There were no treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was recovered with lasting effects.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available clinical data, the event encephalitis most likely represented an intercurrent medical condition not related to vaccination with BNT162B2. This case will be re-assessed when relevant follow-up information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-05-05 impaired work ability Developed severe ongoing pain in left shoulder and arm which has persisted to current date. I had mi... Read more
Developed severe ongoing pain in left shoulder and arm which has persisted to current date. I had minor pain prior to second vaccination but beginning in the hours immediately following the second dose it became much worse. It migrates throughout the arm and shoulder throughout the day. I am taking prescription pain medication and muscle relaxers for the first time in my life. I could not go to work for 5 days, I now can make it through the day with heavy medication. I have also been prescribed physical therapy for 7 more weeks.
42 2021-05-05 sleep disorder, impaired work ability I had minor pain in left shoulder prior to the second injection. In the hours following the second i... Read more
I had minor pain in left shoulder prior to the second injection. In the hours following the second injection, the pain became severe and ultimately debilitating. I missed several days of work and was prescribed muscle relaxers and Norco, I have never taken this type of medication in my life. I cannot sleep more than 4-5 hours total per night due to pain. I have also been prescribed 7 weeks of physical therapy which provides relief at the moment but does not last.
42 2021-05-06 loss of personal independence in daily activities, poor quality sleep, impaired work ability, feeling abnormal Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and f... Read more
Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. His PCP sent him to the ED for evaluation. He was evaluated by neuro consult on 4/4, had an LP. THe LP only showed some elevated protein (somewhat traumatic tap based on 10 RBC in tube 4). MRI brain, cervical/thoracic spine was unremarkable. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. His PCP sent him to the ED for evaluation. He was evaluated by neuro consult on 4/4, had an LP. THe LP only showed some elevated protein (somewhat traumatic tap based on 10 RBC in tube 4). MRI brain, cervical/thoracic spine was unremarkable. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Now experiencing substantial disruption of the ability to conduct normal life functions, including the ability to work.
42 2021-05-09 anxiety Patient fainted after vaccine but was assisted to the floor. States that he has anxiety. Patient car... Read more
Patient fainted after vaccine but was assisted to the floor. States that he has anxiety. Patient carefully watched in observation and did deep breathing exercises. He stated he felt better and vitals were within normal limits
42 2021-05-10 insomnia Ringing and buzzing in ears and head; insomnia; high blood pressure; This is a spontaneous report fr... Read more
Ringing and buzzing in ears and head; insomnia; high blood pressure; This is a spontaneous report from a contactable consumer reporting for himself. A 42-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Apr2021 12:00 (Batch/Lot number was not reported) as 2nd dose single for covid-19 immunisation (Age at vaccination 42 years) . The patient medical history was not reported. The patient received the first dose of BNT162B2 vaccine on 14Mar2021. The patient's concomitant medications were not reported. The patient experienced ringing and buzzing in ears and head on 06Apr2021 08:00 with outcome of not recovered , insomnia on 06Apr2021 08:00 with outcome of not recovered , high blood pressure on 06Apr2021 08:00 with outcome of not recovered. All the reported events were considered Important Medical Events. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 22Apr2021 Nasal Swab. The patient received prednison and zolpidem (AMBIEN) as a results of the event. Information on Lot/Batch number was available. Additional information has been requested.
42 2021-05-16 feeling abnormal, sleep disorder, memory impairment At first it was a lot of joint and muscle pain all over, and then I got shingles by the weekend. I t... Read more
At first it was a lot of joint and muscle pain all over, and then I got shingles by the weekend. I thought they were bug bites and I wasn't sure where all the pain was coming from and I ended up in the emergency room where I was diagnosed with shingles. After my second shot I started getting shingles by laterally on my right side, but I was already on medication so it didn't get that bad. I also have a lot of joint pain and burning pain in my hands and wrists that shoot up my arms and haven't stopped since the symptoms started. It's much worse at night and keeps me up from sleeping. I have also have been very forgetful and my mind is always cloudy.
42 2021-05-17 impaired work ability Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) sever... Read more
Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) several weeks ago. Pt states that after receiving his 2nd dose on 05/06, he noticed his leg stiffness got significantly worse. He tells me that he tried to "push through the pain" and mow his lawn but had to stop d/t severe cramping of the LLE and pelvis. He states he rested his leg and went to bed, and when he woke up he noticed that his left leg was severely swollen. Pt decided to take 3 days off work to continue to rest the leg, but ultimately came in for evaluation at the suggestion of his coworkers. Pt denies fever, chills, chest pain, or SOB. He denies history of smoking, prior clotting, long car travel, air travel, leg injury, or recent surgery. On exam, the left lower extremity is significantly swollen, erythematous, and hot to the touch. Physical exam otherwise unremarkable. Will admit to the hospitalist service for further medical management. ED Course: Hypertensive with BP 170/93. Initial workup significant for WBC 13, K 3.3, glucose 159. CT chest/a/p with findings suggestive of multiple PE's of the left and right lower lobes as well as extensive LLE DVT extending slightly into the IVC. Trop <0.03. BNP 66. ECG shows sinus tachycardia.
42 2021-05-18 sensation of foreign body Sore shoulder for a week after the shot. Also had a lump in my throat for about 2 weeks after. Felt ... Read more
Sore shoulder for a week after the shot. Also had a lump in my throat for about 2 weeks after. Felt like a sick lymph node, but no adverse affect to me, I didn?t feel sick at all after the shot.
42 2021-05-20 loss of personal independence in daily activities Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild na... Read more
Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild nausea. Within an hour started having trouble with focusing his vision. Was given IV fluids at hospital in ER 5 hours after the injection, while leaving the hospital developed a slight limp on right leg Felt feverish when he got home, took Tylenol when he got home. Noted extreme fatigue. The next morning was lethargic, dizzy and right side of face felt heavy, around 11 am. Called for a telemedicine visit around 12:30p. Became weak and unable to use right side of body, upper and lower extremities and right side of face was drooping, visible to wife. Wife had support of right side of body to move around. Went to urgent care around 2p. During urgent care evaluation, his vision became more impaired and speech became unclear, had to really focus to speak. Transferred to ER. Lost ability to write name, couldn't respond when asked for SSN. Admitted as a "stroke 4". Had CT scan, CT angiogram, MRI, blood labs, cognitive tests, neurologic tests. Neurology consult. Had lost sensation to heat and pressure. All imaging and labs were normal. After MRI, had convulsions. Wasn't dx'd as a seizure. Neck felt tight afterwards. Admitted to hospital x 1 week. Had a burning, red, rash on hands, feet. No bumps, hives, but just a "splotchy" red discoloration on surface of skin that would burn and itch, often flaring at night. Rx'd ativan. Checked for autoimmune disease, Bell's palsy, followed by neurologists, repeat MRI normal. Started to improve, discharged after one week with no clear diagnosis. Discharged to rehab facility. Patient preferred to transfer care to outpatient rehab service closer to home with more social support. Repeat hospitalized 3 weeks later, less extreme, went back to ER, stroke eval neg. Developed more aphasia. Called back to ER for further evaluation of C-spine due to mild abnormality on first scan. On further evaluation not thought to be connected to symptoms. EEG report pending. +Right hemiplegia, aphasia persists. +Rash, itching, burning persist.
42 2021-05-22 impaired work ability Stayed home from work the Monday I got the shot as well as the following Tuesday. Woke up Wednesday ... Read more
Stayed home from work the Monday I got the shot as well as the following Tuesday. Woke up Wednesday with my By Sunday the 16th I began having pressure and some irritation. Went to urgent care Monday the 17th. They said I had pink eye. I immediately began using the prescribed eye drops. It's important to mention no one in my family has or had pink eye nor have I knowingly come in contact with it. By Friday the 21st there was no improvement from the medication and I began t developed severe light sensitivity and blurry vision. I went back to urgent Care 5/22. They prescribed a different medication for pink eye and referred me to an eye specialist.
42 2021-05-22 insomnia - Uncomfortable feeling in chest around 8pm on 4/24, tried to sleep it off - Couldn't sleep very wel... Read more
- Uncomfortable feeling in chest around 8pm on 4/24, tried to sleep it off - Couldn't sleep very well, and woke up with a tightness of chest and unable to draw a full breath - Went to county ER and was advised I was suffering a heart attack (non stemi) (troponin levels were over 7,000) - transferred to hospital for further diagnosis and treatment - Had a echocardiogram, cardiac catheridisation and MRI, which found that I had inflammation of my heart muscles - treated symptoms with medication and was discharged after an overnight stay
42 2021-05-22 sleep disorder I woke up from sleeping with one big cough. I felt chest pressure and some pain, trouble breathing, ... Read more
I woke up from sleeping with one big cough. I felt chest pressure and some pain, trouble breathing, nausea but did not vomit. My wife called 911 and I was admitted to the hospital.
42 2021-05-26 disturbance in attention, restlessness pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restl... Read more
pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restlessness; difficulty concentrating; gas; extreme thirst; headache; shakes; This is a spontaneous report from a non-contactable other hcp (health care professional). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262) via intramuscular route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 42-year-old), at a single dose for covid-19 immunization in doctor's office/urgent care. The patient had no allergies and medical history. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246) via intramuscular route of administration, administered in left arm on 11Jan2021 at 11:45, at a single dose for covid-19 immunization and received Influenza vaccine (within 4 weeks of vaccine) on an unknown date for immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 19:00, after receiving the second dose of vaccine the patient experienced fever, chills, joint pain, muscle pain, fatigue, restlessness, difficulty concentrating, gas, extreme thirst, headache, shakes and on 03Feb2021 (24 hours later), the patient experienced pain at injection site. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
42 2021-05-26 feeling abnormal Weakness began after first dose and was accompanied by malaise. Second dose intensified symptoms an... Read more
Weakness began after first dose and was accompanied by malaise. Second dose intensified symptoms and progressed to body aches, loss of taste and smell, episodes of sweating, shivering and brain fog.
42 2021-05-27 insomnia I almost immediately started getting soar in my arm. After a few hours my arm down to my elbow was ... Read more
I almost immediately started getting soar in my arm. After a few hours my arm down to my elbow was VERY soar, my back around my shoulder blade became soar, and over my shoulder up to my neck into the left side of my head was very soar and achy. Headaches were present most of the first day. That night, around supper time I felt nauseous and then had some severe stomach cramps. I didn?t sleep well and woke up with the same bad pain from my elbow to my shoulder and also my shoulder blade to my neck and head. Most of the symptoms were gone after 48 hrs.
42 2021-06-02 sleep disorder Skin began to ache and became sensitive about 11 hours after vaccine was received. Began having chi... Read more
Skin began to ache and became sensitive about 11 hours after vaccine was received. Began having chills, lethargy, body aches (it felt like both inside of body and outside of skin), nausea, and high fever. Took Tylenol and Advil to attempt to alleviate symptoms. Could not get to sleep until about 12:30 a.m. and woke up at 2:30 a.m. with headache, extreme chilling, and intense body aches. I didn't know if I could walk. I put a sweatshirt and a coat on, and my teeth were chattering uncontrollably. I can't remember the last time that I was that sick. I contemplated going to the ER but didn't think I could drive. The entire day was a headache, nausea and lethargy. When at the clinic, I stated that I had heard that there could be some minor side effects with the 2nd shot and was told, "Nah, people make things up." I'm so glad that I'm vaccinated, but people need to be forewarned of those kinds of side effects. They have to be aware because that was dangerously sick and was totally unprepared to combat it. 103+ degree fever and this kinds of symptoms aren't things that a person should have to try to make it through alone.
42 2021-06-07 nervousness decline in muscle function; sick; aches and pains all over his body; did not feel well; muscle mass;... Read more
decline in muscle function; sick; aches and pains all over his body; did not feel well; muscle mass; scared; he really thinks the biologics in the Humira he takes and the biologics in the vaccine are counter acting each other and putting him into a major flare; he really thinks the biologics in the Humira he takes and the biologics in the vaccine are counter acting each other and putting him into a major flare; generalized aches and pains; This is a spontaneous report from a contactable other HCP (patient's mother). This other HCP reported for patient (reporter's son). A 42-year-old male received (age at vaccination: 42 year) first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0169 and expiry date was reported), via an unspecified route of administration, in Arm Right, on 22Apr2021, as a single dose for COVID-19 immunization. The patient's medical history included spinal muscular atrophy, osteoporosis, and ankylosing spondylitis. Concomitant medications included adalimumab (HUMIRA) which was started about a year and a half ago for ankylosing spondylitis, denosumab (PROLIA) which started about a year ago for osteoporotic bones and Evrysdi: (Start: Dec 2020 Stop: Ongoing). This female consumer reported her son/patient received his first injection of the Pfizer covid-19 vaccine on 22Apr2021. The patient has been taking Evrysdi over the past year and experienced some gains in muscle function. After receiving the Pfizer covid-19 vaccine, the patient began experiencing a decline in muscle function described further as losing all the muscle function he had gained while taking Evrysdi. The reporter/mother said her son has been sick ever since receiving the Pfizer covid-19 vaccine and was experiencing flare-up and been prescribed prednisone as treatment. The reporter stated that since their son got the vaccine, he had gone downhill and clarified he had generalized aches and pains all over his body since the vaccine, mostly in the spinal and sacral area, but they were also in his arms, elbows, everything ached, he really did not feel well and could not do anything he used to do after the vaccine. He was starting to gain muscle mass and everything and since the vaccine all that was gone. The reporter stated they took him to both doctors, and they have been zooming with him and want him to get the second dose. He really thinks the biologics in the Humira he took and the biologics in the vaccine were counter acting each other and putting him into a major flare. The patient was treating symptoms with a dose pack of prednisone, getting a little better but did not have strength back at all. The reporter also stated that prior to this vaccine, the doctors were saying was an anomaly, the newer medication he was on was supposed to stop the progression of muscular dystrophy and he was doing so well on the medication until he got the vaccine. The patient was scared he was going to get worse; they were looking for information about getting the second dose, stated their doctors did not have a lot of information. The reporter asked could the Pfizer COVID-19 vaccine reverse the progress our son made in his muscles while taking Evrysdi for spinal muscular atrophy and should her son get the second dose after what has happened after the first dose of the Pfizer covid-19 vaccine. Also asked how long you could wait to get the second dose of the Pfizer covid-19 vaccine and was there an interaction with Humira. The reporter got response that spoke per FAQ and referred to HCP. Outcome of the event generalized aches and pains was not recovered and for all other events, it was unknown. Additional information has been requested and will be provided as it becomes available.
42 2021-06-09 feeling abnormal 3/21/21 - SVT event with easy exercise (2 weeks afer first vaccine) 3/23/21 - worst SVT event of lif... Read more
3/21/21 - SVT event with easy exercise (2 weeks afer first vaccine) 3/23/21 - worst SVT event of life with intense exercise. stopped exercising 4/12/21 - PVC 4 a minute never had them before. irregular rythm. feeling heart irritation (2 weeks after second dose) 4/25/21 - continues heart inflamation issues pvc's, rythm issues, chest tighteness, complete uncomfortableness 5/14/21 - after 3 weeks of absolute hell worst feeling of my life with my heart inflamation/irritation. test not showing anything I started 600mg of Ibuprofen 3 times a day. 5/18/21 - Cardiac MRI but most irritation was going away after ibuprophen 5/25/21 - EP study and SVT ablation. most issue had subsided before the proceedure from ibuprophen 6/5/21 - inflamation symptoms returned. possible due to proceedure 6/9/21 - 600mb ibuprohen 3x a day started again. conidtion starting to improve again I was running 40 miles a week for over 4 years with no issues. This all blew up shortly after starting vaccination and has been the most horrible experience of my life by far!
42 2021-06-09 impaired work ability, motion sickness Motion sickness without motion and vertigo lasting from June 1st through June 10th. Affects abilit... Read more
Motion sickness without motion and vertigo lasting from June 1st through June 10th. Affects ability to function properly at work.
42 2021-06-22 impaired work ability I was giving my second dose of the Pfizer at the drug store, the shot was administered and a little ... Read more
I was giving my second dose of the Pfizer at the drug store, the shot was administered and a little dribbled out so the pharmacist gave me a double dose. I don't believe this was necessary and could have been avoided if the pharmacist would have followed better protocol administering the due to the poor quality of the administration of the shot I missed three days of work. My arm was unusable for 3 days.. I had some mucus buildup in my lungs.. but luckily after 5 days of good rest I'm okay.
42 2021-06-22 impaired work ability The pharmacist carelessly gave me the second shot of my Pfizer.Some dribbled out of the arm.. withou... Read more
The pharmacist carelessly gave me the second shot of my Pfizer.Some dribbled out of the arm.. without asking my permission he gave me a second dose Basically overdosing me. My tongue felt strange my lips sweated. The injection site hurt for 7 days and is still uncomfortable. My lungs have been extra congested with mucus. I missed 3 days of work due to the inability to use my left arm (sore) and general fatigue. Experienced strange twitching of the left arm muscle at injection site on the third day.
42 2021-06-23 feeling abnormal Heart rate speed up to over 180 beats a minute. Fatigue. Out of breath. Felt horrible for two d... Read more
Heart rate speed up to over 180 beats a minute. Fatigue. Out of breath. Felt horrible for two days prior to ending up in hospital for heart.
42 2021-06-24 loss of personal independence in daily activities, anxiety For 1st vaccine- I experienced first vaccine- one week later I got sick for 15 days, symptoms like I... Read more
For 1st vaccine- I experienced first vaccine- one week later I got sick for 15 days, symptoms like I had Covid, body aches, chills. For 2nd vaccine- after one week I experienced had excruciating headaches and shakiness that do not go away. I take Tylenol for pain and as a result have upset stomach. I went to see my PCP who performed exams, lab work, x-rays, CT scan of the head, CT scan of the abdomen and my doctor does not find anything wrong for me. To this day I continue wit the headaches that do not go away. I do not feel well to do my daily living activities and I get anxiety. I feel very tense and frustrated due to my symptoms. I do not have the lot # for my vaccines to provide.
42 2021-07-01 feeling abnormal Arm really sore; Felt like he had a cold and felt like he was coming down with the flu; Felt like he... Read more
Arm really sore; Felt like he had a cold and felt like he was coming down with the flu; Felt like he had a cold and felt like he was coming down with the flu; Tired; Got pretty sick after the second vaccine; He just felt blah; This is a spontaneous report from a contactable consumer (patient wife). A 42-year-old male patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date, at the age of 42-year-old, (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. The vaccine was administered at airforce base. The patient medical history and concomitant medications were none. No other additional vaccines administered on same date of the suspect. No other vaccine was administered within 4 weeks. Historical vaccine included first dose of BNT162B2 (as reported), via an unspecified route of administration on an unspecified date, at single dose for COVID-19 Immunization and the patient had no reaction. The reporter mentioned that her husband got pretty sick after the second vaccine. The patient was still able to work but his arm was really sore, felt like he had a cold and felt like he was coming down with the flu, and he was tired but not throwing up or anything. He just felt blah. This only lasted 24 hours and then he was fine. The patient did not take any treatment and did not had emergency room/physician office visit and it was gone the next day (as reported). The patient did not have any relevant tests performed. The reporter stated that she guessed it is normal for the second one (second dose of vaccine). The outcome of the events was recovered. Information on the lot/ batch number has been requested.
42 2021-07-02 disorientation, loss of personal independence in daily activities Received first dose of Pfizer on 6/4. Four days later (6/8) I developed debilitating dizziness and ... Read more
Received first dose of Pfizer on 6/4. Four days later (6/8) I developed debilitating dizziness and accompanying nausea. After 24 hours of vomiting I visited the emergency room (6/10) and received IV fluids. Head CT scan, ECG, blood, and urine all tested negative. Nausea subsided but dizziness continued. Consulted ENT on 6/15 and was diagnosed with vestibular neuritis. Confirmed with ENG/VNG testing on 6/25. As of 7/3 I am still experiencing disorientation when moving head. Activities like driving and grocery shopping are difficult. Next step will be vestibular rehabilitation therapy. Not sure if this will be a permanent condition.
42 2021-07-08 anxiety Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightnes... Read more
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: patient describes shakiness, anxiety, swelling under and around arm, and pain. Reports taking 600 mg ibuprofen on tues and wed (600 mg po bid on Tues and Wed) "went away a bit and came back a little bit"
42 2021-07-09 disturbance in attention Rather intense headache and fatigue night of vaccination, but that was expected. Since then (from d... Read more
Rather intense headache and fatigue night of vaccination, but that was expected. Since then (from day 2 up till now), persistent headache (dull at the back of the head), neck and shoulder ache. Very annoying and makes it difficult to think and/or concentrate. Also having strange inflammation (both in the head and cardiac) and erratic heartbeat, likely contributing to increased blood pressure.
42 2021-07-20 anxiety, sleep disorder Had typical sore arm 1-2 days after. Then went away. Started noticing my arm was sore again April 9-... Read more
Had typical sore arm 1-2 days after. Then went away. Started noticing my arm was sore again April 9-10th. However, woke up on April 11th with a high pitched changing ringing in my right ear. Over the course of about 3-4 weeks ringing became louder and more intense. Culminating to such a loud ringing in my ear April 29-May 5 or so. Was so loud I could not get normal sleep for almost a month. Went to see my primary doctor who didn't seem worried about it. Was told it was anxiety. Went to see an Audiologist to have my hearing checked. Hearing was fine. Went to see an ENT and confirmed hearing was fine and no infection. Was told the Tinnitus would go away or not go away. No likely cause. Over the last 3 months since the loud ringing the sound has abated ever so slightly week by week. I can tolerate quieter environments ever so slightly. I hear multiple tones. At first it was a loud screeching modem type sound. Then that went away/got quieter. Was replaced with a loud EEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE. That got quieter as well then was replaced with a high pitched hissssssssssssssssssssssssssssssssssss, which has changed/got quieter but is still around. There is a third sound that sounds like grinding metal ever so slight. I noticed as the sounds dissipated I could pick up sounds that were not audible. I first remember hearing the fridge running, then hearing crickets, to my PC fan etc. As the ringing got quieter I could pick up minute sounds again in my right ear. Still the ringing is there.
42 2021-07-21 depression Have not yet sought out medical attention, joint pain, fatigue (had these issues, but they were exac... Read more
Have not yet sought out medical attention, joint pain, fatigue (had these issues, but they were exacerbated). Pain in knees, back, and hands (marked increase in pain). Depression has been getting much worse, have sought therapy (father died recently, so can't point to vaccine specifically, may be a coincidence).
42 2021-07-21 impaired work ability Severe headache, had to take off work 2 days
42 2021-07-21 loss of personal independence in daily activities I started with left sided chest pain, which was worse when I was laying down or taking deep breaths.... Read more
I started with left sided chest pain, which was worse when I was laying down or taking deep breaths. I was out of the county when I experience it. We came home early. Motrin helped a little. I keep getting worse I went to my doctor, and they did an x-ray and EKG which both came back normal. Those were done on May 20th. By the 23rd I couldn't walk with chest pain. The cardiologist did a scan of my heart, and they found a small left sided pleural effusion. They still do not know why I have that pleural effusion. They check my labs which I had a small elevated inflammatory lab. Over the next few days after that it went way, and I was able to go back to my normal activities. I have not had problems since.
42 2021-07-27 feeling abnormal All issues are still present to this day: Fatigue, lethargic, Brain fog, mild Vertigo, hands and le... Read more
All issues are still present to this day: Fatigue, lethargic, Brain fog, mild Vertigo, hands and leg numbness (feels like they are asleep), out of breath, can't think of simple words or statements, forgetting what I am doing in the middle of a process (simple stuff), heart arrhythmia.
43 2021-01-04 anxiety Client started c/o headache, tightness in chest, and was anxious. He was helped out of his truck and... Read more
Client started c/o headache, tightness in chest, and was anxious. He was helped out of his truck and taken to triage where they administer o2 4Liters via nasal cannula. He self administered his albuterol inhaler. He admits to having anxiety issues. He was monitored for 20 mins and no other problems arose and he felt better after that. He has had no other problems related to the vaccine since that occasion. He did not contact his doctor.
43 2021-01-04 anxiety Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period ... Read more
Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period and was transferred to the treatment area in the vaccine clinic. Vital signs were assessed by a Registered Nurse and a Physician. Oxygen saturation was noted to be 88% on 2 liters of O2 by nasal cannula. Verbal order received at 10:03am from Physician and EpiPen administered to right thigh with improvement of symptoms. She was transferred to the Emergency Department (ED) via stretcher. In the ED, she was re-dosed with an EpiPen secondary to her airway type symptoms. She was reevaluated after 15 minutes and received Solu-Medrol, Pepcid, Benadryl IV, as well as IV fluids. She also received Ativan for her generalized jitteriness and anxiety. She improved and felt significantly better at approximately 11:43am. She was monitored for 3 hours in the ED and was discharged home at 3:34pm in good clinical condition and advised to continue to take Benadryl as needed. She carries and EpiPen on her person and was advised to return immediately if symptoms return.
43 2021-01-06 anxiety SWEATING ANXIETY, HEADACHE, NAUSEA, SWEATING AT APPROXIMATELY 1410. HR 100-105. OBSERVED 5 MINUTES. ... Read more
SWEATING ANXIETY, HEADACHE, NAUSEA, SWEATING AT APPROXIMATELY 1410. HR 100-105. OBSERVED 5 MINUTES. DENIED SOB. NO TACHYPNEA, RASH OR ORAL SWELLING. NO AUDIBLE WHEEZING OR STRIDOR. SENT TO ER AT 2:19 FOR OBSERVATION. OBSERVED 1 HOUR.
43 2021-01-07 feeling abnormal 100.6 Fever, body aches, mental fogginess
43 2021-01-07 feeling abnormal 100.6 Fever, body aches and mental fogginess
43 2021-01-07 feeling abnormal Fever, body aches, Mental fogginess
43 2021-01-07 impaired work ability fever, muscle aches, joint pain staying home
43 2021-01-10 confusional state Confusion, Dizziness, 11:33 Tingling in forehead BP 137/87 HR 91 O2 98% 11:48 138/84 HR 79 O2 100%.... Read more
Confusion, Dizziness, 11:33 Tingling in forehead BP 137/87 HR 91 O2 98% 11:48 138/84 HR 79 O2 100%. Felt better Narrative:
43 2021-01-11 anxiety myositis; This is a spontaneous report from a contactable physician. A 43-year-old male patient re... Read more
myositis; This is a spontaneous report from a contactable physician. A 43-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date in Dec2020 reported as around the end of December, at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date after he received the vaccine he had right arm pain and swelling (states it was in his bicep brachial radialis in the muscle) which is the opposite arm of the injection site. He had an MRI done on an unknown date that showed myositis. He thinks could be due to the vaccine since it started two days after he received the vaccine. His pain peaked at about a week and a half and now the pain was improving and the swelling was down. He still had function in the right arm but when he strained it would hurt. His concern was that the reaction may be an autoimmune reaction and the first response was muted. He was worried the second dose may elicit a larger response. At the time of the reporting the patient was recovering from the events. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the available information, the company considers that a causal relationship between the myositis and vaccination with BNT162B2 cannot be excluded. Additional information regarding onset latency, relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
43 2021-01-13 feeling abnormal Sore throat, chills, headache, body aches, cough, sneezing, runny nose, fatigue, mental fogginess, a... Read more
Sore throat, chills, headache, body aches, cough, sneezing, runny nose, fatigue, mental fogginess, and soreness at the injection site.
43 2021-01-17 sleep disorder The day after receiving the second vaccination, I began to have mild intermittent abdominal pain2-3/... Read more
The day after receiving the second vaccination, I began to have mild intermittent abdominal pain2-3/10. The pain gradually increased, became more intense, and more constant. Mild fever and chills started happening, and I took Ibuprofen. By about 4 days after the vaccine, the abdominal pain was severe enough that I had some difficulty walking and I couldn?t sleep at night. Pain was 6-8/10. I went to the ER, and CT scan with IV contrast showed 18 mm appendicitis. I underwent laparoscopic surgery and it was found to be perforated. It was removed. I am currently recovering in the hospital. I received the vaccine as a health care provider at my hospital, specifically I am a practicing pediatrician physician for over 10 years.
43 2021-01-19 impaired work ability A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i ... Read more
A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i noticed that my heart rate would increase when walking around and that the heart beat felt heavy. If i was lying down the heart rate would be slightly elevated compared to normal resting heart rate. The heart rate beat felt heavy. I went to bed early and slept through the night. I woke up the next morning and felt fatigued, dizzy, slight body ache and nauseated. no fever, no headache. i tried to take a shower but symptoms got worse. i was unable to go to work that day. I took a few naps during the day and by late afternoon most symptoms where going away. the last symptom was the issue with the hands and feet. Heart rate returned to normal. The next day i was able to return to work.
43 2021-01-20 nightmare, sleep disorder I had a very bad dream over night. It was a nightmare. I woke up and went back to sleep 3 times and ... Read more
I had a very bad dream over night. It was a nightmare. I woke up and went back to sleep 3 times and the night continued each time until about 4am. Then I couldn't sleep again.
43 2021-01-20 sensation of foreign body After the required wait period of 15 minutes I started to drive back home which is 77 miles from the... Read more
After the required wait period of 15 minutes I started to drive back home which is 77 miles from the hospital that administered the vaccination. Around 15 minutes down the road I started feeling like something was caught in my throat and was coughing a little. At that time I decided to turn around and go back to the hospital. I took an oral Benadryl 25mg and decided to wait in my car and see if it was something else. After 30-45 minutes I took a drink of water and realized I was having trouble swallowing. I then preceded into the ER and was admitted immediately. In the ER, they started an IV, administered Benadryl, methylprednisolone and a bag of saline. The physician discussed with me and we agreed to hold the Epinephrine to see how I reacted to the previous medications. I was then monitored for a couple hours then released with a prescription of Prednisone 60mg for 5 days and an EpiPen. One day out, no new symptoms besides injection site pain.
43 2021-01-21 feeling abnormal Body aches, tired, hard time catching my breath, mind foggy
43 2021-01-26 disorientation, feeling abnormal numbness in right side of face and right arm; hard time swallowing; felt foggy; dizzy; disoriented; ... Read more
numbness in right side of face and right arm; hard time swallowing; felt foggy; dizzy; disoriented; This is a spontaneous report from a contactable consumer. A 43-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on arm left from 11Jan2021 to 11Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was reported as none. There were no concomitant medications. The patient states about 24 hours later he felt foggy, disoriented, and dizzy (all three occurred on 12Jan2021), states he then woke up at 3 am this morning and had a lot of numbness on right side of face and arm and had a hard time swallowing (both occurred on 13Jan2021), states a couple hours later he went to hospital, went to ER and had to do an MRI, states the MRI of brain and neck came back clear and checked out, states doctors concluded it was an adverse reaction to vaccination. Outcome of the events was recovered on 13Jan2021. Information on the batch/lot number has been requested.
43 2021-02-02 feeling abnormal I had some sort of reaction. I was glad to get the shot and was not nervous about getting the shot.... Read more
I had some sort of reaction. I was glad to get the shot and was not nervous about getting the shot. 5 minutes after the shot I felt something cold go down my left arm from my shoulder to my hand. A minute or two after that both my hands went numb, then both my arms went numb. I asked others around me if anyone felt anything and everyone else was fine. A minute or two after that both my legs went numb. I started to black out but made it to a chair before this happened, I drank some cold water and felt awake about 5 minutes later. 30 minutes after that i felt comfortable enough to walk. For the rest of the day i felt like i was legally drunk and felt lots of pins and needles on the back of my hands and feet. I did not feel dizzy or nauseous at that time. i also felt a lot of pressure on the inside of my skin all over my body. I've never felt anything like that and it was a bit uncomfortable. The next day i was too dizzy to walk without becoming very nauseous. I still had pins and needles on my feet. i had chills as well which i guess is a good sign. my appetite was fine. i felt clear-headed as well. Two days after the shot i felt slightly dizzy and by the third day i felt fine except for minor muscle cramps all over my body. For the three days after the shot i also had some pretty strong forearm and calf muscle cramps and my arms (biceps and triceps) felt pumped up like i just had a great arm workout, but they weren't swollen at all.
43 2021-02-04 confusional state Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal respo... Read more
Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal response (previous history of syncope with vaccinations/procedures). Patient received 1st dose of Pfizer vaccine around 11am today. Within 2 minutes of receiving the vaccine, he started to feel dizzy and passed out for around 45 secs. He had cold extremities, looked pale and was sweating. He was immediately transferred from chair to floor and his legs were raised. Cold towel was placed on his head. He regained consciousness but was confused for less than a 1min. Vitals were checked and his BP was 95/50's and HR was around 56. Pulse O2 was 99% during entire event. He was able to converse well after that and was oriented. He informed having anxiety/panic attacks, had taken his medication that morning. He reported similar syncopal episodes in the past. He was monitored in same posture. He was gently hydrated orally with water and soda. He was given sublingual zofran due to nausea and retching. He did not vomit. We continued to monitor his BP on regular intervals. He had slow improvement in BP and after 2 hrs while sitting his BP was 104/65, pulse 56/min (reports being an athlete and previous records show baseline bradycardia). He denied any symptoms and was awake, alert, oriented. As he was not accompanied by anyone, his wife was contacted who came to clinic in 10mins and helped to drive him home. He was transported by wheelchair till entrance of clinic. He reported feeling better and thanked for helping. He does not have any contraindications to receive 2nd dose of vaccine.
43 2021-02-04 impaired work ability Left arm at injection site felt cold after five minutes after injection. Lasted a minute. Dizziness... Read more
Left arm at injection site felt cold after five minutes after injection. Lasted a minute. Dizziness. Has lasted so far four hours Jaw bones hurt Running temperature. Started three hours after injection. Current temp is 100.2. taken orally at 4:15pm PST I called in sick for work, stating it's vaccine related for my shift on 2/5/2021. My shift would have started at 11:00pm.
43 2021-02-05 disorientation Patient felt warm, off balance, disoriented, and was sweating profusely after his vaccination. This ... Read more
Patient felt warm, off balance, disoriented, and was sweating profusely after his vaccination. This reaction started less than 5 minutes after administration of the Pfizer vaccine. EMS took the patient's blood pressure. The first reading was 80/50 mmHg and the second reading was 104/66 mmHg. After having water and sitting for 30 minutes the patient felt fine.
43 2021-02-06 impaired work ability 11/17/20 J&J Ad26.CoV2.S vaccination. The next morning patient began mild achiness & fatigue that ... Read more
11/17/20 J&J Ad26.CoV2.S vaccination. The next morning patient began mild achiness & fatigue that lasted 48 hours and mild arm pain that lasted 72 hours. severity: Gr 1 1/5/21 Pfizer #1. Sudden onset at 10 hours of shaking chills, temperature 103+, severe myalgias and malaise. Severe for 36 hours. 80% better at 48 hrs; at baseline by 72 hours. 1/26/21 Pfizer #2. 10 hours later again noted shaking chills, temperature >103, severe myalgias and malaise. 1/27 could not work. Worked 1/29 & 1/29 at half capability. 1/30 & 1/31 felt worse with temperature >103 both days. 2/1 had to leave work early; noted multiple aphthous ulcers on palate and tongue. Continued to have myalgias and temperature 102-3 through 2/3; tempera
43 2021-02-08 excessive sleepiness Approx 10-15 minutes after the shot client started c/o severe nausea and did vomit. He was sweating,... Read more
Approx 10-15 minutes after the shot client started c/o severe nausea and did vomit. He was sweating, and c/o throat tightening, was pale and still nauseated. Benadryl 50 mg Im given. His brother in law was called to drive him home. After he was stable, and no longer c/o any symptoms he was release to his brother-in=law. He says he went home and slept 3 hours and then slept til noon the next day which is not normal for him.
43 2021-02-11 sleep disorder, impaired work ability Headache (severe), muscle aches (mild), chills (mild), and fatigue (mild). Symptoms lasted approxima... Read more
Headache (severe), muscle aches (mild), chills (mild), and fatigue (mild). Symptoms lasted approximately 48 hours after onset. Could not work/bedridden for approximately 36 hours. Tylenol did nothing to help, ibuprofen effective to lessen the headache so I could sleep.
43 2021-02-16 abnormal dreams, insomnia, hallucination hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth;... Read more
hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth; muscle soreness; joint pain; headache; nausea; This is a spontaneous report from a contactable consumer reporting for self. A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 01Feb2021 08:15 at single dose for covid-19 immunisation. Medical history included allergies to azithromycin, erythromycin, amoxicillin, penicillin. Concomitant medication included influenza vaccine inact split 4v (FLUZONE), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). The patient experienced Insomnia, extremely vivid and realistic dreams, hallucinations 16-20 hours after injection (that night), metallic taste in mouth, muscle soreness, joint pain, headache, nausea, drowsiness for approximately 36 hours on 01Feb2021 11:00. Outcome of events was recovering.
43 2021-02-17 anxiety Vomiting. He anxiety with symptom vomiting. Heart rate decreased as relax sat in lobby away from pe... Read more
Vomiting. He anxiety with symptom vomiting. Heart rate decreased as relax sat in lobby away from people and felt better went home
43 2021-02-19 impaired work ability Entire body rash for 7 days, started at my neck and then to involve my entire body. Fever 101.8-102... Read more
Entire body rash for 7 days, started at my neck and then to involve my entire body. Fever 101.8-102.9 for 3 days with 1 gram Tylenol and Benadryl. Weakness for a week, unable to work.
43 2021-02-25 anxiety Pt reported increased HR, anxiety, and sweaty.
43 2021-03-02 feeling abnormal After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensati... Read more
After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensation done both arms and my tounge. My heart was beating fast and I was struggling to get my breathing under control. My throat also got tight or warm and that feeling seem to go down through my chest. The monitor told me to take off my mask and gave me water. Shortly after I started to gag and almost vomited. The monitor checked my blood pressure and it was 180 over 120. I was admitted to the ER. I stayed there for about an 90 minutes as was released as the symptoms seemed to leave. While driving home many of the symptoms resurfaced. When I returned home I took a zyrtec and an anxiety medication. A day after I am light headed and a little nautilus but otherwise ok.
43 2021-03-02 feeling abnormal Day after second vaccine dose, patient began having extreme fatigue, overall body chills on/off thro... Read more
Day after second vaccine dose, patient began having extreme fatigue, overall body chills on/off throughout every day, joint aches in fingers and ankles, bilateral calf pain, wheezing, heart burn, brain fog, cold feeling in feet. These occur throughout every day, on and off. We are now at week 5.
43 2021-03-04 nervousness Per patient, left site feeling fine, after being monitored for 15 minutes per protocol. Claims he fe... Read more
Per patient, left site feeling fine, after being monitored for 15 minutes per protocol. Claims he felt light headed, nervous, and blacked out and hit a car in front of him. Per client, he was taken to the hospital and all tests came back clear. He later walked to another mini pod and reported the incident to them.
43 2021-03-08 excessive sleepiness Bloody diarrhea. Blood dripping from anus. Fever. Lethargic. Sleeping constantly. Body aches all ... Read more
Bloody diarrhea. Blood dripping from anus. Fever. Lethargic. Sleeping constantly. Body aches all over. Extreme abdominal pain.
43 2021-03-10 impaired work ability Narrative: As written per ED notes dated 3/9/2021: This 42-year-old female is here for evaluation ... Read more
Narrative: As written per ED notes dated 3/9/2021: This 42-year-old female is here for evaluation of increasing nausea and vomiting. The patient has gotten worse the past 24 hours. She got her second COVID-19 shot yesterday here at the VA Medical Center. She is complaining of consistent nausea and vomiting and can't keep any fluids down. She is here for evaluation of possible dehydration and weakness. The patient feels markedly improved after oral Zofran. I counseled her at length about this is a possible intolerance to the second Covid 19 immunization. She will be discharged home with Zofran 4 mg tablets 3 times a day as needed for nausea #20, increase fluids and rest, no work until Thursday, March 11, 2021. First covid19 vaccine: 2/15/2021, no adverse events Second covid19 vaccine 3/18/2021: presented to ED
43 2021-03-11 impaired work ability significant persistent nausea unrelieved by zofran. no vomiting. same reaction with vaccine on 2/7 b... Read more
significant persistent nausea unrelieved by zofran. no vomiting. same reaction with vaccine on 2/7 but reaction is more severe this time causing work loss
43 2021-03-18 impaired work ability Severe spinning, nausea, vomiting, occurred at 2:15 a.m. while on duty, was transported to ER and di... Read more
Severe spinning, nausea, vomiting, occurred at 2:15 a.m. while on duty, was transported to ER and diagnosed with Peripheral Vertigo. Follow ups with ENT, Neuro and PCP have continued with Vestibular Rehabilitation. While in ER, the MRI, MRA, CT, CT with Contrast was done, showed no signs of anything that could have caused this. Ironically tracking back, I received my 2nd Dose of the Pfyzer Vaccine on January 6, 2021 at 8:45 a.m. and this occurred on February 13th at 2:15 a.m. I have not had any other issues before this nor any signs of damage to the nerve or ear that regularly affects Vertigo Patients per my Neuro and ENT. The incident took place 4 weeks and 2 days after the 2nd vaccine. 2 days after the 2nd dose, I experienced Low grade fever, chills, and body aches that lasted only 12 hours, but nothing with the 1st vaccine nor anything after the 2nd dose issue until the Vertigo. I am unable to drive, conduct my job, which requires me to go to emergency calls and carry a Taser (CEW). I have been off work since this occurred and still not eligible to go back to work.
43 2021-03-22 insomnia Day 1 none 3/21/21 at approx 8pm Dizziness Nausea Joint pain Light fever Dehydrated Insomnia 3/22... Read more
Day 1 none 3/21/21 at approx 8pm Dizziness Nausea Joint pain Light fever Dehydrated Insomnia 3/22/21 all day Joint pain Dizziness Nausea Vertigo Foot pain Insomnia
43 2021-03-23 sensation of foreign body Dry mouth, "feels like a knot in my throat" ED Note: 43 y.o. male with a history of hypertension and... Read more
Dry mouth, "feels like a knot in my throat" ED Note: 43 y.o. male with a history of hypertension and eosinophilic esophagitis presenting s/p allergic reaction. Patient received his first dose of the Pfizer COVID vaccine around 17:30 today and states that he developed hives down his left arm and was having difficulty swallowing. He does have a known egg allergy and states that he has had prior anaphylaxis reactions to the flu vaccine. Patient was given PO Benadryl with complete relief of his symptoms. He has no complaints at this time and states that he feels "perfectly fine". At bedside for initial evaluation. Discussed plan for continued Benadryl throughout tomorrow and follow-up with his PCP. Patient is agreeable. Plan for discharge. The patient is comfortable with further observation of his symptoms at home. I discussed our workup, answered all questions and made sure there were no other concerns. I provided counseling about standard home and self-care measures and advised on standard return precautions including new, persistent, or worsening / concerning symptoms.
43 2021-03-24 confusional state, incoherent Rapid onset of blurred vision and partial blindness, confusion, inability to form complete or cohere... Read more
Rapid onset of blurred vision and partial blindness, confusion, inability to form complete or coherent thoughts or sentences. Started with blurred vision around 5:45pm. I immediately sat down on the couch, and tried to explain to my wife what was going on. However, I was unable to complete the thoughts I was trying to form. Eventually I began confusing words (such as saying "king" when I wanted to say "kind" or "kite") and was unable to produce more than one word every 1-2 seconds with great difficulty. Then a headache came that was both extremely painful and somehow "painless," as if I was observing myself having the pain as a bystander. All of this happened within one minute of onset. I laid down and after about 10 minutes from onset the difficulty speaking subsided and I could make complete sentences, although with some difficulty. After around 20 minutes from onset my vision had fully returned. I called 911 out of concern for stroke-like symptoms. The dispatcher sent an ambulance, and I was taken to the Hospital Emergency Department for treatment. Around three hours after the onset of the incident I was diagnosed with a complex migraine and discharged.
43 2021-03-27 excessive sleepiness, mental impairment Extreme fatigue starting day following the vaccination. Slept for three days nearly continuously. L... Read more
Extreme fatigue starting day following the vaccination. Slept for three days nearly continuously. Loss of appetite. Did not eat for three days. Decreased cognitive functions. Sweats and chills (sometimes simultaneously)
43 2021-03-29 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Syncope-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Bradycardia
43 2021-03-30 impaired work ability Patient reports he has noticed over the past week increased shortness of breath on exertion--at base... Read more
Patient reports he has noticed over the past week increased shortness of breath on exertion--at baseline able to exercise with walking 45-60 minutes without dyspnea, however noticed over the last week getting some shortness of breath even walking to the garage. No chest pain, no fevers, chills, cough. He saw his PCP for these symptoms who ordered EKG and CXR 1 day PTA which per patient were normal--plan was for referral to cardiologist. However on the morning on presentation around 6:45 AM after taking an elevator for work he began feeling lightheaded and lost consciousness, awakening on the floor. He went home as he was not feeling well however proceeded to have another 2-3 episodes of loss of consciousness at home witnessed by his girlfriend--the later 2 occurred while lying down and were not clearly associated with any presyncopal symptoms.
43 2021-03-31 poor quality sleep hot and cold, restless sleep the night of vaccination. Next day felt fatigue, sick
43 2021-04-05 sensation of foreign body, feeling abnormal On March 24 I got the first dose of the Pfizer COVID-19 vaccine and I experienced side effects almos... Read more
On March 24 I got the first dose of the Pfizer COVID-19 vaccine and I experienced side effects almost immediately. By the time I got to the resting/observation area I felt that the site of the injection got really warm and I became dizzy/lightheaded and started to feel heavy on the chest and little problem in swallowing and breathing. I was taken to the paramedics on site, they checked my blood pressure (which a little high 150/90), oxygenation, pulse, and EKG (which were normal). It did not became too bad after and was allowed to come back home. However, the heavy chest and swallowing problem lasted for three days. The heaviness in the chested turned into a sensation of feeling like my trachea or the anything under the sternum area was behind strangled. Although I felt like this my breathing and swallowing was almost normal. Every now and then when I swallowed I felt some pain but I could withstand it.
43 2021-04-06 feeling abnormal Next day fatigue, and brain fog. Within 24 hours noticed swollen lymph node in left armpit and tend... Read more
Next day fatigue, and brain fog. Within 24 hours noticed swollen lymph node in left armpit and tenderness (same side as shot). Swelling about the the size of a fist. 7 days later swelling remains, but reduced by 1/2 the size. Within 48 hours notices pain and swelling lymph node under right collar bone and tenderness (opposite side of shot). Swelling is minimal, but collar bone discomfort. 6 days later since onset and collar bone discomfort remains.
43 2021-04-09 insomnia Below and above normal temperature, headache, lower back ache, general body ache, nausea, insomnia.
43 2021-04-10 anxiety Patient received vaccine at 1144a, left site, started feeling palpitation and drove back to site. M... Read more
Patient received vaccine at 1144a, left site, started feeling palpitation and drove back to site. MD assessed, O2 at 93%, O2 4L initiated by onsite Paramedics. Pt vomited and stated he feels dizzy and has SOB. Ambulance called, vitals taken: BP 159/96, HR 88, 98% 4L NC. Last taken BP was 133/66, patient stated he was feeling anxious, recommended to go to the hospital for further assessment. Patient was driven by his wife.
43 2021-04-10 sleep disorder Severe muscle spasms from muscle scarring from an accident 20 years ago. See earlier accident histo... Read more
Severe muscle spasms from muscle scarring from an accident 20 years ago. See earlier accident history for more details.
43 2021-04-12 impaired work ability At around 10 pm on the day of vaccination, I started to develop a sore throat, runny nose and minor ... Read more
At around 10 pm on the day of vaccination, I started to develop a sore throat, runny nose and minor headaches. The following day, April 8, I had more severe symptoms. I had a pounding headache, body aches, chills, fatigue, low grade fever, sore throat, and a runny nose. I spent the day in bed and could not go to work. Towards the end of the day, my low grade fever had subsided, and my sore throat as well. Now I had a slight cough but still had minor chills, fatigue, headache, and body aches. I was able to sleep mostly, and by the following morning, April 9, I was only suffering from body aches, a cough, and a runny nose. I was able to attend work remotely but found my desire to engage in almost any activity very minimal. By that night, most evertything was returning to normal, though a runny nose was still present.
43 2021-04-13 abnormal dreams Vivid Dreams Body felt like I was hit by a truck. Had trouble getting around. Pain and stiffness thr... Read more
Vivid Dreams Body felt like I was hit by a truck. Had trouble getting around. Pain and stiffness throughout body. This was at 3am At 6am when I woke up, I felt like there was a band around my right calf, and there was shooting pains through my left foot / ankle The second night, I woke up at 3am in a night sweat and feverish. Headache and vivid dreams.
43 2021-04-16 feeling abnormal Headache, fever, painful joints, painful teeth, sore dry throat, brain fog, fatigue
43 2021-04-16 loss of personal independence in daily activities, sleep disorder The night after I received my first dose, my tinnitus has gotten very loud, to the point where I fin... Read more
The night after I received my first dose, my tinnitus has gotten very loud, to the point where I find it hard to sleep or function. That started on 04/09/2021 and still just as loud on 04/17/2021
43 2021-04-17 feeling abnormal Fever of 103.5 Fatigue Headache Dehydration Diarrhea Foggy brain Itchiness
43 2021-04-19 insomnia Within a few hours my left should joint started to hurt. Within 8 hours I was in extreme pain and ... Read more
Within a few hours my left should joint started to hurt. Within 8 hours I was in extreme pain and could not move my left arm. Any movement of my left arm resulted in strong stabbing pain in my shoulder. After three days it improved and after one week it was completely gone. The AE reminded me of calcific tendonitis flare up which I have in both shoulders. I went to urgent care as I could not sleep due to pain and they told me to wait a few days and take OTC pain meds.
43 2021-04-20 anxiety Patient while sitting in the post-vaccination area for 15 minutes, started experiencing lightheaded ... Read more
Patient while sitting in the post-vaccination area for 15 minutes, started experiencing lightheaded and faint when he got up. I instructed the patient to sit back down and he complied. I went to grab the patient water and calm him because he seemed a little anxious and then he started shaking, so we immediately called 911. I tapped him to see if he was okay, and he said yes was okay but really faint and the patient was sweating. I asked if he was having trouble breathing, but he denied. He drank the water and had chocolate and I kept conversing with him to assess for any physical/mental status changes, and during the conversation the patient said he usually feels faint and anxious when he gets blood drawn but did not mention it during the screening because he never has when receiving vaccinations. The patient was appearing to improve, less anxiousness, less sweating, and getting more color back to his face. When the EMS arrived within 5-10 mins, they assessed his vitals which were all normal and the patient requested not to be taken to the hospital. The EMT personnel felt the patient was doing okay and left. I had the patient stay for another 30 minutes to make sure he was remaining okay before he left.
43 2021-04-22 disturbance in attention Fever 101-103.4 / fever chills every day for 6 days. Neck pain with swollen neck lymph nodes x 9 da... Read more
Fever 101-103.4 / fever chills every day for 6 days. Neck pain with swollen neck lymph nodes x 9 days, Ringing in ears interrupted sleep for 1 month, had decreased some although continues to this day. Malays for 2 weeks. Vomiting for the first 4 days.
43 2021-04-23 loss of personal independence in daily activities At first, my nose hairs were itchy, then I got runny nose. I sprayed Flonase, which didn't seem to h... Read more
At first, my nose hairs were itchy, then I got runny nose. I sprayed Flonase, which didn't seem to help that much except to dry out my nasal passage. Then, I started feeling lightheaded in the same evening and somewhat disconnected from my body. Then, the next morning, and all day, I've been clumsy and uncoordinated.
43 2021-04-24 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient was coherent after shot sat down passed out. Hit head trauma scrape on head and knees and called ems showed up 5 minutes took pt walking away.
43 2021-04-25 feeling abnormal Had minimum side effects during my first shot on 2/9/21 (lot # EL-9261). About 3 hours after my sec... Read more
Had minimum side effects during my first shot on 2/9/21 (lot # EL-9261). About 3 hours after my second shot on 3/2/21, the room was spinning wildly to the point I could not look at the ceiling, I may have started to have "brain fog" that night as well. 3/3/21 I had chills, no fever. 3/4/21 while talking to a coworker I experienced a "neurological event", I felt like I received a flash software upgrade to my brain, and things "paused" for a short amount of time. Later on 3/4/21 brain fog was significantly impacting me and it was hard to complete sentences and communicate effectively. From 3/2/21 to 3/ 3/7/21 I experienced brain fog, fatigue, dizziness, and chills (no fever). I was fine on 3/8/21. All 4 side effects came back on 3/24/21. I was having chills, no fever, early in the day then led a meeting in the early afternoon and could barely finish my briefing. I was having issues with fatigue, some dizziness, and brain fog. From 3/24/21 to 4/19/21 the side effects that mainly bothered me was dizziness/vertigo and some brain fog. Majority of time throughout this period the side effects were sporadic. I was able to function at 100% then wham, I was out of commission for 2-3 hours, then back to normal again for a multi-hour window. Hydrochlorothiazide worked well. I also took Meclizine with limited impacts. Also took a prednisone pack that took the edge off.
43 2021-04-25 nervousness Pt. had a Syncopal episode post 10 from vaccination. Was lowered to floor without injury .Did not re... Read more
Pt. had a Syncopal episode post 10 from vaccination. Was lowered to floor without injury .Did not recover immediately . Became nauseous and shaky then began vomitting. Pt remained lightheaded and near syncopal whenever brought to a sitting position or standing position. Pt. refused Benadryl . Pt. admitted having nausea and diarrhea for past 1-2 days intractable vomitting 5 yrs ago Agreed to EMS transport to ED
43 2021-04-27 sleep disorder Pt received Pfizer COVID vaccine on 3/26 at facility. Pt presented to the ED on 3/30 for evaluation ... Read more
Pt received Pfizer COVID vaccine on 3/26 at facility. Pt presented to the ED on 3/30 for evaluation of chest pain at around 0722 on 3/30. Per ED provider note, "This patient is a 43 y.o. male who presents to the ED for evaluation of chest pain. The patient drove here two days ago and was feeling well when he went to sleep. He was awoken from sleep early yesterday morning with "intense" left sided chest pain with radiation and tingling sensation down his left arm. The patient says that his pain has since been fairly constant, waxing and waning in intensity. He says that his chest pain is still currently present, mostly localized in his left shoulder, but improved when compared to the pain that woke him up again this morning around 03:00. No reported vomiting, abdominal pain, fevers, chills, cough, or shortness of breath. Patient notes that he received the second dose of the COVID-19 vaccine 4 days ago. Patient reports family history of cardiac disease in his father. He denies any personal history of cardiac disease, and says that his last cardiac work up was a couple years ago for PVCs. The patient is not a smoker and denies any history of diabetes, hypertension, or high cholesterol. There are no other complaints. There are no other exacerbating or alleviating factors. There are no other reported associated signs or symptoms" Pt was given nitroglycerin ointment and aspirin chewable 324mg in the ED. " In addition, "This is a 43-year-old male presenting to the emergency department with just over 24 hours of left-sided chest pain with radiation into the left shoulder and down the left arm. Symptoms were more severe prior to the patient's arrival to the hospital. He was given nitroglycerin and aspirin upon arrival here. EKG shows subtle ST abnormality in the inferior lateral leads. Troponin is elevated at 11. Differential includes non ST-elevation myocardial infarction, myopericarditis. Patient will be admitted to telemetry. He will undergo a cardiac catheterization today." Pt was admitted, and per hospitalist note on 4/1, "Patient presented hospital with chest pain and EKG changes-there was initial concern for NSTEMI. Had cardiac catheterization with clean coronaries. Then thought to have pericarditis. Patient had trivial pericardial effusion on echocardiogram. Had MRI that demonstrated myocarditis as well. Patient improved on colchicine and NSAID therapy. Discussion had with cardiology will continue this and to be tapered in the office setting. Will continue NSAIDs for approximately 2 weeks then begin tapering. Will likely need colchicine for approximately 3 months. Patient was placed on beta-blocker to help with symptomatic treatment and help alleviate plain. Patient was started on metoprolol, was cautioned side-effects of hypotension, bradycardia, exercise intolerance .Patient should monitor heart rate and blood pressure daily. Hold if heart rate <50 or blood pressure less than 100 systolic and notify provider. Patient was advised he may follow-up with Dr. Caution GI upset, nausea vomiting diarrhea. If diarrhea with colchicine would recommend back down to daily from b.i.d. treatment. Patient was ambulatory and functional without significant symptoms, vital signs within tolerable limits, and agreeable to discharge plan.. Patient ultimately discharged in stable condition. All questions answered to apparent satisfaction. Patient cautioned side effects of medications. Patient was instructed if reoccurrence or any concerning symptoms to contact provider or present to nearest emergency department based on acuity. Patient and family voiced understanding of recommendations and in agreement with discharge plan."
43 2021-04-29 panic attack Left shot clinic after 15 min with no adverse effects. Driving home mouth and tongue went completel... Read more
Left shot clinic after 15 min with no adverse effects. Driving home mouth and tongue went completely dry instantly and could not swallow. This was 28 min after initial shot (2nd dose). Concerned that airway would be restricted. In a panic went to ER at different hospital that I was near. No signs of anaphylaxis. Waited in hospital for ~3 hours. Symptoms did not get worse and could breath through nose. Decided no steroid shot (did not want to negate covid shot). Went home without additional treatment. Mouth was dry for 1 additional day, but not as extreme as initial dryness.
43 2021-04-30 panic attack, anxiety Systemic: Pt had a panic attack and felt weak, laid on floor to avoid fainting-Mild, Additional Deta... Read more
Systemic: Pt had a panic attack and felt weak, laid on floor to avoid fainting-Mild, Additional Details: PT has severe vaccine anxiety. Pt always passes out after vaccination from the anxiety and adrenaline. Pt took a valium at some point prior to receiving vaccination at home.
43 2021-05-01 sleep disorder Patient developed acute psychosis w/ transient changes in cognition, sleep, mood, and psychomotor ac... Read more
Patient developed acute psychosis w/ transient changes in cognition, sleep, mood, and psychomotor activity.
43 2021-05-03 feeling abnormal Right after receiving the vaccination began to develop very high resting heart rate(150bpm), along w... Read more
Right after receiving the vaccination began to develop very high resting heart rate(150bpm), along with dizziness and some mild shortness of breath, along with an out of body feeling. Some muscle tightness in neck. Took one benadryl after 15min, began feel better after 1hr. Then had more common reactions later that evening. Regular bpm is 55-60.
43 2021-05-05 loss of personal independence in daily activities Severe neurological and cognitive decline. Patient is currently unable to walk unassisted and is be... Read more
Severe neurological and cognitive decline. Patient is currently unable to walk unassisted and is between a walker and a wheelchair. His cognitive function has also been affected to the point that some days he is unable to process how to even feed himself.
43 2021-05-06 anxiety, feeling abnormal, panic attack during the following 3 weeks, I'd experienced weird things like anxiety( excessive worries about any... Read more
during the following 3 weeks, I'd experienced weird things like anxiety( excessive worries about anything, feeling of my heart beating fast, sometimes feeling my breathing is very fast, chest tightness or heaviness, and feeling that I'm losing control for few seconds, feeling cold that I put on the heavy jacket that I never used except in cold winter! feelings of boneaches especially in my fingers joints, some days I'd nausea and feeling that my stomach torture me! All the previous symptoms were on and off many times per day, I was using Tylenol and Ibuprofin almost every day. lately, I'd 4 days of continuous symptoms, that I feel like panic and cold with all the above symptoms.(from 29th April to May 3rd).
43 2021-05-07 crying, depressed mood, suicidal thoughts he started having thoughts of killing himself for no reason that it would be very nice for him to go... Read more
he started having thoughts of killing himself for no reason that it would be very nice for him to go and shoot himself; what a nice day for killing himself, he was self-thinking that all day; He got really sad and he had cry; He started crying; He got really sad and he had cry; He started crying; This is a spontaneous report from a contactable reporter. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 on 23Apr2021 (Lot Number: ER8735) and dose 1 on 30Mar2021 10:00 (Lot number was not reported) as both via an unspecified route of administration, administered in Deltoid Left SINGLE DOSE for covid-19 immunisation (Age at vaccination: 43 years). The patient's medical history and concomitant medications were not reported. The patient stated that he started having thoughts of killing himself for no reason that it would be very nice for him to go and shoot himself. He also think that what a nice day for killing himself, he was self-thinking that all day, he got really sad and he had cry; He started crying on an unspecified date. Outcome of the events was unknown. Information on the lot/batch number has been requested.
43 2021-05-07 sleep disorder, excessive sleepiness The night after getting the vaccination I had extreme pain in the joints and muscles as well as head... Read more
The night after getting the vaccination I had extreme pain in the joints and muscles as well as headache and fatigue. The pain kept me from sleeping, and woke me up at night for several nights in a row. The joint pain didn?t completely subside for over two weeks. I was also very fatigued, sleeping 10 to 12 hours a night for two weeks. I normally sleep 7 to 8 hours a night. My muscles also felt weak and sore for over a week. Shot one messed me up bad. The first night I also had clammy feeling skin and a slight feverish feeling, although I didn?t take my temperature.
43 2021-05-16 disorientation 18 hours after receiving the vaccine, passed out while walking in my house. No signs of dizziness or... Read more
18 hours after receiving the vaccine, passed out while walking in my house. No signs of dizziness or nausea preceded the episode. Lost consciousness for about 10 seconds, then was disoriented for about 2 minutes before being able to get up with assistance and move to my bed.
43 2021-05-17 sleep disorder In between my first and second shots I started having pain in my right side back and right side fron... Read more
In between my first and second shots I started having pain in my right side back and right side front. Dull kinda pain, soreness...not super sharp or anything. It was severe enough that I couldn't sleep at night. I still kept my second vaccine appointment which was in a couple days and booked an appt. with my doctor. It was about a week until I could get in to the office. In that time I got a small herpetic rash about the size of two fifty cent pieces on my right side. I went to the office and the doctor identified it as Shingles...which is not something I've had before. He put me on an oral steroid for 6 days, anti-viral medicine(Valacyclovir), and something for nerve pain (Gabapentin). All of which helped and I appear to have recovered so far.
43 2021-05-19 feeling abnormal Migraines 5 days after 1st dose Head Pressure Tinnitus Headaches Brain Fog Eye Floaters
43 2021-05-19 sleep disorder arm where injection occurred has had pain since injection. Can be enough to wake him from sleep. ... Read more
arm where injection occurred has had pain since injection. Can be enough to wake him from sleep. Better if avoids using arm, worse if exercises or uses arm in other ways. Also tingling from upper arm to fingers, off/on with no clear pattern
43 2021-05-23 feeling abnormal Increased heart rate a couple of minutes after the shot. Unusual sensation. Had to lower my mask fo... Read more
Increased heart rate a couple of minutes after the shot. Unusual sensation. Had to lower my mask for additional air. Symptoms subsided completely after about 5 minutes following the shot. Remained in the lobby area for a few minutes past my required 15 minutes. After leaving I felt fine. No symptoms hours later or to this point, 5/24/2021 other than pain at the injection site for 2-3 days.
43 2021-05-25 incoherent Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in f... Read more
Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in face. Severe fatigue, low blood pressure readings of 112/60 and 110/90. Hot flashes and nausea. Non-coherent with glassy eyes with no awareness. Fluctuations in symptoms and slept for Three days in and out. Pt. Took approx. Three days to feel back to himself.
43 2021-05-30 loss of personal independence in daily activities Upper arm pain and decreased range of motion remaining at 5 weeks post shot. Unable to do typical a... Read more
Upper arm pain and decreased range of motion remaining at 5 weeks post shot. Unable to do typical activities of daily living as pain is restrictive and severe.
43 2021-05-31 disorientation Patient was administered shot by RN and he immediately stiffened up and eyes became distant and twit... Read more
Patient was administered shot by RN and he immediately stiffened up and eyes became distant and twitched. He was like this for 10 sec and was disoriented when he became aware of surroundings. EMS was contacted. They assessed him and took him to the hospital
43 2021-06-01 sleep disorder chest pain made him go to the emergency room because it was too much, it was multiple throughout the... Read more
chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time; his penis sensations are a lot different; has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen; when he falls asleep he wakes up in an hour; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; limbs twitch; This is a spontaneous report from a contactable consumer. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021), 1ST DOSE SINGLE via an unspecified route of administration, administered in Arm Left on 27Mar2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time, has had a bad headache where it feels like he has vibrating inside of his head, in his chest and on 31Mar2021, when he falls asleep he wakes up in an hour 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, limbs twitch on 31Mar2021, his penis sensations are a lot different. It was reported that 5 days after he got the first dose of the COVID vaccine he started getting pains and the major thing is at night. If he falls asleep, he wakes up in an hour and that has been every night for a month and a half. That is the main thing that is pissing him off. He confirms that he is having issues with his chest and his intestines like he mentioned previously and he has started keeping track and has kept a journal of the pains. This stuff is new. He has never experienced this before and it has been happening every day starting 5 days after when he got the COVID vaccine. He had the COVID vaccine on 27Mar2021 and on 31Mar2021 he got the first shock in his chest at 0120 in the morning when he was sleeping. Then that went on for a week, he had it on 31Mar2021, 01Apr2021, 02Apr2021, 03Apr2021 and 04Apr2021 where he was getting shocked in the middle of the night when he is sleeping. On 04Apr2021 he had to go to the emergency room and have them look at him. But since 31Mar2021 he has been getting up every hour after he falls asleep. This was all worse when it first started because he has never experienced anything like this. The first shock he had was a hard feeling in his chest and then he couldn't go back to sleep. It is so bad. After he went to the emergency room, that is when it started being not as much of a shock pain that woke him up but he was still waking up every hour. The pains are in his upper chest and in his intestines. Also his limbs twitch and he has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen. He confirmed that these also began on 31Mar2021 and have been happening whenever they want and he has never experienced all of that before. Never. Everything has all stayed the same. The sad part is that he just thinks that he is getting used to this "new normal" because he is now going on the second month of this and his body is adapting but this is not normal. Also, he guesses that he shouldn't be shy now but the last thing is that his penis sensations are a lot different and he didn't notice until the first time that he was having relations with his wife after the COVID vaccine and it is all different. He noticed and she did too as far as whenever they were trying to have relations. It has been more than once, it has been every time they have tried afterwards. He says his doctor is going to send him to a sleep lab but he wasn't expecting that. He thought that maybe he would need to go somewhere else. But there he will go to sleep and be hooked up and they will read his whole body and tell the reason why he is waking up every hour. The outcome of the event headache, sleep disorder, chest discomfort, muscle twitching was not recovered and penis order, headache was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-06-07 disorientation I woke up disoriented; I had severe double vision; loss of balance; severe nausea; diagnosed a 4th n... Read more
I woke up disoriented; I had severe double vision; loss of balance; severe nausea; diagnosed a 4th nerve palsy of my left eye; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176), via an unspecified route of administration at the age of 43-year-old administered in arm left on 18May2021 10:30 AM at single dose for covid-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient's concomitant medications included ibuprofen received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0176), at the age of 43-year-old at the arm left on 27Apr2021 01:30 PM for COVID-19 immunisation. The patient had his second dose of the Pfizer COVID vaccine at 10:30am on 18May2021. By 2:30am on 19May2021, he woke up disoriented and realized that he had severe double vision resulting in loss of balance and severe nausea. A 19May2021 visit with his primary care doctor diagnosed a 4th nerve palsy of my left eye. This was confirmed by a 19May2021 visit to an ophthalmologist. It is now 21May2021 and nothing has improved and an MRI (Magnetic resonance imaging) was pending. The adverse events result in Doctor or other healthcare professional office/clinic visit. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was not recovered.
43 2021-06-07 feeling abnormal Dryness in his throat/ extremely, extremely sore and dry throat; Headaches; Feeling terrible; Fever;... Read more
Dryness in his throat/ extremely, extremely sore and dry throat; Headaches; Feeling terrible; Fever; Chills; Chest pain; Oppression in his chest that does not allow him to breathe normally/ pressure in his chest not letting him breathe normally; Sore throat/ extremely, extremely sore and dry throat; Chest pain is like a pressure; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 43-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 27May2021 09:00 as 2nd dose, single dose (at the age of 43-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Patient mentions that yesterday (27May2021) he got the second dose of the Pfizer covid vaccine at 9 am and since then he had fever, chills, sore throat, chest pain like a pressure in his chest, oppression in his chest that does not allow him to breathe normally. On 28Feb2021, experienced dryness in his throat (extremely sore and dry throat), headache, feeling terrible. He wants to report the situation. Patient what should he do, does he need to go to a hospital. Communication included Advising patient to seek medical attention or the care of a doctor. The outcome of the events was unknown. No further information is provided or obtained. Information on lot/Batch number has been requested.
43 2021-06-13 feeling abnormal Vertigo, dizziness, on-a-boat feeling, headache, sinus pressure, brain fog, elevated blood pressure,... Read more
Vertigo, dizziness, on-a-boat feeling, headache, sinus pressure, brain fog, elevated blood pressure, elevated pulse. Most symptoms lasted for 6-9 weeks. Dizziness, on-a-boat feeling, occasional headaches continue still (3 month after)
43 2021-06-19 sleep disorder 1) Event: Unilateral Tinnitus (right ear) on 5/16/21 9PM turned into Bilateral Tinnitus on 5/17/21 7... Read more
1) Event: Unilateral Tinnitus (right ear) on 5/16/21 9PM turned into Bilateral Tinnitus on 5/17/21 7AM (~12kHz tone and slight ~4kHz tone both in both ears). Sleep is interrupted Treatment: None Outcome: Saw primary care (5/25/21), had an audiogram and tympanometry (5/27/21) showing normal hearing, and saw ENT (6/10/21). Bilateral Tinnitus and resulting interruped sleep persists. 2) Slight dizziness accompanied the Unilateral Tinnitus only (5/16/21 9PM)
43 2021-06-20 feeling abnormal With my 1st vaccine I just had soreness around the injection site. After the 2nd vaccine I woke up a... Read more
With my 1st vaccine I just had soreness around the injection site. After the 2nd vaccine I woke up at 4am on 1/31/2021 with muffled hearing in my left ear and mild numbness in the entire left side of my body from top of my head to bottom of my feet. I experienced vomiting and diarrhea also. I had blood pressure of 150 /105 and pulse rate of 100. My doctor was afraid I had a stroke, so I went to the ER and had a CT scan in brain. I tried to go to work the next day but my head was foggy so I had to leave work. I had a test for carotid arteries and heart test that came back fine. I was sent to a neurologist. He suspected I had possible swelling in the spinal cord, but since I was feeling a little better he thought it was ok to wait to have a spinal tap. He described that the symptoms were MS dialed symptoms but did not feel I had MS. I've gotten better but continue to have a neuropathy pain in my left foot, left hand, and left side of my face. It tends to get worse at night but in the morning it is ok. It continues through the day. None of these symptoms were there before the vaccine.
43 2021-06-21 feeling abnormal, confusional state At 1258. Patient started feeling itch, slightly lightheaded when sitting up, "weird tingle" in throa... Read more
At 1258. Patient started feeling itch, slightly lightheaded when sitting up, "weird tingle" in throat, dizziness, slight confusion. Vital sings 140-78/HR76 /R16, 93@ O2Sat. Skin warm and dry. Forehead is slightly flushed and war, Cap refill good, breath sounds clean bilaterally. Had patent lay down for vital signs, sat up and given water. Patient became dizzy upon sitting, returned to supine position. 1313 vital signs 122/80/HR76/R20. Skin warm and dry, good cap refill, breath sound clear bilaterally. 1328 had patient sit up, no initial dizziness orthostatic vital signs: Supine 118/80/HR80/R20. Sitting 140/100.. Patient discharged in stable condition in the company of his wife. Pt is alert and oriented times 3. Skin pink, warm and dry. Agrees to follow up with PCP or EMS if any signed of diff breathing, throat tightness were to occur on his arrival home.
43 2021-06-21 loss of personal independence in daily activities, impaired work ability After 2nd dose following events occur deteriorating overall health. I don't have any preexisting hea... Read more
After 2nd dose following events occur deteriorating overall health. I don't have any preexisting health conditions. 1. On May 24th at around 12.15 am, I started experiencing 100 degree fever followed by chills. The blood pressure shot up to 165-95 and heart rate was around 140. Was feeling breathless and sweaty and was being rushed to ER . 2. On 30th May again experienced BP at 165-90 and pulse was at 150 and rushed to ER 3.Again on May 31st, BP shoot up to 170-90 and pulse 145 and ER visit. 4. Consulted cardiologist and on Metoprolol medicine 5. Always feeling dizzy and lightheaded with unprovoked rise in BP and pulse. 6.Unable to resume regular day to day activities including office work. 7. Daily fluctuation in BP and pulse observed till now since 2nd dose of vaccine.
43 2021-06-23 anxiety PATIENT COMPLAINED OF FEELING ANXIOUS. WANTED TO LAY DOWN. LAYED DOWN ON COT AND WAS OBSERVED.
43 2021-06-28 anxiety tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stingi... Read more
tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stinging sensations localized; chest had a weird feeling like pressure, along with some stinging sensations localized; passed out while he was sitting and hit his head that left a bloody scrape; felt dizzy, hot, clammy; felt dizzy, hot, clammy; felt dizzy, hot, clammy; heart rate increased; felt anxious; passed out while he was sitting and hit his head that left a bloody scrape; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in arm right on 11Jun2021 15:00 (at the age of 43-year-old) as single dose for covid-19 immunisation. Medical history included slight heart myopia, high tryglicerides that medicine was keeping at normal levels. No past drug history. Concomitant medication included atorvastatin and fenofibrate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Within 5 minutes of the injection (11Jun2021 15:05), the patient felt dizzy, hot, clammy, his heart rate increased and felt anxious, then he passed out while he was sitting and hit his head that left a bloody scrape. Then it took about 45 minutes to feel a little better. Then 24 hours later (12Jun2021) the patient really was tired, headache, fatigue, soreness, and his chest had a weird feeling like pressure, along with some stinging sensations localized. The outcome of events felt dizzy, hot, clammy, heart rate increased, felt anxious, passed out while he was sitting and hit his head that left a bloody scrape were recovering, the rest of events were unknown. No follow-up attempts are possible. No further information is expected.
43 2021-06-29 disorientation First four days normal symptoms. Patient started having tremors and shakes. Patient felt somethin in... Read more
First four days normal symptoms. Patient started having tremors and shakes. Patient felt somethin in his lung almost like he had Pneumonia. Patient stated that he would go to sleep and wake up disorientated. patient is experiencing neck stiffness and tightness in his right arm.
43 2021-06-30 feeling abnormal Almost about 1 week after getting second shot of covid-19 vaccine I started feeling weird on right s... Read more
Almost about 1 week after getting second shot of covid-19 vaccine I started feeling weird on right side of my body. Swollen right side of my body specially facial area, which got worse over the period of time. Now main symptoms i am having are tender facial muscles , hoarseness, loss of voice and blurry vision on right side. Symptoms got worse last week.
43 2021-07-03 insomnia Insomnia, chills, body aches, headache (next day, following sleepless night)
43 2021-07-06 impaired work ability I got Bell's Palsy. Over 5 weeks later and still no improvements. Also have severe vertigo from t... Read more
I got Bell's Palsy. Over 5 weeks later and still no improvements. Also have severe vertigo from the Bell's Palsy and cannot work.
43 2021-07-08 sleep disorder About 6 hours after the first dose, I started experiencing ringing in my ears. Mainly I thought it w... Read more
About 6 hours after the first dose, I started experiencing ringing in my ears. Mainly I thought it was the left ear but the fact is both are ringing and the left side is worse. I was panicking and I didn't know what was going on. I went to urgent care three days later and they found nothing that was causing the ringing. They urgent care doctor made a phone call a specialist and she stated that the ringing in the ears is a rare side effect of the COVID vaccine and it should go away. I then went to my primary care doctor and she thought she saw some redness in my left ear and thus prescribed me methylPREDNISolone and an ear drop with the name Ofloxacin. They both did not work. She then prescribed me Azithromycin which also did not work. Since I was not responding to medication, I was diagnosed with tennitus by my primary care doctor. About a week later after the vaccine, I was been experiencing popping in my left ear as well as the noise. But on the right ear, there is only noise. Prior to vaccination, I never had any issue with my ears before. The tennitus is debilitating and life altering in so many ways. I'm still not getting more than four hours of sleep even with melatonin and I'm someone that has never used melatonin or had sleeping issues prior to vaccination.
43 2021-07-26 confusional state Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Med... Read more
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Patient received vaccine and 10 minutes later, he fainted. We sat with patient until emergency services arrived. Patient reporst history of fainting for the past 10 years and takes no medication. Patient was breathing normally and regained consciousness fully AxO x3 after recovering from fainting. Patient drank water. After emergency services arrived, patient began vomiting under their care. Patient ended up leaving with the emergency crew.
43 2021-07-26 feeling abnormal Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old... Read more
Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old daughter who was with me. Apparently I fainted but she described me as twitching and having my hands up and my head to the side with my eyes closed. I can remember a repetitive loop that I was experiencing. It was an image that was distorted and I could not control it and I could not get out of it I could hear my daughter but not control my actions. After I came to a few moments later my legs felt tingly and tired and were shaking like they had the chills. Was advised to go to hospital by EMS Still having very achy joints all over my body. Diarrhea, sweats/chills
44 2021-01-05 disorientation nausea, fatigue, disorientation
44 2021-01-11 agitation extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple lin... Read more
extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an "amped" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an "amped" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the BP increased and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-01-12 loss of personal independence in daily activities Fluid collection and discomfort of left axilla, no erythema, hematoma starting approximately 1.5 d... Read more
Fluid collection and discomfort of left axilla, no erythema, hematoma starting approximately 1.5 days after injection and ongoing. Also had low grade temp and dizziness that was self-limiting.
44 2021-01-12 sleep disorder Arm soreness 1st day, 3pm next day body aches, weakness and fatigue, heavy head, fever 102. Next da... Read more
Arm soreness 1st day, 3pm next day body aches, weakness and fatigue, heavy head, fever 102. Next day, still experiencing fatigue and body aches but not as much. 1/12/21 feeling flu type symptoms again body aches, muscle, nausea, chills, severe sweating during night sleeping awoke several times . 1/13/2021 feeling flushed and sweating again while working, stomach cramps, nausea and then vomited x1. Tiredness and extreme fatigue, almost hard to walk, heavy head, chills, fever 100. Has taken Tylenol some relief
44 2021-01-14 impaired work ability vomiting, diarrhea, cramps. called in sick to work.
44 2021-01-23 feeling abnormal On same day of the first Pfizer COVID-19 vaccine, patient developed left facial numbness, left arm a... Read more
On same day of the first Pfizer COVID-19 vaccine, patient developed left facial numbness, left arm and left leg weakness with difficulty negotiating stairs, and left arm > left leg involuntary muscle "spasms." Symptoms have improved, but not totally gone away. Patient also complained of severe "brain fog," and severe left arm tenderness after Pfizer vaccine.
44 2021-01-28 feeling abnormal Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wake... Read more
Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown. Information about lot/batch number has been requested.
44 2021-02-28 anxiety Nausea Dizziness / lightheaded Weakness Anxiety
44 2021-03-07 confusional state Arm and hand twitchy, extreme fatigue, double vision, mental confusion
44 2021-03-09 restlessness sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is... Read more
sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is a spontaneous report from a contactable consumer (reported for himself). A 44-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: 9262), on Left Arm via an unspecified route of administration on 26Jan2021 13:30 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot no: 3248) on left arm on 07Jan2021 12:00 PM for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 10:00 PM No symptoms besides a sore arm and restlessness for first 12 hours. Body aches, chills, fatigue for following 24 hours. Fatigue for an additional 24 hours. Swollen lymph node under left clavicle starting at 36 hours and still present. Outcome of the events was not recovered.
44 2021-03-18 panic attack pt got vaccine and was sitting for observation. Pt thought he was having a panic attack so he put h... Read more
pt got vaccine and was sitting for observation. Pt thought he was having a panic attack so he put his head between his knees, he fainted, hit is head on the floor, and a witness said he was shaking on the floor. The patient came to quickly and said he passed out due to stomach cramps . EMS was on site and did an evaluation. Pt was given ice for his head and had vitals checked and and EKG done. EMS recommended hospital transport but patient refused.
44 2021-03-20 insomnia I have had off and on chills; sometimes fever; body aches; fatigue; tiredness; can't sleep at night;... Read more
I have had off and on chills; sometimes fever; body aches; fatigue; tiredness; can't sleep at night; This is a spontaneous report from a contactable Other HCP. A 44-years-old male patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302; dose number=2) via an intramuscular on 01Feb2021 at 14:00 at single dose for Covid-19 immunization. Medical history included colitis ulcerative and gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. Also, the patient had covid-19 prior to vaccination. The patient had allergy to erythromycin. The patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EN9581; dose number=1) via an intramuscular on 11Jan2021 at 14:00 at single dose for Covid-19 immunization. Concomitant medications included famotidine, finasteride and omeprazole. As per the adverse event description, on 02Feb2021 01:00 AM, the patient had off and on chills, sometimes fever, body aches, fatigue, tiredness since the second dose. He can't sleep at night, because each night around 2am, he woke up with severe chills. He probably have a fever, but don't tested himself. He took 800mg of Ibuprofen and within an hour to his chills break. That usually lasts till midafternoon. Then he get the chills again, take more ibuprofen and wait for bed. He usually an active person, but have been unable to work out since the shot. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
44 2021-03-27 feeling abnormal Tiredness, body aches, discomfort in lungs, brain fog (15 days, acetaminophen)
44 2021-03-31 feeling abnormal I had shingles. Starting next date I had a poking feeling in my forehead, and head heck for couple d... Read more
I had shingles. Starting next date I had a poking feeling in my forehead, and head heck for couple days guess 3rd day started seeing pimples in forehead and it started developing on my left forehead and until my left eye.
44 2021-03-31 nervousness Unsteady feeling in my head and body, like a shaky feeling and headaches. Been experiencing this for... Read more
Unsteady feeling in my head and body, like a shaky feeling and headaches. Been experiencing this for almost 3 weeks now.
44 2021-04-05 feeling abnormal Tinnitus. Fuzzy, ringing in ears. Tinny hearing. Inner ear inflammation.
44 2021-04-05 feeling abnormal Loss of appetite, malaise, nausea, falls, mental fog, death.
44 2021-04-06 amnesia seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a ... Read more
seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727) via an unspecified route of administration, administered in Arm Left on 22Mar2021 12:30, at the age of 44-year-old, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); fish oil (OMEGA 3 [FISH OIL]). On 23Mar2021, at 03:00 AM, the patient fell off his height and had a seizure. This was his first seizure in his life. The patient was rushed to the ED where a CT of the head and neck was done in Mar2021. The CT did not show any bleeding or fracture. The Neurologist dismissed the patient home and had the patient go back and see him in 2 days. The patient has been complaining of headache and taking Tylenol PRN for it. His walking was wobbly and not steady. The patient had a total amnesia of the accident. The patient did not receive treatment for seizure, fall, total amnesia and walking was wobbly and not steady. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID since the vaccination. Outcome the events was not recovered.
44 2021-04-06 sleep disorder With in a few hours of the shot I had pain up and down my right arm, up and down my right side and i... Read more
With in a few hours of the shot I had pain up and down my right arm, up and down my right side and into my shoulder/ neck. I went to home and had a slight fever with chills and could not sleep that night. I called off from work and stayed home. Over the weekend the pain in my neck. shoulder and arm continued. I went to a chiropractor treatment that Tuesday 3/2/21. He made some adjustments and the shoulder / upper arm still did not feel better. My right arm became more numb and weak on Thursday 3/4/2021 . My wife was sitting next me on our couch when I suddenly had a spasm in the upper arm. The next morning I waking and had even more trouble lifting the arm or moving it. I attempted to suffer through it thinking it would get better. Over that weekend conditions with the arm became even worse and was unable to lift it. I returned to chiropractor. He evaluated me and i described what had happened after the second covid shot. He recommend an MRI and I attempted to contact my PCP. With no answer from the PCP i went to the ED who said My PCP would need to order a MRI. I was then sent to physical therapy and Orthopedics. They ordered an X ray and MRI. Both showed nothing. Still seeing physical therapy with some improvement and movement. Have a EMG scheduled for April 22,2021
44 2021-04-07 anxiety Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: ANXIETY-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient drank water as we talked to him. He started to look and feel better after a few minutes. He was able to hold a steady conversation throughout event. Within 5 minutes of being notified of event, patient was scrolling through his phone with no difficulty. We made patient wait for 20 additional minutes while monitoring him and patient stated \"I feel back to normal\" before leaving.
44 2021-04-09 disturbance in attention Fever from 2pm until about 2am. Next day felt OK. Day after that was fatigued with slowed brain func... Read more
Fever from 2pm until about 2am. Next day felt OK. Day after that was fatigued with slowed brain function and mild headache. This lasted about 5 more days.
44 2021-04-09 feeling abnormal Patient received their vaccine at 5:12pm and at 5:15pm felt light headed, sweaty, and spaced out. He... Read more
Patient received their vaccine at 5:12pm and at 5:15pm felt light headed, sweaty, and spaced out. He did not faint, he did get back to baseline after drinking a bottle of water, and resting .
44 2021-04-09 insomnia couldn't sleep one night; have had a tightening in the chest; This is a spontaneous report received ... Read more
couldn't sleep one night; have had a tightening in the chest; This is a spontaneous report received from contactable consumer (patient). This 44-year-old-male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6206) via an unspecified route of administration on 04Mar2021 at 13:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure and COVID-19 diagnosis on an unspecified date prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included lisinopril and hydrochlorothiazide from unknown dates for unknown indications. On 07Mar2021 at 23:00, the patient could not sleep one night and since had a tightening in the chest. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of couldn't sleep one night and tightening in the chest were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
44 2021-04-11 feeling abnormal, disturbance in attention Temporary, minor brain fog for a few hours, approximately 18 hours after injection. Noticed when wor... Read more
Temporary, minor brain fog for a few hours, approximately 18 hours after injection. Noticed when working on a simple excel spreadsheet and had trouble concentrating. I was able to complete the task in about 5 minutes with focus. I was back to normal a couple hours later. Would have not realized the brain fog had it not been for the spreadsheet project.
44 2021-04-11 feeling abnormal Following injection, patient reported arm and hand numbness and feeling "dizzy" and stated they "Fel... Read more
Following injection, patient reported arm and hand numbness and feeling "dizzy" and stated they "Felt weird in my head." Patient was given water and noted that they had not eaten anything this morning. Vital signs at 11:30am - Blood pressure :140/80, Heart rate: 80, temperature 99.1, O2 sat: 98% on Room air. EMS was called. Assessed by EMS, vital signs reassessed by RN at 11:43, standing blood pressure: 150/100, heart rate:82, O2 sat: 98%. Patient released by EMS to home with partner driving car. Patient stated "I will be okay"
44 2021-04-11 insomnia I got the Phizer 2nd shot this past Wednesday. 24 hrs later I had the normal symptoms, headaches, fa... Read more
I got the Phizer 2nd shot this past Wednesday. 24 hrs later I had the normal symptoms, headaches, fatigue. Through the weekend things were fairly normal till Sunday night. I had a hard time sleeping and a low grade temperature 99.4. Over night I hoped it would get better but in the morning it got a little worse 100.0. Didn't sleep till 2am. A little bit ago I took my temp again and it's 100.2. I don't have flu type symptoms, just tired and fever. I've been taking Tylenol every 8 hrs or so. Drinking water and resting.
44 2021-04-13 sleep disorder Bad Migraine with sensory issues - sensitivity to sounds, Trouble sleeping, Acidity, Sweating
44 2021-04-19 loss of personal independence in daily activities I have fever, throats scratch, cough, breath with dificulties, body pain, back pain, very very tire,... Read more
I have fever, throats scratch, cough, breath with dificulties, body pain, back pain, very very tire, thirsty, Head pain, congestion, dificulties to function
44 2021-04-20 feeling abnormal Woke up with extreme severe migraine dizziness, vertigo nausea and loud tinnitus! Scalp and face ti... Read more
Woke up with extreme severe migraine dizziness, vertigo nausea and loud tinnitus! Scalp and face tingling. Ear fullness, head pressure, sinus pressure, visual haze, brain fog. Never experienced this in my life! Persisting for weeks and weeks and continues. Still ongoing. Please help!
44 2021-04-21 feeling abnormal Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water... Read more
Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water and as I was giving it to him he started to pass out. He was conscious but slightly convulsing. He appeared to have a minor seizure for approximately 5-10 seconds. He was transferred to a wheelchair and sent into our recovery room. As we were transporting him, he had two episodes of vomiting and continued to feel diaphoretic and weak. He rested laying down but was not feeling better. He could not tolerate any water or juice.
44 2021-04-24 disorientation Extreme fatigue; Light dizziness; disorientation; Sore/stiff muscles, particularly lower extremities... Read more
Extreme fatigue; Light dizziness; disorientation; Sore/stiff muscles, particularly lower extremities; Sore/stiff muscles, particularly lower extremities; This is a spontaneous report from a contactable consumer (Patient). A 44-year-old male patient received first dose of BNT162B2 (Pfizer COVID Vaccine, solution for injection, Lot# EN6202), via an unspecified route of administration, administered in left arm on 23Feb2021 at 05:00 AM (at the age of 44-years) as single dose for COVID-19 immunisation. Medical history included sleep apnea, headache and CALM supplement. The patient had no known allergies. Concomitant medication(s) included naproxen sodium for headache. On 23Feb2021 at 06:15 (1-hour and 15-minutes after vaccination), patient experienced extreme fatigue, light dizziness, disorientation, sore/stiff muscles, particularly lower extremities. The patient had not taken any other vaccine four weeks prior vaccination. The patient not had COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.
44 2021-04-26 anxiety 44 year old male, while in post-vacc recovery area, c/o diaphoresis, feeling anxious, wiping sweat ... Read more
44 year old male, while in post-vacc recovery area, c/o diaphoresis, feeling anxious, wiping sweat from brow and forehead. Initial vitals: 144/80, 60, 20. Encouraged to do breathing exercises to assist with relaxation. Remained seated, upright. Second set of vitals at 0850: 11/60, 60. Reassessment of client- clam, no s/s of distress. Final set of vitals at 0905: 110/78, 60. Discharged from clinic at 0906, unassisted.
44 2021-04-26 sleep disorder, disturbance in attention nausea, headache, fatigue on 4/19/21. He begin having difficulty concentrating today, 4/20/21 and ad... Read more
nausea, headache, fatigue on 4/19/21. He begin having difficulty concentrating today, 4/20/21 and admits to sleeping poorly last night. He has not taken anything for his symptoms. It was advised for him to obtain quality restful sleep tonight, take multivitamin with D and C, APAP/NSAID for pain/fever, drink plenty of fluids. 4/21-Woke up this morning feeling better after a restful nights sleep. He did not take anything for his symptoms and his symptoms resolved completely.
44 2021-04-28 restlessness, delirium Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous ... Read more
Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration administered in arm right on 14Apr2021 09:30 AM (Lot Number: EW0158) at vaccination age of 44 years old as single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol, Cephalosporin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included atorvastatin calcium (LIPITOR) taken for blood cholesterol increased; tadalafil (CIALIS). The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6206) via an unspecified route of administration administrated in Left arm on 24Mar2021 at time of 09:45 AM at vaccination age of 44 years old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe fever, 102+, aches, chills, delirium, restlessness, headache, weakness on 14Apr2021 at time of 11:00 PM. No treatment received for the adverse event. The patient underwent lab tests and procedures which included body temperature: greater than 102 fahrenheit on 14Apr2021. The outcome of events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
44 2021-05-01 anxiety Anxiety attacks began after taking the vaccine. Never had anxiety before getting the vaccine.
44 2021-05-03 feeling abnormal, mental impairment, emotional distress Adverse event occurred Friday February 5th around 1430hours, I began to feel "not right" Having bee... Read more
Adverse event occurred Friday February 5th around 1430hours, I began to feel "not right" Having been in mental health services and care for a number of years, I naturally am and have developed great self-awareness of my condition. I began to feel a developing despair and decline to overall mental function. As if a switch had been turned in my brain, and it became more difficult to focus. Myself and others close to me started to notice that I would space out and kind of shut down at random moments without regard to what was currently going on around me. I must note that I did not have anxiety related to receiving the vaccine, even after becoming ill after the first dose. I cannot get back to my baseline level of functioning (mentally), and I struggle every single day (some worse than others) to focus, be productive, stay connected to those around me, and sometimes just stay on track getting through the day. I understand "battle-fatigue" and this long, on-going pandemic and it's toll of myself and others around me. I am an infection preventionist, during the pandemic, in an acute care hospital, being only in my role for a year when it all hit. Absolutely something occurred after receiving the vaccine. I have waited this long to help rule-out other potential causes, and to see if things would get better. I feel broken, though things are not getting worse, I cannot get back to where I was.
44 2021-05-05 feeling abnormal May 1 18:15 dose 2 of vaccine received. No immediate adverse effects. Shot hurt less than first one.... Read more
May 1 18:15 dose 2 of vaccine received. No immediate adverse effects. Shot hurt less than first one. May 2 09:00 woke up with severe muscle soreness, joint pain, mental fog, extreme fatigue and a slight temp. Took Advil and went back to sleep. Didn't get out of bed majority of the day due to continued fatigue and muscle soreness and joint pain. May 3 went to work with continued mental fog, extreme fatigue, muscle soreness (still everywhere), and joint pain. Continued taking Advil to keep working. Condition did not get better at all throughout this day. May 4 woke up with mental fog lifted, fatigue gone, however; the muscle soreness and joint pain continued... but ONLY from my lower back all the way down both legs. I have never felt anything quite like this before. Continued to take Advil to deal with the pain May 5 aching and pain still present in lower back and both legs May 6 aching and pain still present and annoying in lower back and both legs and is not getting better. At this point I'm concerned as I was completely healthy before receiving the second dose of the vaccine with ZERO health problems and ZERO pain. Please tell me what is going on and if this will pass with time. I was healthy before and want to be healthy again. I'm dealing with the pain and will not miss work if I can help it. My wife is a pharmacist and insisted I get the vaccine.
44 2021-05-10 impaired work ability Vision and gait disturbances began 4/9/21, progressively worsened and he began nausea/vomiting 4/11/... Read more
Vision and gait disturbances began 4/9/21, progressively worsened and he began nausea/vomiting 4/11/21, requiring ER visit on 4/12/21 then hospitalization for 5 days. Comprehensive labs done. Follow-up advised with Dr. (has not occurred). Per Dr. (Neurology), do not get second dose of Covid-19 vaccine as there is a chance the vaccine contributed to development of these symptoms. Doctor said it could possibly be Guillain-Barre Syndrome. As of 5/11/21, significant vision impairment still exists and patient is unable to work. Patient is uninsured.
44 2021-05-13 mental status changes Patient is a 44 y/o gentleman with acute renal failure, elevated BNP and LE edema. Pulmonary consult... Read more
Patient is a 44 y/o gentleman with acute renal failure, elevated BNP and LE edema. Pulmonary consulted for medical management. Thrombocytopenia: - plt count stable today, Hgb stable - hematology consulted, appreciate recs: plan to send for serum antibodies to test for drug induced thrombocytopenia for carbamazepine and valproic acid - will hold protonix as possible offender - peripheral smear (Mercy OKC, 5/8/21): macrocytic red blood cells, moderate thrombocytopenia, rare focal platelet clumping present - less likely vaccine induced TCP---usually this is seen with the AstraZenca and Johnson and Johnson vaccine, not in Pfizer vaccine - if plt remains stable, may d/c home with plan for f/u with Dr outpt COVID-19: - case discussed with Health Department, COVID test for variant testing sent 5/6 - for now, will cont care in isolation - patient with positive COVID-19 test - positve COVID-19 test in January 2021, negative COVID-19 screen in April 2021 - pt with no active respiratory sx AMS: unchanged - waxing and waning mental status - improved AMS with improved renal fxn Acute renal failure: improving - Cr: 1.64, cont PO intake LE edema: - unchanged, low albumin levels, need to increase protein intake Chronic systolic heart failure: stable - cont to hold diuresis Disposition: - cont care in COVID unit, Pulmonary to follow Estimated length of stay is 5 day(s).
44 2021-05-14 feeling abnormal I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection ... Read more
I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection site soreness; redness; skin sensitivity; brain fog; hot flashes; fatigue; swollen lymph nodes (left armpit); This is a spontaneous report from a contactable other hcp. A 44-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9268), via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included migraines. Patient had no known allergies. Patient had not covid prior and post vaccination. Concomitant medication(s) included ibuprofen (ADVIL LIQUI GELS); acetaminophen (ACETAMINOPHEN). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 02:45 (at the age of 44-year-old) as 1st dose, single for COVID-19 immunization. The patient stated that on 13Feb2021 02:00, he had a 102.5 degree fever off and on for two days, severe body aches, chills, headaches, injection site soreness, redness, skin sensitivity, brain fog, hot flashes, fatigue, and swollen lymph nodes (left armpit). Patient did not received any treatment for the events. The outcome of the events was reported as recovering. Follow-up attempts have been completed and no further information is expected.
44 2021-05-16 impaired work ability, excessive sleepiness Severe body ache, chills, sweating, nausea, and vomiting. Vomited 9 times in a row and spent the ent... Read more
Severe body ache, chills, sweating, nausea, and vomiting. Vomited 9 times in a row and spent the entire night with a bucket. For the next week every morning, diarrhea and unsettled stomach, lack of energy, excessive sleep, no ability to exercise without severe fatigue or a return of digestive problems. This lasted a week. Sexual activity also impossible, erection quality greatly reduced. Many of these symptoms got better but have now returned with my second dose. Second dose has given me significant fatigue, digestive problems again, diarrhea, and reduced erection quality once more. I hope these problems resolve themselves. The vaccine has made going to work very difficult and I will seriously reconsider taking any vaccine in the future.
44 2021-05-18 hallucination possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under m... Read more
possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball.; This is a spontaneous report from contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7533) via an unspecified route of administration, administered on the right arm on 30Apr2021 09:15 (Batch/Lot Number: EP7533) as unknown, single for COVID-19 immunization. The patient had no medical history. Concomitant medication included ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient had severe chills, severe back spasm, nausea, dizziness, possible hallucinations, and the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball on 30Apr2021 07:00 PM. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Outcome of the events was recovering.
44 2021-05-20 feeling abnormal Fatigue, back pain, joint pain, lack of mental acuity
44 2021-05-20 sleep disorder This is a 44 M with NIDDM, HTN, HLD, Schizophrenia here with c/o fever and generalized body aches fo... Read more
This is a 44 M with NIDDM, HTN, HLD, Schizophrenia here with c/o fever and generalized body aches for about 7-8 days. Says was having body aches for about 8 days, had COVID 19 vaccine first dose on 5/14/21. Since then, had worsening body aches and also started having fever(not sure how much). Urine color changed to brown in the past week. No change in appetite or nausea or vomiting prior to admit as per him. No new medications and does not consume recreational drugs. Not an alcoholic, no recent trauma, does not work out and was not exposed to extreme heat or cold recently. In ER, patient was found to having AKI, shock liver, CK level which is too high to be calculated, had 1 episode of high-grade fever. He was therefore started on IV fluids and admitted for further management of rhabdomyolysis. Overnight had no urine output and having poor urine output since this a.m.. Had 1 episode of nausea and vomiting this morning. No more fever since on the floor. Complaining of epigastric pain that woke him up from sleep this afternoon.
44 2021-05-25 anxiety the first 36 hours was normal pain with flu type symptoms, now there's vision changes and I had to g... Read more
the first 36 hours was normal pain with flu type symptoms, now there's vision changes and I had to go to the ER because it was really bothering me. They only helped with the anxiety and did an eye exam. It seemed to have gone away some but now it's coming back and it's like having dirty contacts in and having hypersensitivity to light and dark textures.
44 2021-05-27 anxiety Patient experienced apprehension, flushing and numbness and tingling. Patient verbalized "Throat ti... Read more
Patient experienced apprehension, flushing and numbness and tingling. Patient verbalized "Throat tightness" and elevated BP even though pt reports being on BP medications. O2 sat and pulse remained normal. Lungs CTA. Patient has a history of reactions to bee stings. Pt was given 50mg Diphenhydramine observed by staff and released
44 2021-06-01 restlessness, insomnia rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/proble... Read more
rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/problems with sleep; felt movements in his chest at times; felt like he had COVID all over again/ if he possibly has COVID-19 again; soreness; heart rate accelerated; some swollen in lymph nodes; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer sponsored program. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 at around 13:00 or 13:30 (at the age of 44 years old) (Lot Number: EP7534, unknown expiration) as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 in Nov2020; sneezing and runny nose both on 21Mar2021. The patient's concomitant medications were not reported. The patient reported that he received his first dose of Pfizer COVID vaccine on 22Mar2021. He felt fine after receiving the vaccine, but there was little bit rash on arms just afterwards and felt maybe a little restless but felt fine and went for a walk on 22Mar2021. As the night went on, he really noticed how sore his arm was/pain in his arm and when he was sleeping, he had trouble sleeping/problems with sleep (Mar2021) and felt movements in his chest at times (Mar2021). It felt like he had COVID all over again and had chills, soreness, and his smell was kind of gone in Mar2021. He was previously feeling pretty good. He had COVID-19 in Nov2020, and his symptoms feel very similar including loss of sense of smell but no coughing. He had a fever but that has gone away in Mar2021 and he did not take aspirin or anything for it. He also had fatigue, some swollen in lymph nodes, and his heart rate accelerated in Mar2021. He had sneezing and runny nose the day prior to receiving the vaccine. The patient would like to know if his symptoms are related to the vaccine or if he possibly has COVID-19 again. His symptoms are the same as COVID as far as what he can see, and his symptoms are really high. He would like to know if he can still receive the second dose of the vaccine if he has a positive COVID test after the first dose of the vaccine. The patient mentioned that there was very pretty high percentage of people having the symptoms after having the vaccine, kind of virus "causing". The patient asked if he needs to be tested to see if he had the virus before he was vaccinated and to know if these are one of the side effects or one of the symptoms of the virus, and to make sure that these are not actually corona virus. The patient recovered from fever in Mar2021, while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.
44 2021-06-02 abnormal behaviour About a week and half to two weeks after getting the shot, I had a short (3-4 days) but severe spike... Read more
About a week and half to two weeks after getting the shot, I had a short (3-4 days) but severe spike in the symptoms of my ongoing mental health issues. Symptoms of the spike included wild mood swings, VERY strong emotional reactions to otherwise manageable situations, and very erratic, even reckless, behavior. I can't remember ever having symptoms this severe before. No other source for the symptoms could be identified.
44 2021-06-17 anxiety Throat/tongue and neck area swelling for about an hour. Anxiety and some dizziness. Problem began a... Read more
Throat/tongue and neck area swelling for about an hour. Anxiety and some dizziness. Problem began about half hour after injection then went away after an hour or so after it began - but my doctor recommended that I do not to get second shot because of this reaction.
44 2021-06-18 feeling abnormal Since the day after my first injection (4/3) I have had a constant headache. Every single day since ... Read more
Since the day after my first injection (4/3) I have had a constant headache. Every single day since that headache has not left. It varies in intensity, it is generally the worst in the morning and evening or at least I block it out enough to do my job. Pain is in the back of my head/upper neck, in front of my ears on the sides of my head, sometimes I also get it on the crown of my head. I have also been nauseous pretty much every day since then. I have vomited once. Nausea is worst in the mornings. Occasionally I feel like I have a concussion, hard to describe that feeling.
44 2021-06-22 sleep disorder Altered sense of taste and smell. Things tasted different. I had a very dry mouth as well. I also sm... Read more
Altered sense of taste and smell. Things tasted different. I had a very dry mouth as well. I also smelled things that were not there. I lost my sense of smell 10 years ago due to sinusitis. I experienced lethargy about 5 days after the shot up to 4 weeks after. I had some tightness in my chest, my albuterol inhaler helped with that. The tingling in my hand and feet happened on a few occasions. I had numbness that lasted about an hour. I had frequent night sweats that woke me. I had muscle tightness in my leg and abdomen. I also had soreness in my arm, which made it hard to grasp a pen. I did test my reflexes which were normal.
44 2021-06-29 fear Approximately one month after my second shot, beginning around 5/20, I began to lose the sense of ta... Read more
Approximately one month after my second shot, beginning around 5/20, I began to lose the sense of taste on the right side of my tongue. I thought it would go away but by 5/23 I had partial paralysis on the right side of my face. Fearing a stroke I went to the ER and after a full battery of tests I was diagnosed with Bell's Palsy. The symptoms worsened for a few days and I was unable to close my right eye, had difficulty breathing out of my right nostril and both eating and drinking were difficult because my lips would not close fully. The symptoms stabilized and then finally began to improve after steroid and antiviral treatment for a week, then on to regular aspirin.
44 2021-06-30 sleep disorder Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his thro... Read more
Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his throat; Rapid heart rate; really bad chest pains; vomit; nausea; gasping for air; Neck spasms; Blood pressure, clarified as low blood pressure; It was like he was catching pneumonia but then his nose was running,; severe congestion, like bad stuff in his chest and lungs; severe allergies; tired; he got really sick; It was like he was catching pneumonia but then his nose was running,; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and from a Pfizer sponsored program. A 44-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0167, Expiry date: UNKNOWN, NDC number: Unknown), via an unspecified route of administration at the right arm on 29May2021 11:15 as a SINGLE DOSE for covid-19 immunization. Medical history included myocardial infarction from an unknown date and unknown if ongoing, illness from Feb2020 to an unknown date, whole family was sick in February, palpitations from an unknown date and unknown if ongoing. History and investigation included "he said he had nothing to add during that time. But about a year ago he had gone to the emergency room for a heart attack scare. he thought, because this was when COVID first started happening, his whole family was sick in February and they would not test them at that time because they had not been to China and they never found out if they had it but he ended up getting tested for COVID when he was sick like 6 months later and then that went away and he started having heart palpitations and then after that he thought he would get a COVID antibody test and that came back negative, they told him by the time he got the antibody test, they told him he could have had it but it is not showing up on their antibody rapid test thing. He confirms this all occurred last year in 2020, he thinks it was almost a year ago. He would be sitting on the couch and his heart started racing like crazy. He did not know what that was all about". He said he had no discomfort at all. Concomitant medications were not reported. On an unspecified date in 2021 patient experienced it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running, on an unspecified date in 2021 severe allergies, on 29May2021 rapid heart rate, really bad chest pains, stuff in his throat/weird stuff on his throat , cough, on an unspecified date in May2021 vomit, nausea, on an unspecified date in May2021, gasping for air, on an unspecified date interrupted his sleep. Caller received his first dose and was experiencing symptoms such as rapid heart rate and neck spasms and blood pressure. He was too tired to go to the emergency room. He had the weird cough and also stated he had weird stuff on his throat and severe allergies. Regarding his second dose, he wanted to receive but he wanted to know if he could receive a half dose. He also had really bad chest pains and he was going to go to the emergency room but he was too tired to even go. The other reason for calling, he was trying to find out because he was afraid to take the second dose, he wanted to know if he could take a half dose or something, he was trying to find out what he should do. Severe allergies, caller clarified it was like severe allergies or like hay fever kind of, but it was different. Rapid heart rate: He said this began happening the same day as the dose was given, 29May2021, 4 hours after he got the shot. It was not ongoing, it lasted about a day. The rapid heart rate went away the next morning, it stopped doing the crazy things it was doing the next morning, 30May2021. He confirmed that has recovered completely. The chest pain coincided with the rapid heart rate. It went way the same time as the rapid heart rate. It seemed like they both would come and go until the next morning, He confirmed that had recovered completely. He said then the low blood pressure was going on too. It was like it interrupted his sleep, he did not know how to explain it, like he had low blood pressure or like his heart would stop beating and he would wake up gasping for air. It was kind of like a nauseous feeling, he wanted to vomit. It happened with the low blood pressure and was mostly when he was sleeping and a little through the day, the nausea he means, it lasted about a day and a half. The nausea went away on the 30May or the 31May he cannot remember for sure. The cough and stuff in his throat began at the same time the heartbeat stuff started and the cough went away after 2 days. He felt pretty good for about 3 days and then he got really sick, with severe congestion, like bad stuff in his chest and lungs. It was like he was catching pneumonia but then his nose was running, it felt weird like a sickly poison kind of feeling like after he got the shot, he could not tell but it seemed like severe allergies or like hay fever kind of but it was different, it was a weird feeling. He had taken a bunch of herbal remedies Benadryl took herbal allergy stuff and it worked really fast and after like 3 days it was gone. He does not know what that was but it was pretty intense. No further information provided. It was reported that, caller got his first dose of the Pfizer Covid-19 vaccine on 29MAY2021 and had side effects. He wanted to know if he could get only a half dose of the COVID-19 vaccine. He also wanted to know if there was any correlation to having COVID-19 and having more of a reaction. Caller wanted to know if there was a correlation between having COVID-19 and having more side effects to the vaccine. He stated that his Pharmacist said there might be a correlation to people having COVID before getting the vaccine and having more problematic side effects from the first vaccine instead of the second. Response was given as "he should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. He was referred to speak to healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider would have known the health situation and could access to information that better help inform the decision. From the CONS document on efficacy. Two shots were generally needed to provide the best protection against COVID-19 and the shots were given several weeks apart. The first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. Side effects after the second shot might be more intense than the ones experienced after the first shot. The side effects are normal signs that body is building protection and should go away within a few days". The patient underwent lab tests and procedures which included sars-cov-2 antibody tested negative. Therapeutic measures were taken as a result of severe allergies (drug hypersensitivity). He visited emergency room due to the event chest pain. On an unspecified date in 2021 the outcome of the events it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running was unknown, on an unspecified date in 2021, severe allergies was recovered, rapid heart rate, really bad chest pains, cough was recovered on 30May2021, on an unspecified date in May2021 vomit, nausea was recovered, gasping for air, interrupted his sleep and stuff in his throat/weird stuff on his throat was unknown. Information on the lot/batch was available, Additional information has been requested.
44 2021-07-01 anger Pt stated that in addition to the expected side effects of the vaccine, he experienced extreme anger... Read more
Pt stated that in addition to the expected side effects of the vaccine, he experienced extreme anger and rage for about3 days after the vaccine. The anger resolved after that period and the proximity of the anger to the vaccine made him feel the two were related.
44 2021-07-01 disturbance in attention Headache, congestion, aches and pains, joints, loss of energy, Concentration, loss of testosterone, ... Read more
Headache, congestion, aches and pains, joints, loss of energy, Concentration, loss of testosterone, chest pain, heart
44 2021-07-02 agitation Throbbing in my head as if to start a headache, shortness of breath, pressure in the chest, dizzines... Read more
Throbbing in my head as if to start a headache, shortness of breath, pressure in the chest, dizziness, fluttering of the heart, feeling agitated.
44 2021-07-15 irritability Hard lump in left arm near injection site. Swollen lymph node. Slight fever. Irritability. Tiredness
44 2021-07-23 feeling abnormal, sleep disorder Beginning the second day following vaccination to current day, I have the following symptoms: a st... Read more
Beginning the second day following vaccination to current day, I have the following symptoms: a stiff neck, severe headache, brain fog, and highly disturbed sleep.,
44 2021-07-27 nervousness, insomnia Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration... Read more
Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration (no muscle pain); he's been feeling a light body (not hard to move); elevated liver enzymes; he told him he doesn't get enough sleep; nervous; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration on 22Apr2021 (at the age of 44-year-old) as dose 2, single for covid-19 immunisation. Medical history included, hypertension from 29Apr2021 to an unknown date, glucose tolerance impaired from 2010 to an unknown date Verbatim: Prediabetes, haemorrhoids from 09Mar2021 to an unknown date Verbatim: Hemorrhoids, hypovitaminosis from an unknown date and unknown if ongoing, asthenia from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) taken for haemorrhoids, pain, start and stop date were not reported; ascorbic acid, biotin, folic acid, iron, nicotinic acid, pantothenic acid, pyridoxine, riboflavin, vitamin b1 nos, vitamin b12 nos, vitamin e nos (CENTRUM ADULT B+ IRON) taken for hypovitaminosis from an unspecified start date and ongoing; ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) taken for covid-19 immunisation from an unspecified start date and ongoing; vitamin b complex (VITAMIN B) taken for asthenia from an unspecified start date and ongoing. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 01Apr2021 (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. On 25Apr2021, patient experienced losing some muscles, 0n 26Apr2021, patient experienced weakness, on 27Apr2021, patient experienced tiredness, on 29Apr2021, patient experienced hypertension. on an unspecified date in 2021, patient experienced muscle deterioration, he's been feeling a light body, elevated liver enzymes, he told him he doesn't get enough sleep, nervous. The patient underwent lab tests and procedures which included aspartate aminotransferase: 28 on 22Sep2020 Normal, aspartate aminotransferase: 46 on 30Apr2021 slightly elevated, blood test: elevated liver enzymes on 30Apr2021. Therapeutic measures were taken as a result of hypertension included losartan 25mg. The outcome of the events losing some muscles, tiredness, weakness were not recovered and the outcome of the remaining events were unknown.
45 2020-12-31 feeling abnormal LEFT HAND NUMBNESS, FEELS DIFFERENT. 97.8, 118/77, 80
45 2021-01-06 feeling abnormal I am an anesthesiologist reporting my own event: injection received 0900. At 1400 I began low grade... Read more
I am an anesthesiologist reporting my own event: injection received 0900. At 1400 I began low grade fever and not feeling well. By 1600 I had extreme fatigue and severe mental fogginess. This fogginess lasted approximately 24 hours. Other reactions included chills, fever, myalgia, arthralgia, headache as expected. I feel the mental effects could put patients in danger if healthcare practitioners are not aware of the possibility of this and receive the vaccine while on duty. I did not experience this with the first dose.
45 2021-01-06 nervousness Patient received vaccination approximately at 10:45 am, he had told immunizer he had felt nervous ... Read more
Patient received vaccination approximately at 10:45 am, he had told immunizer he had felt nervous and had fainted previously with other vaccinations. Patient was monitored after vaccination patient said he felt dizzy, approximately 11:15 am he feel forward from chair and was attended to by staff. EMTs were called and patient was taken to hospital for observation. After vaccination pt had blood pressure readings of 130/80 5 min after 150/80 15 minutes after his blood sugar readings reported by family member on scene were 325 the previous evening and 255 the morning before he came in. EMTs took a blood sugar reading 365 upon their arrival.
45 2021-01-08 feeling abnormal Mild Fuzzy head, light headed Narrative: occurred for only that night after the vaccine
45 2021-01-09 feeling abnormal Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swoll... Read more
Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swollen lower lip, nauseated, weird sensation of not feeling right almost like out of body
45 2021-01-10 feeling abnormal He developed episodes of vertigo like dizziness, allong with feeling like he was going to pass out,... Read more
He developed episodes of vertigo like dizziness, allong with feeling like he was going to pass out, feeling unsteady, sweaty, nauseated. They would last for about less than a minute, but he had several episodes. He had pulsatile tinnitus. He also had an elevated LFT.
45 2021-01-13 feeling abnormal Pfizer-BioNTech COVID-19 Vaccine EUA - I woke up in the middle of the night sweating, and felt tired... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - I woke up in the middle of the night sweating, and felt tired the next morning with slight brain fog. Otherwise, I felt fine.
45 2021-01-17 sleep disorder, insomnia Starting from the first night after the vaccination and each and every night after that to date of t... Read more
Starting from the first night after the vaccination and each and every night after that to date of this form completion, I have had extremely interrupted sleep. I have woken up several times in the middle of the night (i.e., 2 am, 4 am, etc..). Each time I have woken up and felt wide awake and difficulty going back to sleep. As a consequence each of the following days after this poor sleep I have been in extreme fatigue and not able to function properly. I do not have any other notable side effects. No fever or major headaches. This disturbed sleep which coincidentally started right after the vaccination is highly concerning for me, especially since it has happened on 4 consecutive nights. This has not happened to me before. In the past even if I woke up in the middle of the night, I would fall back asleep relatively quickly. Furthermore, it has not been the case of this type of lack of sleep for this many consecutive nights. Another observation is that my feeling of hunger seems to have increased for some reason. Even in the middle of the night when I wake up I have felt great hunger and then starting in the morning that hunger continues. This is more hunger than normal for me. My diet and eating patterns have not changed compared to what it was before getting the first dose of the vaccination. Given that today is Martin Luther King Day and a Holiday my PCP is closed, so could not make an appointment or report this to her. I will call my PCP again tomorrow, 01/19/21. If this disturbed sleep continues, then I am sure how I can properly function during a normal work day on the job. Given all the above I am also concerned about the second dose of the vaccination and what side effects that may result in.
45 2021-01-18 feeling abnormal feeling bad; 100 degree fever; chills; body aches; headache; This is a spontaneous report from a con... Read more
feeling bad; 100 degree fever; chills; body aches; headache; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number CH9899), via an unspecified route of administration from 11Jan2021 08:30 to 11Jan2021 08:30 at a single dose for covid-19 immunization. The patient's medical history was not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) On 21Dec2020 at first dose. Concomitant medication included melatonin. It was reported that the patient feeling bad after injection, got 100 degree fever, chills, body aches and headache; all on 11Jan2021 16:00. Took aspirin to reduce side effects but headache remains. The outcome of the event headache was not recovered while recovering for the other events.
45 2021-01-24 motion sickness Motion sickness, and fatigue started about 11am; Motion sickness, and fatigue started about 11am / s... Read more
Motion sickness, and fatigue started about 11am; Motion sickness, and fatigue started about 11am / slept for 3 hours woke to just severe fatigue; Headache started about 6 hours after, progressively worsening about 12hrs; This is a spontaneous report from a contactable consumer (patient). This 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EH9899), via an unspecified route of administration at single dose in the left arm on 11Jan2021 14:00 to for Covid-19 immunisation. Medical history included was none. Concomitant medication included fluticasone propionate and multi vitamin. The patient experienced headache started about 6 hours after, progressively worsening about 12hrs on 11Jan2021 20:00, motion sickness, and fatigue started about 11am on 12Jan2021. Completely wiped out by noon and had to lay down could not work slept for 3 hours woke to just severe fatigue, slight headache no nausea. Therapeutic measures were taken as a result of headache included Advil but no help. No treatment received for the other events. The vaccine was administered at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
45 2021-01-25 feeling abnormal brain is still in a fog; received the first dose of the Pfizer COVID Vaccine and then 2 weeks later ... Read more
brain is still in a fog; received the first dose of the Pfizer COVID Vaccine and then 2 weeks later got COVID again; received the first dose of the Pfizer COVID Vaccine and then 2 weeks later got COVID again; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for Covid-19 immunization and tetanus vaccine (manufacturer unknown) via an unspecified route of administration on unspecified date at single dose for immunization. Medical history included COVID diagnosed in Mar2020. Concomitant medication was not reported. The patient received the first dose of the Pfizer COVID Vaccine and then 2 weeks later on 05Jan2021 got COVID again. He wanted guidance as to when he can get the second dose of the vaccine. His vaccination provider refused his second dose and the 21-day interval has passed. He was tested for COVID on 05Jan2021 and was positive. The patient said that his brain is still in a fog on unspecified date. He is normally not this cloudy. It was also reported that around the same time he got a Tetanus shot, and he can not remember which one was given in which side. The outcome of the events was unknown.
45 2021-01-27 sleep disorder Days after receiving first shot, would wake up within 2 hours of falling asleep with a sharp headach... Read more
Days after receiving first shot, would wake up within 2 hours of falling asleep with a sharp headache on left side of head. Would sit up and move around and headache would dissipate with 30 minutes. Am not able to lay on back or on side. Received booster on 1/26/2021 and have had same events. OTC pain killers are not working. Once I initially wake up I move to recliner and fall asleep. We have a sleep number bed and have not had this issue in the past, although don't know if it is the vaccine or a unknown subtle change in day to day activities.
45 2021-01-30 confusional state approximately 30 minutes after injection of shot, felt dizzy, confusion, face and throat swelling, ... Read more
approximately 30 minutes after injection of shot, felt dizzy, confusion, face and throat swelling, rapid heart rate, feeling on the verge of passing out. Was driving home at the time and pulled over to call 911. 3 to 4 minutes of very intense reactions, had initial difficulty calling 911 and driving off the road to pull over. Paramedics arrived 10 minutes after the initial call to 911, symptoms had improved greatly after 3 to 4 minutes and after 10 was starting to feel back to normal.
45 2021-02-04 feeling abnormal Patient finished observation period and went to his car 50 minutes post vaccine where he then starte... Read more
Patient finished observation period and went to his car 50 minutes post vaccine where he then started feeling tingling to tongue and fat and fuzzy feeling. Returned to site - received Benadryl IM with good resolve. DC'd home to care of friend for further observation.
45 2021-02-06 impaired work ability Symptoms began 12 hrs after injection and lasted for 24 hrs from onset of symptoms. Sore deltoid/ine... Read more
Symptoms began 12 hrs after injection and lasted for 24 hrs from onset of symptoms. Sore deltoid/inection site, chills, body aches, fatigue, mild headache, max recorded oral temp = 99.6 degrees (personal norm 96-97 degrees oral). Out of work x1 day due to COVID-19 screening/symptom algorithm.
45 2021-02-07 impaired work ability, loss of personal independence in daily activities Local nerve injury/significant numbness and weakness in his upper extremities specifically in his le... Read more
Local nerve injury/significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work; At the time of vaccination he experienced discomfort in left deltoid which was the injection site; Cannot lift his arm greater than 45 degrees; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; This is a spontaneous report from a contactable pharmacist. A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular n deltoid left on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. At the time of vaccination he experienced discomfort in left deltoid which was the injection site, cannot lift his arm greater than 45 degrees, local nerve injury, systemic fatigue ,myalgia and other arthralgia for 24-36 hours, developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work or task, all in Jan2021 with outcome of unknown. He called the employee health on 17Jan2021 and 19Jan2021 he saw a neurosurgeon. The neurosurgeon didn't think it was a cervical spine injury rather a local nerve injury related to the injection itself and he was prescribed a steroids taper, unclear whether if it was a temporary or permanent issue. Because this was like 10 days after the vaccine and he didn't really describe how much this issue affected his ability to perform usual work or task but he was a surgeon. The outcome of the events were unknown.; Sender's Comments: Based on the compatible time association, the peripheral nerve injury is possibly related to the injection technique, not vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-02-18 anxiety PATIENT STATES IS HAVING DIFFICULTY SWALLOWING ON HIS OWN . PATIENT APPEARS IN NO APPARENT DISTRES... Read more
PATIENT STATES IS HAVING DIFFICULTY SWALLOWING ON HIS OWN . PATIENT APPEARS IN NO APPARENT DISTRESS BUT SEEMS ANXIOUS. PATIENT GIVEN WATER AND DRANK WATER WITH NO DIFFICULTY. HEART RATE 80 AND REGULAR. PATIENT MONITORED ADDITIONAL 15 MINS AND STATES STILL HAS SYMPTOMS BUT ARE LESS INTENSE . PATIENT APPEARS TO HAVE NO APPARENT DISTRESS AND DOES NOT APPEAR AS ANXIOUS. PATIENT REFUSES ANYMORE MONITORING AND LEFT. PATIENT WAS INSTRUCTED THAT IF SYMPTOMS PERSISTED OR GOT WORSE TO FOLLOW-UP WITH EMERGENCY DEPARTMENT.
45 2021-02-18 feeling abnormal, feeling drunk 2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and ... Read more
2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and palpitations. Vision (only have one eye) has been hazy when looking at computer. This is still on going. Work up done by optometrist at this point eye checks ok but problem persist. Referral to ophthalmologist is place. Feeling of fogginess in head - "drunk like feeling" persisted for several weeks. This still seems to be on going. Palpitations and some check pain. - This was never a finding prior to 2nd dose of vaccine. This has resolved.
45 2021-02-23 disturbance in attention moderate fatigue/tiredness; some difficulty concentrating; This is a spontaneous report from a conta... Read more
moderate fatigue/tiredness; some difficulty concentrating; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL 3247, expiry date unknown) in the workplace clinic, via an unspecified route of administration on 26Jan2021 at 13:45 at a single dose on the left arm for COVID-19 immunization. The patient had no medical history and no known allergies. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that on 27Jan2021 at 06:45, the morning after the patient was vaccinated, he had moderate fatigue/tiredness with some difficulty concentrating. The patient stated that it felt similar to getting 2-3 hour sleep, but he had no issue sleeping last night. The patient did not receive treatment for the event. The patient was recovering from the events. The events were reported as non-serious.
45 2021-03-02 feeling abnormal Mental fogginess, to the point a coworker had to drive him home. In the evening became achy all over... Read more
Mental fogginess, to the point a coworker had to drive him home. In the evening became achy all over severe arm pain at injection site, and temperature. Phoned PCP who told to go to the ER and he did not. went to PCP office 2/1/21.
45 2021-03-04 anxiety Complaint of "tingling" and "feeling" of edema in lips. Patient subsequently went to the bathroom t... Read more
Complaint of "tingling" and "feeling" of edema in lips. Patient subsequently went to the bathroom to see if his lips were swollen and they were not. Paramedic reported that the patient expressed anxiety about injections/needles and this may have contributed to perceived adverse effects. Patient asked for Benadryl and was given 25 mg po x 1.
45 2021-03-10 feeling abnormal Recipient reports feeling bad all over started immediately, shaking but waited in his car in the par... Read more
Recipient reports feeling bad all over started immediately, shaking but waited in his car in the parking lot after the 15 minute waiting period. Reported back into the vaccination site approx 45 minutes after his injection. Elevated BP 150/105, few minutes later was 170/110 hr 125 rr 20 skin clammy at intervals. Glucose 148 per his report from his insulin pump. No hypertension history or meds per his report.
45 2021-03-14 nervousness, feeling abnormal FEELING FUNNY, QUEEZY AND NERVES
45 2021-03-23 anxiety A few days after receiving the vaccine my blood pressure became elevated to 190. If I calmed down it... Read more
A few days after receiving the vaccine my blood pressure became elevated to 190. If I calmed down it got better. I felt like my heart rate raised a couple of times a day. The spikes in my blood pressure and heart rate lasted about four days. It felt a little like an anxiety attack. I was prescribed a Diuretic which I took for a week. When you got the second dose I did not have any of the same symptoms.
45 2021-03-24 feeling abnormal Burning Skin (face, feet) alternating with deep chills (but no fever); Extreme fatigue; Brain fog f... Read more
Burning Skin (face, feet) alternating with deep chills (but no fever); Extreme fatigue; Brain fog fatigue and brain fog still persistent 6 days after symptom onset (13 days post-vaccination). Burning skin significantly lessened after 5 days (still happens occasionally)
45 2021-03-25 feeling abnormal The patient reported vision changes and not feeling normal. Patient returned to baseline after 15 m... Read more
The patient reported vision changes and not feeling normal. Patient returned to baseline after 15 minutes.
45 2021-03-30 feeling abnormal Within the first few day - typical AEs (low grade fever, sore arm, fatigue). However, the atypical ... Read more
Within the first few day - typical AEs (low grade fever, sore arm, fatigue). However, the atypical AEs included daily and persistent dizziness, "brain fog", fatigue, difficulty going up the stairs without getting winded (difficulty with physical exertion). These symptoms are still present on March 31st (11 days post injection). GI / diarrhea symptoms are also present. Of note, I did have COVID in the past (January 2021) - and had similar symptoms that had resolved at the time of the vaccine. These symptoms are severe enough that it may prevent the second shot (due to concerns of worsening AEs or prolonged events). Of note, the fatigue was worse with the actual disease vs. the vaccine.
45 2021-03-31 confusional state All started the morning of the day after the vaccine shot and got progressively got worse the entir... Read more
All started the morning of the day after the vaccine shot and got progressively got worse the entire day. They were all gone by the next day. Fatigue Nausea Muscle Aches Confusion/dizziness
45 2021-03-31 impaired work ability There were chills (like I was having a fever) at mid-night of the shot (shot was given in the mornin... Read more
There were chills (like I was having a fever) at mid-night of the shot (shot was given in the morning), to the extent that I was shivering. I had a low grade fever for most of the day. I measured it once and it came to 99F. I felt like I had a bad cold or mild flu. Symptoms prompted me to take the day easy (took off work and stayed in bed). Symptoms completely resolved by the next morning. I did not take any medication. I had no reaction to the first shot at all (besides a sore arm which was common for both shots)
45 2021-04-01 feeling abnormal sore arm, brain fog, headache, swollen lymph nodes, pain in brain stem, sore neck, lethargy, diarrhe... Read more
sore arm, brain fog, headache, swollen lymph nodes, pain in brain stem, sore neck, lethargy, diarrhea, bowel discomfort, arthritis flare-up
45 2021-04-05 anxiety Within 60 seconds of receiving the injection, I experienced moderate breathing difficulty. After 1... Read more
Within 60 seconds of receiving the injection, I experienced moderate breathing difficulty. After 10-20 minutes, I noticed that my throat felt slightly swollen (slight difficulty swallowing). Due to a hyperallergic event that occurred about 12 years ago, I occasionally run into something that triggers the respiratory effect - although usually the reaction is milder than that caused by the vaccine. However, the throat swelling is new. I took a single puff of an Albuterol inhaler around 5 minutes after the injection, but it had no effect (usually the case for me when the cause is allergic in nature). About 37 minutes after the injection, medical staff advised me to take an antihistamine. I took approximately 6 mg of doxylamine succinate (orally). However, by this point, the breathing had already started to ease slightly. Approximately 30 minutes later, my breathing was back to normal and the throat inflamation was gone. It's uncertain how much of that would have occurred through time alone and how much of it was the antihistamine starting to take effect. My BP was very high when measured during treatment. Partially explained by the albuterol inhaler combined with pseudoephedrine taken earlier in the day, along with anxiety and exertion from the event itself.
45 2021-04-05 insomnia Persistent mild fever (99.5+) Ache (bone-ache, almost like arthritis) Fatigue Sleep trouble
45 2021-04-08 sleep disorder Dull pain at the injection site; second shot seemed fairly high on my shoulder/ pain at injection si... Read more
Dull pain at the injection site; second shot seemed fairly high on my shoulder/ pain at injection site and general shoulder area was severe; I could'nt move my arm at all due to pain; barely sleep due to shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL9266, Expiration Date: Not provided) via unspecified route on 16Feb2021 at 09:45 AM in the left arm as single dose for covid-19 immunisation. Patient's medical history included shoulder injury due to fall (5 years ago). Concomitant medications were none.The patient previously took Ibuprofen and Amoxicillin and experienced allergies, also historical vaccine includes on 26Jan2021 at 10:00 AM, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EN5318, Expiration Date: Not provided) via unspecified route in the left arm as single dose for covid-19 immunisation. The patient did not receive any other vaccines in four weeks. On 16Feb2021 at 15:00, the patient experienced pain at the injection site, "barely sleep due to shoulder pain", shoulder injury. Clinical course of the event as follows: On 16Feb2021, about 5 hours after the shot in the left arm, patient started feeling the typical dull pain at the injection site, about at 11pm (13 hours after injection) the pain at injection site and general shoulder area was severe. About 9 out of 10 he could barely sleep due to shoulder pain. Patient couldn't move his arm at all due to pain. The pain began receding about 24-36 hours later till 8 days after injection, he still had shoulder pain when he moves arm a certain way. It was reported that it felt like a shoulder injury for him. It was further stated that, the same shoulder was injured mildly about 5 years ago due to a fall but made a full recovery a couple months later. The patient informed that pain after first shot was only mild dull pain at injection site. Also, of note is that the injection site for second shot seemed high on shoulder as opposed to the side of the deltoid for the first shot. Events were not treated. Outcome of events was resolving.
45 2021-04-09 confusional state Patient had generalized weakness, dizziness, fatigue, confusion, blurry vision, lethargy, neck pain ... Read more
Patient had generalized weakness, dizziness, fatigue, confusion, blurry vision, lethargy, neck pain 5 minutes after the first dose of Pfizer coronavirus disease vaccine. MRI C spine negative for COVID related transverse myelitis. CT head negative. His glucose was also low that was treated. He felt better the next day and was discharged.
45 2021-04-13 nervousness Patient had gotten COVID-19 vaccine (Pfizer) and he had finished his 15 minutes waiting time. We was... Read more
Patient had gotten COVID-19 vaccine (Pfizer) and he had finished his 15 minutes waiting time. We was leaving when his wife and his mother mentioned he had swollen eyes. Pt said he was feeling well and that his eyes were fine. However, family member insisted he had an allergic reaction to the vaccine and he mentioned he started to feel lightheaded and nervous afterwards. His BP was 107/81 mmHg and pulse 100 bpm and he mentioned he wanted to take something for allergies, so patient was given 50 mg Benadryl after confirming his weight (80 kg). After 15 minutes waiting, patient mentioned he was feeling fine, and he wanted to leave. BP was taken again and it was 125/76 mmHg and pulse was 89 bpm. Pt refused calling 911 because he was feeling ok and he did not feel his eyes swollen.
45 2021-04-15 confusional state, excessive sleepiness 2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. heada... Read more
2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. headache. confusion. 48 hours after 2nd shot random blurred vision and Hives all over but more on the arm I received the shot. Random cough followed by extreme heartburn with a lot of saliva being produced and nasua.
45 2021-04-15 restlessness - In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restle... Read more
- In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restlessness, pallor, R arm pain. - Telephone visit 4/14/21 complained of chills, nausea, vomiting, abdominal cramping, diarrhea. Fluids and rest recommended. - 4/15/21 presented to Kaiser with chest pain, shortness of breath, abdominal pain. Diagnosed with late presentation of acute coronary syndrome / anterior ST elevation MI. Echo with low EF < 25%, LV apical thrombus - 4/16/21 heart catheterization showed 100% occlusion of LAD treated with PCI / DES x 2, IABP. Endotracheal intubation for respiratory failure.
45 2021-04-19 feeling drunk, feeling abnormal I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I... Read more
I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I've had several small episodes and two big episodes in the span of 2 weeks and ongoing. A big episode will knock me out for hours even up to a day. See symptoms below. Small episodes: Dizziness-feel tipsy Nausea Headaches Vomiting Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking. Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly This has affected my work. My doctor told me to report this to you. I got the 1st vaccine shot on 04/05/21. I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I've had several small episodes and two big episodes n the span of 2 weeks and ongoing. . A big episode will knock me out for hours even up to a day. See symptoms below. Small episodes: Dizziness Nausea Headaches Vomiting Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking. Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly My second does is scheduled for 04/26/21, should I take it?
45 2021-04-19 insomnia SWOLLEN MOUTH, EVERY 4-6 HOUR LEFT SIDE LUNG DISCOMFORT BELOW THE RIB BUT ABOVE THE STOMACH. ULCER ... Read more
SWOLLEN MOUTH, EVERY 4-6 HOUR LEFT SIDE LUNG DISCOMFORT BELOW THE RIB BUT ABOVE THE STOMACH. ULCER LIKE PAIN AND DISCOMFORT EVERY 4-6 HOURS, LESS SLEEP LIKE 5 HOURS DAILY.
45 2021-04-20 anxiety ~2230 chest tightness/pain (unlike asthma) that radiated to neck and left arm with left arm numbness... Read more
~2230 chest tightness/pain (unlike asthma) that radiated to neck and left arm with left arm numbness, anxiety He had taken 325mg of ASA 4x that day d/t right shoulder pain from previous injury
45 2021-04-20 feeling abnormal Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm... Read more
Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm. By 630 pm at a 102 fever. Very high blood sugars that I couldn't manage for the day. Night sweats and fever over night but fever broke by morning. Felt off on the third day. On the fourth day woke up with a locked neck which never happens and felt ill, tired, sore, had a cough and mild vertigo for next 4-5 days.
45 2021-04-21 feeling abnormal Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol. 4 h... Read more
Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol. 4 hours after that (8 hours after vaccination) he was still experiencing extreme headache and also vomiting and took another dose of Tylenol. Was still feeling poor at 1am but coherent and talking, not thinking that it was serious enough to warrant going to hospital, as he believed it was just a bad headache and the vomiting was from the headache. At 6am, he was found blue/dead in his bed.
45 2021-04-22 depressed mood Patient reports that 3-4 days after 2nd dose of Pfizer COVID vaccine, he developed auditory and visu... Read more
Patient reports that 3-4 days after 2nd dose of Pfizer COVID vaccine, he developed auditory and visual hallucinations, paranoia, depressed mood. Symptoms lasted about 1 wk and then improved.
45 2021-04-22 euphoric mood, feeling abnormal After first dose, Subject was on the way to observation area when staff were summoned to an adverse ... Read more
After first dose, Subject was on the way to observation area when staff were summoned to an adverse event. Responding staff observed Subject had vomited on himself in the car. Subject reports he felt very euphoric, leaned his head back and was floating. Thinks he may have passed out (does not know how long) and woke up with vomit all over him. Thinks he may have had a seizure as his neck was stiff and had bite marks on his tongue. As of 4/23/2021 Subject reports full recovery. Has passed out before after having blood drawn x 2 in the past, but not shots.
45 2021-04-22 sensation of foreign body Patient notes knot in throat and feeling like her throat is being coated. Given Benadryl and monitor... Read more
Patient notes knot in throat and feeling like her throat is being coated. Given Benadryl and monitored for 45 minutes. She felt better and left in stable conditions.
45 2021-04-23 insomnia Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizz... Read more
Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizzy. Nausea. Like bad flu symptoms, like the worst flu I have ever felt.
45 2021-04-25 sleep disorder Starting around 9am Tuesday 4/6/21 I began getting chills and my entire body hurt. By 12 noon I had... Read more
Starting around 9am Tuesday 4/6/21 I began getting chills and my entire body hurt. By 12 noon I had a splitting headache. I left work and went home to sleep. I was unable to sleep due to the headache. I took my temperature with a digital thermometer around 4PM. I was running a 102 fever. I took three 200 mg Advil around 6pm. My headache got better over the next hour. My fever broke around 9pm that night. I soaked through a shirt. That afternoon and evening I experience joint pain. It felt like needles being jabbed into my joints. Or like lightening strikes in my joints. I got a full nights sleep and the next day I felt 95% better. This was my second shot. I got it at the pharmacy.
45 2021-04-26 amnesia, feeling abnormal He received the show on 4/23. That night he thought he was a little more achy. The next morning he w... Read more
He received the show on 4/23. That night he thought he was a little more achy. The next morning he was driving his family to a track meet around 9:30. He and his wife were having a conversation. According to his wife, he seemed to become dazed. Their conversation just stopped. The car started to veer off the road and they were onto the rumble strips. He wasn't making a correction, so his wife had to tell him to drive back into their lane, but he overcorrected and ended up into the lane of oncoming traffic. He was able to correct that and pull the car off of the road. He and his wife switched so that she was driving. He seemed to have a glazed look on his face, but he didn't have any difficulty walking or getting in/out of the vehicle. He does not remember the incident of the car veering and overcorrecting. When they got to the track meet he felt tired and just laid down for 10-15 minutes. Afterwards, he felt like he was fine. They entire incident lasted about 30 minutes. He has been fine since.
45 2021-04-26 disturbance in attention Tinnitus. The ringing in my ears has become so bad that I can?t hear and I can?t concentrate. I do... Read more
Tinnitus. The ringing in my ears has become so bad that I can?t hear and I can?t concentrate. I don?t want to live any longer like this.
45 2021-04-27 insomnia Dull pain in injection shoulder two weeks after injection. Major discomfort. Unable to sleep comfort... Read more
Dull pain in injection shoulder two weeks after injection. Major discomfort. Unable to sleep comfortably. Advil doesn?t help. Ice has helped some.
45 2021-04-27 loss of personal independence in daily activities, disturbance in attention, feeling abnormal 12 hours after vaccination developed debilitating inability to think clearly, brain fog, shortness o... Read more
12 hours after vaccination developed debilitating inability to think clearly, brain fog, shortness of breath, activity intolerance, heat intolerance , headaches, fatigue that have not subsided since.
45 2021-04-28 feeling abnormal, confusional state When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had... Read more
When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had intense chills and hot flashes. Never a fever. I felt nauseated. Completely lethargic. Muscle aches all over my body, was hard to move. I couldn't stay awake. My eyes hurt. I had intense migraines. And no appetite. My right arm hurt, but not as bad as many others' reported. I took ibuprofen to help, it didn't. I drank lots of water and gatorade zero for the electrolytes. It didn't help either. On day #3, this was when it got scary. The previous symptoms carried over, minus the nausea and I was able to be mobile (less lethargic). But something new started to happen. I took my dog out for a short walk, a slow pace, I am very athletic, and I had shortness of breath. I was winded from just walking slowly. Then the brain fog started to set in. This I hated the most. I wasn't able to comprehend things. I tried to assemble an item I bought from Amazon and it was extremely hard to follow simple instructions. I wasn't able to see clearly for some reason. And even comprehending emails that I was receiving was troublesome. I kept drinking water, and was able to eat a little. Had two more bottles of Gatorade Zero. On day 3, most of all the symptoms subsided except that I still got winded from movement. On day 4, I was fine.
45 2021-04-30 abnormal behaviour, feeling abnormal stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor functi... Read more
stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor function including movement and speech/couldn't speak; head was very tingly; speech was not slurred but more like there was an impediment; he couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to; Caller states he thought he was going to die, his body was shutting down; behavior change; his legs are shaky; eyes feel a little dry; thumbs weren't working right; rule out MS or Parkinson's; rule out MS or Parkinson's; I have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head; he was a little dry thought he may be dehydrated; very tired; pounding headache in the back of his head constantly; he was twitching; really off-feeling; digestive issues/digestive problems; eyes were real mucusy/First week mucous in my eyes/could be allergy; eyes were real mucusy/First week mucous in my eyes/could be allergy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as single dose for COVID-19 immunization on an unspecified facility. There were no medical history. No known allergy. The patient had no health issues with any severity, he is pretty athletic, pretty healthy. The patient's concomitant medications were not reported. No COVID-19 prior to vaccination. On 26Mar2021, the patient had digestive issues/digestive problems, eyes were real mucus, first week mucous in my eyes which could be allergy which resolved on 01Apr2021. On 06Apr2021 08:00 the patient reported that he couldn't move/loss of motor function and movements were off but his cognitive functions were fine, loss of motor function including movement and speech/couldn't speak, had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, suffered a stroke or mini stroke and was sent to the emergency room. On 06Apr2021 at unspecified time the patent couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, head was very tingly, speech was not slurred but more like there was an impediment, very tired, pounding headache in the back of his head constantly, he was a little dry thought he may be dehydrated, he was twitching, really off-feeling, and states he thought he was going to die, his body was shutting down. On an unspecified date, the patient had eyes feel a little dry, thumbs weren't working right, his legs are shaky, and noticed behavior change. The patient was hospitalized for 3 days from 06Apr2021 to 09Apr2021 due to thought he was going to die, his body was shutting down, stroke/mini stroke, couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak. The patient underwent lab tests and procedures which included IGG antibody test: positive and IGM antibody test: negative both on 19Apr2021, computerised tomogram: showed nothing on 06Apr2021, echocardiogram: unknown result on unspecified date, magnetic resonance imaging brain: showed nothing both on an unspecified date in Apr2021 (not sure if 15Apr2021 or 16Apr2021) and on 07Apr2021, COVID-19 test: negative on 06Apr2021, repeat COVID-19 test: negative on 07Apr2021. Therapeutic measures were taken as a result of stroke/mini stroke, loss of motor function including movement and speech/couldn't speak have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head which includes TPA and digestive issues/digestive problems were treated with high fiber diet. The outcome of the event he was going to die, his body was shutting down, stroke/mini stroke, he couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak, have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, very tired, pounding headache in the back of his head constantly was not recovered, for the events digestive issues/digestive problems, eyes were real mucusy/first week mucous in my eyes/could be allergy was recovered on 01Apr2021, while for the rest of the events was unknown. Caller states he has an appointment with a neurologist and he's trying to get it moved up. Caller states his doctor wants to do a lumbar puncture to rule out MS or Parkinson's that sort of thing. Caller states but at this point they are trying to rule things out. Caller states he doesn't have a family history of really either them. Caller states there was no diagnosis. Caller states the doctor said he was pretty sure its a stroke, mini stroke, but his general practitioner doesn't think its a mini stroke. Caller states the effects are so long going and they will improve and fall back and then the doctor also said at the fact that has been cognitively aware the whole time, so there's been no official diagnosis yet.
45 2021-04-30 feeling abnormal It's difficult to pinpoint the exact time the symptoms started, but they were definitely present by ... Read more
It's difficult to pinpoint the exact time the symptoms started, but they were definitely present by the time I awoke the following morning. No arm pain -- but nine days of brain pain, waking up feeling like my head was split, at least five days of altered vision, and most disturbed were my breathing and my heart. I felt for many days like I had a Brillo Pad in my lungs and heart, as well as lots of pressure in the chest and shortness of breath/labored breathing. Two days ago I thought I might be having a heart attack. The symptoms lightened yesterday morning (day nine) though I still have strange sensations in the head and taking a full, deep breath is not totally easy yet. .
45 2021-05-04 disorientation, feeling abnormal cold sweat; headache; cramping/spasm; bumps on the side of neck; body aches; Bumps on his head that ... Read more
cold sweat; headache; cramping/spasm; bumps on the side of neck; body aches; Bumps on his head that were also painful; stomach cramps; diarrhea; he threw up several times; nauseous; disorientated; just not feeling good at all; tired; neck pain; felt weird; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; /Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 04Apr2021 (at the age of 45-years-old) at 14:00 as single dose for covid-19 immunisation. Medical history included COVID: he had gotten diagnosed with COVID back in December or January and twice tested positive for covid and his body had fought it off (as reported). Medical history included also back pain Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken to sleep, start and stop date were not reported. The patient reported that around the night of vaccination he experienced cold sweat, headache, and cramping for several hours then subside and come back later. Patient had some bumps appear on the side of his neck. He stated that he could not say that's from the shot, something may have bit him. The patient did bump his head a chandelier and went to the ER. He received Ibuprofen for the symptoms. Patient stated that the reported events occurred the same day as his COVID Vaccine and began a couple of hours later and wakes up every night in a cold sweat; stated he was in and out of the emergency room in about an hour and they gave him Ibuprofen 400mg and a of nights had to take two Ibuprofen because his head and body was hurting so bad and he had to take some kind of relief and he does not like taking stuff like that and pain pills make his stomach hurt. Patient stated he did a whole Ibuprofen and did not feel good after that and can't take the Ibuprofen anymore and then took 1-2 Aleve after that and does not like taking pain medication. He stated he was healing with the bumps but had this every day since the Pfizer Vaccine and he was starting to heal but the bumps were still there on the side of his neck and were improving and healing and he had the bumps on his head that were also painful; states the bumps occurred the same day as his Pfizer COVID Vaccine; states he was up in his attic and could have gotten into a spider nest and might have poison in him from the spiders and then went to the hospital emergency room with these issues. States he told the emergency room about the bites and bumps and that he had the Pfizer COVID Vaccine and they gave him the Ibuprofen and sent him home. The patient stated that this was a real concern for him due to the blood clots stuff coming out about how people have different reactions after a vaccine. States he felt like the hospital did not even do anything; he could have hit his head a couple of times on a chandelier; states the emergency took an image of his head and they did not address the bumps or anything else and said his head was not bleeding and gave him Ibuprofen and he did not think you should take Ibuprofen like when you have COVID and they sent him home and nothing was done. Caller states he does not know but when he received the Pfizer COVID vaccine he noticed a patch of bumps in his neck, and his neck got really tight and his neck still hurts on the left side; states he could have gotten bitten by something. The patient reported that after he had the Pfizer COVID vaccine, he was waking up every night with cold sweats, and recently last night had extreme cramps in his stomach area like was crawling around the floor getting away from the pain and is still having abdominal cramps. He ate a burger and had extreme cramps and diarrhea for days and this was after his Pfizer COVID vaccine and he is doing this again with stomach cramps and diarrhea; he can't distinguish what the cramps and diarrhea were from and maybe he ate something bad and is confused about his body; states the cramps are way worse and the diarrhea began after the burger. States the diarrhea is a lot and this time is less diarrhea but more abdominal cramps and he threw up several times last night and did not throw up a lot but was so nauseous and threw up twice a little bit. Patient stated that the reported events were just like when he had covid and after waking up at 12:00 he had body pains and was not able to go back to sleep until 4:00; states he had pretty bad headaches which are ongoing and had had headaches ever since he was diagnosed with COVID, stated it is the same thing also as when he had covid; states with covid he got sick and was up from 12:00 4:00 and had fatigue, had body pain, had headaches and nausea and then it got better and he started sleeping through the night. States the Pfizer COVID shot and it was like the same all over again where he was up from 12:00 4:00, had pain and was disorientated, just not feeling good at all which has gone on since the shot; states there were two nights where he slept through the night and was up in a cold sweat which wakes him up and drenches him head to toe and he has to get out of bed to change clothes and sit there til he is tired again and sometimes goes to sleep in the chair and then sleeps ok. Patient stated he took Benadryl just to sleep through the night and did not and got up once and then went back to sleep. He stated on the left side where the headaches were and he had neck pain and it was kind of the left side and felt weird. The patient stated also that in the emergency room he was given Valium in his arm and also has a knot on the back of his neck and tried to address it with the emergency room and they said it was a spasm and did not seem concerned and it felt hard and not a bump under his skin in his neck and it just felt like maybe a pea sized hard knot and noticed this after his Pfizer COVID Vaccine. Caller stated he actually felt pretty good and was sleeping through the night after he had COVID and felt back to normal and then after his Pfizer COVID vaccine everything went downhill. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.
45 2021-05-04 sleep disorder Tinnitus got worse. I had very low level tinnitus before. The second night after the vaccine the tin... Read more
Tinnitus got worse. I had very low level tinnitus before. The second night after the vaccine the tinnitus was quite bad, then the next day it settled down to be two or three times as noticeable as my baseline tinnitus was prior to the vaccine, at least. At this point, normally don't hear it, but when I'm going to sleep it's very noticeable. Ten weeks later, it's steady and hasn't gotten worse or better since it steadied out on the third day.
45 2021-05-20 disorientation Shortly after receiving the vaccine the patient fainted and bumped his head from the fall. He was ve... Read more
Shortly after receiving the vaccine the patient fainted and bumped his head from the fall. He was very pale, clammy, hot and somewhat disoriented from the reaction. After some water, food, and sitting patient recovered almost fully. He does report having similar reactions to other vaccines/blood draws. He was checked on by phone that same night and about 36 hours later and overall was doing ok.
45 2021-05-22 sleep disorder Chills, fever of 101 degrees, body aches, headache, unable to sleep. 18 hours.
45 2021-05-24 insomnia Upon injection, felt immediate soreness at injection site (left arm, near shoulder). Had also felt s... Read more
Upon injection, felt immediate soreness at injection site (left arm, near shoulder). Had also felt soreness after first shot in series, which went away. Ten weeks after the second shot, I still feel considerable soreness at the injection site, which sometimes increases from general soreness to mild pain. A specific example is a general difficulty sleeping on my left side, which will wake me with pain and often cause mild pain for the remainder of the day.
45 2021-05-25 feeling abnormal, excessive sleepiness A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel rig... Read more
A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel right and hands were very sweaty cold his eyes rolled back in head. Lost his color loss control of bodily functions( urine). Throwing up hard. EMT were called vitals were alright. Once we were home vomiting subsided and he slept hard.
45 2021-05-25 sleep disorder From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of i... Read more
From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of improving left arm heaviness/left hand cramping in the setting of getting his second Pfizer COVID-19 vaccination in his right arm 3 days ago and 3 weeks of mildly increased exercise/intermittent fasting. The patient reports getting his first Pfizer COVID-19 vaccination on April 7, 2021. Reports some mild symptoms afterwards. Around that same time, the patient reports having a checkup with his primary care doctor that was notable for a cholesterol elevation to 200. This prompted him to try and lose weight including intermittent fasting and increase in exercise, especially for exercises and cardio. The patient reports approximately 20 pound weight loss over the past 3 weeks. 3 days ago, the patient reports getting his second Pfizer COVID-19 vaccination in his right arm. Reports fever (maximum 103 Fahrenheit) and mild headache the subsequent 2 days after the vaccine. Last night, the patient went to sleep on his left side at around 8 PM. He woke up at 4 AM with significant left arm heaviness and left hand cramping. He tried to massage his hand with some slight improvement of the symptoms but otherwise the symptoms persisted. Hence, this morning, he called his PCP, who told him to come into the ER for further evaluation. Here, the patient reports improving left arm heaviness/left hand cramping. He also does report family history of heart attack and an uncle at a similar age and massive heart attack of his grandfather in their 60s. He denies fever, anorexia, unexpected weight change, headache, blurry vision, sinus pressure, cough, hemoptysis, orthopnea, PND, SOB, DOE, chest pain, pleurisy, changes in taste/smell, N/V/D, abdominal pain, flank pain, urinary sxs, genital sxs, black stools, incontinence, absence of flatus, calf pain, leg swelling, numbness/tingling, streaking redness/rash/skin changes, easy bruising. Also, deny history of HTN, DM, smoking, prior MI, prior PCI, prior CABG, prior TIA/CVA, or history of PAD. Further, denies recent trauma/fall, history of cancer, blood thinner use, recent drug use, recent travel, sick contacts, family history of connective tissue disease/congenital aortic anomaly, or family history of similar sxs. --- Hospital Course by Problem # Troponinemia (Likely myopericarditis) The patient has a family history notable for MI and CABG in relatives aged 50-70 on his mother's side. The patient notes that most of these family members were heavy smokers and drinkers, which he is not (never-smoker, rare EtOH, never illicit drugs). His symptoms are notable for L arm heaviness/cramping that began around 8pm on 4/30/21 at 9/10 severity and subsequently was 3-4/10 severity on presentation to ED and is 0-1/10 severity at time of admission to the floor; he has no associated numbness, weakness, coolness, or pallor. His symptoms are non-exertional. He denies CP, SOB, lightheadedness, nausea, jaw pain, abdominal pain, fatigue. He noes that he recently got the second COVID shot in the R arm, and had a post-vaccine course notable for Tmax 103 ~3d ago and 101 as recently as yesterday. His EKG was notable for ST-elevation in II/III/aVF and his troponins were elevated 305 -- > 298 -- > 328. Of note, his CRP was elevated at 69. The patients symptoms and findings could certainly be compatible with atypical ACS and, given the low risk of bleeding associated with heparin, he was treated conservatively upon admission with heparin infusion, metoprolol tartrate 6.25mg q6h, atorvastatin 80mg (he received ASA 325mg in the ED). However, given his recent covid vaccination and elevated CRP and reported fevers, this could also be compatible with myocarditis or other inflammatory etiology. TTE on 5/3 demonstrated preserved EF 55% with no WMA. Given reassuring TTE, a cMRI was ordered to assess for myocarditis vs scar tissue from recent ischemic event. Cardiac MRI on 5/5 was notable for finding consistent with myopericarditis (see below). Aspirin and atorvastatin was stopped on discharge. Patient was discharged with metoprolol 25 mg daily."
45 2021-05-26 loss of personal independence in daily activities cannot talk properly; his body and mind are responding slow; It affected him and he didn't know a ca... Read more
cannot talk properly; his body and mind are responding slow; It affected him and he didn't know a car was coming and didn't even see them; Not able to make good decision/made the wrong decision; weak when he walks and knees are bending; left side very slow and weak, unable to use left side; weak; could not stand up or be on his feet/ left side weak an unable to stand or walk; cannot type on the keyboard; fell on the floor; numbness on his left hand/numbness and tingling in hand; tingling in hand/numbness and tingling in hand; This is a spontaneous report from a contactable consumer (Patient, self-reported) via medical information team. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER729; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in Hand Left (shoulder) on 10Apr2021 12:00, as 2ND DOSE, 0.3 ML SINGLE; for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes dose 1 (Batch/Lot Number: EP75334, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Hand Left (shoulder) on 20Mar2021 02:30PM, as 1ST DOSE, SINGLE. It was reported that patient received the second dose of the Pfizer Covid-19 vaccine on 10Apr2021 and he started experiencing numbness on his left hand and next morning he could no feel anything on the left side of his body, it was so weak that he could no lift his hand, walk on stand on his feet. He went to the ER, they made some tests, but primary care doctor did not provide a diagnosis. He started feeling better but today he could not stand up or be on his feet, he cannot talk properly, cannot type on a keyboard and the left side of his body is very slow and weak. Reportedly, the primary care provider was not able to provide him with any diagnosis. He was feeling better, but today, he noticed that he was not able to stand up on his feet again. He cannot talk properly due to weakness. He cannot type on the keyboard. The left side is very slow and very weak. It has been several weeks and he is not feeling better. Stated that he is 46 and was 46 when he experienced these events. Last week, patient went to the neurologist and no one had helped him. The only thing was about the side effects and were not telling him how that can be fixed. Numbness in hand has been more than 2 weeks. He doesn't feel numbness now but is very weak. The left side of his body has less strength. The numbness was minutes after the shot and the tingling was immediately after. The numbness and tingling lasted 30 to 40 minutes after the shot. The emergency doctor gave him some medicine but he does not remember what medicine. They also gave him fluids and then he got some strength. Woke up the next day and was unable to stand. He tried to go to the restroom and was so weak, he fell on the floor. They did all the tests and could not find anything. He is still not feeling normal. His right hand is fine. The left side, where they did the shot had less strength. He can't even move his finger properly and can't type on the keyboard, from the left hand side. if there are any cases like this and how that person got better and what was the root cause. So many weeks, this has been affecting his day to day life. He can not work. He is a software programmer. He needs to use his hands. He can't use his hands. Is feeling like his body and mind are responding slow. When he drives, he is not able to make good decisions. One time he really made the wrong decision. It affected him and he didn't know a car was coming and didn't even see them. States that he spoke to medical information, they could not provide any medical advice. Everyone is making this hard. They could not find another person with similar symptoms. Patient did not receive other vaccine in four weeks of vaccination. On an unspecified date, the patient experienced cannot talk properly, on 10Apr2021 12:05, numbness on his left hand/numbness and tingling in hand, 12:01 tingling in hand/numbness and tingling in hand, on 11Apr2021 weak, could not stand up or be on his feet/ left side weak an unable to stand or walk (was reported as worsened), fell on the floor, cannot type on the keyboard, weak when he walks and knees are bending, left side very slow and weak, unable to use left side, on an unspecified date his body and mind are responding slow, it affected him and he didn't know a car was coming and didn't even see them, not able to make good decision/made the wrong decision. Patient went emergency room on 11Apr2021 they made some tests, but primary care doctor did not provide a diagnosis. Patient was sent home to recover at home. wife was with him and brought him home. They gave him medicines and fluids. He was able to walk and stand up and somehow was recovering well. The patient underwent lab tests and procedures which included blood test: didn't find anything, nothing significant, electrocardiogram: didn't find anything, nothing significant, laboratory test: didn't find anything, nothing significant on an unspecified date. Therapeutic measures were taken as a result of left side very slow and weak, unable to use left side (asthenia). Outcome of the events numbness on his left hand/numbness and tingling in hand and tingling in hand/numbness and tingling in hand was recovered on 10Apr2021 12:45; left side very slow and weak, unable to use left side was not recovered and other events outcome was unknown. Follow-up attempts are needed. Further information is expected.
45 2021-05-28 anxiety PT was feeling anxious after shot. Stated last time BP was high.
45 2021-06-06 confusional state Fever, headache, confusion, encephalopathy, hospitalized 5/28/21-6/1/21.
45 2021-06-07 feeling abnormal 1 day after receiving vaccine I experienced "brain fog". Approximately 10 days afterwards (around 2... Read more
1 day after receiving vaccine I experienced "brain fog". Approximately 10 days afterwards (around 2/25), I experienced symptoms of a minor stroke - I experienced lack of coordination in typing and later that evening experienced difficulty with speaking and comprehension, but only for a few minutes. A few days later, that weekend, I had some issues playing songs on the piano I had played before, making a lot of mistakes. About another 2 weeks afterwards, on 3/9/2021, I experienced more symptoms of stroke. For most of the day I had issues with typing, and later that evening I had some coordination issues with closing a soda bottle. On the morning of 3/10/2021, I continued to experience issues with typing and also had difficulty speaking and understanding my wife. At this point I went to the emergency room and was found/diagnosed to have experienced multiple TIA strokes.
45 2021-06-10 anxiety 15 - 20 min post vaccine, patient complained of bilateral hand/feet tingling/numbness. Vague heavine... Read more
15 - 20 min post vaccine, patient complained of bilateral hand/feet tingling/numbness. Vague heaviness across chest and throat. Feels warm and anxious. Treated with diphenhydramine 25 mg po x 1, diphenhydramine 25 mg IV x 1, Diphenhydramine 50 mg IV x 1 (had developed angioedema/throat swelling). Admitted to hospital and then transferred to another facility.
45 2021-06-15 impaired work ability, emotional distress, feeling abnormal, loss of personal independence in daily activities Severe migraine severe dizziness vertigo brain fog it?s relentless nonstop 24 seven from the time I ... Read more
Severe migraine severe dizziness vertigo brain fog it?s relentless nonstop 24 seven from the time I wake up until the time I go to sleep severe pain in every single droid back arms legs feet it doesn?t matter I literally can?t function thank you I really appreciate the vaccine and went along way to help give me Covid symptoms is what I did I?m beyond frustrated every single day I can?t go to work I can?t do anything I can?t live I can?t function I?m in chronic pain. Let?s not forget the increased heart rate where I feel like I?m going to die Please get this poison out of me help me The pain is relentless in all my joints I can?t function why did I take this my push something. Everywhere I?ve ever had a problem from concussion two herniated disc it seems like the pain is exacerbated in all these areas even my notes wrist arms. I was perfectly fine until I got the shot. Oh I also can?t look at a cell phone I can?t look at screens that makes the migraines worse. 2 months of daily suffering thanks
45 2021-06-17 sleep disorder - Chest pain after 1.5 months from the second shot - Left arm numbness - Shortness of breadth - Har... Read more
- Chest pain after 1.5 months from the second shot - Left arm numbness - Shortness of breadth - Hard to stay asleep - Lack of energy
45 2021-06-23 feeling abnormal, loss of personal independence in daily activities After the 1st dose (3/29/2021), neck inflammation started on the right-side of the neck. The neck in... Read more
After the 1st dose (3/29/2021), neck inflammation started on the right-side of the neck. The neck inflammation got worse after the 2nd dose (4/19/2021). The neck inflammation is still present. Starting 5/11/2021: Intense adrenaline surges started happening every night between 3 am-7 am. My heart feels like it is beating extremely hard. I have checked my pulse and it is normal during the events (ranges from 65-90 bpm). I have checked blood pressure and it is usually in the 120/80 range (normal for me). However, there have been occasions where blood pressure drops to 100/70. These adrenaline surges and hard heart beats tend to get better if I stand up and move around. It will get worse again if I lay down. I have these on occasion during the day, but I am usually able to calm myself down. I have had scenarios where I feel fine during the day, but will lay down. The hard heart beats start almost immediately. I'm also exercise intolerant now. If I do anything more than a brisk walk, I feel very terrible and faint with a hard heart beat. One interesting data point, my father has the same symptoms and his started about the same general timeframe after his second dose of the Pfizer vaccine.
45 2021-07-05 feeling abnormal patient came in for his second dose of the Pfizer covid vaccine, patient stated on their intake form... Read more
patient came in for his second dose of the Pfizer covid vaccine, patient stated on their intake form that the TDAP vaccine had caused him to faint in the past. after discussion with the patient, he stated that the first dose of the Pfizer vaccine did make him dizzy for a few minutes after the vaccine, but he did not faint following the first dose. After the first dose, because of his history with TDAP, patient was asked to stay for 30 minutes on site, after 30 minutes not further side effects other than the temporary dizziness. After that discussion it was decided to administer the second dose. Immediately after the dose, patient appeared to suffer from syncope, immediately becoming dazed and his eyes closing, within 1 to 2 minutes he became alert, aware of name and dob, etc. Patient's pulse and vitals were WNL. Offer was made to call ambulance for further evaluation, but patient declined. The pharmacist, remained with patient for 30 minutes to monitor, he continued to be fine.
45 2021-07-09 restlessness Sense of restlessness requiring exercise to relieve it. Akathisia? Intermittent started approx 3 mo... Read more
Sense of restlessness requiring exercise to relieve it. Akathisia? Intermittent started approx 3 months after 2nd dose and increased over the next two months. Now much improved. Note: I have low suspicion that this is related to vaccination, given the time course. However, the folks at V-Safe asked me to report in VAERS.
45 2021-07-12 fear Numbness in left arm from elbow to 4th and 5th digits. The numbness largely went away but persists ... Read more
Numbness in left arm from elbow to 4th and 5th digits. The numbness largely went away but persists to this day with the sides of the ring finger and pinky finger remaining numb. I fear at this point is is permanently damaged nerves
45 2021-07-15 sleep disorder Experienced twitching in right ear in or around ear drum at night after my second dose in the aftern... Read more
Experienced twitching in right ear in or around ear drum at night after my second dose in the afternoon. The twitching produced a sensation of throbbing sound and was very frequent and constant, occurring almost every other second. The next day was even worse with constant twitching throbbing sensation and I my sleep was hugely affected. I would stay up and walk at night. Got an appointment on May 11 with my Dr. who said basically I have ringing ears, Tinnitus, which might be due to hearing loss from childhood etc. He checked hearing which was still fine. I did mention it all started happening right after 2nd dose of COVID vaccine but he didn't think there was any connection with that. He did say he will keep this in mind and see if any link between vaccine and Tinnitus is found as cases are reported. He said there is not much that can be done for Tinnitus other than reducing noise levels.
45 2021-07-20 anxiety Client reported anxiety and nausea about one minute after receiving the COVID vaccination Pfizer. Cl... Read more
Client reported anxiety and nausea about one minute after receiving the COVID vaccination Pfizer. Client moved from a regular chair into the in anti-gravity chair. The client reported feeling anxiety and nausea. The client denied any other s/s of anaphylaxis. The client reports a history of anxiety with is controlled with an oral medication he takes daily for "stress". The client was unsure of the name of the medication name. Vitals obtained at 7:04PM were as follows: automatic BP 135/96, HR 88, O2 99%. The client stated he was "feeling better." The client denied any history of anxiety with injections. The client his current status was a new feeling for him. The client began drinking a juice. Repeat vitals obtained at 7:10PM were as follows: automatic BP 129/88, HR 96, O2 98%. The client denied any persistent nausea at 7:13PM. The client reported "numbness" around the vaccination site. No redness was observed around the vaccination site. Palpated around the vaccination site and client reported in tact sensation to physical touch. Repeat vitals obtained at 7:10 PM were as follows: Client ambulated to EMT observation area unassisted with a steady gait. At 7:23 PM asked the client if he was feeling okay, and the client replied "yes." At 7:36PM the client stated that he "still feels good." Repeat vitals obtained at 7:36PM were as follows: automatic BP 132/86, HR 88, O2 98%. The client left the vaccination site at 7:36PM. The client ambulated unassisted with a steady gait.
45 2021-07-20 feeling abnormal, disturbance in attention Foggy headedness; difficulty concentrating; This is a spontaneous report from a contactable consumer... Read more
Foggy headedness; difficulty concentrating; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 08:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient was reported as none. The patient was allergic to fruits and nuts. Concomitant medications included ibuprofen (ADVIL) taken for an unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 02Apr2021, at 09:30, the patient experienced foggy headedness and difficulty concentrating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events foggy headedness and difficulty concentrating was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
45 2021-07-21 feeling abnormal Terrible pain in left arm; Sore throat; Runny nose; Grogginess; Lethargy; Fogginess; Wobbliness; Mil... Read more
Terrible pain in left arm; Sore throat; Runny nose; Grogginess; Lethargy; Fogginess; Wobbliness; Mild general achiness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 17:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as no chronic health conditions. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021, the patient experienced terrible pain in left arm, sore throat, runny nose, grogginess, lethargy, fogginess, wobbliness and mild general achiness. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events terrible pain in left arm, sore throat, runny nose, grogginess, lethargy, fogginess, wobbliness and mild general achiness was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-27 disturbance in attention slight achiness to upper back; slight inability to focus on complex tasks; Reduced sense of taste; T... Read more
slight achiness to upper back; slight inability to focus on complex tasks; Reduced sense of taste; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 14:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included hemochromatosis. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (ALLEGRA), both from unknown dates for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration on 10Mar2021 at 11:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 12:00, the patient experienced slight achiness to upper back, then slight inability to focus on complex tasks, then reduced sense of taste. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events slight achiness to upper back, slight inability to focus on complex tasks and reduced sense of taste was recovered with lasting effects. No follow-up attempts are needed. No further information is expected.
45 2021-07-27 insomnia Partial clot; has been experiencing pain and aching in his leg; didn't sleep at all that night; hear... Read more
Partial clot; has been experiencing pain and aching in his leg; didn't sleep at all that night; heart was feeling weird; having pain in the vein; Venous insufficiency; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date : unknown), dose 2 via an unspecified route of administration, administered in arm right on 27Apr2021 11:15 as dose 2, single for covid-19 immunisation. Medical history included peripheral venous disease from 2019 and ongoing. The patient's concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID-19 immunization on Mar2021 at the age of 45-year-old as per first dose. Prior Vaccination (within 4 weeks prior): None. He has no family medical history, just his personal medical history. He already had venous insufficiency to some degree present but the COVID vaccine made it worse. He was diagnosed in 2019. Caller says that he got the Pfizer COVID vaccine and he is having some little adverse events. He has called a couple doctors today for an appointment to go in and be seen and they all suggested for him to call Pfizer as well. He clarifies that his adverse event is that he has a little bit of venous insufficiency already but it was relatively okay but with both doses of the COVID vaccines, immediately it was like a a switch. As soon as he got the COVID vaccines the situation got much worse for him. He had pain in his leg that felt like a clot for the first week and a half to two weeks after his first dose. Then he got a little bit better, even though he had almost went to the emergency room but he got better after a couple weeks. After his second COVID vaccine, starting that same night, last Tuesday, to now he has been experiencing pain and aching in his leg and he feels like his venous insufficiency went from a 5 to a 10 and it doesn't seem to be getting better so he is going to go see a doctor but they suggested for him to let Pfizer know about this. It was reported that first dose, his pain began the day after he had his COVID vaccine. His second dose was on 27Apr2021 and his 1st dose was 4 weeks before that, so his first dose was either on 30Mar2021 or 31Mar2021. His clarifies that his pain actually began the second day after his first dose. Second dose, the same day of his COVID vaccine, 27Apr2021, he felt pain in his legs and his whole body was flushed and he felt hot. He also didn't sleep at all that night and his heart was feeling weird. He had read that the racing feeling is part of the initial reaction so he had let it go. Then the next couple of days he had felt better and then he started having this feeling of stinging, burning pains in his leg where he knows that vein is, it's his superficial great saphenous vein. He has been having pain in the vein and it has been stinging, burning and aching and he can't sit for more than 20 minutes. He has been exercising every day, drinking water, elevating his leg on the wall to drain it but as soon as he sits again it starts hurting. He feels like it could be a partial blockage but he doesn't really know. He doesn't know if it is actually a partial clot or if it is just his venous insufficiency to such a degree that the fluid pressure inside is making it hurt. It has been this way everyday even though he has been exercising. Honestly, before the COVID vaccine he could exercise and his circulation would be fine that night and for about the next 3 days with no problems but since the COVID vaccine he has been exercising everyday and it doesn't seem to make a difference. He already had a situation but then the vaccine was like a switch and instantly made it worse both times. Probed for 2nd dose outcome and he says that when he is moving around, exercise is the only thing that provides relief, but after that he typically would of been okay for the next few days, but when he gets home from the gym tonight he knows his legs are going to start hurting as soon as he sits down. Even though he sits on his bed and elevates his legs on the wall he knows that as soon as he stands up his legs will start hurting. That's what has happened every day since last Tuesday. Therapy start date populated as Mar2021 since caller is unsure of the exact date of his first COVID vaccine and the therapy stop date populated as the date for his second COVID vaccine. History/ Investigations showed probed for test results, medical conditions or concomitant products and caller says no, there has been nothing out of the ordinary. Anatomical Location of Administration of Pfizer vaccine considered as suspect: right arm for both. No, but he is waiting for the doctor's office to call back him back to schedule for testing. He spoke with them and they said that if it gets worse or continues like it is for another day then he needs to go to the emergency room. The outcome of event pain and aching in his leg was recovered. The outcome of remaining events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-27 insomnia Severe muscle spasms in the bicep of arm he got the vaccine/now it is (muscle spasms) spread to othe... Read more
Severe muscle spasms in the bicep of arm he got the vaccine/now it is (muscle spasms) spread to other muscle groups; He could not sleep; This is a spontaneous report from a contactable physician (patient's wife). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in Arm Left on 03May2021 at 11:00 (at an age of 45-year-old) as dose 1, single dose for COVID-19 immunization. The patient medical history was not reported and had no problems with vaccines in past. Concomitant medications were not reported. The patient had no other vaccines given the same day or 4 weeks prior. On 03May2021, approximately 3-4 hours after the injection (dose 1), he developed a severe muscle spasm in the bicep of the same arm of the injection. Physician saw the contraction of the head of the bicep muscle. The first night was very frequent, overnight, and he could not sleep. He had not had that before the vaccine and did not do any exercises that could have caused it. After 5-6 days, it had improved but now spasms had spread in other muscle groups (at the time of report), like the quadriceps and on the back, but less severe compared to the arm. Spasms have continued, although improved and it was mainly at night now (at the time of report). The reporter was concerned if this could happen to anywhere in the body. Wonders if this could happen to any other part of body for the rest of his life. The reporter asked if patient should get his second dose if he has developed severe muscle spasms after the first dose. Physician did not feel that it was medically significant. On 03May2021, patient recovered from event could not sleep, the patient had not yet recovered from severe muscle spasm. Information on lot/batch number has been requested.
45 2021-07-27 insomnia Temperature 100.4; Muscle aches; Insomnia; Chills; Headache; Inflammation/feeling of significant ful... Read more
Temperature 100.4; Muscle aches; Insomnia; Chills; Headache; Inflammation/feeling of significant fullness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO171), via an unspecified route of administration in the arm left on 28Apr2021 at 14:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history was not provided. The patient previously took bupropion for hives. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate 60 mg QD (ADDERALL) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 for COVID-19 immunisation (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150), via an unspecified route of administration in the arm left on 07Apr2021 at 11:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021 at 20:30 (after 6 hours of vaccination), the patient experienced inflammation/ feeling of significant fullness at site. On 29Apr2021 at 01:30 (after 11 hours of vaccination), the patient experienced insomnia, chills, headache and muscle aches. On 29Apr2021 at 08:30 (after 18 hours of vaccination), the patient experienced high temperature. On 29Apr2021 at 08:30, the patient underwent body temperature and the result was 100.4. The clinical outcome of the events headache and muscle aches was recovering; while the clinical outcome of the events inflammation at site, insomnia, chills and high temperature was not recovered. No follow-up attempts are needed. No further information is expected.
46 2021-01-04 poor quality sleep, abnormal dreams, restlessness, feeling abnormal No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the ... Read more
No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the day with mild chills and nausea starting around 7:00 pm (Approx 11 hrs after injection). Chills steadily intensified, with fever beginning, became severe over the next 2-3 hours, and persisted throughout the night. Along with the fever/chills & nausea, there was also moderate muscle/joint pain (mainly neck and back), moderate to severe fatigue and weakness, weird freaky dreams, restlessness, and moderate headache. Symptoms started to relent around 6:00 am the morning after injection, however fatigue/weakness, nausea, and mild fever/chills have persisted throughout the day with minimal improvement.
46 2021-01-07 disturbance in attention Pfizer-BioNTech COVID-19 Vaccine Approx 8 hours after receiving the vaccine, I suddenly became slig... Read more
Pfizer-BioNTech COVID-19 Vaccine Approx 8 hours after receiving the vaccine, I suddenly became slightly dizzy and moderately nauseous. I also became very tired even though I was well rested. The nausea and dizziness lasted approx 2-3 hours. At that time I developed moderate injection site pain. I was very fatigued for the remainder of the night and through the next day (6 Jan). I was no longer fatigued as of 7 Jan but starting that morning I had a very difficult time focusing mentally. That condition lasted until late on the evening of 7 Jan. As of 8 Jan, all symptoms have resolved and I feel fine.
46 2021-01-07 disturbance in attention Approx 8 hours after injection I suddenly became slightly dizzy and had moderate nausea. I also bec... Read more
Approx 8 hours after injection I suddenly became slightly dizzy and had moderate nausea. I also became very tired and fell asleep for about 1.5 hrs even though I was well rested. For the remainder of the night of 5 Jan and all day on 6 Jan I was fatigued and had moderate injection site pain. On 7 Jan, I felt much better (no fatigue or injection site pain) but had a very hard time mentally focusing. All symptoms resolved by the night of 7 Jan and as of 8 Jan feel normal.
46 2021-01-12 impaired work ability About an hour after taking vaccine I begin to get a headache. I went to get breakfast & coffee think... Read more
About an hour after taking vaccine I begin to get a headache. I went to get breakfast & coffee thinking that would help but it didn't. While eating I become nauseous. I stopped eating but still vomited (only once). At this time I started having shoulder pains and headache was worsting so I left work. About 2/3 hours after taking vaccine my entire upper body(shoulders up) was stiff! I took muscle relaxers and rested remainder of day. About 10/12 hrs after vaccine my headache was gone but still had moderate muscle pains. Upon waking up up my body aches were only moderate so I went to work. 26 hrs after vaccine, I'm still having mild/moderate body aches.
46 2021-01-12 insomnia EH9899 - Lot number wasn't indicated as different on the second dose. Few hives returned - had taken... Read more
EH9899 - Lot number wasn't indicated as different on the second dose. Few hives returned - had taken Benadryl 50mg - prophylactically . Subsided. Next evening (7th) - Hives returned and I took Zyrtec - 10 mg and they went away. (24 hours also - on the 7th) Did feel feverish, chills and achy after 24 hours after and I took an ibuprofen for that. Bumpy night; fitful sleeping but when I woke I was symptom free. Feverish went away sometime in the night and hives by the morning.
46 2021-01-14 feeling abnormal feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm;... Read more
feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0140), via an unspecified route of administration on 24Dec2020 10:00 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 31Dec2020, the patient experienced headache, "lungs felt uber clean and clear," and nausea. The patient stated about a week afterward he started feeling "not quite right" He stated his arm was sore for about 12 hours after the shot, but this has resolved. He has already seen his PCP, lungs are clear, and Covid test was negative. He said that a week ago, he started to feel not quite right. He said that his lungs felt uber clean, but stated that he had a headache and nausea every now and then. He was wondering if it is related to the vaccination. He said that he went to the doctor and his O2 sat was 99% and she did not even think he needed a Covid test, but the rapid test was Covid negative. He stated that on the website that it says that up to 7 days after vaccination 77% of people reported fever, chills, headache and other symptoms. He said that he did not know that you could experience side effects a week after getting a vaccine. He said that his eases his mind a little bit. He wanted to know if it could be because of the vaccine? He stated that sometimes he feels fine and other times he feels strange. He stated that sometime he just feels different. He said that he received the vaccine on 24Dec2020. Caller said that sometimes he is perfectly fine and then he will get the headache or nausea for a few moments and then it would go away. Caller said that at the doctor's office his blood pressure was 118/78 and his O2 sat was 99% He stated that he does work around Covid patients and takes all precautions when he is around them. He said that exactly 12 hours later after receiving the vaccine at 2200 24Dec2020, he said that it felt like someone shot him in the arm. 2-3 hours after he got up on 25Dec2020 it was gone. Caller said that he rarely gets sick and has not had the flu vaccine. The outcome of the events nausea, and headache was not recovered, and arm was sore was recovered on 25Dec2020, while unknown for the event feeling abnormal.
46 2021-01-25 impaired work ability That evening extreme funny feeling in left arm. Next day chills. After slight pain above chest and b... Read more
That evening extreme funny feeling in left arm. Next day chills. After slight pain above chest and below neck. Lathirgec and joints creeking. These feelings off and on even to today. Unable to go to work and stayed in bed with very little movement for over 12 hours. Able to function once I got up.
46 2021-01-28 anxiety, panic reaction 30 minutes after injection started feeling extreme anxiety, panic, and feelings of doom. Fast heart... Read more
30 minutes after injection started feeling extreme anxiety, panic, and feelings of doom. Fast heart rate, headache, and fatuige.
46 2021-02-02 feeling abnormal headaches for 20+ days, fatigue; brain fog and vertigo that still continue 38 days now.
46 2021-02-07 loss of personal independence in daily activities, mental impairment, impaired work ability, insomnia AFTER INJECTION GOT FEVER, NORMAL, NEXT DAY I STARTED TO GET RINGING IN MY EARS, SAW PRIMARY PHISIIS... Read more
AFTER INJECTION GOT FEVER, NORMAL, NEXT DAY I STARTED TO GET RINGING IN MY EARS, SAW PRIMARY PHISIISON AND HE SAID IT WAS FROM THE VACCINE, RINGING IN EARS FOR 11 DAYS NOW, CAN'T SLEEP, THINK, WORK, SCHOOL, ALL EFFECTED.
46 2021-02-11 feeling abnormal 12/15 vaccination 1/1 4:30 started having tingling and numbness in face, L side. Felt 'off'. My le... Read more
12/15 vaccination 1/1 4:30 started having tingling and numbness in face, L side. Felt 'off'. My left arm started to tingle and numb. Didn't last very long. Would come and go. Laid down. Ate some dinner; queasy. 1/2 Still felt 'off' 1/3 Symptoms occurred again with the numbness; face down to arm. HR was high for resting; 130's. BP 200/100. ED - CTA head/neck EKG, blood panel Symptoms resolved in ED; vitals normal 1/7 Neurology. Normal exam. MRI of brain; normal. Referral to cardiologist. Echocardiogram; normal Heart Monitor - waiting on results COVID - negative *DR/MGR of vaccine clinic
46 2021-02-15 sleep disorder Got First Pfizer Covid vaccine on 06JAN2021. About 4 days after that I started noticing allergy symp... Read more
Got First Pfizer Covid vaccine on 06JAN2021. About 4 days after that I started noticing allergy symptoms and mild intermittent wheezing. Then on about the 5th day after, my lower back pain increased, causing significant sciatic pain worse than ever before. On 22JAN21 I ended up going to urgent care for increased breathing problems, and also had to have pain management appointment within days as sciatic pain was debilitating and also significantly interfered with my sleep. After steroid injection (In spine)on FEB 3rd for sciatica/back pain, and steroids/inhaler treatment for the breathing stuff, I would say I was pretty good to go . I didn't think too much of these unusual events for me both in timing and severity. On 12FEB2021, I got my second pfizer covid dose. I 14FEB I started noticing allergy symptoms again, and slight shortness of breath, used inhaler I had from before to help as breathing in seemed to not give me full breaths. Then, on 15FEB2021, in the evening out of nowhere while walking, my lower back/sciatica pain came back in full force, as if my leg were a lighting rod like before. So it almost seems as if the covid vaccine triggered an inflammatory reaction in my body. I am not certain, but because the series of events seem the same and in timing after my first covid vaccine, I figured I would at least report it.
46 2021-02-17 impaired work ability, loss of personal independence in daily activities, excessive sleepiness 1/10/2021-Approximatley 34 hours after vaccination developed left facial numbness followed by severe... Read more
1/10/2021-Approximatley 34 hours after vaccination developed left facial numbness followed by severe dysequilibrium 5 hours later. 1/11/2021-left facial numbness and dysequilbrium significantly worse along with severe rotary nystagmus in the left eye. Had appointment with primary care and then ENT , who started me on prednisone 30 mg and antivert. ENT refered me to Neurology. Neurology ordered MRI/MRA that night and increased my prednisone to 60mg/day for 5 days followed by a taper over next five days. Currently, Symptoms of dysequilibrium and numbness have not subsided, on a second course of prednisone 60 mg/day for 3 days followed by taper. MD , Neurologist, provided Diagnosis of vaccine induced polyneuropathy affecting cranial nerves 5 and 8. Since the onset on January 10, Cannot work(physician/anesthesiologist) , drive, or perform minor tasks due to the severity of the symptoms. Symptoms during 1/10/21-1/17-21, bed-ridden, slept 18-20 hours/day, could not walk without assistance-would fall to the left, could not read, nystagmus of left eye, had to keep eyes closed due to severe vertigo/dysequilibrium, nausea. 1/18/21-1/24/21 slight improvement in disequilibrium/able to walk, no change in facial numbness severity , started on 100 mg gabapentin at night, and low dose valium 1.25 mg to 2.5 mg to help with dysequilibrium 1/25/21-1/29/21 50% improvement in facial numbness, began vestibular PT, slow improvement in dysequilibrium and ability to walk and read 1/30/21 Symptoms worsened again, facial numbness returned, dysequilibrium returned to its original severity, difficulty reading/focusing 2/1/21 Followed up with Dr, started another prednisone 60mg/day for 3 days, followed by taper over the next 5 days 2/4/21 Left Facial numbness not improved, dysequilibrium still severe, having difficulty focusing and reading
46 2021-02-23 nightmare "I had an uncomfortable night and bad dreams, left arm soreness more painful than flu soreness. 1/4... Read more
"I had an uncomfortable night and bad dreams, left arm soreness more painful than flu soreness. 1/4/21 5am fever 100.5, and took Tylenol at 5am." Reported feeling better now at 10:30 am
46 2021-02-26 confusional state Shortly after the vaccine confusion and hard time focusing along with fatigue, muscle aches, chills,... Read more
Shortly after the vaccine confusion and hard time focusing along with fatigue, muscle aches, chills, and swollen glands around his neck,
46 2021-02-27 feeling drunk Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Ref... Read more
Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Refused transport.
46 2021-03-04 feeling abnormal Patient received his Pfizer vaccine at 08:10 and at 08:25 he started feeling light headed and nausea... Read more
Patient received his Pfizer vaccine at 08:10 and at 08:25 he started feeling light headed and nauseated and had a vagal response. Episode lasted about 40 seconds but he did not become cyanotic or stop breathing. Pt denies any chest pain but was diaphoretic after episode. Called EMS for transport to CPH. Pt had syncopal episode with persistent Bradycardia. Current VS are P=40 R=22 BP 101/63 Pt A&O x4 with no focal neural deficits. Pulse ox is 100% on RA and pt states still feels a little "foggy". No rash or evidence of an allergic reaction.
46 2021-03-12 excessive sleepiness Starting about 5-6 hours after the shot I developed severe bloating, cramping and gassy-ness, litera... Read more
Starting about 5-6 hours after the shot I developed severe bloating, cramping and gassy-ness, literally constant burping. My stomach has been in constant pain. I?ve also had a slight fever and a very sore arm. Tylenol and rest has worked for the fever and arm, and I've had some addition body aches. Not sure how much is due to being in bed for an extended period. Also on Friday (about 24 hrs after getting the shot I was pretty fatigued. I just woke up from 13 hours of sleeping. But the stomach cramps/pains was severe and prompted me to try to find a way to report it, especially since it doesn't seem to be too common. It's been really bad.
46 2021-03-18 anxiety Progress Notes (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/18/2021 2:57 PM Expand All... Read more
Progress Notes (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/18/2021 2:57 PM Expand AllCollapse All Subjective male who was seen at Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness. He denied rash, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension and rapid progression of symptoms. Pmh: htn, hld and sleep apnea. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches (negative for headaches) Denies vision changes.: +lightheaded, lips tingling: Previous Reactions: none Objective Vitals Vitals: 03/16/21 1429 03/16/21 1432 BP: (!) 182/96 (!) 173/105 Pulse: 86 SpO2: 99% Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is obese. He is not ill-appearing. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Tingling resolved. Still feeling lightheaded. Pt rested and had snacks and water. Slowly lightheadedness was reducing in severity. After 15 minutes of observation, he was able to stand w/o increased lightheadedness. He ambulates the bay w/o difficulty. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Lightheadedness/elevated bp. Anxiety as well. Review of his prior bp numbers in epic records show fluctuation of his bp ranging from 180's to 140's. Recommended that he monitor bp at home. He doesn't have red flag symptoms related to elevated bp. He's to follow up with pcp accordingly. Electronically Signed 3/16/2021 2:29 PM
46 2021-03-18 insomnia Woke up next morning at 7am with itching hands, slight swelling in lips and ears, nausea and diarrhe... Read more
Woke up next morning at 7am with itching hands, slight swelling in lips and ears, nausea and diarrhea. Itching and swelling subsided with a dose of Loratadine. Nausea worsened that night and vomiting ensued with diarrhea worsening. At bedtime, itching returned, sleeplessness, vomiting and sweating profusely from the scalp and face, slight difficulty filling lungs with air. Another dose of Loratadine calmed symptoms. Wednesday (10th) through the next Thursday (18th ), nausea persisted, but eased with Benadryl and Emerton. Diarrhea persisted through Monday (15th). No fever, no soreness, no headache.
46 2021-03-23 anxiety, panic reaction facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety;... Read more
facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety; chills; This is a spontaneous report from a contactable consumer(patient) reported for himself. A 46-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:00 at single dose for covid-19 immunisation. Medical history included left kidney missing. Patient had allergies to Ambroxol, levofloxacino, cefalosporina, hidrocortizona. The patient's concomitant medications were not reported. First symptom took place 5 minutes after receiving the vaccine, it started with a severe dizziness followed by body weakness, quite accelerated and uncontrolled palpitations, tingling and extremities numbness, mild right-sided facial paralysis, panic feeling and anxiety. Finally, severe chills. Full recovery after 40 minutes with a mild lightheadedness for a few hours. Vital signs kept stable at all times according to paramedics' diagnosis. Patient received treatment for these events. Outcome of events was recovered. Information on the lot/batch number has been requested.
46 2021-03-23 feeling abnormal Weird sensation on jaw area BP 130/88
46 2021-03-25 agitation Patient describes fatigue starting 1 hour after receiving vaccination. Patient now calls COVID19 hot... Read more
Patient describes fatigue starting 1 hour after receiving vaccination. Patient now calls COVID19 hotline 3 days after initial symptoms and states fatigue is more moderate. Patient experiencing loose stool. Patient has hx of IBS however symptoms are worse than baseline. Patient describes mild headache and increase in agitation/moodiness. Hx of bipolar disorder.
46 2021-03-25 insomnia, impaired work ability I had trouble sleeping and became very emotional. This may be unrelated to the vaccine but I thought... Read more
I had trouble sleeping and became very emotional. This may be unrelated to the vaccine but I thought it best to report because I had an unusual night. I called off from work today because I couldn't sleep.
46 2021-03-26 nervousness Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient's wife communicated ... Read more
Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient's wife communicated that patient was nervous before getting his shot. Shortly after getting shot, he vomited.
46 2021-03-30 fear Patient felt faint and feared passing out. Staff help patient to prone position and elevated feet. B... Read more
Patient felt faint and feared passing out. Staff help patient to prone position and elevated feet. BP monitored and after ten minutes, patient returned to seat, waited another thirty minutes and left under own accord.
46 2021-04-02 feeling abnormal Same day experienced heart racing and palpitations on a regular basis, usually every 40 min.- 1 hr. ... Read more
Same day experienced heart racing and palpitations on a regular basis, usually every 40 min.- 1 hr. Since that first day, heart has felt enlarged.
46 2021-04-02 impaired work ability Body has been weak and shaky since I got the vaccine. I have had 2 episodes where I am short of brea... Read more
Body has been weak and shaky since I got the vaccine. I have had 2 episodes where I am short of breath and my blood pressure has gone up. The doctor has put me on anxiety medication but I still feel no difference. I have not been able to work for the past 3 weeks.
46 2021-04-04 sleep disorder, thinking abnormal Headache, nausea, cloudy thinking, overall body aches, swelling in neck and under arm pit-breast are... Read more
Headache, nausea, cloudy thinking, overall body aches, swelling in neck and under arm pit-breast area on arm where shot was given, fatigue not able to sleep, day 5 and symptoms have continued and are getting worse.
46 2021-04-06 anxiety, panic attack patients appointment is the same day as Covid vaccine, 28Feb2021; States he was told by the physicia... Read more
patients appointment is the same day as Covid vaccine, 28Feb2021; States he was told by the physician that it is possible the Covid vaccine is note safe; them on Saturday and his kinase was 1015; he wasn't feeling well; nausea; unable to articulate how he feels due to depressed ability to speak; panic; anxiety; This is a spontaneous report from a contactable pharmacist. A 46-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 04Feb2021 15:45 as single dose for COVID-19 immunization. Medical history included learning disability (found out last March he has a genetic disability, MECP2, which is a gene that carries Rhett's, autism, and Asperger's), rectal hemorrhage, fecaloma. The patient previously took Lipitor and experienced blood creatine phosphokinase increased, Aricept (2 doses, 1 in am and 1 in pm) and experienced gait inability and rhabdomyolysis, simvastatin (20mg for years and that was discontinued back in Jan or Feb of 2020), atorvastatin and experienced rhabdomyolysis and coumadin and experienced atrial fibrillation. Concomitant medications was not reported. Around Apr or Mar of 2020, the patient was hospitalized, and his creatinine kinase level was about 6000 and got better and was diagnosed with rhabdomyolysis. The creatinine kinase level on 16Jun2020 was 131 and on 17Dec2020 his creatinine kinase total level was 56 and that the range is 44-196. After receiving the first dose of vaccine, the patient wasn't feeling well, he reportedly has at baseline of being unable to articulate how he feels due to depressed ability to speak, but "he began talking to himself, had nausea and wasn't feeling well". So they took him to the doctor and had labs drawn on 12Feb2021 which showed elevated creatinine kinase levels measuring 1,019. They were instructed to speak to a rheumatologist and got another level on 22Feb which came back as 66. The pharmacist reported that back in Dec2020, the patient's kinase level was 55. Kinase was 1015 (blood creatine phosphokinase increased) on 12Feb2021, feeling unwell, nausea, unable to articulate how he feels due to depressed ability to speak, panic, anxiety in 2021. The pharmacist reported that he was told by the physician that it is possible the COVID vaccine is not safe. They were instructed to speak to a Rheumatologist and got another level on 22Feb which came back as 66. The patient's appointment is the same day as COVID vaccine, 28Feb2021. The patient is scheduled to receive his second dose of the vaccine this Thursday and he asked if it is safe to receive the second dose of the vaccine after reacting to the first. The patient underwent lab tests and procedures which included blood creatine phosphokinase: 6000 on 2020, 131 on 16Jun2020, 55 on Dec2020, 56 on 17Dec2020, 1015 on 12Feb2021, 1019 on 13Feb2021, 66 on 22Feb2021, magnetic resonance imaging: diagnosed with MECP2 on 12Feb2021, weight: 180-190 lbs, weight: 141-142 lbs, weight: 140.2 or 140.8 lbs on 12Feb2021. The reporter assessed the events to be non-serious. The outcome of the events was unknown. Information about lot/Batch requested.
46 2021-04-06 hallucination Hallucinations lasting approximately 1.5 hours
46 2021-04-08 confusional state Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: ... Read more
Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium, Additional Details: PT HAD FLUSHING AT 9 PM HEADACHE AND PASSED OUT FRACTURING HIS MANDIBLE IN PROCESS. PT HAD ATRIAL FIBRILLATION PT IS IN STABLE CONDITION ON DILTIAZEM HAD NO HX OF HEART DISORDERS PRIOR TO VACCINE
46 2021-04-10 feeling abnormal After sitting in waiting room at 10:00, at 10:03 a.m. began to feel strange with a sort of coldness ... Read more
After sitting in waiting room at 10:00, at 10:03 a.m. began to feel strange with a sort of coldness and dizziness. Woke up on the floor with nurses around. Was told by nurses, I was convulsing and was placed on the floor by nurse. After several minutes paramedics arrived and checked all vitals and blood pressure.
46 2021-04-10 insomnia Tinnitus. Continuous ringing in ears that will not go away. I was perfectly healthy before the sh... Read more
Tinnitus. Continuous ringing in ears that will not go away. I was perfectly healthy before the shot.. then several days after developed an ache in my right abdomen, fatigue and constant ringing in ears that will not go away. I'm also having a very hard time sleeping.. sometimes only being able to get 2 or 3 hours a night regardless of how tired I am. I'm very disappointed and not sure if I should get the second shot or not given how I'm feeling now. Before the shot I was perfectly healthy. I eat well, exercise and have never in my life experienced tinnitus or any type of hearing problem. This shot was the ONLY thing that could have caused this. I'm not sure what to do next or if I should get the second shot which could make it worse. I'm very worried because the ringing and aches have been constant for 10 days.. some days worse than others.
46 2021-04-12 anxiety Patient began experiencing feeling hot and flushed approximately 10 minutes after injection. He fel... Read more
Patient began experiencing feeling hot and flushed approximately 10 minutes after injection. He felt it was similar to his anxiety attacks he had in past. He had multiple "waves" where he said he would feel anxious, his heart rate would increase. His vital signs remained stable. At 09:26 am, he had a tightness in chest and states he normally gets that with his anxiety. Site captain consulted and continued to monitor patient and vitals. At )9; 33 a.m. he had chest pressure, and tightness. Described the pressure was 'different' than his usual. EMS was called and recommended follow up at hospital since his father died of heart attack at age 38, and he has had no follow up with heart since he was in high school. Patient refused EMS transport but his wife said she would drive him to be evaluated. EMS loaded patient into private vehicle.
46 2021-04-13 impaired work ability Symptoms: lethargic, exhausted, tired, sleepy, low energy, short of breath while talking, short of b... Read more
Symptoms: lethargic, exhausted, tired, sleepy, low energy, short of breath while talking, short of breath even with minimal physical activity , it's been 7 days since vaccine, unable to finish 8 hr shift at work
46 2021-04-16 disturbance in attention, memory impairment, confusional state A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetful... Read more
A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetfulness, and cough with chest tightness. Covid symptomatic in November. Received Covid Pfizer vaccine on 4.13.21 at 1pm. Felt fine headed into the vaccine. He completed the observation period and felt chest tightness after about 5 minutes similar to Covid in November. He felt slightly better and went to work. At work his cough and chest tightness worsened. Very tired, unable to eat with no appetite. Extreme fatigue Wednesday sleeping most of the day. Cough and chest tightness and feeling he cannot catch breath like being submerged in a pool. On 4.15.21 his feet became numb and tingling bilaterally. He felt more confusion, forgetting what he was doing, left frozen food in the sink and unable to recall why. He is also having headache posteriorly 7-8/10 which began on 4.14.21. He reports headache is not common, now 3-4/10 and feels very similar to Covid in November. Does have some mild neck stiffness associated. Chest tightness almost identical to Covid in November. Reports numbness and tingling in the feet has been ascending in nature. He felt unsteady on his feet yesterday morning. He is having tingling and cramping in the bilateral calf muscles today. His cough continues with no phlegm. Comes in coughing spells with chest tightness. He also noted cough is worse with exertion. Fever 99.8 yesterday. No diarrhea. No loss of smell or taste. In ED noted to have right LE weakness. Wife reports that he seemed unsteady while walking Kept for observation. difficulty concentrating - back to baseline 4/17/21 at 3:26 pm assessment SOB: CTA thorax 4/16/21 unremarkable CT angiogram thorax Symptoms began approximately 5 minutes after his Pfizer. Reports that his cough and shortness of breath now seems to be improving. Continues to have some mild chest tightness, intermittent cough. Robitussin significantly helped. Extensive workup including CT angiogram of the thorax reveals no evidence for pulmonary embolism or infiltrate. COVID-19 PCR testing is negative x2, severe respiratory isolation has been discontinued. Patient has a negative D-dimer, LDH, ferritin, CRP. Cardiac troponin has been negative x2. Patient does have some wheeze, after cough, suggesting some bronchospasm. Will trial albuterol inhaler q.i.d.. Patient does report a history of what sounds like an environmental triggers asthma like event in the past, though reports that he has undergone evaluation for asthma and was told that he does not carry a diagnosis of asthma. Patient is currently on room air. I have reviewed the reported adverse reactions from the Pfizer vaccine and coughing shortness of breath are not listed. Continue supportive care, with Tessalon and Robitussin, IS
46 2021-04-18 insomnia Following the first shot I have developed what appears to be tennis elbow in my left arm. Not sure ... Read more
Following the first shot I have developed what appears to be tennis elbow in my left arm. Not sure if it is related or not. Symptoms did not begin until after I received the shot. Also, I have not been sleeping as well. I have never had a sleeping issue but now find myself waking up around 4-5AM whereas this never occurred before. These are not terrible side effects but just wanted to report them to see if anyone else is experiencing anything similar.
46 2021-04-18 sleep disorder On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the ... Read more
On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the left side of my neck and head. By March 28 the pain had become so excruciating I went to an Urgent Care facility and they sent me to the Emergency Room. While in the ER I had blood tests and a CT scan which all came back negative. I was given Oxycodone-Acetaminophen for the pain and prescribed Cephalexin in case there was some type of infection. They also ruled out Shingles. I continued to have pain and contacted my Primary Care Physicians Office and spoke with one of the Physician Assistants two times the next week. She prescribed Baclofen 10 mg and took me off the Cephalexin and put me on Amoxycillin because we thought the problem might have been an ear infection. The next week I spoke with my Primary Care Physician, and he believed I was suffering from Trigeminal Neuralgia, so he put me on Carbamazepine 200 mg twice a day. That same week, on April 9, I was finally able to meet with the Physician Assistant at the Neurologists office and she also believed I was suffering from Trigeminal Neuralgia. I continued to take the Carbamazepine daily and the Baclofen and Oxycodone-Acetaminophen as needed. On Monday April 12 I informed the nurses at the Neurologist office that I was experiencing several symptoms/side effects that included dizziness, weakness, difficulty swallowing and a pounding heartbeat. The nurses talked with the PA and the PA took me off the Carbamazepine and put me on Oxcarbazepine 150 mg twice a day and she prescribed Methylprednisolone 4 mg. On Thursday April 15 I began to have intense prolonged pain behind my left ear down to the neck and in the Trigeminal nerves in the forehead and top of the head on the left side. I was in so much pain I slept for less than 2 hours. The next morning, I vomited and went to the Emergency Room again. At the ER they treated my pain with a headache IV cocktail that included Ibuprofen, Benadryl, an anti-nausea medication, Fentanyl, and a steroid. Within an hour my pain level dropped from a 9 to a 3 and I was released. The ER prescribed Gabapentin 300 mg (3 times a day) which I started the evening of April 16. I have had less constant pain since leaving the ER and starting the Gabapentin, but I continue to have pain in the Trigeminal nerve areas and neck with some flare ups that reach a 7 out of 10 in pain. I am scheduled for an MRI on April 23 and a visit with the Neurologist on May 10.
46 2021-04-20 confusional state Pt recieved 2nd dose of pfizer vaccine on 4/14. on 4/15 pt had fever up to 103. Pt has had ongoing ... Read more
Pt recieved 2nd dose of pfizer vaccine on 4/14. on 4/15 pt had fever up to 103. Pt has had ongoing fevers since. On 4/20 pt became confused and displayed s/s of stroke. Brought to hospital by EMS and evaluated for stroke like sx. Pt was treated for stroke- given TPA and placed in ICU. CT showed show evolving subacute infarct. Pt has word difficulty, confusion, diaphoresis. Currently still in ICU.
46 2021-04-21 nervousness Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand ... Read more
Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand and stated he felt weak. He was pale and diaphoretic. Helped him to ground and allowed to rest. Felt better. Pt evaluated by paramedics. VS @ 1107 HR 68, OxSat 99%, BP 96/47. @1115 Sit in chair. BP 104/56, HR 70, OxSat 100%. @ 11:45 Pt ambulated w/o difficulty. Taking bus home. Told to call nurse when he arrives home.
46 2021-04-27 confusional state Within 15-minutes of vaccination, the patient reported dizziness, but they did not syncopize. EMS ev... Read more
Within 15-minutes of vaccination, the patient reported dizziness, but they did not syncopize. EMS evaluated the patient on-site. The patient was slightly hypertensive (147/92). EMS transported the patient to Emergency Department. In the ED, the patient presented with dizziness and confusion. Physician administered 1L normal saline bolus. Labs and imaging were unremarkable. Physician spoke with patient's mother who stated that the patient is at baseline given significant psychiatric history. Patient was discharged with a diagnosis of dizziness.
46 2021-04-27 nervousness After both shots. About 1-2 minutes after I started feeling nauseous, shaky, dizzy and then my heart... Read more
After both shots. About 1-2 minutes after I started feeling nauseous, shaky, dizzy and then my heart pounding out of my check for 30-40 seconds. My heart settled down and I was shaky and jittery the rest of the day.
46 2021-04-28 anxiety 46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, a... Read more
46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, and cirrhosis suspected 2/2 schistosomiasis, who presents with 1wk of dyspnea, w/ waxing waning subjective fevers. Per ED Note: Endorses chronic fatigue until 4/16 when he received first dose of Covid vaccine (Pfizer). Since then, pt reports persistent dyspnea, worsening fatigue. Reports 2 days of left-sided chest pain w/ periumbilical abd pain and enlarging abdomen. Pt believes these are 2/2 covid vaccination. Chest pain is described as constant generalized discomfort under left breast that worsens with pressure. Also worse with deep inspiration. No radiation or migration since onset. Pt describes abdominal pain as periumbilical tightness, "pain". Describes subjective, unmeasured fevers that "come and go" over last week. When asked to repeat the story of what happened on arrival to the unit, wife speaks for the patient since he is slightly dyspnic. States this morning, went to small clinic, husband had a headache and slight fever. Clinic said to come in to the big hospital. Fever and pain in legs and head, started a few days after he got the covid vaccine. The fever came and went. Didn't measure the fever. Also has some problems with Abdominal pain - doesn't know how to describe it. Feels like stomach ache. Stomach pain is getting better. Has since gone away since arriving to the hospital. He denies any cough, denies chills, denies nausea or vomiting. States he took some medications at home for constipation because he felt like he couldn't go. From the conversation it appears he does not take lactulose for HE, more for constipation. ED workup included an Xray, CT C/A/P with multifocal lung lesions suspicious for multifocal pneumonia. Lactate of 16. Na of 124. Noted to be anemic and thrombocytopenic. UA cloudy, pyuric, w/protien >100. Chest and abdominal pain resolved by the time pt was examined on the floor. Still tachypnic and tachycardic. Stated most bothersome was feeling anxious. Has anxiety at a baseline. Not complaining of any pain at the moment. Cannot describe chest pain in more detail, put his hand over the right side of his chest and presses on it but does not say if it hurt more when he would press on it, does not say it was reproducible. Not painful when he touches or presses on it now. Per chart, patient recently re-established care after long-time from follow up during pandemic. At visits last month c/o gingival bleeding, fatiguem & found to have Hgb drop from 13 in 2018-> 9.7 on 3/2/21. Referred for EGD but cancelled due to anxiety. I am the Infectious Diseases attending asked to see him for septic shock. He developed septic shock and respiratory failure requiring mechanical ventilation and 3 vasopressors. He has evidence of DAH, DIC, acute renal failure, progressive liver failure and he has Klebsiella pneumoniae bacteremia.
46 2021-04-30 confusional state Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins... Read more
Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins; right lower extremity weakness; cough; shortness of breath; chest tightness; confusion; This is a spontaneous report from a contactable physician reporting for a patient. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 13Apr2021 13:00 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation at 46 years old. Medical history included DJD cervical spine and Raynaud's Phenomenon from an unknown date. Concomitant medications included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and paresthesia bilateral feet and shins; right lower extremity weakness, cough, shortness of breath, chest tightness, confusion on 13Apr2021 13:15. Treatment included albuterol. The patient was hospitalized for the events on an unspecified date for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab): negative on 16Apr2021 and 17Apr2021, and blood test (SARS-CoV-2 antibody test) negative on 16Apr2021.Outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available information and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-05-03 feeling abnormal, anxiety Initially developed fatigue, myalgias, and headache after vaccine administration. On 5.3.2021 devel... Read more
Initially developed fatigue, myalgias, and headache after vaccine administration. On 5.3.2021 developed "brain fog" where patient had difficulty focusing, completing tasks, and subsequently developed anxiety symptoms.
46 2021-05-03 loss of personal independence in daily activities I had a Stroke; Blood clot travelled to my brain; effected left side of my body; ability to speak; T... Read more
I had a Stroke; Blood clot travelled to my brain; effected left side of my body; ability to speak; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER 8729), via an unspecified route of administration in left arm on 10Apr2021 (at the age of 46-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have covid prior vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had a stroke. Blood clot travelled to his brain and effected left side of his body and ability to speak on 15Apr2021 at 17:30. The events resulted to emergency room/department or urgent care, hospitalization for 3 days, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received unspecified treatments for the event. Covid test post vaccination on 15Apr2021 with result of negative. The outcome of the events was recovering.
46 2021-05-04 feeling abnormal This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male pati... Read more
This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:20 (Lot Number: EW0162) (received at the age of 46-years-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included right knee pain. Concomitant medications were not reported. The patient received the Pfizer 1st shot 18Apr2021 11:20 am. On 19Apr2021, at midnight, he had low grade fever then swelling right leg. On the day of the report, 20Apr2021, he had swelling to both legs. The patient had taken ibuprofen as treatment beside propping legs up. The reporter wanted more information on the swelling and if it's related to taking ibuprofen. It was further reported that the patient experienced severe swelling from the knees down to the calves on both legs on 19Apr2021. He also experienced night sweats, fever, lightheadedness and dizziness on 19Apr2021. They want to know if there are any reports regarding the swelling side effects and if it is from the vaccine. The first dose of the vaccine was given 2 days ago (18Apr2021) and the second dose is due on 09May2021. The patient got his first shot on 18Apr2021 about 11:20am. After about 15 hours he developed swelling in one leg, she later clarified this to be his right leg, and now reports that both of his legs are swollen at the time of report (20Apr2021). She noted that patient told her his legs are not painful. She doesn't know if it's a blood clot or if they needed to go to the hospital. She also wanted to know if there is information about this as a side effects or if other people are having this too. She then reported that the patient started experiencing a fever, profuse sweating, and was spacey about 12 hours after the vaccine, a little after midnight 19Apr2021. She doesn't know if the dehydration made it worse. His fever was low-grade 99.8 degrees and lasted 4 and a half to 5 hours and has now resolved. When asked if patient received any treatment for fever, caller said it was so recent, and that was listed as a common side effect that goes away. Reported the patient drank fluids and she kept an eye on him. Leg swelling was about 15 hours after the vaccine, early morning 19Apr2021. She noted that the swelling in the right leg got bigger and didn't go down, but the left leg did. But today the left was more swollen and more prominent today. She further clarified that the patient takes ibuprofen for pre-existing right knee pain. Caller also reported that the patient propped his legs to alleviate the swelling, it has improved some but the swelling did not go away. The adverse events did not require a visit to the physician office or emergency room. Outcome of the event fever was resolved on 19Apr2021 (lasted 4 and a half to 5 hours); outcome of the event "severe swelling from the knees down to the calves on both legs" was not resolved; outcome of the remaining events was unknown.
46 2021-05-04 feeling abnormal full body aches; headache/headachy; fogginess/cloudiness; This is a spontaneous report from a contac... Read more
full body aches; headache/headachy; fogginess/cloudiness; This is a spontaneous report from a contactable consumer reported for himself that a 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 02Apr2021 (Lot Number: EP7533; Expiration Date: 30Jul2021) as SINGLE DOSE for covid-19 immunisation. Patient took the first dose of vaccine on 12MAR2021 (Lot number: EN6208, Expiry date: 30Jun2021), also at age of 46 years old for covid-19 immunization. He didn't have any kind of soreness after the first COVID vaccine. He had no tenderness, no side effects, nothing. For the first time it was about 13:30 in the afternoon and then the second time was he wanted to say about 10:00 am. He had both dose in his shoulders, one was in the left and one was in the right. Vaccine Administered at Military Facility was No. Vaccination Facility was Hospital. Prior vaccination (within 4 weeks prior) was none. The patient medical history and concomitant medications were not reported. Patient had the headaches and also had bad fogginess about 6 hours after the COVID vaccine was administered and the full body aches kicked in the next morning which was about 20 hours after the COVID vaccine was administered and then like he said the body aches went away and the only thing that has really lingered from time to time was the headaches. The body aches started on 03Apr2021 and were over by the following Monday, so 05Apr2021. The cloudiness and the headaches began on 02Apr2021 but he did not have the cloudiness anymore. He got headachy very easily now and he has never experienced that before. He got headaches really easy, they were lingering, but they were not migraines it was just an achy head in the background, in the distance, and he can tell it was something different. The outcome of event headache was not recovered, the outcome of event full body ache was recovered on 05Apr2021,the other event was unknown. No follow-up attempts are needed. No further information is expected.
46 2021-05-05 panic attack Pt. self identified panic attack post second pfizer vaccine. PT declined RN interventions, self mana... Read more
Pt. self identified panic attack post second pfizer vaccine. PT declined RN interventions, self managed symptoms. Pt. ambulated from clinic after describing improved symptoms
46 2021-05-06 amnesia, mental impairment, feeling abnormal Within seconds of my first vaccine I had a massive headache. 20 mins later I had brain fog. An hour ... Read more
Within seconds of my first vaccine I had a massive headache. 20 mins later I had brain fog. An hour later I had exhaustion and then injection site arm began hurting. This lasted for 48 hours and then I was fine. It came on fast and stayed. I had difficult time thinking or retaining a memory. Second shot had no instant reaction, injection site just slowly began hurting. An hour later, and very suddenly, brain fog hit me and i lost all short term memory, mid sentence. Similar to what I would consider a form of Alzheimer?s. At the same time I developed a headache, not as severe as the first shot, but I was more exhausted than the first shot. Forming sentences, being able to think was very difficult for 72 hours. I was exhausted, arm hurt. After the 72 hours, I lost my sense to smell. I am in my 96 hour since my second injection and still have no sense of smell. I can taste. Never had a fever but for both shots it felt like it was absorbed by my muscles and was then converted to something else which was then released back into my system. It was like I had sore muscles it was like my muscles became the poison. This effect was grossly more profound after the second vaccine. The ability to think was the scariest side effect.
46 2021-05-07 insomnia On 4/14, had a series of rashes on left side of face - eye lid, eye brow, forehead and well into the... Read more
On 4/14, had a series of rashes on left side of face - eye lid, eye brow, forehead and well into the scalp. Following a visit to Dr, He confirmed this to be Shingles and referred me to the Ophthalmologist as the Shingles had affected eye surroundings. I have been prescribed and taking Valacyclovir, Gabapentin, and Prednisolone eye drops to treat the Shingles. Into week 3, Shingles rashes have all healed, blisters have all crusted out and cleared, however nerve pain continues in the head and around the eyes. The ophthalmologist suspects this to be post-Shingles effect, i.e., Postherpetic Neuralgia. My current condition results in Insomnia during various nights, and itchiness/tingling sensations, for which I have to apply cold/wet compress and Calamine Lotion to provide temporary relief. As a result of above following the 1st COVID vaccine, I have postponed my 2nd COVID-19 (Pfizer) vaccine to 5/22. However, my confidence level to proceed and get this 2nd vaccine on 5/22 is low at this time, until CDC is able to let me know whether there is a link between the COVID-19 vaccine and this causing Shingles in rare cases, to help me avoid a repeat of the stressful experience after the 1st COVID-19 shot. I would greatly appreciate a callback or an email.
46 2021-05-12 feeling abnormal NORMAL COMMON SYMPTOMS FIRST THREE DAYS, EVERY 4 OR 5 DAYS FLU LIKE SYMPTOMS NO FEVER. WEEK THREE HI... Read more
NORMAL COMMON SYMPTOMS FIRST THREE DAYS, EVERY 4 OR 5 DAYS FLU LIKE SYMPTOMS NO FEVER. WEEK THREE HIVE LIKE BUMPS ON BOTH ARMS SMALL BUMPS ON FOREHEAD, LOSS OF APPETITE, KIDNEY, LIVER PAIN, BACK ACNE. COGNITIVE CLARITY LOSS.
46 2021-05-14 feeling abnormal brain fog; itching; hives; Rash; This is a spontaneous report from a contactable consumer (the patie... Read more
brain fog; itching; hives; Rash; This is a spontaneous report from a contactable consumer (the patient, reported for self) A 46-year-old male patient received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in arm left on 03Mar2021 10:15 (At 46-year-old) as single dose, for COVID-19 immunization. The patient medical history included ongoing anxiety, blood cholesterol, cardiac disorder from an unknown date. Patient reported that he was diagnosed with anxiety like 8 years ago. Patient reported that he started to have issues with his cholesterol maybe 5 or 10 years ago. Patient reported that his cholesterol had been going up and down. Patient reported that couldn't keep it down so he started taking medication, Atorvastatin. Patient reported that he has heart problems, with his bicuspid aortic valve. Patient reported that the problems with his heart valve were diagnosed when he was 14 years old. Additional Administered Vaccines were None. No Family Medical History Relevant to adverse event. Concomitant medications included sertraline hydrochloride (ZOLOFT) 100 mg, by mouth, once daily taken for Anxiety, atorvastatin 20 mg, by mouth, once daily taken for blood cholesterol for all start and stop date were not reported. Additional Information for Concomitant Products Zoloft included: Patient reported that he took the after market off brand of Zoloft. No further details provided regarding this statement. Patient stated that he began taking Zoloft like 8 years ago. Patient reported that he began taking Atorvastatin about a year ago, maybe in 2019 or 2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, patient reported that he doesn't normally take the flu shot and hasn't had a vaccine in 10 or 15 years. Patient reported that on 04Mar2021 he had the first shot of the Pfizer vaccine for Covid-19, a week and a half into it, he developed a rash all over his body. Patient stated that the rash came up at night and was gone the next morning. Patient reported that 2 days later, the rash came up again and went away and then came up again, the rash is currently present, that he has a little bit all over in certain spots. Patient reported that he is due for the second dose of the Covid-19 vaccine on Wednesday, 24Mar2021. Patient stated that the report said if you develop a rash all over your body it is listed as a serious side effect. Patient reported that he didn't have any issues other than the rash/itching and that he is looking for some advice as to whether he is at risk and if he should take the second dose of the Covid-19 vaccine or not. Patient reported that he went to see his physician regarding the rash that developed after the first dose of the Covid-19 vaccine. Patient reported that his physician stated that it was a side effect and didn't really say much as to whether he should worry or not. Patient reported that he went to see his physician the following day after the rash disappeared, patient showed his physician pictures of the rash as he didn't have the rash at the time. Patient was unable to provide NDC number, lot number, or expiration date of the Pfizer Covid-19 vaccine as he does not have his vaccine card with him and was in his car and that he would be able to provide that information at a later date if he was contacted by Pfizer for a follow-up. Patient reported that he didn't want to end up in the ICU or anything like that and that he wants to be protected. Patient reported that he was looking at the Covid-19 vaccine fact sheet from Pfizer provided to him by CVS. Patient stated that it says there's risks and they're all listed- listed under signs of severe allergic reactions is a bad rash all over your body. Patient reported that he doesn't know if his rash would be considered severe, it was just itchy and a little scary, but he felt fine besides that. That is why he is seeking guidance on what to do for the second dose. Rash: Patient reported that in the beginning when the rash first developed it was itchy, now he doesn't feel the rash and there is very little of the rash now. Patient doesn't know if the rash is getting better but it seems like it has improved. Therapeutic measures were taken as a result of the adverse event, Treatment: Patient reported that he just took allergy medicine to treat the rash, he tried Benadryl at first and then Claritin. Patient reported that the Claritin seemed to work a little better. Patient reported that Benadryl didn't really do anything for the rash. Lot: 1800414; Expiration date: Aug2022; NDC: 50580-228-24; Strength: 25 mg; Package size: 24 capsules. Relevant tests: Patient reported that his physician looked at pictures of rash and looked at information about the Pfizer Covid-19 vaccine. No Emergency Room visit, but patient had visited the Physician Office. Outcome of the event rash was reported as recovering, outcome of other events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-05-14 mental impairment mental dullness; Severe fatigue; muscle aches; body heaviness; This is a spontaneous report received... Read more
mental dullness; Severe fatigue; muscle aches; body heaviness; This is a spontaneous report received from a contactable consumer reported for himself and a other healthcare professional. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EW0170) at left arm on 26Apr2021 13:00 at single dose for COVID-19 immunization in Hospital. Medical history and Concomitant medications were none. No Known Allergies. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient did not receive within 2 weeks of vaccination. It was reported nothing that made him feel in danger. Severe fatigue, mental dullness, body heaviness, muscle aches, all on 27Apr2021, 06:00 AM. Received shot at 1pm. Bicycle ride that late afternoon. No side effects until next morning. Major effects lasted until about 2pm the next day. All was back to normal the following morning after a normal night's sleep. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has note been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered on 28Apr2021. Batch/Lot number has been obtained. further information has been requested.
46 2021-05-21 feeling abnormal Almost fainting 3 minutes/Almost fainted/Really close to blacking out; Almost passed out; Nauseated/... Read more
Almost fainting 3 minutes/Almost fainted/Really close to blacking out; Almost passed out; Nauseated/Swirling strong nausea through the body up to the chest; Rapid heart rate; Hyperventilation; Labored breathing; 5-10 minutes before able to uncramp his hands; Waves of the feelings came throughout the day; This is spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 15Apr2021 11:00 as single dose for covid-19 immunization. Medical history included sensitivities to ephedrine from an unknown date and unknown if ongoing. The patient had no concomitant medications. The patient experienced almost fainting 3 minutes/almost fainted/really close to blacking out, nauseated/swirling strong nausea through the body up to the chest, rapid heart rate, hyperventilation, labored breathing, 5-10 minutes before able to uncramp his hands, waves of the feelings came throughout the day, almost passed out/ really close to blacking out; all on 15Apr2021. The events were not required a visit to emergency room, nor physician office. Caller is a 47 years old patient who received the 1st dose of the Pfizer Covid vaccine on 15Apr2021. He complained of feeling nauseated, and rapid heart rate, with hyperventilation, and almost fainting 3 minutes after the 1st dose of the Pfizer Covid vaccine. This lasted approximately 15 minutes. 3 minutes after receiving a vaccine. He started to complaint about feeling nauseated. He started rapid heart rate which caused him to have hyperventilation and almost fainted. The episode last for 15 minutes and he just want to go and report it. Consumer confirmed it was the Pfizer Covid19 vaccine. The consumer wasn't still experiencing the side effects. They lasted to 5pm. I got my shot at 11am. The event was no longer persisting but he was wanting to understand the effect of the second shot, the consumer wasn't took any treatment for adverse event. Caller states that he is calling about the Covid Vaccine. Says with the first round of the vaccine he had an adverse event. He is looking to Pfizer and his doctor for some feedback to understand whether or not he should get the second dose. Says that about three minutes after the vaccine he felt a swirling, strong nausea throughout his body up to his chest. He had labored breathing and a really fast uncontrolled heart rate for about 5 minutes. States he was hyperventilating and almost passed out. He had to sit on the ground of the parking garage where he had gotten his vaccine. About 5-10 minutes later he was finally able to uncramp his hands. States that before the vaccine he was calm and not at all in an elevated state. States he is wondering about the second dose being stronger. He almost blacked out after the first dose. States it was close to the limit of what he could tolerate. States he needs further details. He was reading about clinical trials and some doctors. States that he did not have all the symptoms of anaphylaxis that they described. Says his symptoms lasted about 5 minutes or so. About 10-15 minutes later he was recovered. Says waves of these feelings came over him throughout the day. Says they decreased each time and ended that evening around 1700. Caller says he did not go to the Emergency Room when it happened. The nurses at the vaccination site attended him. At the end of the call the caller mentions that he has a sensitivities to ephedrine. States he does not take any Sudafed or Dayquil or anything like that. States he didn't know if that was relevant to mention or if anything like that is in the vaccine to make him have the response that he did. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No prior Vaccinations (within 4 weeks). No family medical history relevant to events. No Relevant Tests. The outcome of events was resolved on 15Apr2021.
46 2021-05-23 feeling abnormal A week after second shot: Intermittent 2 degree fever, lower back pain, tiredness, headache, weaknes... Read more
A week after second shot: Intermittent 2 degree fever, lower back pain, tiredness, headache, weakness, brain fog.
46 2021-05-28 confusional state Headache, Malaise, Confusion, Blurred Vision, Nausea, Joint Pain, Dizziness, and TMJ flare ups. All ... Read more
Headache, Malaise, Confusion, Blurred Vision, Nausea, Joint Pain, Dizziness, and TMJ flare ups. All symptoms have not subsided since the day after the 2nd vaccination shot. It has been 10-days.
46 2021-05-28 sleep disorder, thinking abnormal I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back... Read more
I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back hurt.; Dry mouth; coughing; random thoughts; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 15May2021 12:00 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15May2021 12:15, the patient only slept 1 hour, his arm, head and back hurt. Dry mouth, coughing, random thoughts. He felt like he was dying over here. Events were considered serious, disability. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-06-01 insomnia Spasms in hands and feet/spasms in his feet was a weird sensation like little explosions going off, ... Read more
Spasms in hands and feet/spasms in his feet was a weird sensation like little explosions going off, like a nerve issue, around feet, toes, and ankles; Both hands went numb; Both hands went numb and were tingling quite a bit and the next day when he woke up it was worse; He is having the tremors around ankles and feet; It is very uncomfortable and has not been able to sleep well because of it.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0183), via intramuscular route administered in left arm (left shoulder as reported) on 17May2021 (age 46-year-old at time of vaccination) (in noon as reported) as single dose for preventative/COVID-19 immunisation. Medical history included had an allergy to penicillin and that was when he was a child, he thinks he had a rash. He does not know if he was still allergic. Prior Vaccinations (within 4 weeks) were none. Concomitant medications were none. It was reported that the evening after getting the first shot on 17May2021, both hands went numb and were tingling quite a bit and the next day when he woke up it was worse. On the third day after getting the shot he started getting and was still have spasms in hands and feet on 20May2021. The spasms in feet was a weird sensation like little explosions going off, like a nerve issue, around feet, toes, and ankles, stated it was also in his hands but not quite as much in hands. He still has numbness and tingling in hands and fingers. It was worrisome since he was an artist and paints. It is hard to paint with numbness and tingling. The numbness and tingling has stayed the same but there are periods of it getting intense from time to time, it has not subsided. He was hoping it would only last 2 or 3 days. As he was talking, he was having the tremors around ankles and feet in 2021. It was very uncomfortable and had not been able to sleep well because of it in 2021. The spasms are still the same, if anything they have worsened. No treatment received for events. The outcome of events tremor and insomnia was unknown and for remaining events was not recovered. Follow up needed, further information has been requested.
46 2021-06-03 loss of personal independence in daily activities had to go to sleep; Could not function correctly; They had headache; body aches; chills; He felt rea... Read more
had to go to sleep; Could not function correctly; They had headache; body aches; chills; He felt really exhausted and drained.; Pfizer Covid Vaccine first dose Date: 19 Apr 2021/Pfizer Covid Vaccine second dose Date: 03 May 2021; Pfizer Covid Vaccine first dose Date: 19 Apr 2021/Pfizer Covid Vaccine second dose Date: 03 May 2021; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable 46-year-old male patient reported that who received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number and expiry date unknown) via an unspecified route of administration at left arm as a single dose for COVID-19 Immunisation. Past drugs included Lisinopril taken for quite some time, 3 or 4 years, Nifidipine for blood pressure. Historical vaccine BNT162B2 via an unspecified route of administration (Lot Number / Expiry Date was not reported) on 19-APR-2021 as a single dose at left arm for COVID-19 immunisation. On an unknown date patient could not function correctly the day after both shots. They had to go to sleep. He said that the headache, body aches and chills started the same day as the shot after both shots. He felt exhausted and drained. Patient did not visit physician office or emergency room visit due to the event. Outcome of the events were recovered on an unknown date. Information on the lot/batch number has been requested.
46 2021-06-07 loss of personal independence in daily activities treatment received for the adverse event?: Yes: Advil; Started to feel fatigue; fatigue/fatigue inte... Read more
treatment received for the adverse event?: Yes: Advil; Started to feel fatigue; fatigue/fatigue intense that prevent me to do habitual physical activity; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration, administered in left arm on 09Mar2021 at 09:30 (age at the time of vaccination: 46-year-old) as unknown, single dose for covid-19 immunization. The patient also received ibuprofen (ADVIL [IBUPROFEN]), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included hypertension and allergy with shellfish. Patient not administered other vaccine in four weeks. Patient not had Covid prior vaccination; Patient was tested Covid post vaccination. Concomitant medications included losartan potassium (COZAAR), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), vitamin d (VITAMIN D [VITAMIN D NOS]). On 14Mar2021 at 13:00 after vaccination, the patient experienced fatigue and received Advil for the treatment of adverse event. It was reported that the patient started to feel fatigue on 14Mar2021 (D5) but on Mar162021 (D7) fatigue intense that prevent him to do habitual physical activity. (Patient was an athlete preparing for a triathlon but 16Mar2021 and he was not able to finish a 4mile run, which was very simple to his fitness level. The outcome of the events was resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-06-08 feeling abnormal, anxiety, depression Depression and anxiety/gotten worse; Depression and anxiety/gotten worse; Brain fog/gotten worse; Br... Read more
Depression and anxiety/gotten worse; Depression and anxiety/gotten worse; Brain fog/gotten worse; Brain fog/gotten worse; Fatigue /gotten worse; This is a spontaneous report from a contactable other health professional (registered nurse reporting for her son).A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.On an unspecified date, A week or two later after first dose he started getting a lot of fatigue and brain fog and became depressed and anxious over the last few months. The patient had second dose 09Mar2021. States it has just gotten worse. Caller wants to know if this has been reported or if this could be related to the vaccine. The outcome of the events was not recovered. Information about batch/lot number has been requested.; Sender's Comments: Based on the plausible temporal relation, the association between the events of anxiety aggravated, depression worsened, brain fog, brain fog condition worsened and fatigue aggravated with the suspect product of BNT 162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-06-08 loss of personal independence in daily activities Could not function correctly; Headache; Body aches; Chills; They had to go to sleep; He felt really ... Read more
Could not function correctly; Headache; Body aches; Chills; They had to go to sleep; He felt really exhausted and drained.; This is a spontaneous report from a contactable consumer or other non-Healthcare professional. A 46-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 19Apr2021 at 11:30 am (age at vaccination was 46 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. The patient did not have any family medical history relevant to adverse events. Concomitant medications included lisinopril (40 mg, taking for quite some time, 3 or 4 years) taken for blood pressure and nifedipine (30 mg, taking for same amount of time as Lisinopril) taken for blood pressure. The facility where the most recent COVID-19 vaccine was administered was other. The vaccine was not administered at Military Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other additional vaccines were administered on same date of the Pfizer Suspect. On an unknown date, the patient could not function correctly and experienced headache, body aches and chills. The caller and his wife had both doses of the Pfizer vaccine. After the first dose, both could not function correctly. The caller explained that both he and his wife could not function correctly the day after both shots. They had to go to sleep. He said that the headache, body aches and chills started the same day as the shot after both shots. The caller reported that he took Advil and he was sleeping. The patient did not have physician office or emergency room visit due to the events. No relevant tests were done. The outcome of the events could not function correctly, headache, body aches and chills was resolved on an unknown date in 2021. The outcome of the events they had to go to sleep and he felt really exhausted and drained was unknown.
46 2021-06-09 anxiety, agitation feel minor aching; I felt faint/ inconsistent dizziness spells; It could of been anxiety; feeling of... Read more
feel minor aching; I felt faint/ inconsistent dizziness spells; It could of been anxiety; feeling of adrenaline rush; my vision was slightly askew as though I could not focus on objects.; my vision was slightly askew as though I could not focus on objects.; This is a spontaneous report from a contactable consumer, the patient. This 46-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8735) via unspecified route on 21Apr2021 at 10:00 (at the age of 46-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included migraines. Patient had allergies to sulfa. Patient did not have COVID-19 prior to vaccination. There were no other vaccines received within four weeks of vaccination. Concomitant medications taken within two weeks included collagen, multivitamin and THC-free cannabidiol (CBD). On 21Apr2021 at 10:00, after a few seconds of being injected, patient felt faint. It could have been anxiety but then minutes later he had these inconsistent dizziness spells and a feeling of adrenaline rush. He felt many times like he could faint. It subsided after a few hours. Also his vision was slightly askew as though he could not focus on objects. On 22Apr2021, the next morning, he just felt minor aching. There was no treatment received for the events. The clinical outcome of the events felt faint/dizziness spells, anxiety, feeling of adrenaline rush, vision was slightly askew, could not focus on objects, and minor aching was recovering. Patient was not COVID tested post vaccination.
46 2021-06-10 fear This is a spontaneous report from a contactable consumer (father) or other non health care professio... Read more
This is a spontaneous report from a contactable consumer (father) or other non health care professional. A 46-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration administered in arm left on 24Mar2021 as 1st dose, single dose for COVID-19 immunization. Medical history included Parkinsons diagnosed 12 years ago and dystonia diagnosed 8 years ago from an unknown date and unknown if ongoing states the patient has had four deep brain stimulations and was in neurological care and takes a lot of medications. The patient's concomitant medications were not reported. Patient did not receive any vaccination 4 weeks prior to receiving Covid 19 vaccine. On 24Mar2021, the patient had the Pfizer Vaccine and a day and a half later could not feel his legs and has not been able to walk since; states the vaccine was the only different thing he had and everything else was routine and going on for years and his dystonia did not just jump and he can't say the reason this happened but it should be looked at. He can't say the Pfizer Vaccine was the reason for the reported events and he can't say it isn't the reason. On 26Mar2021, the caller stated that in the morning but could have been the night before as the patient was in bed and said he could not feel his legs and couldn't walk; states he could not stand up to this day on an unknown date and was in a wheelchair and everything was done in a wheelchair. Caller stated the patient had nothing new and no kinds of other medication or vaccines done other than what was prescribed by his doctor. Stated he was healthy other than what the disease has done to him. Stated for treatment everything was exactly the way it has always been and they adjust his deep brain stimulations once in a while and basically try to help out the dystonia and the Parkinsons seems to be taken care of but the dystonia was really the culprit. Stated that the patient had the Pfizer Vaccine and a day and a half later could not feel his legs and had not been able to walk since, the patient went to the health care professional and was going back again next week and the health care professional tried to adjust the batteries and increased his medication to see if that would help and the increased medication did nothing and nothing changed. The medication that did nothing was Carvidopa or Levodopa or whatever it was called and he went from taking 2 pills twice per day to taking three pills twice per day after the incident with the Pfizer Vaccine trying to help out and nothing changed. Caller states for some reason the Pfizer Vaccine just went in and did something to some part of his brain and must have gone after the weakest point and he was only guessing this as no doctor has answers and they don't know. The patient had been Carvidopa Levodopa for 12 years. Patient was afraid to take 2nd dose which was scheduled on 14Apr2021, and the patient did not take that. The event he could not stand up to this day and was in a wheelchair and everything was done in a wheelchair was assessed as serious (disability).The adverse events resulted in physician office visit. The vaccination facility type was reported as hospital. The outcome of the events was reported as unknown.
46 2021-06-10 mental impairment, confusional state, memory impairment Bad headache on Left side of head where ear is toward the back. Confusion, Dizziness, , Light headed... Read more
Bad headache on Left side of head where ear is toward the back. Confusion, Dizziness, , Light headed, Tingling and numbness from left eye to jaw. Drooping of left eye and lips. Memory and processing information issues. One month later still some head pain off and on and numbness around left eye. Still have memory and processing issues. I've never had any other prior issues with the head or face. No falls or activities such as boxing
46 2021-06-13 anxiety Patient was waiting in our observation area when he began to experience dizziness, cold sweats and t... Read more
Patient was waiting in our observation area when he began to experience dizziness, cold sweats and tunnel vision. He lay down on the floor, and our technician asked him if he was OK. I immediately went out to him, and he told me he was already feeling better. I had him put his feet up on the chair, and he told me that he thought this reaction was due to anxiety. He was talking and breathing normally. I offered to check his blood pressure and get him some water, but he declined. He rested on the floor for approximately 5 minutes and then said he was feeling well enough to go.
46 2021-06-24 feeling abnormal her husband said he got itchy immediately after receiving his first COVID-19 Vaccine; She clarified ... Read more
her husband said he got itchy immediately after receiving his first COVID-19 Vaccine; She clarified her husband's rash is on both sides of his left and right upper abdomen, between his ribs and hips, and on both his left and right shins; a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad; her husband said he felt run down a week after he received his first COVID-19 Vaccine dose; Injection site pain; This is a spontaneous report from a contactable consumer (patient's wife). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, Expiration date: Not reported) via an intramuscular route of administration, administered in Arm Left on 12Jan2021 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included ongoing psoriasis, Allergic to penicillin. The patient's concomitant medications were not reported. It was reported that her husband had the same experience after he received his first COVID-19 Vaccine dose on 12Jan2021, clarifying her husband said he got itchy immediately after receiving the COVID-19 Vaccine. She said her husband has had psoriasis for a long time. She said her husband has had psoriasis outbreaks before, but not in that area of his body. She said her husband usually has a psoriasis outbreak at his waist where his belt buckle is located, as well as, his elbows, and knees. She said her husband doesn't have any allergies, except for Penicillin. She said her husband didn't think anything of his itchiness and rash after he received his first dose of the COVID-19 Vaccine because he has a history of psoriasis. She said the rash he developed after his first COVID-19 Vaccine dose went away. She clarified her husband's rash is on both sides of his left and right upper abdomen, between his ribs and hips, and on both his left and right shins. She said a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad, and felt run down. She said he was told at that time what to expect after receiving the COVID-19 Vaccine, and after a couple days he was OK. She said her husband said his left arm was so painful with the first COVID-19 Vaccine dose, that he said couldn't put on his shirt. The outcome of the events was recovered on Jan2021. Follow-up attempts are completed. No further information is expected.
46 2021-06-26 confusional state Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient reported extreme dizziness and light headedness; found on floor in waiting error. Remained conscious the entire time. Improved with water and cold compress. Called 911 but by the end of conversation patient was up and moving, no need for them to respond.
46 2021-06-28 hallucination I am unable to locate my vaccine card for that information but the adverse event started about a wee... Read more
I am unable to locate my vaccine card for that information but the adverse event started about a week after my vaccine. So after I had the second dose, my blood platelet count dropped dramatically, also my ammonia levels were elevated. Normal ammonia levels are 11-32 MM/L and my ammonia levels spiked up to the 70s on 4/29/2021. My vaccination was received on the 19th of April I think, I am not positive. So my levels spiked and I became hallucinogenic. It was quite an event, I had three police officers in my house. So we have had problems controlling my ammonia levels since then. My iron levels are also elevated and my platelet count is way way down as well. The vaccine may have triggered some sort of autoimmune response is kind of what my DRs are thinking right now. Once we get more information on that then we will be able to see why my body reacted the way it did. I went to the ER on 4/29/2021 and they did tests and then they sent me home. I have follow up appointments with DRs.
46 2021-06-29 anxiety Diaphoresis; Dizzy/lightheaded; Increased anxiety; Chills; This is spontaneous report from non-conta... Read more
Diaphoresis; Dizzy/lightheaded; Increased anxiety; Chills; This is spontaneous report from non-contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration, on 18Mar2021, (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Mar2021, during 15-minute waiting period after the vaccination, the patient experienced diaphoresis, dizzy/lightheaded and increased anxiety. The patient also complained of chills and dizziness. The patient denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light headedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient received treatment as a result of adverse events experienced which included water, snacks and laying down. The patient had excellent response to treatment. The patient was stable to go home and was asked to follow up with primary care physician (PCP). The clinical outcome of diaphoresis, dizzy/lightheaded, increased anxiety and chills were recovered on 18Mar2021. No follow-up attempts are possible. No further information is expected.
46 2021-07-01 loss of personal independence in daily activities Approximately 1-2 days after my second dosage i developed progessivly severe pain in what i can best... Read more
Approximately 1-2 days after my second dosage i developed progessivly severe pain in what i can best describe as my rotator cuff. Over a couple days I then developed severe pain in both rotator cuffs, both knees throughout my back and in both thumbs at the bases between my thumb and wrists. This pain has persisted in all areas to this day and continues at varying levels and has at times severely affects my mobility/activity. I wore at times two or alternated knee braces and took lots of advil, ice, heat and self therapy with a vibrating muscle massager. I honestly feel that although the vaccine may not have caused all these issues it somehow attacked or targeted previous injuries or weak points in my body. I have had injuries or pain in these areas before but most not for 5-15 years and they all became almost unbearable within days for no reason. The severe lower groin pain that I felt very shortly after the first dosage had lessened substantially over the month. After the second shot it abruptly came back and has not left. It changes in severity but is now continually present and i will be seeking medical attention for it.
46 2021-07-09 disturbance in attention Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling b... Read more
Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling behind left knee which has resolved. Rash behind left knee resolved but right knee rash (burning/itching) has persisted but improved and using topical steroid. Severe diffuse headache, difficulty concentrating, slow performance, tachycardia to 120's mainly and some shortness of breath and left sided chest pressure for 48 hours along with fatigue. June 01, had tinnitus for a day. June 07, general intense feeling of not feeling well and headache. June 15, developed severe left leg pain and malaise. June 23, 8-9/10 pain behind left thigh and difficulty walking. Later developed exacerbation of prior mild right knee pain of recent onset to point could not walk.
46 2021-07-14 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: After giving the vaccine to the patient he fainted and fell off the chair hitting his head on the floor. This was a few minutes after the vaccine was administered. After fainting the pt was a little out of it and was bleeding on his nose/forehead. I gave him a water and ice pack for his head. I had him stay sitting on the floor and after 20 mins we decided to the ambulance because his family was not coming. He was checked out and decided not to go to the hospital.
46 2021-07-17 fear Next day left arm soreness lasted 2 days. Also 2nd day started feeling tired, exhausted for 1 week a... Read more
Next day left arm soreness lasted 2 days. Also 2nd day started feeling tired, exhausted for 1 week and nauseous for about 4-5 days. I fely hung over, achey, had slight fever and chills for 5 days. I am feeling 95% better now going on 9 days. I'm scared 2nd shot will be worse?
46 2021-07-17 feeling abnormal Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both ye... Read more
Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; This is a spontaneous report received from a contactable consumer (patient himself). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: Ew0164) via an unspecified route of administration in left arm on 05May2021 10:00 for COVID-19 immunization. Patient medical history included High blood pressure and acid reflux. Concomitant medications included amlodipine besilate, benazepril hydrochloride (LOTREL) and esomeprazole magnesium (NEXIUM) 40mg. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE and lot number: Ew0164) administered in left arm on 01May2021 10:00 for COVID-19 immunization. On 29May2021 06:00 patient was experienced with Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting. Patient was went to physician office/clinic visit, Emergency room/department or urgent care. Patient was treated with Steroid shot and prednisone 50mg from urgent care. Outcome of events was not recovered.
46 2021-07-19 feeling abnormal Dose 1: 4/10/21, Dose 2: 5/3/21 hx obtained 6/24/21: per wife: was out of town, came home 6/13. 6/1... Read more
Dose 1: 4/10/21, Dose 2: 5/3/21 hx obtained 6/24/21: per wife: was out of town, came home 6/13. 6/17 went to casino, came back 6/18. ate a bag of sausage. dog bite that Friday. stomach felt weird. 3 days of HA, stomach ache, vomiting started Monday, went to urgent care the 21st - noticed some nystagmus, given tdap, given meclizine. was told if still not better, to ER. ER yesterday - was told dehydration, got IV fluids, got zofran IV, no imaging, had bloodwork and urine (WBC normal, h/h normal, abn neutrophils/lymphocytes. normal CMP), per wife was told blood in urine. since yesterday, continued HA, nausea, vomited in ER x 1. after zofran no vomiting today was ok, was getting out of car, felt like tripped, then almost fainted. no head trauma, no LOC. heaving. no chest pain, no shortness of breath, has not eaten today. Did take Tylenol today. 325 mg x 1. and ibuprofen 200 mg x 1. 730 am. since out of town, has been drinking couple drinks per day. marijuana gummies. marijuana from dispensary. no other drugs, no cigarettes. no hx of HA or lightheadedness sometimes when flying gets sinus HA on landing. no fever did have 99F when sleeping/hot, normal since then no blood in stools. primary sx is HA - constant throbbing 10/10 (currently 6/10) b/l frontal HA, nonradiating, better with lying down. +light sensitivity. no sound sensitivity. +nausea, +vomiting, several times per day. 2 episodes in 24 hours. no abdominal pain. has had lower back pain. tolerating PO. has had zofran and Tylenol. 2 days ago also had meclizine x 1. per pt always had low HR. no other changes to diet/medications. no facial droop, no one-sided weakness no speaking nonsense. several weeks ago "my heart felt like constant adrenaline" thought was stress - felt like something scared you adrenaline, lasted several days, coming on for several minutes at a time. last dose tadalafil was 1 week ago Pt sent to ER after this visit, but was then discharged home. pt presented to urgent care couple days later and was transferred to hospital after findings below
46 2021-07-28 emotional distress PATIENT CALLED PHARMACY TO REPORT FACIAL SWELLING. WAS ADVISED TO TAKE A COUPLE BENADRYL AND GO TO T... Read more
PATIENT CALLED PHARMACY TO REPORT FACIAL SWELLING. WAS ADVISED TO TAKE A COUPLE BENADRYL AND GO TO THE EMERGENCY ROOM. HE WAS UPSET AND ACCUSED US OF MAKING HIM TAKE THE VACCINE AND CLAIMED THAT WE SHOULD BE ABLE TO FIX HIS ADVERSE REACTION WITHOUT HIM HAVING TO VISIT THE ER OR COME BACK TO THE PHARMACY. HE CLAIMED THAT HE TOOK 3 BENADRYL AND THAT HE WILL WAIT TO SEE HOW HE FEELS.
47 2021-01-12 impaired work ability Myalgia Malaise missed one day of work following second dose due to symptoms
47 2021-01-13 sleep disorder patient was up all night after vaccine with high fever and chills, went to ER due to symptoms and wa... Read more
patient was up all night after vaccine with high fever and chills, went to ER due to symptoms and was admitted to hospital overnight for observation. He said his temperature hit 107. Was released from hospital and resting . Was COVID + previously where he had to be hospitalized .
47 2021-01-14 abnormal dreams 1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not... Read more
1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not experience anaphylaxis or other symptoms of vaccine injury. I took 1gram of Tylenol PO when I got back to my motel by 0830. By 0924 I noted that my left deltoid (injection site) and arm were very sore/achy. I fell asleep until 1740. I noted that I was experiencing more body aches at this time (joint and muscle, especially in my bilateral shoulders, lower back, knees and pelvis). Calf muscles were quite sore. I made pasta with red sauce and made a pot of blueberry tea, ate and went back to bed. 2327 I woke again with weird fever dreams and my right bicep was intermittently twitching. I think I was starting to run a low grade fever at this time (my ears felt hot, and my stomach was queasy but was not nauseous), no diaphoresis, shortness of breath or airway constriction. I remained awake until 0200, 1/14/21. By 0400 I was experiencing mild chills, face was flushed, headache on the right, with pressure behind my right eye, parietal and occipital areas of my skull. The pain extended into the right muscles of my neck (trapezius, levator scapulae and sternocleidomastoid muscles). Bilateral upper arm muscles and joints were 5:10 pain. I was also experiencing mild photophobia, but not migraine related, and a mild non-productive cough and pressure behind my facial and ethmoid sinuses with scant viscous secretions at the back of my throat. 0433 I forced myself to get out of bed and head to the bathroom. My temp was 101. I took a very hot shower and am back in bed. Experiencing a lot of malaise and lethargy. 1/15/21 0830 temp is currently 99.1, headache is present, 3:10. Joint aches have mostly subsided. Injection site is warm and tender, but no erythema is present.
47 2021-01-14 feeling abnormal Pulse dropped to 30. Low pressure too. Brachycardia. Lost consciousness. Did not seem to be Vasovag... Read more
Pulse dropped to 30. Low pressure too. Brachycardia. Lost consciousness. Did not seem to be Vasovagal. Saline IV. Blurred vision. Very. Strange. Girl friend said I seemed catatonic for about 5-10 seconds. Cold sweat. Dizziness. Immediate Symptoms lasted about an hour. Injection site very sore 10 hours later. Body pains.
47 2021-01-14 feeling abnormal Day of the vaccination, patient went home and developed a bilateral nosebleed and had a seizure. Pat... Read more
Day of the vaccination, patient went home and developed a bilateral nosebleed and had a seizure. Patient continues to feel poorly as of 1/15/2021 but has returned part time to work.
47 2021-01-19 disorientation On monday night Jan 11 after the covid vaccine shot i had a runny nose and flem. i also felt muscle... Read more
On monday night Jan 11 after the covid vaccine shot i had a runny nose and flem. i also felt muscle aches and very tired and disoriented. the symptoms continued through the week. on Wed i got covid tested and the results were positive. i began to have light chills through the week but no fever. on Jan 15-16 my symptoms peaked and i had a low grade fever and diarrhea for 2 days. i also developed a rash on my tighs and torso. on Jan 19 my fever went away along with my other symptoms except for an occasional flem cough.
47 2021-01-21 impaired work ability, feeling abnormal About 4 am the night after the vaccination, I developed significant left arm pain. Hurt; throbbed ... Read more
About 4 am the night after the vaccination, I developed significant left arm pain. Hurt; throbbed and didn't want to use it. Went to work but about 7:00 am- I noticed my right arm began to work as well - almost in the the same severity. Spell- lose consciousness alost- had bad headache; - it abated and it happened again - almost lost consciousness. It left. And it happened again a third time and went to a stretcher - nurse took my BP 220/110 - blood pressure - very high for me and laid on the stretcher and had nurses hook me up ot monitors; No change on cardiogram and my oxygen saturation level never altered and never dropped; My BL remained elevated - significantly. 180/90 before I went home. Continued to check my BP when I went home - queasy; nauseated - upset stomach and then fever the following day - remained for 4-5 days. Fever was one day and got 100.5 and then was gone after that day. BP continued to check regularly through next few days - it did improve a bit but was still elevated - 180/150 (systolic) and 110/95 (Diastolic) - Slowly got back to normal by day 7 after vaccination. Went to work the 30th the day before New Year's Eve, finally and had dizziness never got quite as severe - 50% but left arm pain very very painful - almost numb; right arm hurt some, too. Blood 190/110 .Oxygen Saturation remained good. Arm pain very bad - ordered EKG - was normal Admitted my self to ER - Had a full work up - repeated EKG - negative; two sets of troponins - negative; chest x-ray - nothing - BMP - elevation in my creatine which I've never had before. CBC - normal; They treated me with fluid hydration; Tylenol; fentanyl and hours later I felt a bit better. Things calmed down and I was released. BP remained elevated for next two days. I got better after two days _ enough to work - but still would get a little disequilibrium not enough to pass out but just like an odd feeling and then it would go away after a few seconds. And that is only recently disappeared - within the last week or so. I feel better now but my BP remains elevated - 160/140 (systolic) over 105/95 (dystolic) - that's al new for me. I have declined the second vaccination. Have sort of recovered but it did come back after time and so it may come back again - don't know. I may have been exposed to COVID the week before my vaccination. About 4 days after the severe symptoms that lead to my leading to take off work; I took test for COVID - PCR at CVS (returned positive) and COVID test PCR and rapid antigen (returned negative) at Public Health -
47 2021-02-01 impaired work ability Staff experienced left shoulder tenderness and general malaise after vaccination. The malaise was de... Read more
Staff experienced left shoulder tenderness and general malaise after vaccination. The malaise was determined to be enough for the staff to miss work to stay home and rest.
47 2021-02-03 impaired work ability Muscle aches, fever of 102, got/cold feeling, loss of appetite, dry heaving, lethargic and sleepy, n... Read more
Muscle aches, fever of 102, got/cold feeling, loss of appetite, dry heaving, lethargic and sleepy, numnous in hands
47 2021-02-04 feeling abnormal PT had a bloody nose, it resolved quickly, then had a funny sensation in the back of the neck.
47 2021-02-18 nightmare, irritability, agitation, anxiety, depression, confusional state, feeling abnormal Within a half hour, I felt dizzy and light headed. in 45 minutes - I could barely stay awake. I had ... Read more
Within a half hour, I felt dizzy and light headed. in 45 minutes - I could barely stay awake. I had to stop driving. Within two hours, I had a bad headache. I became slightly agitated that day. The headache lasted throughout the day - I took Ibuprofen but that didn't help much. Sunday, the headache was still there. It wasn't a migraine; but intense. I was agitated. My agitation level grew and my irritability grew and the headache I had the whole day. Sunday evening about 7 pm the agitation and irritability got very intense - I was having impulse control issues with it. I don't have anger issues but I wanted to yell at TV or throw my phone. From 8- midnight, I was lethargic and fatigued - I didn't have the energy to roll over;: had extreme anxiety I was sweating and having weird thoughts like harming my animals and harming myself; my mind was racing and then I would get really depressed. Until about midnight, I have had past struggles with anxiety and depression - there had been a past feeling like this - but it was really extreme - it was worse night of my life. Lasted four hours, and finally I slept for about one hour. I remember thinking, I finally can take a breath. My racing thoughts were gone and sweating was gone. The irritability had subsided enough that I could try to gain control of my thoughts again. I had really bad nightmares the rest of that night; I was confused _ I didn't know where I was - confused about that - occurred about three different times until I got up at 5:30 am for work. To summarize, for the next week, I had moments of anxiety and depression. I had mental fog. I played pro football - and I had post concussion syndrome. It was very identifiable to what I had had. So this was occurring in moments - forgetful; depressed; and random moments of anxiety - like I was going to go play football again. 7-10 days - it got a little better each day. Ten days it took to subside. I still exercised and taking extra fluids to get back to my normal. Exercised help. No fever occurred. With COVID - I had had a sense of anxiety and depression and some mental fog when I had COVID I didn't have it to this extreme. Did not get the second dose.
47 2021-02-24 sleep disorder Pfizer COVID-19 Vaccine EUA Pt received 1st dose of vaccine 1/9/21 with no initial adverse events. ... Read more
Pfizer COVID-19 Vaccine EUA Pt received 1st dose of vaccine 1/9/21 with no initial adverse events. By the end of the day, he developed pain at the injection site, could not move arm, could not lie on left side, could not sleep. Felt pain was at injection site, not joint. Sunday morning patient took naproxen and pain subsided for a while but came back. Swelling went down a bit. On Monday, 1/11/21 pain came back, but pt was able to work through it. Pain was much better than Saturday. On Tuesday, the pain and redness was gone, but pt did still not feel 100%.
47 2021-03-07 feeling abnormal, sleep disorder I had adverse event to both vaccines, The second was and second dose EL 8982 Both times I had a sli... Read more
I had adverse event to both vaccines, The second was and second dose EL 8982 Both times I had a slight fever. Painful enlarged lymph node in left armpit. Body aches that kept me up at night. And feeling mentally cloudy. Symptoms lasted for 203 days. I called my oncologist on the phone.
47 2021-03-16 disturbance in attention, impaired work ability tinnitus Received a second shot of the Pfizer vaccine shipped to Hospital. Next day had fever , noi... Read more
tinnitus Received a second shot of the Pfizer vaccine shipped to Hospital. Next day had fever , noise and ringing (both). Fever disappeared after 3 days but noise and high pitched ringing remained and is still an issue as of today. Saw PCP, they were not sure if it is related and could not identify a cause. It seems moderate but affect ability to concentrate at work and read.
47 2021-03-17 feeling abnormal, anxiety Patient received COVID vaccine (Pfizer, lot# ER2613, exp 7/2021) at 3:00pm. EMT asked patient how he... Read more
Patient received COVID vaccine (Pfizer, lot# ER2613, exp 7/2021) at 3:00pm. EMT asked patient how he felt at 3:27 during his 30min observation, patient report he felt "spacey" because he had not eaten since breakfast. EMT alerted PHN'S. 3:30 blood pressure 200/130, pulse 86, respirations 18, O2 93%. Patient was A&Ox4, denied headache, dizziness, swelling, tingling, altered vision. Medications: simvastatin, amlodipine, gabapentin, methocarbinol, vitamins. Medical conditions include kidney problems, hypertension, polycythemia, spinal fusing, chronic pain. Patient receives therapeutic phlebotomy and is 1 week overdue. 3:35 blood pressure 182/120, pulse 88, O2 99%, respiratory rate 20. 3:40 blood pressure 192/119, repiratory rate 24, paitent reported anxiety and lightheadedness, continued to deny headache, blurry vision. PHN called 911 at 3:42, offered Bendaryl to patient who declined. 3:50 911 assumed care, reported blood pressure 210/palpated and temp 101.1. Patient's partner arrived. Patient declined 911 transport at 3:53. Patient reported he would have his partner drive him to urgent care. Patient left with steady gait at 4:09.
47 2021-03-18 anxiety The pt received the vaccine and after approximately 5-10 minutes while waiting, informed the staff h... Read more
The pt received the vaccine and after approximately 5-10 minutes while waiting, informed the staff he was experiencing some anxiety and added he gets this when he only drinks coffee and not having eaten anything. His vital signs were done by the nurse and the PA spoke with him, too. He was given 6 8oz water bottles, a few pkgs of graham crackers and a banana while he waited in the rear of the pod. When he mentioned "chest" breathing the PA decided he should be brought to the E.D. The pt was going to walk but the staff requested he be wheeled down. He went to the E.D> with an RN and the Pod Mgr. ED: 47 yo m no pmhx p/w lightheadedness after receiving his covid vaccine. AFVSS, well-appearing, nad. Feeling better after eating, no cp or sob. Do not suspect acs. No signs of allergic reaction. Possible vasovagal vs anxiety related to vaccine. Reassurance provided, Plan for dc
47 2021-03-18 impaired work ability I had to miss work for two days due to these symptoms: nasal congestion, fever of 100 degrees, joint... Read more
I had to miss work for two days due to these symptoms: nasal congestion, fever of 100 degrees, joint pain, severe fatigue, severe dry mouth, muscle and body aches, nausea, pounding headache, also just feel "out of it"
47 2021-03-19 impaired work ability 1. Slight soreness around injection site starting around 6 hours after injection. Lasted about one d... Read more
1. Slight soreness around injection site starting around 6 hours after injection. Lasted about one day. No treatment needed. 2. Light headed starting around 8 hours after injection and lasted only a few hours. No treatment needed. 3. Headache starting around 8 hours after injection and lasted about 1.5 days. No treatment. 3. Strong lethargy starting about 12 hours after injection and lasting about 2 days. Lethargic enough that I had to take a day out of work. No treatment. 4. Flare up of what looks like plaque psoriasis on scalp and on face starting about 5 days after FIRST injection on 02/20/2021. Ongoing. No treatment yet.
47 2021-03-19 sensation of foreign body Patient felt like something was in his throat, tongue felt thick, dizziness/lightheadness, and tremo... Read more
Patient felt like something was in his throat, tongue felt thick, dizziness/lightheadness, and tremors
47 2021-03-23 impaired work ability Headache, Myalgia, NauseaVomiting, fatigue, chills occurred within days of 3/15 and 3/17 which resul... Read more
Headache, Myalgia, NauseaVomiting, fatigue, chills occurred within days of 3/15 and 3/17 which resulted in unable to work 3/16/2021 and 3/17/2021.
47 2021-03-25 insomnia, agitation I was feeling hot and agitated the night of the injection, the 22nd of March. It felt as if I have t... Read more
I was feeling hot and agitated the night of the injection, the 22nd of March. It felt as if I have too much coffee, I was unable to sleep. I was tired the next morning the 23rd of March, but by the afternoon I felt normal again. My left shoulder where I got the shot had a little muscle soreness for about a day.
47 2021-03-25 memory impairment, confusional state, mental status changes 47 year old Gynecologist with PMH of severe MDD, GERD, asthma, referred to the ED by his PCP, after ... Read more
47 year old Gynecologist with PMH of severe MDD, GERD, asthma, referred to the ED by his PCP, after 5 days of gait instability, and about 4 weeks of altered mental status, confusion, short term memory deficits and malaise. ADEM suspected and extensive infectious, inflammatory and neoplastic workup was initiated. CT brain - reported NAD MRI brain consistent with Acute Diffused Encephalomyelitis and suspected ADEM. MRI cervical spine with evidence of demyelination involving posterior cord. ICU course complicated by new onset of aphasia, partial left frontotemporal seizures, LGIB due to proximal rectal laceration and central diabetes insipidus. Admitted 3/15/21. On 3/17 he developed aphasia with right sided facial droop and stroke alert was called. Later on 3/17 he developed GI bleeding and was taken for emergent colonoscopy, from which no significant conclusions could be made due to lack of preparation and subsequent poor visualization. No foreign body was reported. After he continued to have ongoing bleeding, the patient had a sigmoidoscopy, during which the migrated clip could be removed and two new hemostatic clips were placed. He subsequently developed large volume urine output and nephrology was consulted; the patient was diagnosed with likely diabetes insipidus. On 3/20 acyclovir was discontinued after HSV PCR was negative. High dose solumedrol for ADEM completed 5 day course 3/21. VDRL was non reactive. There were no oligoclonal bands. Solumedrol 1g daily was started 3/24/21: MRI showed L>R patchy enhancement and diffusion abnormalities consistent with ADEM. Repeat MRI showed new restricted diffusion of the left superior cortex, bilateral medial temporal lobes and hippocampi, genu of the corpus collosum, and pericallosal white matter, with ddx including status epilepticus, autoimmune encephalitis and infectious encephalitis including herpes simplex. Completed 5 day course of high dose steroids, 6 days of IVIG and on ongoing PLEX. Neurological improvement noted 3/25
47 2021-03-30 feeling abnormal Got my first Pfizer shot on March 24 at 2 pm. The first day I felt way off like I was drunk or on so... Read more
Got my first Pfizer shot on March 24 at 2 pm. The first day I felt way off like I was drunk or on some kind of drug that gets you high with bouts of dizziness and some major hypertension. My back and chest were very tight the whole time. The tension finally subsided around 11 pm that night but I was still uneasy. The 2nd day I felt ok in the morning and throughout the day until about 3 or 4 pm I started getting really nauseated and tired. I went to lay down to sleep and felt a little better when I woke an hour later. Day 3 I started feeling extremely tired and fatigued with some major chills. Basically slept most of that evening and throughout the night. Woke that next day and couldn't get that dizzy foggy feeling out of my head the whole day. Day 4-5 still bouts of dizziness, chills and fatigue with some nausea also I noticed I developed a wheezing dry cough which points towards respiratory distress. Day 6 still feeling yucky, tired, fatigued, some nausea and that dam cough. Today 03-31-21, still feeling weak and tired with some episodes of dizzy spells, nausea and respiratory distress cough. Also forgot to mention on day 2 and 3 I had some major tingling on the right side of my head for most of the day. Felt like spiders crawling on my head and face. The last time I felt tingling like that I got shingles which also got me very sick and put me in the ER and ICU years ago. So there is also some post traumatic stress from that as well. Made an appointment to see a Doctor on 03-30-21 to have my blood pressure checked and get an overall check up. My blood pressure is elevated and stress levels are high with anxiety. Dr prescribed me some anxiety medication. No other recommendations from the Doctor.
47 2021-03-31 agitation, confusional state Pt received Pfizer vaccine dose 1 at 12:05pm, immediately experienced seizure for aproximately one m... Read more
Pt received Pfizer vaccine dose 1 at 12:05pm, immediately experienced seizure for aproximately one minute. Postictal state symptoms include agitation and confusion. At 12:20 pt is AOx4, BP 188/118, HR 116, O2sat 99% 8 LPM NRB. Pt transported via EMS to hospital to receive further care.
47 2021-03-31 disorientation, feeling abnormal within 1 hour I was slightly disoriented (foggy), my balance was compromised. at 24 hours I was swea... Read more
within 1 hour I was slightly disoriented (foggy), my balance was compromised. at 24 hours I was sweating and shivering, at 32 hours the fever broke, at 48 hours I was +80% of usual, at 7 days out I still have minor pain at the injection sight that feels like a deep bruise
47 2021-04-01 hallucination Severe Chills, Fever 102.2 on Tylenol, Body Aches, Headache, Arm soreness. Began about 10 hours aft... Read more
Severe Chills, Fever 102.2 on Tylenol, Body Aches, Headache, Arm soreness. Began about 10 hours after shot. Next day, fever down to 99 on Tylenol, still body aches. During severe chills was having hallucinations (I'm sure related to the fever).
47 2021-04-04 anxiety Pt arrived to post vaccination having not eaten yet this morning. Per the Pt wife, Pt has white coat... Read more
Pt arrived to post vaccination having not eaten yet this morning. Per the Pt wife, Pt has white coat syndrome and get very anxious when in clinical settings. Pt almost fell while walking up the stairs to the bleacher as he was dizzy and diaphoretic. Aid was called and took over care of PT at 1025. EMT released Pt with wife at 1029 as he was back to baseline. Pt finished observation time and wife drove Pt home. Vitals at 1025 VItals: Bp 120/70 HR 64 RR 16 O2 99% on RA Pt is not a diabetic no BG was taken.
47 2021-04-04 feeling abnormal 3/31 pt call: Pt states he's has progressively worsening nausea for over a week. Woke up this mornin... Read more
3/31 pt call: Pt states he's has progressively worsening nausea for over a week. Woke up this morning and could hardly get out of bed. Denies abdominal pain but feels nauseated and has been vomiting off and on all day. No other GI sx. Pt has known hiatal hernia but doesn't take anything for GERD right now because he doesn't have heart burn sx. Denies chest pain. Gets sweaty randomly and chilled, but this is more chronic. Sees neuro for early onset parkinson dx but no change in medicine in over a month. No new supplements. Denies dark stools. Pt taking all his medications with compliance. Has been getting more headaches lately too but thinks this is stress and from wretching. Has chronic headaches. Pt has OSA and has been wearing his Cpap with compliance. Gave patient zofran, prilosec, carafate for suspected gastritis sx. Recommended he come get labs in the morning as well. Pt agreed. 4/1 ER HPI: 47 y.o. male who presents with complaints of nausea vomiting abdominal pain ongoing now for the past day reports that is better with rest worse with movement denies any other complaints issues 4/1 Admission HPI: 47 y.o. male that was recently diagnosed with Parkinson's disease. He presented to the emergency room with the a several day history of fluctuating blood pressure and nausea/vomiting and generally feeling very poorly. He has been having a lot of new onset health issues lately and so his wife and family were concerned. He was brought into the emergency room. He denies any severe abdominal pain. However, he states he has been feeling extremely nauseous. He is vomited at least once a day for the last 5 days. He does admit that he is under an extraordinary amount of stress between his new onset Parkinson's, his insurance business, and his full-time job as a pastor. The patient also does have a history of alpha-gal allergy. He states it is possible he ate some cross contaminated meat, but states that this nausea and vomiting does not act like his typical response to eating something that he is allergic to. The patient states that about a month and a half his neurologist did increase his Requip up from 0.5 mg 3 times a day to 1.5 mg 3 times per day. However, it has never made him nauseous before. He denies any definite chest pain. He denies any exertional dyspnea. He does admit that his blood pressure has been fluctuating for quite some time. He states he was having a skin biopsy done last week and they almost abandon the procedure because his blood pressure was so high. He currently takes a combination of Benicar and hydrochlorothiazide. In the emergency room his lipase was found to be a little bit elevated. Creatinine was found to be a little bit elevated. His blood pressure was very elevated in the systolic 170 range and he did require some IV labetalol. The patient states he really has not missed any doses of his medications.
47 2021-04-05 anxiety Floating Anxiety
47 2021-04-05 sleep disorder tinnitus: high-frequency hissing/ringing non-stopping, volume - low, more on right ear. wakes me up ... Read more
tinnitus: high-frequency hissing/ringing non-stopping, volume - low, more on right ear. wakes me up at night. learned to train my brain to ignore. two weeks after the 1st vaccine shot, hearing another high-frequency ringing on right ear, louder, on and off, needing more effort to handle. other reactions: right after the 1st shot, felt face swelling. these symptoms disappeared 4 hours later. left arm sore for rest of the day, back to normal next day.
47 2021-04-06 feeling abnormal, anxiety Pfizer vaccine given IM and approximately 13 minutes after injection pt states that his throat felt ... Read more
Pfizer vaccine given IM and approximately 13 minutes after injection pt states that his throat felt tight and "funny". States he can swallow but it felt "funny". Denied shortness of breath or any other symptoms. Oxygen sat was 96%. BP 172/80 pulse 74. He was on hemodialysis treatment at the time. No other medications had been given. After initial assessment, S Standish, NP notified and Diphenhydramine 50mg was given IV and oxygen was given. Pt states he felt sleepy and after about 30 minutes his symptoms subsided altogether other than feeling anxious. Nursing staff stayed right with pt and helped to let him know that we were with him and pt verbalized that he was "fine." Vital signs remained the same and treatment continued. Pt left after his 3:30 treatment with all symptoms completely resolved.
47 2021-04-10 anxiety feeling of swelling in tongue and lower lip. Scratchy feeling also in same areas. Started about 25 m... Read more
feeling of swelling in tongue and lower lip. Scratchy feeling also in same areas. Started about 25 minutes after shot on drive home. Took allegra and it went away in 30-60 minutes. Tongue was sore the next day. I also suffered a mild anxiety attack at the same time. Treatment for that was meditation and cessation of throat swelling symptoms. Lastly, I also had a severe flare up of my fibromyalgia symptoms in my forearms starting 3 days after the injection. I don't know if this was a primary effect from the vaccine, or secondary from the additional nociceptive input from the joint and muscle pain I was experiencing in my forearms. I increased my lyrica to compensate. Two weeks out from the shot I'm almost back to baseline.
47 2021-04-10 feeling abnormal Experienced intermittent, temporary loss of hearing ( seconds duration) in ears during 4/8 and 4/9 ... Read more
Experienced intermittent, temporary loss of hearing ( seconds duration) in ears during 4/8 and 4/9 (approximately 3 times per ear) Each ear was was affected individually, not simultaneously. Subjectively, hearing seemed to recover, but hearing test has not been performed, yet . Since 4/9, have persistent tinnitus in both ears. Had telemedicine visit on 4/11 and will schedule evaluation with ENT specialist.
47 2021-04-11 confusional state Dizziness, vertigo, confusion, numbness in legs, loss of balance
47 2021-04-11 feeling abnormal Patient reported that he felt like he was having heart palpitations that started the evening of the ... Read more
Patient reported that he felt like he was having heart palpitations that started the evening of the day after his vaccine. He stated that he had a history of atrial fibrillation in the past, and that this did not feel the same. Patient consulted his primary care physician.
47 2021-04-12 feeling abnormal Headache, fogginess, malaise. These have mostly resolved as of 07:31 on 4/13/2021. Ringing in both... Read more
Headache, fogginess, malaise. These have mostly resolved as of 07:31 on 4/13/2021. Ringing in both ears and slight pressure in ears(pressure was mildly painful 4/11-4/12. Ringing and pressure still present as of 07:31 on 4:/13/2021.
47 2021-04-12 nightmare, confusional state Pain from injection. Lasted 2 days. Bad dreams 12 hours after injection. Very low energy 30 hours a... Read more
Pain from injection. Lasted 2 days. Bad dreams 12 hours after injection. Very low energy 30 hours after injection with a metallic taste in my mouth, Aches and pains, diarrhea, nausea, racing heart, confusion, exhaustion, 5 days after injection energy is better. All other symptoms are slowly subsiding.
47 2021-04-16 sleep disorder, feeling abnormal First day after the COVID 19 second shot was good. Felt tired in the afternoon and slept early at 9 ... Read more
First day after the COVID 19 second shot was good. Felt tired in the afternoon and slept early at 9 PM. Woke up at 1 AM and since then couldnt sleep. Later in the night got a sinking feeling like when you are coming down on an elevator at high speed. In the morning when I tried to get out of the bed I couldnt sit as I had sever Vertego. Finally had to ask my wife to help me sit. After few mins was ok then my wife walked to the restroom. I was feeling dizzy the whole time. I came back and was lying on the bed. Next time when I tried to wake up same problem. I was trying to sit and falling down. The dizziness was there for about couple of hours after that I didnt face that issue again. I never had Vertego problem in my life and this was a severe one on the second after taking the 2nd dose of the vaccine. Since that afternoon I am feeling normal but thought of reporting this adverse event.
47 2021-04-18 loss of personal independence in daily activities @ 2 HOURS AFTER RECEIVING VACCINE, ELBOW STARTED TO BECOME SWOLLEN, RED, VERY PAINFUL AND HOT TO THE... Read more
@ 2 HOURS AFTER RECEIVING VACCINE, ELBOW STARTED TO BECOME SWOLLEN, RED, VERY PAINFUL AND HOT TO THE TOUCH. SYMPTOMS DO NOT APPEAR TO BE EASING. PAIN AND SENSITIVTY IS RESTRICTING MOVEMENT AND INTERFERING WITH NORMAL DAILY ACTIVITY. ALSO DAY OF VACCINCE - VERY ITCHY, NO RASH OR HIVES PRESENT.
47 2021-04-22 confusional state Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-M... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Additional Details: Patient reported that he had difficulty hearing. Patient sat in the chair and then lost conciousness. He was laid down on the ground, vitals were checked, and water was given. Noted high blood pressure. Patient regained conciousness within 3-5 minutes. Vitals were rechecked and returned to normal.
47 2021-04-24 sleep disorder Sound or noise in my right ear. At times can?t hear nor sleep properly.
47 2021-04-25 anxiety Patient reported lightheaded and dizziness. Blood pressure was elevated. Patient reported improvemen... Read more
Patient reported lightheaded and dizziness. Blood pressure was elevated. Patient reported improvement of symptoms. Education provided for blood pressure and anxiety.
47 2021-04-25 insomnia Next day of vaccine, I got severe pain at my lower back with bloating. had low bowl movement. Pain w... Read more
Next day of vaccine, I got severe pain at my lower back with bloating. had low bowl movement. Pain was so sever, I could not even sleep, could not walk, and could not stand for minute because of pain. Also got constipation like symptoms. after two days, I got some relief in pain, but still have it
47 2021-04-26 anxiety Rapid heart rate, slight nausea, slight numbness to front right cheek and lips. Onset within 1 minu... Read more
Rapid heart rate, slight nausea, slight numbness to front right cheek and lips. Onset within 1 minute of injection. No treatment given. Heart rate started to decrease after 10 minutes and returned to normal within 30-40 minutes. Numb areas returned to normal within 45-60 minutes. Slight feeling of anxiety for several hours, but this could have been simply from stress from the initial reaction. I also occasionally have random panic attacks and could have potentially had a small one at the onset of my face going numb which could have contributed to the length of unease.
47 2021-04-27 disorientation Difficulty operating a motor vehicle at speeds over about 45 mph. I drove to the first vaccination a... Read more
Difficulty operating a motor vehicle at speeds over about 45 mph. I drove to the first vaccination appointment that morning (3/2/2021) and everything was fine. Driving home from the jab I started to experience trouble driving my car when crossing a major bridge in Pittsburgh. The feeling was akin to the anticipatory feeling of being on a climbing roller coaster or drop ride in an amusement park. Elevated heart rate; disorientation and a sort of adrenaline like rush. The feeling returns every time I attempt to drive on a freeway/bridge/etc though local driving is fine. (I was driven to the 2nd jab.) The issue continues now, close to 2 months after it began 45 minutes after receiving the 1st jab. In the several months prior to the jab I was driving extensively with no issues.
47 2021-04-28 panic attack Patient received first dose of Covid-19 vaccine on 03/08/2021 and while waiting the 15 min period af... Read more
Patient received first dose of Covid-19 vaccine on 03/08/2021 and while waiting the 15 min period after getting the vaccine the patient stated they felt their tongue swelling. Patient was still able to breath, but felt more like a panic attack. Patient was given 25 mg of Benadryl, and after waiting the patient felt fine and said he no longer felt any symptoms. Patient left the pharmacy.
47 2021-05-02 feeling abnormal 10:01am lightheadedness, weird. Patient advised to wait 15 min for reassessment but left. 150/100, H... Read more
10:01am lightheadedness, weird. Patient advised to wait 15 min for reassessment but left. 150/100, HR 84, 154/100, BS 123, O2Sat 97%.
47 2021-05-04 disturbance in attention Within 72 hours, constant ringing in ears, headaches, slight vertigo and nausea, trouble focusing. ... Read more
Within 72 hours, constant ringing in ears, headaches, slight vertigo and nausea, trouble focusing. Ringing and headaches persist to this day. -Antibiotic as well as Claritin and Flonase prescribed with no change in symptoms.
47 2021-05-06 feeling abnormal Lingering, ongoing, and severe: Headaches, Brain Fog, Nausea, Fatigue
47 2021-05-09 feeling abnormal, insomnia Light headed, dizzy night of shot. Went to bed. 400 am fever and shivers for 5 hours. Massive hea... Read more
Light headed, dizzy night of shot. Went to bed. 400 am fever and shivers for 5 hours. Massive headache. Lymph nodes and testicles swelled. All pounded to my heart beat. Kept taking Tylenol and didn?t seem to matter. Last for 5-6 hours. Massive headache continued...tired but hard to sleep sleep and in zombie like state. Woke up Friday feeling a little better. Went downhill about 5pm Friday. Headache returned. Tired and couldn?t sleep much. Brain in fog. Went to bed. Woke up with headache on Saturday. A wave of fatigue came over Saturday around 3pm. Tried to nap but couldn?t sleep. Persistent dry cough developed Saturday night. Lasted through Sunday. This is all to the best of my recollection.
47 2021-05-10 confusional state generalized convulsion/second seizure witnessed by medical staff; elevated CSF protein to 79, CSF Gl... Read more
generalized convulsion/second seizure witnessed by medical staff; elevated CSF protein to 79, CSF Glucose 73; elevated CSF protein to 79, CSF Glucose 73; severe headache; confused; This is a spontaneous report from a contactable physician. A 47-years-old male patient received the first dose of BNT162B2 (PFIZER COVID 19 VACCINE), intramuscular on 22Apr2021 09:30 (Batch/Lot number was not reported) at age of 47 years as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19. On Friday 23Apr2021, patient woke up with severe headache, per wife was confused. Then had a generalized convulsion. Presented to the ED, had a second seizure witnessed by medical staff. Workup with MRI, CTA and LP were notable for an elevated CSF protein to 79, CSF Glucose 73, otherwise no structural abnormality was identifed. Patient was clinically improving after being treated with seizure medications as of 26Apr2021. The adverse event result in Emergency room/department or urgent care, hospitalization. Covid 19 pcr nasal swab on 24Apr2021 was negative. Outcome of events was unknown. Follow-up needed. Information about batch/lot number has been requested.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported event seizures, CSF glucose increased, CSF protein increased, headache, confusional state cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
47 2021-05-11 disorientation, agitation Elevated heart rate; disorientation and a sort of adrenaline like rush; Elevated heart rate; disorie... Read more
Elevated heart rate; disorientation and a sort of adrenaline like rush; Elevated heart rate; disorientation and a sort of adrenaline like rush; I started to experience trouble driving my car; sort of adrenaline like rush; This is a spontaneous report received from a contactable consumer, the patient. This 47-year-old male patient reported for himself that he received the first dose of BNT162b2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in the left arm on 02Mar2021 at 10:15 as a single dose and the second dose of BNT162b2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in the left arm on 23Mar2021 at 10:15, both doses at the age of 47-years-old, both for COVID-19 immunization. Medical history included high blood pressure, pre-diabetic, and overweight. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine besylate 5mg and ibuprofen (ADVIL). On 02Mar2021 at 11:00, the patient experienced difficult operating a motor vehicle at speeds over about 45 mph. He drove to the vaccination appointment that morning and everything was fine. Driving home from the jab, he started to experience trouble driving his car when crossing a major bridge. The feeling was akin to the anticipatory feeling of being on a climbing roller coaster or drop ride in an amusement park described as elevated heart rate; disorientation and a sort of adrenaline like rush. He was driven to the second jab. The events were reported as serious for Disabling/Incapacitating and resulted in disability or permanent damage. The patient reported that the issue continues now, close to 2 months after it began 45 minutes after receiving the first jab. He stated can drive on local streets but not on a freeway or significant bridge. In the several months prior to the jab, he was driving extensively with no issues. The patient was not treated for difficult operating a motor vehicle/ trouble driving my car, elevated heart rate; disorientation and a sort of adrenaline like rush. The clinical outcome of events difficult operating a motor vehicle/ trouble driving my car, elevated heart rate; disorientation and a sort of adrenaline like rush was not recovered. It was also reported, "Device Date: 28Apr2021" (not further specified). Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162b2 , was not provided and will be requested during follow-up.
47 2021-05-18 mental status changes Within 12-24 hours, patient noted to have altered mental status - transferred to ICU where it was la... Read more
Within 12-24 hours, patient noted to have altered mental status - transferred to ICU where it was later discovered that patient had an intracranial hemorrhage
47 2021-05-21 sleep disorder Woke up 12 hours after second shot at 3:30 in the morning. Was not able to sleep well for the next w... Read more
Woke up 12 hours after second shot at 3:30 in the morning. Was not able to sleep well for the next week. Had a prolonged headache. All of that eventually cleared but the lasting change is I now have tinnitus. It is constant and it does not go away.
47 2021-05-23 disturbance in attention, confusional state 1) Extremely sleepy - began the same evening as vaccination (5/7/21) and continues through current d... Read more
1) Extremely sleepy - began the same evening as vaccination (5/7/21) and continues through current date and time - fell asleep on the job while operating forklift the following night (5/8/2021); 2) Eyesight has worsened (depth perception, double vision) - began within a couple days of vaccine and continues through current date and time - had eye exam (5/18/21) needed new prescription - previously always near-sighted, now needs bi-focals; 3) Confusion/lack of concentration - began 5/9/21 and continues through current date and time; 4) Abnormally "lazy"/unmotivated - began 5/9/21 and continues through current date and time; 5) Little interest in sexual relations - began 5/9/21 and continues through current date and time; 6) Seems distant/ somewhat despondent - began 5/9/21 and continues through current date and time; 7) Generally speaking he is not himself
47 2021-06-01 loss of personal independence in daily activities Next day: debilitating fatigue, headache. Nausea and chills. Slowly going away, but its been 6 weeks... Read more
Next day: debilitating fatigue, headache. Nausea and chills. Slowly going away, but its been 6 weeks and still have the symptoms, just not as severe. It is preventing me from exercising and doing activities and eating like I normally would.
47 2021-06-09 feeling abnormal symptom: chest pain, pain in my left arm approximately 4 inches from my arm pit (injection side), sh... Read more
symptom: chest pain, pain in my left arm approximately 4 inches from my arm pit (injection side), shortness of breath, heart felt as though rhythm was off a bit. This happened about three days after my first dose for about 4 days. Starting to feel better now though. I didn't know what was happening and was tempted to go to the emergency room a couple of times but didn't. I'm just finding out about this from an article I'm just reading about 30 minutes ago and thought I should report this. I've only had my first dose and now I'm very concerned about the second due June 22nd.
47 2021-06-13 disturbance in attention i) Pain in left arm and shoulder started same evening. Lasted 3-4 days ii) High fever for next 2 day... Read more
i) Pain in left arm and shoulder started same evening. Lasted 3-4 days ii) High fever for next 2 days. Temperature was as high as 102 iii) Dry coughing and breathlessness iv) Ongoing asthma attacks and breathlessness. Started the day after second shot. v) General feeling of tiredness and lack of focus. (Ongoing)
47 2021-06-15 loss of personal independence in daily activities Patient experienced usual arm soreness from the shot, but as the days wore on, the soreness progress... Read more
Patient experienced usual arm soreness from the shot, but as the days wore on, the soreness progressed into pain. Within a few days, patient realized the pain was more than a usual vaccination soreness. Within 7 days, Patient's shoulder was making loud popping sounds, and he kept feeling like it was falling out of socket. Basic movements like combing hair, teeth brushing, driving, and typing were painful and difficult with his left arm. Patient visited a physical therapist, and he said it isn't rotator cuff, but it could be a laberal tear. An MRI would better diagnose the issue. The physical therapist recommended 6 weeks of immobility on his shoulder. Patient purchased a brace and is wearing that to prevent mobility. Patient had not done anything else to injure his shoulder and was perfectly healthy when he presented himself to be vaccinated.
47 2021-06-16 restlessness difficulty walking; headache; chills; aching of bones; tiredness and weakness; tiredness and weaknes... Read more
difficulty walking; headache; chills; aching of bones; tiredness and weakness; tiredness and weakness; loss of weight; loss of appetite; my joints got pain; it's the pain at the injection site; Muscle pain; Fever; Nausea; Feeling unwell; Restless; congestion; dizzy; swollen; constantly using the bathroom, having bowel movements; peeing a lot; can't stand up; I can't get out of the bed; my legs are so weak; I can't even stand now; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0191), via intramuscular route of administration in right arm on 01Jun2021 at 01:00PM as single dose for covid-19 immunisation. The patients medical history included large prostate, gold stones in 2014, high blood pressure, operation on Gall Bladder (gall stones that were in gall bladder in 2014). Concomitant medication included lisinopril (20 mg, 1xday) for blood pressure measurement. Patient had the Pfizer covid vaccine on 01Jun2021. Patient went to get the Moderna but he got the Pfizer. Nurse told him that everybody was different, and it work in different kind of ways and she said that once he got the vaccination to fight the COVID, it just maintains that. On 03jan2021, Patient did not get out of the bed, he became dizzy, weak, his legs were so weak, lost massive weight (dropped to 145kg/2 pound) and the pain at the injection site, feeling tired, had a headache, got muscle pain, had the chills, joints got pain, bone aches. He had a fever, nausea, congestion, feeling unwell, swollen, was restless and pain to walk. He did not stand up. Took tylenol (spoonful, once a day, orally) for the headache and the fever. Had also been using the bathroom a lot. his most recent weight was 135 after he took the shot at 1:00pm on 01Jun2021. On 22Jun2021 to patient has get the second one but did not feel like taking it. Patient did not had any prior vaccinations within 4 weeks. The outcome of the event cannot stand was unknown and other event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
47 2021-06-23 feeling abnormal Patient had an acute MI died after within 8 weeks of last vaccine patient had been complaining of di... Read more
Patient had an acute MI died after within 8 weeks of last vaccine patient had been complaining of dizziness and feeling different since second vaccine
47 2021-07-09 anxiety Received first Covid shot April 6 (same location as the data entered for this one, Pfizer Lot EW0153... Read more
Received first Covid shot April 6 (same location as the data entered for this one, Pfizer Lot EW0153). April 10 had uncontrollable muscle spasms in both legs for 5 minutes. Did not seek treatment. Received second Covid shot April 27. April 30 had muscle spasms increasing throughout day and anxiety. Did not seek treatment. Anxiety increased through May 5 when I went to the hospital around 2AM due to muscle spasms, muscle pain, anxiety. In hospital I experienced over 1 hour of constant full body muscle spasms/seizures where all my muscles would tense up uncontrollably over and over. This eventually subsided and I was released. Diagnosis absent any other cause was anxiety. From May 5 through ~June 11, experienced frequent random muscle spasms and tics mostly in left leg but also encompassing abdominal, lower back, chest and rib pain. Experienced feeling of left arm heaviness through July 3. Arm pain in shot area recurred since the time of the second shot at least six separate times (last July 3). Was stared on Gabapentin for nerve pain, muscle spasms, anxiety, which eased symptoms. As of July 10 feeling mostly normal, no longer experiencing muscle spasms with any frequency.
47 2021-07-12 feeling abnormal Slight headache; Brain fog; This is a spontaneous report received from a contactable consumer, the p... Read more
Slight headache; Brain fog; This is a spontaneous report received from a contactable consumer, the patient. A 47-Years old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) as a single dose via an unspecified route of administration in his right arm on 25Mar2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patients medical history was reported as none. Concomitant medications included regular vitamins and tamsulosin hydrochloride (FLOWMAX) received within 2 weeks of vaccination. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER6202) as a single dose via an unspecified route of administration in his right arm on 25Feb2021 at 17:00 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not tested for COVID-19. On 28Mar2021, the patient experienced slight headache and brain fog. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcomes for the events slight headache and brain fog were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-07-20 memory impairment At Midnight I was going to sleep, I was sweating profusely and could not feel my pulse. When I asked... Read more
At Midnight I was going to sleep, I was sweating profusely and could not feel my pulse. When I asked my wife to call 911, I went into the bathroom to change into clothes to get ready to go. I do not remember going to get dressed, I passed out and 911 had arrived and they believed I was in cardiac arrest. I went to the ER, there was a right artery blockage and put in a stint. They also found out I had 8 facial facial fractures due to the fall I had. I was all swelled up in my face so in May I went back for surgery on my face to fix the multiple facial fractures. And now I am back to normal, except I am on blood thinners. The DR could not find anything wrong after follow up, so no one knows why the cardiac happens.
47 2021-07-21 feeling abnormal, memory impairment feeling incredibly sick; achy muscles; nausea; diarrhea; foggy memory; extreme fatigue; very bad hea... Read more
feeling incredibly sick; achy muscles; nausea; diarrhea; foggy memory; extreme fatigue; very bad headache; sore neck muscles; sneezing; runny nose; brief periods of rapid heart rate; no appetite; Sometimes it felt like a specific part of body was under attack, i.e. GI tract, various muscle groups, sinuses; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical fusion C3-C7. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (ADVIL) both for an unknown indication. The patient's history of allergies to medications, food or other products was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 10:00, approximately 20 hours after injection, the patient experienced feeling incredibly sick with no fever, but achy muscles, nausea, diarrhoea which still continued, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite and sometimes it felt like a specific part of the body was under attack, i.e., GI tract, various muscle groups, sinuses. The patient reported that likely forgot some symptoms, but these ranks among the worst that patient ever felt in life without running a high fever. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events feeling incredibly sick, achy muscles, nausea, diarrhoea, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite, felt like a specific part of my body was under attack, i.e., GI tract, various muscle groups, sinuses was resolving at the time of report. No follow-up attempts are needed. No further information is expected.
47 2021-07-22 restlessness his liver panel showed issues; Graves' disease; white blood cells came down; loss of appetite; weak;... Read more
his liver panel showed issues; Graves' disease; white blood cells came down; loss of appetite; weak; Diarrhea; he would get tired very quickly.; spiking fevers; Increased blood pressure; high resting heart rate; baseline heart rate was over 105/his heart rate from 60 to about 80 in the month of April.; his pulse is starting to slow; They did the TSI test on the patient and noticed an extreme increase; having thyroid issues; blood sugar was dropping; The caller's symptoms went from being mild to very acute.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; Palpitations/extreme palpitation in his chest and aorta that would pulsate; Weight loss; Sinus pain; Eye irritation; restlessness at night; extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in left arm on 27Mar2021 as dose 2, single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, he was diagnosed from 4 years (in 2017). The patient no other products taken. Prior to March the patient had no problem (before vaccination). About 2 weeks after the second dose of the vaccine on 11Apr2021, the patient had extreme nausea, palpitations, baseline heart rate was over 105 and lost 40 pounds. Patient also started having sinus pain and eye irritation, and restlessness at night and started waking up very early. The caller had a weight loss of 8 pounds for the month of April without changing his lifestyle. Patient had a slow increase in his heart rate from 60 to about 80 in the month of April. Towards the beginning of May the patient had loss of appetite and he would get tired very quickly. When it all hit the patient at once it was around May202, he started spiking fevers, nausea, extreme palpitation in his chest and aorta that would pulsate, and increased blood pressure. The patient went and saw his doctor and checked his thyroid levels that were normal nearly 6 months prior. The patient's T3 and T4 were extremely high and his TSH was extremely low. They did the TSI test on the patient and noticed an extreme increase and then diagnosed him with Grave's disease. The patient did all of the scans. The patient was hospitalized for nearly 6 days because they put him on methylprednisolone and had a toxic effect on his system. The caller's white blood cells came down, it attacked his bone marrow, his liver panel showed issues. The caller was hospitalized on 27Jun2021 to 02Jul2021 for this. The patient had never had any indications of having thyroid issues or Grave's disease prior to this event. The patient's symptoms went from being mild to very acute. The patient was weak right now (at the time of report) because of the weight loss, his pulse was starting to slow and still has palpitations and his nausea was still there and lots of diarrhea. Everything had worsened until now that he had sought treatment (at the time of report). The patient's blood sugar was dropping during this time and had an A1C of 6. The patient underwent lab tests and procedures which included blood sugar was dropping during this time and had an A1C of 6: positive on 07Jul2021, TSH (thyroid stimulating hormone): .008 on 07Jul2021, radioactive iodine uptake assays: show diffuse uptakes of the radioactive tracers and is consistent with Grace's disease on 07Jul2021, 08Jul2021 and 09Jul2021, free thyroxine: >30 on 07Jul2021, T3 (tri-iodothyronine): >8 on 07Jul2021, Free T3 (tri-iodothyronine free): > 32.6 on 07Jul2021, patient's CBC and platelets were in the normal range. Outcome of the event grave's disease was resolving; weak, diarrhea and pulse was starting to slow was unknown and outcome of rest of the events was not resolved. Follow-up attempts are needed. further information is expected.
47 2021-07-28 insomnia Difficult to sleep; Both feet hurt; Feet were slightly swollen, but not discolored; This is a sponta... Read more
Difficult to sleep; Both feet hurt; Feet were slightly swollen, but not discolored; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 24Apr2021 at 09:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient previously did not receive any medications. Concomitant medications included simvastatin (STATIN) taken for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021, Saturday morning, the patient received the shot. On 26Apr2021, Monday night, the patient noticed both his feet hurt. The patient's pain increased on Tuesday and Wednesday (28Apr2021) making it difficult to sleep on Wednesday. On Thursday and Friday, they hurt less but the patient still experienced a little hurt. The patient never had foot pain for any reason in the past, except after a long hike or other extreme exertion. The patient did not do anything unusual to make his feet hurt. On an unknown date in Apr2021, the patient's feet were slightly swollen, but not discolored and they were not sore to the touch. The clinical outcome of the events both feet hurt, making it difficult to sleep and feet were slightly swollen, but not discolored was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-01-06 excessive sleepiness Fatigue that requires daily naps and 12-14 hours of sleep daily. Shortness of breath, despite normal... Read more
Fatigue that requires daily naps and 12-14 hours of sleep daily. Shortness of breath, despite normal saturation 97% on room air. Dyspnea with exertion with normal sinus rhythm rate in 80s. Cheat tightness.
48 2021-01-10 feeling drunk three hours after administration felt fatigued (drunk) and uncoordinated. slept for four hours woke ... Read more
three hours after administration felt fatigued (drunk) and uncoordinated. slept for four hours woke up with no affects
48 2021-01-12 disorientation, confusional state This patient is a 48 y.o. male presenting to the emergency department with a chief complaint of alle... Read more
This patient is a 48 y.o. male presenting to the emergency department with a chief complaint of allergic reaction s/p 1st COVID vaccine at 1330 this afternoon. Patient states he became very flushed to his face/chest 2-3 minutes after receiving the vaccine. EMS was on scene and evaluated the patient. He was found to be a little confused/disoriented upon questioning which quickly resolved. Patient was also having mild difficulty swallowing, however states he was not gasping for air. He had an IV placed for precautions, however no medications were given. Patient was transferred here for evaluation. He currently feels asymptomatic aside from a dry throat. Patient denies having any hives, shortness of breath, or syncopal episodes. He also denies having prior episodes of anaphylaxis requiring epinephrine.
48 2021-01-17 feeling abnormal After the injection my arm got really sore. I began to feel really tired and begin to have chills a... Read more
After the injection my arm got really sore. I began to feel really tired and begin to have chills and shakes. I started having diarreah and began throwing up. I had a sever headache and body aches which all symptoms lasted for about 3 days and I felt so bad so on Wed 12/30 I went to Urgent Care and was given fluids which did make me begin to feel a little better. On Monday I was sent for a COVID test which was negative. On Friday 1/1 i was finally able to return back to work.
48 2021-01-21 anxiety Hot and tingling face and hands, slight dizziness and weakness, pulse 130-140, high level of anxiety... Read more
Hot and tingling face and hands, slight dizziness and weakness, pulse 130-140, high level of anxiety. Symptoms came on suddenly, after about 30 minutes they began to subside slightly. Returned to 90% of normal after approximately 2 hours. Remained jittery for another 6 hours after that.
48 2021-01-21 anxiety Within 5 minutes Patient became, pale, light headed with nausea.
48 2021-01-21 depressed mood Some background: I normally react badly to flu/respiratory vaccines in that I generally get sicker a... Read more
Some background: I normally react badly to flu/respiratory vaccines in that I generally get sicker after the vaccine than I do when I get the virus. So this isn't entirely unexpected. However, the timing is really strange and Now I wonder if I should get COVID tested. Here is the chronology of events. Day of shot (Friday) - pain in arm lasted about 2 days but wasn't too intense. As the pain in the arm began to fade, I started getting really sleepy. I slept probably 48 hours over the next three days but did not experience any pain except maybe slight muscle aches and a little of the accompanying eye burn that is associated muscle aches and sleepiness. By Tuesday, the sleepiness had passed. Thursday night (last night), I started to experience ALL general symptoms of a respiratory flu/COVID. I developed an intense cough and associated phlem (though it is very sporadic rather than persistent) and the precursors to intense muscle pain. I woke up at around 3am Friday with a fever, the muscle pain, burning eyes (associated with flu-muscle pain and fever), and extreme chills (though my windows was open... a normal practice as my computer makes it hot in my room). I felt oddly rested however, as though the getting sick, while making me tired, was also helping me sleep better. My body is definitely reacting to something. If it wasn't 6 days afterward, I would say it was my normal reaction to virus shots. However, the timing is alarming. I have not knowingly been exposed to anyone with COVID. This morning the chills are gone, the fever is down (though not entirely gone), but I still feel "down for the count." Like I said... it is my normal reaction to virus vaccine except that it is about 6 days late (usually sets in within 24 hours). This morning is the week "anniversary" of the shot.
48 2021-01-21 feeling abnormal 36 hours later fog, headache, floaty. no fever. no gi issues. No cough
48 2021-01-21 impaired work ability 8 minutes after the vaccine i satrt to experience some tingling to my left earlobe. It then radiated... Read more
8 minutes after the vaccine i satrt to experience some tingling to my left earlobe. It then radiated to my left jaw line where i felt an onset of numbness. the numbness hten radited to my left shoulder all the way down to my left extrremity digits. atthat time i waived over a nurse who waived a physician who check my radial pulse, pulse was noted in the 70's. At that time the physician asked a EMT perofrmed four evalautions of my BP and my BP was reading syttolically between was 140-150 and my datolics was reading 110-115. Throughout that time the numbness was still to my left side of my face and shoulder and arm and to myfingers. This was only localized to those two areas. At that time it was requested for me to go to the hospital to seek medical attention. I deferrred to going home to check my BP and at that time i was running 150/100. The numbness was still present and mu thought process my body was stressed out. I then took a nice cold shower with breathing techniques. I did orthastatics on myself. I then followed with my PCP the next day and she ordered bunch of labs, CRP, triponents, CBC, bubble study and chest x-ray and EKG. ALl the testes were deemed to be negative. My systolics were 120/80 when i saw my PCP, however i was recommedned to take the whole week off and was recommended to go back to work after the new year. After five days the numbness went away to my digits went away but not to my face. My grips were equal. I had no Bal palsy nor stroke. The numbness sill persisted up till day 9 and the umbness to the face went away.
48 2021-02-05 anxiety PATIENT FELT LIGHTHEADED BUT THINKS IT MAY BE ANXIETY RELATED. PATIENT HELD EXTRA 5 MINS THEN SYMPTO... Read more
PATIENT FELT LIGHTHEADED BUT THINKS IT MAY BE ANXIETY RELATED. PATIENT HELD EXTRA 5 MINS THEN SYMPTOMS RESOLVED.
48 2021-02-06 fear Injection site pain on 2-5-2021 and headache The following was present on 2-6-201 Shoulder and upp... Read more
Injection site pain on 2-5-2021 and headache The following was present on 2-6-201 Shoulder and upper arm and warm to touch. Fear / chills, severe headache, body ache, loss of appetite, nausea. On 2-7-2021 site injection pain mildly present, mild to moderate headache body ache,
48 2021-02-07 restlessness, insomnia Extreme shivering and feeling of freezing temp even in hot shower. legs and knees ached very painful... Read more
Extreme shivering and feeling of freezing temp even in hot shower. legs and knees ached very painfully, headache, nausea, vomiting, diarrhea, sweating, fever at 100 degrees, full body aches and felt very restless. Not able to sleep well. Symptoms lasted until 2/7/2021 @ 1200pm. Worse than reaction to 1st dose.
48 2021-02-11 sleep disorder Within 30 seconds pain on my arm and it increased slightly. I was able to do my work. But every time... Read more
Within 30 seconds pain on my arm and it increased slightly. I was able to do my work. But every time I was stable and tried to use it again I felt pain again. Pain was always there - it was tolerable. I was told to take Ibuprofen about three hours later. Second day, I could feel it but I didn't take medication. It slowly went away. No swelling, nothing. On January 4th started having symptoms nose bleeding; diarrhea; cold sweats; had a fever - but I didn't take it to know what it was. I very tired/ extremely sleepy; my eyes started feeling warm- these symptoms creeped up on me. It started around 10:00 am and within an hour an a half I had to tell my boss and they told me to leave work - but I couldn't drive. I stayed in my car and just slept and I was extremely tired. I had a coworker keep an eye on my because I looked really bad. I slept two or three hours in my car. I was still tired and I couldn't drive yet. So I stayed in my car a little longer until I felt stronger and drove home. I had started coughing and knocked out - but I was beginning to coughing a lot on drive home- the first hour I couldn't sleep because I was coughing so much - lasted an hour. Chest coldness for a couple of days - cold chest. It wasn't tight. Next day, January 5, 2021 - went to doctor and they ordered COVID test. Dr thought I had a stomach virus. Diarrhea continued for two days. Weak and fatigue for 5 days. My Fever - temperature was on the first day was one day only. Second day, I did have a lot of fatigue and I was coughing a lot. The fatigue lasted 10 days.
48 2021-02-16 feeling abnormal passed out; terrible headache; still some body aches; general bad feeling all over; nausea/tremendou... Read more
passed out; terrible headache; still some body aches; general bad feeling all over; nausea/tremendous chills and nausea; tremendous chills and nausea; low grade fever 99.5; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 48-year-old) on 02Feb2021 at 10:30 AM as a single dose for COVID-19 immunisation, lot number: EL9262. Medical history included high cholesterol and allergies to some seaweeds. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 via an unspecified route of administration in Left arm (at age of 48-year-old) for COVID-19 immunisation, lot number: EL3246. Concomitant medications in two weeks prior to the vaccination included atorvastatin and multi- vitamin. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient started about 12 hours after getting vaccinated (reported as 02Feb2021 at 10:00 PM) with a general bad feeling all over, 15 hours after (03Feb2021 at 01:00 AM) patient got out of bed because of nausea and passed out, his wife found he on the floor. Patient had tremendous chills and nausea with a low grade fever 99.5 for several more hours, maybe 6 hours, (onset date 02Feb2021) the next morning patient had a terrible headache and still some body aches. Patient was treated with extra strength paracetamol (TYLENOL) and ondansetron (ZOFRAN). Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.
48 2021-02-16 sleep disorder, feeling abnormal I awoke from sleep freezing cold. Colder than I have ever felt. violent shakes. So much that I wa... Read more
I awoke from sleep freezing cold. Colder than I have ever felt. violent shakes. So much that I was worried my muscles would begin to sieze up and cramp. I had warm clothes and 5 blankets and could not get warm for over 2 hours. Elevated heart rate and breathing. Nothing warmed me. Eventually (and with ibuprofen) the incident subsided. I felt weak and just "off" with slight body aces and fatigue for the next day and a half.
48 2021-02-17 disorientation, impaired work ability Headache, vertigo, body aches, fever, axillary swelling and pain for 3-4 days immediately following ... Read more
Headache, vertigo, body aches, fever, axillary swelling and pain for 3-4 days immediately following the administration. Headaches and vertigo continued and became sustained leading to an MRI to be done on 2/1/21 resulting in a neurology consult and high doses of prednisone for short term treatment of symptoms. Further lab work revealed elevated ANA levels. Now awaiting a rheumatology consult. Although moderately improved, vertigo and disorientation remains, unable to work.
48 2021-03-03 disorientation During observation period after receiving vaccine, client became nauseous, short of breath, and itch... Read more
During observation period after receiving vaccine, client became nauseous, short of breath, and itchy. Our staff moved patient to lay down on a mat, shortly after that pt was no longer oriented x2. Client quickly became oriented x3 after that but began complaining of intermittent chest pain. SP02 was 94%, HR 94-97, client still short of breath and diaphoretic. Gave Bendadryl around 5:15pm with resolution of itchiness. Patient rated chest pain as 10/10 specifically on right side and his back. Complained of metalic taste in mouth. Heart rate up to 114 and SP02 sitting around 96%. Ambulance arrived at 5:25pm and took pt to hospital.
48 2021-03-16 sleep disorder 2nd Dose of Pfizer vaccine administered at 9:30 am on Saturday 3/6. Saturday afternoon through Sunda... Read more
2nd Dose of Pfizer vaccine administered at 9:30 am on Saturday 3/6. Saturday afternoon through Sunday evening felt feverish, chills, body aches. Felt fine Monday morning. Monday about 11 am began to feel tightness in chest, thought it was bad heartburn. Pain kept me awake Monday night, and continued into Tuesday morning. Called the doctor, was sent to urgent care. Urgent care detected elevated tritonin and had me transported to the emergency room. Elevated heart rate and rising tritonin levels had me admitted to the hospital. Given heperin and a beta-blocker, given a CT scan, and monitored over night. On Wednesday had a echocardiogram and then a heart catherter and imaging, which showed a healthy heart, no plaque, no blockages. Tritonin levels and heart rate returned to normal. Released from hospital on evening of 3/10.
48 2021-03-17 feeling abnormal, confusional state, abnormal dreams Fever chills muscle aches confused foggy mind, aches, weird taste vivid dreams mild ear ache total e... Read more
Fever chills muscle aches confused foggy mind, aches, weird taste vivid dreams mild ear ache total exhaustion debilitating exhausted since 8 hrs after 2nd shot. 1st dose only mild soreness at injection site but 2nd dose is awful. On 3rd day getting worse as is my partner. Both literally bedridden.
48 2021-03-17 feeling abnormal, sleep disorder As per patient reporting : Sx: Sorearm; 10pm : Shivers ; Next day (1/12/21). 12pm : Nausea ; exhaust... Read more
As per patient reporting : Sx: Sorearm; 10pm : Shivers ; Next day (1/12/21). 12pm : Nausea ; exhaustion, feelings i was going to die ; unable to sleep at night for 2 nights. As per my evaluation : Patient presented with worsening of psychosis and manic sx.
48 2021-03-21 emotional distress In the past, I have had a very mild and intermittent case of tinnitus. However, immediately after ... Read more
In the past, I have had a very mild and intermittent case of tinnitus. However, immediately after receiving my first Pfizer dose -- within an hour -- I noticed that my tinnitus got much, much worse and louder -- it became a constant loud hissing in both ears. More than a week later, the tinnitus is almost debilitating -- CONSTANT and never getting any lower. A "whooshing" sound that just won't stop. It's maddening. I've never had tinnitus this bad in my life and there is no reason for it to have gotten worse besides the vaccine. It is high-pitched, and constant, and this is two weeks after receiving my dose. It's only getting worse -- there has been no hint of quieting down. I am very upset over this and it's obvious that my tinnitus got severe directly after I got the first Pfizer vaccine. I've been living at home alone for the last year so it's certainly not due to loud music or anything like that.
48 2021-03-26 sleep disorder On 3/24/2021 about 1 hour, after I received the shot I started to have lower stomach cramps, they go... Read more
On 3/24/2021 about 1 hour, after I received the shot I started to have lower stomach cramps, they got more server as the night progressed. I could not sleep with the pain. Then on 3/25/2021 at about 2 am in the morning I started getting a headache while still having stomach cramps. At about 7:00 am I had a fever of about 99.5 degrees then at about 11:00 am I had a fever of about 100.2 degrees and the stomach cramps were still there. I drank lots of water and Pedialyte to stay hydrated but had a very difficult time urinating. it was very little. At about 10 pm the cramps started to subsided but were still lightly present. my appetite went to almost nothing but soup for 2 days, I have had leg and arm cramps off and on during this process as well. I did not want to eat. today 3/27/2021 is the first day I have started to feel normal.
48 2021-03-27 disorientation Directly after receiving vaccine pt became disorriented for approximately 15 seconds and then had sy... Read more
Directly after receiving vaccine pt became disorriented for approximately 15 seconds and then had syncopal episode for approximately 60 seconds., pt was layed down. EMS called initial BP 92/69 P- 58 with pt awake stating this happens everytime he gets any vaccine. After continued observation Bp 123/80 P- 64 and pt stating he feels fine. Pt taken to high obs for additional 30min obs and released.
48 2021-03-28 delirium At around 10:00pm person stated that he began with swelling in mouth, "delirious", slurring of speec... Read more
At around 10:00pm person stated that he began with swelling in mouth, "delirious", slurring of speech, right arm pain, trouble breathing. These symptoms continued until 8:00am on 3/27/2021. No meds were taken at this time. Person did not go to ER for a visit and did not phone Dr.
48 2021-03-28 sleep disorder The day of vaccination had general soreness. Over a week later the soreness spread to my shoulders,... Read more
The day of vaccination had general soreness. Over a week later the soreness spread to my shoulders, side, and neck. It got worse to the point to where I could not sleep through the night, and the pain is continuous.
48 2021-03-29 feeling abnormal PT was administered vaccine at 1025 and shortly there after started to shake, felt sweaty and just f... Read more
PT was administered vaccine at 1025 and shortly there after started to shake, felt sweaty and just felt weird. Then passed out. PT was quickly assisted by vaccination staff at car side and then medical staff was notified. Upon arrival PT was very pail and lacked color, but was awake and stated that he has never had that happen before. Denies any history of having adverse effects to medications. NKDA. Ambulance was called. 1045 Vitals BP: 80/60 Pul: 68 Sp02: 97 1045 Ambulance arrived 1050 BP: 92/58 PT was taken to local ER for further observation.
48 2021-03-30 nervousness After receiving the Pfizer vaccine in the Left arm, patient bled from the site after the syringe was... Read more
After receiving the Pfizer vaccine in the Left arm, patient bled from the site after the syringe was pulled out. About 20 seconds later, patient said he was nervous and started sliding down in the chair. Patient was guided to the ground by vaccinating nurse. Patient was unresponsive for about 5 seconds, pulse present, face and lips blue for about 3 seconds and then transitioned to pale. Patient did not fall and did not hit his head. Vitals assessed, BP 152/93, Pulse 78, Temp 98.1, RR 17, SaO2 98%. Patient able to respond shortly after fainting, answered questions correctly. Patient stated he has a phobia of needles and has fainted in the past when getting blood drawn. 911 called by another vaccinating nurse during this time. Paramedics arrived at 1304. Patient safety and comfort maintained. Patient treated by paramedics. Vitals stable, EKG showed no abnormalities. Patient refused to be taken to the hospital after incident. Patient stayed moved from the vaccination area to observation without incident. Patient tolerated water and sitting up-right in chair. Patient monitored by RN and LVN. Vitals at 1328 BP 143/88, SaO2 98%, Pulse 98, Temp 98.1, RR 18. Patient tolerated waiting 15 minutes in observation and requested to ?get some fresh air.? Patient tolerated standing outside with two nurses observing him at that time. Patient was stable to leave site. Last vitals @ 1345 BP 148/94, Pulse 83, Temp 97.1, SaO2 97%. Patient left site without further incident.
48 2021-03-31 anxiety Body aches, unable to raise arm where vaccine was administered, fever between 102 to 104, extreme fa... Read more
Body aches, unable to raise arm where vaccine was administered, fever between 102 to 104, extreme fatigue, lose of appetite, and anxiety.
48 2021-04-03 irritability Tinnitus. Moderate fuzzy tingly pitch. No treatments.
48 2021-04-05 anxiety Felt dizzy after the vaccination. Some features of vertigo, but he was unable to further character... Read more
Felt dizzy after the vaccination. Some features of vertigo, but he was unable to further characterize. No HA, CP, SOB, Nausea. No numbness orally or peripherally. He was quite anxious about even coming for the vaccine. Initial BP was 129/78, P 88 O2 sat - 95%. No orthostasis. All VS remained stable. He felt better sitting up than lying down. Felt better after apple juice. He didn't know his symptoms of hypo or hyperglycemia. Ambulated comfortably before discharge to home. Not classic Vaso-vagal reaction. Suspect anxiety.
48 2021-04-05 confusional state, disorientation C?O numbness in legs, became confused, disoriented. Transferred to Emergency Department. Diagnosed ... Read more
C?O numbness in legs, became confused, disoriented. Transferred to Emergency Department. Diagnosed with CVA event. Still being treated at this time.
48 2021-04-06 anxiety Anxiety, Panic, Weakness, unable to stand, generalized weakness. 98/60 68. Pt. observed with gene... Read more
Anxiety, Panic, Weakness, unable to stand, generalized weakness. 98/60 68. Pt. observed with generalized weakness. unable to keep eye open. Emergency personnel notified and pt. was transported to Hospital for further evaluation.
48 2021-04-06 sleep disorder DURING VACCINE, PATIENT FELT A SHARP TINGLING/SHOOTING PAIN DOWN HIS ARM. PAIN WENT AWAY, BUT HE WAS... Read more
DURING VACCINE, PATIENT FELT A SHARP TINGLING/SHOOTING PAIN DOWN HIS ARM. PAIN WENT AWAY, BUT HE WAS AWOKEN FROM SLEEP THAT NIGHT FROM THE PAIN. ARM WAS SORE AGAIN IN THE MORNING BUT THAT EVENING FELT AS THOUGH IT WAS SHOOTING AGAIN. PATIENTS WRIST STILL HAS TEMPERATURE SENSITIVITY AND CONSTANT NERVE PAIN, AND PATIENTS ARM IS SWOLLEN TO THE ELBOW.
48 2021-04-07 excessive sleepiness Extreme fatigue. Inability to stay awake past 5:00 PM in the afternoon. Very high blood sugar.
48 2021-04-08 anxiety Light headedness, sweating, Anxious. BP 84/64, 82/46, 100/60, HR 82, O2Sat 98% 1:15 BP 118/70, talki... Read more
Light headedness, sweating, Anxious. BP 84/64, 82/46, 100/60, HR 82, O2Sat 98% 1:15 BP 118/70, talking with friend on phone, stated feel better.
48 2021-04-11 disorientation, confusional state Today on 12 April, 2021 I woke up feeling dizzy. I am also having nausea, feeling light headed, and ... Read more
Today on 12 April, 2021 I woke up feeling dizzy. I am also having nausea, feeling light headed, and a feeling of wanting to faint. Energy level feels down. Feeling slight confusion and disorientation.
48 2021-04-17 abnormal behaviour displaying odd behavior; had a due second dose last March 19, he didn't want to take it and so he mi... Read more
displaying odd behavior; had a due second dose last March 19, he didn't want to take it and so he missed the dose; This is a spontaneous report received from a . A contactable consumer (patient's mother) reported for a 48-year-old male patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: solution for injection, Batch/Lot number: unknown), via unspecified route of administration on 17Feb2021 as single dose for COVID-19 immunization. Patient's medical history included head injury, road accident (had a head injury because of a car accident years ago). The patient concomitant medications were not reported. Reporter stated patient had a due second dose last 19Mar2021 and he did not want to take it and so he missed the dose. After a week of receiving the vaccine, he is displaying odd behavior and he was admitted in a psychiatric hospital on 27Mar2021. Reporter asked is there a 42 day window after receiving the first shot to get the second shot. The outcome of event was unknown. Information about lot/batch number has been requested.
48 2021-04-17 feeling abnormal I started shivering around 1am. It got so bad that my teeth were chattering, too. I slept poorly a... Read more
I started shivering around 1am. It got so bad that my teeth were chattering, too. I slept poorly and at 6am took my temperature. It was 101.4. I used a digital thermometer under the tongue. I took 2 acetaminophen at 8am. At around 10am my fever broke. My temperature stayed around 99 throughout the day. I felt "whoozy" and weak for the rest of the day. Today, April 18th at 10am I don't have any symptoms.
48 2021-04-17 insomnia Extreme dizziness and nausea resulting in fainting twice and hitting chin on furniture. Diarrhea al... Read more
Extreme dizziness and nausea resulting in fainting twice and hitting chin on furniture. Diarrhea all night at least once per hour. Chills and shaking. Sweats, very fatigued, no appetite, no sleep. Rested all Sunday, no more chills but still nauseous, diarrhea all day. No energy or appetite.
48 2021-04-17 nervousness Pfizer 1st Shot gave me loud Tinnitus and hasn't stopped.; headache; Had fever for a few days; fatig... Read more
Pfizer 1st Shot gave me loud Tinnitus and hasn't stopped.; headache; Had fever for a few days; fatigued; arm soreness; he was scared; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 11:30 (Batch/Lot Number: EN6204) as SINGLE DOSE for covid-19 immunisation, age of vaccination 48 years old at workplace clinic. Medical history included Heart Disease and Covid-19 from an unknown date. No other vaccines in four weeks. Concomitant medication included losartan taken for an unspecified indication, start and stop date were not reported. The patient experienced loud tinnitus and hasn't stopped. Described as screaming High Pitch Ringing. Patient stated he was praying it will go away. Patient had headache, had fever for a few days, fatigued, and arm soreness on 19Mar2021 20:30 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 20Mar2021. Treatment was not received for tinnitus, headache, had fever for a few days, fatigued, and arm soreness. Physician office visit was made for tinnitus, headache, had fever for a few days, fatigued, and arm soreness. The patient stated "This is really scary stuff. Please stop blaming it on Covid". Patient further stated, "Since day 2 of shot which I got on St Patty's Day 17Mar2021. I am on Day 13 of this new hell with no end in sight". He filed a VAERS report and notified his Primary care Dr and ENT. Patient won't get the 2nd shot, as he was scared (Mar2021)." Outcome of the event scared was unknown while not recovered for the other events. The patient considered the tinnitus as serious (very serious and others have experienced this). No follow-up attempts are possible. No further information is expected. Lot number has been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366081 Same reporter/drug/AE, different patient;US-PFIZER INC-2021366082 Same reporter/drug/AE, different patient
48 2021-04-18 disturbance in attention Tinnitus - Five minutes after injection had ringing in both ears which subsided during the say. Sun... Read more
Tinnitus - Five minutes after injection had ringing in both ears which subsided during the say. Sunday was off and on. Today (Monday) woke up to severe ringing. Having problems concentrating with the loudness.
48 2021-04-20 sleep disorder ringing in my ear started while i was asleep. i think i woke up due to it. was difficult to get back... Read more
ringing in my ear started while i was asleep. i think i woke up due to it. was difficult to get back to and stay asleep. the next day, 4/20/21, it was only noticeable when it was quiet. that night, it was very faint and didnt disturb my sleep, from 11pm to 5am. woke up with ringing at that time and was in and out of sleep til 7am. it was faint all day until about 7:30pm, now it may be as loud as it was when it started. it is 8:05pm at this time.
48 2021-04-21 feeling abnormal About ten minutes after getting the shot I got a weird feeling in my chest and then within a few min... Read more
About ten minutes after getting the shot I got a weird feeling in my chest and then within a few minutes a rapid heart rate. My normal heart rate is around 72 and my heart rate after the shot was 110. The symptoms lasted for about an hour. In 2011 I experienced the same exact symptoms from intravenous benadryl and the both contain Polyethylene glycol.
48 2021-04-22 irritability Irritability. Sensation of being startled out of sleep repeatedly all the while being fully awake ... Read more
Irritability. Sensation of being startled out of sleep repeatedly all the while being fully awake and alert. No trigger other than a sensation of falling or waking up from a sleep in a startled manner.
48 2021-04-23 feeling abnormal 4 weeks after 2nd dose, suffered minor head ?cloudiness? and numbness in right hand. Lasted about 1 ... Read more
4 weeks after 2nd dose, suffered minor head ?cloudiness? and numbness in right hand. Lasted about 1 hour
48 2021-04-24 insomnia Chest pain; Palpitations; Shortness of breath; Cant Sleep; This is a spontaneous report from a conta... Read more
Chest pain; Palpitations; Shortness of breath; Cant Sleep; This is a spontaneous report from a contactable consumer reporting for himself. A 48-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 17:00 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation (Age at vaccination 48 years) . Medical history included anxiety,Post traumatic stress disorder , hypertension , blood cholesterol increased. On 24Feb2021 the patient received the first dose of BNT162B2 vaccine. Concomitant medication included clonazepam (CLONAZEPAM) taken for anxiety, start and stop date were not reported. The patient previously took penicillin b. The patient experienced chest pain , palpitations , shortness of breath , cant sleep all on 23Mar2021 with outcome of not recovered. Course of events. This past Sunday would be 3 weeks post receiving his vaccine. Since he got the vaccine, about 3 days later he experienced chest pain, palpitations, Shortness of breath. He checked his own Blood pressure and its not high and his pulse is normal also. He's not a doctor and he doesn't know if its anxiety, but he also cant sleep, he's been getting like 4 hours of sleep every night since this started. No follow-up attempts are needed. No further information is expected. Lot information already received.
48 2021-04-24 irritability, anxiety Regular - Arm pain. Adverse - Abdominal pain / pressure, green stools, dizziness, fast heartbeat, a... Read more
Regular - Arm pain. Adverse - Abdominal pain / pressure, green stools, dizziness, fast heartbeat, anxiousness, irritation, body hyper alert, triggered.
48 2021-04-25 disturbance in attention Headache, pain in joints , lack of focus, lose of appetite, lose of smell.
48 2021-04-26 fear When I got up in the Morning of the next day of my second shot, I had a fever (100 degrees Fahrenhei... Read more
When I got up in the Morning of the next day of my second shot, I had a fever (100 degrees Fahrenheit) and took Loxoprofen. I was in my bed all day and my temperature dropped down by the night and I felt getting better.
48 2021-04-28 feeling drunk Feeling dizzy almost as if drunk.
48 2021-04-29 anxiety 7 days after vaccine I had a pretty intense, unprovoked anxiety attack. I was not under any stress, ... Read more
7 days after vaccine I had a pretty intense, unprovoked anxiety attack. I was not under any stress, have never had anything like this occur, was not doing anything strenuous and all of a sudden had what I thought might even be a stroke or heart attack. I walked back to the house and took BP and it was 172/75 and pulse rate was only 64...but I was sweating, faint feeling, blurred vision, completely exhausted and it felt like my heart was pounding...but it wasn?t.?? I took BP multiple times but it was fine. Just a really strange anxiety attack I guess that lasted a few hours. I wasn?t worried about it and was t going to report it but have had 3 other people who unsolicited told me about their anxiety attack between 5 -7 days after shots. Two were phizer and one was Modena. Figured I would report it in case it helped someone else to not panic if they had an event like this. It was quite scary and I don?t get worried about things like that!
48 2021-04-30 feeling abnormal syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; bo... Read more
syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; body pain; headache; felt uneasy; nausea/Felt like throwing up; dizzy/lightheaded; Profuse sweating; EKG showed low heart rate, blood pressure; EKG showed low heart rate, blood pressure; feeling weak; could not stand; Feeling worse; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Cholesterol (blood cholesterol abnormal) from an unknown date. There were no concomitant medications. The patient previously received first dose of BNT162B2 for covid-19 immunisation on 24Mar2021. The patient also previously received naproxen and experienced allergies. The patient experienced syncope, soreness overnight in left arm, expanding pain to left shoulder, strong fever/low fever, body pain, headache, felt uneasy, nausea/felt like throwing up, dizzy/lightheaded, profuse sweating, ekg showed low heart rate, blood pressure, feeling weak, could not stand and feeling worse all on 15Apr2021 at 13:00. All the reported events caused hospitalization for 1 day. It was reported that After receiving Pfizer vaccine at 4pm developed Soreness overnight in left arm, expanding pain to left shoulder. Strong Fever and body pain in morning. Feeling worse throughout morning after breakfast of tea and fruits. While having lunch at 1.30 pm felt uneasy and nausea and could not complete lunch. Felt like throwing up and got up feeling dizzy and lightheaded. Experienced syncope and had to lie down on kitchen floor. Tried to get up with help from family members but could not stand and had to lie down again on floor. Profuse sweating. Wife called 911 and ambulance who arrived and checked pulse, EKG showed low heart rate, blood pressure. Taken by ambulance and paramedics to hospital Emergency where IV fluids were given to stabilize and discharged after 4 hours of observation. Still feeling weak, headache, low fever. Taking Tylenol and fluids while recovering. Adverse event start date: 15Apr2021. Adverse event start time: 01:00 PM. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): low on 15Apr2021, EKG (electrocardiogram): showed low heart rate, blood pressure on 15Apr2021 and pulse/heart rate (heart rate): low on 15Apr2021. Therapeutic measures were taken as a result of all the events which includes IV fluids and Tylenol. Outcome of all the events was recovering Information on batch/lot number was requested.
48 2021-05-02 disturbance in attention, feeling abnormal, depression, anxiety, sleep disorder, insomnia Insomnia, being "jolted" awake or just waking up at random times and unable to go back to sleep. Ver... Read more
Insomnia, being "jolted" awake or just waking up at random times and unable to go back to sleep. Very tired and groggy most days. Hard to concentrate at work. Depression, excessive anxiety. Always worried about there not being a cute for this. Tingling, burning back, shoulder, and neck pain. Never too severe, but there a lot. Painful to sleep after a few hours. Nausea over half the time. Loss of appetite. Eating significantly less. Lost 15 lbs in two months. Fatigue, brain fog, dizziness, lightheadedness. Extremely tired. Originally neck pain in the front, now teeth/jaw hurt in the mornings. Random sensitivity to cold/hot foods. Unpredictable desire to have a bowel movement or to urinate. Usually unproductive. Sweaty hands/feet. Elevated heart rate randomly. Skin tingling/burning on the tops of arms and cheeks. Numbness in fingers. Originally ring/pinky, now thumb/index/middle finders. Mostly left side. Tinnitus, ear pain. Has gotten slightly louder and more noticeable. Symptoms appeared starting a few days after vaccine #1 and are still ongoing as of date of VAERS report.
48 2021-05-04 sleep disorder Extreme pain during vaccination. Worsening pain and would wake me when I rolled on to my arm for 4 ... Read more
Extreme pain during vaccination. Worsening pain and would wake me when I rolled on to my arm for 4 days. Evolved into joint pain that would not resolve with medication. Developed a loss of range of motion and pain that mimicked a rotator cuff tear. This worsened over months. Doctor prescribed meds and PT. After PT I suffered a partial tear of the biceps tendon. MRI pending. Shoulder pain improved after the tear.
48 2021-05-06 confusional state, memory impairment Starting on the day after my shot I was completely fatigued and unmotivated. This continued for four... Read more
Starting on the day after my shot I was completely fatigued and unmotivated. This continued for four full days afterwards before easing off on the fifth day, and gone by the sixth. During this time I also had some confusion and difficulty comprehending reading and verbal explanations. Unsure what day it was. I found myself misspeaking words with the wrong meanings. I also was confused if I had completed tasks such as going for a scheduled unrelated blood test, taking my car in for maintenance, etc, and could not recall if I had done these things or if they still needed done. I would stay awake no more than a few hours, 5 at most, then sleep for 8-10 hours. This went on until the fifth day.
48 2021-05-06 feeling abnormal pt states he developed symptoms of covid. His body is itchy feeling all over his body on the inside... Read more
pt states he developed symptoms of covid. His body is itchy feeling all over his body on the inside. His muscles felt heavy, he felt hot and was sweating with no fever. His heart beating about 125 bpm. On 4/30/21 he went to ER. EKG was normal. Blood test results showed TSH low and T3 is high. He repeated test 4 days later and had the same results. These test were normal before taking the vax. He was discharged to see a endocrinologist on 5/26/2021. Pt still has the itchy sensation, his eyes burn, still feeling extremely tired and feels like he dying.
48 2021-05-06 mental impairment Woke up with dizziness/vertigo (couldn't walk straight, couldn't think straight, needed to hold onto... Read more
Woke up with dizziness/vertigo (couldn't walk straight, couldn't think straight, needed to hold onto things to support myself). Symptoms have persisted (but severity has lessened) thru 5/7. I received the second dose on 5/1, and symptoms started the morning of 5/4. I'm still experiencing some dizziness today on 5/7.
48 2021-05-10 confusional state -Presented to ED with complaint of fever onset yesterday. Had the 2nd COVID-19 2 days ago. He has be... Read more
-Presented to ED with complaint of fever onset yesterday. Had the 2nd COVID-19 2 days ago. He has been having fever since yesterday morning running 102.7-103.9F. Called PCP and was advised to present to the ED yesterday but he did not. He fell after losing his balance today. Endorses nausea, confusion. Has extensive medical history. Patient has signs of sepsis with likely bacterial infection acute cystitis/pyelonephritis. His lactate and procalcitonin are unremarkable and vitals remained stable however he does have an elevated total bilirubin as a possible sign of a more serious systemic response. The patient does have chronic cirrhosis and persistent fever and tachycardia. Given these clinical findings he is referred for admission for IV antibiotics and further close monitoring. Unfortunately, urine cultures were not sent. His blood cultures however did grow 2 of 2 bottles positive for Klebsiella pneumonia. These are both sensitive to Levaquin. In the course of his hospitalization, he has improved. He is now requesting discharge. Will discharge home on p.o. Levaquin. Is discharged in improved condition.
48 2021-05-10 impaired work ability TC FROM PT: HAS RT SHOULDER AND NECK PAIN SINCE 5-2-21. VERY PAINFUL TO MOVE ARM. HAS MISSED WORK A... Read more
TC FROM PT: HAS RT SHOULDER AND NECK PAIN SINCE 5-2-21. VERY PAINFUL TO MOVE ARM. HAS MISSED WORK AND GONE TO ER. ADVISED TO CALL PCP AND REPORT TO CDC.
48 2021-05-14 amnesia Mini Stroke; Weakness on left side; memory loss; This is a spontaneous report from a contactable con... Read more
Mini Stroke; Weakness on left side; memory loss; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0153) via an unspecified route of administration, administered on the left arm on 20Apr2021 10:30 1st dose, single for COVID-19 immunisation. Medical history included COVID (prior to vaccination), pre-diabetic, anxiety, chest tubes and chest pain. The patient's concomitant medications were not reported. On 29Apr2021 22:00, the patient had a Mini Stroke. Also have weakness on left side and memory loss. The events resulted in Emergency room/department or urgent care visit/hospitalization. The patient was hospitalized for 2 days. Treatment was received for the events which included bloodwork, MRI, CT scan. Since the vaccination, the patient has not been tested for COVID-19. The facility where the vaccine was administered was in a pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.
48 2021-05-14 memory impairment heart beat is going to 144 and 120; his body is a heavy weight/he is very tired; his body is very pa... Read more
heart beat is going to 144 and 120; his body is a heavy weight/he is very tired; his body is very pain; has a headache in his head; when he wants to walk he feels dizzy; forgot a lot of things after the vaccine and he forgot his wife.; feel his heart go bum bum bum, too fast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunisation. The patient medical history included inflammatory bowel disease- IBA colon and blood pressure. Concomitant medication included enalapril 5mg for blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration as single dose for COVID-19 immunisation. On 25Apr2021, at 04:00, the patient started experiencing symptoms, the body was heavy weight and his heart beat was going to 144 and 120, very tired. Patient did not know what was going on as he was heavy for too long, which he though will last for 2 days but it was 7 days now. The patient heart beat fast and when he slept he could feel his heart go bum bum bum, too fast. Patient had body pain and headache. He felt dizzy when he wants to walk. Patient informed that he cannot go to his work and he wanted to know what to do next as the symptoms continue day by day to today. Patient started to forget lot of things after vaccine and he forgot his wife. The patient stated that the symptoms are getting worst and he wants be normal as he finds it very hard to play with his children and that when he stands up to walk his heart goes bum bum bum. The patient underwent lab tests and procedures which included heart rate: 144 and 120 on 25Apr2021. The patient spoke to his primary doctor and was informed to take Tylenol. The patient took Tylenol 2 tablets 500 mg, 1000mg and it was no benefit. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
48 2021-05-15 insomnia On May 9th I began to experience severe pain in my back extending down my left side. The pain was se... Read more
On May 9th I began to experience severe pain in my back extending down my left side. The pain was severe enough to prevent sleeping that night. The pain continued throughout May 10th becoming worse with deep breaths or any type of internal strain (cough, sneeze, etc). That evening, I took two Tylenol and later two Ibuprofen and was able to sleep. The pain persisted for the next week, slowly improving but not fully going away. On May 15th I conducted a telemedicine appointment and was advised to go to either Urgent Care or the ER. I chose the ER at Hospital. A D-Dimer test showed elevated results and a CT scan was ordered. The CT revealed blood clots in my right lung, specifically "Subpleural conslidation in the posterior basilar segment the right lower lobe is present, compatible with pulmonary infarct. Question additional pulmonary infarct in the lateral basilar segment the lower right lobe. Probable atelectasis in the left lung base." MD prescribed Eliquis @ 10mg 2x daily and I was discharged with a referral to .
48 2021-05-17 anxiety, nervousness Patient told pharmacist he has habit of passing out when giving blood or getting shots. He was nerv... Read more
Patient told pharmacist he has habit of passing out when giving blood or getting shots. He was nervous. He did well getting shot, set in room for 5 min., then moved him to waiting room where I asked him to stay 15-20 more min. Over a few min he looked very pale, we offered him water. (he barely sipped any). after 5 min he started sweating. He did not call for help, but technician on duty saw him put his head in his lap. We both went out to tend to him. While we were talking to him, he passed out. We called 911. While giving vitals and info to 911, he came to before they got on scene. While paramedics were assessing him, after about 5-10 more min...he passed out again. This time when he came to, seconds later...he projectile vomited on the paramedics. They tended to him until about 1:15-1:30. PT refused their suggestion and urging to go with them to hospital. Paramedics left him in pharmacy to leave facility on his own will. Pt refused our suggestion to call someone to come pick him up and not drive. After sitting outside to get some fresh air, PT came through our drive thru to tell us he was much better and leaving Store. We told him we would call and check on him 5/17/2021. We have called now 2 days (5/17/ and 5/18) and can not get him to return our call.
48 2021-05-17 feeling abnormal Pt states he passed out & not feeling good. Diaphoretic. BP 102/67 Via w/c taken to Observation are... Read more
Pt states he passed out & not feeling good. Diaphoretic. BP 102/67 Via w/c taken to Observation area to lie down. Feeling cold, tingly all over & "wiped out". 3:25PM Taking juice & crackers. Still dizzy when tried to stand up. BP 127/92 3:40PM Left w/o assistance. Feeling much better
48 2021-05-17 sleep disorder Strong shoulder pain started on Sat 4/17 in the early morning that woke me up. Went away by 10a afte... Read more
Strong shoulder pain started on Sat 4/17 in the early morning that woke me up. Went away by 10a after taking tylenol and having a coffee. Sun 4/18: pain again woke me up and was more severe. Had to get out of bed to move around as pain was pretty bad. Went to urgent care. Found nothing serious (not a heart attack or clots, etc). Referred me to go see my PCP if it did not resolve in a few days. Thu 4/22: went to PCP. Pain had subsided for the most part, but started having reduced range of motion when lifting arm straight forward...could not get past 90 degrees (straight out) without pain and a feeling of physical binding in the joint. Suspected bursitis. Prescribed a steroid pack and muscle relaxer. Sat: 4/24: my son noticed my shoulder blade sticking out when attempting to reach for a glass of water while seated. Decided to make appt with an orthopedic. Fri 4/30: went to orthopedic. Took xray. Found no physical damage, trauma, etc. Noticed winged scapula as reason for lack of range of motion. Prescribed physical therapy. Fir 5/14: still same lack of range of motion and no pain. Went to first PT appt. They took range of motion measurements and agreed I was limited. Tested for other pain or signs of trauma and found none. Prescribed a PT regimen. After my own research combined with symptoms, and no physical trauma as the source. My suspicion is Parsonage Turner Syndrome brought on by the vaccination.
48 2021-05-19 feeling abnormal Balance issues, equilibrium issues, buzzing on the brain. Still going on today
48 2021-06-02 restlessness prolific cold sweats; Muscle pain; restlessness; severe chills; This is a spontaneous report from a ... Read more
prolific cold sweats; Muscle pain; restlessness; severe chills; This is a spontaneous report from a contactable Consumer. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955) via an unspecified route of administration, administered in left arm on 06Mar2021 at 12.45 PM (at the age of 48-year-old) as single dose for COVID-19 immunization. The did not have allergies to medications, food, or other products. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not diagnosed with COVID-19. On 07Mar2021 (next day of vaccination) It was in the middle of the night (probably after midnight), the patient experienced muscle pain, restlessness, severe chills, prolific cold sweats. Did not received treatment for the adverse event. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
48 2021-06-03 insomnia Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Aller... Read more
Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: RASH ON ARM-Severe, Systemic: Unable to Sleep-Mild, Additional Details: PATIENT BROKE OUT IN RASH 2 TODAYS AFTER RECEVING 2 DOSE OF PFIZER COVID 19 VACCINE AND HE IS STILL ITCHING UNTIL NOW
48 2021-06-03 suicidal thoughts On the same day of COVID vaccination, patient presented to the ED with suicidal ideation. He was hos... Read more
On the same day of COVID vaccination, patient presented to the ED with suicidal ideation. He was hospitalized for 2 days.
48 2021-06-06 sleep disorder, panic attack, delirium, disorientation, impaired work ability april 3 hyperacusis april 8 hyperacusis amplified to inability to work and tinnitus started. disor... Read more
april 3 hyperacusis april 8 hyperacusis amplified to inability to work and tinnitus started. disorientation feelings. no sleep possible. no sound masking possible. tinnitus was louder than two sound machines on FULL volume. april 13. GP prescribes claritin, flonase (double dose), neomycin drops april 18 brain on fire with headache, pain april 19 ENT did blood work, visual and hearing tests. stopped flonase. started azelastine. april 26. started to hear crackling in right ear april 27 soreness below right ear may 2 SETBACK almost a panic attack (I assume) hyperacusis returned but not as severe as before. may 3 new ENT restarted flonase (double dose) may 6 brain on fire again. reduced flonase to normal dose. may 10 rock hard lymph node right side below ear. feeling better on lower flonase. may 11 lesser panic attack. lesser hyperacusis reaction. may 13 given doxycyclene 7 days june 3 slept without sound machine 8 weeks in
48 2021-06-09 feeling abnormal Roughly two days after the second Pfizer shot my arm muscle was sore, but then I started having ligh... Read more
Roughly two days after the second Pfizer shot my arm muscle was sore, but then I started having lightheadedness and dizzy spells along with severe fatigue. I've been to several doctors since.
48 2021-06-13 feeling abnormal, memory impairment - presents with a cc of chest and shoulder pain - he had the 2nd dose of covid vaccine pfizer May 7t... Read more
- presents with a cc of chest and shoulder pain - he had the 2nd dose of covid vaccine pfizer May 7th and then soon after started having chest pain into his back, both shoulders, and down both arms; also into his neck and head and jaw; pain is constant and worsening - pain is achy; it is worse with sitting and walking around/standing makes it better - denies numbness but has has tingling in his arms - sometimes his heart is beating fast, has palpitations - feels overall weak - reports lower back pain for a while prior to the vaccine, sometimes this goes down his legs bilaterally, he is not worried about - HA is hard to describe, he has never had headaches before the vaccine; sometimes his head feels light, other times it feels heavy; hurts all over his head and into his neck; turning his head makes his head worse; pain is constant - sometimes he has blurry vision, not currently - sometimes he feels presyncopal but has not actually passed out; he sits down and feels better; its a fleeting sensation - symptoms are worse with sitting, moving around makes all his symptoms better - has intermittent room spinning sensation - has general overall fatigue and weakness, nonfocal - denies dyspnea on my exam - denies rash - feels intermittent diaphoresis and chills/rigor like shaking - reports he was evaluated by an ER since the symptoms started (5/28) and also has seen his pcp who is working him up for fibromyalgia - reports brain fog and feels slower and harder time with his memory
48 2021-06-13 insomnia patient presented to emergency department 6/12/2021 after testing positive 6/7/2021 (approximately 6... Read more
patient presented to emergency department 6/12/2021 after testing positive 6/7/2021 (approximately 6 months after completing Pfizer mRNA vaccine series). He describes feeling generally unwell, difficulty sleeping and difficulty moving left upper extremity. Neurology and infectious disease consulted; ruled out stroke/TIA and treated with dexamethasone even though not requiring supplemental oxygen.
48 2021-06-19 insomnia, restlessness My first symptoms from COVID developed in Apr 2020 after having been presumed positive with COVID. I... Read more
My first symptoms from COVID developed in Apr 2020 after having been presumed positive with COVID. I had never had problems with nausea before, but have needed nausea meds ever since for every meal since that time. No change since then. Vaccine dose 1 given Mar 18. On Mar 24 began having body temperature regulation issues. For example my feet would be freezing and buzzing, similar to restless leg/body, but my upper body would be so hot I couldn't rest my hands on my chest. This happened every time I would lay down. Walking around or sitting up made it netter, but laying down the symptoms would begin quickly. This made it impossible to sleep without taking some type of strong medicine that would relax my body enough to even it out. Luckily I was taking morphine for back pain and that seemed to help. Normal OTC pain killers would not make any effect. This still occurs nightly, or even daily if I'm trying to nap during the day. Without morphine or something similar in my system at the time my body temperature and buzzing / restless body feeling continues. On Mar 27 I began experiencing a worse inability to stay asleep than I have ever experienced. This continues to this day. I awake every hour to an hour and a half regardless of how exhausted I am. Without a significant sleeping pill, which I am not currently prescribed, I cannot remain asleep through the night. Xanax has helped but does not always keep me asleep. I am still searching for a sleep doctor to assist to help address this sleep issue which was largely controlled by my CPAP once I finally was diagnosed and treated with sleep apnea. But now I am having nightly issues of awakeness, what appears to be called "coronasomnia" in some places, which makes me exhausted during the day. Finally, I ended up in the ER for kidney stones on Apr 8, the day I was scheduled for my second vaccination shot. I have never had kidneybstones before. Though I understand they would not develop so quickly, I understand there have been many reports of kidney stones making themselves known shortly following COVID vaccinations. I have not received my second vaccination and do not plan to do so given the effects I've had so far.
48 2021-06-23 agitation, insomnia Phase 1. Injury (6 APR) Pain during Injection (tip of needle) and immediate flinch/twitch in heart ... Read more
Phase 1. Injury (6 APR) Pain during Injection (tip of needle) and immediate flinch/twitch in heart area. Racing heart, Intensity of beat, Severe tinnitus left ear only, adrenaline, Can?t sleep; Symptoms worst when I get into bed Phase 2. (10 APR) Urgent Care Visit: Chest very weak, each day gets worse; inflammation left side of body (chest, hand, face), felt like hole in heart, shortness of breath, numb hand, easy to excite, pain when lean forward; heart out of rhythm; Phase 3: (13 APR) Nighttime rushed by wife to ER due to symptoms of a heart attack couldn?t breathe, numb hands, shivering, heart going berserk, dizzy, aggressive, heart out of rhythm. Did EKG and diagnosed with Arrhythmia and Palpitations Phase 4: 14 APR Condition Stabilizes with bed rest; heart speed and intensity reduces slightly, heart still out of rhythm; ringing in left ear continues; noticed left hand, face, chest all swollen, out of breath walking to mailbox; can?t breathe deeply; Chest begins to bubble, gargle, fizzle when I lay down. Palpitations in throat, legs, need to drink a lot water; can?t sleep due to heart racing then sore and breast bone enlarged; chest tenses up often. Phase 5: Visit to Cardiologist (26 APR) He mentions potential Nerve damage with injection and prescribes Ultrasound. Days later I have second ?ER like? Scare and confirm in my mind this also nerve related. Phase 6: Mid May Start Recovery: Chest still tenses up doing emails, phone, late at work; easily excited; Each night total relaxation; start to feel nerves twitching like electric pulses in left chest; Feels like Electric Pulses/Pain from injection site to location of original twitch in heart area. Lean forward pain/discomfort; Still very weak chest muscles that get painful and sore easily Phase 7: Early June: Ultrasound at Heart Dr. (2 JUN) looks better /normal size. Heartbeat steadier and quiet but palpitations persist (extra heart beats felt in my throat); Overall body feeling stronger but chest muscles still weak and sore after ultrasound experience. Ringing in the left ear is better and milder twitches in chest at night. Teeth sensitive to cold liquids and Numb hands while walking esp 4 June; tense chest at work/home and need to step away and breath; Heart faster; long time to calm after warm/hot bath Currently late June still suffer from muscle weakness especially left chest, left arm where shot went in. Hands are still numb and Heart races when in bed.. Chest also still freezes up during work. Have to focus on breathing calmly. Overall though my condition continues to improve.
48 2021-06-28 feeling abnormal Crohn's Flare Up; Brain Fog; fever; cramps and major abdominal pain; cramps and major abdominal pain... Read more
Crohn's Flare Up; Brain Fog; fever; cramps and major abdominal pain; cramps and major abdominal pain; heart rate increased; neck area twitching and in face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Jun2021 15:00 (Batch/Lot number was not reported) at the age of 48 years old as dose number unknown, single for COVID-19 immunization. Medical history included ongoing Crohn's. The patient's concomitant medications were not reported. The patient previously took fexofenadine (ALLEGRA) and fluoxetine (PROZAC), with known allergies to both. No other vaccine was received in four weeks. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Jun2021 19:00, the patient experienced Crohn's flare up, brain fog, fever, cramps and major abdominal pain, heart rate increased, and neck area twitching and in face. Adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit. No treatment received for AE. Outcome of events was recovering. Information about batch/lot number has been requested.
48 2021-07-01 impaired work ability, excessive sleepiness Stated that he had shot on May 15, 2021 and had flu like symptoms for 48 hours afterward (fever, bel... Read more
Stated that he had shot on May 15, 2021 and had flu like symptoms for 48 hours afterward (fever, belly aches, very tired-and slept for 14 hr.) Seven days later he noticed feeling dizzy, having chest pain described as very heavy feeling in chest, light-headed and exhausted. Had biometric screening done at work on 6/29/21 and began to "feel faint". BP 73/42. He layed supine on floor, took deep breaths and drank apple juice and felt better. He said he had gone to the ER on 6/28/21 with shortness of breath and chest pains. BP went up to 98/66 and he was sent home from work. He went to his family doctor who did x-rays and referred him to cardiologist. Has an appt. with Dr., cardiologist, on July 12, 2021.
48 2021-07-12 sleep disorder, insomnia I received my first Pfizer vaccine on March 30, 2021 at the store. On April 5 I was woken up at 3 AM... Read more
I received my first Pfizer vaccine on March 30, 2021 at the store. On April 5 I was woken up at 3 AM with a very loud ringing in my right ear. The ringing was so loud I couldn't sleep for 3 days. Since I've never had ear problems and had no hearing in my right ear I called my Dr. office. They referred me to an ENT Dr. He referred me to Audiology for a h earing test. The test showed my hearing in my right ear was greatly diminished compared to my healthy ear. I went to see my regular physician. He had me get an MRI at Hospital. Then I went back to the ENT Dr. and he is arranging a referral to have a BAER test to see if a hearing aid might help with this condition I'm suffering from almost 4 months after my vaccination. I still am having the nonstop ringing in my right ear. Dr. implied that he thinks my hearing problem may be permanent. I'm still currently waiting to have my BAER test referral to appointment.
48 2021-07-13 feeling abnormal, sleep disorder 48 year-old man referred for admission from outpatient echo appointment after finding of large peric... Read more
48 year-old man referred for admission from outpatient echo appointment after finding of large pericardial effusion. Patient's history includes iron-deficiency anemia from hiatal hernia and season allergies. Was in usual state of health until received second Pfizer mRNA Covid-19 vaccine 5/18/21. A few days later developed cough, 'brain fog,' dyspnea. Had remote outpt visit and treated with abx for sinusitis. Covid test was negative 5/28/21. Symptoms worsened and developed swelling of legs and abdomen, worse exertional dyspnea and had to sleep sitting up due to orthopnea. Began on lasix 20 PO BID as outpt with significant improvement in swelling and other symptoms over past week - thinks he lost 20 lbs. Still feels more bloated than usual. Had outpt echo as part of eval and sent to ED. Denies chest pain, palpitations, dizziness. Brain fog is improving. Mildly constipated. No black or bloody stools. No abd pain. PERICARDIAL EFFUSION (6/15/2021) Assessment: echo Large pericardial effusion noted mostly post and no echo evidence of tamponade. Smaller in size. no need for pericardiocentesis Discharge home on lasix 20 mg daily Net neg 5.4 L chest xray looks improved unbale to get thoracentesis due to not enough fluid Vitals stable
48 2021-07-17 feeling abnormal sudden strong dizzy feeling while walking/ light headed feeling; felt off; This is a spontaneous rep... Read more
sudden strong dizzy feeling while walking/ light headed feeling; felt off; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 30Mar2021 at 12:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included eszopiclone (LUNESTA) 3mg and cetirizine hydrochloride (ZYRTEC) as OTC, daily night time. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 20:30, the patient experienced sudden strong dizzy feeling while walking. It was reported that, the patient was cleared, felt off (feeling abnormal) and slightly light headed. Light headed feeling was persisting, slightly dizzy almost like the patient could become nauseous but not. Slightly dizzy was persisting. The adverse event did not result in doctor/other healthcare professional office or clinic visit/emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of event sudden strong dizzy feeling while walking/ light headed feeling was not resolved and felt off (feeling abnormal) was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-17 insomnia trouble sleeping; Fatigue,; general muscle soreness all over; injection site soreness; skin redness ... Read more
trouble sleeping; Fatigue,; general muscle soreness all over; injection site soreness; skin redness at injection site; headaches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (at the age 48-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, GERD and sleep apnea. The patient was allergic to casein and dust mites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), paracetamol (TYLENOL), pravastatin (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and ESCILOP, all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 01Mar2021 at 10:30 (at the age 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 23:00, the patient experienced fatigue, general muscle soreness all over, injection site soreness, skin redness at injection site, headaches and had trouble sleeping. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment with paracetamol (TYLENOL) for the events fatigue, general muscle soreness all over, injection site soreness, skin redness at injection site, headaches and trouble sleeping. The clinical outcomes of the events fatigue, general muscle soreness all over, injection site soreness, skin redness at injection site, headaches and trouble sleeping were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
48 2021-07-17 insomnia Moderate chills; Difficulty sleeping; Mild headache; Mild injection site pain; This is a spontaneous... Read more
Moderate chills; Difficulty sleeping; Mild headache; Mild injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 03Mar2021 at 13:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 12:00, the patient experienced mild injection site pain, also experienced the same on 25Mar2021. On 26Mar2021, the patient experienced moderate chills, difficulty sleeping and mild headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of vaccination site pain, chills, difficulty sleeping, headache and included treatment with TYLENOL. The clinical outcomes of the events vaccination site pain, chills, difficulty sleeping and headache were resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
48 2021-07-17 sleep disorder, loss of personal independence in daily activities, feeling abnormal heaviness that feels like he needs to cough/Kind of heaviness on my chest like I have to cough or so... Read more
heaviness that feels like he needs to cough/Kind of heaviness on my chest like I have to cough or something; every joint hurts and aches; He also has headache, nausea which was on and off; He also has headache, nausea which was on and off; trouble sleeping because of the neck and joint pain; having trouble sleeping because when he lays his head on the pillow, because his neck is hurting, it's very uncomfortable to sleep at night; he was in so much pain that he can't work; feeling awful/miserable; its like every joint and muscle in his body, he literally feels everything and it aches; cough; that his muscles just kind of tense up from lack of sleep; he's so tired; unable to work; This is a spontaneous report from a contactable consumer (patient) and nurses via Medical Information Team. A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 11Jun2021 13:00 (Batch/Lot Number: EW0167) (at the age of 48-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no prior vaccinations in 4 weeks. Medical history included high blood pressure for years and high cholesterol about 2, maybe 3 years ago. Family history also includes high blood pressure and high cholesterol, both on his dad's side and also reported that diabetes was really high on his dad's side of the family. Ongoing concomitant medications included lisinopril taken for blood pressure and atorvastatin taken for cholesterol. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8736) administered in left arm on 21May2021 (at the age of 48-year-old) as DOSE 1, SINGLE for covid-19 immunization where patient experienced arm just got a little swollen from 22May2021 to May2021; also received flu shots and pneumonia shots for immunisation and never had any problems. He received the second dose of the bnt162b2 on 11Jun2021 and the next day or 12Jun2021, he said that every joint hurts and aches. He also has headache, nausea which was on and off, heaviness that feels like he needs to cough, and trouble sleeping because of the neck and joint pain. He said that he was unable to work. He had COVID pay for the first 2 weeks but in the third week he's not getting paid. Starting on Sunday he stop getting paid. He wanted to know what he needs to do and how long the symptoms will last. He already contacted his doctor and was advised to call Pfizer because his doctor doesn't know what to do either. He was asking if his doctor can call Pfizer. Additionally, patient reported that he has been seeing his doctor for about 3 weeks now and his doctor does not know what to do, so he advised the caller to contact Pfizer. Patient reported that he got his first dose of the Covid-19 vaccine back in May2021 and then 3 weeks later, he came in on 11Jun2021 and got the number two shot. Patient got the number two Covid-19 shot on 11Jun2021. Patient reported that he came home, everything was fine, he woke up the next morning, and he's been feeling god awful for 3 weeks. Patient stated that basically what was happening was, its like every joint and muscle in his body, he literally feels everything and it aches. He stated that every joint and muscle in his body he literally feel everything and it aches: patient reported that the only way he can describe it was when you've been in a car ride for many hours and you get the leg jerks. That's what his entire body feels like. Patient reported that his shoulder are and then going up his neck, that's where the aggravation was so bad that it actually hurts. Patient reported that he was having trouble sleeping because when he lays his head on the pillow, because his neck was hurting, it's very uncomfortable to sleep at night. Also, patient has had a mild headache this entire time. Patient reported that every once in awhile, the headache will actually get worse. When the headache gets worse, he can literally feel the blood pumping in his temples. That's how bad it gets. The headache getting worse has only happened a couple of times. He has had a mild headache for 3 weeks now. The patient also reported that he has had nausea and a kind of heaviness on his chest like he has to cough or something. Patient reported that from talking to his doctor, the first thing that he had the patient do was take another Covid test. Patient reported the Covid test came back negative. Patient reported that his doctor then turned around and had him to see the practices urgent care. Patient reported that the doctor from urgent care said that, most likely from the way it was sounding, most side effects of the Covid-19 vaccine either happen immediately or within 12 hours. Patient reported that the urgent care physician informed him that the patient going to bed the night of 11Jun2021 and waking up the next morning and feeling awful, that coincides with possible side effects to the Covid-19 vaccine. The urgent care physician informed the patient that the side effects were going to last roughly 2 weeks. Patient reported that its been past 2 weeks and he's still feeling miserable so he went back to the doctor Monday, 28Jun2021, and his physician ran some blood tests. Patient reported that his physician did a complete blood count (CBC), sedimentation (sed) rate, and also did an electrocardiogram (EKG). Patient reported that his sed rate was elevated but all his other stuff looked pretty decent. Patient reported that he called his physician's nurse and asked what they do now because the caller was still in a lot of pain. Patient reported that his physician's nurse stated that he had not heard of anyone having these kinds of side effects and stuff, and recommended that the patient contact Pfizer. Patient reported that his physician's nurse gave him the number for Pfizer and instructed the caller to call and ask what Pfizer thinks he should do. Patient reported that he only got Covid pay for 2 weeks at work, and since this is his third week off, he was not getting paid. Patient stated that whatever he needs to do to get better because he needs to go back to work as he has a wife and child to support. Patient reported that right now he was in so much pain that he can't work. Caller stated so we've got to figure something out. Furthermore, patient reported that he has been experiencing nausea off and on. Patient reported that his physician gave him these pills that dissolve in your mouth. When he talked to the doctor about it, he said they're nasty but they give those to people that are recovering from cancer. His physician instructed him not to be alarmed, but it was just the best medicine they could give him to get rid of the nausea. The medication instructions state not to take the medication with water and let it dissolve in your mouth, but it just tastes nasty so he takes it with water. Patient reported that the nausea was getting slightly better. Patient reported that at first, he was so nauseous that he was afraid to eat anything. Patient reported that now he gets a little nauseous when its time to eat but as soon as he eats he feels better, so he's not having to take those dissolving pills as much anymore. Patient reported that he was prescribed Ondansetron 8 mg. Patient reported that the urgent care physician also prescribed him Fluticasone 50 mcg spray, 16 count. The patient also reported that he was having trouble sleeping because when he lays his head down on his pillow, it puts pressure on his neck and it hurts. Patient reported that he was only averaging 5-6 hours of sleep per night. Patient reported that his trouble sleeping was basically the same. Patient reported that since he's not working, he has been sleeping on and off all day long. Patient reported that he has been having some car trouble and needs to get new tires and brakes on his car, but he hasn't been able to do it because he's so tired. The patient also reported that the heaviness on his chest was why his doctor did an EKG. Patient reported that he tried telling his doctor that for years, every time his chest gets tight its normally because of lack of sleep. Patient reported that his muscles just kind of tense up from lack of sleep. Patient reported that his doctor informed him that they just wanted to check him out anyway. Furthermore, patient reported that his physician ran a CBC and there was one thing that was slightly above the green. Patient reported that the way his physician was acting with all the others, he was not concerned about it. Patient reported that his sed rate was 28 and the normal was 0-15. Patient reported that his physician instructed him not to be concerned about the result. Patient reported that he asked if his physician was sure the result was ok as his sed rate was almost double the normal range and his physician instructed him not to freak out and informed the patient that he was not concerned. CBC on 28Jun2021 showed the following results: white blood cell (WBC): 9.3, red blood cell (RBC): Within green range; Hemoglobin: Normal; Hematocrit: Normal; mean corpuscular volume (MCV): Normal, patient reported it was lower on the green scale; mean corpuscular hemoglobin (MCH): normal; mean cell hemoglobin concentration (MCHC): Normal; red distribution width (RDW): patient reported that between 11 and 15 was normal and his was 15.7, so it was slightly up; Platelets: 253; mean platelet volume (MPV): 8.1; Neutrophils: 68; Lymphocytes: 24; Monocytes: 6; Eosinophils: 2; Basophils: 0; Absolute (Abs.) Neutrophil count: 6.31; Abs. Lymphocyte count: 2.2; Abs. Monocyte count: 0.51; Abs. eosinophil count: 0.2; and Abs. basophil count: 0.03. The patient also reported that his Covid-19 test was collected on 15Jun2021 and he got the results on 17Jun2021. Patient reported that the results stated SARS Cov-2 not detected. Patient reported that he had a Zoom call with his physician and his physician instructed the patient to go get tested for Covid. Patient reported that the test results came back negative and his physician instructed him to come into the office, but it was Thursday night and there were no appointments for the next day. Patient reported that his physician instructed him to go to urgent care. Patient reported that when he went to urgent care, the physician informed the patient that him getting the Covid-19 vaccine and waking up the next day coincides with what they've seen with side effects. Patient reported that the physician informed him that he would be miserable for 2 weeks, some people feel better sooner and some people it takes longer, but the average length of time for side effects was 2 weeks. The events "every joint and muscle in my body I literally feel everything and it aches, headache, nausea, heaviness on chest" did not require emergency room visit, but did require physician office visit. Additionally, the nurse reported that the patient said that they have the ongoing symptoms and patient was frustrated and he wanted to know what was causing the patients symptoms. He has ongoing joint aches, Headache, nausea on and off, neck pain, and cough. The doctor has run tests and labs, showing nothing and was asking. The outcome of the event nausea was recovering; outcome of feeling awful/miserable and tiredness was unknown, while outcome of the rest of the events was not yet recovered.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
48 2021-07-21 abnormal dreams, excessive sleepiness Interesting dreams while sleeping perhaps from extra sleep.; Interesting dreams while sleeping perha... Read more
Interesting dreams while sleeping perhaps from extra sleep.; Interesting dreams while sleeping perhaps from extra sleep.; Blotchy face and blotchy around neck; Redness or flushed; Sore arm at injection site; Very tired; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6455 or EP6955), via an unspecified route of administration in the right arm on 20Mar2021 at 09:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergy and COVID-19. The patient did not receive any other medications in two weeks. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 at 09:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 21Mar2021 at 09:00, the patient experienced sore arm at injection site, redness or flushed, blotchy face, blotchy around neck, very tired and interesting dreams while sleeping perhaps from extra sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore arm at injection site, redness or flushed, blotchy face, blotchy around neck, very tired and interesting dreams while sleeping perhaps from extra sleep were recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-22 sleep disorder All other symptoms, like headache, muscle pain, dizziness, were gone 1 week after the shot (this is ... Read more
All other symptoms, like headache, muscle pain, dizziness, were gone 1 week after the shot (this is the second shot). But starting from 2 weeks after the shot, I started to have tinnitus in my right ear, then my left ear. The ear ringing is high pitched. Its magnitude will increase along with the background noise. It's affecting my sleep and mood a lot.
48 2021-07-27 memory impairment fever; Chills; headache; Body Aches; forgetting stuff worsening; This is a spontaneous report from a... Read more
fever; Chills; headache; Body Aches; forgetting stuff worsening; This is a spontaneous report from a contactable consumer (male patient reported for himself). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 (at the age of 48-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included allergies, migraines, nerve pain, acid reflux, JC levels getting too high, ongoing pneumonia, ongoing COVID-19. The patient concomitant medications included teriflunomide (AUBAGIO), hydrocodone bitartrate, paracetamol (NORCO), gabapentin, omeprazole (PROTONIX), azelastine, fluticasone propionate (FLONASE ALLERGY RELIEF), montelukast sodium (SINGULAIR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), allergy shots. The patient experienced fever, chills, headache, body aches, forgetting stuff worsening on 18Mar2021. The patient underwent lab tests and procedures which included JC levels getting too high. Outcome of the events was recovered on an unspecified date in 2021. No further information was reported. Information on lot/batch number has been requested.
49 2021-01-05 feeling abnormal, anxiety after 5 minutes states her fingers felt weird -numb and felt like her hear was racing, very anxious ... Read more
after 5 minutes states her fingers felt weird -numb and felt like her hear was racing, very anxious started to hyperventilate. Took her to ER via WC . During transfer stated her fingers were twisting (noticed definite contractures in both hands. States her heart was beating very fast. Denies any allergies but did states she has history of low potassium and has had issues with medications nad vaccines in the past. However no sx like this but does get "a little loopy" even when taking motrin. Instructed her to notify any provider prior to any vaccinations of the above sx. If I would have know any off this I would have highly recommended her to get authorization from her PCP prior
49 2021-01-07 poor quality sleep approximately 5" after receiving injection, headache developed. Progressively got worse within 30",... Read more
approximately 5" after receiving injection, headache developed. Progressively got worse within 30", rated 6/10. described as "felt like the Hulk was squeezing the back of my neck". Returned back to CVCU and coworkers commented on how red he looked- "face and arms were red like he had just ran a marathon, but not blotchy or rash". HIs entire arm began hurting and has been hurting and waking him up every night and needing repositioned several times throughout the night. L arm shakes/tremors, constantly - described incident where he was holding a plate at home a few days after injection and his left arm involuntary shook, uncrontrollably.
49 2021-01-08 feeling abnormal employee received Pfizer Covid vaccine 12/28/20 afternoon 2:30 PM at 2:45 PM, he began feeling "odd"... Read more
employee received Pfizer Covid vaccine 12/28/20 afternoon 2:30 PM at 2:45 PM, he began feeling "odd". States he felt chilled, but no fever states he "could not warm up" Whole body felt bad had 2 to 3 hour episode of diarrhea symptoms lasted 2 days, then he felt better
49 2021-01-10 anxiety The reason I'm reporting is that how I felt was similar to my sensitivity to Claritin: increased lev... Read more
The reason I'm reporting is that how I felt was similar to my sensitivity to Claritin: increased level of alertness, difficulty falling asleep; minor anxious feeling with diastolic BP in low 90's/ high 80's( usually in 70's) on home electronic BP cuff, and increased feeling of feeling my heart beat in my chest. It's now 6 days later and I feel about 50% better, but with continued elevated diastolic BP at similar levels.
49 2021-01-11 sleep disorder rash/ super itchy at night; maculopapular rash; he can not sleep great; This contactable physician r... Read more
rash/ super itchy at night; maculopapular rash; he can not sleep great; This contactable physician reported similar events for two patients. This is the first of two reports. This physician which was a 49-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899), via an unspecified route of administration on the right deltoid 17Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient stated that he received the first dose of the COVID vaccine and he had a pretty bad rash that started 3 days after (noted on 20Dec2020). The rash has since improved since it started but it took forever to improve and mentioned that he was super itchy at night. He also used to be itchy in the day, but now it was just at nigh which was driving him insane. The physician also mentioned that it was a raised maculopapular rash. It started on his neck on the left side as well and increased of both elbows and behind his knees (it was diffuse). He mentioned that he was able to carry on during the day, but he cannot sleep great. He mentioned that it reminded him of poison ivy - the thought of it happening again makes him want to cringe especially with all the terrible stuff he has seen he was scared that his skin will slough off or its going to kill him or something. But overall, he was more concerned about the itching. The physician took over the counter antihistamines and hydrocortisone cream. He did take one dose of expired liquid prednisone (from 5 years ago that his daughter who had for an ear infection). He downed a sip of prednisone and it prevented his itchiness for a day and now was thinking of getting on steroids. The physician also stated that there was one guy he worked with had something similar (AER 2021010285). He received the same lot number and has been itching like crazy. They have both been trying to figure out what to do. It was clear as mud. Then, last week (Jan2021) they saw each other, and they were both having the same issue and suffering separately. They had no exposure to anything similar besides the vaccine. The physician stated that he was about due for 2nd shot. He has been researching and trying to figure out what to do, if he should get the second dose or not. He reported this to VAERs and talked to CDC, but nobody has any recommendations or information. He also tried to look up trial data to see if anyone had reported a similar rash, and he did not find anything. He was calling to see if he should get the second dose, and if Pfizer has any information on this rash being reported. Outcome of pruritic rash was not recovered; recovering from maculopapular rash and unknown for the remaining event. As per causality: He was unsure. It was most likely from the vaccine as he has done nothing differently.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021010285 same reporter/drug, similar events, different patient;US-PFIZER INC-2021010285 same reporter/drug, similar events, different patient
49 2021-01-12 fear, confusional state Confusion, Headache, Myalgia, Arthralgia, SkinRash, CoughWheeze, Rash, UrticariaPruritus, NauseaVomi... Read more
Confusion, Headache, Myalgia, Arthralgia, SkinRash, CoughWheeze, Rash, UrticariaPruritus, NauseaVomiting Narrative: Employee reports he was so ill he thought he was going to die. He is very fearful of getting second vaccination. He currently is refusing to get it.
49 2021-01-16 feeling abnormal Pfizer-BioNTech COVID-19 Vaccine EUA on 1/15/21 at 8:00 p.m. On 1/16/21 I had body aches in the morn... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA on 1/15/21 at 8:00 p.m. On 1/16/21 I had body aches in the morning. I had increasing chills and shivering in the afternoon. My temperature was 102.5 degrees by 6 p.m. with severe body aches. On 1/17/21 my temperature was 99.5 in the morning and 98.3 in the afternoon with continued body aches. I had an uncommonly large bowel movement in the morning and needed to make about 5 more trips to the bathroom due to a small amount of loose stool. I felt lightheaded and spacy in the afternoon and evening.
49 2021-01-20 anxiety Increased level of alertness; Difficulty falling asleep; Increased diastolic blood pressure(high 80'... Read more
Increased level of alertness; Difficulty falling asleep; Increased diastolic blood pressure(high 80's/low 90's) which is usually in 70's; feeling heart beat in chest; Minor anxious feeling; This is a spontaneous report from a contactable other HCP (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no: EK9231, expiry date: unknown), via unspecified route of administration on left arm on 05Jan2021 08:15 at a single dose (1st dose) for Covid-19 immunization. The patient received the vaccine in a hospital. There were no other vaccine administered in the last four weeks. The patient's medical history included penicillin allergies, seasonal asthma, and increased cholesterol. Concomitant medications included Fish oil, D3, Vitamin C, Bilberry, Chromium. On 05Jan2021 20:15, patient experienced increased level of alertness, difficulty falling asleep, increased diastolic blood pressure(high 80's/low 90's) which is usually in 70's feeling heart beat in chest and minor anxious feeling. There was no treatment given for all reported adverse events. It was unknwon if patient had COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of all events was recovering.
49 2021-01-22 poor quality sleep Aching joints at 8p.m. followed by severe chills through the night. After restless sleep, woke with ... Read more
Aching joints at 8p.m. followed by severe chills through the night. After restless sleep, woke with headache, body aches, general fatigue through the next day.
49 2021-01-25 insomnia Received the vaccine on 01/20/21.Patient reports on 01/21/21 started having myalgia throughout his ... Read more
Received the vaccine on 01/20/21.Patient reports on 01/21/21 started having myalgia throughout his body and fatigue. He had difficulty sleeping due to discomfort. Reports vomited x1 on 01/20/21. He reports that he noticed DOE on 01/21/21 and SOB with in one block of walking. Asthma wise: takes ventolin/combivent with no relief of symptoms. Reports he is specifically having pain in his lungs/pleuritic in nature worse with coughing/sneezing, went to the ER on 01/22/21.Chest xray,EKG and blood work were done. Xray and,EkG were normal with blood work showing anemia. Treated with IV pain medication with relief and D/C home with advise to take Nebulizer at home.
49 2021-02-02 anxiety 49 year old male, history of hypertension and high cholesterol 3:15 Vaccinated 3:25 complained of f... Read more
49 year old male, history of hypertension and high cholesterol 3:15 Vaccinated 3:25 complained of feeling lightheaded and anxious, escorted to medical tent 3:35 BP 153/88, P 108, 02 96% now complaining of chest pain 6/10 O2 via nasal cannula, EMS notified One paramedic placed monitor 3:45 BP 153/88, P 108 ? O2 100% 4:05 EKG rate- 104, possible L atrial enlargement 4:12 Staff arrived and ordered transport to hospital 4:20 Transported
49 2021-02-03 feeling abnormal headache; body aches; fatigue; fever; nausea; vomiting; brain fog; chills; This is a spontaneous rep... Read more
headache; body aches; fatigue; fever; nausea; vomiting; brain fog; chills; This is a spontaneous report from a contactable health professional, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EJ1685), via an unspecified route of administration on 18Jan2021 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included an unspecified multivitamin, as well as levothyroxine sodium (SYNTHROID), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), fish oil/tocopheryl acetate (OMEGA 3). The patient did not receive any other vaccine within 4 weeks of the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020 (at the age of 49-years-old) for COVID-19 immunization. On 19Jan2021, the patient experienced headache, body aches, fatigue, fever, nausea, vomiting, brain fog, chills. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of experienced headache, body aches, fatigue, fever, nausea, vomiting, brain fog, chills was resolved on an unspecified date in Jan2021. No follow-up attempts are possible. No further information is expected.
49 2021-02-04 abnormal behaviour, feeling abnormal oxygen dropping to 89; causing me to have breathing problems; heavy breathing when I walked and wore... Read more
oxygen dropping to 89; causing me to have breathing problems; heavy breathing when I walked and wore the mask; sensitivity to the cold; had instances where I felt an unusually high chill on my chest and wavy feeling; fever rising as high as 100.4; had instances where I felt an unusually high chill on my chest and wavy feeling; was told that I looked red; Had soreness on site the night of the injection; headaches; tiredness; This is a spontaneous report from a contactable contactable consumer (patient) . A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at left arm on 14Jan2021 14:30 at SINGLE DOSE for COVID-19 immunization.Medical history included Type one diabetes, obesity, high cholesterol.No COVID prior vaccination . Facility where the most recent COVID-19 vaccine was other .The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. No Concomitant medications reported.Clincal course was reported as follows: on 14Jan2021 I had soreness on site the night of the injection, had headaches, tiredness, and was told that I looked red and was not myself beginning on the next day. I have had sensitivity to the cold, which I never had before, and heavy breathing when I walked and wore the mask. I had instances where I felt an unusually high chill on my chest and wavy feeling, causing me to have breathing problems. I have had fever rising as high as 100.4, and oxygen dropping to 89. The events were reported as non-serious. The patient went to Emergency room/department or urgent care and was treated with Prednisone, inhaler and Tylenol.The patient had been tested for COVID post vaccination (Nasal Swab(20Jan2021) :unkonwn results).Outcome of the events was recovering. Information on lot/batch number has been requested.
49 2021-02-15 memory impairment, feeling abnormal 1/6/2021 vaccination; Later that afternoon, I started to go into a 'fog', tired, HA. I could functi... Read more
1/6/2021 vaccination; Later that afternoon, I started to go into a 'fog', tired, HA. I could function but nothing seemed 'clear' or 'sharp', 1/7/2021 fatigue, arm sore. The 'fog' was worse; 1/8 fog was really bad; forgetting conversations. 1/9 2:45 in morning. Went to bathroom. Walking, about 1/2 way there, felt like a 'spike' and instant HA. I went to bathroom, door closed, I got sick/vomiting. The shiver, shakes, and fever spiked. I bent down to throw up and I cant relieve. I fell into the wall, pushed self to stand up. Was back in bedroom, laying on floor and passed out. Wife woke me, I was bleeding. Don't know how long I was on the floor. BP144/78, 133 blood sugar, O2 was 98%, temp 98.1. 3:45 I decided to go to hospital, EKG, CT scan, Xray, etc. 'Just fainted' *PCP stated it was due to shot / vaccine. **busted lip, ER bill ***2nd vaccine; minor side affects (slight HA, )
49 2021-03-01 abnormal behaviour Early Wednesday morning (2/24) around 5:00AM, I woke up to extreme pain in my left arm, primarily al... Read more
Early Wednesday morning (2/24) around 5:00AM, I woke up to extreme pain in my left arm, primarily along the upper forearm, inside of my elbow, and lower bicep. There was no trauma or unusual behavior prior to onset of pain. It came on suddenly and worsened with extension of the arm. Symptoms worsened over the next few days, with pain intensifying and extending down into my hand and up into my armpit and shoulder. I tried ice, Ibuprofen, Acetaminophen, and Vicodin for pain relief, but nothing really helped other than the ice. On Saturday morning (2/27), I visited Urgent Care and was diagnosed as brachial plexis neuritis, aka Parsonage-Turner Syndrome by Dr and prescribed Prednisone and rest. On Sunday evening (2/28), I went to the ER seeking pain relief and second opinion. On Monday (3/1) morning, I was seen by ED doctors, and then three different neurologists. After doing an ultrasound which ruled out vein/artery thrombosis, the neuro team diagnosed Parsonage-Turner Syndrome. They've prescribed Gabapentin, Acetaminophen, and Ibuprofen for pain relief, a follow-up neuro consult, an MRI for next Friday, and an EMG in a few weeks. Last night while sitting and reading, the same pain began in my right arm, similarly to how it presented in my left arm last week. The right arm pain is less than the left arm pain, but at this point seven days later, I am experiencing neuropathic pain in both arms.
49 2021-03-01 loss of personal independence in daily activities Decreased sensation from chest/abdomen through lower extremities, diminished strength and mobility ... Read more
Decreased sensation from chest/abdomen through lower extremities, diminished strength and mobility of left side. Symptoms started approximately 24 hours after receiving the vaccine starting with decreased sensation in the lower extremities . 02/14/2021 I started experiencing weakness on the left side. 02/16/2021 symptoms progressed to limited movement on the left side preventing ability perform normal daily functions and digestion was effected.
49 2021-03-06 sensation of foreign body Developed prickly feeling and slight rash...perhaps some mild hives about 11 hours after the vaccine... Read more
Developed prickly feeling and slight rash...perhaps some mild hives about 11 hours after the vaccine. I also felt like I had a bit of a lump in my throat. I called the Doctor's office and spoke with a nurse who suggested I take Benadryl. I did so at around midnight and that seemed to take care of things. Went to bed and woke up the next morning feeling ok (though groggy from the Benadryl).
49 2021-03-10 anxiety Pt very anxious after receiving the pfizer covid vaccine c/o itchy throat and chest tightness. VSS ... Read more
Pt very anxious after receiving the pfizer covid vaccine c/o itchy throat and chest tightness. VSS on RA color pink throughout. Pt encouraged to take deep breaths and relax. Given water to drink. Tolerated well. Then given Benadryl 25 mg PO and observed for 15 mins more. Pt calmed down and denied further symptoms and went home without issue.
49 2021-03-14 feeling abnormal On the day of the shot I had a little soreness in my arm but on day 2 I couldn't lay down on that ar... Read more
On the day of the shot I had a little soreness in my arm but on day 2 I couldn't lay down on that arm because it hurt. For 4 days I had to have a nap during the day because I ran out of energy. However, since that shot I feel like I have been living in a "brain fog" because I can tell I'm processing things slower and it's not getting better.
49 2021-03-18 mental status changes fever, altered mental status, aseptic meningitis.
49 2021-03-18 sleep disorder A few days after the shot I experienced persistent swelling and pain in the hard palate directly beh... Read more
A few days after the shot I experienced persistent swelling and pain in the hard palate directly behind the incisors, extending back about an inch. It was as if I'd burned my mouth with hot coffee. Pain was intense enough to wake me at night and make eating solid food difficult. I had to use topical benzocaine to get through meals. The episode lasted a full week before subsiding.
49 2021-03-25 disturbance in attention Upset stomach...no nausea. Headache, difficulty concentrating with loss of focus
49 2021-03-25 feeling abnormal, sleep disorder Had a very strong erection through night most of the morning; Very horrible side effects; very unusu... Read more
Had a very strong erection through night most of the morning; Very horrible side effects; very unusual side effects, Was pretty crippling; Lost my voice; Left groin is terribly painful; I go urinate and it would come back; was very really weird; Groin is so tender; Leg is uncomfortable; couldn't walk/Balance was off; I was on the floor; couldn't even make me anything to eat; Lethargic; I pee pretty frequently; Head, the base of head is very uncomfortable; Had sweats last night really strong; Couldn't sleep; Left buttock and all the way down to my toes was extremely painful; Body aches and chills; Glands swollen; Headache; Sick most of the day; This is a spontaneous report from a contactable consumer. A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 15:00 (Batch/Lot number was not reported) at singe dose for covid-19 immunisation. Medical history included genital herpes, TBI (Traumatic brain injury), chronic laryngitis, low blood pressure, seasonal allergy, appendix taken out, sinus surgeries, no sense of smell, tonsils removed, allergy. It was reported that he got her vaccine (unspecified Vaccine) Friday afternoon at 3 o'clock pm mountain standard time. He was fine on Friday and Saturday, he was horrible, very horrible side effects, that's why he thought he need to call, very unusual side effects he had typical, he was really struggling to talk today. On on 19Feb2021 23:00 he lost my voice, my glands were swollen, body aches he experienced. He got my shot in my left arm, my left buttock and all the way down, all the way to my toes was extremely painful and it cuts through my groin area. My left groin which is terribly painful. patient left buttock, all the way down to the toes extremely painful and that continued into my groin. And he had erection, he had a very strong erection through night, most of the morning. He go urinate and it would come back that was very really weird. That was when he knew it was really weird. And he knew that Pfizer was the one that makes Viagra. And my groin is so tender. When he pee, he pee pretty frequently. He think that was the most unusual side effects. His head, the base of my head was very uncomfortable. He had sweats last night really strong. Today, he woke up, he could not sleep, he went to the bed early. He had no energy today, he was doing a lot (not clarified over the call). He do have a headache today and obviously my voice hasn't come back completely and my leg is uncomfortable, he couldn't walk he was like if he was drunk yesterday, he couldn't, my balance was off. He was on the floor. He couldn't even make me anything to eat. It was pretty crippling that it made me feel like. He was very lethargic and he was sick most of the day. he was just hoping to give you information. He waited for long time on the phone to share experience. I hope this information helps you, I mean the other people if having the same problems or maybe not. Consumer also stated, he cannot locate the card that was given to me. He could not locate today. He was doing my laundry today maybe it is in my pocket. he dig into my pocket, he guess could not find it. They gave me card but he was not sure if he had it. Date when started experiencing the events: Consumer stated, I would say the date of the vaccine 19Feb2021. It probably towards the evening, I would say late at about 11 o'clock. Still experiencing Consumer stated, I am experiencing mild headache. I am experiencing dull pain at the base of my neck. I am experiencing the tenderness in my left groin. I am experiencing a little pain when I pee. I am experiencing a little bit of body aches, chills. I haven't fully gotten my voice back. I feel so sick. The erection has subsided but my penis is painful, it is uncomfortable. For treatment Consumer stated he did today he took this afternoon about maybe 3 pm, he took 4 Ibuprofen. Outcome of the event had a very strong erection through night most of the morning was recovering, outcome of the events lost my voice, left groin is terribly painful, groin is so tender, left buttock and all the way down to my toes was extremely painful, body aches and chills, headache not recovered. Outcome of the other events unknown. Information about lot/batch number has been requested.
49 2021-03-31 impaired work ability Severe nausea and vomiting, headache, ear/neck pain, ear infection, eye infection, blisters in and a... Read more
Severe nausea and vomiting, headache, ear/neck pain, ear infection, eye infection, blisters in and around nose, eye, face, scalp, vision loss, inability to read/work 2+ days.
49 2021-04-01 irritability Loss of taste, smell Achy Fever and shakes Loss of appetite Irritability Lethargy
49 2021-04-05 restlessness Extreme sweats Chills Severe Headache Cough Sinus issues Restlessness Has taken over the counter ... Read more
Extreme sweats Chills Severe Headache Cough Sinus issues Restlessness Has taken over the counter meds - not helping
49 2021-04-06 feeling abnormal Numbness on side of face and cheek/numbness went from his cheek up on to the temple area and jaw are... Read more
Numbness on side of face and cheek/numbness went from his cheek up on to the temple area and jaw area; Mouth pulls weird; Previous nerve damage in his neck that hadn't been acting up in about a year but it was acting up now; Previous nerve damage in his neck that hadn't been acting up in about a year but it was acting up now; Felt loopy; Some weird palsy going on in his face/mild palsy in the left side of the face/Felt like face was heavy on left side or drooping/left side of his face was sagging; This is a spontaneous report from a contactable consumer reporting for himself. A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), via an unspecified route of administration on 23Mar2021 14:40 at single dose for COVID-19 immunization. Medical history included he had some previous nerve damage in his neck that had not been acting up in about a year. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (Lot Number: EL9269) on 02Mar2021 for COVID-19 immunization. On 24Mar2021, patient had some facial numbness and mild palsy in the left side of the face. He stated he had some previous nerve damage in his neck that had not been acting up in about a year, but it was acting up then. He stated it was the feeling like when you go to sleep on something, and it felt heavier. He asked what he should do, if he should seek medical attention and for information on this. After providing information from the Prescribing information, he asked if the Bell's Palsy went away in these individuals in the clinical trials? He stated his wife just said that the left side of his face was sagging. He stated he did not think it was a stroke though because he could move that side of his face and can articulate everything. He felt loopy but did not feel like it was a stroke. Patient reported that basically he felt numbness on the side of his face and cheek. There were reactions when he smiled, it seemed a little bit off. There was a weird feeling and numbness in his face. The numbness went from his cheek up on to the temple area and jaw area, the numbness was primarily on the left side of his face. Patient had nerve damage in his neck already. Patient wanted to know if he should go somewhere with it, was it ok, what was going on with the numbness in his face. Patient thought the numbness in his face and cheek had worsened. Felt like face was heavy on that side or drooping: Caller reported that looking in mirror, the left side of his face did not react the same. Patient's face felt like it was heavy or drooping on the left side, but that it pulls up higher. Patient reported that his face looked ok. Mouth pulls weird: Patient reported that this could be from his prior nerve damage, it was like he had got some weird palsy going on in his face. Patient stated that he just wanted someone to tell him dude wait it out, go to the emergency room, go to the doctor. Patient inquired if the facial numbness was because he had prior nerve condition and if the Covid-19 vaccine had exacerbated his existing nerve condition. The outcome of the events were unknown.
49 2021-04-07 disorientation He got the vaccine, 15 minutes later he got very fatigued, could not walk in his house and could bar... Read more
He got the vaccine, 15 minutes later he got very fatigued, could not walk in his house and could barely make it to the bed and had to lie down. He had headache, nausea, disoriented. Then he went to bed, woke up at 9:00 AM and had a seizure, which he has had in the past but it had been over a year. He rested after the seizure and knew what to do and it took 2-3 days to recover from that due to the weakness in the legs, disoriented. He has gotten stronger and is pretty much back to his normal self. He has not had any additional seizures since then. He had his FU physical today and she is aware of the seizure and told them to report the incident.
49 2021-04-08 amnesia, mental impairment Rash all over my body that looks like chicken pox, which started in my hair. I have a bad patch betw... Read more
Rash all over my body that looks like chicken pox, which started in my hair. I have a bad patch between my breasts. It itches horribly. Severely tired. My body, especially my ears and face, have this feeling of being on fire occasionally. Stomach upset with diarrhea that hits suddenly. Horrible headache. Skin is extremely itchy and dry. I cannot think. Memory loss.
49 2021-04-08 feeling abnormal I went with my wife, whom we were more concerned about possible reactions to the vaccine given her h... Read more
I went with my wife, whom we were more concerned about possible reactions to the vaccine given her history of anaphylaxis reactions to bee and wasp stings, has had to carry a Epi-pen always, so we stayed an additional 15 minutes for 30 minutes total before we left. She was completely fine throughout, I however as we were walking out I began to feel a little ?Off?, not necessarily nauseous or dizzy, just a bit Off. Told my wife that and that I wasn?t sure I should drive us home (I drove us there), so she drove. About 15-20 minutes into the drive, it got worse and I passed out. My wife says my eyes rolled in the back of my head with my eyes open but no responsive. She says she kept hitting my chest but I didn?t respond. I came to about 2 minutes after passing out. She asked me if I felt like I needed to goto the hospital, I told her I needed to eat, that I felt like what I needed was food, then we go from there. I did eat breakfast, an English muffin at about 8am that morning, it was almost 12:30 by that point. When I finally got food in me I felt much better and have had no adverse reactions since.
49 2021-04-09 feeling abnormal, disturbance in attention, insomnia, memory impairment 3/30/21 at 1:30 am until 4/1/21 approximately noon: 103 F fever, chills, joint aches, extreme fatigu... Read more
3/30/21 at 1:30 am until 4/1/21 approximately noon: 103 F fever, chills, joint aches, extreme fatigue, loss of appetite, difficulty sleeping, headache, brain fog. 4/1/21 until present: tachycardia / racing heart rate as high as 125 bpm, feeling flushed as though I have sunburn but without any sun exposure, forgetfulness / trouble focusing / brain fog , Insomnia and frequent awakenings from sleep, feeling dehydrated and head achy or thirsty frequently, more frequent than normal urination, urine clear or pale yellow.
49 2021-04-10 disturbance in attention I felt general fatigue, found it difficult to concentrate, and had a low-grade fever. I spent most o... Read more
I felt general fatigue, found it difficult to concentrate, and had a low-grade fever. I spent most of the day resting and took some ibuprofen. The symptoms lasted less than 24 hours. I was fine the next day.
49 2021-04-11 anxiety Within 10 minutes patient with complaints of shortness of breath, tongue discomfort and roof of mout... Read more
Within 10 minutes patient with complaints of shortness of breath, tongue discomfort and roof of mouth discomfort. Patient states that he also had a weird taste in his mouth. NP and paramedics at patient side. Patient appeared anxious. Lungs clear, posterior pharynx normal, uvula with no inflammation noted. Legs elevated. Patient placed on O2 and initial vitals normal. Patient then became hypertensive with SOB. Patient states that he can not take Benadryl because his doctor advised him not to ever take it. Patient is unsure if allergy. Initial EKG patient with inverted Twaves on 4 lead, then patient with normal EKG with 12 lead. Patient given 0.3mg of Epi and fire rescue notified. Fire Rescue arrived at 1256 and patient transported to ER at 1pm. Patient remained with weird feeling to tongue and roof of mouth on transport, shortness of breath was improving.
49 2021-04-12 feeling abnormal Had subarachnoid hemorrhage 1 hour after getting shot. Ended up in hospital for 13 days. Had drain ... Read more
Had subarachnoid hemorrhage 1 hour after getting shot. Ended up in hospital for 13 days. Had drain placed in head and multiple CT scans and MRI exams while there. Discharged with home PT and neurologist follow ups. Experiencing left side weakness and head fogginess still.
49 2021-04-12 insomnia Sudden onset back and hip pain Insomnia Diabetes # climbing, harder than usual to regulate.
49 2021-04-13 disorientation, confusional state Extreme Nausea began about 12 hours after shot and continued for about 24 hours. Only vomited once.... Read more
Extreme Nausea began about 12 hours after shot and continued for about 24 hours. Only vomited once. No diarrhea. Was drinking water and about 200 mL of Pedialyte. Hyponatremia (114) symptoms of confusion and disorientation began about 36 hours after the shot.
49 2021-04-14 impaired work ability, feeling abnormal Started experiencing some dizziness on March 8th that lasted for approximately 3 weeks. Did get the ... Read more
Started experiencing some dizziness on March 8th that lasted for approximately 3 weeks. Did get the second dose of the Pfizer vaccine and a week later felt a sort of hot feeling in my head similar to that ballon sensation when first coming down with the flu but nowhere near as intense. The dizziness was worst on March 10th then slowly resolved itself over the next few weeks. It was mild to moderate in intensity, I could feel a continuation of movement after turning my head sideways, it felt like the head was still going. Strange. I was still able to go to work but the effect was noticable. The only variables in my life recently were beginning Humira on Feb 2nd 2021 and getting the series of Pfizer Covid vaccines on Feb 19 and March 12. I did notify my gasteroenterologist because at first I assumed it was the Humira. He said that is not a side effect. On further research I have seen a lot of people reporting vertigo several weeks out after the Covid shots as if the antibody formation produces and inflammatory response in the ear in some patients. Unknown the symptoms are related to the shot or not. I had one outbreak of Meniere's Disease in 2006 and has not recurred. Perhaps the vaccine can cause a recurrance?
49 2021-04-17 feeling abnormal Sudden severe vertigo upon waking up on 4/14, Had to lay on back and was ok, took 2hrs to go away.... Read more
Sudden severe vertigo upon waking up on 4/14, Had to lay on back and was ok, took 2hrs to go away. Have similar but much less severity every morning for short time. Throughout day still feel "off" and not perfect. Also noticed tinnitus seems worse since all day long. Blood Pressure, O2 level and pulse all seemed normal during vertigo spells.
49 2021-04-20 feeling abnormal Extended period of lethargy after second injection, from day 7 (post injection) to at least day 18. ... Read more
Extended period of lethargy after second injection, from day 7 (post injection) to at least day 18. Afternoon and evenings are mentally cloudy, low energy, and sleepy, requiring afternoon naps, and loss of work every day. Symptoms were worst at about day 10 to day 14, post second injection, and gradually reducing in severity through day 18 (though still existing at this time of reporting).
49 2021-04-20 loss of personal independence in daily activities I was fine after 1st Pfizer shot on 3-11-21. I have had nothing but problems since 2nd Pfizer shot o... Read more
I was fine after 1st Pfizer shot on 3-11-21. I have had nothing but problems since 2nd Pfizer shot on 4-1-21. I started with severe vertigo and left ear pressure on 4-3-21. I have never had this problem in my life. I was okay by 4-5-21, and I though everything was fine. On 4-15-21, the severe ear pressure in my left ear returned along with the severe vertigo. I have now had 24-7 vertigo daily since 4-15-21. I went to my family doctor, on 4-16-21. I was given meclazine which has done absolutely nothing. I feel absolutely awful, and it is at its worse after 6 pm. I can not live like this. Daily activities are an absolute chore now.
49 2021-04-21 feeling abnormal, nervousness Patient reports feeling dizzy and shaky several minutes after receiving his vaccine. He was brought... Read more
Patient reports feeling dizzy and shaky several minutes after receiving his vaccine. He was brought to med obs on a wheelchair. He reports similar reactions to medical procedures (vaccines, blood draws, etc) in the past. Associated symptoms include vision an hearing changes, and feeling "overheated". Pt ate breakfast around 9am. He denies trouble breathing, rash, and swelling of the face/nose tongue. Pt reports complete resolution of symptoms at time of discharge. Pt discharged at 1342, he has a ride home. Vitals as follows: 1325 HR- 85 BP- 138/92 SpO2- 96 1330 HR-85 BP- 133/93 SpO2- 95 1335- sitting HR- 87 BP- 126/85 SpO2- 96 1340- standing HR- 89 BP- 123/85 SpO2- 95
49 2021-04-24 irritability High blood pressure and heart rate elevated tired and very irritable this lasted 4 days with the 2... Read more
High blood pressure and heart rate elevated tired and very irritable this lasted 4 days with the 2nd and 3rd days being very bad.
49 2021-04-28 anxiety Flushing - feeling of warmth, anxiety. Received water. BP 144/61 (pulse 89), 160/78 (pulse 82).
49 2021-04-28 sleep disorder Increased resting heart rate. Noticed that my heart started to pump harder, first during an afterno... Read more
Increased resting heart rate. Noticed that my heart started to pump harder, first during an afternoon while sitting, no stress or agitation. The next morning, I woke up in the middle of the night due to some discomfort. I was at 100 BPm (normally at 60).
49 2021-04-29 anxiety Client received COVID vaccine @ 3:45pm. Client in observation area, reported having "cold sweats" t... Read more
Client received COVID vaccine @ 3:45pm. Client in observation area, reported having "cold sweats" to EMT staff @ 3:55pm. EMT staff provided client with water, attempted to assist client to zero-gravity chair. Client became unresponsive @3:58pm. Client became responsive @4:01pm, transferred over to cot with assistance, with legs raised. Client able to speak, denies shortness of breath, reports "anxiety with injections and anything going in to my body". Vital signs @ 4:06pm, BP 102/58, P 87, RR 12, O2 sat 97%. Client continued with observation, provided with water. Vital signs @ 4:14, BP 104/60, Pulse 82, RR 12. Client reports he feels much beter, able to sit up in chair. Client advised to follow up with primary care, client reports he will call parents for ride home. Client left observation area @ 4:30pm, walking with steady gait.
49 2021-04-29 panic attack 1st shot: No adverse reactions after the shot. 2nd shot: 3 minutes after the second shot, felt warm ... Read more
1st shot: No adverse reactions after the shot. 2nd shot: 3 minutes after the second shot, felt warm wave in my body and became dizzy. Did not have additional side effects and left in 20 minutes. During driving back and 1 hr after the vaccination became even more dizzier and fatigued, with walking balance issues. Second day dizziness disappeared, but I had a pain in the area of the shot, headache, body aches, and fatigue, balance issues. 3rd day started recovering. 3-8 day side effects gradually disappeared but started having panic attacks and generalized anxiety which I suffered years ago.
49 2021-05-01 feeling abnormal Approximately 10 minutes after vaccine administered patient reported itching on chest and funny feel... Read more
Approximately 10 minutes after vaccine administered patient reported itching on chest and funny feeling down both arms. Both palms had severe redness and welts on them, as well as some minor swelling. Patient was given 50mg of Diphenhydramine capsule and monitored for an additional 45 minutes. At time of leaving pharmacy the redness was still present on palms, but the white welts had gone down quite a bit. Pharmacist recommended patient go straight to urgent care for further treatment. Patient never had any difficulty breathing, speaking or swallowing during event.
49 2021-05-02 loss of personal independence in daily activities I'm being diagnosed with Parsonage Turner Syndrome and have been in severe pain for over a week. I'v... Read more
I'm being diagnosed with Parsonage Turner Syndrome and have been in severe pain for over a week. I've also lost control of 3 fingers on my left hand making it difficult to perform normal tasks.
49 2021-05-05 insomnia Cramps on leg, cold sweats on hand and feet, heart beat faster than usual and dizzy when that happe... Read more
Cramps on leg, cold sweats on hand and feet, heart beat faster than usual and dizzy when that happens, discomfort in the stomach, symptoms of insomnia, weakness in the whole body, pain in the thighs, knees, and calves
49 2021-05-05 sensation of foreign body Pt presents to ER from prompt care after having reaction to covid vaccine. Pt states he received fir... Read more
Pt presents to ER from prompt care after having reaction to covid vaccine. Pt states he received first dose of Pfizer vaccine at 0930 and starting itching at approx 1010. Pt states he also feels like there is a pill stuck in his throat. Pt was given epinephrine at prompt care and then sent to emergency deparment for further evaluation and treatment. No swelling of tongue or lips noted.
49 2021-05-09 anxiety 10:12am Client complaint of anxiety and dizziness. EMS onsite evaluate client: BP 72/43, P 53, O2 ... Read more
10:12am Client complaint of anxiety and dizziness. EMS onsite evaluate client: BP 72/43, P 53, O2 98%. 10:24am Client report feeling better. BP 81/36, P 48, O2 99%. 10:30am Client was transported to Hospital.
49 2021-05-09 feeling abnormal He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even ... Read more
He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even joked he probably would die that night. He also complained that despite his protest, the person who administered the shot insisted to inject on his shoulder joint. He developed a bigger-than-quarter-size bruise on his right inner arm the next day. He was feeling tired the following days. On May 4 around 3:30, I heard he was making loud noises. I came to his side immediately. At the time I thought he was making louder than usual snores. I nudged him gently but he didn't respond. After about 15 seconds, the sound stopped, and he had no breath. I then called 911 within 10 seconds, tried to do CPR on him. It took EMS 6 minutes to arrive even though we live very close to a fire station in a well-accessed urban area. EMS worked on him for about 30 minutes before transported him to hospital. They continued to work on him for a while. He never regained breath.
49 2021-05-11 feeling abnormal, disorientation have some clots; Neuropathy; autoimmune disorder; Fell and hit elbow and 3 ribs on left side; lost 6... Read more
have some clots; Neuropathy; autoimmune disorder; Fell and hit elbow and 3 ribs on left side; lost 6 (lbs) pounds/Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight; falling; felt super strong; dizziness; failed all the tests for motor skills for his arms and legs; Fell and hit elbow and 3 ribs on left side; Fell and hit head; Sensory nerves are all gone; Fatigue; scabs; delusional; tore tendons in between ribs; They are tender(ribs); hurting all over; Cannot walk or lift anything; chest pain; his arm was sore a little; Left arm injection site pain; Disoriented; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 03Feb2021 (batch/lot number and expiration date not reported) at the age of 49 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date, vascular disease, bilateral stents placement, cataracts since he was born. Concomitant medication included gabapentin taken for an unspecified indication from an unspecified start date and ongoing. On 04Feb2021, the patient experienced left arm injection site pain. The patient experienced dizziness, falling, and couldn't go to work on unspecified date. He was treated by his (MD) physician, was given a CT scan, echocardiogram, and found to have some clots. He stated he has a history of vascular disease and had bilateral stents placed a year ago. He was placed back on an aspirin/Plavix regimen and referred to a neurologist because he has no motor skills anymore. He stated he failed all the tests for motor skills for his arms and legs. He was advised not to take the second dose of the vaccine and was diagnosed with neuropathy and autoimmune disorder (caller does not specify which disorder). He reported being positive for Covid-19 in Dec2020. He wanted to know what else he can do for his symptoms and is offering to be tested by Pfizer for treatment. The symptoms come in really hard seven days later. He actually had to go to the (ER) emergency and they worked on him and a whole string of doctors. He went to the emergency room and something was going on and wanted him to go to a family practitioner. They sent him to vascular, neurological and now they want to send him to a research center. It was a whole week after receiving vaccine before he began having symptoms. With the neuropathy and autoimmune, he cannot work like he did. He can hardly walk. Unspecified autoimmune was diagnosed last week. He can't remember the name of it. They told him not to take second one because the first one did what it did to him. It hurt a little and it was quick. The next day (04Feb2021), he said his arm was sore a little. He is only taking 4 medications and they looked it up. He did not think they were relevant. He was disoriented and fell and hit his head a couple of times. They ran an MRI on his head trying to figure that part out. That was done last week. He doesn't know the date and said it may have been on Friday. Results were good. The date he was disoriented was Wednesday 03Feb2021, when he took the shot. He has been disoriented and has been that way ever since. They kept him for 15 minutes to make sure no one passed out. He has been disoriented since then. He could not think clearly, and he could not do his job. He tore tendons in between ribs. He first thought he actually broke his ribs, but did not. There were two different falls. He cannot feel feet or anything. His motor skills are OK but when they did neuropathy test, they put needles in and shocked him to make his motor fire. His reflexes were really bad. He fell and hit elbow to keep from falling on face and twisted going down hitting 3-4 ribs on left side. It has been over 3 weeks now for his ribs. They are tender but they are not like the initial blow. It feels like they are healing. He fell and hit head a week ago. He was unsure of the exact date. He did not go to the emergency room with this one because the bed caught him. He fell and hit his head. All he has left is scabs. He cannot walk or lift anything (11Feb2021). That next Wednesday, he got ready to go to work and was so delusional and could not go in. He slept from 5:30 all that day and all that night. Then Thursday, he gets up and goes to work and goes slower, just to see what happened on Wednesday. He had fatigue and was disoriented. He did not provide start date or outcome for fatigue. He walked in and said either call an ambulance or he would go home. He went home and that was the last day of work. He then stated he laid in the car for 30 minutes and he said he is going to the emergency room. He went straight there that day. He had stents put in lower part of his body a year before. The neuropathy and the autoimmune kicked in 7 days later after the shot. The reason he went to the ER is because he thought it was his stent. He had bilateral, 4 of them. He was having chest pain and hurting all over on 11Feb2021. He thought he was having a heart attack. He was seen in the emergency room and released. It depends on how far he goes, how the chest pain worsens. Right now, he is ok, but when he gets up and moves around, it does the same thing. Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight. He was about 200 something and was kind of built and now is skin and bones. He lost 6 (lbs) pounds within a week and is eating like crazy. Sensory nerves are all gone. If hit with a baseball bat and he would not feel it. It came on slowly almost that he did not know it was happening. That is why they want to send him to Privacy for a research center and he does not want to go. He never had this happen before. ER or physician's office required: 1st date was on Thursday, 11Feb2021, when he went to Privacy. He was having chest pain and hurting all over. He thought he was having a heart attack. He was released. The patient stated he wanted to change the information he had provided since he was not in his right mind since he had taken the wrong medication dose than the doctor had given him. He stated the medication dosage he wanted to change was for Amiripyin. He stated he wanted to say he told the representative the symptoms he had experienced was enhanced which they were yesterday because he was trying to fight everything and stay awake. COVID 19 vaccine: he stated the doctor did not want him to take the second dose of the vaccine. He stated one of the symptoms he had experienced after the vaccine that he wanted to change the outcome for is the neuropathy. He stated he is back to where he used to be and yesterday it was bad he could hardly walk or talk. He stated also the other symptoms he wanted to change the outcome for is the autoimmune. The patient has not recovered from neuropathy, autoimmune disorder, disoriented, can't walk or lift anything, chest pain, and sensory nerves all gone; while outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
49 2021-05-18 feeling abnormal Zero arm pain until around 8PM. Then came on and intensified for next two hours. Became very tired. ... Read more
Zero arm pain until around 8PM. Then came on and intensified for next two hours. Became very tired. Went to bed at 10PM. Woke up at 12;30AM with a 101 degree fever and intense pain in lower back/upper buttocks. Fever/pain persisted and worsened throughout the night. Aches spread to other areas of my body but still centralized to back/buttocks. Headache introduced in the AM. Fever bounced all day between 102 and 104.2 degrees all day until about 8:30PM on Sunday. Tried ibuprofen to manage pain and temperature but had minimal effect. General tingly and buzzy feel after 8:30PM and into Monday. Headeache reappeared on Monday evening with cold sweats. Strange calf ache in right leg Monday night into Tuesday AM that consistently woke me up. Tried massage, stretching, to no avail. Tuesday AM most everything dissipated with just a bit of fogginess throughout Tuesday (though less than Monday).
49 2021-05-18 feeling abnormal When I put a magnet at the injection stop, it sticks and I can feel the pull in my arm.
49 2021-05-26 feeling abnormal Dizziness, Nausea, Fatigue, Light Diarrhea and stomach feels empty and uneasy all the time. These ... Read more
Dizziness, Nausea, Fatigue, Light Diarrhea and stomach feels empty and uneasy all the time. These symptoms have been around for a long time over 3 weeks and do not seem. to go away.
49 2021-05-30 feeling abnormal Odd taste in mouth, heart racing, sweating. Next day developed tinnitus and pain in right ear/eye. ... Read more
Odd taste in mouth, heart racing, sweating. Next day developed tinnitus and pain in right ear/eye. Fatigue and brain fog. Severed headache. Felt like stabbing pain in head. Saw ENT 6 days later. Was prescribed steroids and ear drops. Have hearing loss in right ear and tinnitus
49 2021-05-31 disturbance in attention, insomnia, anxiety 4/21: Felt "explosion in head," lightheaded, poor focus, vision off, felt like concussion, fatigue, ... Read more
4/21: Felt "explosion in head," lightheaded, poor focus, vision off, felt like concussion, fatigue, "my computer short circuit", spinning, dizzy, anxiety, "eyes darting", racing thoughts at night while trying to sleep. 4/26: light sensitivity, new onset sciatica, hypersensitivity, inability to focus, spinning. 2nd phase: right posterior occipital pain (neuralgia). 3rd phase: moving eyes, felt crunching noise. Vertigo treated with vestibular therapy. Anxiety/insomnia treated with Xanax.
49 2021-06-01 feeling abnormal titers before the vaccine and they were 4400, after the vaccine they were 275; titers before the vac... Read more
titers before the vaccine and they were 4400, after the vaccine they were 275; titers before the vaccine and they were 4400, after the vaccine they were 275; vaccine put his Lupus in remission; Low grade fever; feel he had sickness; Lethargic; felt he had a little cold; feeling achy; felt Bleh; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 49-year-old on 31Mar2021 15:00 (Lot Number: EP6755) as 2nd dose, single dose; and dose 1 on 10Mar2021 (Lot Number: EN6206) as 1st dose, single dose, both via an unspecified route of administration for covid-19 immunisation. Medical history included ongoing systemic lupus erythematosus (diagnosed lupus diagnosed 15 years ago [2006]), antiphospholipid syndrome which is also called hughes syndrome and he was diagnosed 15 years ago [2006] (his numbers are so high that University came over and taken his blood samples as he is a unique case. It is on the national order of rare diseases), ongoing overweight, tachycardia, thyroid under-productive, ongoing neuropathy peripheral, lupus anticoagulant, ministrokes and 2 massive strokes that affected his left side. It was reported that his blood was clotting in his veins and he was having mini strokes and then he had 2 massive strokes. He has a lot of joint and RA factor in his blood. In his back, he had L4-5 disc removed in January and he has stiffness and pain from Lupus. He mentioned that his family has many autoimmune disorders. His son has the worst case of Grave's disease. Concomitant medications included gabapentin (GABAPENTIN) taken for neuropathy peripheral from Feb2021 (reported as taken a month before the first vaccine) to unknown date; iron oxides taken for an unspecified indication from an unknown date in 2021 (reported as few months before the first vaccine) to an unknown date; and propranolol to keep away tachycardia. The patient did not receive other vaccines on the day of covid-19 vaccination. The patient narrated that his plasma was high that he sells his plasma and they make test kits out of his antiphospholipid titers and he never runs under 4,000 on any of those. The patient mentioned that he has been 15 years they have been checking his titers. They checked his titers before the which was 4400 and after the vaccine (07Apr2021), they were 275. The patient mentioned that he has taken the 2 shots and the vaccine put his Lupus in remission (07Apr2021). The patient added that it knocked his titers for anticardiolipin IgM, and alphaglycoproteins IgM down (2021). The patient stated that it has been going on with him for 15 years, and nothing else has brought them down like that. The only new medications he started this year (2021) were Gabapentin and Iron pill so nothing else could have affected his titers except for the Covid vaccine. They checked his titers again (unknown result) so they could do his draws, they could not believe it. The patient further stated that he got a hold of the CDC and health department and they are supposed to be getting ahold of Pfizer. The patient stated that this is a good thing, the vaccine basically put his Lupus in remission and mentioned that he does not know the correlation. The patient has had no rashes, boils, hives, his joint pain has greatly decreased. The vaccine is suppressing all of those antiphospholipids that cause all of those problems. He does not know how close to a cure for Lupus the vaccine is, but this happened a week after the second shot. This has never happened before, so the patient thinks there has to be something there and Pfizer may have stumbled onto something amazing. The patient stated that every medicine he has been on for Lupus, and nothing has controlled his Lupus and Antiphospholipid syndrome. He further added that he has connective tissue pain, it is still there but not near as much as it was and his back was messed up and now that the Lupus is under control his back does not have real pain, just discomfort. In his back, he had L4-5 disc removed in January and he has stiffness and pain from Lupus and now it is not anywhere near as bad. He mentioned that after that it seems like once they got his results, they could not believe it. He has never been turned down for draws before and this was the first time that it was normal. He further mentioned that it is as if the Lupus has gone away. He stated that he had very little side effects from shots which included he felt Bleh and had a low-grade fever on 01Apr2021. The patient added that after the first shot, he had no problems. After the second on 01Apr2021 to 02Apr2021, he felt like he had a little cold or sickness, achy and he was lethargic for a couple of days, and then after that, he was normal again. The patient stated that he has not been having the flare ups that he usually has with Lupus. The inhibitors are what causes his Lupus and APLS which he has had them for 15 years, with no relief. The first time he has relief, was getting a vaccine for a Covid strain. The patient did not received treatment for the adverse events. The patient contacted the main guy that makes the test panel kits, and all they can think of is there is something in the vaccine that is suppressing his immune system. He does not know how long it will last but so far it has lasted about 4 weeks. He feels way better than before, and he will know if it wears off because his symptoms will start. The adverse events did not result in emergency room or physician office visit. The outcome of the events 'titers before the vaccine and they were 4400, after the vaccine they were 275' and 'vaccine put his Lupus in remission' were unknown while the outcome of the other events was recovered on 02Apr2021. No follow-up attempts are needed. No further information expected.
49 2021-06-03 confusional state started getting dizzy about a week after the shot. about two weeks after the shot the dizziness is w... Read more
started getting dizzy about a week after the shot. about two weeks after the shot the dizziness is worse. I fell at work when I was just standing by my desk when I suddenly became extremely dizzy. At home I am having to hold onto things to help with balance. I am also having headaches, tinnitus, confusion, some mild congestion, and extreme tiredness. The vaccine is the only thing thing that is different the last couple of months. None of my medications have changed. I am due for the second shot next week, but I am not getting it due to the side effects I am experiencing.
49 2021-06-05 agitation, hallucination Arm alittle sore for less than a day. During the time dated on this report. Personality changed. Bec... Read more
Arm alittle sore for less than a day. During the time dated on this report. Personality changed. Became extremely agitated, paranoid, showed symptoms of a Mood Disorder such as Bipolar 1 or 2. Family noticed a significant change in personality and mood. Also some hallucinations mostly at nights. This all occurred suddenly with no explanation
49 2021-06-10 anxiety Pt presented with complaint of mild SOB. Pt denied CP. Full assessment performed and V/S obtained. P... Read more
Pt presented with complaint of mild SOB. Pt denied CP. Full assessment performed and V/S obtained. Pt denied any significant PMH. (+)breath sounds and equal bilaterally, (-)stridor noted. Pt stated that he felt as though it may have been an anxiety reaction. Pt rested in observation area x10 mins. At conclusion of time, pt noted relief of symptoms. Pt stated that he did not want to go to the hospital. Pt informed of risks of refusing, up to and including death. Pt accepted risks and stated he would follow-up with his PCP. Pt signed AMA and released without incident.
49 2021-06-16 anger, sleep disorder His arm was slightly sore after the injection on the day he got it; could not move nor lift his arm;... Read more
His arm was slightly sore after the injection on the day he got it; could not move nor lift his arm; muscles ached so bad; not been able to sleep since then; He is upset; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration on an un-specified date (at the age of 49-year-old) at a 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced his arm was slightly sore after the injection on the day he got it, could not move nor lift his arm, muscles ached so bad, not been able to sleep since then, he is upset. Reporter is a 49 year old male patient who has received his 1st dose of the Pfizer COVID Vaccine on Tuesday last week. He mentioned that he has a side effect that has been on going for 6 days, with the 7th day being tomorrow. His arm was slightly sore after the injection on the day he got it. By the next day, he could not move nor lift his arm. His muscles ached so bad and he has not been able to sleep since then. He mentioned that he has never had anything like this before the vaccination. He thought he was doing the right thing but now he is in a very bad situation. He is upset because he can't even work. He and his family is very concerned because of this. He mentioned that there is absolutely no way in heck he is getting the 2nd shot. Outcome of the events was unknown. Follow up (PRD14Jun2021/SRD15Jun2021): This is a follow up spontaneous report from a contactable consumer. This 49-year-old male consumer (patient) reported that: When consumer was again informed about the role of Pfizer Drug Safety and requested to probe, consumer stated, consumer really just want to know, consumer really concerned about what happened. Consumer want to know whether he is going to be okay or consumer need to go to the hospital. Consumer don't want to file nothing for no safety or no stuff like that, consumer want to know whether he is okay. Because consumer thought consumer was doing the right thing by getting this and now consumer can't even move my arm for 6 days, so consumer am very concerned about it. Information regarding the Lot/Batch number has been requested.
49 2021-06-16 memory impairment, feeling abnormal today feels out of it; can't remember/recall things; This is a spontaneous report from a Pfizer Spon... Read more
today feels out of it; can't remember/recall things; This is a spontaneous report from a Pfizer Sponsored Program. A contactable other health care professional and a contactable male consumer (patient) reported that a 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 18Mar2021 (at the age of 49-years-old) (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR 11mg strength), oral from 04Mar2021, at 11 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 on unspecified date for COVID-19 immunisation. The patient reported no missed doses. On 18Mar2021, after start of therapy receiving his second coronavirus vaccine, the patient reported that he feels out of it and can't remember/recall things.The action taken in response to the events for tofacitinib citrate was dose not changed. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
49 2021-06-23 disturbance in attention, impaired work ability After the vaccine I waited 15 minutes before returning to my desk. After sitting at my desk for 10-... Read more
After the vaccine I waited 15 minutes before returning to my desk. After sitting at my desk for 10-15 minutes I began to feel light headed/dizzy. I was having a difficult time concentrating and my immediate supervisor noticed right away and sent me home. Walking out of the workplace I was extremely dizzy and dropped my bag once, but thankfully didn't break my laptop. That evening I began to feel an extremely sore throat and nausea. For the next several days 7-8 days I had a wet cough with thick yellow mucus, and fatigue. After 2 weeks I slowly began to have less of a cough. 15 days (day of this report) my cough is minimal but still present. Symptoms are continuing to lessen daily.
49 2021-06-23 impaired work ability, loss of personal independence in daily activities Day 2- slight red rash on chest. Day 3 - severe vomiting, Day 5 - called 911 taken to the Emergency... Read more
Day 2- slight red rash on chest. Day 3 - severe vomiting, Day 5 - called 911 taken to the Emergency Room for supraventricular tachycardia, Heart Rate of 158. Day 9 - had an additional SVT, Heart Rate 171. Day 10 - additional SVT, Heart Rate 150. Have not been able to engage in pre-vaccine regular life activities without my heart rate severely rapidly increasing. I had to quit my job. Saw my doctor on Day 9 who examined blood levels from ER visit on Day 5, and ordered an echocardiogram. I have an echocardiogram scheduled in the next 3-4 weeks, which was the soonest I was able to be seen.
49 2021-06-23 mental impairment, altered state of consciousness, anger, loss of personal independence in daily activities, memory impairment On 04/06/2021 Patient got his first Pfizer COVID-19 vaccination. Within 24 hours, he got sharp pain... Read more
On 04/06/2021 Patient got his first Pfizer COVID-19 vaccination. Within 24 hours, he got sharp pain in the injection site and shoulders with an increase in brain fog type issues. He thought it was due to induced immune response depleting energy from the body. However, a week or so in his usual daily activities started slowing down (e.g., going from daily showers to 3 times a week, not getting chores done in a timely manner). On 04/27/21, he got his second shot, resulting in complete mental shutdown. Patient was not showering or shaving and only ate when forced. All internal sense of motivation and intuition was gone. He experienced memory issues, trouble speaking, and suffered from a ?complete state of nothingness which I?ve never experienced before? also known as abulia. He rarely took part in activities he did daily before the vaccine such as spending time on PC and reading the news. On 5/16/21, his condition started to improve and his precious feelings of "nothingness" turned to anger. He got intense neuropathy escalation in fingertips at this time which lasted about a week and half. His reaction lasted two months and now he is currently able to shower, shave, and exercise daily but still has memory and executive functioning issues.
49 2021-06-24 anxiety "Pt w/ allergy to Penicillin (hives). PMH Psoriasis, HTN, HLD, GERD, CAD (NSTEMI 1/20), anxiety, car... Read more
"Pt w/ allergy to Penicillin (hives). PMH Psoriasis, HTN, HLD, GERD, CAD (NSTEMI 1/20), anxiety, carpal tunnel. PSH Nerve repair Left index finger, Cardiac Cath. 1/2020 hospitalization for NSTEMI: s/p cardiac cath on 1/30/2020, which showed dominant RCA with proximal 70% lesion followed by 99% mid RCA lesion (LM/LAD/LCx without significant CAD) now s/p PCI of mid RCA with 3.0 x 15 mm Onyx DES and PCI of proximal RCA with 3.5 x 22 mm Onyx DES. Today, via Spanish interpreter) , he reports that he has localized right chest discomfort 2/2 right arm tingling and pain when he received the vaccine today. Pt also has flushing/sweating. He is alert and oriented x 4. He was very ""anxious"" and tears in his eyes. He states that he has ""panic attacks"" in the past and he feels very ""anxious"" after getting the shot. C/o tingling and pain right arm. Pt given 2L O2 via NC. Slowly sx of chest discomfort resolved after 5 min. Pt stable and released from the vaccination site. Pt verbalized ""he feels fine now"". VSS. His is back to baseline. Right arm pain resolved, tingling improved. Denies CP, dizziness, HA, or palpitations. His son is driving him home. Instructed patient to rest at home. He has NTG prn for CP. ED precautions discussed. If CP recurs, he agrees to call 911. FU with PCP if right arm numbness and tingling are worsening or persist after 3 days or CP/pain/palpitations/HAs/syncope. Current medications: acetaminophen (TYLENOL) 500 MG tablet Take 1 tablet by mouth every 6 (six) hours as needed for Pain. adalimumab (HUMIRA) 40 mg/0.8 mL subcutaneous injection pen kit Inject 0.8 mLs into the skin every 14 (fourteen) days. aspirin 81 MG EC tablet Take 1 tablet by mouth daily. atorvastatin (LIPITOR) 40 MG tablet Take 1 tablet by mouth at bedtime. carvedilol (COREG) 6.25 MG tablet Take 2 pills by mouth in the morning and 1 pill in the evening famotidine (PEPCID) 20 MG tablet Take 1 tablet by mouth 2 (two) times daily. gabapentin (NEURONTIN) 300 MG capsule Take 1 capsule by mouth 3 (three) times daily. For hand numbness hydrocortisone 2.5 % cream Apply to affected areas 2 (two) times daily. lisinopril (PRINIVIL,ZESTRIL) 10 MG tablet Take 1 tablet by mouth daily. loratadine (CLARITIN) 10 mg tablet Take 1 tablet by mouth daily. nitroglycerin (NITROSTAT) 0.4 MG SL tablet Dissolve 1 tablet under tongue every 5 minutes as needed for chest pain, max 3 tablets. If pain continues 5 minutes from first dose call 911 "
49 2021-06-25 insomnia, anxiety Migrating numbness and tingling in both arms and legs, (4 months, still present). Insomnia (4 months... Read more
Migrating numbness and tingling in both arms and legs, (4 months, still present). Insomnia (4 months, still present). Muscle twitching all around my body. (4 months, still present). Fasciculations especially in both calves, constant (3 months, still present). Acid reflux (without heartburn, but reflux in my esophagus, 1 month, still present). Difficulty swallowing (1 month). Cramping or discoordination in hands (4 months, still present). Anxiety (4 months, still present).
49 2021-06-26 feeling abnormal MYOCARDITIS shortness of breath, brain Fog, chest Pain pain left shoulder and Arm i gave blood and a... Read more
MYOCARDITIS shortness of breath, brain Fog, chest Pain pain left shoulder and Arm i gave blood and alot of chest pain has decreased.
49 2021-06-27 insomnia About a week after shot 1 I started to feel very fatigued and run down. I was able to function but ... Read more
About a week after shot 1 I started to feel very fatigued and run down. I was able to function but got tired easily. On May15, I received shot 2 and my fatigue got worse. I started to get tremors and shakes in my hands and arms. Legs felt weak, its difficult to hold my arms up at times. I felt hyper, yet weak. Unable to stay asleep. On June 6 I took a hot shower and barely made it out before collapsing. I went to the emergency room .
49 2021-06-29 confusional state vision was off and even confusion; vision was off and even confusion; dizzy; showed the lymph nodes ... Read more
vision was off and even confusion; vision was off and even confusion; dizzy; showed the lymph nodes were inflamed; got hives; arm swelled; This is a spontaneous report from a contactable consumer. A 49-years-old male patient received first dose of BNT162B2 (Formulation: Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 16May2021 10:00 AM as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included drug allergy to penicillin from an unknown date and unknown if ongoing. COVID-19 from an unknown date and unknown if ongoing. The patient concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and sertraline hydrochloride (ZOLOF) taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with COVID-19 prior to vaccination and not diagnosed since the vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received shot on Sunday May 16th at 10 am, slept for 23 or 24 hours and would not eat or drink, second day better but arm swelled and got hives gave Benadryl and missed two day of work went back on Wednesday then on May 23rd, woke up dizzy and vision was off and even confusion, went to ER and started stroke protocol, did all testing including a chest x-ray that showed the lymph nodes were inflamed, kept treating as if a possible stroke, MRI machine down so they admitted and waited for machine next day was released after negative scan. The adverse event result in emergency room/department or urgent care. The patient received treatment with adverse event all testing for stroke protocols. Seriousness criteria was Caused/prolonged hospitalization. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included chest x-ray: lymph nodes were inflamed on 23May2021, magnetic resonance imaging: negative scan on 23May2021, sars-cov-1 test positive: positive on an unspecified date. On an unspecified date, the events were resolved.
49 2021-07-04 feeling drunk While getting my hair cut the following day I was sitting in my chair and started to feel intoxicate... Read more
While getting my hair cut the following day I was sitting in my chair and started to feel intoxicated for about 2 minutes and then started to sweat, I then passed out and started to shake as if I were having a seizure. This went on for about a minute I was told.
49 2021-07-04 sleep disorder Headache began at 3:00pm. Woke up at 11:00 pm violently shaking all over. I was not hot or cold. ... Read more
Headache began at 3:00pm. Woke up at 11:00 pm violently shaking all over. I was not hot or cold. Woke up several times after the 11:00 pm also violently shaking. Seemed to have stopped by 3:00 am.
49 2021-07-10 disturbance in attention headaches, fever, heavy sweats at night, chills (which lasted for 8 days), shortness of breathing, r... Read more
headaches, fever, heavy sweats at night, chills (which lasted for 8 days), shortness of breathing, red patches spread over cheeks, neck and body (which started on the 5th day and most visible on the 8th day). Up to today (July 11th), still experiencing shortness of breath, fatigue, lack of focus, and mild coughing
49 2021-07-10 nervousness Pt. received the 1st dose COVID vaccine (Pfizer, Lot# EW0191, Exp. 09/30/2021) at 1210 in the L arm.... Read more
Pt. received the 1st dose COVID vaccine (Pfizer, Lot# EW0191, Exp. 09/30/2021) at 1210 in the L arm. At 1218, client reported he has "a racing heart rate and is feeling really nervous" Observer. Observer provided translation. Observer reported findings to Co-Lead who immediately assessed client, transferred client to zero-gravity chair, and provided him with a bottle of water. The patient was A&O to person, time, place, and situation. No loss of consciousness or dizziness occurred. At 1220 vitals were taken by observer with BP 148/98 in R arm laying down, HR 98, O2 Saturation 98%, and RR 20. At 1225 client reported that he was feeling better but had a "dry throat". Co-Lead assessed throat and observed no swelling. Client denied swelling or any trouble swallowing. At 1228 the patient denied numbness, tingling, or shortness of breathe. Client denied taking medication, denied any significant medical history, and has NKDA. Client reported to Co-Lead that he has a history of anxiety including a racing heart rate and feelings of nervousness. Client has no hx of fainting or dizziness with other vaccines or needles. At 1230 client said he was feeling better and his heart was no longer racing and his "throat feels fine now". Client continued to take sips of water. Vitals at 1250 were BP 128/88 in R arm laying down, HR 76, O2 Saturation 98%, and RR 18. At 1255 client was stable and Co-Lead educated about V-safe information, ER precautions, and when to follow up with PCP. Patient ambulated with even and symmetrical gait when leaving site at 1305.
49 2021-07-12 irritability, disturbance in attention extreme fatigue, decreased lung capacity, irritability, difficulty concentrating
49 2021-07-17 insomnia 12 hours after receiving my second dose I became very ill.; skin hurt; I became to shiver uncontroll... Read more
12 hours after receiving my second dose I became very ill.; skin hurt; I became to shiver uncontrollably and could not get warm enough; I developed a fever of 101.4; My muscles ache. Instead of feeling "sick"this was more painful than "ill".; it is difficult tosleep.; I'm in somuch discomfort; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 29Mar2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, sleep apnea and pre-diabetes. Concomitant medications included propranolol 120 mg (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and armodafinil (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Mar2021 at 15:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation and morphine on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021 at 00:30 after 12 hours of second dose, the patient experienced illness, skin hurt, shivered uncontrollably and was not getting warmed enough, fever - 101.4 (unspecified unit), muscle ache, hurt to move, discomfort and difficulty sleeping. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of illness, skin pain, shivers, fever, muscle ache, sleep difficult and discomfort were not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-07-18 insomnia It started with just extreme exhaustion. Within about an hour I had extreme pain in both legs, star... Read more
It started with just extreme exhaustion. Within about an hour I had extreme pain in both legs, starting from my waist all the way down to my toes. It was not a "coming and going" type of pain. It was constant, and severe. It was so painful that I could not walk. The pain was not relieved by lying down and elevating my feet. It was so painful that I could not really rest or sleep. It lasted about 48 hours before it started getting a little better. It has been nearly 72 hours now, and I'm starting to feel a bit normal again. I did not seek treatment because I did not think there was anything a doctor could do to help me.
49 2021-07-26 loss of personal independence in daily activities INFLAMMATION OF THE HEART REQUIRING ME TO GO ON 24HOUR NITROSTATE, AND PLAVAX. THE INFLAMMATION WAS ... Read more
INFLAMMATION OF THE HEART REQUIRING ME TO GO ON 24HOUR NITROSTATE, AND PLAVAX. THE INFLAMMATION WAS TERMED ENDOCARDITIS BY EMERGENCY DOCTORS. I HAVE HAD TO GO TO THE EMERGENCY MULTIPLE TIMES. THE INFLAMMATION HAS MADE IT DIFFICULT TO PERFORM ALL ACTIVITIES OF DAILY LIVING.
50 2021-01-05 feeling abnormal Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; P... Read more
Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; Pale; I felt weak; Bones ache; Have not been feeling good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 28Dec2020 at single dose on arm for suppress the COVID-19 (COVID-19 immunization). The patient's medical history included blood pressure, stomach ulcer and psoriatic arthritis. The concomitant drug was reported as colecalciferol (VITAMIN D), potassium citrate, multivitamin, etanercept (ENBREL) at once a week, pen shot in stomach, omeprazole (PROTONIX) at once a day for stomach ulcer and blood pressure medications. The patient was a correction officer, patient work at the prisons in (state name) and were given vaccination of Pfizer on Monday and he did that on Monday and have been getting sick and it's getting worse everyday, so yesterday at work everything was fine and he went home at 8 'O' clock at night because he was getting pale, felt weak, bones ache and have not been feeling good and today he called it in because he woke up with the cough, flu like symptoms. And it's worse today than it was yesterday. Consumer stated today, bones ache was worsening of like weaker, it hurts to walk and bone ache was really, today was worse than yesterday for the bone. Today flu like symptoms was worse, today patient have more heavier cough, was coughing more today and have a stuffed up nose, I did not have it yesterday. Wanted to know if this was a side effect or is that normal with that vaccine. Start date of events was on 28Dec2020. When patient started feeling some symptoms that started getting progressively worse on 29Dec2020. Treatment included Tylenol for bone pain and hurts to walk. Lab test blood work done in Dec2020, once a month through psoriatic arthritis doctor. The outcome of events, weak, Bone pain, Cough, Flu like symptoms, was not recovered. The outcome of other events was unknown. Information on Lot/batch number has been requested.
50 2021-01-05 sensation of foreign body 1011-2nd Dose of Pfizer administered; 1025 pt began feeling a quivering in his stomach about where h... Read more
1011-2nd Dose of Pfizer administered; 1025 pt began feeling a quivering in his stomach about where his diaphragm is located. the feeling went away and pt went back to his office. 1045-Symptoms began again flushed/faintness accomapanied the initial quivering. Pt bean feeling tingling his fingers and toes and felt like a lump was in his throat, his neck felt tight. 1052-Reported back to COVID pop up vaccine clinic reporting symptoms to staff in the clinic. 1100-BP 200s/90s HR 110s SPO2 96%. pt interviewed by lead FNP and evaluated. PT given water and granola bar as he reported he did not eat that morning, only took Excedrin. 1115-BP 165/86 HR 92 SPO2 98%RA. pt reports symptoms starting to resolve. 1120-HR 84 SPO2 98%RA. 1122-Pt dc'd to work. pt asked to not leave the hospital for 4-6 hours, not even to work offsite. pt agrees to report to ED if symptoms return.
50 2021-01-07 sleep disorder I developed symptomatic palpitations that started on 12/23 in the early morning, awaking me from sle... Read more
I developed symptomatic palpitations that started on 12/23 in the early morning, awaking me from sleep. Palpitations became so frequent that I went to my PCP's office, where I was found to have an abnormal rhythm on my EKG (non-sustained V-tach, runs of 4-5 beats at a time). I then went to hospital where I was admitted to observation in the ED for monitoring.
50 2021-01-10 impaired work ability nausea, headache, fever. called in sick to work.
50 2021-01-12 feeling abnormal Dizziness, Headache, numbness of tongue, then fogginess in head, then at 1pm started with headache,... Read more
Dizziness, Headache, numbness of tongue, then fogginess in head, then at 1pm started with headache, the arm soreness; transient 1/6/2021 light headeness and weakness; all resolved Narrative:
50 2021-01-13 impaired work ability Feverish feeling and chills with myalgias and weakness at 4am on 12/18/2020. Took 800mg advil and 10... Read more
Feverish feeling and chills with myalgias and weakness at 4am on 12/18/2020. Took 800mg advil and 1000mg tylenol. Felt perfect by 7 am. Despite this, fearing covid, I did not go to work, was rapid trsted covid negative that day and pcr tested that day retirning negative 2 days later. Days later I began to have vague nagging chest pain with occasional sharp chest pain over my heart. I had what I would describe as chest tightness in addition in which it felt hard for me to expand my chest fully like pressure without being short of breath. This would last at most several minutes and perhaps occurred three or four times over a seven day period. Throughout this. I could exercise with no chest pain no increasing shortness of breath, including a PR on Peloton and two hours of tennis without cardiac symptoms. Yesterday, my smart internist heard a split S2 heart sound as I lay on my left side and held my breath; the EKG showed a depressed PR interval ad some ST elevstions consistent with pericarditis, which I am treating with motrin. I assume this is a viral pericarditis. I had two types of Covid tests during that time period. My second dose of the vaccine was January 8. The feverish feeling occurred before dose 2, as did some of the chest oains and tightness.
50 2021-01-14 impaired work ability 1/12/2021 @ 2200hrs - Muscle/body aches, injection site tenderness 1/12/2021 @ 2300hrs - Muscle/body... Read more
1/12/2021 @ 2200hrs - Muscle/body aches, injection site tenderness 1/12/2021 @ 2300hrs - Muscle/body aches, chills 1/13/2021 @ 0300hrs - Muscle/body aches, chills, fever of 99.0, general malaise 1/13/2021 @ 0600hrs - Muscle/body aches, chills, tired, no energy, difficult to get out of bed. Did not go to work. 1/13/2021 @ 1000hrs - Symptoms continued. Advil 600mg PO taken. Allowed sleep from 1030-1230hrs. 1/13/2021 @ 1230hrs - Woke up feeling damp as if having had night sweats. Rested the entire day. 1/14 to 1/15/2021 - Left arm site tenderness with raised hard area at site of injection. Left armpit raised/swollen, appears as lymphadenopathy.
50 2021-01-18 nightmare facial and eye flushing, hot breath
50 2021-01-24 feeling abnormal 1:28: BP: 168/99, HR: 117, O2:98%, felt different 1:30: Complaint of throat tightning, BP: 169/99; H... Read more
1:28: BP: 168/99, HR: 117, O2:98%, felt different 1:30: Complaint of throat tightning, BP: 169/99; HR: 110, O2:98%, Med team alerted 1:34: Benadryl 25 mg, IM to right thigh 1:35: BP: 150/88, HR: 100, O2: 97% 1:40: MD report symptoms throat tighning after vaccine, no rash, no hives, talking fine, no change in voice, symptoms mild, no swelling of tongue, lips, or pharynx, pt refused epinephrine, improved over a few mins. Plan send to ED for continued observation; transferred at 1:43
50 2021-01-26 impaired work ability At 1:30 am the following morning I woke up very nauseous and started vomiting. Was nauseous all tha... Read more
At 1:30 am the following morning I woke up very nauseous and started vomiting. Was nauseous all that day needing to take nausea medicine. Unable to eat anything I started to vomit stomach acid. It is now 2 days later and I still have a degree of nausea and am unable to work today. I got the 2nd vaccine on Monday. It is Wednesday and I still have no appetite for food and have lost about 7 lbs since the weekend. I feel that I am starting to round the corner to recovery though.
50 2021-02-02 irritability Sore arm day after shot, mild flu like symptoms, tired, chills, body ache, feel like on the edge of ... Read more
Sore arm day after shot, mild flu like symptoms, tired, chills, body ache, feel like on the edge of getting real sick.
50 2021-02-14 sensation of foreign body Pfizer-BioNTech COVID-19 Vaccine: About 15 minutes after vaccination, patient started to feel that ... Read more
Pfizer-BioNTech COVID-19 Vaccine: About 15 minutes after vaccination, patient started to feel that there is a lump in his throat and both hands had tingling. Paramedic was on site and put patient on EKG monitor and observed patient for 20 minutes. The patient left the site independently and stated no further issues.
50 2021-02-17 delirium delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous rep... Read more
delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous report from a non-contactable consumer. A 50-year-old male patient received BNT162B2 (lot# unknown) on 03Feb2021 01:30 PM at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Fever of 100.8, chills, flushed, overall soreness, delirium, and deltoid pain on 04Feb2021 04:00 AM with outcome was Recovering. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-03-04 feeling abnormal About an hour after the shot, I felt some tingling in my face; that was followed by a few odd sensat... Read more
About an hour after the shot, I felt some tingling in my face; that was followed by a few odd sensations, all of which are basically the same as when I have a flu shot. Eight hours after the shot, I noticed that I was smelling smoke; my sense of smell started to do weird things an hour before (for example, smelling rotten food in the fridge), but this became clear when the smoke smell started. Over the first 48 hours, my left arm was sore (sore to touch at 24 hours, gone at 48), and I had some mild flu symptoms (sore throat, stuffy nose, fatigue), plus some chest "tightness" which I have been feeling from time to time since March 2020. The flu-like symptoms were all basically gone except the stuffy nose. I still have a slight stuffy nose, and the strange smell issue. I have been able to smell things fine all along, it's just overlaid with a smell that started as smoke or BBQ, and varies in strength; it's a bit like smelling dirt now. It's always possible this is coincidental, but I wasn't exposed to smoke or anything that I think could cause my nose to go haywire.
50 2021-03-06 confusional state Initial confusion upon waking at 7AM. Uncomfortable but unable to determine why. Tried to re-arrange... Read more
Initial confusion upon waking at 7AM. Uncomfortable but unable to determine why. Tried to re-arrange pillows but could not get arms to complete the process even though fully mobile. A minor amount of weakness in arms/legs and tingling across the lower face, particularly on the right side. Once up, had an inability to form words even though thoughts were coherent. Minor difficulty swallowing water. Speech slurred badly enough to be incomprehensible to my wife. By 7:30 we arrived at the hospital where symptoms were improving.
50 2021-03-20 restlessness, sleep disorder nausea; Headache; Mild muscle soreness at injection site; alternating chills/sweats starting 12 hour... Read more
nausea; Headache; Mild muscle soreness at injection site; alternating chills/sweats starting 12 hours post-2nd dose; alternating chills/sweats starting 12 hours post-2nd dose; fever (100.3) taken under arm; restlessness preventing sleep most of the night; restlessness preventing sleep most of the night; periodic dizziness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 12:00 PM, (lot number: EL3247), at the age of 50-year-old at vaccination, as SINGLE DOSE for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of the vaccine on 21Jan2021 01:30 PM (lot number: EL3247) on Left arm. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Feb2021 00:00, 12hours post vaccination of second dose, the patient experienced mild muscle soreness at injection site within a couple hours; alternating chills/sweats starting; Fever (100.3) taken under arm; restlessness preventing sleep most of the night; periodic dizziness and some nausea; and headache. The outcome of the events was recovering. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19.
50 2021-03-24 sleep disorder Patient received vaccination at 1:45 PM on 3/16/21. Woke up at 3:00 AM on 3/17/21 with difficulty b... Read more
Patient received vaccination at 1:45 PM on 3/16/21. Woke up at 3:00 AM on 3/17/21 with difficulty breathing. Went to ER where he was diagnosed and treated for angioedema secondary to a vaccination. Given IV steroids and benadryl. Discharged home with oral prednisone, hydroxyzine and epi pen. ECG, cardiac enzymes, CT neck negative for any acute process. Patient has a history of stephens johnsons syndrome secondary to taking Bactrim. Followed up with PCP on 3/25/21. All symptoms had fully resolved.
50 2021-03-31 insomnia 30 minutes after shot administered in left arm, pain in left shoulder blade along with pain on left ... Read more
30 minutes after shot administered in left arm, pain in left shoulder blade along with pain on left side of neck. After 2 days, pain in neck subsided as pain in left shoulder blade and left shoulder increased and after a week left index finger and thumb became numb. Pain remains in left shoulder, however pain in shoulder blade after 2 weeks moves from left should blade to neck and sometimes both. Loss of sleep due to pain and on a scale of 1-10 pain is an 8-9 constantly. Went to a Chiropractor on Monday, March 29, 2021 for an adjustment and assessment, nerve test reveled nerves in that area not firing properly. Followed with a massage with no avail or reduction in pain or numbness. Have an appointment with DO my doctor on Thursday, April 8, 2021 or if she can get me in sooner.
50 2021-03-31 sleep disorder I experienced muscle soreness at the injection site (upper-left arm) around 9P followed by cramping ... Read more
I experienced muscle soreness at the injection site (upper-left arm) around 9P followed by cramping of my left calf. I went to bed and work up at 2A with body aches, stiffness, and joint throughout my body. The next day I continued experiencing the cramp in my leg and body aches, stiffness, and joint pain throughout my body, and general fatigue. The symptoms were mostly gone after my second night's sleep. I am still feeling lingering (mild) soreness and fatigue today, 4/2/2021.
50 2021-04-02 delirium Major (extreme) chills (almost uncontrollable chills and coldness, teeth rattling, slight delirium);... Read more
Major (extreme) chills (almost uncontrollable chills and coldness, teeth rattling, slight delirium); body aches, major headache. Couldn't get warm despite spouse providing me with multiple blankets that night. Took tylenol to help with headache through the night. Woke up the next day with major body aches throughout my body. Continued headache and fatigue like symptoms along with the pain. Used tylenol PM the second night to combat continued headache but no chills the second night. Started to feel better today, April 3rd, which is 48 hours since my 2nd Pfizer vaccination.
50 2021-04-03 insomnia Had loud tinnitus I both ears, but left ear is louder. Hard to sleep at night.Saw a doctor and recei... Read more
Had loud tinnitus I both ears, but left ear is louder. Hard to sleep at night.Saw a doctor and received steroids treatment, and getting better 3 days later, but would not go away.
50 2021-04-06 feeling abnormal No immediate reaction but 5 days later (April 1) lymph nodes on neck were painful but went away afte... Read more
No immediate reaction but 5 days later (April 1) lymph nodes on neck were painful but went away after a day. But nausea and loss of appetite which started 5 days later on April 1 still remain as of today 4/7. It doesn't prevent me from eating or any other problems just definitely not myself. What's even more strange is my desire to drink 7up because of feeling sick. Haven't drank this stuff in over 30 years. But the feeling of nausea triggered past memoires of drinking 7up to feel better.
50 2021-04-07 feeling abnormal, impaired work ability, excessive sleepiness First dose, next morning. Slight body aches low fever (below 100), lethargy and foggy headedness. ... Read more
First dose, next morning. Slight body aches low fever (below 100), lethargy and foggy headedness. Arm hurt at injection site and pain spread slightly. All symptoms seemed worse day 2 post shot (3/17/2021). Persisted for about 4 days, gradually getting better. Went to work but was pretty miserable. Took Tylenol and Ibuprofin alternating every 2 hours for fever. Second dose next morning. Higher fever (topped at about 101 and change), severe fatigue, slept 18 hrs and took off work. Alternated tylenol and ibuprofin every 2 hours. Also chills, heavy night sweat body aches.. Next day, sub 100 fever that "rollercoastered" all day. Alternated tylenol and ibuprofin every 2 hours. Body aches, arm ached at injection site. Worked from home. Day 3 post injection (4/8/21) felt better, went to work, fine in the am, slight fatigue towards shift's end.
50 2021-04-07 insomnia Fever and chills beginning approximately 14 hours after second shot. Insomnia and racing heart all ... Read more
Fever and chills beginning approximately 14 hours after second shot. Insomnia and racing heart all night. Body felt extremely cold, and I had to add three layers of sweatpants/sweatshirts/socks to stay warm. Headache and fatigue lasted approximately 48 hours. Took 72 hours to feel back to 100%
50 2021-04-08 insomnia Pain in right big toe. Pain got worse throughout the night, pain on touch and in joint of toe. Una... Read more
Pain in right big toe. Pain got worse throughout the night, pain on touch and in joint of toe. Unable to put pressure on it, unable to sleep. Pain subsided~12 hours after start. After 24 hrs no pain at all. No other adverse effects.
50 2021-04-08 panic attack Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mi... Read more
Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: patient described as an almost panic attatck reaction - shakiness, dizziness, blurry vision, nausea. Blood pressure and heart rate not elevated. SAt for 20 minutes and started feeling better then got the chills and more shakiness
50 2021-04-09 feeling abnormal I am dizzy and can't hardly stand up, having severe hot flashes, throwing up, gagging, fatigue , out... Read more
I am dizzy and can't hardly stand up, having severe hot flashes, throwing up, gagging, fatigue , out of it and dry mouth. I need help. The room keeps spinning!
50 2021-04-09 insomnia fatigue; chills; hot flashes; headache; insomnia; This is a spontaneous report from a contactable 50... Read more
fatigue; chills; hot flashes; headache; insomnia; This is a spontaneous report from a contactable 50-year-old male consumer reported that a 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Age at vaccination: 50 Years), dose 2 via an unspecified route of administration, administered in Arm Right on 11Feb2021 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications included amlodipine besilate (NORVASC); telmisartan (MICARDIS); zinc; VITAMIN C [ASCORBIC ACID]; vitamin d nos. The patient previously received first single dose of bnt162b2 on Right arm on 21Jan2021,11:00 single (Age at vaccination: 50 Years) for Covid-19 immunization. the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; List of any other medications the patient received within 2 weeks of vaccination: Norvasc, Micardis, multivitamin, vitamin C+D+zinc. On 11Feb2021 21:15, patient had fatigue, chills, hot flashes, headache, insomnia. Patient received treatment with Advil. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.
50 2021-04-10 depressed mood, suicidal thoughts, confusional state Two days after injection, I began to feel very depressed, suicidal, confused. I also felt like my ... Read more
Two days after injection, I began to feel very depressed, suicidal, confused. I also felt like my methadone dose was not working or was lowered, maybe feeling like withdrawal. Please note that prior to injection my behavioural health was fine and stable, and same with my methadone maintenance therapy.
50 2021-04-10 excessive sleepiness Vaccine administered 9.20am. Fatigue shortly after vaccine was administered - slept most of afternoo... Read more
Vaccine administered 9.20am. Fatigue shortly after vaccine was administered - slept most of afternoon. Injection site pain - feels like been punched in arm. Headache in the evening. Night chills and complained of "tight" (not acute) chest pain... but no breathing problems. Morning fever of 101F. Headache, Dizzy, Fatigue, Muscle Pain (esp in legs, asif he had "run a marathon"). He spent most of the day "resting". Evening on day two, we noticed a large bump under his vaccinated arm. Radius about 5cm - larger than what I know swollen lymph nodes to look like - almost looks like a bicep between his armpit and nipple. Tender to touch. Morning of day three (48 hours after vaccine) bump under his arm remains and all other symptoms seem milder.
50 2021-04-10 impaired work ability pt stated he was experiencing dizzy spells and didn't know if he would be able to continue his shift... Read more
pt stated he was experiencing dizzy spells and didn't know if he would be able to continue his shift at work
50 2021-04-12 feeling abnormal About 6.5 hours after vaccination my throat got a bit dry and feeling like a start of a cold /raspy ... Read more
About 6.5 hours after vaccination my throat got a bit dry and feeling like a start of a cold /raspy feeling and I felt two spots on the front of my neck itching. I looked in mirror and saw two pimple size type spots itchy. over the neck 30 mins another itchy pimple grew and neck got a bit red and under an ear got red and itchy. over the next hour my breathing felt a little more difficult, though oxygen level oximeter reading still good. 8.5 hours after vaccination both sides of my upper back/shoulders were covered in hives. I felt a bit foggy also. I administered epinephrine pen to my thigh. Over next few minutes the hives disappeared (except for a few pimple size spots though they basically disappeared)and the itch was gone. My breathing felt fine. I monitored signs and symptoms with no noticeable issues for the next day+. This was the 1st time I ever used an epi pen.
50 2021-04-12 feeling abnormal Roughly 30 mins (10:30am) after I received my 2nd Pfizer vaccine shot, I was about 5 mins from my ho... Read more
Roughly 30 mins (10:30am) after I received my 2nd Pfizer vaccine shot, I was about 5 mins from my home and began to feel tingling/numbing in my mouth and tongue. I got in my house and told my wife I was not feeling right and started to notice a dizziness coming on. I was to call the pharmacy to find out what I should do, but noticed my heart rate was up, I looked at my Apple watch monitor and my BPM was 164. I felt flush and told my wife to call 911. Ambulance arrived and took my vitals and ( I do not recall the blood pressure, but it was high for me) when they put me into the ambulance I began to shake uncontrollably and then began to sweat profusely. They took me to the emergency room, but did not administer any drugs. The Dr. came in and said he did not think it was related to the vaccine, but my personal Dr. agreed with me based on my medical history that it had to be related to the vaccine. My resting heart rate (I monitor this daily) is between 45 - 60 and my last blood pressure reading at my yearly physical on April 2nd, 2021 was 100/70.
50 2021-04-14 impaired work ability Severe gout in left knee that is not responding to nsaids indomethacin, ibuprofen, aleve or colchici... Read more
Severe gout in left knee that is not responding to nsaids indomethacin, ibuprofen, aleve or colchicine or cortisone injection. Have been unable to walk for almost 2 weeks now and have not been able to go to work.
50 2021-04-14 panic attack Dizziness, heavy feeling in head, panic attack.
50 2021-04-15 feeling abnormal Severe anaphylactic shock Hives, Rash, etc.. Started 3/29/2021 lasting until 4/15/2021 Still feelin... Read more
Severe anaphylactic shock Hives, Rash, etc.. Started 3/29/2021 lasting until 4/15/2021 Still feeling off
50 2021-04-19 disorientation Was flying on 2 Apr 21 at cruise about 1 hour into flight, experienced loss of color in vision, went... Read more
Was flying on 2 Apr 21 at cruise about 1 hour into flight, experienced loss of color in vision, went from full color to red and gray, somewhat washed out, experienced lightheadedness and a bit of disorientation but not dizziness. Needed to use the bathroom and try to move to improve circulation and had to think about moving my body. I was not uncoordinated but my steps and balance were deliberate vs. unconscious and automatic. I was able to walk down the aisle to the lavatory without any problem but my vision did not immediately improve as I had hoped. I went into the lavatory and leaned against the side (I'm 6'4" and it was the rear lavatory on a 737). I was not dizzy and my lightheadedness began to clear up slowly as I urinated. The color was also coming back slowly as I finished up and walked back to my seat, again, I had to think about each step and my balance, although I was okay walking back. As soon as I sat down, I began sweating profusely. It lasted about two minutes or less, not long at all and I didn't get wet from the sweat. As suddenly as the sweat came, it went. My eyesight went back to normal and I felt nothing had happened. I am sure I was awake, aware and lucid the entire time, although it felt like what I imagine a psychedelic episode would be like (I've never used any form of hallucinogen, however). I was back to normal when I disembarked the aircraft, felt no adverse or lingering effects either. Nothing to report since.
50 2021-04-20 feeling abnormal Pt felt "strange and uneasy" right after the vaccine. Sunday (3 days post shot) pt had very dry mo... Read more
Pt felt "strange and uneasy" right after the vaccine. Sunday (3 days post shot) pt had very dry mouth, numb tongue, and sore inside his mouth. Patient's wife reports slurred speech. Symptoms have been slowly getting worse since Sunday.
50 2021-04-22 feeling abnormal Shortness of breath, heart palpitations, vertigo/dizziness, phantom body pains appearing and disappe... Read more
Shortness of breath, heart palpitations, vertigo/dizziness, phantom body pains appearing and disappearing in various places, occasional itching sensation, numbness, brain fog, double-vision, extreme tiredness. Symptoms tapered off over 3-5 days. Similar experience with 2nd vaccine but less pronounced with a shorter timeframe, tapering off after 2-3 days. Strongest side effects after first vaccine, symptoms did not become noticeable until a couple of hours after it was administered, increasing next 24 hours before lessening over time. Basically identical to long covid symptoms but lasting only for a few days after vaccinations and not before.
50 2021-04-23 confusional state, anxiety Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: anxious before the shot. started sweating and felt dizzy 2-3 minutes after the shot. gave water to patient and asked them to take deep breaths. patient then started to become unresponsive,pale with no blood flow to face. no improvement was seen and then epinephrine shot (adult) was administered. patient started to regain consciousness and became slightly responsive after a couple minutes. had the patient sit down and put theit legs up on a chair. EMT arrived and out of caution took them to ER.
50 2021-04-23 feeling abnormal 2 weeks from the day I received the shot I developed a half dollar sized round rash on the opposite ... Read more
2 weeks from the day I received the shot I developed a half dollar sized round rash on the opposite arm that the shot was administered. The rash was red in color, raised skin and was located near my right bicep, inside elbow area. This rash subsided for most part the day after. Also had the chills for over 48 hours, slight headaches on and off and was extremely tired with low energy. It felt like I was in a fog for a couple of days.
50 2021-04-26 agitation, disorientation 42-43 hours after receiving the first dose of the Pfizer vaccine, patient starting projectile vomit... Read more
42-43 hours after receiving the first dose of the Pfizer vaccine, patient starting projectile vomiting, approx. or 10 times, every hour from 10am Sunday, 4/25 until approx. 2pm 4/25. Patient also had extreme abdominal pain (score of 10 on a 10 point scale) , showed signs of extreme agitation, discomfort , weakness, mild disorientation. no fever at this time nor diarrhea . Due to extreme abdominal pain and vomiting, patient was taken to Emergency Room where he was given medications to stop the vomiting, cramping . Tests run: EKG, CAT scan and blood work. Blood was normal, and EKG. CAT scan showed extreme swelling and inflammation to the entire abdominal cavity. Patient was discharged after pain was brought under control . Within hours of coming home the patient started to experience sever diarrhea, (watery discharge every hour for about 6 hours - patient estimates at least a gallon or more of liquid loss). Patient was on Gatorade, water intake , as much as he could take , continuously. No vomiting was experienced, but at this point patient was on the medications to control symptoms given at ER discharge. Patient experienced intermittent sharp pain despite medications to stop cramping and coat stomach and nausea continued despite nausea medication . on Monday, April 26th, around 3pm the abdominal pain increased, and by 10pm a high fever was present: 102.8 without ibuprofen, 101.4 with ibuprofen, and at this writing, Tue 4/27/21 at 2:30pm, the fever continues at 101.4 with continuous ibuprofen. The patient has not eaten solid foods and is now on Pedialyte, He has vomitted twice since 7am and is currently experiencing diarrhea .
50 2021-04-28 anxiety During 15 minute observation period, patient complained of dizziness, lightheadedness and minor stom... Read more
During 15 minute observation period, patient complained of dizziness, lightheadedness and minor stomach upset. Patient was instructed to sit down, his feet were elevated, a cold compress was applied. Patient's blood pressure, heart rate and pulse ox were taken. First blood pressure reading was 168/54 mmHg, first pulse was 71 bpm and pulse ox was 98-99%. Patient was shaky, anxious, and flushed. No complaints of shortness of breath, itching, or swelling of the face/mouth. Repeat vitals after 10 minutes were 185/105 mmHg, pulse was 76 bpm, and pulse ox was 100%. Patient was still dizzy and shaky. Administered 50 mg of diphenhydramine orally and contacted transport to emergency room. While waiting for transport, patient complained of forehead and forearm itching. Still no complaints of shortness of breath, no coughing or lip swelling. Noted red hives starting to appear. EMT arrived and took over care.
50 2021-05-02 disorientation 2 hours after vaccination, pt is feeling disoriented & lightheaded during lunch. BP 170/110. After... Read more
2 hours after vaccination, pt is feeling disoriented & lightheaded during lunch. BP 170/110. After 10 minutes lying down BP 200/130. Said he is on BP meds & was anxious getting shot. Pt refused to have EMS called. He was advised to f/u with primary Dr. today. His wife agreed & pt left w/o assistance.
50 2021-05-02 loss of personal independence in daily activities High fever for two days. First day could not get out of bed to get water to drink. Followed by half ... Read more
High fever for two days. First day could not get out of bed to get water to drink. Followed by half day of moderate fever. One week later very itchy rash appeared on left armpit, left groin and left hand. This was accompanied with slight fever and general weakness. Rah eventually resolved a week after four days of Valacyclovir therapy. The Valacyclovir helped with to reduce the itching. Viral cause of the rash suspected.
50 2021-05-03 feeling abnormal About 4 hours after receiving the 2nd dose, my left arm started to become sore (where the shot was g... Read more
About 4 hours after receiving the 2nd dose, my left arm started to become sore (where the shot was given) About 10 hours after receiving the 2nd dose, I started feeling "fluish" (achy, feverish, nauseous) All throughout that evening, the symptoms became worse and worse where I repeatedly took my temperature thinking I had a very high temperature only for it to read "below" normal at 97.3. The symptoms continued to get worse, without much sleep throughout the night and into the next day and evening. I almost scheduled an appointment with my primary care physician on 4/24 because I felt so horrible. It wasn't until about 11 am on the 2nd day after receiving the shot (4/25) that I felt somewhat better and by that evening around 6pm, felt normal again. The 2nd dose was absolutely, without a doubt, MUCH worse of symptoms than the first dose. I hope this helps and please contact me with any questions or to help further.
50 2021-05-03 feeling abnormal Pt says that he has had "fuzzy thinking," having trouble recalling words and was off balance. He ha... Read more
Pt says that he has had "fuzzy thinking," having trouble recalling words and was off balance. He had slurred speech. He also had left side chest pain and trouble breathing.
50 2021-05-04 confusional state 1st dose- I did not have a reaction other than sore injection site 2-nd dose- I had fever/chills, vo... Read more
1st dose- I did not have a reaction other than sore injection site 2-nd dose- I had fever/chills, vomiting/diarhea, strong headache, sluggish, muscle aches, joint aches, confussion or foggy thoughts
50 2021-05-08 feeling abnormal I felt well for the 8-9 hours after the shot, around 8pm that evening, a headache and mild fever st... Read more
I felt well for the 8-9 hours after the shot, around 8pm that evening, a headache and mild fever started. By 1am, fever, chills, increased headache, severe joint pain were in full swing, muscle almost felt like they were on fire. Even rolling over in bed HURT. Fever got as high as 101.8 (I usually am around 97.6 or so). Symptoms started to abate by mid morning, but I was essentially useless until that evening. By May 6, I felt like I had a really bad hangover all day, then was mostly recovered by that evening. It is now May 9. I have a long history of knee/arthritis pain, and am generally a rather active person, but since the second dose, my knee pain as well as my hands to a large degree, have been extraordinarily sore and painful. My knees in particular, while the symptoms were really peaking, I experienced some very acute,atypical pains a couple times in both knees that seem to keep recurring 2-3 times per day, as well as exacerbated, continual soreness and general pain when I am active.
50 2021-05-10 confusional state, sleep disorder I was just falling asleep when my body started shaking. It was not violent, but enough to wake me a... Read more
I was just falling asleep when my body started shaking. It was not violent, but enough to wake me and confuse me. I would call them tremors or convulsions but not sure if there's a better description. It lasted about 1 minute. The "tremors" were at a rate of roughly 2.5 per second somewhat like a very rapid heartbeat almost. In fact, I checked my pulse with my watch thinking it may be a heart issue but it only registered 58 bpm.
50 2021-05-10 feeling abnormal This is a spontaneous report from a contactable consumer (patient's spouse). A 50-year-old male pati... Read more
This is a spontaneous report from a contactable consumer (patient's spouse). A 50-year-old male patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Apr2021 12:45 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No Prior Vaccinations (within 4 weeks). No AE following prior vaccinations
50 2021-05-10 feeling abnormal I had a swollen upper left side , arm, and chest , severe pain, a uneasy feeling, and sharp or weird... Read more
I had a swollen upper left side , arm, and chest , severe pain, a uneasy feeling, and sharp or weird throbbing type pain ever so often. After a week of the symptoms getting worse and not stopping I went to the emergency room.
50 2021-05-19 sleep disorder I got my second dose of Phizer May 10th at facility. May 16th I started to have back pain over my le... Read more
I got my second dose of Phizer May 10th at facility. May 16th I started to have back pain over my left kidney. May 17th the pain was unbearable at night. I was not able to sleep. I went to the Clinic May 18th at 9am. I was diagnosed with Shingles.
50 2021-05-21 excessive sleepiness, loss of personal independence in daily activities, feeling abnormal nurse stated it could possibly be blood clots; Patient is afraid he is going to have a stroke or sca... Read more
nurse stated it could possibly be blood clots; Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines; blurred vision in right eye that comes and goes; ringing in his left ear; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Fullness in face; Body aches; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; feeling dizziness/had to stop driving; This is a spontaneous report from a contactable consumer (patient's wife). A 50-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 (may have been in morning) (Batch/Lot Number: Unknown; Pfizer COVID-19 vaccine) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 50 years old. The patient's medical history and concomitant medications were not reported. History and Investigations: Doesn't take any medications. Has no medical conditions, unless age was considered a medical condition. Historical vaccine included first dose of COVID-19 Vaccine reported as on Third Friday in Feb2021 (First dose: between 1430-1530), and experienced AEs: Brain fog; Headache: Thinks in the back of the head, but moved around too, sometimes in the front. Has affected his balance. Dizziness: Had to stop a couple times while driving home from vaccine facility. Aches and pains. All symptoms from the first dose went away within 3-4 days. Caller would say patient recovered completely from symptoms associated with first dose. The patient experienced nurse stated it could possibly be blood clots on an unspecified date with outcome of unknown, patient is afraid he is going to have a stroke or scared he had one after the covid-19 vaccines on an unspecified date with outcome of unknown, brain fog: at times he can't do the simplest things. he will look at the clock on the wall and says he knows what it is, but can't find the words to say. cannot carry on a conversation intelligently on 12Apr2021 with outcome of not recovered, headache all over the back of his head/affecting his balance. in back of head, moves around, sometimes the front on 12Apr2021 with outcome of not recovered, feeling dizziness/had to stop driving on 12Apr2021 with outcome of not recovered, blurred vision in right eye that comes and goes on an unspecified date with outcome of not recovered, ringing in his left ear on an unspecified date with outcome of not recovered, fullness in face on 12Apr2021 with outcome of not recovered, body aches on 12Apr2021 with outcome of not recovered, very fatigued throughout the day, sleeping a lot/tired and sleeps a lot on an unspecified date with outcome of not recovered, date received first dose: third friday in feb2021/received second dose on 12apr2021, six weeks after first dose on an unspecified date with outcome of unknown. Patient was caller's husband. Had both doses and had the same problem. His experience is very bad with the second dose and has had it for a month. Within a day after the first dose, had brain fog, headache, and dizziness where he had to stop driving a couple times. This went away within a few days. Patient and caller were concerned about the second dose. They spoke with patient's doctor and the local Health Department, both said it couldn't be from the vaccine. Patient was advised to get the second dose. Had the same symptoms with second dose, but occurred within an hour of received second dose. Symptoms have continued. Also experiencing blurred vision in right eye that comes and goes. Patient had an appointment with his doctor this week, but the doctor basically didn't look at him. Doctor advised patient to see a neurologist. Another nurse stated it could possibly be blood clots. Caller is trying to find help. Caller wanted to add with the second dose, patient experienced ringing in his left ear, fullness in his face, and headache all over the back of his head. Was feeling dizziness after second dose and had to stop driving. Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines. If the COVID-19 Vaccines woke up some other health issues, patient wants to get it taken care of. Received second dose on 12Apr2021, six weeks after first dose. Got second dose at a different location. Second dose COVID-19 Vaccine AEs: Started experiencing symptoms within an hour. Headache: Affecting his balance. In back of head, moves around, sometimes the front. Comes and goes. Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently. Dizziness. Blurred vision in right eye: Doesn't know if this started on 12Apr2021 or a couple days after. States as the day goes on and he gets tired, it will worsen. It comes and goes. Ringing in left ear: Began on 12Apr2021 or a few days after. Fullness in face: Stated this comes and goes, but has stayed the same. Documented as provided. Body aches: Comes and goes. Seems to worsen as the day goes on. Very fatigued throughout the day, sleeping a lot: He's tired and sleeps a lot. It was hard for him to get out of bed. Caller stated patient's symptoms worse as the days goes on. Patient never experienced pain at the injection site. Guesses patient received COVID-19 vaccines in his left arm because the county was doing a dive-thru clinic. Since he didn't get out of his car, she believed patient would have received the vaccines in the left arm. The events REQUIRE A VISIT TO Physician office: Doctor doesn't think anything is wrong. ER: Not yet. Is considering going to the ER today. PRIOR VACCINCATIONS WTIHIN 4 WEEKS was None. RELEVANT TESTS: None. Events Clot blood and stroke considered medically significant. Follow up attempts are needed. Information of Lot/Batch number has been requested.
50 2021-05-31 insomnia Sleeplessness/Insomnia; This is a spontaneous report from a contactable consumer or other non hcp (p... Read more
Sleeplessness/Insomnia; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered on the left arm on 28Feb2021 15:45 (at the age of 50-years-old), as first dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included probiotics (manufacturer unknown); unspecified daily multi-vitamin (manufacturer unknown); and curcuma longa (TURMERIC) all taken for an unspecified indication and all start and stop dates were not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sleeplessness/insomnia, so far two nights in a row, on 01Mar2021 00:00. The patient did not receive any treatment as a result of the events reported. Patient did not consult physician nor urgent care for the events reported. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-06-07 anxiety I started to have a severe anxiety until now today; This is a spontaneous report from a contactable ... Read more
I started to have a severe anxiety until now today; This is a spontaneous report from a contactable other HCP (patient). A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration, administered in left arm on 05May2021 at 15:00 (at the age of 50-year-old) at single dose for COVID-19 immunization. No other vaccine received in four weeks. Medical history included bipolar disorder; prior to vaccination, patient was diagnosed with COVID-19; had known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 50-year-old at single dose for COVID-19 immunization and got a little anxiety. After patient received a second one of Pfizer's vaccine on 05May2021, he started to have a severe anxiety from 07May2021 until now 23May2021. Some medications won't help him out as enough. Event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days. The patient underwent lab tests which included Nasal swab: Positive on 11Dec2020; since the vaccination, patient had been tested for COVID-19 with unknown result on an unspecified date. Therapeutic measures were taken as a result of the event included Lorazepam. The outcome of the event was not recovered. This report was reported as serious with seriousness criteria-Caused hospitalization. Information on the lot/batch number has been requested.
50 2021-06-07 mental status changes, feeling abnormal BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; ... Read more
BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; brain fog; pressure in the back of my head; severe vomiting; shortness of breath; Pyrexia; Mental status changes; This is spontaneous report from contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 (Batch/Lot Number: EWO161), at the age of 50 years, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 on 30Mar2021, at the age of 50 years, Time: 03:45 PM, Lot no. EW8730, anatomical location: Left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Apr2021 19:30 the patient experienced Benign Paroxysmal Positional Vertigo (BPPV) (hospitalization, life threatening). On 30Apr2021 19:30 the patient experienced fullness and burning sensation in ears, tinnitus, brain fog, pressure in the back of head, severe vomiting, shortness of breath, pyrexia, mental status changes. On 12May2021 the patient experienced partial loss of hearing. On 28May2021 the patient experienced burning sensation. Clinical course: Nine days after taking a second dose of the Pfizer vaccine it started with multiple episodes of vertigo for 2 days, followed by severe vomiting, non-stop vertigo, shortness of breath. Taken into Emergency Room (ER) by ambulance on 02May2021, multiple tests performed (CT scan, blood, EKG) diagnosed with BPPV. Discharged the same night. The symptoms escalated into fullness and burning sensation in ears, partial loss of hearing, tinnitus, brain fog, pressure in the back of my head. Went to primary care physician on 05Jun2021, again multiple tests (blood, urine, EKG). Referred to ENT. Visited ENT on 12May2021, audiology test confirmed partial hearing loss. On 28May2021 the patient was still suffering with burning sensation and fullness in the right ear, as well as loss of hearing (high frequencies) and tinnitus. Periodic episodes of brain fog and severe vertigo. The patient underwent lab tests and procedures which included blood test: diagnosed with BPPV on 02May2021, blood test: unknown results on 06May2021, CT scan: diagnosed with BPPV on 02May2021, electrocardiogram: diagnosed with BPPV on 02May2021, electrocardiogram: unknown results on 06May2021, audiology test: partial hearing loss on 12May2021, urine output: unknown results on 06May2021. The patient received treatments due to the events: Diazepam, Meclizine, Potassium Chloride, Metoclop. The outcome of the events was not recovered.
50 2021-06-09 insomnia, restlessness Swollen Lymph Node-Right Supraclavicular. Lethargic, loss of sleep and restlessness.
50 2021-06-10 amnesia Transient memory loss--unable to find way to daughter's school or back home. Doesn't know what time... Read more
Transient memory loss--unable to find way to daughter's school or back home. Doesn't know what time school starts. Mild headache, occasional shortness of breath, cough, fatigue, generalized malaise. Neurology consult and examination--- normal. Patient treated with diazepam. Patient discharged home
50 2021-06-12 insomnia, anxiety Cryptogenic Ischemic Stoke. At approximately 11am on the morning of the incident I felt the blood le... Read more
Cryptogenic Ischemic Stoke. At approximately 11am on the morning of the incident I felt the blood leaving my arms and legs, began to feel feint. Laid down on ground with legs elevated. Began shaking. Called 911. Was taken to the hospital by ambulance. Once at hospital, felt arms and legs were numb. After a period of time going through testing at the ER, feeling returned to all but left leg. Stayed overnight, went home on 5/6/2021. Strength returned to left left over the next several days. Since 5/6/2021. Have been dealing with increasing debilitating anxiety, as well as photosensitivity, insomnia, and other related issues since returning home.
50 2021-06-20 feeling abnormal Pt received his 1st Pfizer vaccine on 3/31/21 and presented to the emergency room with chest pain on... Read more
Pt received his 1st Pfizer vaccine on 3/31/21 and presented to the emergency room with chest pain on 4/16/21 that was ongoing x 1 week. he also reported some shortness of breath. he reported a cold feeling on the side of his chest as well. he also was feeling his heart racing at times. he denied any recent illness, fever or chills or hx of covid 19 infection, he was evaluated and sent home to follow up with his primary care and cardiology if his chest pain returned. He then received his 2nd pfizer COVID-19 vaccine on 4/21/21 and called the hospital on 6/18/21 reporting that since the second vaccine he was experiencing a weird feeling of coldness to his ears, vertigo and dizziness and has suddenly developed a fixed, hard, kidney bean sized lymph node to the r side of his neck. he now has to have imaging and work up with possible biopsy of the lymph node. He reported he has not felt right since his vaccines were given .
50 2021-06-22 hallucination, excessive sleepiness, feeling abnormal, disturbance in attention, amnesia After first shot an uptick in paranoia as every day got worse. Before second shot I was having the ... Read more
After first shot an uptick in paranoia as every day got worse. Before second shot I was having the vivid dreams. I was also hearing, seeing, smelling, tasting things that weren't there. The second shot put me over the edge immediately. I felt as if I was being poisoned, the vial with medicine inside turned amber color and I shut down as paranoia turned into an orchestrated conspiracy against me. for the next 3- 4 weeks I hallucinated daily, I believed reality was a dream and fiction was my reality. My wife tried multiple times to make me understand that what I was going through was not real, yet because my paranoia and psychosis I remained shut down and basically sleeping for two weeks. I could not speak about what was going on b/c I could not formulate a tangible and coherent thought. During this time I believed everyone was against me, which now I know is not true. It was a nightmare that lasted months. On June 4th I saw Dr., whom recommended a psychologist. I was able to book the first appointment on June 15th and have been going to Dr. on a weekly basis. The internal hysteria, paranoia, hallucinations kept me mute for about a month. About a month after my second shot I began to speak about it although it was disjointed. It was on May 13th. It took weeks of trying to formulate thoughts to go to a doctor. I am still having issues remembering words. Psychologist suggests I see a neurologist. That is why it has taken me so long to report.
50 2021-06-23 excessive sleepiness Near narcoleptic sleep events, twice. Just fall asleep despite being well rested and sleep for 4-5 e... Read more
Near narcoleptic sleep events, twice. Just fall asleep despite being well rested and sleep for 4-5 extra hpurs. This includes sleeping through alarms and recieving phone calls.
50 2021-06-24 confusional state swelling of tongue; difficulty breathing; headache (bad one); numbness in right side; confusion; swe... Read more
swelling of tongue; difficulty breathing; headache (bad one); numbness in right side; confusion; swelling of face; slurry words; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9810, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Feb2021 at 09:00 am (age at vaccination was 50 years) as 1st dose, single for COVID-19 immunization. Medical history included asthma. The patient had known allergies to iodine, shrimp and iodide (like the CATSCAN contrast fluid). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) and One-A-Day Mens over 50 vitamin. The patient previously received first dose of flu shot in upper right arm on 12Jan2021. The facility where the most recent COVID-19 vaccine was administered was Hospital. On 10Feb2021 at 15:00 pm, the patient experienced swelling of tongue, face, confusion, slurry words, difficulty breathing, no pains though, headache (bad one) and numbness in right side. The patient received treatment with DECADRON (steroid) and Diphenhydramine (Benadryl). Since the vaccination, the patient has been tested for COVID-19. The patient underwent Nasal Swab COVID test (COVID Nasal/Nasopharynx COVID test) on 28Feb2021 and the result was negative. The outcome of the events was resolved on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-06-26 altered state of consciousness, feeling abnormal First: I had the coronavirus infection at the end of December/beginning of January. Second: I recei... Read more
First: I had the coronavirus infection at the end of December/beginning of January. Second: I received my First dose of the Pfizer shot on May 24th. Got a fever and body aches for about 24 hours. Thursday June 24th: T-0: Received PFIZER-BIONTECH COVID-19 VACCINE (Link is to the Pfizer Factsheet) T-11.5: Began having fever of 100°F and chills. Took a dose of Nyquil. T-14: Woke up in a daze and was half sleep walking around the room. While walking around in the room I passed out and fell to the floor. Was out for about 10 seconds. My wife woke me. I then passed out a second time and experienced a mild incontinence for about 15 seconds, came out of it and then went to the bathroom. When in the bathroom I passed out on the toilet for about 30 seconds, I experienced incontinence of everything left in me, bowel and bladder, I experienced convulsions and altered state(thousand yard stare). When I came too I began vomiting and had extreme body shakes. Some of this information was relayed to me by my wife obviously. T-15.3: Arrived at hospital and during check in I had another episode. (15 seconds) T-25: In hospital bed I had another episode duration unknown, no one saw me go out but I recall regaining consciousness. T-29: In hospital bed I had another episode duration unknown, no one saw me go out but I recall regaining consciousness. I passed out a total of 6 times.
50 2021-06-27 feeling abnormal The morning after the vaccination I began feeling fuzzy headed. As the day progressed I developed a... Read more
The morning after the vaccination I began feeling fuzzy headed. As the day progressed I developed a mild fever, chills and muscle aches similar to a severe flu throughout my body (arms, legs, back). This lasted through the night and into the next day, slowly subsiding from mid-day of the second day fading to only general weakness the second evening (48 hours after the vaccination).
50 2021-06-27 loss of personal independence in daily activities Initially I had a more severe pain than i had with the first dose. Swelling and Soreness at the inj... Read more
Initially I had a more severe pain than i had with the first dose. Swelling and Soreness at the injection site was worse than the first dose. Later at night when trying to go to sleep I felt a SUDDEN Onset of CHILLS. I then had Muscular Pain thruout various parts of my body. I had Headache. I felt cold thruout the first night after I got the vaccine. I felt tired and unable to do day to day tasks the following day.
50 2021-07-01 impaired work ability I've never had seasonal allergies or hay fever before in my life. A month or so after getting the p... Read more
I've never had seasonal allergies or hay fever before in my life. A month or so after getting the phizer vaccine, I had a strong allergic reaction to high grass pollen count in my area. So much so I missed a day of work, had to buy Zertec for first time in my life... same arwa and house I've lived in for 20 years. Cauging, sneezing,, runny nose was so bad I though I might have gotten covid, and the vaccine was keeping the symptoms mild with not fever, but I got tested and it was covid negative. Zyrtec helped for a few days, but then I reacted to pollen again after stopping zyrtec for a day, so indication is I've developed new allergies where I didn't have any before.
50 2021-07-02 nightmare, restlessness Pressure in eyes; Pressure in ears; soreness in complete body; sleepy; restless; bad dreams; diarrh... Read more
Pressure in eyes; Pressure in ears; soreness in complete body; sleepy; restless; bad dreams; diarrhea; This is a spontaneous report from non-contactable consumer, the patient. A 50-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) in the right arm on 22Mar2021 at 14:00 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. The patients medical history included penicillin allergy, grass allergy and tetracycline. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. THE patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not received medication within 2 weeks of vaccination. The past drug history included codeine (CODEINE). On 22Mar2021 the patient experienced pressure in eyes and ears, soreness in complete body, sleepy, restless, bad dreams and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The therapeutic measures and treatment were not taken as a result of the events. The clinical outcomes of the events Pressure in eyes and ears, soreness in complete body, sleepy, restless, bad dreams and diarrhea were recovering at the time of report. No follow-up attempts are possible; Information about batch cannot be obtained.
50 2021-07-08 feeling abnormal Chest pain; Shortness of breath/could not breathe while sweating profusely; Shortness of breath/coul... Read more
Chest pain; Shortness of breath/could not breathe while sweating profusely; Shortness of breath/could not breathe while sweating profusely; He turned white as a ghost; The patient all of the sudden didn't feel right; troponin was elevated; The patient's blood pressure has never been high but it was high when he got to the hospital; The doctors are leaning more toward myocardiopathy; This is a spontaneous report from a contactable consumer (wife of the patient). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8737; Expiration Date: 31Jul2021), via intramuscular route of administration, administered in left arm on 31Mar2021, as dose 2, single (age at vaccination: 50 years), for covid-19 immunization. Medical history included type 2 diabetes mellitus which was diagnosed about 3-4 years ago and sleep apnoea which was diagnosed about 10 years ago and the patient sees a lung doctor for this yearly and uses CPAP machine (both are unknown whether ongoing or not) and the patient has never smoked or done drugs. The patient did not administer any vaccinations within four weeks prior or on same date of the Pfizer Suspect. There was no family medical history relevant to adverse events. The patient concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206, expiration date 30Jun2021) on 10Mar2021, administered on right arm muscle as dose 1 single, (age at vaccination: 50 years), for covid-19 immunization and had no adverse effect. Patient's wife said that nothing like this has happened in the past. The patient was sitting at the kitchen table at about 5:30 pm and it was about an hour since they ate. The patient all of the sudden didn't feel right, couldn't breathe, was having chest pains, and was white as a ghost, started sweating profusely. The reporter and the patient got in the car and went to the hospital and they did a cardiac work up on him, they gave him nitro paste on his chest and was hospitalized or admitted because of the events. All the symptoms started at the same time. On 26Jun2021, they did an electrocardiogram/EKG which was fine (normal) but the patient's troponin was elevated. They transferred the patient to another hospital. The patient had a stress test on 27Jun2021, which was normal (They took pictures of the patient's heart during the stress test). Reportedly, the patient's blood pressure had never been high but it was high when he got to the hospital. The patient is not back to normal but was not complaining of anything. They put the patient on a heparin drip at the hospital for the troponin levels. The doctors are leaning more toward myocardiopathy and think it was related to the vaccine. The hospitalization duration was of 2 days, i.e., from 26Jun2021 to 27Jun2021. The patient was going to see a cardiologist on Tuesday. The outcome of the events: The doctors are leaning more toward myocardiopathy, blood pressure has never been high but it was high when he got to the hospital and troponin was elevated reported as unknown and the outcome was assessed as resolving for rest of the events. Information on Lot/Batch number was available. Additional information has been requested.
50 2021-07-20 feeling abnormal Appox mid May 2021 noticed a strage feeling when swallowing and slight enlargement of L lymph node. ... Read more
Appox mid May 2021 noticed a strage feeling when swallowing and slight enlargement of L lymph node. Lack of other indications decided to give it 2 weeks to resolve. 07 June presented to my PCP, referred to ENT on 10 June. Subsequent biopsy showed Malignant Neoplasm BOT. Referred to specialist.
50 2021-07-20 nervousness, feeling abnormal, confusional state, anxiety 1st shot 3/25/21 2nd shot 4/15/21 Within a couple minutes of shot, sharp pain in center chest to the... Read more
1st shot 3/25/21 2nd shot 4/15/21 Within a couple minutes of shot, sharp pain in center chest to the left. A strange confusion and unknown stress/anxiety within 15 minutes, couldn't find the door easy to exit the convention center. Within 1-7 days, a internal trembling or pulsating of inner tissue, muscles and organs. Within 2 months, twitching of muscles when put under strain or exercise Within 2-3 months, visible shaking when fingers extended for instance onto a cell phone Within 3-4 months, symptoms seem to be getting worse or evolving into other related inner and very subtly outer shaking or trembling Within 4-5 months, overall feeling of body shaking getting worse. Please contact so that I can get help.
50 2021-07-21 sleep disorder The night of my second Pfizer shot I developed very bad paresthesia. Very intense "electrical shock... Read more
The night of my second Pfizer shot I developed very bad paresthesia. Very intense "electrical shocks" in my shins. Strong enough to wake me from sleep. These seemed to pass away for a few weeks but then returned about 3 weeks later and have continued as of this date (7/22/2021). I feel shocks and pin pricks globally all over my body several times a minute. Sometimes more than once within ten seconds. This has been my daily experience since early June 2021. The intensity of the sensation is less, but the frequency is extreme.
50 2021-07-22 emotional distress He is currently 203 pounds; it is starting to work on him mentally; He has not felt well; His energy... Read more
He is currently 203 pounds; it is starting to work on him mentally; He has not felt well; His energy levels are terrible; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180; Expiration Date: 30Sep2021, NDC: unknown) via an unspecified route of administration, administered in arm right on 07Jun2021 14:00 (at the age of 50-year-old) at dose 2, 0.3 ml single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0182; Expiration Date: 31Aug2021, NDC: Unknown) via an unspecified route of administration, administered in right upper arm on 07May2021 14:00 (at the age of 50-year-old) at dose 1, 0.3mL single for covid-19 immunisation. On an unspecified date the patient experienced he is currently 203 pounds, it is starting to work on him mentally and on 10Jun2021 he has not felt well, his energy levels are terrible. Patient is calling about the Pfizer covid vaccine. He received the second dose of the covid vaccine on the afternoon of 07Jun2021. He has not felt well since 10Jun2021. He is going to see a doctor on Tuesday. He has not seen his doctor recently because of covid. He had to find a new doctor. His energy levels are terrible. He wishes he did not take the covid vaccine. He drives for a living. He feels terrible. He did not get a fever. He has not felt this way in years. He is currently 203 pounds. He is normally 215 pounds. He has lost 12 pounds. He does not know how common this is. He really does not want to make conversation with people, because people will be scared to take the covid vaccine. He started to feel terrible three days after the covid vaccine, and it is starting to work on him mentally. This has been going on for a month now. His energy levels are terrible: Whenever he eats something, he feels a little better. He does not feel terrible whenever he wakes up. He goes through the stresses of the day and started to not feel well around noon. He will eat lunch and fell and little better. Then start to feel bad again, and then eat again and feel better. Indication: He lives with his elderly mother and has two older sisters. He has to be as healthy as possible to be around his 84-year-old mother. Outcome of the events he has not felt well, his energy levels are terrible was not resolved and he is currently 203 pounds, it is starting to work on him mentally was unknown.
50 2021-07-23 confusional state 5/24 got second covid vaccine, symtpoms sated 30 hours after. he laid on the floor , couldn't talk, ... Read more
5/24 got second covid vaccine, symtpoms sated 30 hours after. he laid on the floor , couldn't talk, was having shaking. ER visit. nl labs he felt a little better the next day 1 week later got up off of the couch, severe pain in achilles. given shots, pain med, x ray. 1 week after that, he had pain in the right (other ) achilles. given muscle relaxer, motrin. he got a splint. last night started getting "electrical shocks" arms, legs. he started having confusion, couldn't talk. he was shaking. h got second covid vaccine he feels his symptoms have been exacerbated
50 2021-07-23 feeling abnormal Starting 1 week after second dose; ear ringing, just getting better Starting from 3 weeks after sec... Read more
Starting 1 week after second dose; ear ringing, just getting better Starting from 3 weeks after second dose to now: swollen hands, feet, ankles, tingling pain along tibia bones, brain fog, joint pain whole body, nuscle weakness and twitching
50 2021-07-27 impaired work ability Chills, fatigue, began during evening time (evening of vaccination day), lasted during the night. Ch... Read more
Chills, fatigue, began during evening time (evening of vaccination day), lasted during the night. Chills went away in the course of the following day, as did fatigue. Unable to work much that day. Anecdotal evidence from others suggests that these are common side effects for second Pfizer Covid19 shot.
50 2021-07-29 abnormal dreams, agitation, anxiety Extreme Agitation; Anxiety; Extreme Agitation and Anxiety but most disturbing are the vivid dreams; ... Read more
Extreme Agitation; Anxiety; Extreme Agitation and Anxiety but most disturbing are the vivid dreams; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0150) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Medical history of the patient included none. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 00:00 the patient experienced extreme agitation and anxiety but most disturbing were the vivid dreams. The clinical outcome of the events extreme agitation, anxiety and vivid dreams were not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
51 2021-01-07 feeling abnormal I am still sick; Fever/my fever was up to 101.7. It is down to 99 now but I still have the fever; Ch... Read more
I am still sick; Fever/my fever was up to 101.7. It is down to 99 now but I still have the fever; Chills; Aches; joints ache; Some muscle pain; Headache; Tiredness; Injection side swelled up; feeling poorly; This is a spontaneous report received from a contactable nurse (who is also the patient). A 51-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: 28Dec2020 (as reported)), via an unspecified route of administration, on 28Dec2020, at single dose, as a preventive measure for Covid. Medical history included blood pressure abnormal (reported as blood pressure). Concomitant medication included amlodipine besilate and amlodipine besilate (NORVASC 5 mg) both for blood pressure. The patient reported, "I received my first dose of Covid19 vaccine on Monday (28Dec2020) and it is now Friday and I am still sick and I am wondering how long these symptoms typically take to get better from because it seems like it is day 5 now so". When probed for events the patient stated, "Everything on the list, fever, chills, aches, my joints ache, some muscle pain, headache, tiredness, injection side swelled up. I was not nauseas or anything like that. I still have fever today. I did not get symptoms till like 2 days later and then my fever was up to 101.7. It is down to 99 now but I still have the fever." The patient mentioned, "I kind of like started feeling poorly on the 29th (29Dec2020) late at night but on the 30th (30Dec2020) I had fever and everything." The patient underwent lab tests and procedures which included blood pressure measurement: is always good on an unspecified date, body temperature: 101.7 on 30Dec2020, body temperature: 99 on 01Jan2021 (reported as "I did not get symptoms till like 2 days later and then my fever was up to 101.7. It is down to 99 now but I still have the fever"), and laboratory test: unknown results on Dec2020 (reported as "I did go for full series of stuff, checkup but that was more than 2 weeks ago"). The outcome of the events was not recovered.
51 2021-01-09 feeling abnormal 3 hours after 2nd dose almost fainted when exercising. 4 hours after injection started to feel ache... Read more
3 hours after 2nd dose almost fainted when exercising. 4 hours after injection started to feel achey, headache, and stiff neck. 12 hours after injection started shivering and increased heart rate. Took advil which helped, but shivering resumed 18 hours later. Took more advil. Body aches, sore arm, and headache continued for 48 hours. I still don't feel great 48 hours later but much better
51 2021-01-10 loss of personal independence in daily activities, confusional state I am a front line physician and got my first dose of Pfizer vaccine on 12/21/2020. For the first t... Read more
I am a front line physician and got my first dose of Pfizer vaccine on 12/21/2020. For the first two days after the shot, I had only injection site soreness and mild headache, but nothing serious (Grade 1 effects). was able to go to work with that easily. On the tenth day (December 31, 2020) after dose 1 of Pfizer vaccine, I started to get severe myalgias, headache, chills, neck and back pain, mental fogging, malaise, altered taste, and fever spiking up to 101.2. I took Tylenol and tried to sleep. Woke up at 2 am with worst chills of my life, not improved my several blankets. My initial thought was that I have gotten COVID 19 before vaccine could take effect. I got 3 negative PCR tests done at hospital, first one on 1/2/2021 (day 3 of symptoms and day 13 after vaccine), second one on 1/5/2021 (Day 6 of symptoms and day 16 after vaccine), and third one on 1/8/2021 (Day 9 after symptoms and day 19 after vaccine). My symptoms are still persisting (today is Day 12 of symptoms and Day 22 after vaccine), but have slightly improved in last few days. I have not been able to do any activities of daily life (Grade 3). Have been taking Tylenol 3 times a day, bed rest, hydration. I have been the biggest supporter of the vaccines, but now totally unsure. I have talked to several ID and Immunology colleagues and nobody can explain it. I reviewed Pfizer EUA document, and on page 41, a subset of people have been described who had COVID type symptoms but negative tests. May be I have a n atypical delayed and prolonged systemic reaction to dose 1. I have decided not to take the Dose 2 and wait for a more traditional vaccine like Jonson and Johnson.
51 2021-01-11 delirium, feeling abnormal got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was... Read more
got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; Left arm was extremely painful; This is a spontaneous report from a contactable Other-HCP. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EL1284) on 02Jan2021 at 10:00 AM at single dose via intramuscular on left arm for COVID-19 immunization. Medical history included allergy to codeine hypertension and asymptomatic HIV infection. Concomitant medications were not reported. Patient got home from the shot on 02Jan2021 at 11: 45 am. Fell asleep until 930p:m. During sleep was told by family that He was angry, cursing and yelling in his sleep. He didn't remember any of it, He felt delirious and out of control. Left arm was extremely painful. At the time of the reporting had recovered from the events without any treatment.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event delirious cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
51 2021-01-19 insomnia 2 days after 1st dose: severe headache and body aches. Severe tinnitus. Insomnia, constipation. Afte... Read more
2 days after 1st dose: severe headache and body aches. Severe tinnitus. Insomnia, constipation. After 3 days tingling numbness and weekends in extremities. Loss of appetite. Weight loss. Symptoms persisting for 3 weeks.
51 2021-01-25 anxiety After receiving vaccination, I started experiencing intermittent bouts of anxiety, rapid heart rate,... Read more
After receiving vaccination, I started experiencing intermittent bouts of anxiety, rapid heart rate, sleeplessness and "dark thoughts." This symptoms began approximately a week after the vaccination. I have no history of any of these conditions.
51 2021-01-29 feeling abnormal Began with a slight headache that eventually got worse. Started, when treated, at a 5 of 10. Left ... Read more
Began with a slight headache that eventually got worse. Started, when treated, at a 5 of 10. Left facility with a 7 of 10 headache. Then I had a weird taste in my mouth (metallic like). My tongue started to tingle and was a bit numb. Eventually after Doctor at facility took me in, I was given benedryl 50 mg and an antacid. After a few minutes the right side of my mouth became itchy but the tingling stopped. The itch was not unbearable but it was getting there. I was already having a slight difficulty breathing but that was from the morning even with inhalers. As an instrument player a doctor said I have super lungs so my results would be skewed due to how much air I take in. But any loss of air, although in the safe range for others, is like breathing through a straw for me. My blood pressure was 139/90 at the time. My normal blood pressure is 117/70. I went home feeling cold and just not feeling well, relatable to flu symptoms. This is the next day after taking benedryl every 6 hours at 50mg/dose. My breathing is slightly labored. I feel ok but my arm hurts, I have been moving it around a lot just to get it mobile. My chest feels like there is a slight weight on it which is weird for me. At the moment my pulse is 81bpm and my oxygen is at around 96. My norm is around 70bpm and oxygen at 99. No temperature is consistent at 97.3. I feel a little weird today. I am stiff all over as well. Little aches here and there but that is a norm. Doing my stretches and exercise is not a go today. Can't breathe as normal.
51 2021-01-31 feeling abnormal I am a pediatric critical medicine physician and received my COVID-19 vaccine at my workplace. 1st ... Read more
I am a pediatric critical medicine physician and received my COVID-19 vaccine at my workplace. 1st Pfizer EH9899 (on Dec 18, 2020) and 2nd Pfiszer EL1283 (on Jan 9, 2021). Both IM through my left arm. Directly for about less 48H post vaccination I had muscle pain that were self-resolved. On Jan 18, 2021, I started having funny sensation (like having a foreign body) over my left eye medial /innercantus area. The next 2 days I started to have pain over my left external ear canal, then it progressed into pain over my left lower jaw, left vertex of my head, inner side of left eye. My SS progressed on 1/30/21 at around 3:30 PM to numbness over my left sided tongue and left sided lip. Then on 1/31/21 at around 5 AM, I started having left facial paralysis. I have left BELL's PALSY which was confirmed. following a negative non-contrast brain MRI to rule out stroke and negative SARS-CoV2 PCR test. I start taking Prednisone 60 mg daily and Acyclovir 1 g TID on Jan 31, 2021. To this date I still have left facial paralysis but not worsening.
51 2021-02-08 nervousness Approx 14 minutes after receiving the vaccine, client felt like his heart was racing and his blood p... Read more
Approx 14 minutes after receiving the vaccine, client felt like his heart was racing and his blood pressure elevated, and dizzy. vital signs monitored, his BP was 150/108. He was clammy and shaky He was taken behind the white curtain and took his mask off, which he said helped tremendously. He was monitored. BP down to 140/100. He recently started BP medication. Told to discuss this episode with his PCP.
51 2021-02-16 feeling abnormal felt rush in chest and then "felt Off"
51 2021-03-02 insomnia Blurry Vision; Headaches; Left ear pain; Loss of taste, smell; Loss of taste, smell; Insomnia; Fatig... Read more
Blurry Vision; Headaches; Left ear pain; Loss of taste, smell; Loss of taste, smell; Insomnia; Fatigue; Joint pain; Neck pain; This is a spontaneous report from a contactable consumer reporting for himself. A 51-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunisation. Medical history included allergies to penicillin and COVID-19 prior to vaccination. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. Concomitant medication included unspecified drug. On 09Jan2021, the patient experienced blurry vision, headaches, left ear pain, loss of taste and smell, insomnia, fatigue, joint pain and neck pain. The patient received meloxicam as treatment medication. The events were considered as non-serious. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
51 2021-03-03 feeling abnormal, insomnia Dizziness/felt woozy/light headed; Weakness; vision changed; increased heart rate/heart rate went up... Read more
Dizziness/felt woozy/light headed; Weakness; vision changed; increased heart rate/heart rate went up slightly; had pressure in his head; pressure in his hands and feet like he could not move his feet; pressure in his hands and feet like he could not move his feet; headache; muscle tightness/muscles tightened in his back and in his calf muscles/tightness in his neck; he felt like he was just not himself; lethargic; lump in his throat; lymph nodes got tight on the same side as the vaccine/lymph node on his left side was tight throughout his neck; cringing in his stomach muscles; kind of like a muscle spasm in his stomach; didn't sleep that well last night; wobbly; back was hurting; muscle pain; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9261, expiry date: unknown), via an unspecified route of administration, from 01Feb2021, at single dose, for COVID-19 immunization. Medical history included anemia (anemic), inflammation, acid reflux (esophageal), pain, on blood thinner, high cholesterol, sinus disorder (sinuses), overactive bladder/bladder control, acid reflux, stools hard (to soften stool), nerves, blood pressure high (high bp), car accident, and costochondritis in chest. Concomitant medication included atorvastatin calcium for high cholesterol from an unspecified date and ongoing; docusate sodium to soften stool; famotidine to soften stool from an unspecified date and ongoing; garlic [allium sativum] as blood thinner from Nov2020 (3 months ago) and ongoing, gabapentin for nerves from an unspecified date to an unspecified date and from Nov2020 (got back on this 3 months ago) and ongoing; hydrocodone for pain; iron for anemia from Nov2020 (been taking this for the last 3 months) and ongoing; meloxicam for inflammation, omeprazole (PROTONIX) for acid reflux from an unspecified date and ongoing; tadalafil for overactive bladder/bladder control from an unspecified date and ongoing; vitamin c (ascorbic acid), colecalciferol (VITAMIN D), vitamin b for trying to build up his immune system; ranitidine hydrochloride (ZANTAC) for sinuses; "One a Day Men's" from 2016 and "50+" (as reported, pending clarification). On 01Feb2021, after the shot, the patient experienced dizziness/felt dizzy and had weakness. When he walked to the desk to check out he felt his vision changed and his heart rate went up slightly but it did go down once he sat down but he felt woozy and had pressure in his head and pressure in his hands and feet like he could not move his feet. He was kind of like dizzy and light headed. He walked somewhere to sit down, he stayed 30 minutes and left after and sat 30 minutes in the car and he got a headache and his muscles tightened in his back and in his calf muscles and he felt like he was just not himself. He felt lethargic and felt like his lymph node on his left side was tight throughout his neck. He felt like his lymph node was getting tight and he just sat until he felt like his symptoms had dissipated. He also had lump on his throat. He had stuff going on with his stomach like cringing in his stomach muscles, it was kind of like a muscle spasm in his stomach. He didn't sleep that well last night (01Feb2021) as he felt some symptoms come on again, the tightness in his neck again and when he sat up, he got dizzy and wobbly, his back was hurting, his calf muscle was tight. He felt more muscle pain. He checked his blood pressure and it was good, but he just felt a little dizzy on 02Feb2021. The patient stated that all his symptoms have improved since 01Feb2021. The patient also mentioned that the girl looked really young (referring to the person who administered the vaccine), "maybe she jacked it up, he knows it supposed to be a very little bit, maybe she put more in him than she was supposed to". He went back to his doctor as he wants to come off of some of his medications because he is supposed to have another shot and he want to take the second shot. He wanted to stop taking all the medications around the second shot in case it was his medications that caused it. The patient asked since he had complications with the fist dose, should he still take the second dose. The patient was recovering from the events.
51 2021-03-07 sensation of foreign body Mild Fatigue, pain in right aram and foreign body sensation
51 2021-03-07 sensation of foreign body Sore right arm, foreign body sensation, mild fatigue
51 2021-03-10 impaired work ability fatigue, malaise, severe nausea. Nausea progressed and became debilitating. Missed two days of wor... Read more
fatigue, malaise, severe nausea. Nausea progressed and became debilitating. Missed two days of work. Given Zofran to return to work. resolved after 7-10 days. lost 5 lbs.
51 2021-03-11 impaired work ability I had to wait for 15 min and was released. I started getting a really bad headache about 5 min later... Read more
I had to wait for 15 min and was released. I started getting a really bad headache about 5 min later above my ear. I then got nauseous. I went back to vaccination location and was given a cold compress. I was taken to the ER and given Benadryl and multiple nausea meds. I was there for about 5 hours. I was released and instructed to drink lots of water. I was told by the doctor that my body was doing what it was supposed to do, but to come back if I got worse. I took 2 days off and returned to work with no remaining complications.
51 2021-03-11 impaired work ability I got my shot, 18 hours later I woke up with a mild headache and it go worse. I went into work and h... Read more
I got my shot, 18 hours later I woke up with a mild headache and it go worse. I went into work and had to have my wife come get me because it was so bad. It lasted 3 days. I had some arm soreness.
51 2021-03-14 sleep disorder Warm left arm at the injection site after 4 hours. Both shoulder joints and hip joints were painful... Read more
Warm left arm at the injection site after 4 hours. Both shoulder joints and hip joints were painful about 8 hours after injection. Took Tylenol. Light headache and tingling under hairline on the back of the neck. 8 hours after injection. 2:30am chills until 3:00am. Fell back to sleep. 8:00 am - 9:30 am. Sore muscles and bones from head to toe. 9:45am took Motrin and Tylenol seems to work. I feel better.
51 2021-03-17 anxiety After immunization, patient immediately felt nausea and complaint of tingling down (r) arm. Patient... Read more
After immunization, patient immediately felt nausea and complaint of tingling down (r) arm. Patient was very anxious, also complaint of (r) arm burning. Patient takes Gabapetin, Flexaril, ibuprofen. Patiet felt light headedness. Smoker, anxiety, hiatal hernia, chronic neck pain, history of shoulder surgery.
51 2021-03-18 feeling abnormal 3-17-21 1:10PM PT STATES HE 'DOESN'T FEEL WELL'. SYNCOPE APROX 1 MIN - WIFE HELD PT IN CHAIR. RN ... Read more
3-17-21 1:10PM PT STATES HE 'DOESN'T FEEL WELL'. SYNCOPE APROX 1 MIN - WIFE HELD PT IN CHAIR. RN X3 AND MEDIC ASSISTED PT TO FLOOR AND ELEVATED LEGS. PT BECAME RESPONSIVE. PT PALE AND DIAPHORETIC. 1:16PM ASSISTED PT TO CHAIR 'FEELS BETTER NOW'. A/O, PINK, W/D, RESP REG WITH EASE. WIFE HERE TO DRIVE PT HOME. 3-19-21 3:30PM TC: PT STATES 'FULL RECOVERY'.
51 2021-03-24 anxiety, sleep disorder I was given the first shot and sent to an observation room. I felt slightly flushed, it went away. B... Read more
I was given the first shot and sent to an observation room. I felt slightly flushed, it went away. By the evening, I started to feel flushed again. I commented to my wife that I felt like my blood pressure was up. (I don't have high blood pressure). That is the best way I can describe it. I can't recall if the ringing in my ears was noticeable at that time. My the next day I could still feel the flushed feeling and the ringing was clearly noticeable and increased over time, until it can overcome TV or someone speaking to me. I also had a feeling of persistent light headedness. About Feb 3 I had pain in my ear and went to a clinic. I was diagnosed with a minor ear infection (right). I was given and took a course of anti-biotics. The infection went away but the ringing never did, sometimes it would lessen, but always louder than prior to the shot. I went ahead and took the second shot on Feb 11, thinking my problem was probably and ear infection. I the ringing could get so loud it would wake me up and keep me awake. On Feb20 I woke up to very loud ringing, nausea, and general feeling of unease. I went to a clinic the next day. I was told there was probably some inflammation and was given a steroid shot. After about 4 hrs the ringing lessened and I felt better, the first relief I had from the start. On Feb 23, I saw my ENT Dr. He gave me a course of steroids and ordered a brain MRI. The MRI came back with negative results...no abnormal indications. The ringing is starting to increase again as of the last several days.
51 2021-03-25 feeling abnormal I got the shot w/o any issues, was observed for 10 minutes at the Vaccine site w/o issues. On the dr... Read more
I got the shot w/o any issues, was observed for 10 minutes at the Vaccine site w/o issues. On the drive home, I felt lite headed, lips, tongue and back of throat felt weird. I got home at 4:30, systems remained but lessened throughout the rest of the day. At 11:00 I went to be and felt fine, woke up today and took 2 Advil. No pain today and fell normal, but reporting just in case, concerned about 2nd dose and would like guidance.
51 2021-03-28 depression ALOPECIA AREATA UNIVERSALIS: I have complete hair loss of my entire body. Head/ scalp, eyebrows, e... Read more
ALOPECIA AREATA UNIVERSALIS: I have complete hair loss of my entire body. Head/ scalp, eyebrows, eye lashes, nose hairs, mustache, some armpits, chest hair, pubic/ groin hair, arm/ legs. 1. DEPRESSION/ sadness with no head/ scalp hair, eyebrows, eyelashes. Dramatic change of identity. I am BALD and my family/ friends/ patients think I have cancer b/c I have a CHEMO HEAD/ SCALP. 2. EYES/ NOSE/ THROAT irritation due to NOT having eyelashes or nose hairs. Watery eyes/ eye sensitivity due to dust/ environament, nasal congestion and irritation due to NO nose hairs. Time: 1st injection Dec 20, 2020 noticed some hair loss but after 2nd dose Jan 8, 2021 -> ALL HAIR GONE AFTER 1 WEEK. HAD PRIMARY CARE PHONE CALL JAN 27, 2021 TO REPORT W/ LABS (SEE BELOW) AND EARLIEST APPT WITH DERMATOLOGIST Feb 8, 2021: DX of alopecia areata universalis . TREATMENT AND STILL ON TREATMENT: 1. VITAMIN D2 1250 MCG WEEKLY, 2. 300 MG PREDNISONE PO EVERY 30 DAYS, ALLEGRA 120 MG DAILY, MINOXIDIL 5% TWICE DAILY
51 2021-03-28 insomnia Headache for ~48 hours (ibuprofen taken without relief) Sleeplessness Fatigue
51 2021-03-29 nervousness, feeling abnormal 2.8kg 51 yo M with hx of hypothyroidism and allergy to pencillin was given his first Pfizer vaccine ... Read more
2.8kg 51 yo M with hx of hypothyroidism and allergy to pencillin was given his first Pfizer vaccine around 0915 3/27 at Medical Center (lot # not reported). Within 5 minutes he states he felt a "jolt" throughout his body and became very nervous and had sweaty hands. Patient reported symptoms at the vaccination location. Blood pressure was reportedly "low" and patient was told he could leave if he felt better. After about 30 minutes from the injection, patient decided to go home but continued to feel nervous and was twitching all over and decided to come to urgent care. He presents with chest pressure (4/10), muscle tremors, mouth dryness and mild dizziness. Denied any history of Covid.Denied any previous reactions to any vaccines. Denied any shortness of breath/trouble breathing, lightheadedness, nausea, or vomiting. No history of high blood pressure or high cholesterol. Denies any history of anxiety or nervousness. States he felt fine prior to the vaccine. Patient did drink his coffee and have a flour tortilla along with a breakfast bar today. HR 82 but BP elevated 199/122.at 1125. BP treated with SL nitroglycerin and four 81mg aspirin. Chest pain improved 1/10. EKG showed inverted T waves V4-V6 with no ST elevation or depression. Sent to ED where EKG was repeated. Incomplete right BBB. BP 128/73 and pulse 47. CXR negative. Unknown if patient was admitted. ED was at Medical Center.
51 2021-03-31 feeling abnormal, disturbance in attention I suffer from Tinnitius, and my tinnitus has doubled in severity since receiving the vaccine; I also... Read more
I suffer from Tinnitius, and my tinnitus has doubled in severity since receiving the vaccine; I also experienced a number of non-headache migraine symptoms, including aura, eye strain, head, neck and eye strain, scalp sensitivity, light sensitivity, spotty and blurry vision, difficulty focusing and brain fog
51 2021-04-01 insomnia has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringin... Read more
has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringing; stomach pain; high BP; sore arm; tinging in in throat and right side of face,; irritated right eye; Right Ear ringing worsened culminated in 8 days of insomnia from severe ringing; mesenteric inflammation; This is a spontaneous report from a contactable nurse (patient) and a consumer. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 29Jan2021 (Batch/Lot Number: EL3247) at single dose for COVID-19 immunization. Medical history included sciatica (resolved), and the patient took the first dose of BNT162B2 (lot/batch number: EL0142) at 15:00 on 29Dec2020 administered in arm right for COVID-19 immunization and developed paresthesias in right arm, into axilla, nex and right side of face and burning irritation of right eye, both on 24Jan2021. The patient's concomitant medications were not reported. Clinical course: 3 days after vaccination, patient developed sore arm, tinging in in throat and right side of face, irritated right eye. 6 days after vaccination, patient woke up with tinnitus in right ear, stomach pain and high BP. On 30Jan2021 (as reported), patient went to Emergency Room. CT scan showed mesenteric inflammation. Right Ear ringing worsened which culminated in 8 days of insomnia from severe ringing. Tinnitus continues to persist. He also had a constant severe headache. All events were reported as serious and seriousness criteria were disability. No allergies to medications, food, or other products. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
51 2021-04-06 anxiety pt c/o feeling hot. Denies SOB pain, itch or diziness. appears diaphoretic. said he feels anxiety. ... Read more
pt c/o feeling hot. Denies SOB pain, itch or diziness. appears diaphoretic. said he feels anxiety. Used interpreter. 140/92 HR 128 O2 sat 97 BS 196
51 2021-04-06 loss of personal independence in daily activities General muscle soreness 2 days after vaccine, then peripheral neuropathy started day 3 after vaccine... Read more
General muscle soreness 2 days after vaccine, then peripheral neuropathy started day 3 after vaccine. Signs progressed to dizziness, numbness of feet and hands, prickly sensations over arms and legs. Unable to resume normal daily functions. Symptoms still present as of today
51 2021-04-07 feeling abnormal First symptom was weakness and fatigue approximately 8 hours after injection. Onset of fever of 101... Read more
First symptom was weakness and fatigue approximately 8 hours after injection. Onset of fever of 101? F approximately 12 hours after injection, 24 hours after onset still had 100? F temperature, gone by beginning of day 3. Headache and body aches that lasted about 3 days. After fever was gone the weakness/fatigue/headache/body aches lasted an additional 12 hours or so. Approximately a day after all these symptoms disappeared I got a very minor sore throat and some congestion that has lasted a couple of days. Treatment was Alleve every 8 hrs, lots of fluids and rest.
51 2021-04-08 amnesia I received the vaccine at 12:15 PM. I was a little tired but generally fine the rest of the day. I ... Read more
I received the vaccine at 12:15 PM. I was a little tired but generally fine the rest of the day. I woke up at 2:30 and didn?t feel well. I got up to go to the bathroom. I started getting the chills and feeling dizzy. I passed out. My wife found me passed out on the ground and bleeding. I needed six stitches in my head and have a black eye as well as other facial lacerations. I have no recollection of anything until my wife woke me. I have never passed out in my life prior to this.
51 2021-04-10 impaired work ability, insomnia I had the usual sore arm, fatigue, and body aches. But the one side effect I had was insomnia for tw... Read more
I had the usual sore arm, fatigue, and body aches. But the one side effect I had was insomnia for two days. I missed work the day after receiving the shot (Wednesday). Went to work on Thursday with no sleep. Missed on Friday due to not being able to sleep.
51 2021-04-14 feeling abnormal High fever, chills, headache, nausea, tiredness, overall bad feeling
51 2021-04-17 impaired work ability headache, severe drowziness. i couldnt get out of bed for 2 days.
51 2021-04-18 sleep disorder, disturbance in attention Tingling and numbness in both arms and hands, but mainly in the left arm. The tingling and numbness... Read more
Tingling and numbness in both arms and hands, but mainly in the left arm. The tingling and numbness began about a day after the shot and I thought at first that it had to do with yardwork, but it has continued for about nine days so far. It goes away for a few hours a day and some nights are not as bad as others, but it's painful - like your hand/arm falling asleep for an extended period of time - and interferes with sleep as well as concentration during the day.
51 2021-04-20 memory impairment, feeling abnormal Become so forgetful since I had the injection that it feels like I have Alzheimer's; brain fog; Brai... Read more
Become so forgetful since I had the injection that it feels like I have Alzheimer's; brain fog; Brain fog and fatigue is unreal/fatigue; chilling pain; it feels like I have Alzheimer's; Arm is till really hurting; Hematoma; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Arm Left on 28Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included ongoing hypertension, anxiety, blood cholesterol increased, hypertriglyceridaemia, covid-19 from Sep2020 ("My wife was tested positive, I had it back in September, my wife was tested positive in January and that's when I started experiencing loss of smell and taste). Concomitant medications included lisinopril taken for hypertension, propranolol taken for hypertension, alprazolam (XANAX) taken for anxiety, atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal, bacopa monnieri, eleutherococcus senticosus root, rosmarinus officinalis essential oil, schisandra chinensis fruit (BACOPA COMPLEX) taken for hypertriglyceridaemia. On unknown date patient experienced "become so forgetful since i had the injection that it feels like I have Alzheimer's", fatigue, brain fog, chilling pain and on 01Apr2021, arm is till really hurting and hematoma (described as I went to ER last night and he said that the pharmacist might have punctured a vain or a capillary). Patient had no temperature, blood pressure is normal, patient stated he never had anything like that from other vaccines.
51 2021-04-23 insomnia severe chills, severe body aches, headache, loss of sleep night following shot used ibuprofen took s... Read more
severe chills, severe body aches, headache, loss of sleep night following shot used ibuprofen took several days to be back to normal
51 2021-04-26 anxiety chest pain. anxiety -- resolved
51 2021-04-26 poor quality sleep Skin became severely dry and itchy. Rash and nonspecific skin eruption. Blanching erythematous papul... Read more
Skin became severely dry and itchy. Rash and nonspecific skin eruption. Blanching erythematous papules and excoriation on arms and upper back. No rash in groin. Well developed, well nourished, male in no acute distress, oriented and without outward signs of anxiety or depression. Complete examination of the scalp and hair, head, face, ears, nose, lips, eyelids and conjunctiva, neck, chest, breasts and axillae, back, abdomen, right and left arms, digits/nails, right and left legs was normal except for the following significant findings: - Erythematous papules coalescing in areas into nummular plaques with scattered excoriations on the back, flanks, lower legs. Eczematous dermatitis - Start Triamcinolone acetonide 0.1% ointment BID over affected area, no more than 2 weeks per month. - Reviewed side effects of prolonged steroid use including skin atrophy, telangiectasia, hypopigmentation, and striae. - Recommended bathing with lukewarm water, using minimal fragrance-free soap only in intertriginous areas. Options include Cetaphil and Dove. - We discussed the importance of regular moisturizing (2-3x per day) with an emollient (Hydrolatum or Aquaphor) or thick cream (Cetaphil, CeraVe, Vanicream, Eucerin etc) even when eczema seems to be doing well. - For itch and poor sleep, start hydroxyzine 25 mg PRN at bedtime. Reviewed potential SE including sedation.
51 2021-04-28 anxiety Within 30-minutes of vaccination, the patient reported a headache, slurred speech, and right side we... Read more
Within 30-minutes of vaccination, the patient reported a headache, slurred speech, and right side weakness. EMS evaluated the patient on-site. The patient was hypertensive (197/129) with a FSBG of 95mg/dL. During stroke assessment, the patient had new onset facial palsy/droop and need speech abnormality which signaled a stroke alert. 12-lead EKG was unremarkable. EMS transported the patient to Emergency Department. In the ED, the patient presented with a headache, chest heaviness, and slurred speech, but no aphasia. NIH stroke scale was 0. Patient remained hypertensive (170/109). Labs, tests, and imaging did not indicate rtPA administration. ED physician administered 0.4mg SL Nitroglycerin, 10mg IV Hydralazine, and 325mg PO Aspirin prior to admission for suspected Transient Ischemic Attack. Upon admission, differential was TIA vs. CVA vs. ACS. Admitting physician ordered HbA1C, lipid panel, MRI brain, CTA head/neck, 2D echo, and neurology consult. Throughout course of admission, patient had recurring midsternal chest pain that was relieved with Nitroglycerin. Imaging ruled out CVA. Given elevated TGs and Cholesterol, patient was started on Atorvastatin 40mg PO. Suspected TIA and ACS. Neurology consult reviewed the labs and imaging, and stated the episodes of stuttering are most commonly associated with anxiety or stress reaction. Neuro did not recommend any further workup unless this happened again unprovoked. Patient was discharged after a 3-day admission with diagnosis of cerebrovascular disease, unspecified. The patient was prescribed 81mg PO Aspirin, 20mg PO Lisinopril, and 40mg PO Atorvastatin.
51 2021-04-28 confusional state PATIENT FELT DIZZY, FAINTED AND WAS NOT RESPONSIVE FOR FEW MINUTES. LATER HE REGAINED CONSCIOUSNESS... Read more
PATIENT FELT DIZZY, FAINTED AND WAS NOT RESPONSIVE FOR FEW MINUTES. LATER HE REGAINED CONSCIOUSNESS, FELT COLD , CONFUSED AND WAS SWEATING. CALLED EMS AND THEY DID A ROUTINE CHECK, ALL VITALS WERE NORMAL AND PATIENT REFUSED HELP
51 2021-04-28 disorientation Bilirubin level of 12 (jaundice); Bilirubin level of 12 (jaundice); Peeling & itching hands, feet; P... Read more
Bilirubin level of 12 (jaundice); Bilirubin level of 12 (jaundice); Peeling & itching hands, feet; Peeling & itching hands, feet; faceSweats; lung pain with deep breaths; abdominal pain; lower back pain; disoriented; This is a spontaneous report from a Contactable Consumer. A 51-Year-old male patient received BNT162B2 (Pfizer Covid-19, Formulation: Solution for injection, Batch/Lot no: EW0153) first dose via unspecified route of administration, administered in left arm on 11Apr2021, as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Patient not had COVID prior vaccination. Patient not tested for COVID post vaccination. On unspecified date Bilirubin level of 12 (jaundice) Peeling & itching hands, feet, & face Sweats, lung pain with deep breaths, abdominal pain, lower back pain, disoriented. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event) hospitalized up to six days. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
51 2021-04-28 sleep disorder, abnormal dreams, feeling abnormal Disturbed sleep , Intense uncomfrtable dreams , daytime "fog" . Has been 3 weeks now and stilloccuri... Read more
Disturbed sleep , Intense uncomfrtable dreams , daytime "fog" . Has been 3 weeks now and stilloccuring .
51 2021-05-03 anxiety Systemic: Fainting / Unresponsive-Medium, Systemic: Anixety-Mild, Systemic: Flushed / Sweating-Mediu... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Anixety-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: Patient discussed vaccination with immunizer for a few minutes before injection was given. After the injection was given, patient experienced brief syncope episode with brief 2-3 seconds of "seizure-like" activity. Patient woke back up and was pale and diaphoretic. EMS services were activated and patient rested, given water and orange juice. Maintained a slow, steady heart rate of 48 bpm while awaiting EMS. EMS evaluated patient and transported to hospital
51 2021-05-03 sleep disorder Had a sore arm immediately after the shot. didn't think much of it, of course, I just had a shot. ... Read more
Had a sore arm immediately after the shot. didn't think much of it, of course, I just had a shot. I was already on some prednisone for Gout from the first shot, After this shot, the Gout really kicked up even higher, so my Dr. increased the steroid, pain in arm/shoulder was there, but again, just thought was normal shot kind of thing. (saw dr. a week after shot for Gout pain increase). Pain in arm stayed steady, now pain is just worse and worse each day, and it's been well over a month, so I know this is NOT normal. I went to Dr. on 4/26. He was unfamiliar with SIRVA. He said see how it goes, and we can do a shot in the arm (I'm AFRAID Of a SHOT in the ARM) , an MRI, to see what is happening. We decided to give another week. Well, this week was HORRIBLE! I cannot sleep, the pain at night is unbearable, and taking aleve, tylenol, etc do nothing. The pain during the day is getting more each day, I've been doing exercises I've found online with no relief.
51 2021-05-04 feeling abnormal, anger, anxiety, confusional state The next day I noticed a measles like red spotty rash all over my arms legs and torso. This rash at... Read more
The next day I noticed a measles like red spotty rash all over my arms legs and torso. This rash at first did not itch but later itched mildly and intermittently this rash continues today, May 5th 2021. Furthermore I've suffered what I can only describe as brain fog that has left me discombobulated, absent mind, stumbling for words. Also my mood is significantly altered as I am suffering from anxiety and a short temper.
51 2021-05-04 loss of personal independence in daily activities Last shot was March 17, 2021. On April 8, 2021 started having dizzy spells. On April 12, 2021, I had... Read more
Last shot was March 17, 2021. On April 8, 2021 started having dizzy spells. On April 12, 2021, I had a dizzy spell, fell into door and vomited. Missed 2 weeks of work before a previous scheduled vacation took affect. Went to doctor and was diagnosed with Vestibular Neuritis. Was told it was unknown if this could have come about due to my receiving the Covid-19 Vacine
51 2021-05-04 sleep disorder High fever, chills, nausea, headache, during 12-24 hrs after injection. Treated with (1) Acetaminoph... Read more
High fever, chills, nausea, headache, during 12-24 hrs after injection. Treated with (1) Acetaminophen (500mg) every 6 hrs (2x total) . Periodic sharp pains in legs (calves) about 25-27hrs causing awakening from sleep. Took 320 mg aspirin, symptoms alleviated.
51 2021-05-05 feeling abnormal Since my 2nd Pfizer vaccination, I have been experiencing consistent fatigue, weakness, body aches, ... Read more
Since my 2nd Pfizer vaccination, I have been experiencing consistent fatigue, weakness, body aches, chills, headaches, brain fog, and an itchy cough.
51 2021-05-05 feeling abnormal Flushed face, "felt like I had a glass of wine." Felt dazed.
51 2021-05-06 abnormal dreams Mild headache following second shot that has lasted 3 months. Dreams more frequent, vivid, very diff... Read more
Mild headache following second shot that has lasted 3 months. Dreams more frequent, vivid, very different than prior to vaccine.
51 2021-05-07 confusional state Patient states that symptoms of confusion and lack of normal hand-eye coordination began during his ... Read more
Patient states that symptoms of confusion and lack of normal hand-eye coordination began during his last shift at work.
51 2021-05-07 sleep disorder Symptoms: Headache: stabbing pain headache especially right temple Tinnitus: ringing in right ear Sk... Read more
Symptoms: Headache: stabbing pain headache especially right temple Tinnitus: ringing in right ear Skin: rt ear red, swollen & bumpy. hair / scalp pain sensitivity Dizziness / Vertigo: Equilibrium and balance are off, walking like a drunk. Vision swims on head turn, phone appears to rotate in dark. Slight associated nausea. Occasional dry cough causing headache to explode. Progression SUNDAY 4/18/21 Second shot pfizer COVID-19 vaccine Gradual onset starting Thursday 4/22/21 (Day 4 since vax) or Friday (day 5 since vax.). SATURDAY 4/24/21- day 6 (since vax) , 0 (since full onset) - sharp stabs of headache every once in a while, noticed at game & really set in in evening. Feverish at night. SUNDAY - day 7,1 - low energy, body aches, difficult to get out of bed, 3 hour nap, severe headache. MONDAY - day 8,3 - Dr 9:45. 185 lbs, 97.8. Flu, strep, COVID negative. 5 day course of steroids, Start Flonase, Still fairly dizzy TUESDAY - day 9,4: Significant headache still but manageable with acetaminophen. Balance issues, vertigo? WEDNESDAY day 10,5 - 5:30am - Awakened by splitting headache. feverish. 1 acetaminophen, 1 chlorphenirmine @ 6am. By 10 AM, headache is back, high sensitivity to loud noise. Difficulty walking straight. THURSDAY day 11,6- 5:30am - awakened by splitting headache, 99.9 deg. 2 x acetaminophen. FRIDAY- calls back, Will call in a prescription for anabiotic, meclizine. SATURDAY 4:30am 2 x Acetaminophen 4am. first antibiotic @ noon , Diarrhea & cramping 7pm. Probiotic. 11 PM: 2X acetaminophen, anabiotic. SUNDAY- antibiotic 8, probiotic 10, Meclizine noon. TUESDAY- day 11 - Didn?t sleep well; 1x acetaminophen @ 5am. Headache pulse WEDNESDAY- Day 12 - 1x acetaminophen @ 1am, Headache seems just enough to prevent sleeping well without meds. Dizziness continues at same level. Meclizine doesn?t work. THURSDAY - Second visit with Dr : might be shingles based on lesions on ear, will prescribe anti-viral. Less likely: Ménière?s, something else. Call on for MRI Monday if symptoms not resolved. SATURDAY 5/8/21 - Day 15-still on antibiotic and antiviral, neither seems to be doing anything. Headache mostly gone, but dizziness /vertigo persist. Can not successfully walk heel to toe without falling over.
51 2021-05-08 insomnia Patient with no family or personal cardiac ischemic history, appropriate diet. Prior evaluation 6 ye... Read more
Patient with no family or personal cardiac ischemic history, appropriate diet. Prior evaluation 6 years prior showed 10% stenosis. Performs regular cardiovascular exercise (Peloton). No smoking or drug or alcohol history. Normal lipids before and after event. Normal lipid subfractions (MRI advanced profile). Pfizer Vaccine Dose #1 received 12/31/2020. First mild angina episode 1/17/2021. Pfizer Vaccine Dose #2 received 1/21/2021. Increasing angina developed 1/22/2021 through 1/27/2021. Normal echocardiogram 1/27/2021. NSTEMI occurred 1/28/2021 at 3:30am necessitating Emergency room visit, Catheterization demonstrating a new 95% LAD stenosis and stent placed. Patient subsequent developed questionable dysautonomia (tachycardia and insomnia of unknown etiology). Currently in recovery.
51 2021-05-10 insomnia dehydration; low blood sugar; fatigued; Appetite; Pneumonia; Night sweats; Headache; Couldn't eat an... Read more
dehydration; low blood sugar; fatigued; Appetite; Pneumonia; Night sweats; Headache; Couldn't eat anything; Wheezing; migraine; Light, hacking cough; Fever/ 103.9 degrees; Chills; No more than 2-3 hours of sleep per night for 5 nights; Short of breath; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received the second dose of BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration, administered on left arm on 14Apr2021 10:45 (Batch/Lot number was not reported) at age of 51 years as single dose. The patient medical history and concomitant medications was reported as none. Historical v for covid-19 immunisation accine included the first dose of BNT162B2 administered on left arm on 24Mar2021 at age of 51 years for covid-19 immunisation and experienced no issues. Patient reported that after the second dose of the Covid-19 vaccine, he had a fever for 8 days and was diagnosed with pneumonia on 21Apr2021. Patient reported that he was tested for both Covid-19, Influenza A, and Influenza B twice on 19Apr2021 and 21Apr2021 and tested negative for Covid-19 and influenza both times. Patient reported that he had no pre-conditions and that he was feeling great the night before he received the second dose of the Covid-19 vaccine, 13Apr2021. Patient reported that he was planning to go to work following the second dose of the Covid-19 vaccine on 14Apr2021. He began running a low-grade fever (102 degrees) on 14Apr2021 after receiving the Covid-19 vaccine and then his temperature flared up to 103.5 degrees on 15Apr2021. Fever: He received the second dose of the Covid-19 vaccine at 10:45 on 14Apr2021 and about 2:00 in afternoon on 14Apr2021 was the first fever that was significant. The last fever he had on 21Apr2021, his temperature was 103.9. He was put on antibiotics for pneumonia. He contacted the on-call nurse for his company. The on-call nurse advised him to see a doctor on Saturday, 17Apr2021.He went to the doctor on Monday, 19Apr2021. The doctor only ran a Covid-19 swab for testing and a flu swab. His doctor did not do blood work and stated that the patientwas experiencing an ill effect of the Covid-19 vaccine and sent the patient home. He went back to the doctor on Wednesday, 21Apr2021. When he went back to the doctor, the staff performed a chest X-ray and ran 4 different blood works to see what the patient had. The second Covid-19 test that he received on 22Apr2021 was performed with both the rapid test and the test that was sent off. Both Covid-19 tests came back negative. SARS test on 22Apr2021 was negative. 508-3 High Sensitivity CRP: One of his numbers that was parts per liter, 3 is considered to be high risk and he had 300 (300+) of whatever it was on 21Apr2021. He went back to the physician and was given another steroid shot an additional prescription. He had been back to the doctor 3 times since then. Fever: His fever was 103 consistently after 15Apr2021. 508-3 High sensitivity CRP: This value showed abnormal. The results said that relative risk was greater than 1 mg/liter and high was greater than 3. 1000 CBC with auto differential on 21Apr2021: The abnormal results were red blood cells measured at 4.38; hematocrit measured at 13.82; MCHC measured at 36.4; Neutrophils measured at 84; Lymphocytes measured at 12; and absolute Lymphocytes measured at 0.57. He wore a Garmin and that it recorded that he received no more than 2-3 hours of sleep per night for 5 nights. He didn't know anything about pneumonia previously and that he had specifically told his physician's office everything about what he was experiencing. He told his physician about the wheezing in his chest (on 17Apr2021), cough (on 16Apr2021), fever, and chills (on 14Apr2021). His physician told him it was a normal reaction to the Covid-19 vaccine and sent him home on 19Apr2021. He then consulted Google and started to realize that his side effect were very atypical. Wheezing: When he breathed really light, the crackling would continue. If he breathed shallow, the wheezing was audible but if he breathed deeply, it was not. The pneumonia was in the left side of his chest. He was still being treated for the pneumonia. He has his last dose of medication tomorrow, 27Apr2021, and that he was also being released to go back to work tomorrow. Cough: He had a little cough that would then go away. The cough began late Friday, 16Apr2021. It was interesting because it wasn't a main part of the illness. The cough was just kind of a hacking cough every once in awhile. The cough was not continuous like go and go and go and stop. The cough came, went away for awhile, then came again.The cough being worse was relative. He was coughing more than he did on Wednesday 21Apr2021, Thursday 22Apr2021, and Friday 23Apr2021. The cough was consistent more so at night when he laid down. He would probably say that it was a different feel towards the cough but it was still a cough. The cough was still the same volume but not the same effect. Headache (on 18Apr2021): He had been waking up with headaches in the morning and going to bed with them at night. On Wednesday, 21Apr2021, the headache was due to dehydration from the fever and night sweats. Once he got away from the dehydration headaches, the headache got better but he had woken up with a headache the last few days and had a headache at bedtime a few nights in a row. The headache was usually a frontal headache and this morning, 26Apr2021, the headache was toward the back of his head. The headaches last a few hours until he started moving around. On Saturday, 17Apr2021 he experienced a migraine that would not go away. He didn't usually get migraines. The migraine lasted hours if not for a day and that the headache was something furious. Sunday 18Apr2021 was pretty much the same thing with the headache. Because of the massive fever, he couldn't eat anything at all (17Apr2021). The headache was mostly due to low blood sugar and dehydration. Appetite: His appetite improved after his second doctor's appointment on 21Apr2021. The second provider was a lot more straightforward and advised the patient that he needed to start taking care of himself and trying to force himself to eat. He forced himself to eat on 21Apr2021 and by Thursday 22Apr2021, he had a full appetite and was craving food again. Shortness of breath (Apr2021): Patient reported that the shortness of breath was just from being fatigued. Patient reported that he got out of breath from going up and down the stairs. He was unsure when the shortness of breath began because he was moving very little, but that he noticed the shortness of breath on Monday, 19Apr2021 when he got up to go to the doctor.On Friday 16Apr2021 and Saturday 17Apr2021, he had a really good break.On Friday 16Apr2021 from 9 AM to 1 PM, he had no fever and it was like the sun was coming out, then the fever hit really hard. The same thing happened on Saturday, 17Apr2021, but the fever free period lasted maybe a little longer. His fever returned and that the afternoon of Saturday 17Apr2021 was the worst he had been the entire time. On 13Apr2021 to get away from arm soreness, he did a few laps in the pool. On 13Apr2021 he had a new best time on the 100 in freestyle in the pool and that he felt really strong going into 14Apr2021 to get his second dose of the Covid-19 vaccine. There was nothing that would have indicated that he had anything going on before getting the second dose of the Covid-19 vaccine. Up until Saturday, 17Apr2021, he had only been taking Motrin and just taking 2 tablets. He had no break in between fevers and chills and was not able to get ahead of the fever with the Motrin. There was a long stretch where the Motrin wasn't working and his temperature didn't get below 100 for several days. He tried to cycle acetaminophen in beginning Saturday 17Apr2021 to try to get the acetaminophen in between the Motrin doses. When he went back to the doctor on 21Apr2021, the provider told him that he could take 3 to 4 Motrin tablets at a time but not to exceed 4 doses per day. He never took more than 3 tablets. Motrin was generic ibuprofen. Night sweats (on 21Apr2021): The last couple of nights have been the same. He had a fan on to keep a little cooler and that it was 61 degrees outside and he felt the night sweats. He had a buckwheat mat that was cool that he put on the floor to stay cooler with the night sweats. Come Thursday, 22Apr2021, he said we're done with this and he couldn't sleep from it (Apr2021). Last night, 25Apr2021, he knew that he had night sweats because he was sweating at night and the temperature in the room was 64 degrees. AEs did not require a visit to Emergency Room. AEs required a visit to Physician Office for fever, wheezing, cough, shortness of breath, chills. Outcome of events was unknown.
51 2021-05-11 loss of personal independence in daily activities First week soreness of arm, patient can't lift up the arm without extreme pain and assistance of the... Read more
First week soreness of arm, patient can't lift up the arm without extreme pain and assistance of the other arm. Patient cannot lift anything with this arm. This has been a gradual decline per patient which is still continuing to occur 2 months after the vaccine.
51 2021-05-18 insomnia, suicidal thoughts Chills and tremors two weeks after vaccination. Possible aggravation of underlying psychiatric diso... Read more
Chills and tremors two weeks after vaccination. Possible aggravation of underlying psychiatric disorder including anxiety, desire for a drink and additional anxiolytics medication, suicidal ideation. Sleeplessness. Not absolutely certain these were related to the vaccine although I was doing well before it. Dr. suggested it might be an allergic reaction or unspecified cause.
51 2021-05-20 impaired work ability Having adult onset severe asthma I am prone to lung inflammation from a number of sources including ... Read more
Having adult onset severe asthma I am prone to lung inflammation from a number of sources including some foods and allergens as well as viruses and smoke of any kind. I had been doing fine that week until the day after the second shot. I had severe shortness of breath, bad enough to keep me home and using my rescue inhaler several times that next day. This also occured when I had Covid in November 2020. It took me longer to test negative, 3 weeks. I believe that the shot caused an immune reaction, like it should, but also triggered an asthma attack that lasted several days but progressively reduced as time went on. Last week I had dizziness and heart palpitations. I have no idea if it was the shot still or the meds for my asthma, but I thought I should include it.
51 2021-05-20 loss of personal independence in daily activities 4/14/2021 I received 2nd Pfizer at 8 am, but around 10 am I started to feel my left leg tighten up. ... Read more
4/14/2021 I received 2nd Pfizer at 8 am, but around 10 am I started to feel my left leg tighten up. In two days I could not walk. They tried to give me muscle relaxants and pain meds. But It did not cure anything. I have had a low-grade temperature(usually exactly 99.5 but sometimes higher ) for 38 days and does not go away. I felt inflammation and at the hospital, they did a C-Reactive Protein (CRP) and it showed 144 mg/L. I entered the hospital from 5/21/2021 till 5/25/2021. They ran many tests but found no infections. They did possibly find some preexisting condition that I might have had all along. The only problem I have is I was completely healthy per se (even with the preexisting condition that I didn?t know about) right before the vaccine I was able to exercise, able to lift weights, good energy level, and eating properly. I feel like the vaccine is still somehow working in my body even that is not supposed to be the case. I feel like my body is still in a state of hyper inflammation and it killing me.
51 2021-05-26 anxiety, abnormal behaviour On 5/20/21 the patient was at home with his mother when he had acute nausea, light-headedness, and a... Read more
On 5/20/21 the patient was at home with his mother when he had acute nausea, light-headedness, and abdominal pain. He presented to the ED by ambulance. Excerpt from ED notes od MD follows: "Initial ED interventions: iv fluids, low dose iv ativan, iv toradol, iv zofran. ED course: patient arrives very anxious, writhing on bed, difficult to redirect. With chronic tonicity, not seizing. Mother arrives, and he recognizes her, seems to be consoled somewhat by her presence, but she is unable to direct him, and describes his behavior as irregular, and events acute this evening at her home. Patient rests, and then HR decrease to 50s on monitior and patient found to be pulseless - I immediately start chest compressions, and achieve ROSC after PEA arrest with administration of EPI/compressions. Patient intubated per procedure note without complication. L femoral central attained per procedure note without complication. CPR performed over ED course intermittently (always PEA arrest) with ROSC achieved with administration of EPI, EPI drip started in addition to sedation meds, and iv fluids. No obvious STEMI on ECG to administer lytics, with suspicion of dissection and AAA prominent. I am able to stabilze and accompany patient to CT suite, where I recognize B/L massive PE immediately. I discuss with Dr. of Cardiology, who agrees with admininstration of alteplase. I disucss risks with mother who consents verbally. Patient without response to alteplase, and with continued pattern of PEA arrest following bradycardia. I discuss etiology of presentation with mother,and that patient is with very poor prognosis of survival, and likely poorer prognosis of neurological status, and patient is made comfort care, and fentanyl drip increased, patient is taken off of ventilation and drips. Pronounced deceased at 22:00. MDM: Initial concern for but not limited to appendicitis, AAA, diverticulitis, renal stones, pyelonephritis, musculoskeletal pain, pancreatitis, toxic ingestion, ACS, obstruction, perforation, sepsis (2/2 PNA, UTI, meningitis, intra-abdominal infection), AAA, dissection, PE - as ED course progresses, differential narrows and consider more likely PEA arrest secondary to ACS, PE, dissection, AAA, necrotic pancreatitis, tension PNX (less likely). Considered but do not suspect seizures, stroke. Imaging studies reviewed - CXR with ETT in place, no acute pathology. CTA chest/A/P remarkable for massive proximal B/L PE. Labs reviewed. ECGs without STEMI, with sinus tach initially, LBBB after initial ROSC, and then AFib in RVR on subsequent ECG. Per above, patient suffered massive B/L PE, with subsequent cardiac arrest, despite heoric efforts including thrombolysis. Death called art 22:00. Diagnosis: massive B/L PEs, PEA arrest. Disposition: deceased."
51 2021-05-30 feeling abnormal Very sluggish,cold not chills no fever,out of sorts feeling,lasted only 1 day,feeling better on 2nd... Read more
Very sluggish,cold not chills no fever,out of sorts feeling,lasted only 1 day,feeling better on 2nd day
51 2021-06-02 feeling abnormal have a Infected abscess and the infection got really bad at the Same time as my vaccination; serious... Read more
have a Infected abscess and the infection got really bad at the Same time as my vaccination; serious "brain fog"; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 09May2021 11:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 51-year-old. Medical history included Infected abscess. The patient previously took the bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 51-year-old. The patient received Antibiotics within 2 weeks of vaccination, but no other vaccines within 4 weeks prior to the COVID vaccine. The patient reported I had 12 of the side effects but 2 weeks later, and after missing 2 weeks of work I still have serious "brain fog". I have an Infected abscess and the infection got really bad at the Same time as my vaccination. The events started on 10May2021 12:00, and result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. The patient was put on antibiotics. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination but tested for COVID-19 on 15May2021 with negative result. Information on lot number/batch number was requested.
51 2021-06-03 loss of personal independence in daily activities Rapid heart rate. Resting rate of 120 to 130 beats per minute for at least 2 days. Then 100 to 110 f... Read more
Rapid heart rate. Resting rate of 120 to 130 beats per minute for at least 2 days. Then 100 to 110 for another 2 days. After 2 weeks still having trouble with normal activities. Heart beat feels different and I get weak whenever moving quickly for example doing laundry or cleaning the house.
51 2021-06-05 feeling abnormal Vertigo, dizziness, brain fog minutes after, then roughly weekly each week thereafter. No treatment.
51 2021-06-08 feeling abnormal All over body rashes; Shortness of breath; Dizzy; Foggy head; Nausea; Tired/ Fatigue; horrible excru... Read more
All over body rashes; Shortness of breath; Dizzy; Foggy head; Nausea; Tired/ Fatigue; horrible excruciating migratory arthritic pain; Have variety of symptoms very painful; Areas of my body have been in serious pain; I couldn't walk for days and it affected my right foot and right hip; Really been destroying my health; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 51-years, and administered in left arm on 02Apr2021 (Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was completely heathy before this vaccine. There were no concomitant medications. Historical Vaccine included the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient stated that she was having really horrible excruciating migratory arthritic pain and all over body rashes on 07Apr2021 since she took the Pfizer vaccine. it was reported that she had went emergency twice and she had been to the doctors going back to the doctors again and she was going to ask him can she see rheumatologist, they're taking blood test and urine test and she had variety of symptoms very painful. Areas of her body have been in serious pain like it felt like a migratory arthritis kind of pain that just moved area to area every three to four days and twice it got her unable to walk. The patient couldn't walk for days and it affected her right foot and right hip and she was unable to walk since in two instances she was left unable to walk for a few days and it was very painful but she also had like all over body rash, shortness of breath from time to time, dizzy, foggy head, nausea, tired, fatigue. The patient was completely heathy before this vaccine. It had really been destroying her health basically. The patient had been taking pain pills and Benadryl(Treatment) because of the rash and stuff, pain pills for pain but it had not really helping a lot it was just she had been taking like generic Tylenol(Further not clarified). And patient stated above symptoms still happening. The patient underwent lab tests and procedures which included blood test and urine test: normal on Apr2021 (They couldn't find anything wrong with patient). No follow-up attempts needed. No further information expected.
51 2021-06-17 feeling abnormal He also reports his right leg and foot started swelling; He also reports his right leg and foot star... Read more
He also reports his right leg and foot started swelling; He also reports his right leg and foot started swelling; Sweating; feels weird; Shaking; Later that day he states his left arm (injection arm) started twitching; he vomited; and his left pinky and ring fingers were numb; right leg blew up; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0181), via an unspecified route of administration in left arm on 28May2021 as single dose for covid-19 immunization. The patient's medical history included alcohol use stated that all he does was drink some liquor and beer. No medications or surgeries. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient stated that after he received his first Pfizer COVID-19 vaccine dose on 28May2021, later that day he states his left arm (injection arm) started twitching, he vomited, and his left pinky and ring fingers were numb, and the patient felt nervous like he was shaking. On 14Jun2021, the patient also stated that he got the shot and the band aid that they cover the injection area with, it was branded in his arm and he got the shot 3 weeks ago and it looks like a band aid is on his arm. He thought it would be gone and it stayed. On an unknown date, the patient reported that his right leg and foot started swelling. The patient's right leg blew up. He reports the band aid to his injection site looks like it "burned" into his arm. He states his right/foot leg swelling and left arm twitching have continued and wants to know if this is a reported side effect. Now after he got the shot his arm has been twitching, he's sweating and vomiting all morning. His right leg blew up and he feels weird. He just doesn't feel like himself. Right after the shot, the patient felt like there's a bunch of fluid. It's ongoing, it has gone down a little bit. It's improved a little, very irritating when it does happen. He can't eat. It won't stay in his stomach and he can't hold water. It has improved but when it happens, he feels terrible. There was no emergency or physician room visit for the events. The clinical outcome for the events was unknown, the other events muscle twitching, and shaking was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
51 2021-06-17 nervousness rash around the body/rash all around body was reported as worsened.; sore throat/sore throat was rep... Read more
rash around the body/rash all around body was reported as worsened.; sore throat/sore throat was reported as worsened; sweating; shaking; weakness; pain around the kidney; Pain around back; muscle pain in his back; a little scared.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29May2021 (Batch/Lot Number: FW0187) as 1st dose, single for COVID-19 immunization. No medical history and concomitant medication were reported. The patient experienced the following symptoms: weakness on 29May2021, pain around the kidney on 29May2021, muscle pain in his back in 2021, sweating on 29May2021, shaking on 29May2021, rash around the body on 30May2021/rash all around body was reported as worsened and sore throat on 30May2021/sore throat was reported as worsened, a little scared in 2021, pain around back on 29May2021. Clinical course: A couple hours after the first vaccination, he started to feel weakness and pain around his kidney and back part. Also, some symptoms that are very common. He felt sweating and shaking and stuff like that. That night he noticed he started to have a rash all around his body and day by day it has been getting worse. On 01Jun2021, he went to the hospital emergency room and they gave him some medicine. He received a shot of diphenhydramine hydrochloride (BENADRYL) in the hospital. They also gave him an IV to flush out his body. Then the doctor gave him three prescriptions. He was released from the emergency room yesterday as well. 1. Aluminium hydroxide gel, dried, magnesium carbonate (PEPCID) 20 mg Expiration- Nov2022 in a pharmacy bottle, No lot number; 2. diphenhydramine hydrochloride (generic one) 25mg Expiration- Nov2023 in a pharmacy bottle, no Lot number; 3. Methylprednisolone tablet 4mg (NDC: 68001-005-01; Lot number: 20P0432, Brand: Bluepoint). Dose details: 6 days- First day to take 6 together, second day to take 5 together, fourth day to take 4 and so on for 6 days. So far, he has just taken the first dose which is 6 together. When he woke up today, he noticed that his rash was even worse. He didn't know how far the rash will go. The rash was like a burn and watery. The rash was all around his body. It started on his head; under his head and all around his face, then stomach, back and legs. His primary doctor and the emergency doctor suggested for him to not get the second dose because the second dose of BNT162B2 was going to have a stronger reaction. Some event details described as follows: weakness: Experienced 5 hours after receiving the shot. Considering how it has worsened his daily activities, from zero to 10, was like a 4. Pain around kidney: Like a muscle pain around kidneys that started about 8-10 hours after the shot. That pain came and went. It's not that much pain but still with him. Zero to 10 is like a 4 or 5 on pain level. Pain around back: pain was like a muscle pain. He experienced this 10 hour after vaccine. The pain has sort of improved. It was almost resolved. Sweating: He experienced on first night. 12 hours after. It came and went, but still ongoing. It was not that much, but still he still had it. Shaking: He experienced this on same night as the sweating. 12 hours after. It was almost recovered. It has happened one or two times over the past two days. Rash all around body: He noticed this a day after his shot. It was a couple of them around his body. It started from his head and spread all around body, but it was not that much at first. Day by day it has been getting worse and today is the worst day so far. The emergency room doctor checked his kidneys just in case. They told him everything was fine with the kidneys. It seems like it is a problem with the muscle. Also, he had a sore throat. It started 3 days ago. When he drinks or eat something, he felt burning. He noticed it the first time at nighttime. The emergency room doctor is assuming he had a vaccine reaction. Reporter seriousness for events weakness, pain around kidney, pain around back, sweating, shaking, rash all around body and sore throat was provided as unspecified. The outcome of event muscle pain in his back and a little scared was unknown; of event shaking and pain around back was recovering; of rest events was not recovered.
51 2021-06-18 feeling abnormal Fever; pain at injection site; joint pain; chills; tiredness; nausea; muscle pain; feeling bad; head... Read more
Fever; pain at injection site; joint pain; chills; tiredness; nausea; muscle pain; feeling bad; headache; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 13:00 (Batch/Lot Number: EN6207) (at the age of 51) as single dose for covid-19 immunisation. Medical history was not reported. No concomitant medications in two weeks. No other vaccine in four weeks. No covid tested post vaccination. The patient experienced fever on 20Mar2021 01:00, pain at injection site on 20Mar2021 01:00, joint pain on 20Mar2021 01:00, chills on 20Mar2021 01:00, tiredness on 20Mar2021 01:00, nausea on 20Mar2021 01:00, muscle pain on 20Mar2021 01:00, feeling bad on 20Mar2021 01:00, headache on 20Mar2021 01:00. The events were not treated. The events outcome was not recovered. No follow-up attempts are possible. No further information is expected.
51 2021-06-21 mental impairment After second dose, had the typical feeling like the flu, but lymph nodes were swollen. The flu sympt... Read more
After second dose, had the typical feeling like the flu, but lymph nodes were swollen. The flu symptoms passed, but continued to have problems with lymph nodes. Fatigue set in just after flu symptoms, have never recovered. In June, I started having pain in my upper maxillary. Saw my dentist, who sent me to a dental surgeon. They determined that it was wire from a jaw surgery 30 years ago. They removed the wire, but all of the other wires are giving me pain, and may need to be removed. They had not bothered me prior to the vaccine. Mental health has also declined and not recovered. My medications are now higher than pre vaccine. Fatigue is still a major problem.
51 2021-06-26 anxiety, insomnia, nervousness, irritability The first dose resulted in Graves disease, with an acute hyperthyroidism , palpitations, fatigue, ne... Read more
The first dose resulted in Graves disease, with an acute hyperthyroidism , palpitations, fatigue, nervousness, anxiety and irritability. Unintentional severe weight loss and imsomnia. Coughing, and bronchitis
51 2021-06-28 sleep disorder Tinnitus, ringing in both ears. Started within a week of the first shot, has not gone away so far t... Read more
Tinnitus, ringing in both ears. Started within a week of the first shot, has not gone away so far to date. Loud enough to keep me from going to sleep.
51 2021-07-03 insomnia Sciatica, severe pain down right leg, unable to sleep/walk normally for several weeks
51 2021-07-05 hallucination, anxiety Hallucinations: they happen sometimes, not all the time, and only when he is anxious, after first va... Read more
Hallucinations: they happen sometimes, not all the time, and only when he is anxious, after first vaccine.; when his anxiety is high; This is a spontaneous report from a contactable consumer (patient himself). A 51-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0187) via an unspecified route of administration in right upper arm (as reported) on 20Jun2021 10:35 as dose 1, single (at the age of 51-years-old) for COVID-19 immunization. Vaccination Facility Type was reported as pharmacy. Vaccine was not administered at Military Facility. Patient medical history included ongoing high blood pressure from about 20 years ago, ongoing depression from 1996, ongoing anxiety from 1996, ongoing obsessive-compulsive disorder from about 3.5 years ago. The concomitant medications included ongoing citalopram oral tablet at a dose of 40 mg from 1996 taken for antidepressant therapy, ongoing trifluoperazine oral tablet at a dose of 5 mg from 1996 taken for antipsychotic therapy, ongoing clonezapan oral tablet at a dose of 0.5 mg taken for anxiety, started about 5 years ago, ongoing lisinopril oral tablet taken for high blood pressure started about 15 years ago. On an unspecified date in Jun2021, patient stated his hallucinations began after the vaccine, stated they happened sometimes, not all the time, and only when he was anxious after 1st vaccine. Patient stated the hallucinations were somewhat better. The adverse events did not result in physician office visit or emergency room visit. The outcome of the events was recovering.
51 2021-07-05 excessive sleepiness, insomnia Within an hour of the second dose, I was so tired that I fell asleep and slept over 24 hours. When ... Read more
Within an hour of the second dose, I was so tired that I fell asleep and slept over 24 hours. When I awoke, I had soreness in my muscles and cramps. The cramps migrated to my chest area and I have had severe chest pains, soreness in the back of my neck on the left side and in my left chest with occasional tingling in my right arm. The pains have slowly subsided and went away for about 5 days and returned fiercely last Friday in the middle of the night. It hurt so bad I couldn't sleep, so I took an Advil and after 30-45 minutes, the pain subsided. When the Advil wore off, the pains returned, so I attempted to contact a walk in clinic, they referred me to an urgent care facility. The urgent care facility took my vitals, asked about my symptoms and then hooked me up to an EKG. They told me I have an abnormal T-wave and sent me to the emergency room. The emergency room triaged me, took blood samples, reviewed my EKG and took chest X-rays. After several hours, they ruled out heart conditions and sent me home with a prescription for heartburn medicine. I do not have heartburn, I have symptoms that mirror Myocarditis/Pericarditis.
51 2021-07-11 feeling abnormal Brain Fog, Long Fatigue,
51 2021-07-12 sleep disorder Body stiffness to the point where other people have noticed it. Knee pain. Sleep disturbance problem... Read more
Body stiffness to the point where other people have noticed it. Knee pain. Sleep disturbance problems. Tingling sensation on my back. I will be seeing a doctor soon regarding these issues.
51 2021-07-15 sleep disorder, impaired work ability Shortly after receiving the second Pfizer shot I developed extremely severe spasms and cramping thro... Read more
Shortly after receiving the second Pfizer shot I developed extremely severe spasms and cramping throughout my chest and back. The pain level is profound and unrelenting and has not changed in two months. Pain free time is rare, 50% of every day is spent trying to survive the pain, but I am frequently at the hospital. I cannot eat or sleep or work and dropping weight dangerously fast. I am completely incapacitated and now have a caretaker
51 2021-07-18 disorientation Two days of severe body aches, chills, mild fever. Five additional days of severe leg cramps, loss o... Read more
Two days of severe body aches, chills, mild fever. Five additional days of severe leg cramps, loss of strength, headaches, disorientation, extreme fatigue.
51 2021-07-22 feeling abnormal, depressed mood sweaty hands and feet/his hands and feet were sweating and really clammy; tingling in tongue; brain ... Read more
sweaty hands and feet/his hands and feet were sweating and really clammy; tingling in tongue; brain fog for two months; losing weight/States he was 220 pounds. States not he is around 160-170 pounds; Was walking 5-10 miles a day, has not been; Caller states the she feels her husband is handicapped from this; now introverted where previously he was the life of the party; he's not speaking much; The patient states he feels like he's dying on the inside/She says some doctors say he is depressed but he has never had any kind of mental health disorders; Says his mentality is not right; Abdominal Pain; Says his voice went from being vibrant to low and monotone; flat affect; irregular bowel movements; double vision; Caller says her husband has a small appetite, but he had always previously been an avid eater; This is a spontaneous report from a contactable nurse (patient's wife) and consumer (patient's sister). A 51-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 19Feb2021 (Batch/Lot Number: EQ3249) and dose 1 administered in Arm Right on 29Jan2021 (Batch/Lot Number: E19263) as single dose for covid-19 immunisation at the age of 51-year-old. Medical history included ongoing type 2 diabetes mellitus which was diagnosed 2-3 years ago, the patient was not on insulin or anything, unspecified Allergy, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity. There were no concomitant medications. The patient experienced losing weight in Feb2021, flat affect in 2021, sweaty hands and feet on 20Feb2021, tingling in tongue in Feb2021, brain fog for two months in Feb2021, irregular bowel movements in 2021, double vision in 2021, small appetite in 2021, was walking 5-10 miles a day, has not been in Feb2021, handicapped from this in 2021, now introverted where previously he was the life of the party in 2021, not speaking much in 2021, feels like he's dying on the inside/she says some doctors say he is depressed but he has never had any kind of mental health disorders in 2021, his mentality is not right in 2021, abdominal pain in 2021, his voice went from being vibrant to low and monotone in 2021.The patient was hospitalized from 07May2021 to 09May2021.The patient underwent lab tests and procedures in 2021 which included colonoscopy: normal, computerised tomogram: normal, echocardiogram: normal, endoscopy gastrointestinal: normal, magnetic resonance imaging: normal, weight: 160-170 pounds, blood test: normal. The outcome of the events was not resolved. The nurse reported that her husband received his second dose of the Pfizer BioNtech covid 19 vaccine on 19Feb2021. The next day he woke up with the following symptoms: sweaty hands and feet, tingling in tongue, brain fog for 2 months, irregular bowel movements, double vision, and flat affect. The nurse reports he was now introverted where previously he was the life of the party, he's not speaking much, not doing things he previously enjoyed such as previously doing yard work, driving, and walking 5-10 miles every morning. He is losing weight without trying 220 lbs to 160-170 lbs now. The nurse reported they have been in and out of the emergency room and sought medical care from many different people including a psychiatrist. The nurse reported they have had labs and bloodwork drawn that all resulted normal. The patient states he feels like he's dying on the inside. The nurse was seeking treatment recommendations as one doctor suggested that these reported symptoms could be caused from the Pfizer BioNtech covid 19 vaccines. He has been losing weight and his affect and demeanor are different since he got the second vaccine. They have been to every doctor and specialists. His blood work is perfect, and they cannot find out what is wrong with him. The nurse says that her husband was happy and jovial. he was 220 pounds and now is around 160-170 pounds. his mentality is not right; he has no affect. he used to be cutting grass and gardening. Now he is not speaking to family and friends; he is not even speaking to her as much. no one knows what is wrong. The nurse states that several doctors believe it to be from the vaccine because nothing happened until after the second dose of the vaccine. The nurse is uncertain about this. He has lost weight quickly. On 20Feb2021: He woke up and his hands and feet were sweating and really clammy. States she could touch them and feel the moisture. He went to the (privacy) and they gave him a roll-on for his hands. The following week he kept saying that his tongue was tingling; like as if he had bit it. He started seeing the dentist about it and they prescribed medications. A week after the tongue tingling he started experiencing brain fog. She states this brain fog lasted for 2 months. Along with the brain fog, he started to lose weight and complain of intense abdominal discomfort, Abdominal pain. He said that his bowel movements were not regular. He went to a gastroenterologist and they did a colonoscopy and EGD and found nothing on these tests. He kept the gastrointestinal issues for a long time. he has been wearing glasses because he is nearsighted. After the vaccine he complained of double vision. He saw his optometrist who said everything was fine. He has been in and out of the emergency room. Everyone says that he is fine. All of his labs are within normal limits; blood work, urine tests, and stool. He is steadily losing weight; he was 220 pounds, now he is 160-170 pounds. He was bright and affectionate. And he loves the outdoors and would walk 5-10 miles a day. But he has not been walking since Feb2021. He has a small appetite, but he had always previously been an avid eater. He was admitted into the hospital around 07May2021-09May2021. She had to push for that admission. her husband would wake up every morning saying he felt like he was about to die. she has been taking him to the emergency room about twice a week since February. While hospitalized he had CT Scans, MRI, Echocardiogram, and nothing was found on these tests. she feels her husband is handicapped from this. Their daughter is getting married, they are about to be grandparents, and her husband's affect is just flat. She says some doctors say he is depressed but he has never had any kind of mental health disorders. she has not seen her husband smile since February or March. his voice went from being vibrant to low and monotone. Patient's sister reported Her brother was fine, he had the first one then he got the second one and after the second one he is now having these foggy brain, mental kind of stuff happen. He got it in February and it started right there after, this is still going on and she wants to know how long it may last. No follow-up attempts are needed. No further information expected.; Sender's Comments: Based on close temporal association there is reasonable possibility of causal association between the reported serious events and the suspect drug Comirnaty. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
51 2021-07-26 impaired work ability, anxiety 51yo Male, received 2nd COVID pfizer vaccination 6/17, since then has had chills, fatigue, DOE, head... Read more
51yo Male, received 2nd COVID pfizer vaccination 6/17, since then has had chills, fatigue, DOE, headaches, body aches, dry cough, random easy bruising. Had been ruled out for ACS 6/18 in ED, CXR neg. Many of symptoms typical post-vaccination symptoms, but cough/DOE atypical. Patient also tested neg for COVID 6/22/21. Afebrile (fevers only lasted first 2 days after vaccination). 1 month later, symptoms are unchanged. I am repeating a D-dimer, CXR, CBC, INR. Patient has been unable to keep his job due to his ongoing symptoms. Patient has been very worried about symptoms, likely strong anxiety component contributing as well, but etiology of symptoms still unclear. consulted ID, recommended further labs. Repeat CXR 7/26 clear, repeat D-dimer neg.
52 2021-01-05 anxiety Employee became diaphoretic, stated he felt his heart was racing, and that he was very anxious. Stat... Read more
Employee became diaphoretic, stated he felt his heart was racing, and that he was very anxious. Stated he has history of fear of needles. He also does extreme exercise program. Evaluated by EMT's BP 152/97, HR 56, SpO2 100% After 15 extra minutes observation employee stated he felt fine to go to work.
52 2021-01-11 impaired work ability Headache, Myalgia, Arthralgia, Angioedema, Nausea Vomiting & HYPOtension Narrative: Extensive >4 day... Read more
Headache, Myalgia, Arthralgia, Angioedema, Nausea Vomiting & HYPOtension Narrative: Extensive >4 days symptoms, lost work time
52 2021-01-12 impaired work ability Fever & Nausea Vomiting missed one day of work following second dose vaccine
52 2021-01-12 impaired work ability missed one day of work following 2nd dose
52 2021-01-12 insomnia lightheaded right after shot for 30 ninutes, then chills for the whole night after. The next day, he... Read more
lightheaded right after shot for 30 ninutes, then chills for the whole night after. The next day, headache and then respiratory symptoms with dry cough and 02 sat down to 93%. More headache and body aches/fatigue that day. Insomnia for two nights after the injection.
52 2021-01-12 sleep disorder, fear At first I has some injection site pain and soreness nothing too bad. But around 01:30 I awoke with ... Read more
At first I has some injection site pain and soreness nothing too bad. But around 01:30 I awoke with a really high fever. My fever was 102.8 when I first woke up. I was very nauseous and my fever felt worse. My thermometer would not read any more until my temp came down. I can only guess how high it got but at least 103 degrees. I took Advil Liquid Gells and then my fever broke. I was actually scare for my life. In March I actually caught coronavirus and developed anti bodies for Covid. I can only guess my body was fighting for it's life.
52 2021-01-13 impaired work ability A PCR test was done and received results Monday (4th) as positive; A PCR test was done and received ... Read more
A PCR test was done and received results Monday (4th) as positive; A PCR test was done and received results Monday (4th) as positive; Had some scratchy throat late friday night; Saturday called out sick to work as the cough started; Saturday called out sick to work as the cough started.; Lost taste and smell monday; Lost taste and smell monday; Running fever; fatigue; This is a spontaneous report from a contactable Pharmacist (the patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1686, expiration date unknown) via an unspecified route of administration on 28Dec2020 at 12:00 PM (at the age of 52-years-old) via an unspecified route of administration at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included hypertension, high blood cholesterol from unknown dates. Allergy information was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was administered the vaccine at a Nursing Home/Senior Living Facility. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN/HYDROCHLOROTHIAZIDE), atorvastatin (LIPITOR), fenofibric acid (FENOFIBRIC ACID), amlodipine besilate (NORVASC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the vaccine on Monday 28Dec2020. A PCR test for COVID was done on Tuesday and a rapid test on Wednesday both of which were negative. The patient experienced some scratchy throat late Friday night on Saturday, 02Jan2021 the patient called out sick to work as a cough had started. A PCR test was done on 02Jan2021 and he received results Monday (4th) as positive. The patient continued to say that the cough had subsided, as he took Delsym. He lost taste and smell on Monday. He reports running a fever that varies from 99-101.5. He took Tylenol and Motrin to control the fever. In addition he has experienced fatigue. It was also reported, in contradiction of the above reported chronology of events, that the onset date of events was 25Dec2020 (CONFIRMATION PENDING for onset date of events relative to vaccine administration). The patient experiences of COVID 19 positive test, scratchy throat, sickness, cough, loss of test and smell, fever and fatigue resulted in a physician office visit (date not specified). The patient underwent lab tests that includes a PCR test on 29Dec2020 which was negative, a rapid test on 30Dec2020 which was negative and a PCR test on 02Jan2021 which was positive. Treatment for the events was reported as Motrin and Tylenol for fever and Delsym. for cough. The clinical outcome of COVID 19 positive test, scratchy throat, sickness, cough, loss of test and smell, fever and fatigue was reported as not recovered.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020, and COVID-19 PCR test positive on 02Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.
52 2021-01-14 feeling abnormal fever went up 99.9; woke up covered in sweat; shaking so bad; shivering; had trouble keeping balance... Read more
fever went up 99.9; woke up covered in sweat; shaking so bad; shivering; had trouble keeping balance; swaying when walking; felt like crap; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at a single dose SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 in Apr2020. The patient's concomitant medications included celecoxib (CELEBREX). After receiving the vaccine fever went up 99.9, woke up covered in sweat, shaking so bad, shivering, had trouble keeping balance, was swaying when he was walking on an unspecified date. The patient also stated he felt ill for 3-4 days. The outcome of the events was unknown. Information about lot/batch number has been requested.
52 2021-01-14 restlessness Started with chills, then severe headache, body aches, and ETOH like withdrawals (mind racing, delus... Read more
Started with chills, then severe headache, body aches, and ETOH like withdrawals (mind racing, delusional thoughts), nausea, tossing and turning unable to get comfortable (Though I spent 18 hours in bed, Fitbit recorded only 3.5 hours of sleep). Please note this writer has never experienced etoh withdrawal personally, however he has taken care of many patients requiring hospitalization for the same. The bulk of all simultaneous symptoms occurred from 0200 on 1/14 to 1030 hours of same day. Headache unrelieved by Tylenol (500mg at 2230 on 1/13, 1000mg at 0245 on 1/14, then Advil 400mg at 0945 on 1/14).
52 2021-01-17 excessive sleepiness I felt fine until 2 hrs after shot. Then became very drowsy. Needed 3 hr nap. Then got up for a few ... Read more
I felt fine until 2 hrs after shot. Then became very drowsy. Needed 3 hr nap. Then got up for a few hours. Went to bed 2 hrs early. Slept very soundly that night. For the rest of the week, I needed a 5 to 6 hrs extra sleep every day. I missed a week of work because of fatigue. On 3rd and 4th days after shot I had diarrhea. On 3rd and 4th days after shot I had slight nausea. Slight ringing in ears on days 2, 3, and 4 after shot. Only slight fatigue on 5th day after shot. All other symptoms gone. 6th day after shot all symptoms gone. I feel fine. I'm glad I was vaccinated.
52 2021-01-20 insomnia Body ache starting 11 hours after vaccination; headache shortly after, then fever 99.5, up to 100.9;... Read more
Body ache starting 11 hours after vaccination; headache shortly after, then fever 99.5, up to 100.9; insomnia; aches lasted ~14 hours
52 2021-01-25 feeling abnormal his brain was still a little cloudy; tested positive for covid; tested positive for covid; lost 10 p... Read more
his brain was still a little cloudy; tested positive for covid; tested positive for covid; lost 10 pounds; energy level changed drastically; weak; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EH9899, via an unspecified route of administration in left arm on 21Dec2020 09:00 at a single dose for COVID-19 immunization in a hospital. Medical history included hypertensive and diabetic, both ongoing. Concomitant medication included metformin for diabetic and olmesartan medoxomil (BENICAR) for hypertensive. There were no prior vaccinations within 4 weeks. The patient received the covid vaccine first dose on 21Dec2020 and started developing covid symptoms on the 27Dec2020. He was tested positive for covid on the 28Dec2020. The patient wanted to know what is next. He patient stated that it has been 10 days and he wanted to know if he is still contagious. He is scheduled to get the second dose on 11Jan2021. He wonders if he can get the second dose or does have to start the process over again. He works in a doctor's office. He is a technician. While providing height and weight he commented it has changed drastically. He later clarified it was his weight that changed drastically. He lost ten pounds. His weight and energy level changed drastically, and this was after getting the COVID Vaccine. His symptoms started the weekend after taking the vaccine. He had COVID symptoms. He later clarified and stated they all started on 27Dec2020. He clarified his symptoms as: body aches and fever. The body aches and fever started the night of 27Dec2020 and recovered from 08Jan2021. He was unable to provide an exact time of onset. These have resolved, but at the time of report he was just weak. He had a COVID test done on 28Dec2020 he tested positive. He confirmed he has not had a follow-up COVID test done afterwards. The patient also mentioned that his brain was still a little cloudy since an unspecified date. The patient had not recovered from the event weak; while outcome of "lost ten pounds", "his brain was little cloudy" and "tested positive for covid" was unknown.
52 2021-02-01 impaired work ability At first I started to feel tired and achy. A couple days later a cough came and fatigue got worse. I... Read more
At first I started to feel tired and achy. A couple days later a cough came and fatigue got worse. It was mostly body aches, chills, sore throat, stuffy nose/congestion and a cough. I got released to go back to work on Jan 26 and I worked all day and that night I woke up with serve shortness of breathe and a temp a 103. I went to the ER and had pneumonia. I tested positive on Jan.11 for Covid, I tested on Jan. 4 and it was negative. I still have not went back to work.
52 2021-02-04 insomnia Headache; Body aches; Fever; Insomnia; This is a spontaneous report from a contactable healthcare pr... Read more
Headache; Body aches; Fever; Insomnia; This is a spontaneous report from a contactable healthcare professional (reported for himself). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), intramuscular in the left arm on 19Jan2021 08:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 on 29Dec2020 16:30 in the left arm for COVID-19 immunization. No other vaccines received within prior to COVID vaccine and no other medications received within 2 weeks of vaccination. The patient experienced headache, body aches, fever, and insomnia on 21Jan2021 07:30. The reported events were non-serious. No treatment received for reported events. The outcome of the events was recovered on 21Jan2021. Information on the lot/batch number has been requested.
52 2021-02-07 feeling abnormal Starting the day after the injection he began experiencing arm swelling, stomach cramps and brain fo... Read more
Starting the day after the injection he began experiencing arm swelling, stomach cramps and brain fog. He saw his PCP who recommended Benedryl.
52 2021-02-07 impaired work ability, insomnia Severe insomnia over the past 8 weeks, unrelenting. Start exactly at 24 to 48 hours after vaccine. H... Read more
Severe insomnia over the past 8 weeks, unrelenting. Start exactly at 24 to 48 hours after vaccine. Had no previous illnesses before that. No history of Covid infection. Has done all sorts of CBT modifications with no improvement. Was previously a super high functioning Interventional Cardiologist with no prior history of anxiety, depression or sleep problems. This was very acute and worsened after second dose. Labs are all normal. Now unable to work as this insomnia is quite debilitating.
52 2021-02-08 impaired work ability I was fine and the next morning when I woke up my neck was hurting and stiff. I still can't move my ... Read more
I was fine and the next morning when I woke up my neck was hurting and stiff. I still can't move my neck up down or sideways. It is interfering with my job as well as everyday life.
52 2021-02-11 confusional state *Please note it is not known if event was related to vaccine* On 2/10/2021, at approximately 5:30 A... Read more
*Please note it is not known if event was related to vaccine* On 2/10/2021, at approximately 5:30 AM, patient began to experience dizziness and shortness of breath. Per witnesses, he then began to have seizure activity followed by cardiac arrest. He was treated with CPR and 1 shock from the AED, which resulted in spontaneous return of circulation. He was awake and confused after return of pulse and sent to Hospital Emergency Room. This event occurred 19 days post first vaccine. He was scheduled to get his second dose on 2/12/2021, but did not receive it due to event.
52 2021-02-15 anxiety Patient is allergic to cats, had tightness in chest, unable to breathe. Took a benadryl- it went awa... Read more
Patient is allergic to cats, had tightness in chest, unable to breathe. Took a benadryl- it went away, eyelids was swollen. Sx did improve- eyelids are still swollen. Received #2 COVID 1/19/21 at 8am. Had a dental appt that afternoon for extraction, given Lidocaine w/out Epi, took Ibuprofen after visit. Reports acute onset chest tightness, SOB, audible wheezing at 5pm (approx 9 hrs post vaccine), then felt anxious. Took Benadryl 25mg and started feeling better in 20 min with resolution of wheezing and chest tightness after 1 hour. Also reports left eye swelling the same evening that has gradually decreased, now only mild with itching. Had similar eye swelling, however bilateral, after first vaccine dose. No SOB or wheezing noted since eve of 1/19/21. Denies hx asthma. NKDA. Allergic to cats. Denies swelling of lips, tongue, throat or rash. Reports feeling well today. Denies Covid-like sxs.
52 2021-02-19 confusional state Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Additional Details: About 5 minutes after receiving vaccine, patient was seated in observation area and notified facility staff member who was in charge of observing patients that he felt faint. Staff member reported patient quickly turned extremely red and was showing seizure-like activity, unconscios. She alerted the pharmacists to come over I came over and patient appeared bright red, pupils extremely dilated and was not conscious, grabbed pt arm he woke up and then showed typical vasovagal symptoms thereafter.
52 2021-02-28 nightmare Fever; Chills; Body Ache; Pain in face; Pain in back; pain in hip; Headache for 2 days; Vivid nightm... Read more
Fever; Chills; Body Ache; Pain in face; Pain in back; pain in hip; Headache for 2 days; Vivid nightmares; Sweats; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL3249, expiry date: not reported), via an unspecified route of administration, on 25Jan2021 03:00 PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. Medical history was none. The patient was not diagnosed with covid prior to vaccination. He had no known allergies. Concomitant medications were not reported. On 26Jan2021 01:15 AM, the patient experienced fever, chills, sweats, body ache, pain in face, pain in back, pain in hip, headache for 2 days, vivid nightmares. 2 days later (at the time of report, 27Jan2021), the patient still had low grade fever, sweating, body ache and headache. No treatment was received for the reported adverse events. Outcome of the events was reported to be recovering. The patient was not tested for covid post vaccination.
52 2021-03-02 feeling abnormal 35 Minutes after receiving vaccine, itching on head, then body and face, including welt on chest, hi... Read more
35 Minutes after receiving vaccine, itching on head, then body and face, including welt on chest, hives. 50 minutes later eye itchiness and swelling in left eye, throat felt weird (swelling), dizziness, change in voice, wheezing (not severe, but could tell breathing was more restricted than before shot). Almost went to ER, but symptoms subsided without any medication in 2 hours. Did not go to hospital or ER.
52 2021-03-04 disorientation Severe Headache Random Severe Muscle Pain Fatigue Joint Pain Chills/Feverish Minor Disorientation
52 2021-03-06 disorientation Disorientation, SOB, lightheadedness, throat tightness. Evaluated by EMS, cleared.
52 2021-03-07 anxiety Goosebumps tingly sensation in head; Blood pressure and palpitation/heart rate/heartbeat is getting ... Read more
Goosebumps tingly sensation in head; Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher.; Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher.; feeling weak; Heaviness in the head; Feeling anxiousness in the brain; Localized soreness and pain; This is a spontaneous report from a contactable consumer reported for himself. A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 18:00 (Lot number: EL9263) via unspecified route of administration in the left upper arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included ongoing diabetes (Due to diabetes has low testosterone), High cholesterol both from 2005, Colitis ulcerative from 1999, Glaucoma from 2010, Enlarged prostate gland from 2018 and Chronic sinus infection, Acid reflux and GERD from an unknown date and unknown if ongoing. The concomitant medication included Janumet (Metformin hydrochloride/sitagliptin) ongoing for diabetes mellitus at (50/1000 one tablet twice daily), amoxil (amoxicillin) for low testosterone via topical route at 4 pumps, azelastine at two sprays twice a day for chronic sinus infection, crestor (rosuvastatin calcium) ongoing at 5 mg once a day blood cholesterol increased, tamsulosin ongoing at 0.4mg once a day for enlarged prostate gland, dexilant (dexlansoprazole) at 30 mg once a day for acid reflux and GERD, lialda (mesalazine) ongoing at 4.8 mg, once a day (1.2gram 4 tablets once a day) for colitis ulcerative, canasa (mesalazine) ongoing 1 g once a day (at night time) for colitis ulcerative, timolol ongoing at one drop both eyes at once a day for glaucoma, lumigan (bimatoprost) ongoing for at one drop both eyes once a day for glaucoma, melatonin ongoing at 5mg once a day for insomnia, zyrtec (cetirizine hydrochloride) ongoing at 10 mg (on of them) for insomnia, xanax (alprazolam) 1 mg at 1mg at night time and 1 mg as needed for generalized anxiety and blood pressure, 5-hydroxytryptophan ongoing at 100mg for anxiety, carvedilol ongoing at 25 mg, once a day (12.5mg in the morning 12.5 at night) for blood pressure measurement, valsartan ongoing at 160 mg, once a day (160mg one tablet once day in the morning) for blood pressure measurement, hydrochlorothiazide tablet ongoing at 12.5 mg, once a day for blood pressure measurement, Vitamin E at 400 international units; one capsule once a day, ongoing ambozil for low testeterone, clonidine ongoing at 0.1 mg as needed for blood pressure measurement. History of all previous immunization with the Pfizer vaccine considered as suspect: None, this was the first dose. No other vaccine administered on the same date. The patient had no events prior vaccination within 4 weeks. In all his life. He had vaccines that received and had no adverse event or side effect whatsoever. He had had the regular flu vaccine early November. The patient experienced feeling anxiousness in the brain, Heaviness in the head, feeling weak in Feb2021, Localized soreness and pain in Jan2021, Goosebumps tingly sensation in head, Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher on 04Feb2021. The patient could not take Benadryl as he cannot tolerate Benadryl. With Zyterc he does not have secondary effects like he does with Benadryl. The first week after getting the vaccine he only had kind of had localized soreness and pain in the area. He later clarified it was in the area where got the injection, vaccine. He just had pain soreness in that area. Other than that he had no side effects at that time. The third week, initially stated as, about 5-7 days ago he started to have a feeling of anxiousness in the brain. He could feel anxiousness and sensation in his brain that he did not feel before. It was like he had the flu kind of thing, but he did not have a temperature. However, the feeling is in his head. It is like heaviness feeling from the flu in his head. He has been having the heaviness in the head feeling for 4-5 days. He later further clarified and initially clarified the localized pain and soreness was noticed the second day, the day after getting the vaccine. This only lasted a few days. He does not remember exactly when this ended. He did not take anything for the localized pain and soreness in the same area as the injection. He confirmed he has recovered completely from this event. Caller further clarified the feeling of anxiousness started Thursday or Friday of last week, maybe 05Feb2021. Stated it was like this feeling is getting worse and worse. Stated it was hard to explain, but he started to feel a goosebumps tingly sensation in his brain in head, in scalp Thursday of last week first. It started with that and slowly over the past few days it has changed and transformed into this heaviness feeling that one would feel from the flu, but he has no fever or anything; it is just in his head. Also, along with that feeling at the same time his blood pressure and palpitation/heart rate/heartbeat was getting higher and higher. His regular blood pressure medications won't work anymore to bring it down. His blood pressure typically ranges in the 130/85 or less range with all the blood pressure medications he was taking. Once he started having this tingling sensation in his head he had the higher blood pressure and higher heart rate. Now his blood pressure would average being about 170/110 to 180/115. This was like the upper and lower range. His heart rate was typically around 70-75 and now it goes about 80-85. Later during call, he also added, every six months or so his blood pressure may be elevated on these medications. Sometimes his blood pressure was not maintained by the three different blood pressure medications he takes. He was also prescribed two other medications for emergent use Clonidine and Xanax. Usually every six months he would have to take Clonidine and Xanax and typically in an hour to two hours the blood pressure would come down and it's good. However, this time, he took two Clonidine and Xanax starting last Thursday when had the high blood pressure episode and they were failing to bring the blood pressure down. He further explained it would bring it down for some time, but then it would go back high. The Clonidine is no longer working for the last six days. When probed for labs/testing he sated he could not work anymore due to the events reported. He was feeling weak. He could not really walk. He took time off from work. He went to see his primary care provider on Monday. On Monday the doctor doubled the dose of Carvedilol. Since then instead of taking 12.5 twice a day, he is now taking 25mg twice a day. On Tuesday, yesterday, he went to get blood work done. Blood was drawn but has no results yet. Localized pain and soreness time of onset didn't remember, stated he may have had a little pain right after getting the vaccine, but it was around 21:00 25Jan2021 he really noticed the soreness and pain. The following morning around 9 AM it woke him from his sleep and he could feel it more compared to the first day. Anxiousness in the brain around 16:00. The patient had no emergency visit. Stated he almost felt like going when his blood pressure was 182/116 on Saturday night of last week. He was about to go to the ER but decided not to. He ended up taking two Clonidine and one Xanax, laid down, and eventually his blood pressure came down a little. Therefore, he did not go. The patient had physicians office visit. After getting the vaccine he mentioned started to have a feeling of anxiousness in the brain that was getting worse. He could feel anxiousness and sensation in his brain that he did not feel before. Also, his blood pressure and palpitation/heart rate/heartbeat was getting higher and higher. His regular blood pressure medications won't work anymore to bring it down. Later during call, he also added, every six months or so his blood pressure may be elevated on these medications. Sometimes his blood pressure was not maintained by the three different blood pressure medications he takes. He was also prescribed two other medications for emergent use Clonidine and Xanax. Clonidine: 0.1mg only during times he has episodes of high blood pressure. Usually every six months he would have to take Clonidine and Xanax and typically in an hour to two hours the blood pressure would come down and it's good. However, this time, he took two Clonidine and Xanax starting last Thursday when had the high blood pressure episode and they were failing to bring the blood pressure down. It would bring it down for some time, but then it would go back high. The Clonidine was no longer working. The patient experienced side effects on the 3rd week after getting vaccinated and had already made a report. The patient's second dose was scheduled for 21Feb2021 which was 28 days after the first dose. The outcome of the event Feeling anxiousness in the brain was not recovered, Localized soreness and pain recovered in 2021 and outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.;
52 2021-03-08 excessive sleepiness Severe aches and pains in every joint. Started the morning after (8:00am), started to abate late aft... Read more
Severe aches and pains in every joint. Started the morning after (8:00am), started to abate late afternoon, pain let up early evening, fine by 10:00pm. Took Tylenol. Sunday developed a swollen lymph node in left armpit - about the size of a golf ball. Painful to touch/sleep for 2 days. Lasted approx 10 days. Did nothing, went away on its own.
52 2021-03-11 euphoric mood I felt high
52 2021-03-13 feeling abnormal Patient was lightheaded, felt funny and had a very elevated blood pressure.
52 2021-03-20 insomnia, anxiety 24-48 he's post vaccine— Acute Insomnia with severe anxiety component; 24-48 he's post vaccine— Ac... Read more
24-48 he's post vaccine— Acute Insomnia with severe anxiety component; 24-48 he's post vaccine— Acute Insomnia with severe anxiety component/Anxiety worsening; Completely out of character with no preceding symptoms; very debilitated; This is a spontaneous report from a contactable physician (patient). A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899), via an unspecified route of administration, administered in left arm on 17Dec2020 8:00 as single dose, second dose via an unspecified route of administration, administered in left arm on 07Jan2021 (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. Medical history included hypertension and Increased cholesterol. Concomitant medication included atorvastatin (LIPITOR); lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination were Lipitor and Lisinopril. It was reported 24-48 hours post vaccine (18Dec2020 22:00) patient had Acute Insomnia with severe anxiety component. Completely out of character with no preceding symptoms. No prior history of any recent event to explain acute change in personality and character. Insomnia has now persisted for seven weeks. Was better two weeks after 1st dose then worsened again after the 2nd dose was given. Same timeline. Anxiety worsening. Never suffered form any psych issues. Highly functional Interventional Cardiologist now very debilitated. the adverse event result in doctor or other healthcare professional office/clinic visit; The patient received treatment with Psych therapy, Benzos, Ambien, Trazadone, Melatoni. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The reported seriousness was non serious. The outcome of the events was not recovered.
52 2021-03-23 sensation of foreign body My right eye felt like there was something in it and it still seems to be twitching
52 2021-03-24 feeling abnormal Vertigo like sypmtoms. Nausea, loss of balance for 4 days. Getting worse on day 3 but clearing u... Read more
Vertigo like sypmtoms. Nausea, loss of balance for 4 days. Getting worse on day 3 but clearing up greately on day 4 with some foggyness.
52 2021-03-28 hallucination None stated.
52 2021-03-29 excessive sleepiness Fever, chills, severe joint pain, severe fatigue causing me to sleep 32 hours in a 36 hour period
52 2021-03-31 panic reaction, feeling abnormal I got my first Pfizer vaccine injection on 3/23/2021 and felt no immediate side effects, but almost ... Read more
I got my first Pfizer vaccine injection on 3/23/2021 and felt no immediate side effects, but almost exactly 1 week later I noticed slight dizziness. Yesterday it was more apparent and today I woke up with it worse. It worried me and I found myself a bit panicky and my heart was racing. When I calm down, heart rate is fine. It's more noticeable today. Not to the point of nausea, nor full vertigo, but I feel kinda foggy and unsure about my balance
52 2021-04-02 feeling abnormal Started feeling "off" almost right away. Tinitus and feeling like my ears were clogged began within ... Read more
Started feeling "off" almost right away. Tinitus and feeling like my ears were clogged began within 30 min, but subsided in a few hours. About 6 hours later I felt like I was getting sick, and by 12 hours I had a fever, chills, headache, body aches. It felt like I had the flu. Fever spiked to 100.5 but tended to stay around 99.5-100. Worst of symptoms lasted 36 hours before beginning to subside. Most symptoms subsided in two days, with some lingering fatigue for another day or two.
52 2021-04-03 feeling abnormal Woke up around 4 AM the morning after the vaccine. Had pains are crossed my entire trust and felt as... Read more
Woke up around 4 AM the morning after the vaccine. Had pains are crossed my entire trust and felt as if I was having a heart attack. Got up I had a couple glasses of water and a couple of ibuprofen and it seem to clear up after about 30 minutes. Next day I was very lethargic and had increased stomach issues. Injection site very sore
52 2021-04-04 feeling abnormal Woke up with severe sore throat and developed stuffy/runny nose later that day. Felt weirder (off ba... Read more
Woke up with severe sore throat and developed stuffy/runny nose later that day. Felt weirder (off base / not normal). No headache / fever or chest congestion or ill feelings (stomach).
52 2021-04-06 disorientation Dizziness, weakness, feeling faint, disoriented, headache, some shortness of breath
52 2021-04-06 feeling abnormal Swollen lymph node (in arm pit, same side as shot). Diarrhea. Fatigue. Muscle soreness. Mild fever (... Read more
Swollen lymph node (in arm pit, same side as shot). Diarrhea. Fatigue. Muscle soreness. Mild fever (100F) w/ brain fog.
52 2021-04-07 feeling abnormal 3;57PM PT STATES HIS BLOOD SUGAR IS DROPING - HE TOOK HIS REG DOSE OF INSULIN PLUS COVERED WITH ANOT... Read more
3;57PM PT STATES HIS BLOOD SUGAR IS DROPING - HE TOOK HIS REG DOSE OF INSULIN PLUS COVERED WITH ANOTHER 26 UNITS TODAY. BS 89 PER CONTINUOUS GLUCOSE MONITOR IMPLANT. A/O, PINK, W/D, RESP WITH EASE. STATES THIS IS 'LOW FOR HIM AND HE FEELS FUNNY'. JUICE X2 GIVEN. 4PM BS 87. GLUCOSE TABS X2 GIVEN. 4:10PM BS 83. WATER, FRUIT PACKS X2, HERSHEY KISSES X2 AND PEANUT BUTTER CRACKERS X6 GIVEN. 4:20PM BS 81. 3RD JUICE GIVEN. PT REMAINS A/O , PINK, W/D, RESPONSIVE. 4:25PM BS 83. 4:28PM BS 85. PT STATES HE IS 'FEELING BETTER'. 4:31PM BS 87. 4:35PM PT STATES ' HE FEELS OK TO GO HOME AND WILL EAT A SUBSTANTIAL MEAL. HE HAS LOTS OF FOOD AT HOME'. JUICE AND PACK OF PEANUT BUTTER CRACKERS SENT HOME WITH PT. TO EXIT PER WHEEL CHAIR; CASE WORKER TO DRIVE PT HOME. NO ACUTE OR OBVIOUS DISTRESS. 4-8-21 11AM TC: PT STATES HE 'FEELS FINE NOW.'
52 2021-04-10 anxiety Anxious dizzy resolved wife drove home
52 2021-04-10 impaired work ability Symptoms included: headache, body aches, particularly in lower back and upper back, tenderness at in... Read more
Symptoms included: headache, body aches, particularly in lower back and upper back, tenderness at injection site, fever and sweating, and extreme fatigue. Patient took ibuprofen (200 mg) 3 times over the course of 24 hours. Symptoms subsided after about 36 hours. Patient had to stop working for the day on 4/8/2021 due to symptoms.
52 2021-04-11 confusional state, excessive sleepiness Dizziness, confusion, body aches, sleeping for extended periods
52 2021-04-11 impaired work ability fever over 102.3 for 4 days, headache for 2 weeks, broke out in a rash with red spots 9 days later, ... Read more
fever over 102.3 for 4 days, headache for 2 weeks, broke out in a rash with red spots 9 days later, skin on both hands had sever peeling, lost of taste and smell... misses 3 days of work due to in the bed with high fever
52 2021-04-12 feeling abnormal Head feels a little funny, request to have BP checked
52 2021-04-12 insomnia Sciatica, muscle pain, back pain. Difficulty walking, sleeping, due to pain. 2 weeks duration (so fa... Read more
Sciatica, muscle pain, back pain. Difficulty walking, sleeping, due to pain. 2 weeks duration (so far).
52 2021-04-12 thinking abnormal, hallucination The feeling intensified further over the next 20 minutes until the feeling became almost a psychedel... Read more
The feeling intensified further over the next 20 minutes until the feeling became almost a psychedelic experience.; About 30 minutes after the second shot I began to get very light headed.; My pupils were tiny; the my perceptions were off any my "way of thinking" had changed.; The only other effect was I would get an uncontrollable tired feeling once a day for about 10 days.; This is a spontaneous report from a contactable consumer (patient). This 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in right arm on 09Mar2021 at 09:00 as a single dose for COVID-19 immunisation. The patient medical history included High blood pressure (had a history of drugs having unusual reactions in his system). The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 in the right arm on 16Feb2021 at 10:00 for COVID-19 immunisation and had light head. the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; other medications the patient not received within 2 weeks of vaccination; 30 minutes after the first shot he felt light head. Not too bad but a bit concerning. About 30 minutes after the second shot (09Mar2021 09:30) patient began to get very light headed. The feeling intensified further over the next 20 minutes until the feeling became almost a psychedelic experience. his pupils were tiny, the my perceptions were off any his "way of thinking" had changed. he had take psychedelics in my youth (but not in 30 years) and it were not for that previous experience and ability to stay calm he was very well may have ended up in the emergency room. The whole experience lasted till he went to bed but the "peak high" lasted about an hour. The next morning he again felt like someone who had done a psychedelic drug the night before. The only other effect was he would get an uncontrollable tired feeling once a day for about 10 days. No treatment received for the adverse event; Prior to vaccination, the patient not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19; The outcome of all the events was recovered in 2021. Information on the lot/batch number has been requested.
52 2021-04-13 confusional state Diarrhea since 04/06/2021 everyday two times per day. On April 8th developed heavy abdominal pains ... Read more
Diarrhea since 04/06/2021 everyday two times per day. On April 8th developed heavy abdominal pains and fainted became rigid, clenched fists, and shook like a seizure. My wife stood by my side and witness me waking up pale and confused after about 10 seconds of episode. I continue to have diarrhea.
52 2021-04-16 feeling abnormal As of April 13 I started to feel very bad I took the covid-19 test and it came out POSITIVE.
52 2021-04-18 mental status changes 4 episodes of nausea/vomiting/diarrhea, then found by spouse with altered mental status and nonrespo... Read more
4 episodes of nausea/vomiting/diarrhea, then found by spouse with altered mental status and nonresponsive/snoring. Taken to Emergency department for stroke evaluation. Ruled out for stroke, intubated for airway protection and cerebral edema with meningeal enhancement observed on CTA. Admitted to ICU.
52 2021-04-20 feeling abnormal I continue to experience 'brain zaps' I've read it is common with coming off anti-depressants, which... Read more
I continue to experience 'brain zaps' I've read it is common with coming off anti-depressants, which I am not nor do I abuse/use anti anxiety or MDMA. It was so sever I went to the ER. I CT brain scan was performed with negative results. The other adverse effect is massive pain to my left knee that suffers from arthritis. I received a shot of cortisone 3 weeks before my first dose in the joint and was pain free until 8 hours after my second dose. The pain is still present.
52 2021-04-21 sleep disorder 2:30pm - Vaccine administered. Some muscle soreness at the vaccination site, but otherwise no notic... Read more
2:30pm - Vaccine administered. Some muscle soreness at the vaccination site, but otherwise no noticeable side effects. 1am - 10 hours after vaccine. All over body shaking. Not unlike "chills" but didn't have the cold feeling with it. No accompanying fever at the time. Lasted until 5:30am. 6am - 15 hours after vaccine . Shortly after the shaking stopped, spiked a 101.5 degree fever. That continued until approximately 5am the following day. Took 500mg acetaminophen at 7am, and again at 4pm, and again at 12am. Throughout the following day - 15 hours to 36 hours after vaccine - general body aches (most noticeable in the back), lethargic - but that could have been a result of no sleep the night prior due to shaking. 5pm following day - 27 hours after vaccine - bad headache. That lasted until midnight 5am the next morning - most all side effects gone. Some lethargy but temperature at 98.6 degrees, body aches no longer apparent, headache gone.
52 2021-04-23 disturbance in attention, sleep disorder Pfizer Covid Vaccine First Shot at 945am on Sat. 04/10/21. Woke up in middle of Saturday night/Sun... Read more
Pfizer Covid Vaccine First Shot at 945am on Sat. 04/10/21. Woke up in middle of Saturday night/Sunday morning on 04/11/21 at approx. 3am with very loud ringing and buzzing in both ears. Have had loud ringing in ears since then. Visited primary health care provide NP on 04/19/21 and was prescribed 6 day treatment course of Methyliprednisolone tablets, USP 4 mg, which I began on 04/20/21. This treatment as of 04/24/21 has provided very little relief. On two week anniversary (04/24/21) still have very loud ringing in ears. Cannot sleep. Cannot focus. No appetite.
52 2021-04-24 depression, suicidal thoughts, disturbance in attention Significant mental impacts: Depression (to the point of suicidal ideation); Neuropathy in Face, Arms... Read more
Significant mental impacts: Depression (to the point of suicidal ideation); Neuropathy in Face, Arms, Legs; Sensation of coldness in bones; Extreme sudden fatigue; Significant mental impacts: Depression (to the point of suicidal ideation); Inability to concentrate; Light sensitivity; low grade headache in center of brain; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Apr2021 10:30 (Batch/Lot Number: ER8732) as single dose for COVID-19 immunization, in the hospital. Medical history included nonalcoholic fatty liver disease (NAFLD), now almost gone, from an unknown date. The patient has no history of COVID prior vaccination. The patient was not COVID tested post vaccination. There were no concomitant medications. The patient experienced neuropathy in face, arms, legs, sensation of coldness in bones, extreme sudden fatigue, significant mental impacts: depression (to the point of suicidal ideation), inability to concentrate, light sensitivity, and low grade headache in center of brain, all experienced on 04Apr2021 12:00 AM. No treatment was given for the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
52 2021-04-28 abnormal dreams Since i got the vaccine 2 weeks ago, almost every night since I have had significant dreams, much mo... Read more
Since i got the vaccine 2 weeks ago, almost every night since I have had significant dreams, much more so than I would normally. Normally I would have vivid dreams a couple times a month. This isn't a problem as I like the fact I'm getting deep sleep but I just wanted to report it. Thanks.
52 2021-04-30 feeling abnormal 3/31: earache, headache 4/1 ? 4/4: earache, headache, sore throat, vertigo, vomiting, brain fog. On... Read more
3/31: earache, headache 4/1 ? 4/4: earache, headache, sore throat, vertigo, vomiting, brain fog. On 4/4, doctor prescribed Amoxicillin 125 MG 2x/day 4/5 ? 4/7: sharp earache with pressure, loss of hearing in left ear, sore throat, brain fog, headache 4/8 ? 4/11: noticed Ptosis, numbness left side of face, persistent headache. Went to Emergency Room, performed CT scan, blood test, confirmed there is no stroke, DIAGNOSED FOR BELLS PALSY. Prescribed Prednisone and Valacyclovir for 7 days. 4/12 ? 4/22: Treated by NP for Bells Palsy, referred for rehab/therapy. 4/23: symptoms clear, Bells Palsy 95% return to normal 4/30 : received 2nd Pfizer vaccine dose Lot # ER8737
52 2021-04-30 feeling abnormal fever, chills, joint and muscle aches, night sweats, fatigue, lightheadedness, foggy headedness, - 3... Read more
fever, chills, joint and muscle aches, night sweats, fatigue, lightheadedness, foggy headedness, - 3 days in a row starting April 8 then subsided and started again a few days later
52 2021-05-01 feeling abnormal Headache, foggy, tired Next morning or 40 hours after vaccine back to normal
52 2021-05-01 insomnia Upper arm soreness started at about 8:30 pm, about 10 h after injection. Went to be like normal and ... Read more
Upper arm soreness started at about 8:30 pm, about 10 h after injection. Went to be like normal and arm was just sore, but nothing else at that time. At 1:10 am, patient woke up with horrible shakes, verging on convulsions, and the feeling of freezing to death. Uncontrollable shivers/shaking. At around 1:40 am, patient was able to move enough to get out of bed to find a second blanket and extra strength Tylenol and took the Tylenol with some seltzer water and hid under blankets to get warmer. After about an hour, around 2:30 - 2:40 am, the shaking was reduced enough that the patient was able to relax and try to get to sleep. At 5;30 am, the patient woke up with much the same symptoms, but with the addition of the worst headache he had had since he stopped having migraines in his mid 20s and also his whole body ached like he had been hit by a truck (that [getting hit by a truck] had happened to him once about 15 years ago, so he has the actual reference to compare against). This experience was worst overall body aches/pains ever experienced by the patient. He took additional Tylenol at 6 am and about 30 minutes later, the chills subsided and the pain was reduced enough that he could go to sleep again. Shortly before 10 am the symptoms started to get worse again and he took ibuprofen (400 mg) at 10 am, after the shakes started to come back. He has traded off every 4 hours taking tylenol and ibuprofen, which keeps the temperature perception swings to a minimum and overall body aches lower, but the headache does not go away. He feels exhausted, and has slept for spurts of 15 - 30 minutes on and off all day. He was able to each crackers at around noon and some homemade chicken vegetable soup at about 1 pm as the nausea had subsided. Prior to that, he could only drink water and Gatorade. He is hoping that within 24 - 48 h he will feel much better, without having to take Tylenol or Ibuprofen.
52 2021-05-03 loss of personal independence in daily activities The first 2 days had fever chills fatigue teeth hurt headache tiredness. 4 days after shot have dev... Read more
The first 2 days had fever chills fatigue teeth hurt headache tiredness. 4 days after shot have developed a cough left side chest pain at times twitching in left shoulder area headaches and now have a difficult time doing anything physical like simple walking feel out of breath.
52 2021-05-04 insomnia Evening symptoms, injection site pain, mild headache, sleeplessness caused by mild limb spasms till ... Read more
Evening symptoms, injection site pain, mild headache, sleeplessness caused by mild limb spasms till 1:00 am. Spasm symptoms seem to have subsided, headache remained mild. able to fall asleep. Awoke at 5:30 (normal time) seemed good other than arm soreness. By 8 am I developed Vertigo like symptoms. 48hrs after injection this morning, the headache is gone but vertigo symptoms remain however lesser than the previous day.
52 2021-05-09 memory impairment Pt vaccinated on 5/5/21. On 5/6/21 he developed fatigue, body aches and chills. In the early morning... Read more
Pt vaccinated on 5/5/21. On 5/6/21 he developed fatigue, body aches and chills. In the early morning of 5/8/21 (around 3am), he woke up from a sleep in his armchair and stood up, at which time he lost consciousness and passed out, hitting his head. He does not recall anything after that until he woke up in bed in the morning.
52 2021-05-10 excessive sleepiness blurry eyes; Headache; numb face and arms; Felt dizzy; Had to call out of work to rest and sleep all... Read more
blurry eyes; Headache; numb face and arms; Felt dizzy; Had to call out of work to rest and sleep all day; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 19Apr2021 16:00 as single dose for COVID-19 immunization. The patient's medical history included diabetes. Concomitant medication was not reported. The patient received second dose of Pfizer BioNTech Covid 19 vaccine on Monday 19Apr2021 around 4pm. The next day the patient experienced numb face and arms, felt dizzy, and had to call out of work to rest and sleep all day. Today he felt okay but started feeling dizzy with a headache and blurry eyes. He has diabetes but has been taking his blood sugar in the morning and they have been okay. He has been taking tylenol for the headaches. The patient said he was driving to work next day and face and arm went numb. Had to turn around and go back home. Next day tried going to work again, face and arm went numb also was dizzy and slight headache. Wants to know if this side effect has been reported and what do we suggest. It was reported that the patient went to see his animals and I (sentence incomplete). I am calling you because of the side effects that I am having from the vaccine. Also, I want to know if this was the part of the side effects that was going on with me. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-05-13 insomnia I didn?t have any major reaction from the shot, I?ve had a very light level of tinnitus over the las... Read more
I didn?t have any major reaction from the shot, I?ve had a very light level of tinnitus over the last couple years but within a week after the vaccine the ringing in my ears has intensified to a point that it can be extremely agitating especially during nighttime where it makes it difficult to sleep . Before the shot it was not anywhere near the level it is now
52 2021-05-14 crying Blood Clot in right leg; Severe pain in leg; cry; This is a spontaneous legal report (Marketing Prog... Read more
Blood Clot in right leg; Severe pain in leg; cry; This is a spontaneous legal report (Marketing Program) from a contactable consumer (patient himself). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection) dose 2 (Batch/Lot Number: EW0770) via an unspecified route of administration, on 21Apr2021 11:30, as single dose for covid-19 immunization. Medical history included Asthma ongoing, Diabetes had been on and off since 2018, Covid-19 in an unspecified date in Jan2021. The patient received dose 1 (Batch no/Lot Number: ER8732) via an unspecified route of administration, on 29 Mar 2021, as single dose for covid-19 immunization. The patient's concomitant medications were not reported. On 21Apr2021 around 11:30-12:00 in the night the patient experienced Blood clot in his right leg, had a severe pain and cannot walk, feels like he's being stabbed in the leg every time he gets up. He had to keep his legs up all the time and not put them down. He stated that his life was going to be upside down for 6 months because of the Covid vaccination. Stated that was unacceptable. Reporter also said that if the blood clot breaks off it could be dangerous. Said it was substantial; it was all the way up to his groin, not its down almost to his knee and goes all the way down to his ankle. Patient went to the hospital last Saturday due to pain in the back of his leg. The pain started 12 hours after the second Covid vaccine. He wanted to cry he was in so much pain. He could not take anything for it. Patient stated that if the clot breaks off, he was dead. So, he had to put everything on hold because he did the right thing which ended up being the wrong thing. Patient stated that the pain in his leg was a 13 or 14 on a scale of 1-10. Patient took Tylenol and Pain patches did not work on a blood clot. Patient stated that when he was in the hospital, 4 different doctors, told him the event was at least 50 if not 100 percent caused by the Covid dose of vaccine. Patient stated that after the first dose of vaccine he was sick as a dog and he said that the clot may have started with the first dose of vaccine, stated that he had a 102 degree fever a few minutes after the vaccination, felt dizzy and thought he was going to fall over. Patient stated that he got the vaccination dose to get his life back and now he could not, that what about in 6 months if he had to get a booster vaccine and probably go through it all over again; or to be on quarantine. Patient stated that he went with his 84-year-old mother to get the vaccine. Patient said that the only reason she didn't get a blood clot was because she was already on blood thinners and said that he is the one who takes care of his mom and now he cannot walk barely, he had Covid in January and that people who had Covid shouldn't be taking these vaccinations because they have immunity, he talked to a doctor and a woman yesterday who still have their antibodies a year after having Covid. He said that the vaccine was injuring people. He was hospitalized related to his leg pain and diagnosed with the blood clot from 24 Apr 2021 to 27 Apr 2021. In the hospital he was told to him take Oxycontin or Morphine. He said that he did not want to take those and end up addicted. He said after a motor vehicle accident he had in 2002 he took Naprosyn and it helped, he said could not take that now because he was on a blood thinner. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tested COVID-19 positive prior to vaccination. This is to notify that potential legal action from a reporter in the attached source document booked into AER 2021506757 and 2021506972. The outcome of the event Blood Clot in right leg and Severe pain in leg was not recovered, feels like he's being stabbed in the leg was recovered and cry was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
52 2021-05-16 sleep disorder - fever and chills during overnight hours the past 2 nights after shot, unable to sleep for more tha... Read more
- fever and chills during overnight hours the past 2 nights after shot, unable to sleep for more than an hour at a time. - headache most of the day on Sunday, headache area more so on top of head and some tingling in head at times. - worse chills overnight the 2nd night, had to change pajamas due to chills and sweating 2nd night. - 2nd shot given in left arm, 2 mornings later (Monday), excessive swelling in left armpit and pec muscle, swelling almost size of baseball and protruding, no bruising or pain, just very tender and uncomfortable, feels tight and can certainly feel skin stretched due to swelling.
52 2021-05-19 feeling abnormal Brain fog, fatigue, loss of coordination, mood swings. Symptoms have persisted for 16 days. It cont... Read more
Brain fog, fatigue, loss of coordination, mood swings. Symptoms have persisted for 16 days. It continues to affect my ability to perform daily work/home activities. I have not sought treatment yet
52 2021-05-19 sleep disorder Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason fo... Read more
Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason for Visit ED Discharged 4/30/2021 (2 hours) Treatment team. Providers COVID-19 Clinical impression, Fever, Generalized Body, Aches, Chills. Chief Complaint Patient presents with Fever, Generalized Body Aches, Chills. HPI: 52-year-old male with history of diabetes, hypertension, obesity presents the emergency department with gradual onset of moderately severe generalized nasal congestion with associated cough unproductive of sputum and fever, T-max 103.8 at home the patient states began approximately 1 week prior to arrival. The fever worsened today and he decided to be seen at that time. He states he had his first dose of Pfizer COVID-19 vaccine 3 weeks ago. Denies sick contacts, chest pain, shortness of breath, syncope, dizziness, lightheadedness, numbness, focal weakness, abdominal pain, nausea, vomiting or diarrhea, changes in bowel or bladder habits or other complaint. No other signs or symptoms and no treatment prior to arrival. ED Discharged 5/1/2021 - 5/2/2021 (5 hours). Last attending Treatment team COVID-19 +1 more. Clinical impression, Chest Discomfort, Chief complaint. ED Provider Notes. Expand AllCollapse All. HPI. Chief Complaint Patient presents with. Chest Discomfort. Patient History. 52-year-old male with history of asthma, diabetes, heart murmur, hypertension, obesity, sleep apnea and was seen in the emergency department yesterday complaining of generalized nasal congestion, fever and cough and was discharge with a diagnoses of COVID-19 4/30/2021 presents to the emergency department with complaint of chest tightness. The patient states that tonight he developed chest pain which woke him from sleep. He describes the pain as burning. He states the pain is similar to the pain he had when he had a gallbladder attack. He also states the pain is well localized and does not radiate. Initially the pain was 10/10 initially and is currently a 4/10. He took his temperature and states he had a fever of 101.6 and took 1,000 mg of tylenol just prior to arrival. His O2 saturation today has not gone under 90%. Medical History. Past Medical History: Diagnosis Date Asthma 5/29/2017, Diabetes mellitus, Heart murmur, Hypertension, Obesity, Sleep apnea, obstructive. APAP 8-20CM WME AIRVIEW. Surgical History. Past Surgical History: Procedure Laterality Date CARDIAC CATHETERIZATION 03/2004. OTHER SURGICAL HISTORY ear surgery as a baby. STRABISMUS SURGERY repair of congenital strabismus-childhood. Family History. Problem Relation Age of Onset. Hypertension Mother. Diabetes Father. Hypertension Father. Hearing loss Other. Kidney disease Other. Social History. Tobacco Use. Smoking status: Never Smoker. Smokeless tobacco: Never Used Vaping Use. Vaping Use: Never used. Substance Use Topics. Alcohol use: No. Drug use: No. Review of Systems. Constitutional: Positive for fever. Respiratory: Positive for chest tightness. Cardiovascular: Positive for chest pain. All other systems reviewed and are negative. ED to Hosp-Admission. Discharged 5/4/2021 - 5/6/2021 (2 days) Hospital. Last attending Treatment team Acute hypoxemic respiratory failure due to COVID-19. Principal problem. Presenting Problem/History of Present Illness/Reason for Admission. Acute hypoxemic respiratory failure due to COVID-19. Hospital Course. Patient is 52 yo BMI around 40, presents to the hospital with severe sepsis secondary to COVID-19 pneumonia. He was first positive on 04/30, had progressive shortness of breath with weakness and worsening cough. He presented to the hospital originally on 05/04, and desaturated to 85% on room air. He admitted to the medicine service, pulmonology was consulted. Severe sepsis (tachycardia, tachypnea, and fevers with acute hypoxemic respiratory failure) secondary to COVID-19 pneumonia. He was started on dexamethasone IV, and transition to oral dexamethasone. He will continue 7 more days at home to complete 10-day therapy. He was started on remdesivir therapy and received 3-day treatment. Pulmonary consulted, as he was a possible candidate for Actemra, however his inflammatory markers including D-dimer, ferritin, CRP improved, and his oxygen requirements also improved. On discharge, he will continue with oxygen supplementation 2 L with rest, 4 L with activity, 2 L with sleep to be infused into his CPAP therapy. Hyperlipidemia. Continue rosuvastatin 10 mg Monday, Wednesday Friday. Benign essential hypertension. Holding hydrochlorothiazide Continue lisinopril and metoprolol.
52 2021-05-21 sleep disorder Woke up in the middle of the night with 100.5 fever, cold sweats, aching all over and blurry vision
52 2021-05-24 sleep disorder I had COVID in early December 2020. I waited a few months to get the vaccine. I was fine the day o... Read more
I had COVID in early December 2020. I waited a few months to get the vaccine. I was fine the day of the vaccine 16 MAR. I took the next day off 17 MAR because I was running a fever and and had body aches. I did not have any alcohol on St Patty's day. I pretty much slept the whole day. I went back to work on 18 MAR and was feeling better with only a mild ever. The night of 18 MAR I began to run a fever and had body aches. The body aches worsened during the night I could not sleep. The body aches became centralized in my upper back and shoulders, My neck was hurting too. I began to feel chest pains. The chest pains increased in intensity. I researched the symptom's which suggested I was having a heart attack. I took some aspirin to try to alleviate the pain. The pain continued and more severe so I drove myself to hospital. The staff gave me an EKG and took blood samples for testing. The EKG was normal. The blood test came back with elevated levels of Troponin. The Dr. advised that the Troponin level indicated that I probably had a heart attack. the first hospital did not have a cardiac unit so I was transferred to downtown location. The staff there ran more test. The EKG was again normal and the Troponin elevated so a Coronary angiography was conducted with catheter and dye. The angiography was also normal with no sign of a heart attack the doctor said I probably had a reaction to the vaccine. He suggested that I still get the second vaccine. I did get the second vaccine. After the second vaccine I only had fever and body aches, I pre0-gamed with aprin and plenty of rest for the second vaccine.
52 2021-05-30 disorientation Received the vaccine and then sat in waiting area with no immediate issues. After about 10 minutes ... Read more
Received the vaccine and then sat in waiting area with no immediate issues. After about 10 minutes started to feel flushed and a couple seconds later blacked out. When coming around, felt disoriented and nurse was asking me questions as I was still sitting in chair. My wife reported that I was having a seizure and stiff against the wall with eyes rolled back and unresponsive for about a minute. My right arm was cramping, BP 220/180 and pulse 44. The clinic staff laid me on the floor and call an ambulance that took me to the ER for observation and testing.
52 2021-05-31 loss of personal independence in daily activities The day after receiving the shot i was very tired. Slept part of the day. I am a runner and was un... Read more
The day after receiving the shot i was very tired. Slept part of the day. I am a runner and was unable to run that day but could tell i was very winded even going up and down stairs. The rest of the week was unable to run from being winded. Then after a week was able to slowly get back to my normal routine. I had a calcium score scheduled for 7:00 am on May 19th. I was called into my doctors office to be given the results the next week because my calcium scan came back fine...but doing the scan they found a 3mm nodule on my lung. I have never had any type of lung issues. I do not know that this is related to the shot. But because of how my lungs felt for a week after the shot, i feel this could be related. I am not a smoker and never have been. They say the majority of these type nodules are formed from inflamation or infection. At the time they told me about the nodule they also did my yearly physical. Since i know some are getting inflamation around the heart...i'm curious if there can also be inflamation around the lungs which would have given me the nodule. At this point..the doctor plans to do a ct scan in one year to see if the nodule has grown. I felt like i should report this since this may not be discovered by many others unless they just happen to go from some type of scan of the lungs.
52 2021-06-01 feeling abnormal feels like there are little tiny baby hands pinching his internal organs throughout his abdomen; Eye... Read more
feels like there are little tiny baby hands pinching his internal organs throughout his abdomen; Eyes swollen and his vision was diminished; Eyes swollen and his vision was diminished; On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball/A huge lump appeared a few inches from injection site; Numbness from his ankle to his feet and from his knees to his feet/numbness in legs and feet; feels like it's cold and tingly; feels like it's cold and tingly; ringing ears; pressure in his neck to his injection site; back pain/pain in back; vision is blurry; throat was swollen.; Toes locking up; Really dizzy and really lightheaded; Mind has been foggy; Glands were swollen; Arm soreness; Nose is bone dry; tiredness/tired; injection site pain/injection site soreness; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0173 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08May2021 at 02:38 PM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient's medical history included Bug bite (happened 5 days prior to 30Apr2021 and regimen of an antibiotic). He was completely done with the rotation for a least 8 days before he got the vaccine. It might have something to do with this. concomitant medication included dicloxacillin (started it on 30Apr2021 and it was for 5 days. He did not know what it did was). The patient reported that on 08May2021, day one, he experienced, tiredness and injection site pain. On day 2, until now side effects which had not gone away. It hadn't gotten worse, but it was not any better. The patient felt like congestion, but his nose was bone dry, like crusty dry. It hurts a little bit because it was so dry and he had arm soreness, nothing out of the ordinary. The arm soreness was just normal injection stuff. At first it was a little tender on the injection spot. It went away after about a day. On 10May2021, the patient felt like there were little, tiny baby hands pinching his internal organs randomly throughout his abdomen. It was not a sharp pain, more like a little squeeze all through his abdomen. It felt like his whole throat was swollen. It was not visually swollen, it more felt like a football in his neck. Stretching it was helping. His toes have been locking up like a pre-clamping. He had numbness from his ankles to his feet for 8 days, and now he has numbness from his knees to his feet. It was not completely numb, but it was not normal. The feeling of baby hands pinching his internal organs started the second day after the vaccine and has stayed consistent. The patient's eyes swollen, and his vision was diminished. Day 2 through today, it felt like his eyes were swollen, his vision was seriously diminished, he had a golf ball sized welt on his arm not at the injection site but 2 inches from it, and he was really dizzy and really lightheaded and almost fainted at the corner store. The feeling like his eyes were swollen started on day 3 after the vaccine. The crease of his eye be-low the eyebrow and on top of the socket got red and puffy and looked like sunburnt skin does. It was at the point that now it feels swollen all the time almost like he had pink eye and his vision has been diminished about 30%. He had a test done yesterday and his vision was 20/25. Some-times he could not even read a text and had to stare at his phone for 10 minutes to make out words. He did not have these issues before. The feeling of his eyes being swollen was a little better in the mornings and about 1300 it gets worse when he gets lightheaded to where was when it started. His vision became diminished about day 3 after the vaccine. It was a little better in the morning, but in the afternoon, it goes to exactly the same as when it started. He noticed the golf ball sized welt on his arm about 3 days ago. The doctor seemed to think a drop of the injection might had travelled from the injection site and his body was creating a defense to it. It was scary to take a shower and then see that. It didn't hurt. It was not painful, but it was a weird foreign entity. The cramping in his toes started probably day 3 and was consistent. The numbness started on day 2 after the vaccine, and up until 3 days ago it was just his ankles and feet. 3 days ago, it got to the point where it was from his knees to his feet. It has gotten worse since it was now travelling up his legs. On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball - when asked with his doctor he said that he thinks that a drop of the vaccine travelled and his body building a reaction to it and it was very abnormal. The patient also had numbness from his ankle to his feet worsened and from his knees to his feet- almost feels like it was cold and tingly. The patient also had dizziness and lightheaded about day 2 after the vaccine and it was the same. It came in waves but was consistent throughout the day. He would be fine then had a wave of dizziness. He has been laying down so much because he was so tired, ringing ears, felt like his glands were swollen, pressure in his neck to his injection site, and back pains. The patient stated that his doctor was only form urgent care. The patient Felt like whole throat was swollen, toes locking up, really lightheaded, mind has been foggy, and arm soreness. The patient had bizarre side effects from the Covid Vaccine for 11 days now. He thought it was the smart thing to report them to Pfizer. He didn't like to give personal information. He declined to give his mailing address or his email address. He hated when asked for race, but he guessed it might be important. He did not have a mailing address, phone number, or email address handy for his physician. He went to Urgent Care yesterday to have it checked and they did an EKG and said he had to be sent by ambulance to the ER. The doctor did bloodwork, and she said everything looked alright and to rest a few more days and keep hydrated. The patient underwent the lab work and procedures which included chest X-ray with unspecified result. He thinks it was on 18May2021. His mind has been foggy with all of that. It was yesterday or the day before. He could not be sure. He has been sleeping so much and was in a complete daze. The fogginess he had the whole time as his other symptoms, and it was the same. He has been eating well and hydrating and taking a multivitamin and Gatorade, all the things' people say to do. He asked if Pfizer has heard of this before. He was panicked it might be chronic, and he worries about the safety of the second shot for him. He was sure many people haven't reacted, but these are freaky side effects. He asked for advice and if Pfizer had heard of this before or if he was some weird anomaly. On his way to get the vaccine he asked 2 people at the city health line if they had taken it and they both said no. He asked 3 other patients and they said they took the Pfizer. One woman said she will take it when they make her. The guy who gave him the shot lied and said he wasn't eligible. It might have been his way of not having to discuss it. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not diagnosed with Covid prior vaccination. The patient was tested for Covid post vaccination with Nasal Swab on 18May2021. The outcome of the events was not recovered. Device Date: 23May2021,Additional information has been requested.
52 2021-06-02 feeling abnormal, feeling drunk dizziness; nausea; He did not feel well at all and was not able to feel well enough to stand up.; de... Read more
dizziness; nausea; He did not feel well at all and was not able to feel well enough to stand up.; definite lack of coordination; he vomited on himself; his cholesterol was high at 208.; had very little strength; started feeling like something was wrong; just had sort of a feeling like being really drunk; passed out (fainted) in his car 3 times; He was told he had a vasovagal reaction; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15May2021 10:50 (Lot Number: EW0173; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included vasovagal reactions in high school. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. Within 2 minutes of receiving the Covid 19 vaccine he started feeling like something was wrong. He pulled to the side in the parking garage and as soon as he stopped the car he passed out. He woke back up and was able to put the car in park and he passed out a second time. He woke up again and his foot was on the gas pedal and he tried to roll down the window. He was able to roll down the window but he wasn't able to get anyone's attention. He passed out a third time. When he woke up again he wasn't able to get the door open and he was nauseated. He basically had nausea, dizziness, and a definite lack of coordination. He just had sort of a feeling like being really drunk. He doesn't drink. He had very little strength but he was able to push his car horn. He was out of it. He could see someone in his car mirror a little ways behind his car and the horn didn't get the person's attention so he honked a second time and someone came to help him, maybe from the fire department and maybe some emergency medical technicians. He was placed on a golf cart or ATV to be transported downstairs to a waiting ambulance and while on the ride he vomited himself. He mentioned that the EMTs called it a vasovagal reaction. He was brought to the hospital in which he had a lot of tests done. He did not feel well at all and was not able to feel well enough to stand up. He had tests done at the hospital, a chest x-ray and his blood was drawn. He had a cardiac ultrasound later in the afternoon the next day on 16May2021. The doctor's didn't find anything wrong other than his cholesterol was high at 208. He was admitted to the hospital on 15May2021. He continued to have his blood drawn through the night and the next morning, on 16May2021, he had a CAT scan. For his cholesterol he was told to eat better and maybe follow up with a doctor in a couple months to check his cholesterol again. No one had any answers to the effect of what happened to him. Everything was fine, his tests were normal. He was told he had a vasovagal reaction. He's had vasovagal reactions before and he can tell this was much different than the vasovagal reactions he's had before. In the past when he's had vasovagal reactions the world went black like looking through a small circle, his vision got blacker and blacker and then he'd pass out. He did not have this feeling with the Covid 19 vaccine. He can only describe this feeling that he had like an occasion in his past when he's drank to much and he's stumbling around. He may have passed out briefly to someone helping him move to a bed and his arms are weighted and he can't lift them and he's disoriented but still has a sense of what's going on but he feels like he could vomit at any second. He's comparing his experience to the Covid 19 vaccine to drinking to much alcohol and then falling asleep or passing out. He was pretty much out of it for 5 hours. Between the fourth and fifth hours after receiving the Covid 19 vaccine he was comfortable enough to stand on his own for brief moments. He was feeling better and was able to use the restroom. By the next day, around the 24 hour period after the vaccine he was feeling almost normal. He was released from the hospital the next day, 16May2021 at around 4:00PM. He was maybe in the hospital for about 27 to 28 hours. At the hospital he had all these tests and he was found to be healthy with no problems. He also had a Covid 19 virus test, he never asked what the results were but he's going under the assumption that if he was Covid 19 virus positive the hospital staff would have told him. Passing out, nausea, dizziness required a visit to Emergency Room. The outcome was unknown.
52 2021-06-06 feeling abnormal -Dizziness -Mental fogginess -Tremors
52 2021-06-09 impaired work ability On May 21st @ 10:25am, I received my 1st dose of the Pfizer Covid vaccine. There were no immediate ... Read more
On May 21st @ 10:25am, I received my 1st dose of the Pfizer Covid vaccine. There were no immediate reactions during the 15 minute "holding period", but the following morning, May 22nd @ ~09:00am, I was urinating blood and blood clots with very little urine evacuating. Proceeded to the Urgent Care facility to which they immediately directed me to the ER. Upon arrival, they had me give a urine sample which was blood red, and put me on a picc line and pushed fluids, then performed a CT and an ultrasound of my pelvic area. During this time, my urge to urinate began to become very painful because my bladder was now fully blocked and I could only pass a small amount of blood clots. They then had to install a large 3 way catheter to relieve the urine and allow the passing of the large blood clots coming from my hemorrhaging left kidney. After being in the ER for ~8.5 hours, they released me with the catheter still installed with a mobile bag. I stayed laid up for 2.5 days until Monday when all of the blood clots had passed and my urine had returned to a normal color. They then removed the catheter and sent me on with medication to continue to take. I have a follow up appointment, but I am still having restrictions when I urinate and now when I try to ejaculate, so I am very concerned that this has permanently injured me. I have had ZERO issues in the past and consider myself a very healthy individual who works very hard to stay healthy. I maintain a weight of 206-210 lbs @ 6'1" through a daily rigorous exercise program, diet, and supplements. I don't smoke, do drugs, or drink excessively. This event has cost me money for my deductible (because I don't use it), plus the costs of the copays, medications, and 1 day of missed work. I have all of the paperwork from both the ER visit and Urology visits... Please advise what I can do to recoup my out of pocket costs for a vaccine that the Government has directed the population to receive. You can reach me at this email. Thank you.
52 2021-06-10 feeling abnormal Caller stated he got the second shot two days ago and that next day he had a rash.; when he is in a ... Read more
Caller stated he got the second shot two days ago and that next day he had a rash.; when he is in a hot room like 78 degrees with the window open he can not take the heat like he used to; Hot flashes; rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing; Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging; felt like he was drugged; pulse rate has been a little elevated; Palpitations: Caller stated this started the same day 10 to 12 hours after getting the first shot. Caller stated it was getting somewhat better but after the second shot it got worse.; getting out of breath was reported as worsened; felt like there was pressure in his skull; he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall ove; Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0183; expiry date: 31Aug2021) via unspecified route of administration in left arm on 01Jun2021 as single dose of COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0173; expiry date: 31Aug2021) via unspecified route of administration in left arm on 11May2021 as single dose of COVID-19 immunization and experienced palpitations, felt like he was drugged, felt like there was pressure in his skull, getting out of breath, rash got bright pink, respiratory rate was somewhere around 16, blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle. On an unspecified date in Jun2021, after second dose of vaccination, the patient experienced palpitations, getting out of breath like when he was walking up and down the stairs especially when carrying laundry or a garbage can and he never had this problem doing that unless he had an upper respiratory infection and prior to the vaccine he was perfectly fine, palpitations was reported as worsened, getting out of breath was reported as worsened, rash on his left side where he got the shot on his hand, specifically the top of hand and on his first, second, third, fourth, and fifth finger was reported as worsened, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle was reported as worsened, crack in the knuckle area on the second finger was reported as worsened, rash got bright pink was reported as worsened, felt like he was drugged, Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, felt like there was pressure in his skull, felt like he was going sideways, and on 01Jun2021 experienced hot flashes. On 02Jun2021, he was in a hot room like 78 degrees with the window open he cannot take the heat like he used to. On an unspecified date in Jun2021, patient stated that palpitations got worse after the second shot it was started on the same day of first shot of vaccination, 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse. On 03Jun2021, that next day of vaccination, patient had a rash and explained that on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle, this stopped a week to ten days after the first dose and then it came back after the second. Patient had a crack in the knuckle area on the second finger: patient stated he was scheduled for the dose around 12:20 and they had to get more vaccines and so he had to get it around 3:00pm. The patient stated this started to feel bad in the first two hours. For the event of rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing. Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging. For the event "felt like he was drugged" patient stated this started within 4 hours of first dose, he started to feel better in 5 days and then 10 days after he was completely better and stated he got this again from the second shot and it was getting better but the more he exerts himself the slower he feels but he does not feel like he is on anesthesia. The patient stated that his pulse rate has been a little elevated, stated on the following day after first dose his pulse rate was 114 and 120 was the highest. He stated after the first dose it was between 116 to 120 and after the second dose it was slightly elevated like 90 or something. The patient stated but his pulse rate has been 86, 87, 90 so the pulse rate has been a little elevated. The patient reported he also had hot flashes. He felt like there was pressure in his skull, 10 to 12 day after the first vaccine and this got better, then within 7 to 10 days after the second shot he got it again and he anticipates that for 7 to 10 days he will have to deal with the same crap. The patient felt like he was going sideways, this stopped within two days after the first dose and then it happened within one day or a day in half after the second shot. The patient stated that hot flashes lasted a day or day in a half. The other problem he had noticed is when he is in a hot room like 78 degrees with the window open, he cannot take the heat like he used to. Reportedly, after the second shot they had the patient sit for 15 minutes and so he went to the hospital main area after to get a pass to eat and he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over. He stated the first hour or so after the vaccine he felt like he was drug and he even had caffeine and got his car cleaned, but he felt like his body was behind him like woozy to stomach like in slow motion with exertion and it felt like he was drugged. The patient stated he just wished the vaccine dosage had a high of like if it was 0.3 maybe should be 0.2. The patient stated there should be a different regimen based on height and weight. The outcome of the event "hot flush" was resolved on 01Jun2021, for the event "Palpitations: The patient stated this started the same day 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse", "getting out of breath was reported as worsened", "The patient stated he got the second shot two days ago and that next day he had a rash", "he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over", "felt like there was pressure in his skull", "Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine", "felt like he was drugged", "pulse rate has been a little elevated", "when he is in a hot room like 78 degrees with the window open he cannot take the heat like he used to" was not resolved and for the event "Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging" was unknown, for the event "rash got bright pink, the patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing" was recovering.
52 2021-06-10 insomnia pain; pain was causing blood pressure to be elevated/blood pressure elevation; Headache; injection p... Read more
pain; pain was causing blood pressure to be elevated/blood pressure elevation; Headache; injection pain/injection site extreme pain; pain was so bad could not sleep at night/sometimes he is not going to sleep until 02:00 the next mor; This is a spontaneous report received from a contactable consumer (patient's spouse) via a Pfizer-sponsored program. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 23Apr2021 (lot number: EN0170), as 2nd dose, single dose, at age 52 years old, for COVID-19 immunisation, at a pharmacy/drug store. Medical history and concomitant medications were not reported. Historical vaccine included the first dose BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), administered in the left arm, on 24Mar2021 (lot number: EP6955), at age 52 years old, for COVID-19 immunisation. The patient did not have prior vaccinations within four weeks of BNT162B2. On 23Apr2021, the patient received his second dose of BNT162B2. On 23Apr2021 at 19:30, the patient experienced injection pain/injection site extreme pain. The patient did not act on it because he knew the injection site may be sore for a week. On 24Apr2021, the injection site was hurting bad but again he did not act on it because he knew it may sore but it had been a whole month and it was concerning. The reporter stated that the pain was causing the patient's blood pressure to be elevated. The reporter noticed the blood pressure elevation about 2 weeks after the second injection in the morning time (May2021). The patient also experienced headache at the same time as when the patient's blood pressure was elevated around the morning time, about 2 weeks after the second injection (May2021). It was reported that the pain was so bad that the patient could not sleep at night within a week of the second injection (Apr2021), time of onset was reported as "around 15:00 or 16:00 and as it goes over to the night 190:0 or 20:00, sometimes he is not going to sleep until 02:00 the next morning"). The events required physician's office visit on an unspecified date (reported as "the other day") and the reporter brought the events to the doctor's attention and stated that the patient was in pain throughout the day. The reporter was thinking of taking the patient to urgent care. Treatment for the event "injection pain/injection site extreme pain" and "pain" included heating pads, ice packs, lidocaine patches, unspecified cream and rubbing lotion to try and ease the pain. The reporter was thinking about Advil and asked every how many hours should the patient take the Advil. The outcome of the events was not recovered. Follow-up attempts are needed. Further information is expected.
52 2021-06-13 sleep disorder, feeling abnormal After 2nd shot, I began having a noise in my left ear, for 3 day's it would come and go, on the 4th ... Read more
After 2nd shot, I began having a noise in my left ear, for 3 day's it would come and go, on the 4th day it just stayed on and has been making the noise in my ear at all times. Once or twice a day when I stand up I get dizzy or wobbly feeling, sometimes it is bad enough I have to sit back down. I no longer sleep well. I used to just lay in one spot all night, barely making a dent in the covers. My dog slept in bed every night for over 7 years. But after vax, she stopped sleeping on bed and I wake up to a trashed bed and the covers all balled up on my head. How or what I eat has changed, I no longer like most of the stuff I always liked. I no longer feel right, just always feel off, tired and by the end of most days the noise in my ear is driving me insane. I have never experienced the ear noise or the getting dizzy ever in my entire life until the Govt stuck poison in my arm.
52 2021-06-16 restlessness Chest pain in the upper right chest; Restlessness; Upper right shoulder pain; burning sensation; Thi... Read more
Chest pain in the upper right chest; Restlessness; Upper right shoulder pain; burning sensation; This is a spontaneous report from a contactable consumer (patient). This is Report 1 of 2. A 52-years-old male patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number: EW0179, expiration date: unknown), via an unspecified route of administration, administered in right upper arm on 20May2021 as 2nd dose, single dose; and previously took first dose of BNT162B2(Lot number: EW0172), via an unspecified route of administration, administered in left upper arm on 29Apr2021 as 1st dose, single dose for COVID-19 immunization. Medical history included Depression diagnosed at 4 years old as he was adopted and everything, and had Previously heart attack on 23Oct2003, high cholesterol, and a finger cut off. Patient states it was work related and accidental, he put his hand in the wrong spot, the actuator came down, and took his finger off. States that was years ago, they were able to stitch it back on. Patient reported him and his wife are allergic to cottonwood and he don't know what treatment to take. Patient also reported after forty there is two things that happen, one you start losing your memory, and second you can not remember the other one, and that is exactly what happened to him. Concomitant medications included FLUOXETINE, 40 mg, 2 capsules once a day, every morning, he thinks he takes for cholesterol; ATORVASTATIN, 20 mg daily, he thinks he takes for depression; AMITRIPTYLINE HCL, 25 mg. Takes 3 at night which helps him sleep; LISINOPRIL, 20 mg tablet once daily, taken for an unspecified indication; since 1.5 years and start and stop date of all concomitant medications were not reported. No prior Vaccinations within 4 weeks of vaccination. The patient on an unknown date in May2021, woke up in the middle of the night, he was experiencing restlessness, and not really chest pain, almost like a shoulder pain, up in the shoulder, not like a heart attack or anything and chest pain in the upper right chest which is bearable, but annoying. Patient stated pain comes and goes. Chest pain is still persisting, and started about 2-3 days of second vaccination and has not improved, it is still steady, a burning sensation, and always in the upper right shoulder, above the male breast, up above that, up in the clavicle. The patient underwent lab tests and procedures which included blood cholesterol: only two points up. No investigation assessment. No Emergency Room or Physician Office visits. The outcome of chest pain in the upper right chest was not recovered, upper right shoulder pain was recovering; restlessness and burning sensation was unknown. Information on Lot/Batch number was available. Additional information has been requested.
52 2021-06-22 loss of personal independence in daily activities Mild tinnitus started the day after my second shot, has been constant since then for 6 weeks except ... Read more
Mild tinnitus started the day after my second shot, has been constant since then for 6 weeks except for one day after taking high dose of niacin. Unfortunately, it returned a day later and additional niacin does nothing.
52 2021-06-29 feeling abnormal Fever, second vaccine; Thirsty, second vaccine; spitting up green phlegm; Felt weird, felt bad, felt... Read more
Fever, second vaccine; Thirsty, second vaccine; spitting up green phlegm; Felt weird, felt bad, felt horrible, second vaccine; left side of his body was very sweaty; Chills, second vaccine; sneezing; headache; stuffy nose; loss of smell; Felt knocked out; fatigue, Tiredness; Sleepy, sleepiness, slept for very long hours, second vaccine; Nose running; Sinuses, stopped up, second vaccine; Aches, second vaccine; Did not eat much; he was shaking; coughing; weakness; pain to his left arm; dizziness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm left on 26Mar2021 at 10:00 AM to 10:30 AM as a dose 2, single for COVID-19 immunisation. No family medical history relevant to ae(s). The patient's medical history included prostate and bronchitis, the caller stated that, he had a history of Bronchitis since he was small. The Bronchitis was worrisome with bad weather and a month prior there was bad weather and he had the chills. Past drug event included Tamsulosin for prostate, started about a year and a half ago for his prostate 0.4mg capsule, once a day and Finasteride for prostate, started about a year and a half ago for his prostate 5mg tablet, once a day. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via unspecified route of administration in the left upper shoulder on 05Mar2021 at 11:00 AM to 11:30 AM as a dose 1, single for COVID-19 immunisation. The patient's concomitant medications were not reported. Prior vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as no. Age at time of vaccination was 52 years. Enquired, the caller was a 53 y/o male. The patient received his first Pfizer Covid dose on 05Mar2021 and his second dose on Friday, 26Mar2021. The first and second vaccine both were given in the left upper shoulder. Stated that, his job offered to schedule his vaccines. After his second dose he developed pain to his left arm, which resolved on 28Mar2021. Stated that, on 26Mar2021, he sat down for 10 minutes after the dose and then drove home. Stated that, he drove the home on streets instead of the highway in case he started feeling bad so he wouldn't have to leave his vehicle on the highway. He kind of resisted being dizzy and sleepy, he was not that dizzy. The patient started feeling dizziness, fatigue, weakness a few hours after receiving the vaccine. Stated that, the second dose knocked him out. Stated that, he had a swift reaction about an hour after receiving his second dose, he was very tired, sleepy and sweating a lot and shakiness. The night he received the vacccine, he woke up at 3 AM and stated that, his left side of his body was very sweaty and he was shaking, coughing and sneezing. The patient reported that, a headache, stuffy nose and loss of smell. The patient wanted to know whether these were expected side effects. Response included referred to healthcare professional for further discussion and treatment recommendations. Informed the caller that, Pfizer cannot make treatment recommendations. It was reported that, the caller wanted to know whether the symptoms were immediate or took longer to effect someone after their second vaccine dose. Stated that, he knew everyone's reactions were different, he just wanted to know. Stated that, the patient was drinking a lot of water mixed with sprite to keep hydrated. The patient was sneezing a lot, had a stuffy nose, aches, fever but he could not find his thermometer. Stated that, he felt weird, bad, horrible and it hit him hard. Stated that, he did start to feel a lot better and on Saturday 27Mar2021, the patient thought he had improved. That morning he was ok to eat breakfast and able to smell his breakfast. In between 02:00 PM to 03:00 PM on Saturday, he was sleepy, slept very long hours, sweating on his left side a lot and some on right side of his body. On Friday and Saturday evening, the patient felt the same things, he was thirsty, sweating had chills all through night, was knocked out, had headaches, felt like the room was moving like in hyperspace, anytime he walked he felt like a guy on moon, like the ground was soggy underneath his feet. He stated he was not lethargic and kept his balance but like he was stepping on something soggy underneath him, he was dizzy. He had pain on his left side, his head, his arm as well and the left side of his face. The pain in his arm on Friday was so bad that he felt the pain in his face as well. The caller stated that, he had much less pain in his arm the next day on Saturday. Stated that, he heard the symptoms would start the next day after the shot. His nose was still stuffy. Stated that, the caller did not provide a healthcare professional for the report. Stated that, he had not seen a doctor for 10 years. The caller stated that, he was fine whether safety needed to clarify any documentation from the report. Stated that, his card does not have the Lot or Expiry date of the first dose and second dose. Stated that, with his first vaccine on 05Mar2021, he only had intense pain on his left side of shoulder, it was still there on Saturday and by Sunday the pain was much better. By Monday he was back to normal, only felt a little tired but not too much and he was able to do things. By Tuesday/Wednesday the patient was fine. The adverse events did not require a visit to emergency room and physician office. The reporter seriousness for other events was unspecified. Treatment received for the events was not provided. The relevant tests were reported as no. The outcome of the events pain to his left side was recovered on 28Mar2021 while for the other events was unknown. No follow-up attempts are needed, information about lot/batch number cannot be obtained.
52 2021-06-29 insomnia My body started shivering uncontrollably/feel extremely chilled; I had trouble sleeping and was up m... Read more
My body started shivering uncontrollably/feel extremely chilled; I had trouble sleeping and was up most of the night; high fever/I checked my temperature last night ranged from 101.8 to a high of 103.7; I woke up soaked in sweat; severe migraine; I felt dizzy all through the night; This is a spontaneous report from a contactable other health care professional. A 52-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248, age at vaccination 52 years), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:00 as dose 2, single for covid-19 immunisation. Medical history included irritable bowel syndrome (IBS), asthma, Low lung input and output, covid-19 covid prior vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient previously took BNT162B2, dose1, single (lot number EL3248) for covid 19- immunization on 14Jan2021, 11:00. The patient's concomitant medications were not reported. On 04Feb2021 22:30, the patient started to feel extremely chilled. He went to bed and covered up with 2 blankets. patient body started shivering uncontrollably. Patient normal temperature fluctuates from 94-95 degrees. He checked temperature last night ranged from 101.8 to a high of 103.7. patient had trouble sleeping and was up most of the night due to the high fever. He woke up soaked in sweat. He also had a severe migraine and he felt dizzy all through the night and into 05Feb2021. The patient underwent lab tests and procedures which included body temperature: ranged from 101.8 to a high of 103.7 on 04Feb2021. Seriousness was not serious. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Non-Allergies to medications, food, or other products. No treatment was received for the adverse events. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
52 2021-07-02 insomnia Almost a complete lack of sleep due to ache all over body; Almost a complete lack of sleep due to ac... Read more
Almost a complete lack of sleep due to ache all over body; Almost a complete lack of sleep due to ache all over body; felt exhausted; arm where the shot was is sore and very tender; This is a spontaneous report from a non contactable consumer, the patient. A 52-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via an unspecified route in the left arm on 23Mar2021 at 15:00(at the age of 52 years old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not have any allergies to medications, food, or other products. The patient did not take any concomitant medication and did not receive any vaccination within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 23Mar2021 at 22:00, the patient experienced complete lack of sleep due to ache all over body, felt exhausted, arm where the shot was is sore and very tender, though there are no swelling or shot location issues. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported event. The clinical outcome of the lack of sleep, ache all over body, exhausted, pain in arm and tenderness was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
52 2021-07-06 disturbance in attention, feeling abnormal On night of April 25th I went to ER with a sudden and intense chest pain that brought on high heart ... Read more
On night of April 25th I went to ER with a sudden and intense chest pain that brought on high heart rate, high blood pressure, head ache, dizziness, sweating and nausea. I was admitted into ER and tested for a heart attach which I did not have. I was released from ER in the early morning hours. Since my first dose, I have had persistent brain fog (fuzzy thinking), trouble concentrating, and strange bouts of fatigue. The second dose was a hard recovery with extreme fatigue lasting over 4 days but the strange bouts of fatigue are random and not just after the second dose.
52 2021-07-06 impaired work ability, confusional state, depression, disturbance in attention, feeling abnormal I had positive COVID infection 12/13/2019 and was in the ICU and hospitalized multiple times. I had... Read more
I had positive COVID infection 12/13/2019 and was in the ICU and hospitalized multiple times. I had no adverse events or symptoms with the 1st dose (lot ER732 IM RA). The 2nd vaccine 5/24/2021 (lot EW0187 IMLA), the next day my arm was sore. I felt extremely tired all day. The 2nd day, I had extreme fatigue and could not go to work. My arm was still sore and I had flu like symptoms. These symptoms lasted for 5 days. I started to feel better for a couple days and go to bed and wake up still completely exhausted. I just wanted to sleep all the time. Since the 2nd vaccine, I have lost sense of smell and appetite and don't have the energy to do anything else. I have lost a total 25 pounds since getting the vaccine. My initial weight was 175 lb, my weight now is 149 lbs. My other symptoms include: difficulty regulating my body temperature, cold sensitivity, muscle pains in my hands, shoulders, chest and top of legs thighs. "I feel like my body is eating myself away." I also have confusion, depression, difficulty focusing and brain fog.
52 2021-07-07 amnesia I have severe pain in my leg muscles and bi-ceps in both arms, I'm extremely lethargic at all time... Read more
I have severe pain in my leg muscles and bi-ceps in both arms, I'm extremely lethargic at all times of day. I also have burning sensation in my leg calf nerves and forearms. I have also slight pain in my chest. I also have finger cramping when I wake up in the morning. slight lost in memory.
52 2021-07-13 nervousness Pt presented to the pharmacy to get his first dose of Shingrix. This vaccine was processed correctly... Read more
Pt presented to the pharmacy to get his first dose of Shingrix. This vaccine was processed correctly, however when the immunizing tech saw the VAR form on the counter, she assumed that pt was here for the COVID vaccine and administered Pfizer COVID shot. After pt received his COVID vaccine-card, he realized that he was given incorrect vaccine. Per pt he already completed two doses of Pfizer in the past (04/13/21. 05/04/21). He mentioned he had been fasting from last night for his blood work up this morning. He stated he was feeling little shaky and dizzy. Pt stayed at the waiting area for about 20 mins and he did not complain any further symptoms.
52 2021-07-13 sleep disorder 1. Woke up at 2am with sweats and chills (Fever). An hour later had pain on my left flank (seemed l... Read more
1. Woke up at 2am with sweats and chills (Fever). An hour later had pain on my left flank (seemed like pain from the same area that I had previously had a Diverticulitis event. Previous Diverticulitis event the pain gradually increased in that area. This time it was immediate. Chills and Sweats (Fever) lasted until 7-8AM. Started Antibiotics and diet Monday afternoon (2/15/21). Pain on my left flank lasted until I completed my Antibiotics Treatment 8-9 days later. 2. At some point within about 3 weeks of the 2nd Vaccination I noticed I was wheezing at night while I slept (it would wake me up). I was not really short of breath, but while laying down would wheeze. I had asthma as a child, but since I was a teenager, I have not had any Asthma or Wheezing issues. Doctor gave me a course of Steroids and Albuterol which I am still using daily. It has gotten better but I still need the inhaler daily.
52 2021-07-14 nightmare, abnormal dreams Patient developed cough, runny nose, loss of smell, disturbing vivid dreams, and sore throat on 07/... Read more
Patient developed cough, runny nose, loss of smell, disturbing vivid dreams, and sore throat on 07/11. Tested positive for COVID on 07/14
52 2021-07-25 feeling abnormal Spoke with patient today. He received the pfizer Covid-19 vaccine from us. The first shot was given ... Read more
Spoke with patient today. He received the pfizer Covid-19 vaccine from us. The first shot was given on 4/15/21 (ndc: 59267100001, lot: ew0151, exp: 07/31/21; given in left arm/im) and the second shot was on 5/6/21 (ndc: 59267100001, lot er8736, exp: 07/31/21; given in left arm/im). After the second shot, he stated he began to have adverse effects. He says it started with dizziness and feeling underbalanced. The adverse effects continued to worsen to when he would turn his head left or right, he felt like he was in a fog and had to wait for his mind to caught up. And now within the last 2 weeks, he has had swelling on each side of his neck that is worse in the evening. He has checked with his primary care doctor. Patient reports that his doctor has done bloodwork, which was normal other than his cholesterol being elevated and the doctor did a CT scan of his head that has come back normal. Patient is now following up with an ENT. Patient and I called Pfizer today to get information on whether others have reported these same effects with the duration he is experiencing these effects. The reference number given to us by Pfizer was 51k4tadq.
52 2021-07-27 feeling abnormal Hurt in his arm; The hair is falling out on the arm; He doesn't feel like his arm is normal; Before ... Read more
Hurt in his arm; The hair is falling out on the arm; He doesn't feel like his arm is normal; Before the skin was soft and thin/ it feels thick and rough only on the arm; They are red dots and there is some yellow in the middle; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0158), dose 2 via an unspecified route of administration on 09May2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had the reaction from the first vaccination. He had the first vaccination on 18Apr2021 and the second vaccine was on 09May2021. He had a lot of little dots. They are not pimples. They are dots on the whole arm. They are red dots and there is some yellow in the middle. He mentioned it to the person that gave him the second injection and they said it was normal. He wanted to mention that. He has hurt in his arm and the hair is falling out on the arm. He doesn't feel like his arm is normal. He doesn't feel it as before. Before the skin was soft and thin. Now when he feels it, it feels thick and rough only on the arm. He had the reaction on the first day he had the vaccination. HCP Information: He doesn't have any doctor. He would love anyone to see his arms. He doesn't have medical. Dots on the whole arm: They are going away. Some of them are going away. They are appearing again. He would not say that it has been worse or improving. For example, he can feel a new one there that was going away. They are just coming and going. They appear and disappear. He can feel that his skin is rough and thick. It is not like the arm looks horrible, but it is not either worse or improving. It is both arms.
52 2021-07-28 feeling abnormal He can move and use his hand now,but it was like paralyzed; Gave him autoimmune response/ him hyper-... Read more
He can move and use his hand now,but it was like paralyzed; Gave him autoimmune response/ him hyper-rized his body; felt sick; Had complaints of nausea, felt as if he was beaten with a baseball bat from head to toe; felt as if he was beaten with a baseball bat from head to toe; Bone pain; Numbness in his hands to elbows with knots/Second dose: Has knots coming all over his hands/Second dose: Numbness; numbness in his hands to elbows with "knots" that appeared; Pain/it started in his hands and went up to his arm, to elbow, and had pain/The pain went from his elbows, down to his hands, and knuckles; Pain/it started in his hands and went up to his arm, to elbow, and had pain/The pain went from his elbows, down to his hands, and knuckles; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in right arm on Mar2021 14:45 (Batch/Lot number was not reported) (at the age of 52 years old) as dose 2, single for COVID-19 immunization. Medical history included diabetic, heart disorder, high triglycerides, high cholesterol, blood pressure high, anxiety and sleep problem, all were ongoing; and some kidney stones taken out so he knows pain/ 200 kidney stones and he knows pain (He does not take anything except that time when had kidney stone and took Morphine and it made so hyper) and back pain before the vaccine. Concomitant medications included insulin aspart (NOVOLOG) taken for diabetes, from an unspecified start date to unspecified date in 2021 (Have not used in last 3-4 weeks because diabetes is doing better); insulin glargine (LANTUS) taken for an unspecified indication from an unspecified start date and ongoing; atorvastatin taken to lower triglycerides and cholesterol from an unspecified start date and ongoing; dapagliflozin propanediol monohydrate (FARXIGA) taken as diabetic and heart pill from an unspecified start date and ongoing; lisinopril taken for blood pressure high from an unspecified start date and ongoing; carvedilol taken for high triglycerides from an unspecified start date and ongoing; lorazepam (ATIVAN) taken for anxiety from an unspecified start date and ongoing; and sertraline hydrochloride (ZOLOFT) taken as it helps with sleep or something, does not really know why taking (as reported) from an unspecified start date and ongoing. The patient previously had kidney stone and took Morphine and it him made so hyper and the patient said that he said he would never take it again. This was 18 years ago. No prior vaccinations (within 4 weeks). He got the Flu Vaccine back in September. He gets the flu vaccine and pneumonia each year and no reaction. The patient received the first dose of the Pfizer Covid-19 vaccine in in right arm back in Feb2021 15:00 and had complaints of a euphoric feeling that went away like initially sounded like stated 3 hours. After getting the second vaccine, two days after that everything changed and he and his body was never the same. After the second dose, it started in his hands and went up to his arm, to elbow, and had pain. It was so excruciating. The pain started two days after getting the second dose. The pain went from his elbows, down to his hands, and knuckles. He stated he no longer has any pain. It slowly went away . The pain started going away three weeks ago. He did not take any pain medicine. He does not take drugs or alcohol. The patient had the second dose of the Pfizer Covid-19 vaccine back in Mar2021 and felt sick, had complaints of nausea, felt as if he was "beaten with a baseball bat from head to toe", and afterwards he started developing bone pain and numbness in his hands to elbows with "knots" that appeared. He still has numbness and bone pain but the pain was getting better. Has been to rheumatologists and doctors for complaints he experienced after being administered the second dose of the Pfizer Covid-19 vaccine and HCP wants to put him on pain medication. He has had to see two rheumatologist so far and his family doctor. The knots on his hands started coming up slowly. It was not overnight. It was within 3-4 week time period it started to come up. He showed all of this to the doctor and told this is not right. He did not have anything until he got the Pfizer vaccine. The knots are almost gone, not 100% gone, but almost gone. The knots did not really hurt. However, the knots did move around with a little pain. The pain was not that bad. He stated he still cannot feel his hands. They were so freaking numb. He cannot feel his fingers. He started to feel numb three days after the second dose. It started and then got worse. He could not pick up his hammer. The pain was so excruciating. He reiterated he was very active, physical, exercised, ride bike each day. He worked hard all his life, and did not really have pain except back pain before the vaccine. After day two he started to have pain like never before. It's like the vaccine attacked something in his body. He later, confirmed the numbness is getting better at this time. The numbness use to be from his elbows down. The events did not require emergency room visit. The right one where got shot in was double as bad with the knots than the left. The pain was worse in the right arm than left a little bit. Mentioned he is right handed and uses his right hand more. He stated the vaccine has wrecked havoc on his life. He is a good church going guy. Whatever they put in him hyper-rized his body. Three doctors have told him it's an autoimmune vaccine and it attacked his body. Gave him autoimmune response. It's almost five months now into this and still having some effects. He can move and use his hand now, but it was like paralyzed. He was a very active guy and once his took this, it wrecked his life. He was a physical guy and has to use his arms and hands every day. This vaccine did not coincide with his body. It may with the other 1,000 people, but for him it did not at all. All these symptoms from a vaccine. He normally gets the flu vaccine and pneumonia vaccine each year and never had anything like this. He stated that with the Pfizer Covid-19 vaccine that he is the one guy it didn't work on. He stated that he has missed a lot of work and the vaccine has done a great thing by saving lives but not his life. The Pfizer Covid-19 vaccine was not free because it has caused him so much and he cannot do the physical activities that he was able to do before getting the Pfizer Covid-19 vaccine. His HCP told him not to get the Pfizer Covid-19 vaccine again. He stated that he was still frustrated as he was before this call. He doesn't believe no one else has not had his side effects and feels that there is more information about what he is experiencing. He got upset and stated this vaccine should have been studied more. He commented this vaccine is safe for like 99.99% of people, but it was not safe for him. It's not safe because one would not have these effects and then it slowly start to go away if it was safe. The patient has so much lab work done in the last 3-4 months. Has had enough lab work to last a life time. Now he has a paper to get it done again. He does not have any specific results to provide. Weight was reported as 157 pounds (also reported as 130 something pounds). The outcome of the event He can move and use his hand now,but it was like paralyzed was not recovered; event Numbness in his hands to elbows with knots/Second dose: Has knots coming all over his hands/Second dose: Numbness was recovering; event Pain/it started in his hands and went up to his arm, to elbow, and had pain/The pain went from his elbows, down to his hands, and knuckles recovered in Mar2021; and outcome of the other events was unknown. Information on lot/batch number has been requested.
52 2021-07-29 nightmare, anxiety, feeling abnormal Dizziness; Brain fog; Tinniutis; Unsure of balance; Disequilibrium almost to the point ofvertigo; He... Read more
Dizziness; Brain fog; Tinniutis; Unsure of balance; Disequilibrium almost to the point ofvertigo; Heart Racing; Bizarre nightmares; Benign hypertensive levels; Anxiety; Chills; Fatigue; Muscle Aches; Some burning in leg muscles; Severe joint inflammation in knees and ankles; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included essential hypertension, benign. The patient has taken unspecified concomitant medications. It was unknown whether the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced severe joint inflammation. On 31Mar2021, the patient experienced dizziness, foggy feeling in head, tinnitus, loss of balance, disequilibrium, heart racing, nightmares, benign hypertensive heart disease, anxiety, chills, fatigue, muscle aches and burning in leg muscles. It was reported that the patient experienced 3 days after vaccination, severe joint inflammation in knees and ankles, like a gout attack starting 7 days after vaccination dizziness, brain fog, tinniutis, unsure of balance, disequilibrium almost to the point of ,vertigo, for example at any time, with eyes closed and head up, my body will rock on his heels noticeably, heart racing, especially at night when trying to sleep or stay asleep, waking up numerous times, bizarre nightmares BP elevated above his essential benign hypertensive levels, anxiety starting 7 days after vaccine, but faded chills, fatigue required 2 days of rest muscle aches, some burning in leg muscles inflammation. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event dizziness, foggy feeling in head, tinnitus, loss of balance, heart racing, nightmares benign hypertensive heart disease and anxiety was not resolved. The clinical outcome of the event chills, fatigue, muscle aches, burning in leg and joint inflammation was recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
53 2021-01-07 anxiety within 10 minutes of receiving vaccine, patient reported having neck tightness and chest tightness; ... Read more
within 10 minutes of receiving vaccine, patient reported having neck tightness and chest tightness; patient was feeling warm and blood pressure was elevated; diphenhydramine 25mg was given and patient was taken to ER. ER reported it was a mix of a slight reaction and anxiety from receiving the vaccine. Patient was sent home from ER and is doing fine.
53 2021-01-07 impaired work ability Server pain at the injection site to the point it is hard to move the arm, and it woke me up when I ... Read more
Server pain at the injection site to the point it is hard to move the arm, and it woke me up when I rolled onto it. Migraine headache with visual pain and nausea. I have taken Tylenol and ibuprofen for the pain and discomfort and I have also been icing the injection site. I missed work today because of the migraine
53 2021-01-08 impaired work ability Headache, NauseaVomiting, swollen and painful left axilla and left arm; chills, strange taste in mo... Read more
Headache, NauseaVomiting, swollen and painful left axilla and left arm; chills, strange taste in mouth Narrative: 1/5 received vaccine. 1/6 woke up with left arm/axilla swollen and painful, severe headache, nausea, and chills. Also has a strange taste in his mouth. He stayed home from work. 1/7 employee reports fever overnight, chills, and lump under his left arm has enlarged. Advised to see his PCP. 1/8 left axillary lump has decreased from softball size to baseball size. It's still tender. His arm pain has improved. Headache, nausea, and chills have resolved.
53 2021-01-08 nervousness, anxiety Complaint of racing HR, no other symptoms, no SOB. Verbalized feeling nervous/anxious with some visi... Read more
Complaint of racing HR, no other symptoms, no SOB. Verbalized feeling nervous/anxious with some vision changes. PMH: HIV+ and hyperlipidemia. 0735: HR 110, BP 125/80 L arm, RR 17. 0740: HR 98. Did not take am medications, no breakfast or water, only 2 sips of coffee. Gave him water and he stated feeling better at 0800 and left site and stated partner would drive him home. No treatments administered.
53 2021-01-12 motion sickness Received 2nd vaccination in series on 11 JAN 21. By next morning started to experience some muscle a... Read more
Received 2nd vaccination in series on 11 JAN 21. By next morning started to experience some muscle and joint symptoms. By afternoon of 12 JAN 21 experienced sudden onset loss of bladder control for first time in his life, followed a few hours later by blurry vision, vertigo, motion sickness, emesis and cold sweats that drenched his clothes. Taken to ER by paramedics, and admitted for further observation and evaluation for underlying neurologic vs. cardiogenic problems. Given positional treatments by PT for possible otoliths. Feels much improved on afternoon of 13 JAN 21, but symptoms not fully resolved. Will likely be discharged from hospital on 14 JAN 21 if problems continue to resolve.
53 2021-01-13 sleep disorder Headache; migraine; tenderness at injection site; Ten hours after injection he had shaking, sweats, ... Read more
Headache; migraine; tenderness at injection site; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Fatigue; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on right deltoid on 05Jan2021 07:45 at single dose for covid-19 immunization. Family history included migraine (other family members). Medical history included mild blood pressure and kidney stones, reactive airway disease. Concomitant medication included colecalciferol (VITAMIN D), potassium, allopurinol and hydrochlorothiazide/valsartan for mild blood pressure and kidney stones, fluticasone propionate, salmeterol xinafoate (ADVAIR) for reactive airway disease, atorvastatin, and multivitamins. The patient previously took fluticasone propionate, salmeterol xinafoate (ADVAIR) and experienced dry mouth and lost sense of taste. The patient also previously took Tdap booster on Aug2020, Shingrix on 10Aug2020, and influenza on 12Oct2020; all for immunization; and tetanus injections for immunization and experienced localized tenderness. The patient had the first dose of BNT162B2 (lot number: EH9899) for COVID-19 immunization on 15Dec2020 and experienced localized tenderness at injection point. The received his second dose of COVID vaccine on 05Jan2021. With the first dose he had increased localized tenderness at injection site on 15Dec2020, and he rated it mild to moderate. He would say it was 80% resolved in 24 hours. It had completely resolved in 36 hours. He would say that he has recovered completely form the localized tenderness with the first dose. Then he noted his second dose was yesterday, in the context of not having much sleep the night before. The actual injection was uncommonly eerily painless. The other folks in his department had similar experience. Maybe it was the nurse who gave the injection. Maybe it was because it was the same area and sensitivity was decreased. They had to check the Band-Aid to make sure blood was there. The administration was painless. He was relieved when the arm started getting sore to know he actually received it. He had increased arm tenderness at injection site which he rated as moderate which has now resolved. It got to moderate where lifting the arm up was sore. He definitely knew that he had been vaccinated. He got the vaccine at 7:45AM and now it is 16 to 17 hours later and he would say the pain is mild now. It did persist. The first vaccine hurt a little more. He expects this to go away. Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias. He had unrelenting headache over night that was moderate to severe. He said it kept him awake. It was exacerbated by lying down. Sitting up helped him. It became a migraine which is something he doesn't often experience. Migraines are pretty rare for him. He took 800mg of Advil at 6AM that helped for headache and migraine. The weight of the patient was 250 to 255 pounds. Shaking, sweats, hot and cold flashes, and augmentation of myalgias have resolved. Everything has resolved except for a little headache. In the background he literally had one or two hours of sleep. He thinks that likely precipitated a migraine was increased. Last night he slept literally an hour. He took 800mg of Advil and fell asleep. He is operating on 2 hours of sleep in 48 hours. Most of the stuff is gone except a little headache and expected fatigue. Headache Seriousness Criteria: he would say that it was relatively disabling. He would not have been able to carry on. He wouldn't have been able to operate last night. It would have interfered. It was dissimilar to others. He gets rare migraines. Everything was amplified with a migraine. He certainly felt that. It was fair to say the vaccine precipitated the migraine that was mild or severe. He doesn't want to falsely attribute these things to the vaccine. Causality Headache: precipitated by the vaccine. In the context that he had not slept the night before. He had a nasopharyngeal COVID test and it was negative. He has been in a COVID study where they are looking at combination. They developed a saliva test at (Name). There is a combination of saliva oropharyngeal and immunoglobins. He has been negative multiple times. The outcome of the events headache and fatigue was not recovered and recovered for the rest of the events.; Sender's Comments: A causal association between BNT162B2 and the reported event headache cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
53 2021-01-18 restlessness Fever / chills Restlessness Vomiting HA
53 2021-01-19 impaired work ability Developed fever 12/28/20, tested positive for SARS 12/29/2020. Quarantine for 10 days from onset of... Read more
Developed fever 12/28/20, tested positive for SARS 12/29/2020. Quarantine for 10 days from onset of symptoms, returned to work 1/6/2021
53 2021-01-23 depression After the administration of the second dose of 24 hours, I had severe depression that stays for abou... Read more
After the administration of the second dose of 24 hours, I had severe depression that stays for about 48 hours then reduces and start to go and come
53 2021-01-25 feeling abnormal, anxiety 1/21/2021, blood glucose levels were fluctuating from very low to high, normally stable and consiste... Read more
1/21/2021, blood glucose levels were fluctuating from very low to high, normally stable and consistent. 1/22/2021 spiked a temp of 101.9 that would come and go, nausea with eating, high anxiety with feeling of fatigue and being in a fog. Feels good when first getting out of bed in the morning but about an hour or two he feels tired with his anxiety level rising. PCP contact with new orders to increase daily dose of Prozac to assist with the anxiety and rest. Patient stated that he has been resting and was feeling a little better today.
53 2021-02-13 feeling abnormal 12 hours after shot started chills, body aches, severe headache. 24 hours after shot, same condition... Read more
12 hours after shot started chills, body aches, severe headache. 24 hours after shot, same conditions, with nausea. 48 hours after shot same conditions, with vomitting. Unable to eat or drink and would just throw it up. 72 hours, severe headache, extreme light and sound sensitivity, nausea. 96 hours finally starting to feel better. Mild symptoms, such as slight headache, weakness.
53 2021-03-05 irritability I ate nothing that morning of the shot. The first day: I took the covid-19 vaccine Pfizer shot on T... Read more
I ate nothing that morning of the shot. The first day: I took the covid-19 vaccine Pfizer shot on Thursday the 4th of March; there was pain at the injection site just as any other vaccine I have been administered during military service. After the shot I felt tied, and my left arm did hurt from the shot, I started to feel irritable (angry or even aggressive), my chest became tight and my heart rhyme felt somewhat off causing me to start coughing and sometimes uncontrollable to the point I could not catch my breath I thought about seeking medical attention but did not.. The second day: Pain in my left arm went away at the injection site, tiredness went away, and the feeling of irritable (angry or even aggressiveness) went away, tightness in my chest and coughing went away. I have been having a chronic pain in my left arm for about a year and after the shot the pain was gone I noticed that on the second day. I did notice my body temperature was up and down showing symptoms of histamine reaction but not out of control.
53 2021-03-06 panic attack Diaphoretic, syncope for approximately 2 minutes, panic attack, rapid breathing. Transported to near... Read more
Diaphoretic, syncope for approximately 2 minutes, panic attack, rapid breathing. Transported to nearest ER by EMS.
53 2021-03-08 impaired work ability following injection i had increased pain in back and into legs. it increased to point of week of Feb... Read more
following injection i had increased pain in back and into legs. it increased to point of week of February 1 I was having difficulty at work. on 2/5/2021 i started having fesiculations in both lower extremities at rate of 300-400 per minute. pain increased in lower back and thighs. These increased to point of inability to work related to inability to sit more than 15 seconds and need of walker to mobilize. I scheduled with back specialist and neurologist, ended up hospitalized on 2/18/2021 released on 2/21/21 with diagnosis of benign fesiculations meaning no testing identified cause. currently still unable to work.
53 2021-03-12 sleep disorder Started with itching burning rashes neuropathy headaches fatigue and dizziness. Now have mouth sores... Read more
Started with itching burning rashes neuropathy headaches fatigue and dizziness. Now have mouth sores that won?t heal and debilitating malaise fatigue A few days later: Joint pain and air hunger A few days later: Numb extremities Two weeks to date: Body temp regulation issues , heart pounding, face flush. Sleep disturbance entire time. Extreme fatigue.
53 2021-03-14 feeling abnormal second shot on3/8/21 basically fine all day, 3/9/21 630am one hour and half felt slightly beat up th... Read more
second shot on3/8/21 basically fine all day, 3/9/21 630am one hour and half felt slightly beat up then fine, an hour and half later same thing, and then 2pm same thing then fine. on 3/9/21 woke up with finger tips white and cold and arm cold and sweat from shoulders up,i then got up and moving and was fine after that. dry spot in throat with occasional cough once and a while throuout the day, then friday night had sat down to dinner and had a 3 minute vomitting upset stomach (did not vomit), and then went away. mother in law tested positive on 3/10/21 and wife tested positive on 3/13/21 so i went to test on 3/13/21 just to rule out and received positive result call from test site on 3/14/21 at 2pm.
53 2021-03-14 feeling abnormal Woke up on the 4th with still neck and had Vertigo. Saw Dr. about the vertigo on the 8th. Been takin... Read more
Woke up on the 4th with still neck and had Vertigo. Saw Dr. about the vertigo on the 8th. Been taking Meclaziine. Vertigo and pain in joints persisted for 7 days. Until, approximately the 10. Vertigo and pain in joints has seemed to go away. Still feeling HEAD FOGGINESS since. Constantly tired.
53 2021-03-19 feeling abnormal Felt weird 5 minutes after shot. 10 minutes after shot I called over a tech and said I didn't feel ... Read more
Felt weird 5 minutes after shot. 10 minutes after shot I called over a tech and said I didn't feel right. The took my vitals and found the my blood pressure had dropped to 85/45. They called 911 and hit me with an EpiPen. I never blacked out. After another 10 minutes the fire department arrived and they took vital signs; all normal. Another 10 minutes and ambulance arrived. Vitals in the back of the ambulance were fine. Got to the emergency room and vitals were fine including ekg. Was released from the hospital about 4.5 hours after the initial shot. I feel a little sluggish today but otherwise fine.
53 2021-03-21 insomnia, irritability Chronic tinnitus significantly increased in intensity/volume the day following the first injection--... Read more
Chronic tinnitus significantly increased in intensity/volume the day following the first injection--I estimate about double the volume. In both ears. After 12 days it has not subsided at all. The increase in severity is causing secondary headache, jaw clenching, sleeplessness, irritability, hearing issues.
53 2021-03-23 insomnia Flu like symptoms, body aches, headache, fatigue, insomnia
53 2021-03-25 feeling abnormal Headaches, low neck pain, base of skull pain, lightheadedness, slightly dizziness, brain fog, tightn... Read more
Headaches, low neck pain, base of skull pain, lightheadedness, slightly dizziness, brain fog, tightness in ears, left ear seems to stop randomly. No treatment assigned beyond neck PT that will start 3/31/21. Condition has been experienced for 2 weeks.
53 2021-03-25 feeling abnormal About 30-45 minutes I began to feel tingling in my tongue and throat. A few hours later my face beca... Read more
About 30-45 minutes I began to feel tingling in my tongue and throat. A few hours later my face became numb - it was a circle around my face. The next day (3/7) the right side of my face was numb and showing symptoms of what doctors later decided was Bells Palsy. on 3/7 I had fatigue and general feeling bad like I had the flu. On Monday 3/8, I was feeling worse and I called the advice nurse who advised I go to the Emergency room due to right face partial paralysis, numbness, and face drooping. They diagnosed Bells Palsy and prescribed Valtrex and prednosone. From 3/9-12 the right side of my face was numb, droopy and I had ear pain and a lot of fatigue. By Saturday 3/13 I was feeling better and have gradually gotten better through today 3/26. I still have numbness in my right cheek. and occasional tingling in my lips. My doctor has advised me to go ahead and get the second dose of vaccine tomorrow 3/27. Also, during the week of 3/7 - 3/12 I had some dizziness and a general foggy feeling in my head.
53 2021-03-25 insomnia Insomnia, feeling fatigued and lack of energy all of the time, and periodic sickness or nausea to st... Read more
Insomnia, feeling fatigued and lack of energy all of the time, and periodic sickness or nausea to stomach. Cannot sleep more than 2 hours, awake.
53 2021-03-28 feeling abnormal I am experience severe Diziness and Vertigo like symptoms. I am unable to lay down and can only keep... Read more
I am experience severe Diziness and Vertigo like symptoms. I am unable to lay down and can only keep my head on a straight axis without feeling dizzy and unbalanced. I am feeling in a daized state much of the time like I was hit with a punch.
53 2021-03-30 confusional state In observation area, patient reported feeling dizzy, short of breath and confused. He was brought to... Read more
In observation area, patient reported feeling dizzy, short of breath and confused. He was brought to the observation area where he reporting that he was not able to take his morning insulin. He reported he felt confused and this was typical when he was not able to take his insulin. He did not know the date or the day of the week. He reported having took anti-viral medications this morning, but not diabetes meds, including Lantus He denied chest pain. He had a history of open heart surgery/valve replacement in December 2020. Recommended transfer to Medical Center ED via ambulance for further evaluation.
53 2021-03-31 irritability Very sore arm within 12 hours of 2nd shot on Wednesday March 24th. Woke up the next day feeling "off... Read more
Very sore arm within 12 hours of 2nd shot on Wednesday March 24th. Woke up the next day feeling "off" and irritated. By 9pm Thursday my entire body ached severely as if I had a very bad flu. By 11pm I had very severe cold & hot shakes and felt extremely nauseous until the next morning. I checked my temp every couple hours and never was I above 98.5 but, I felt extremely sick until about 48 hours after the 2nd shot. On Friday, and for the next 2-3 days, I felt fatigued as if I was recovering from the flu. Only a flu that was without fever or any respiratory issues. By Monday I felt normal again.
53 2021-04-02 feeling abnormal Shot arount 4pm. Couple hours later, a little bit of coughing. Around 8pm, more cough from chest. Cl... Read more
Shot arount 4pm. Couple hours later, a little bit of coughing. Around 8pm, more cough from chest. Close to midnite, wheezing and more cough. Took Xyzal and benadryil. Today (20 hours after the shot), lot of coughing, and weird feeling in chest. May need to goto urgent care today , lets see.
53 2021-04-02 insomnia, disturbance in attention Fatigue; Headache; Insomnia; Inability to concentrate.
53 2021-04-05 feeling abnormal Extreme body tremors that wax and wane.
53 2021-04-06 anxiety On April 6th, after 30 hours of receiving the first dose of the vaccine. Approximately at 5:00PM , t... Read more
On April 6th, after 30 hours of receiving the first dose of the vaccine. Approximately at 5:00PM , there was a little bit of heart racing, shortness of breath and dizziness. It lasted only 3 minutes or so. It didn't need any medical attention. The anxiety continued till 7:00PM. With this event, do I still have to obtain the second dose after 21 days?
53 2021-04-07 insomnia Chills, fever, extreme head ache, insomnia, body aches
53 2021-04-08 sleep disorder Patient reports new nerve type pain in shoulder. He cannot sleep on that side (left ) and has diffic... Read more
Patient reports new nerve type pain in shoulder. He cannot sleep on that side (left ) and has difficulty exerting pressure toward his inner body using that arm. Patient has not sought medical attention; he plans to see his chiropractor and possibly his primary medical doctor.
53 2021-04-11 sleep disorder After my second dose, I experienced muscle twitching exactly in the muscle where I got my shot. It h... Read more
After my second dose, I experienced muscle twitching exactly in the muscle where I got my shot. It hasn't stop since the then. the muscle twitching wakes me at night and happens almost every 5 minutes till I rubbed it hard. Please help, my insurance deductible is very high and I am out of work to pay for a visit to my doctor.
53 2021-04-13 insomnia Beginning one day after receiving my second dose of the Pfizer vaccine for Covid-19 I began to have,... Read more
Beginning one day after receiving my second dose of the Pfizer vaccine for Covid-19 I began to have, what I perceived as adverse events different from what is listed as common side effects. 1. Slower heartbeat then what I normally run. 2. Slower breathing and respiratory response 3. Very low energy 4. Loss of appetite 5. Abnormally wide fluctuation of blood pressure while not exerting myself. For example, higher blood pressure readings (155/95) with a slower pulse (60). 6. Difficulty relaxing and sleeping
53 2021-04-13 loss of personal independence in daily activities I received 2nd Covid 19 vaccine on April 9th 20201 at 6pm PT. Then I started to have lower back pai... Read more
I received 2nd Covid 19 vaccine on April 9th 20201 at 6pm PT. Then I started to have lower back pain on Saturday (April 10), but I was still mobile, and was able to perform daily activities. However, on Sunday morning (April 11th), my lower back pain became better, but I started having very severe pain on my left thigh. The pain scale is 10 out 10, and I was unable to move around. I could feel the muscles around the nerve were twitching and cramping, and this gave me such an excruciating pain, and felt like the nerve was squeezed by the thigh muscles. Because of this severe pain, I was not able to mobilize at all on Sunday, then had to go see physician on Monday urgently. The physician was puzzled why I devel
53 2021-04-15 sleep disorder, disturbance in attention I've had mild tinnitus for 20 years, only noticeable when very quiet, like at night when going to be... Read more
I've had mild tinnitus for 20 years, only noticeable when very quiet, like at night when going to bed, but not severe enough to interfere with sleep. Ten days after the shot it was like someone flipped a switch and suddenly the tinnitus was a lot louder, to the point where it is always audible, even over other noise, and does interfere with sleep and concentration.
53 2021-04-16 anxiety Pt felt very anxious, wanted to walk around. EMS took vitals 183/82 HR 112 SaO2 98%. Pt gradually ... Read more
Pt felt very anxious, wanted to walk around. EMS took vitals 183/82 HR 112 SaO2 98%. Pt gradually calmed himself, was able to move out of the drivers seat to passenger side, allowed to leave after 30 min
53 2021-04-21 disorientation He felt nauseous, got up to go to kitchen sink and passed out for a few seconds. When I got to him,... Read more
He felt nauseous, got up to go to kitchen sink and passed out for a few seconds. When I got to him, he was on the ground, eyes open, but seriously disoriented. He got up to the couch. He was very, very clammy and his heart rate was 44 bpm. I held three fingers for him to identify, he correctly answered. He has a small gash on his forehead. His heart rate came up to 70, 20 minutes after episode. Refused to go to urgent care.
53 2021-04-22 sleep disorder Two week later, approximately, I started having real bad headaches. I was having them at least 5 tim... Read more
Two week later, approximately, I started having real bad headaches. I was having them at least 5 times a week. I called my doctor. The headache would last 15 or 20 minutes and then it would go away. Sometimes the pain would wake me up. The headache pain had gone away before I saw the neurologist (the last week of March - maybe the 29th); the doctor had referred me to see a neurologist and they gave me a medication to take: Topiramate. It was a 60 day supply and I'm still currently using it. I have a follow up appt to follow up with neurologist on May 3rd. I've not had the headache symptoms. I had the second dose of the vaccine on January 7th, 2021.
53 2021-04-24 disorientation Severe dizziness/disorientation. Similar to vertigo due to inner ear infection.
53 2021-04-25 panic attack By 3pm a migraine occurred. Migraines continued to cycle for the whole week. Around 4pm-5pm the day ... Read more
By 3pm a migraine occurred. Migraines continued to cycle for the whole week. Around 4pm-5pm the day of the shot a minor panic attack occurred for about 30 min. No medications were taken for panic attack. Nurtec and Excedrin was taken to deal with migraine attacks along with sleep during course of the week. I was unable to maintain other routine doctor appointments that week as a result.
53 2021-04-26 agitation, anxiety Client advised staff that he was feeling faint. Client was given cold water and was seen by EMT. C... Read more
Client advised staff that he was feeling faint. Client was given cold water and was seen by EMT. Client was red/flushed and seemed dizzy. Client also advised that he was very anxious and worried. Client seem to staff to be very agitated. Nurse suggested deep breathing to calm client. Client was kept in observation for another 10 min.
53 2021-04-28 impaired work ability two days after receiving vaccine arm became really swollen. On day 3 pt. had slight headache which c... Read more
two days after receiving vaccine arm became really swollen. On day 3 pt. had slight headache which continued. On 4/25/21, headache became worse and on 4/26/21 pt. checked BP and noticed it was rising. On 4/26/21 pt. was sent home from work. Pt. was taken to Urgent Care that evening where BP was recorded as 205/89. Pt. was given unknown shot and instructed to take Ibuprofen. on 4/27/21 pt. followed up with PCP, who prescribed Hydrochlorothiazide daily and Norco prn for pain. On afternoon of 4/27/21 after taking HCT and BP remained elevated at 190/93. Pt. instructed to go to ER. Per wife upon arrival to hospital BP was 129/90. On the morning of 4/28/21 BP was down slightly to 189/90's
53 2021-04-30 excessive sleepiness Fatigue; Sleeping 10-12 hours most nights; felt cold (not chills); This is a spontaneous report from... Read more
Fatigue; Sleeping 10-12 hours most nights; felt cold (not chills); This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm, on 23Mar2021 at 14:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypogammaglobulinemia immunoglobulin A (IGA) (no IGA present in blood). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C), vitamin D (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12), and naproxen sodium (ALEVE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fatigue, sleeping 10-12 hours most nights, and felt cold (not chills) on 25Mar2021 at 09:30. The events were reported as non-serious. The events were described as: The fatigue set in about 36 hours (as reported) after the vaccine and the patient has been fatigued for 6 days. He has been sleeping 10-12 hours most nights and each day gets a little better. He has felt cold (not chills) and so has been wearing additional clothes, blankets at night and turned up heat in the house. The patient did not receive any treatment as a result of the events. The clinical outcome of fatigue, sleeping 10-12 hours most nights, and felt cold (not chills) was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
53 2021-05-03 feeling abnormal Was ?sick? for 9 days after receiving the Covid shot: Doesn't feel right, Covid Brain, felt like ba... Read more
Was ?sick? for 9 days after receiving the Covid shot: Doesn't feel right, Covid Brain, felt like back of brain was swelling and shaking and would get a head rush when bending over. Felt like he had radiation in his blood like there was amphetamines in it, ?edgy?, fatigue, sleepy. Denies fever or muscle aches. Went to the ER on 4/4 or 4/11 not for sure on date. They didn't do a COVID test and diagnosed him with depression due to his dog dying and divorce.
53 2021-05-04 insomnia Strong chest pressure; fluctuating heartbeat; slower breathing and respiratory response; slower brea... Read more
Strong chest pressure; fluctuating heartbeat; slower breathing and respiratory response; slower breathing and respiratory response; Extreme fatigue; very low energy; Loss of appetite; loss of weight; Abnormally wide fluctuation of blood pressure while not exerting myself; Difficulty relaxing and sleeping; Nausea; dizziness; Stomach pain; diarrhea; Headaches; low grade fever; shortness of breath; intense , powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of my head at the cerebellum.; intense , powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of my head at the cerebellum.; sudden increased heart rates and high blood pressures reading; spikes his heart rate/sudden increased heart rates; intestinal discomfort/strong stomach discomfort; intense chest pressure and some pain; This is a spontaneous report received from a contactable consumer (the patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151) via an unspecified route of administration in right arm on 09Apr2021 12:30 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included high cholesterol, anxiety disorder, known allergies: Clonazepam (KLONOPIN), food allergies: sea bass and orange roughy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication from an unspecified date; lovastatin taken for an unspecified indication from an unspecified date; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified date; ibuprofen taken for an unspecified indication from an unspecified date; fluoxetine hydrochloride (PROZAC) taken for an unspecified indication from an unspecified date. The patient previously took the first dose of BNT162B2 (Pfizer Covid-19 Vaccine, lot number EP7534) via an unspecified route of administration in right arm on 18Mar2021 11:00 AM at age of 53-year-old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was currently 11 days out from receiving his second COVID vaccine and he was still having very strong side effects. This included an emergency room visit on 16Apr2021. He was generally very good health and he exercised regularly including running so these were very abnormal effects for him. Beginning one day after receiving his second dose of the Pfizer vaccine for COVID-19: 1. Strong chest pressure and fluctuating heartbeat. 2. Slower breathing and respiratory response. 3. Extreme fatigue & very low energy (for example, walking up two flights of stairs made him very tired and spikes his heart rate, abnormal for him). 4. Loss of appetite and loss of weight. 5. Abnormally wide fluctuation of blood pressure while not exerting himself. For example, higher blood pressure readings (155/95) with a slower pulse (60) or the opposite scenario, (110/89) elevated pulse 98. 6. Difficulty relaxing and sleeping. 7. Nausea and some dizziness. 8. Stomach pain and diarrhea. 9. Headaches. 10. Low grade fever. As of 26Apr2021, it stated the day after the patient received his 2nd dose of the Pfizer Covid-19 vaccination (10Apr2021 12:00 PM), he began to have side effects which he expected to some extent. However, as of today, he has 17 days straight of side effects or perhaps an adverse event. His symptoms began mildly the day after but suddenly increased greatly within the next couple days and he had been dealing with this ever since. He had made two emergency room visits, seen his general practitioner, and as of today (26Apr2021) a cardiologist who ordered imaging. His symptoms range from, extreme fatigue, nausea, strong stomach and intestinal discomfort, weight loss, shortness of breath, sudden increased heart rates and high blood pressure readings, intense chest pressure and some pain, powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of his head at the cerebellum. His life was basically come to a screeching halt and he was searching for answers! The doctors he had spoken to were unclear as to what was wrong with him and why. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for the events. COVID tested post vaccination on 17Apr2021 included PCR and Nasal Swab, both showed negative result. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-05-04 insomnia Arm swollen, pain in arm, cold chills back pain arm pain right toes hurt fatigue could not sleep tir... Read more
Arm swollen, pain in arm, cold chills back pain arm pain right toes hurt fatigue could not sleep tired dehydrated sleepy shoulder pain bruising at injection site. Waiting for side affects to subsidize before seeking medical attention
53 2021-05-04 nervousness Patient stated he felt dizzy after injection. Had the patient take slow deep breaths. Patient began ... Read more
Patient stated he felt dizzy after injection. Had the patient take slow deep breaths. Patient began to lightly shake, then patient was unresponsive with blank stare. Pt clammy, pale, and diaphoretic, Pt transferred via w/c and taken to medical monitoring.
53 2021-05-04 thinking abnormal, mental impairment, feeling abnormal, amnesia Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thin... Read more
Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Not comprehending; He was very cold; Very tired; Very Sweaty; Headache; This is a spontaneous report from a contactable consumer (Patient's wife). A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 12:30 (Lot Number: EW0164) as SINGLE DOSE (at age of 53 years old) for covid-19 immunisation. Medical history included ongoing epilepsy diagnosed with this when he was 15 years old, seizure from an unknown date and unknown if ongoing (then at 2015 he had a seizure). Concomitant medications included levetiracetam (KEPPRA) 1250 mg, daily (250mg; 5 pills a day) taken for epilepsy from an unspecified start date and ongoing; carbamazepine (CARBAMAZEPINE) 1000 mg, daily (200mg; 5 pills a day) taken for an unspecified indication from an unspecified start date and ongoing. Family Medical History Relevant to events was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 19Apr2021, the patient experienced seizure, Very foggy, not thinking properly, repetitive in what he was saying, very distant, like he was looking at his wife but not seeing her or hearing her, Headache, He was very cold, Very tired, Not comprehending, Very Sweaty, No recollection of anything that happened between 2000 and 2100 hours. The patient received his vaccine yesterday 19Apr2021 at 1230. On 19Apr2021 by 1500 he was very foggy, not thinking properly, and repetitive in what he was saying. He was very distant, like he was looking at the consumer but not seeing her or hearing what she was saying. He was very cold, very tired, and not comprehending. Then at 2015 he had a seizure. She called the paramedics, her husband was very sweaty on 19Apr2021 and that point and had no recollection of anything that happened between 2000 and 2100 hours. Patient was not taken to the Emergency Room or admitted to the hospital. Her husband is completely aware and recovered now. Consumer reported on 19Apr2021 he had a headache that is persisting since the seizure. The consumer reported that her husband is epileptic, but he hasn't had a seizure in over 10 years and hasn't missed any doses of his medication. Patient was evaluated by the Paramedics that came to his home but was not taken to the Emergency Room. Relevant Tests were none. Outcome of Seizure was Recovered/Resolved with Sequel on 19Apr2021. Outcome of Very foggy, not thinking properly, repetitive in what he was saying, He was very cold, Very tired, Not comprehending, Very Sweaty was recovered on 19Apr2021. Outcome of headache was not recovered. Outcome of No recollection of anything that happened between 2000 and 2100 hours was unknown.
53 2021-05-10 feeling abnormal, impaired work ability I had Covid-19 back in December 2020. On the 10th day I ended up in the hospital for 3 days due to t... Read more
I had Covid-19 back in December 2020. On the 10th day I ended up in the hospital for 3 days due to the start of Covid pneumonia. It took me two months to finally feel 100%. I had my 2nd vaccination shot on Friday 5/7/21, I was sick Saturday with a fever of 101.5 and joint pain in fingers, hands and knees and slept all day. The adverse event happened on Sunday. I was still very tired during the day but no fever and felt like I was in a fog. Sunday evening went to bed at 9:30pm woke up at 11:30pm with uncontrollable body tremors. The tremors were muscular twitches from my neck to my feet. Everything was twitching at once. My fiance took my temperature and it was 97.5 so no fever when it started but after 45 minutes of tremors I started burning up, she took my temp again and it was 103.5. She wanted to call 911 or take me to the emergency room but I didn't want to go at that point. I took a baby aspirin thinking about possible blood clots and then 30 minutes later took 2 Tylenol to bring down the fever. The tremors finally stopped and the fever went down to 101. It took me a while to fall asleep and the next morning I woke up still tired and called out of work and slept all day again.
53 2021-05-10 insomnia, feeling abnormal, loss of personal independence in daily activities, sleep disorder This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162... Read more
This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162b2 (COVID-19 VACCINE, lot number: EN6203; expiration date: Jun2021), dose 1 via an unspecified route of administration on 27Feb2021 18:00 as single dose for covid-19 immunisation. Medical history included ongoing lyme disease. There were no concomitant medications. The patient went through post- vaccination especially because he has Lyme disease. He has had this pre-existing autoimmune disease for 8, almost 9 years, he wants to add this information to the database. Caller states the first shot he would say was kind of catastrophic, the second shot, he will go into. Caller states the second shot, he showed up at the military vaccination place locally and they actually declined his ability to get it with them because of his first reaction even though he had the go ahead from his Lyme specialist and primary doctors. Caller states because of this, he went after four weeks instead of three and he went to a high risk clinic to protect him from anaphylaxis. He has received both doses, the first dose was horrendous and the second was quite easy. Caller states no reaction whatsoever with the second, though he still has remaining symptoms. Reporter Details: Caller states his legal name is (Name), he goes by (Name). Caller states he would prefer if company contacted him and also so that maybe they can warn people with autoimmune or Lyme that the first one is going to be kind of rough. Caller states he works with the public. Prescribing Healthcare Professional: Caller states unsure of email address. Caller states the only thing missing off the initial story is that all in all, the second shot was really good. Caller states he does have some very lingering issues still that he is going to be seeing the Lyme specialist about. Caller states the first dose, it's pretty intense. Caller states the second one, he had fatigue and neuropathy from the stupid autoimmune stuff. Caller states there is residual symptoms, but nothing like the initial ones. Caller states what he did was he just jotted some notes down about every third or fourth day up until the second shot just to detail each symptom. Caller states he only wrote about 5 days worth of little sentences. Caller states 27Feb2021, the first dose, it was a Saturday so by Monday 29Feb2021, it started with itching, burning rashes, so like a visible rash on his chest with raised bumps, neuropathy- shooting pains in his fingers and toes that feels like bugs are crawling all over him, headache, fatigue, and dizziness. Caller verifies all of these symptoms actually began on 01Mar2021. Itching, burning rashes: Caller states he would say they lasted about 2-3 weeks because he went to the walk-in to have them check and called his primary doctor and went into his primary and had him check. Caller states it ended sometime in Mar2021 and he has recovered completely. Neuropathy: Shooting pains in his fingers and toes: Caller verifies it began 01Mar2021. Caller states he would say he still has about 20% left. Caller states it is hard to sleep at night because he still gets itching and burning and stuff. Caller states it is persisting, but certainly not as bad. Headache: Caller verifies it started 01Mar2021. Caller states it ended Mar2021 and has recovered completely. Fatigue: Caller states began 01Mar2021. Caller states this is one of the bad ones he would say. Caller states he still, he would like to go for a walk or work out and he barely has the amount of energy to work let alone the others. Caller states he can't workout or walk. Caller states if he goes up and down stairs, he's exhausted. Caller states that's definitely a lasting one. Caller verifies it is ongoing, persisting. Dizziness: Caller verifies it began on 01Mar2021 and is ongoing. Caller states when he walks he literally cannot turn his head quickly or he feels like he's going to throw up or pass out. Caller verifies it is persisting. Caller states he would say about 4 or 5 days later from getting the first shot, this was really interestingly weird, he had mouth sores that wouldn't heal and debilitating malaise and fatigue. Caller states malaise so bad he couldn't get through work, he could barely work. Caller states the mouth sores were so weird. Caller states everything he is telling company he has read about online. Caller states he has had canker sores from low immunity, but this was on the tip of his tongue, either side of the tongue tip, it came and went three or four times through the entire month. Caller states it was like his immune system was on the edge of crashing, then he would sleep a lot more. Caller states he would do whatever he could do to make it come back. Caller verifies this debilitating fatigue is different than overall fatigue that began 01Mar2021. Caller states the debilitating malaise began 04Mar2021 or 05Mar2021. Debilitating Fatigue; Debilitating Malaise: Caller states the debilitating fatigue also began 04Mar2021 or 05Mar2021. Caller states it is acute. Caller states ended sometime in Mar2021. Caller states recovered completely but is still left with some fatigue. Caller states recovered with lasting effects maybe. Caller says the other one, he could barely get up, he could barely work, he literally couldn't function. Caller states the overall fatigue has not left, it's ongoing. Mouth sores that won't heal: Caller states began around 004Mar2021 or 05Mar2021 and stopped sometime in Apr2021, it took about a month. Caller states he recovered completely. Caller states he just wrote what happened down about every 2 days up until 14Mar2021. Joint Pain: Caller states literally every single joint in his body was killing him and felt inflamed. Caller states it began around 03Mar2021 or 04Mar2021. Caller states joint pain is ongoing, but has improved. Air Hunger, shortness of breath upon exertion: Caller states if he went up and down a few stairs, he would breathe almost as if he was having an asthma attack, it was shortness of breath upon exertion and started about four days after. Caller states it began around 05Mar2021. Caller states he actually had it this morning, felt like he just walked up a flight of stairs. Caller states he is very physically fit, so that should not happen. Caller states it's ongoing and has improved. Numb Extremities: Caller states a week later from 01Mar2021 he had numb extremities. Caller states he started being very aware of the fact that his fingers and toes were starting to lose feelings on 08Mar2021. Caller states it resolved within a week on 15Mar2021. Caller states it was a weird sensation that happened for a while but is completely resolved now. Body Temperature Regulation Issues: Caller states two days later, he had body temperature regulation issues. Caller states he was cold when he should have been hot and hot when he should have been cold. Caller states began around 03Mar2021/04Mar2021 and is ongoing, but not terrible, it's probably the least of the issues and has improved. Heart was pounding out of his chest; face was flushed: Caller states a day or two later, his heart was pounding out of his chest and his face was flushed to the point where people were asking if he was okay. Caller states he felt like he got a quick burst of a run and then stood still. His face was visibly red and very aware of his heart beating out of his chest and this is with no exertion. Caller states he was laying on the couch and he could feel his face flush while doing nothing basically. Caller states began 02 or 03Mar2021 and just stopped a week ago around 12Apr2021. He recovered completely, for now, it seems. Caller states he went to (Clinic name) on (Address), he doesn't have the doctors name, it was a walk-in. Caller states they literally said no big deal, it's all side effects of the vaccine, they just said he's fine. Caller states they simply recommended anti-inflammatories, Tylenol, which was smart and he wishes he thought about it. They also recommended Benadryl to stop the reaction. Caller states it was very helpful, the Benadryl really helped a lot. Caller states there was also a good amount of insomnia because of all the symptoms, it would be close to impossible to sleep. Insomnia: Caller states it seemed to get worse, started a week later because it was getting disconcerting to him so he couldn't sleep. Caller states it started 08Mar2021 and have had that on and off with Lyme. Caller states has struggled for years, is ongoing and is persisting. Caller states on 14Mar2021, he couldn't sleep, couldn't get out of bed, completely weak and dizzy, his left leg and quad was spasming like when he had Lyme's, left knee itches, tingles, and burns and that's where he got bit by the tick and that's when he had his symptoms when he was acute. Caller states it resolved within 3 weeks after the initial onset of the shot. Caller states when he had Lyme initially, that's what he experienced, his left knee swelled, burned and itched, his left knee cap. Caller states ended 17Apr2021. Caller states its a situation where some of those are still there because of Lyme and some are gone. Caller states the knee cap stuff and can't get out of bed was gone on 17Apr2021. Caller states he has recovered completely. Caller states he still is weak and dizzy and his left leg and quad are still spasming, but it's better and is improved. Caller states on 20Mar2021, his left knee cap hurt, was twitching and tight, his left toe was numb, felt like something is chewing on his toe with a sensation of worms under the skin and sleep disturbances. Caller verifies the sensation of worms under the skin and something chewing on his toe is all related to neuropathy, which is still there. Caller states he had written down that on 20Mar2021, he was supposed to get his second shot at 1800, but was denied due to side effects he was experiencing and was rescheduled for 31Mar2021 at a local high-risk clinic. Caller states on 22Mar2021, he slept good, but was fairly weak all day. caller states he took a shower mid-afternoon, and couldn't get off the couch. Caller states basically all he did was take a shower and threw himself on the cough the whole day. Caller states he has written that he has the sensation of ants crawling over the top of his back, no desires to go outside, and light sensitivity. Caller verifies the ants crawling over the top of his back was also neuropathy, and he recovered completely within 3 weeks. Light Sensitivity: Caller states throughout the whole thing, had it today and is still ongoing and persisting. Caller states began sometime in Mar2021, its been the whole time. Caller states 28Mar2021, he only slept 6 hours and woke up completely fatigued, could not get out of bed until 2:00 in the afternoon, has a complete loss of appetite, had a drink and 2 eggs and laid down, couldn't move until 1930. Caller states got up, had a nutrition shake, he wasn't desiring solid foods whatsoever, had 100% malaise, fatigue, no appetite, and was dizzy. Loss of appetite: Caller states he has lost 7 pounds since the first shot. Caller states he wasn't really interested in eating. Caller states he has a natural desire to eat and nothing sounded good. Caller states started Mar2021, is ongoing, and has improved. Caller states 31Mar2021, he got the second shot, he had a little bit of irritation, tingling and burning at site and definitely a flushed face throughout the day, almost like a sunburn. Caller states he was joking with clients and said the first shot killed him and the second shot cured him. caller states after the second shot, he is 80% better but can list the remaining symptoms. Caller states what he is left with is fatigue, he does not have any energy to do anything other than work, sleep issues, neuropathy, and dizziness. Dizziness: Caller states the dizziness has been consistent and goes with the sleeplessness, ongoing since Mar2021 and is persisting. Irritation, tingling, and burning at injection site: Caller verifies the irritation, tingling, and burning is at the injection site of the second dose. Caller states it happened within a few hours on 31Mar2021 and resolved within a week on or around 07Apr2021. Covid Vaccine: First Dose: Caller verifies he received the injection in his left arm around 1800. Caller unsure of NDC. Covid Vaccine: Second Dose: Caller verifies he received the second dose on 31 Mar2021. LOT: ER8730, Expiry Date: They didn't write that down so caller unsure. NDC: Caller unsure of NDC. Caller unsure of dosage given. Caller states was given via injection in his right arm around 1300 or 1330. Covid Vaccine: Indication: Caller states first off he owns a business, he did it to be responsible to the public. Caller states he wants his business to appear as safe and compliant as possible. Caller states he definitely was afraid because of the Lyme disease. Concomitant Products: Caller states he made sure he did nothing before purposefully. Test Results: Caller states after the first shot, he went to (Name) family physician, they did a lot of blood work trying to make sure his inflammatory markers weren't going up, to make sure he wouldn't have issues. Caller states the good news was he was great, everything looked normal, there was nothing crazy in the blood work. Caller states they though the shots would have triggered an autoimmune response of Lyme. Muscle/Joint: He reports a bit of muscular/joint pain in the area where the shot is, if he goes to reach The outcome of the event "itching, burning rashes, like a visible rash on his chest with raised bumps", "headache", "can't workout or walk", "exhausted", "immune system was on the edge of crashing", "immune system was on the edge of crashing", "face was visibly red" was resolved in Mar2021; the outcome of the event "debilitating malaise" was resolved with Sequel in Mar2021; the outcome of the event "Numb Extremities" was resolved in 15Mar2021; the outcome of the event "mouth sores" was resolved in Apr2021, the outcome of the event "face was flushed" was resolved in 12Apr2021; the outcome of the event "couldn't get out of bed" "left knee itches, tingles, and burns" was resolved in 17Apr2021, the outcome of the event Back disorder was unknown, the outcome of the event "complete loss of appetite", "Joint Pain", "Body Temperature Regulation Issues", "barely has the amount of energy to work let alone the others/Weak" was resolving, the outcome of the other events was not resolved.
53 2021-05-12 anxiety CHILLS, VERY SHAKY, ANXIETY, VERY TIRED. All began within four hours of injection. Worse 10 hours... Read more
CHILLS, VERY SHAKY, ANXIETY, VERY TIRED. All began within four hours of injection. Worse 10 hours later Have been persistent the last 48 hours.
53 2021-05-18 sleep disorder I have a tooth filling needed to be replaced. After vaccination the pain in my tooth pain which is n... Read more
I have a tooth filling needed to be replaced. After vaccination the pain in my tooth pain which is normally non existent went to a 10. For 2 days I couldn?t sleep or be in a prone position. 800 mg ibuprofen and Tylenol. After that back to normal. 2nd dose is scheduled tomorrow and dentist next week.
53 2021-05-19 loss of personal independence in daily activities About 7 hours after my shot I experienced tingling and radiating pain down my left arm from my shoul... Read more
About 7 hours after my shot I experienced tingling and radiating pain down my left arm from my shoulder to wrist. In the two weeks since my shot my symptoms are getting worse, not better. I used to be able to do two sets of 50 push-ups and I can no longer do one push up. I used to be able multiple sets of 15-20 pull ups for a total of 50 in a couple of minutes. I can no longer do one. I enjoy golf and can no longer play .
53 2021-05-21 excessive sleepiness This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in arm left on 08Apr2021 14:30 (batch/lot number EW0153 and expiry date unknown) at 53 years of age as 1st dose, single for COVID-19 immunization in other facility. Medical history included known allergies many but did not react to vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included meloxicam, omeprazole, levocetirizine; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that he was quite sick after the 1st dose and he suffered from exhaustion and sleeping 15 to 17 hours a day, and a heavy cough, and a minor sinus pressure, for the first 2.5 weeks after the 1st dose. The patient noticed a very faint high pitch in his ears a few days before the 2nd shot but dismissed it as an aberration. The adverse events were reported serious which caused disability or permanent damage. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
53 2021-05-21 loss of personal independence in daily activities 4/22/21 about 1:55 pm I got the shot, 2:45 got a bad headache, dizzy, feeling flush and upset suma... Read more
4/22/21 about 1:55 pm I got the shot, 2:45 got a bad headache, dizzy, feeling flush and upset sumac I left work at 4 pm and when home. around 6 pm i started to get joint pain in my arms, legs and hip. by 730 pm I got the chills, shivers and got extremely tired. I when to bed around 8 pm and woke up around 730 am on 4/23/21. I felt like I was cold till Sunday (4/25/21), The headache remained till Wednesday (4/28/21). I don't know if this is related but I would like to provided the information. Prior to the shot my blood press was between 112 to 120/ 70 to 80. after the shot my blood pressure has been 140 to 150/ 80 to 93. am monitoring my blood pressure, adjusting my diet & trying to start a exercise regiment to address the blood pressure. I did have a epatch right before the shot from 4/19/21 to 4/22/21. .
53 2021-05-25 disorientation Caller reports he had stool that was not fully formed/his stool was liquidy/close to diarrhea; pain ... Read more
Caller reports he had stool that was not fully formed/his stool was liquidy/close to diarrhea; pain in the arm; Double Vision , massive headaches; Double Vision , massive headaches; Achy and tired, like exhausted after the 2nd shot; Pain at the injection site.; achy/He was achy from joint pain; crampy; He was a little achy and had a headache after the second shot; double visions very disorienting; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Injection, Batch/lot number: EWO158, expiration date: Jul2021) at left deltoid, in his shoulder on 28Apr2021 15:00 PM at second dose, 0.3 ml single for COVID-19 immunization. Medical history included overweight. Concomitant medication was none. the patient not received other medications within 2 weeks of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received first dose of covid vaccine (Lot number: EWO158) at Arm Left on 07Apr2021 15:00 PM for COVID-19 immunization and experienced diarrhea (since the first dose), worst headache of his life, Pain at the injection site, pain in the arm. Patient experienced double Vision and massive headaches, both on 05May2021 10:00 AM. patient had double vision about a week after the second dose of Pfizer COVID-19 vaccine (Also reported about 15 minutes after the 2nd COVID Vaccine, pending clarification), he read many times people saying it could be such neurological and/or blood clotting, reporter asked if people died from the vaccine. Caller stated he is overweight and afraid of this possible side effects affecting him even more than COVID-19 infection. He asked what about bowel movements or gastrointestinal side effects. He has had close to diarrhea for about 2 weeks now, since the first dose. Caller stated he does not have a Physician. Patient also reported the Headache after the 2nd vaccine was on 28Apr2021. patient reported he is getting a call. Never mind caller is letting it go to voicemail. Caller reports he was distracted but, he is better now. Caller reports he does not get headaches or neurological issues at all, usually. But after getting the 2nd shot, about a week ago from yesterday, he experienced double vision for about 15 minutes. When he got the 1st shot, the Monday after, he experienced the worst headache of his life worse than any hang over. He never had neurological issues and it terrified him because could not shake it right away, it lasted for about 15 minutes then it was gone. He asked if that is something that is a side effect that could be concern and should he be worried about it. Caller reports double vision for 15 minutes. He got the shot at about 10 am. This happened after the 2nd shot. He got the second shot on 28Apr2021. Caller confirms his first shot was on 07Apr2021. Double Vision: It lasted for about 15 minutes and he waited until it came back. It was scary. The double visions very disorienting, he couldn't see anything, he could not work, he could not do anything. For the double vision he just waited it out, by shutting his eyes and laying his head down, it did not work the first few moments but then it did. He was a little achy and had a headache after the second shot. He was achy from joint pain. He took Tylenol before he to went bed and the headache went away. After the first COVID vaccine he experienced the worst headache of his life: It was so bad it knocked him to knees he took Tylenol and it went away. Pain at the injections site, pain in his arm: Started right away after getting the 1st shot. He could not put weight on the arm or without feeling a little pain. After 09Apr2021 he did not notice much after that. Caller said he was achy all over after the first shot when mentioning the arm pain. He asked if this is all experimental right. He wants to find out as much as he can because he does not trust anything online or anyone that is why he called the source, which is Pfizer. Online there are reports from people against the vaccine and for the vaccine. Headache after the 2nd vaccine: He was achy, not as bad as the 12th. It went away on 29Apr2021 he took to some Tylenol before he went to sleep on 28Apr2021. and it went away in his sleep. The Tylenol took care of it. Achy and tired, like exhausted after the 2nd shot: Caller reports the event subsided on 01May2021. Gastro Issues: patient reports he had stool that was not fully formed, not diarrhea and not normal but, runny. It was not formed. He is feeling like he has to go after the second shot on 28Apr2021. It has not subsided yet, it is still kind of going right now. He is not rushing to the bathroom every 5 minutes, but its not comfortable, so its improved since the first time, he was very crampy and his stool was liquidy and now it is more solid, it is slightly improving. 1st Pfizer COVID vaccine Lot number: EW0158; zero maybe an O. he confirms both vaccines have the same Lot number as far as he knows. It is the same Lot on both cards he got. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for double Vision. Patient was recovered from double Vision on 05May2021, recovered from headache on 29Apr2021, recovered from Fatigue on 01May2021. Outcome of other events was unknown. It was reported as non-Serious, Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all reported as No. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-05-26 disturbance in attention I've been experiencing ear ringing from ear clogging to buzzing, hissing sounds. First it is starte... Read more
I've been experiencing ear ringing from ear clogging to buzzing, hissing sounds. First it is started in my left ear after few days of the first doze then the right ear. It started real bad after the second injection. Presently, the clogging ear state has diminished but the buzzing, hissing and cricket alike sounds yet present. This pulsatile emerging sounds of perhaps tinnitus, disrupts my personal life and to concentrate me at work.
53 2021-06-01 feeling abnormal THE PATIENT SAID HIS ARM WAS SORE THE DAY HE GOT HIS SHOT. HE SAID 2 TO 3 DAYS LATER IT BECAME REAL... Read more
THE PATIENT SAID HIS ARM WAS SORE THE DAY HE GOT HIS SHOT. HE SAID 2 TO 3 DAYS LATER IT BECAME REALLY SORE TO THE POINT OF HURTING. HE SAID HE HAS A PHYSICAL JOB AND HE COULD HAVE EASILY INJURED HIS SHOULDER AT WORK THE DAY HE GOT HIS VACCINE, BUT DOES NOT REMBER INJURING ARM/SHOULDER. THE PATIENT PRESENTED TO THE PHARMACY FOR HIS SECOND VACCINE (OVER A MONTH LATER) AND HIS SHOULDER IS STILL HURTING. HE SAYS IT HURTS WHEN HE LIFTS IT UP, IF FEELS WEAK, AND HE HEARS/FILLS A 'POP'.
53 2021-06-02 insomnia He was tired; Felt discomfort; Feel numbness and swelling in his toes and hands/feel a numbness on f... Read more
He was tired; Felt discomfort; Feel numbness and swelling in his toes and hands/feel a numbness on fingers of hand and feet; Feel numbness and swelling in his toes and hands; Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp; Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp; Inflammation in the stomach; Abdominal pain; Sometimes his blood pressure increases; couldn't sleep with the symptoms; He was not feeling well; He woke up with inflammation in his fingers and toes; This is a spontaneous report from contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8731 and Expiration date not reported), via unknown route on his right arm on 16Apr2021, (at the age of 53 years) as a 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8733 and Expiration date not reported), via unknown route in left arm on 26March2021, (at the age of 53 years) as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization. After the first dose patient had only pain in arm. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced to feel numbness and swelling in his toes and hands, began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensa-tion and transforms into a cramp, he also presents inflammation in the stomach and abdominal pain for which it has already been prescribed with acetaminophen that calmed his symptoms a little, when he gets wet with hot or cold water feels all the discomfort described previously, he had never felt such symptoms, the patient is concerned that sometimes his blood pressure increases. The patient describes the experience as something similar to an allergy to some food that holds up for a long time and feels that its symptoms have increased, the symptoms diminish when performing his normal activities, today he was unable to work because he woke up with inflammation in his fingers and toes. The patient states, that the timing was normal, he just had the pain as normal, like everyone else getting the vaccine at that time, but with the second it became stronger, but still common with everyone else. Then he started to feel them with much more frequency. Numbness on fingers of hand and feet: the second dose he felt that, alongside the abdominal pain, he was generally not feeling good. He took Acetaminophen and it decreased, when the medication is active, then he goes back to normal, and it increases. Tingling in back started at the same time. At the time it was like itchiness on the back, at that point he wasn't able to scratch but it was fine, then it became tingling that he was not able to get rid of. Inflammation in stomach started with the second dose. The first dose was no issue, he was feeling the same, second dose he had those symptoms. It increases when he drinks milk and stuff so he would say it's getting worse. Blood pressure rises sometimes: He had felt his blood pressure rise since the second vaccine, but it's normal during the day, it was tested and normal, he gets to exercise, that's fine, he has no issues with blood pressure before the second, but for example, early this morning, 12 in the morning to 6 this morning, he felt it was increasing, and he was tired and stuff. outcome normal, his blood pressure fine during day, he exercises, but he felt it early this morning, felt discomfort, he was uncomfortable and tired and now, normally it's fine, regular pressure. reported. The patient describes the experience as something similar to an allergy to some food that holds up for a long time and feels that its symptoms have increased, the symptoms diminish when performing his normal activities, today he was unable to work because he woke up with inflammation in his fingers and toes. After receiving the second dose of vaccination patient felt all these symptoms, took some medication, Acetaminophen because he was not feeling well, yesterday he couldn't sleep with the symptoms. He would visit his doctor after making the report. Patient was working for a pharmacy for 3.5 years. When asked for consent to contact, the interpreter was no longer on the line. Primary care doctor's declined, caller states he doesn't have a PCP, states he is a tourist now. Card has on the back the date, where vaccine was done, states he didn't take any medication; he is very healthy. He took Acetaminophen, clarifies as he took Tylenol (UPC unknown. Lot: SPA084, expiry is Oct2024; strength is 500mg), verified, and he just appreciates the help. Details for Vaccine Supplemental Form not provided by caller. Patient was working in supermarket with friends, they said they would vaccinate people, so he took advantage. The outcome of the events, numbness localized, feel tingling in his back, stomach inflammation, abdominal pain was not recovered, the event blood pressure increases was recovered on unknown date in 2021, the event couldn't sleep, Feel numbness and swelling in his toes and hands, Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp not feeling well, couldn't sleep with the symptoms, inflammation in his fingers and toes, he was tired, felt discomfort was unknown. Product complaint was filled: While providing and AE for the Pfizer COVID 19 vaccine, the caller states he had numbness on fingers of hand and feet: He takes Acetaminophen, later clarified as Tylenol, and it decreased, when the medication is active, then he goes back to normal and it increases. Follow up (26May2021): This is a follow up spontaneous report from contactable consumer. This 53-Year-old female consumer (patient) reported for herself new information included event detail, Batch/lot number was updated
53 2021-06-07 confusional state Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
53 2021-06-09 feeling abnormal numbness in his fingers/right leg went numb; fog brain; aches and pains; This is a spontaneous repor... Read more
numbness in his fingers/right leg went numb; fog brain; aches and pains; This is a spontaneous report from a contactable consumer (patient's parent). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) (at the age of 53-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included cardiac pacemaker insertion. The patient's concomitant medications were not reported. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (at the age of 53-years-old) for COVID-19 immunisation. The patient said that his son felt no real results from the second dose of COVID-19 vaccine shot but in 2 weeks his son had numbness in his fingers and what his son called fog brain. He said his son also had aches and pains and went to the Emergency Room. The caller said while in the Emergency Room, they drew blood from his son and couldn't find anything. He said his son has been to doctors and his son can't seem to get any help from his symptoms. He said yesterday, his son's right leg went numb. The caller said he was worried for his son and would like some medical help for his son. The patient's mother said they wanted information so her son won't die. The patient's father said his son had read a lot of people who received the COVID-19 vaccine and experienced side effects 2 weeks after the COVID-19 vaccine shot. The patient's father said it was almost exactly 2 weeks after his son received his second COVID-19 vaccine shot that his son experienced his weird problems. Outcome of events was unknown. Information on the lot/batch number has been requested.
53 2021-06-14 feeling abnormal Nearly constant headache, back of head, almost a buzzing sensation
53 2021-06-16 loss of personal independence in daily activities Breathing Issues, shortness of breath, fatigue, that has gotten progressively worse. I was an active... Read more
Breathing Issues, shortness of breath, fatigue, that has gotten progressively worse. I was an active and healthy person and have been unable to do normal activity and exercise since receiving my second vaccine.
53 2021-06-17 impaired work ability No effects on first shot in left arm for the Pfizer. Second shot had a lot of muscle aches and pains... Read more
No effects on first shot in left arm for the Pfizer. Second shot had a lot of muscle aches and pains especially on the left side and a headache for about a day and a half. Bad enough to miss work.
53 2021-06-18 loss of personal independence in daily activities Fever; It has not worsened but he cannot go to work; This is a spontaneous report from a Pfizer spon... Read more
Fever; It has not worsened but he cannot go to work; This is a spontaneous report from a Pfizer sponsored program (CEP ID: 159558). A contactable 53-year-old male consumer (patient) reported that: A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EWO186), via an unspecified route of administration, administered in Deltoid Left (reported as left shoulder) on 13Jun2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation (reported as because everybody should take it). The patient's medical history and family medical history relevant to adverse event was reported as none. There were no concomitant medications. No prior vaccinations within 4 weeks. The patient previously received flu shot (unspecified manufacturer) on an unspecified date and experienced itches and fever (anytime when he has the flu shot he had a fever). On 14Jun2021, midnight around 01:00, the patient experienced fever and was suffering. It has not worsened but he cannot go to work. He can't make it to work. It was persisting and staying the same. The patient did not receive treatment and stated he was calling to get treatment for fever. The outcome of event fever was not recovered and the outcome of other event was unknown. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-06-29 restlessness Lethargy; Mild headache; chills; Mild soreness; Restlessness followed; This is a spontaneous report ... Read more
Lethargy; Mild headache; chills; Mild soreness; Restlessness followed; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via unspecified route of administration in the right arm on 16Mar2021 at 09:45 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. The patient had no medical and known allergic history. Concomitant medication included glucosamine (MANUFACTURER UNKNOWN), one a day for men at the age of 50 plus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient had experienced mild soreness, 11 hours later at 22:00 severe chills which were strong enough that the patient could not carry a glass of water without spilling it and restlessness followed. On 17Mar2021, next day the patient experienced lethargy and mild headache which continued in the evenings for 2 days. The Patient did not receive any treatment for the events. Event had not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcomes for the events chills, was recovered on 17Mar2021 at 02:00, lethargy and mild headache were recovered on 19Mar2021, restlessness and soreness were recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
53 2021-07-01 insomnia Shortness of breath; Tightness in the chest; Loss of taste; Elevated blood pressure; Back pain; diff... Read more
Shortness of breath; Tightness in the chest; Loss of taste; Elevated blood pressure; Back pain; difficulty sleeping; Extreme fatigue; headaches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG6208), via an unspecified route in left arm on 11Mar2021 at 12:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypertension. The patient had past drug allergy with ibuprofen. The patient received other medications (unspecified) within two weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021, the patient experienced extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure. No treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent nasal swab test on 22Mar2021 and test the result was negative. The clinical outcome of extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure was not resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
53 2021-07-09 confusional state, anxiety Dizziness, difficulty breathing, body aches and pains, fluctuating heartbeat ,anxiety, loss of taste... Read more
Dizziness, difficulty breathing, body aches and pains, fluctuating heartbeat ,anxiety, loss of taste and appetite, confusion, Symptoms have been lasting almost a month,
53 2021-07-11 impaired work ability Within 12 hours, I felt tiredness, fatigue, body was weak. I had loss of appetite. Ran a low grade f... Read more
Within 12 hours, I felt tiredness, fatigue, body was weak. I had loss of appetite. Ran a low grade fever. The cough started 2 days after the vaccine was given. With each day, I felt worse, finally on 5/28/2021, I went to the walk in clinic. They took my vitals and wheeled me to the ER. I had a fever of 101.38, elevated heart rate, high BP. nausea with an upset stomach. Several test were run on me at this time. The ER Dr. said I would feel bad for a week or so, and was put off work for 1 week and a half. My cough got worse each day and I kept that cough for about 4 weeks. The ER Dr. said I should follow up with my regular Dr. I seen Dr. 2 different times during the next few weeks.
53 2021-07-17 feeling abnormal He got chills; problems breathing; Got Covid after receiving the Covid vaccine; felt bad; missed sec... Read more
He got chills; problems breathing; Got Covid after receiving the Covid vaccine; felt bad; missed second vaccine dose; Asthma; Cough; felt crappy; This is a spontaneous report from a contactable consumer (patient), from Pfizer sponsored program. A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0150, Expiration Date: 31Jul2021), via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 53-year-old) as dose 1, single for covid-19 immunisation. Time of the vaccination given was 12 or 1:00 PM. The patient's medical history included diagnosed allergies, obese, hand was beginning hurt, carpal tunnel. Concomitant medications include allergy shots started on an unspecified date of 2019 for allergies. No additional vaccines administered on same date of the pfizer suspect. No prior vaccinations received within 4 weeks. 3 days later after receiving the Covid vaccine he got Covid on the 10Apr2021 and was diagnosed positive on the 11Apr2021. HCP advised to wait 2 months and start over with the first vaccine. No clinics want to do that. He went to two locations and they don't want to give him the first vaccine. They only want to give him the second dose. He went to the clinic and they were going to give him a second dose, but he was wanting to know if that was ok or if he would have to start all over. Patient wants Pfizers recommendation. He was way past 21 days. The patient stated he would want to start over if they don't know how good the second vaccine was if given that late. Patient was asking that this Pfizers recommendation. According to the CDC they are not allowed to give him three vaccines. He was not asking for three. He had to start over because this happened. They said they don't care, and they would just give him the second. He said he told them no and that his doctor told him that he needs to start again. They told him they don't care what his doctor says and that they know more than him. He figures he would go directly to the manufacturer and see what Pfizer says. Pfizer will know the vaccine better than anyone else, his doctor or the pharmacist. Whatever Pfizer tells him to do, he will do. He had been taking for allergy shots two years or a year and a half because they closed the offices for Covid and then his serum expired so he was going to have to restart again this year, name of shots unknown. Patient was taking Covid 19 vaccine to protect self and family, he doesn't want to die. End date of adverse event lasted until the 20Apr2021 according to the state. But he felt crappy for still another week and gives you ten days quarantine. For another week he was still coughing and having problems breathing which kind of still lingers, he still had it. He had asthma he guesses now. Asthma was diagnosed, but now they are saying it may be cardio. The patient stated he had recovered with lasting effects. He had never had asthma in his life until after the vaccine. Now they are saying it may not be asthma, it could be cardio. So, he was going through tests right now. With physical activity he gets out of breath and the only thing that does help was his inhaler. His inhaler does help him for now. He thinks he missed his second dose in Apr2021. He got chills. Everything happened in Apr2021. Cough Came on the second week. It was the week of 12Apr2021. It was three weeks after his first one. Maybe the 21Apr2021 or 28Apr2021. The patient stated it was still ongoing, but he had recovered with lasting effects. The patient stated he was definitely not recovered. It was not everything so he ok with the rest of the stuff. It was just the breathing that was still there breathing issue began on Mother's Day. It was the first time he noticed it. He went for a bike ride and he felt it again maybe two weeks after and since then he hadn't done any physical activity. He was trying to avoid it. Patient The patient stated he does tech support and for a living and was really thorough. It was good, but his hand was beginning hurt and he had carpal tunnel. He started feeling bad on the 10Apr2021. It started then, a week after his first effect. It was 15Apr2021 or 17Apr2021. He was feeling bad until 24Apr2021 or 25Apr2021. Maybe even 01May2021. He was feeling crappy for about a week and then he started to walk around his backyard, and he was having trouble breathing, but he knew he had Covid. They are possible cardio issue, and they are testing but there was nothing concrete. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 11Apr2021. Description of product complaint of Pfizer Covid Vaccine includes patient clarifies he got Covid three days after the vaccine dose 1. He got the vaccine 07Apr2021. He needs to take a picture with his phone because the sticker was so small. Then 10Apr2021 was when he got Covid. The outcome of the event COVID-19 was resolved with Sequel on 20Apr2021, outcome of events asthma, problems breathing, cough was not resolved, event felt crappy was resolved with Sequel on an unspecified date and unknown for other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021814814 similar report from same reporter
53 2021-07-17 feeling abnormal Breathing Issue/problems breathing; Felt bad/crappy; Got Covid after receiving the Covid vaccine; As... Read more
Breathing Issue/problems breathing; Felt bad/crappy; Got Covid after receiving the Covid vaccine; Asthma; Cough; He got chills; hand is beginning hurt; Height shrank he thinks; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0150 and expiration date was 31Jul2021) via an unspecified route of administration, administered in arm left on 07Apr2021 at 12:00 or 13:00 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation. Patient did not receive other vaccinations within 4 weeks prior to vaccination. Medical history included diagnosed allergies (allergy shots from 2019 to unknown date), according to the thing he was obese, and carpal tunnel. No family medical history reported. Concomitant medications included unspecified allergy shots for allergies (he had been taking for two years or a year and a half because they closed the offices for Covid and then his serum expired so he was going to have to restart again this year). The patient did not receive any vaccine prior vaccinations (within 4 weeks). The clinical course of the events was reported as: he got his first dose on 07Apr2021 and six days later he ended up getting Covid. His healthcare provider advised him to wait two months. He went to the clinic and they were going to give him a second dose, but he was wanting to know if that was ok or if he would have to start all over. He went to two locations and they did not want to give him the first vaccine. According to the CDC they were not allowed to give him three vaccines. He was not asking for three. He had to start over because this happened. They said they did not care and they would just give him the second. He said he told them no and that his doctor told him that he needs to start again. They told him they did not care what his doctor says and that they know more than him. He figured he would go directly to the manufacturer and see what Pfizer says. Pfizer would know the vaccine better than anyone else, his doctor or the pharmacist. Whatever Pfizer tells him to do, he would do. He clarified that he got Covid three days after the vaccine dose 1. He needed to take a picture with his phone because the sticker was so small. Then 10Apr2021 was when he got Covid. Height shrank he thought. But he felt crappy for still another week. For another week he was still coughing and having problems breathing which kind of still lingers, he still has it. He had asthma he guessed now. Asthma was what was diagnosed, but now they were saying it might be cardio. Stated he had recovered with lasting effects. He had never had asthma in his life until after the vaccine. Now they were saying it might not be asthma, it could be cardio. So he was going through tests right now (as reported). With physical activity he got out of breath and the only thing that did help was his inhaler. His inhaler did help him for now (as reported). He thought he missed his second dose in Apr2021. It was three weeks after his first one. Might be the 21Apr2021 or 28Apr2021. Cough came on the second week. It was the week of 12Apr2021. States it was still ongoing, but he had recovered with lasting effects: He stated he was definitely not recovered. It was not everything so he ok with the rest of the stuff. It was just the breathing that was still there. Breathing issue began on unspecified date (as reported). It was the first time he noticed it. He went for a bike ride and he felt it again maybe two weeks after and since then he had not done any physical activity. He was trying to avoid it. He stated he did tech support and R and D for a living and Pfizer was really thorough. It was good, but his hand was beginning hurt. He started feeling bad on the 10th. He got chills. Everything happened in April. He was feeling bad until 24Apr2021 or 25Apr2021. Might be even 01May2021. Asthma: He was feeling crappy for about a week and then he started to walk around his backyard and he was having trouble breathing, but he knew he had Covid. It started then, a week after his first effect. It was 15Apr2021 or 17aApr2021. They were possible cardio issue and they were testing but there was nothing concrete. The events were not resulted into emergency room visit and physician office visit, but he did have a tele visit. He did go get tested as well. The outcome of the events asthma, cough was recovered with sequel and the outcome of dyspnoea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021807432 similar report from same reporter
53 2021-07-18 emotional distress Distress
53 2021-07-27 confusional state fast heart beat; difficulty in breathing; dizziness; confusion; This is a spontaneous report from a ... Read more
fast heart beat; difficulty in breathing; dizziness; confusion; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:00 the patient had experienced fast heartbeat, difficulty in breathing, dizziness and confusion after one hour of vaccine administration which was lasted for about 3 minutes or less. The reaction repeated again after 30 hours and lasted for about 2 minutes. But he reported only the effect that happened after 30 hours and not the initial experience. The clinical outcome of the events fast heartbeat, difficulty in breathing, dizziness and confusion was resolved on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.
54 2021-01-06 anxiety localized swelling, hand/wrist numbness, anxious
54 2021-01-06 sleep disorder Date of vaccine 12/7/2020-Patient had very sore painful left deltoid and had to take Tylenol pain le... Read more
Date of vaccine 12/7/2020-Patient had very sore painful left deltoid and had to take Tylenol pain level 7 out of 10 and interrupted sleeping. 2nd day-12/18/2020-Patient had left sided body weakness, pain at injection site, pain all on left side of body taking Motrin. On 3rd day symptoms all subsided and were gone. No fevers or chills during any symptoms.
54 2021-01-10 impaired work ability First right sided parotitis - diag 12/26/ ER; next day right sided facial shingles; - antibiotics a... Read more
First right sided parotitis - diag 12/26/ ER; next day right sided facial shingles; - antibiotics and antiviral and a doctor's visit ; first day back to work was today - SAW 5 DRS VISIT TOTAL - 1 er DR AND 4 OTHER DOCTORS
54 2021-01-10 restlessness, agitation he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless;... Read more
he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much, kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away
54 2021-01-12 impaired work ability Myalgia chills Narrative: missed time from work day following second dose due to above symptoms
54 2021-01-16 anxiety 1. The first 24 hours (date of vaccination 12/29/2020: Minor Pain at the injection site, minor Hot ... Read more
1. The first 24 hours (date of vaccination 12/29/2020: Minor Pain at the injection site, minor Hot flashes, Moderate Headache (took Tylenol 1 gm po x 2 doses), lack of energy, anxiety. 2. 01/16/2021 @ 20:00: Swallen Lynph node in left armpit.
54 2021-01-28 amnesia Short-term memory loss; This is a spontaneous report from a contactable nurse (the patient). A 54-ye... Read more
Short-term memory loss; This is a spontaneous report from a contactable nurse (the patient). A 54-year-old male patient receive his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, expiration date: 31May2021), via an unspecified route of administration on 16Jan2021 06:40 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received his first dose of COVID-19 vaccine with lot #: EJ1685. It was reported that the patient received his second dose of vaccine and he wanted to report a strange side effect of short-term memory loss on 16Jan2021. He does not think that he has it now at the time of report but it never happened before. He mentioned he was walking down the hospital and he had a momentary memory loss. He did not know where he was going. He lost complete direction. He has worked in that hospital for 20 years. The outcome of the event was unknown.
54 2021-01-28 anxiety shot at 11 pm 12:30 - achey. and BLURRED vision- could see more than 2 feet in front of me. 3:00- a... Read more
shot at 11 pm 12:30 - achey. and BLURRED vision- could see more than 2 feet in front of me. 3:00- achey blurred vision worse. 7:00 - achey. chills. Overnight. sick chills fever, soo much paing blurred vision. 6 am- could barely walk without clutching furniture . Could not move my injection arm more than 2 inches. Whole body and joints in exrtreme pain. Incapacitated all day. By friday. my body felt better. My vision not as blurry. but by the weekend I was back. I still feel like my vision is not quite back.
54 2021-01-31 depression Uncontrolled short rhythmic breathing; brief electric shock sensation; little sporadic back spasms; ... Read more
Uncontrolled short rhythmic breathing; brief electric shock sensation; little sporadic back spasms; strong head pressure sensation; depression symptoms; This is a spontaneous report from a contactable Other HCP reporting for self. A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient received first dose of bnt162b2 on 17Dec2020 09:00. The patient's concomitant medications were not reported. The patient experienced Uncontrolled short rhythmic breathing, brief electric shock sensation and little sporadic back spasms, strong head pressure sensation, depression symptoms currently persistent and decreasing gradually on 09Jan2021. Patient had Nasal Swab on 12Jan2021 with negative result. Outcome of events was recovering. Patient received treatment for all events.
54 2021-01-31 disturbance in attention joint pain; difficulty concentrating; severe fatigue; Headache; body aches; low-grade fever; This is... Read more
joint pain; difficulty concentrating; severe fatigue; Headache; body aches; low-grade fever; This is a spontaneous report from a contactable nurse. This 54-year-old male nurse reported for himself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) at single dose for COVID-19 immunization on 15Jan2021 at 15:45. Relevant history included HTN (hypertension), hyperlipidemia, alopecia, seasonal allergies, obese and covid prior vaccination. Relevant concomitant drugs were unknown. No Known allergies. The patient experienced headache, difficulty concentrating to start followed by joint pain, body aches, low-grade fever, and fatigue on 15Jan2021 at 17:30. The next date the patient had severe fatigue. The next 2 days better when first awake then headache, fatigue after about 4 hours. Treatment therapy for the event was received. The outcome of event was recovering. The patient did not have other vaccine in four weeks. The patient did not have covid test post vaccination.
54 2021-02-05 sleep disorder Abdominal pain woke me from sleep at 3 am. 1/29/21. Went to ER that night, studies negative. Sent h... Read more
Abdominal pain woke me from sleep at 3 am. 1/29/21. Went to ER that night, studies negative. Sent home. Went back to ER next day. Studies negative. Sent home. Went back to ER same night. Admitted. Had laparoscopic appendectomy on 2/2/21
54 2021-02-09 poor quality sleep Intense chills and sweats; Multiple body aches including joint pain and headache; Multiple body ache... Read more
Intense chills and sweats; Multiple body aches including joint pain and headache; Multiple body aches including joint pain and headache; Multiple body aches including joint pain and headache; Restless sleep; Frequent urination; Intense chills and sweats; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:1686 (as reported)), via an unspecified route of administration on 05Jan2021 at 13:00 at single dose in left arm for COVID-19 immunisation. Age at vaccination was 54 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. On 05Jan2021 at 21:00 the patient experienced intense chills and sweats, multiple body aches including joint pain and headache, restless sleep and frequent urination. These symptoms started approximately 12 hours after injection (clarification requested) and lasted for approximately 14-16 hours. The events were non serious. No treatment was received for the events. The events resolved in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
54 2021-02-10 anxiety, nervousness A 54yr old male patient had an appt at 4pm. 4:00 pm The patient decided not to get vaccine after h... Read more
A 54yr old male patient had an appt at 4pm. 4:00 pm The patient decided not to get vaccine after he arrived. His wife received hers and told him it was fine to get the shot. The patient agreed. 4:50 the patient received the vaccine. the patient kept stating he was nervous and appeared very anxious. 4:55 patient was sitting in booth with wife and daughter and employee heard the family yell "Daddy" Employee saw the patient slumped over in booth. Employee alerted some one who was in the observation area who then called the Emergency Dept. STAT to the Observation area. 4:56 RN and RN responded to the area. See RN statement below. I was called to the cafeteria by RN for a possible reaction to a vaccine. When I arrived in the cafeteria patient was sitting in the seat with his head leaned on the back with his eyes closed. I asked him how he was feeling and he responded "I feel ok". He stated he hadn't eaten or drank anything that morning so he was given a Diet Coke and picked out a snack from the basket. He ate some crackers and drank some Diet Coke and stated he felt fine. His wife then stated that every time he is around needles he passes out. He said he felt better and was fine now. I told them when he got up if he felt weak or dizzy to call me back and I returned to the emergency room. Emergency Nurses stayed with patient until they were sure he was fine and able to leave under his own power with his wife and daughter. 2/9/2021- 09:30 Follow up call made to patient by Emergency Dept. Manager. Patient stated he was fine and hadn't experienced any other symptoms. ED manager instructed patient the come to the ED or seek medical care if he experienced any other symptoms. Patient stated he understood and will comply. 02/10/21 08:30 call and spoke with patient . Patient states he feels fine , no other symptoms.
54 2021-02-20 impaired work ability 38 hours after vaccination I woke in the middle of the night with extreme abdominal pain, dizziness,... Read more
38 hours after vaccination I woke in the middle of the night with extreme abdominal pain, dizziness, and severe diarrhea. This continued for 2 hours. I lost 6 pounds. After continuing with some diarrhea all day on February 12th, I began having bloody mucous chunks as my stool. I was advised by my doctor to go to the ER. I was diagnosed with colitis in the ER and was admitted for several days for treatment due to the severe blood coming out. CT scan showed severe inflammation, and stool sample showed blood and lactoferrin marker high. I was given many antibiotics and fluids and was released home on February 14th, 2021. I am still receiving treatment with oral antibiotics, and appointments with my physician. I had to be absent from work for over 7 days.
54 2021-02-24 anxiety Pt expressed anxiety over receiving vaccine, then developed lightheadedness. Denies chest pain, SOB,... Read more
Pt expressed anxiety over receiving vaccine, then developed lightheadedness. Denies chest pain, SOB, HA.
54 2021-03-06 insomnia 1. Muscle soreness at injection site, lasting 2 days. Currently resolved. 2. Feeling of overstimula... Read more
1. Muscle soreness at injection site, lasting 2 days. Currently resolved. 2. Feeling of overstimulation throughout day and evening, and difficulty falling asleep at night. "Buzzing" feeling similar to drinking too much coffee. Lasting 3-4 days. Currently resolved.
54 2021-03-08 sleep disorder Ringing in both ears. Started Sunday 3/7/2021 morning 2:00 AM woke up from sleep. It has not stop... Read more
Ringing in both ears. Started Sunday 3/7/2021 morning 2:00 AM woke up from sleep. It has not stopped ringing, but some times the ring is not as loud as other times. Sunday 3/7/2021 was the loudest ring in my ears. I have not seen a doctor yet. I was waiting to see if it will go away. As of today Tuesday 3/9/021 it has not gone away. If this issue does not go away by Friday 3/12 . I will see a doctor about this issue.
54 2021-03-17 excessive sleepiness mild fever ache at injection site day of vaccination, lasting two days. Extreme tiredness that has l... Read more
mild fever ache at injection site day of vaccination, lasting two days. Extreme tiredness that has lasted so far 6 days. I have slept 13 of the last 24 hours.
54 2021-03-18 feeling abnormal Muscle aches Fogginess Fatigue
54 2021-03-19 sensation of foreign body Very soon after I left the parking lot after waiting 15 min for observation ( i was literally 15 sec... Read more
Very soon after I left the parking lot after waiting 15 min for observation ( i was literally 15 sec after ) I started to feel an slight painful tingling in the corner of my mouth on my lips I thought it was like a chapped lip it progressed to my full set of lips and it was tingling and slight painful to touch maybe slight swollen but not a lot I then started to clear my throat and felt like my mouth was very dry like a lump in the back of my throat i was slightly having little difficulty in feeling could not catch my breath and considered going to the closest hospital i was getting a little worried so that may have been the cause of resp issue It started to improve and i drove home and in about 10 to 15 mins all the symptoms were gone and i am symptom free now about 24 hours later
54 2021-03-25 memory impairment headache, nausea, vomiting 15 minutes after vaccine. Trouble speaking/remembering -- EMS transfer
54 2021-03-29 feeling abnormal Head Ache Brain Fog. Drowsiness
54 2021-04-01 loss of personal independence in daily activities, sleep disorder Within approximately a couple of days from the first of two COVID19 Pfizer injections, I developed a... Read more
Within approximately a couple of days from the first of two COVID19 Pfizer injections, I developed a progressive, systemic, neuro/neuro-muscular inflammatory pain response. The inflammation and pain first manifested in my left wrist and hand, greatly worsening recent symptomology that may have been the start of a carpal tunnel syndrome. The inflammation and pain then progressed to my right wrist and hand and right shoulder. Then they progressed to my left shoulder, under my clavicles, my hips, and my upper lumbar/lower thoracic region of my spine. Muscle groups tightened and hurt, chief among them my hamstrings and upper back. All within days. The inflammation and pain were severe, especially from the early a.m. (3 or 4 in the a.m.) to waking hours. And the conditions left me nearly debilitated and incapable of sleeping well or performing many ADLs. Then, on Monday, March 29, 2021, I saw an orthopaedic for the pains in my wrists and hands, and he prescribed me a steroid for a preliminary diagnose of bilateral carpal tunnel. The inflammation and pain throughout my body decreased considerably after only two doses of the steroids. That led me to seek a consultation with the rheumatologist.
54 2021-04-03 feeling abnormal I received the first Covid vaccine (Pfizer) on 3/24. A week later I started to feel very ill; chills... Read more
I received the first Covid vaccine (Pfizer) on 3/24. A week later I started to feel very ill; chills, low grade fever, fatigue, sweaty, head ache in the middle of my face, muscle aches, fuzzy thinking, and later a cold sore. I started taking Tylenol and stayed home from work. It has persisted over the past 4 days but I started to feel better yesterday.
54 2021-04-04 impaired work ability Recv'd first shot 4/3/21, was fine 4/4/21. Early in AM of 4/5/21 I had muscle aches, stomach crampin... Read more
Recv'd first shot 4/3/21, was fine 4/4/21. Early in AM of 4/5/21 I had muscle aches, stomach cramping, and chills. At 1 point I stopped working because I felt tingly, and started to sweat (only happened once). I'm feeling tired, like I have the flu.
54 2021-04-06 nervousness After 1st covid injection, Pt states felt shaken. Went to ER. Had hot & cold flashes, arm pain. Bega... Read more
After 1st covid injection, Pt states felt shaken. Went to ER. Had hot & cold flashes, arm pain. Began to feel better after waiting in ER. Saw Dr . Vitals ok and pt released home. Pt states ok now just tingling in hands.
54 2021-04-07 confusional state, anxiety started 1pm on 4/7 patient experienced dizziness, shortness of breath, tightness of chest and throat... Read more
started 1pm on 4/7 patient experienced dizziness, shortness of breath, tightness of chest and throat, lethargic, and sweat profusely. PT woke up and bed was soaked. Anxiety and confusion lingers to today 4/8 - today patient still feel lethargic but not nearly as bad - Recommended patient to keep monitoring and proceed to ER if needed
54 2021-04-09 feeling abnormal Within an hour started feeling weird. over the course of the next 36 hours, my reaction to the vacc... Read more
Within an hour started feeling weird. over the course of the next 36 hours, my reaction to the vaccine is awful. Worse than my covid. At least I know my body is doing what it is supposed to be doing. But it is just miserable. Massive headache, soreness, weird shooting pains in my leg, sweats and chills and nausea, and now the racing heart and shortness of breath.
54 2021-04-09 feeling abnormal Passed out; Blood pressure was low for him: 112/54; temp was also low: 96.6; thirsty; feel funny; Th... Read more
Passed out; Blood pressure was low for him: 112/54; temp was also low: 96.6; thirsty; feel funny; This is a spontaneous report from a contactable consumer reported for self. This 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Mar2021 14:45 PM on Arm left at single dose (Lot # ER8732) for covid-19 immunisation. Medical history included Sleep apnea, breathing issues, IBS, Hypertension; Anxiety/Depressive disorder. No known allergies. No covid prior vaccination. Concomitant medications included other medications in two weeks. No other vaccine in four weeks. On 26Mar2021 08:00 AM, he went to the bathroom around 8 a.m. this morning and started to feel funny. He stood up and passed out onto the floor. Family members heard him and came to help. Blood pressure was low for him: 112/54. Temp was also low: 96.6. He was very thirsty. No treatments received. No covid tested post vaccination. Outcome of the events was recovering.
54 2021-04-10 memory impairment, feeling abnormal Brain Fog Slow memory Slow thinking Forgetting names
54 2021-04-10 sleep disorder starting 12 hours after injection: unable to sleep, low grade fever, headache, body aches. Lasted ... Read more
starting 12 hours after injection: unable to sleep, low grade fever, headache, body aches. Lasted about 20 hours.
54 2021-04-13 anger, agitation Roughly six (6) hours after I received my second dose I became extremely agitated and angered what I... Read more
Roughly six (6) hours after I received my second dose I became extremely agitated and angered what I would call a homicidal rage that lasted for about an hour which then morphed into a visual hallucinations those lasted for about an hour and those turned into racing heart with heart palpitations and bilateral involuntary hand movements tremors
54 2021-04-13 impaired work ability Nausea, diarrhea, fatigue, tingling in hands and arms. Lasted 4-5 days. Caused to miss work. Conta... Read more
Nausea, diarrhea, fatigue, tingling in hands and arms. Lasted 4-5 days. Caused to miss work. Contacted PCP but did not go in for visit.
54 2021-04-22 insomnia I recently was recovered from Benzodiazepin withdrawals and got the 1st shot of Pfizer and started h... Read more
I recently was recovered from Benzodiazepin withdrawals and got the 1st shot of Pfizer and started having headache and nausea and then started having the withdrawal symptoms come back. Insomnia, air hunger, back and shoulder pain after eating and fatigue, burning feet and Tinnitus.
54 2021-04-26 sleep disorder 5 hours after vaccine I developed a loud ringing/hissing sound in my left ear. It is constant and n... Read more
5 hours after vaccine I developed a loud ringing/hissing sound in my left ear. It is constant and never stops. I cannot sleep or concentrate to due to the constant noise. I fear that this is permanent and my quality of life will be poor. I'm beginning anti-anxiety pills to help me relax. I wish there was some information as to how long this side effect lasts. I have no history whatsoever of hearing issues, or Tennitus.
54 2021-04-27 feeling abnormal Patient states that he began having a headache (frontal) that caused him to have some brain fog. It... Read more
Patient states that he began having a headache (frontal) that caused him to have some brain fog. It lasted approximately four weeks. It would wax and wane. Then one morning he woke up without it. He was not seen for this. Just happened to be seen today for his routine physical and mentioned it.
54 2021-04-28 excessive sleepiness, feeling abnormal I started feeling drugged about 2 hours after the shot. I then experienced extreme fatigue and felt ... Read more
I started feeling drugged about 2 hours after the shot. I then experienced extreme fatigue and felt unwell / sick for 6 days. My joints were extremely sore in my back, ankles and wrists. My body felt heavy and it was hard to stand and walk. It felt as if I was losing circulation in my feet. By 5PM each day I was in bed passing out for about 2 hours each day. Most of each day on couch sick. On day 5, I broke out in hives on my face. All symptoms began to clear on day 7. I was almost feeling normal Apr 28. Today, Apr 29 I feel OK.
54 2021-04-29 disturbance in attention, sleep disorder About 48 hours after the shot, I developed flu-like symptoms: chills, mild diarrhea, body ache, and ... Read more
About 48 hours after the shot, I developed flu-like symptoms: chills, mild diarrhea, body ache, and low fever. These dissipated in the next 36 hours. HOWEVER, during this time I developed bilateral, persistent high-pitch tinnitus. This problem is significant enough to affect sleep and concentration. The tinnitus remains persistent three weeks later.
54 2021-05-02 feeling abnormal Severity of tinnitus increased from 1 to 5 on scale of 1-10 accompanied by "brain fog". Brain fog di... Read more
Severity of tinnitus increased from 1 to 5 on scale of 1-10 accompanied by "brain fog". Brain fog dissipated over next 48 hours, tinnitus has remained at 5.
54 2021-05-03 anxiety, sleep disorder Leukocytes in urine; urinating blood; Dark colored urine; couldn't sleep; anxiety; sweat; arm pain; ... Read more
Leukocytes in urine; urinating blood; Dark colored urine; couldn't sleep; anxiety; sweat; arm pain; lightheaded; Abdominal Discomfort; prostate infections; This is a spontaneous report from a contactable consumer reporting for himself. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 24Mar2021 at 14:30 (at the age of 54 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included benign prostatic hyperplasia (BPH) and cholesterol. The patient was diagnosed with BPH a few years back 2016 or 2017 and had a uralist in 2019 and that resolved his issues. The patient had been on no BPH meds and back to normal since that procedure. Co-suspect medication included atorvastatin (LIPITOR) from an unknown date to 01Apr2021 at 40 mg, 1x/day for blood cholesterol. On an unspecified date in Mar2021, the patient experienced prostate infections, and abdominal discomfort. On 25Mar2021, the patient experienced arm pain, and was lightheaded. He described the arm pain as he had deltoid pain but he also had pain like he had been hit from his right pectoral down his arm to about 4-5 inches above his wrist. On 31Mar2021, the patient experienced couldn't sleep, anxiety, sweat, urinating blood, and dark colored urine. The patient was concerned with the dark urine so he stopped taking atorvastatin, and called his physician who said he didn't need it anyhow. The patient visited the urologist office and was prescribed ciprofloxacin (CIPRO) as treatment for dark colored urine, urinating blood and prostate infection. On 06Apr2021, the patient experienced leukocytes in urine. Relevant lab data on 06Apr2021 included a urinalysis which resulted in leukocytes and blood +3. The action taken in response to the event dark urine with atorvastatin was permanently withdrawn. The outcome of the events prostate infection, and abdominal discomfort was recovered on an unspecified date in 2021. The outcome of the events arm pain, and lightheaded was recovered in 26Mar2021. The outcome of the events couldn't sleep, anxiety, and sweat was recovered on 01Apr2021. The outcome of the events urinating blood and dark colored urine was recovered on 06Apr2021. The outcome of the event leukocytes in urine was unknown.; Sender's Comments: Based on the current available information, the serious events Prostate infection, Blood in urine, and Urine color abnormal are most likely related to an intercurrent or underlying condition which is not related to the suspected drugs. Relevant medical history of benign prostatic hyperplasia (BPH) may provide a plausible explanation for the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021450744 same patient/SD, different AE/dose
54 2021-05-03 sleep disorder Vaccinated Weds 4/28/21. Started shortly thereafter with fever Tm 102 F, chills, headache. Startin... Read more
Vaccinated Weds 4/28/21. Started shortly thereafter with fever Tm 102 F, chills, headache. Starting Thursday with fatigue and metallic taste in his mouth. He has no appetite and reports not eating x 4 days. He has had fever and headache persistent since vaccination. He has not slept x 4 days since vaccination, he reports his mind is racing. He had a syncopal episode x3 night of 5/2/21 back to back. Right before syncope he did not feel lightheaded or dizzy, chest pain, palpitations. He had LOC lasting less than a minute in total.
54 2021-05-07 disturbance in attention, feeling abnormal Nausea, fatigue, loss of taste, facial tingling and numbness, pain in elbows, pressure to front of h... Read more
Nausea, fatigue, loss of taste, facial tingling and numbness, pain in elbows, pressure to front of head and behind eyes, fogginess, memory loss, lack of concentration, muscle tingling in the middle of the night, numerous cysts in rt. arm, shooting pain in rt. thumb and hand, bone spurs and calciumafication of rt. elbow. No treatment. Schedule to neurologist and orthopedic doctor.
54 2021-05-12 loss of personal independence in daily activities, feeling abnormal, depression, confusional state Aches, fluish symptoms, muscle aches, fever (100ish), significant brain fog (confusion, no concentra... Read more
Aches, fluish symptoms, muscle aches, fever (100ish), significant brain fog (confusion, no concentration-still continues), regional shoulder pain, massive headache-several days, significant heart/chest pain upper left quadrant both first and second shot. Went into Atrial fibrillation 4-5 days after first shot. Massive emotional swings from ecstasy to rage and depression starting day after shot and continuing.
54 2021-05-13 feeling abnormal Had tachycardia and high blood pressure, headaches and some nausea yesterday. Tachycardia hasnt r... Read more
Had tachycardia and high blood pressure, headaches and some nausea yesterday. Tachycardia hasnt repeated but headaches and queasiness continue intermittently along with possible high BP Never had this before was wondering if possible side effect? EKG came back same as normal for me and bloodwork fine. Still feeling poorly.
54 2021-05-13 insomnia My previously manageable tinnitus has become unmanageable starting within a week of the second Pfize... Read more
My previously manageable tinnitus has become unmanageable starting within a week of the second Pfizer shot. The tinnitus is extremely loud 24/7 making my days feel like I have PTSD and my nights difficult to sleep. I need music, TV, or white noise on 24/7. The elevated level of tinnitus has not subsided since it ramped up.
54 2021-05-14 confusional state convulsions; Fever (up to 103 F degrees); chills; confusion; dizziness for first 48 hours; body ache... Read more
convulsions; Fever (up to 103 F degrees); chills; confusion; dizziness for first 48 hours; body aches for 96 hours.; This is a spontaneous report from a non-contactable consumer who reported for himself. A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0172), via an unspecified route of administration, in Arm Left on 20Apr2021 at 13:30 (at 54 years) at single dose for covid-19 immunisation . Medical history included known allergies penicillin. Previously, on 29Mar2021, patient took the first dose of the vaccine (lot Number: EQ0150) administered in Arm Left for covid-19 immunisation. The patient's concomitant medications were not reported. Patient had no COVID prior vaccination and was not covid tested post vaccination. On an unspecified date in 2021 patient experienced fever (up to 103 F degrees), chills, convulsions, confusion, dizziness for first 48 hours, body aches for 96 hours. No treatment given. Patient recovered from all the events on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
54 2021-05-19 confusional state After the 15 minute post shot waiting period patient said he felt "confused" with clammy hands. H... Read more
After the 15 minute post shot waiting period patient said he felt "confused" with clammy hands. He sat in the chair and was slow to talk. I asked him if he was diabetic, and he responded that he was, but he never feels this way and had eaten before coming in. After talking a while longer, I was going to ask him if he'd like us to check his sugar, he asked me if we had a blood pressure cuff. I said we did, but he wanted to use the machine in front of the store because he felt well enough to get up and wanted to walk. I walked to the machine with him. He sat and answered the many questions tapping on screen with no issues at all. The confusion was not evident. The maching reported 111/68 or very close, with a pulse of 48. He said, "that's the issue, my pulse is down. I need to walk around." I said he could stay back at the pharmacy where we could see him, or we could call someone for him. He said staying back here would not help his pulse. I told him there was no hurry, he'd been here for his 15 minutes, but we could keep an eye on him or help him and call whatever he needed. He said no, he'd be fine, he just needed to walk around. He now had pressure in his head, not really a headache just pressure, he said it was all related to his pulse. He said if he needed help later he could always go to an Urgent Care, I offered again to call anywhere for him or call for assistance, he was not interested.
54 2021-05-22 mental status changes Fever to T max 105.3, tachycardia to HR 135, altered mental status (lethargic, nonsensical speech)
54 2021-05-25 depression critical sadness like never before/sadness and depression; Flu like symptoms; terribly sick; nausea;... Read more
critical sadness like never before/sadness and depression; Flu like symptoms; terribly sick; nausea; lethargy; body ache; fatigue (he is tired all the time and cannot get off the couch); This is a spontaneous report from a contactable consumer (patient) via a Pfizer. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 22Apr2021 (Batch/Lot Number: EW0162; Expiration Date: Jul2021) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included gabapentin (GABAPENTIN) taken for neuropathy peripheral, start and stop date were not reported. Patient stated that after receiving the first dose of the Pfizer Covid-19 vaccine on 22Apr2021, he has been terribly sick, he feel like his dying. He had nausea, lethargy, body ache, critical sadness like never before, fatigue (he was tired all the time and cannot get off the couch) and it was not going away on 23Apr2021. He had seen three doctors, tested negative to Covid-19 and his blood tests were normal. He had flu like symptoms for 13 days since 23Apr2021, and it never goes away. The symptoms seem to get better and then he exercises a lot and they come back. Patient has been nauseated, had extreme lethargy, sadness and depression, and body aches. The patient was on a plethora of medications now because of this. He wanted to know what does it say about his immune system? He was scared that he was dying, it feels like he's dying. He has worn two masks and not socialized at all and does not understand what has happened, he has done everything right. His inflammatory response was checked on 04May2021 which has not come back yet. The patient underwent lab tests and procedures which included blood test: normal on 06May2021, body height: 175 cm on 06May2021, platelet count: normal on 04May2021, red blood cell count: normal on 04May2021, sars-cov-2 test: negative on 04May2021, weight: 195-200 on 06May2021. He wanted to know when will these side effects go away and he will start getting better, and asked if he should get the second dose. Outcome of the events was not recovered.
54 2021-05-25 feeling abnormal Headache; dizziness; foggy; heavy feeling in chest; heavy feeling in shoulders, and arm; This is a s... Read more
Headache; dizziness; foggy; heavy feeling in chest; heavy feeling in shoulders, and arm; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 54 years old, in left arm on 06May2021 15:30 at single dose for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to vaccination. The patient experienced headache, dizziness, foggy, heavy feeling in chest, shoulders, and arm on 14May2021 05:00. The patient had not been tested for covid-19 since the vaccination. No treatment was received. The outcome of events was not recovered. Information on the lot/batch number has been requested.
54 2021-05-25 excessive sleepiness ALMOST EXACTLY 24 HOURS LATER, FEVER 101, COLD CHILLS, TIRED, SLEEPY. SLEPT 2 HOURS WHEN I GOT HOM... Read more
ALMOST EXACTLY 24 HOURS LATER, FEVER 101, COLD CHILLS, TIRED, SLEEPY. SLEPT 2 HOURS WHEN I GOT HOME FROM WORK . GOT UP FROM NAP AND WENT TO BED. ALL NORMAL IN THE MORNING.
54 2021-05-27 incoherent, amnesia SEIZURE MEMORY LOSS IN COHERENT
54 2021-06-01 impaired work ability 2 weeks after the first dose Awful pain and stiffness in both hands. went to DR on 4/12 did blood w... Read more
2 weeks after the first dose Awful pain and stiffness in both hands. went to DR on 4/12 did blood work diagnosed with RA. Did not think about the vaccine until two weeks after the second dose I struggle to walk with severe pain in my legs, arms, and hands. Life since has been pretty rough passed out from the pain on May 16th had to have 9 staples in my head. Now my life is trying to balance medication so I can sleep at night. And get through the days at work. I have had to miss days.
54 2021-06-02 confusional state, amnesia, hallucination Approximately 24 hours after second Pfizer vaccine dose, patient reported having severe vision and b... Read more
Approximately 24 hours after second Pfizer vaccine dose, patient reported having severe vision and balance problems, headache and severe fatigue and memory loss. Vision symptoms included hallucinations, tunnel vision and blurred. Unable to stand up without staggering. Confusion. Difficulty verbalizing thoughts. Treated with ivermectin, D3, Z, quercitin, aspirin and other supplements on advice of doctor. Symptoms persisted in severe form for 48 hours, then began to improve. At 6/3/2021, blurred vision while reading, higher than normal heart rate during exercise, fatigue and intermittent memory loss. Being treated by doctor and kinesiologist for brain injury from vaccine
54 2021-06-02 impaired work ability Severe allergic reaction, I still have the allergy, I have been treated with prednisone, which alter... Read more
Severe allergic reaction, I still have the allergy, I have been treated with prednisone, which altered the blood sugar, I have thin skin syndrome and my fingers break making my work difficult.
54 2021-06-09 feeling abnormal I began to feel the onset of the AE the next morning at around 3:00 AM after the vaccination. Genera... Read more
I began to feel the onset of the AE the next morning at around 3:00 AM after the vaccination. Generalize pain throughout my body, muscle aches, slight fever, muscular skeletal pain and general feeling of being extremely tired, and I feel like I have brain fog . Asthma and fibro maylagia are worse since I had the vaccination, sinuses I'm constantly congested. I feel more tired now than I did previously. I will never take this Pfizer vaccination again. My symptoms are not as bad as the week after the vaccination but I have not felt normal or as I did prior to the vaccination.
54 2021-06-09 loss of personal independence in daily activities 3 days after receiving the 2nd Pfizer shot, the pt began experiencing numbness in both feet and toe... Read more
3 days after receiving the 2nd Pfizer shot, the pt began experiencing numbness in both feet and toes as well as R hand. A week later R thigh tingling followed by bilateral leg pain. Spread to calf region then knee caps toward the end of May. Then, balance became difficult, feeling like he was falling to the right. Was admitted to medicine service. Over course of week continued to decline and no longer can walk, needs bed lift to use the bathroom. Currently on day 1 of 5-day IVIG treatment. Due to possible tick exposure has also been receiving Abx for Lyme.
54 2021-06-15 confusional state, feeling abnormal Head/sinus pressure. Ears ringing loudly, tinnitus. Head fog, dizziness, mild confusion. At times, c... Read more
Head/sinus pressure. Ears ringing loudly, tinnitus. Head fog, dizziness, mild confusion. At times, can hear my eyes move. Can get dizzy just looking around the room now.
54 2021-06-21 loss of personal independence in daily activities, sleep disorder About two weeks after the second Pfizer covid shot I started to develop chest pains, shortness of br... Read more
About two weeks after the second Pfizer covid shot I started to develop chest pains, shortness of breath and arrhythmia. I didn't connect the dots to the shot until i read about the cases in another cou ntry. I am an avid cyclist who rides over 100 miles a month and I noticed my athletic performance was suffering greatly and I would wake up most nights from a sound sleep with chest pain.
54 2021-06-22 abnormal dreams, sleep disorder The night after my first Pfizer vaccination I experienced vivid, crazy dreams all night and experien... Read more
The night after my first Pfizer vaccination I experienced vivid, crazy dreams all night and experienced a bad night's sleep. I usually do not dream much and these were extremely vivid and real.
54 2021-06-23 feeling abnormal, nervousness double vision whenever he moved his head; vision was disrupted when he would move his head; equilibr... Read more
double vision whenever he moved his head; vision was disrupted when he would move his head; equilibrium was totally off; Head felt wobbly, head was in a fog type haze; The felling was scary; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 at vaccination age of 54-year-old via an unspecified route of administration in the left arm on 22May2021 16:00 (Lot Number: EWO179) as dose 1, single for covid-19 immunisation. Medical history included Covid-19 in Nov2020 to Nov2020 prior to vaccination. The patient has no known allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and alprazolam (XANAX), both indications, start and stop date were not reported. The patient received the most recent COVID-19 vaccine in a public health clinic or facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 2 days after the vaccination (24May2021 08:00), the patient's vision was disrupted when he would move his head. He saw almost what you would call double vision whenever he moved his head, like while driving or looking from one side to the other. He couldn't drive for about 3 days because the movement of one car would look like 2 cars. This didn't happen when head was still and looking straight. His equilibrium was totally off, his head felt wobbly, his head was in a fog type haze for about 2 weeks. The feeling was scary. He mentioned that he did have covid Nov2020. He added that he made phone call to his doctor and they said to give it 2 weeks before coming in which is exactly when symptoms started to subside but still feel a little off. The patient did not received treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
54 2021-06-25 feeling abnormal, disturbance in attention, abnormal dreams Extreme fatigue, brain fog, constricted chest, chest pain for 4 days after my second dose. Now, I've... Read more
Extreme fatigue, brain fog, constricted chest, chest pain for 4 days after my second dose. Now, I've been experiencing continued ongoing fatigue for 6 weeks. My legs grow heavy each day. I pass out from exhaustion early each night. I have trouble concentrating. I'm experiencing ankle and wrist pain with a feeling of low circulation as my feet and hands fall asleep if I sit too long. I'm also having vivid nightmares on an ongoing basis. Other than a back injury, I was healthy and normal before this vaccine. I have not been to a doctor. I have been resting, focused on eating well and taking 3000mg of Vit C a day.
54 2021-07-12 sleep disorder For the first week, he had fever, body aches, and chills. After that, he had chest pain on both side... Read more
For the first week, he had fever, body aches, and chills. After that, he had chest pain on both sides. The pain was also between shoulder blades, stabbing in the chest in the middle of night. He had severe shortness of breath. His feet were cold and he could not sleep most of the nights. Today he said his breathing is okay, slowly getting back to normal.
54 2021-07-15 sleep disorder Within two minutes of receiving the injection, my heart rate increased and my chest became tight. T... Read more
Within two minutes of receiving the injection, my heart rate increased and my chest became tight. The heart rate lowered, but the chest remained tight for multiple days, though lessening. Because there was no pain associated with it, I continued my normal activities and assumed it would return to normal. On the night of 04/26/21, I had palpitations the prevented sleep, needing to sit up to lessen them. This continued on subsequent nights and not having a primary care doctor, I went to the emergency room on 04/30/21. I was able to have an appointment with a primary care doctor on 06/10/21 and a cardiologist appointment on 06/17/21.
54 2021-07-18 feeling abnormal Feeling of dizziness, lose of feeling and uncontrollable shaking in left leg.
54 2021-07-19 insomnia Sleeplessness; exhausted; This is a spontaneous report from a contactable consumer, the patient. A 5... Read more
Sleeplessness; exhausted; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 09Mar2021 at 11:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and allergy to walnuts. Concomitant medications included unspecified anaesthetic (MANUFACURER UNKNOWN) started on an unknown date for root canal procedure at dentist and ibuprofen (IBUPROFEN) started on an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 04:00, the patient experienced sleeplessness. The patient had been unable to sleep for more than a few hours at a time. At first, the patient thought it was psychological (excitement/ anxiety) but this had persisted for weeks and it was unprecedented since the first shot. The patient also reported that he was usually exhausted by mid afternoon or early evening and often took a nap. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 30Mar2021 at 09:45 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events sleeplessness and exhausted was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
54 2021-07-21 feeling abnormal 2 weeks of low grade flu symptoms; including 2 days of being so bad that I couldn't get out of bed.;... Read more
2 weeks of low grade flu symptoms; including 2 days of being so bad that I couldn't get out of bed.; I couldn't get out of bed; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8736) via an unspecified route of administration in left arm on 01Jun2021 as dose 2 single (at the age of 54-year-old) for COVID-19 immunization at Pharmacy or Drug Store. Medical history included Covid-19. Prior to vaccination, the patient was diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm as dose 1 single (at the age of 54-year-old) for COVID-19 immunization and It was awful after the first vaccine, including a day of vomiting and being in bed. On 23Jun2021, patient experienced 2 weeks of low grade flu symptoms, including 2 days of being so bad that patient could not get out of bed. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: covid positive prior to vaccination. Device Date: 06Jul2021. The reported assessed the case as non-serious. The outcome of events was recovered. Additional information is requested. Further information is expected.
54 2021-07-22 depressed mood Flu-like symptoms that persisted more than two weeks. Body aches. Nausea. Lethargy. Sadness. Hopeles... Read more
Flu-like symptoms that persisted more than two weeks. Body aches. Nausea. Lethargy. Sadness. Hopelessness.
54 2021-07-25 loss of personal independence in daily activities, excessive sleepiness About 1 hour after the first vaccine shot, I started to have typical symptoms -- achy body, tightnes... Read more
About 1 hour after the first vaccine shot, I started to have typical symptoms -- achy body, tightness of breath, basic flu like symptoms. About 3 hours after the vaccine I started having sharp pain (like 8 or 9 on a scale of 1-10) running down the insides of my legs. It felt like lightning was running through my body. I tried to sleep Friday as well as the weekend, and the pain was intense. I had to limit and stop all exercise, and to-date, I can only walk for limited times before I feel pain in my legs again. I have also long-term lethargy and tireness, and find I am sleeping 12-16 hours a day. Prior to Covid vaccine, I would only sleep 4-6 hours a night.
54 2021-07-26 disorientation Malaise, fatigue, body aches, non-bloody diarrhea, dizziness, lightheadedness, disoriented, oral Tma... Read more
Malaise, fatigue, body aches, non-bloody diarrhea, dizziness, lightheadedness, disoriented, oral Tmax 100.4
54 2021-07-27 anxiety Ringing in ears; Slight headache; Moderate neck ache; General feeling of unease/anxiety; This is a s... Read more
Ringing in ears; Slight headache; Moderate neck ache; General feeling of unease/anxiety; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 15Mar2021 at 01:15(at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient did not receive any other medications within 2 weeks of vaccination. The patient previously received ciprofloxacin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021, the patient experienced ringing in ears, slight headache, moderate neck ache and general feeling of unease/anxiety. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Patient did not receive any treatment for the adverse event. The clinical outcome of the events ringing in ears, slight headache, moderate neck ache and general feeling of unease/anxiety were not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
54 2021-07-27 restlessness Tired; Slept most of the day; Strong muscle aches; Body aches; Restless all night; Low grade fever; ... Read more
Tired; Slept most of the day; Strong muscle aches; Body aches; Restless all night; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 11Apr2021 at 11:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril 10mg (MANUFACTURER UNKNOWN), allium sativum extract (KYOLIC GARLIC), ascorbic acid, tocopheryl acetate, ubidecarenone, zinc oxide, cupric oxide, betacarotene, selenium, manganese sulfate (COQ10), cyanocobalamin (VITAMIN B12) and colecalciferol (VITAMIN D3), all taken for unknown indications from unknown dates. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 at 11:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 18:00, the patient experienced body aches, was restless all night, slept little and had low grade fever overnight which continued to 12Apr2021. On 12Apr2021, the patient had slept most of the day, had strong muscle aches. On 13Apr2021, the patient felt tired. The clinical outcome of the events body aches, restless all night, slept little, low grade fever, slept most of the day, strong muscle aches and tired were resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
55 2020-12-31 feeling abnormal Vaccine on 12/22/2020 and started feeling bad on 12/27/2020 and tested positive on 12/30/2020 for CO... Read more
Vaccine on 12/22/2020 and started feeling bad on 12/27/2020 and tested positive on 12/30/2020 for COVID 19 Was advised to fill this out by my PCP
55 2021-01-05 feeling abnormal, anxiety "EE reviewed contraindications and verbalized ""non"" to all contraindications. Vaccine administrd a... Read more
"EE reviewed contraindications and verbalized ""non"" to all contraindications. Vaccine administrd at 1045. 1100 EE stated ""I feel weid"". EE complained of SOB and dizziness. RN and LVN assisted EE to floor and elevated lower extremities. EE was taking deep breaths, pulse normal. RN, Called ED to notify them of EE situation. 1110 EE breathing normal and EE verbalized, "" no feeling of dizziness"" and was assisted to sit in chair. 1113 RN escorted EE wo security golf cart and was transported to ED by Manager of security. EE was stable. ED Note 55-year-old male presenting with dizziness and anxiety after vaccination. This is a potentially seriously ill patient with significant medical complexity and risk who was assessed emergently on arrival given their concerning story. Differential includes but is not limited to orthostatic hypotension, cardiac dysrhythmia, atypical presentation of myocardial infarction, allergic reaction, adverse effect of medication. Fortunately, the patient denies any chest pain his troponin is not elevated with no ischemic findings on his EKG. He is nonfocal neurologically make me doubt stroke. He has no findings at this time to suggest an anaphylactic reaction and his vital signs are within normal limits. Orthostats were checked and negative. He has no anemia, leukocytosis or emergent electrolyte derangements that could be participating in his symptoms. Patient is tolerating oral intake and asymptomatic at this time. He was monitored and on serial reassessment developed no no recurrence of symptoms. He is safe for discharge at this time but ED read precautions were given and the patient was discharged from the emergency department in good condition. Impression: Acute dizziness anxiety, suspect adverse medication reaction"
55 2021-01-05 impaired work ability Woke up very fatigued 12/25 only minimal activity performed creating additional fatigue. Was sleepi... Read more
Woke up very fatigued 12/25 only minimal activity performed creating additional fatigue. Was sleeping 12 plus hours a day without feeling rested in the least. No problems with sleep. Also had heaviness of chest - felt like rib cage made of iron- this dissipated by the 28-29th. No excessive cough or fever, did have dyspnea with any exertion and this continues but seems to be lessening. Was not able to work due to fatigue. Yesterday remained tired but felt noticeably different-felt lighter-and today seems promising.
55 2021-01-12 impaired work ability Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: missed one day of work following second do... Read more
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: missed one day of work following second dose due to above symptoms
55 2021-01-22 disorientation 12 hours after injection: 12 hours after injection and then resolved the next day: drenching night s... Read more
12 hours after injection: 12 hours after injection and then resolved the next day: drenching night sweats severe joint pain especially in hips and knees - even ribs hurt passed out and disoriented significant contracture of bilateral upper extremities from elbow to hands when I could not open them for over an hour rt ear tinnitus numbness in hands and feet tiredness
55 2021-01-26 depressed mood, feeling abnormal, mental impairment It started abruptly, i experienced brain frog and super weak, globally with al muscles and was very ... Read more
It started abruptly, i experienced brain frog and super weak, globally with al muscles and was very fatigues and malaise. I had access to a blood pressure cup the reading was 148/92, usually my BP is 100/60. Once they took my BP, then i went to the ER. As time went on, I got more sleepy and tired. The first ER visit they did lab work, CBC panel which was normal, thyroid test which was normal, EKG and aniongap which were negative. They gave me no medications to take and was probably there in the ER for about 6 hours. which was on 01-15-2021. The second time, it was around 11:45am on 01-21-2021. While sitting at the edge of my bed, I felt a total sadness and despair and feeling of being alone. I then went to work felt normal in the morning and as i went to type some notes after a minute i felt the same symptoms happening again, my BP 140/88 and went to the ER. I was really tired and could of fallen asleep, felt oriented but took me a while to process things. I also had trouble moving my entire body. They placed an IV, gave me fluids, did an EKG again which was normal. They did a CT scan, CTA to my chest and neck and CT perfusion, had to inject contrast, exams were both normal. The doctor came in and told me if I was okay to drive home and I drove home. On the third episode. 01-25-2021 it occurred around 9am, the symptoms came back but with less intense. I lied down and rested., could feel my heart racing just like the other two episodes. This symptom lasted for about two hours and kind of lingered all day but i could still function. i felt like I had the flu, moderate malaise with brain fog.
55 2021-01-26 feeling abnormal, depressed mood First episode 01-15-21, started 10am, i was at work, started feeling weak and brain fog so i sat dow... Read more
First episode 01-15-21, started 10am, i was at work, started feeling weak and brain fog so i sat down and another therapist came into the office and told her how i was feeling, they checked my BP 148/92, went to the ER. They took some blood work, CBC panel were negative, thyroid test, normal, anaiongap, normal, glucose reading, normal and an EKG normal. 2nd episode 01-21-2021 started 11;45am, that morning when i woke up i felt really strong feelings of sadness and despair. At 11;45a i was about to eat and i started to feel again brain fog, total body weakness, elevated BP, they took my BP again and it was 144/88 so i went to the ER again. I could not keep my eyes open. They did a EKG again with a CTA and a CT with perfusion both were normal. They gave me fluids, sodium fluids. Agian it was transient my BP slowly went down and went home. Third episode 01-25-2021 started about 9am, i was at home did not have access to a BP cup, symptoms were same but less intense, i could feel my heart pounding, brain fog and body aches and this lingered throughout the day. It felt like I had the flu. No elevated temperature on all three of my episodes.
55 2021-01-26 feeling abnormal After dose two - immediate feeling of fogginess then twelve hours later severe chills and headaches ... Read more
After dose two - immediate feeling of fogginess then twelve hours later severe chills and headaches Muscle and joint aches along with headache lasting 48 hours
55 2021-02-01 feeling abnormal patient complained of feeling "tingly and off". At 1610, BP 173/109, pulse 50, 100% on room air, E... Read more
patient complained of feeling "tingly and off". At 1610, BP 173/109, pulse 50, 100% on room air, EKG in the field WNL. Denied headache and chest pain. Rested for 30 min. BP 183/105 at 1637. Patient reported feeling normal and agreed to follow up with primary MD or go to ER if symptoms worsened.
55 2021-02-24 anxiety upon receiving the vaccine the patients arm immediately turned green and formed small blisters under... Read more
upon receiving the vaccine the patients arm immediately turned green and formed small blisters underneath the skin at the injection site. Patient denied previous adverse reactions to any previous vaccines however reported feeling not well after a vaccine for typhoid years ago, patient could not state exact time. 1125 patient bp 211/114, pulse 100, respirations 20 temp 97.8 oxygenation 98%. Patient reported anxiety. Po benadryl offered but patient refused. Patient reassessed bp 172/118. Pulse 69, resp 18, temp 97.8, spot 96%, patient was offered water and taught deep breathing and relaxation techniques. 1210 pm patient stated he was "feeling much better". Site reduced to a small bruise. Pt educated on locL reactions and scheduled for second appt. Consulted with medical director before booking second appointment. Final VS 158/112, pulse 70, resp 18, temp 97.2, oxygenation 98%.
55 2021-02-28 feeling abnormal Injection site pain Extreme tiredness Headache Muscle, body aches Chills Fever Nausea No appetite... Read more
Injection site pain Extreme tiredness Headache Muscle, body aches Chills Fever Nausea No appetite Swollen lymph nodes Feels horrible
55 2021-03-03 depressed mood, impaired work ability Within two hours Swelling on the left arm - upper part and it was painful. The first dose of the vac... Read more
Within two hours Swelling on the left arm - upper part and it was painful. The first dose of the vaccine, the pain started the second day and the injection site got swollen. But this second dose was within 2 hours of my vaccine even more and overwhelming fatigue. - aches, chills, muscle cramps, coughing, sweating - those lasted three days; headache - ever present and felt like head was in a vice; breathing was an issue - asthma was triggered on Sunday - I started prednisone - informal dr consultation with a friend - on Tuesday because of the asthma and by Friday I was feeling halfway better again and by the following Sunday about 75% better. 9 days later I was back at work. It took that week back at work though to get back out of the funk and by the following weekend I was close to 90%. Pain in the shoulder lasted about two weeks - it was quite tender for that long.
55 2021-03-04 sleep disorder PAIN IN THE BONES, JOINTS, SLEEP, FEVER, RASH ON THE SKIN (LIKE MEASLES), ITCHING ALL OVER BODY. DAY... Read more
PAIN IN THE BONES, JOINTS, SLEEP, FEVER, RASH ON THE SKIN (LIKE MEASLES), ITCHING ALL OVER BODY. DAY 3 AND 4 WAS STRONGER. AFTER TAKING BENADRYL IN PILL AND CALADRYL ON MY BODY, ITCHING WAS REDUCED. EVEN SOMETIMES I HAVE IT, BUT LESS INTENSE.
55 2021-03-07 feeling abnormal Extreme fatigue, loopiness, slight vomiting in first two days but not since, shaking hands (happened... Read more
Extreme fatigue, loopiness, slight vomiting in first two days but not since, shaking hands (happened on two days, was worse in the mornings but improved as day went on), cold sweats.
55 2021-03-08 anxiety Dizziness starting 20 minutes after vaccination. Slightly fast heartrate, sweating, anxiousness star... Read more
Dizziness starting 20 minutes after vaccination. Slightly fast heartrate, sweating, anxiousness starting within 1 hour of vaccination. All of the aforementioned symptoms went away by approximately 5.5 hours after vaccination. Left arm sore starting several hours after vaccination, increasing during the 24 hours after vaccine, then went away by roughly 48 hours after vaccination.
55 2021-03-08 insomnia Fever & chills overnight, difficulty sleeping. Continued fever & chills the next day with fatigue, m... Read more
Fever & chills overnight, difficulty sleeping. Continued fever & chills the next day with fatigue, mild headache and muscle aches, but all diminished as the day progressed. Better on 2nd day with only slight fatigue and muscle ache remaining.
55 2021-03-14 memory impairment, feeling abnormal 'Fuzzy brain' & forgetfulness lasting 24 hours. Sore arm lasting 48 hours
55 2021-03-19 feeling abnormal 30 minutes after receiving vaccine, felt like electric shocks in the head (two to three times). It s... Read more
30 minutes after receiving vaccine, felt like electric shocks in the head (two to three times). It stopped in the evening but got constant low headaches afterwards. Around 5pm, felt like a change in taste (saltier taste) that was temporary. Has uncomfortable wrist pain like twisting a screwdriver too much. Started feeling itchy today after 9 am. Face was swollen after waking up today and has subsided greatly since. Had very low fever last night and now feels like no fever. Right now, feeling has a lot of saliva and then have to swallow and little uncomfortable in arms and knees, and weakness. Only took one Aleve pill last night. Around 4:30pm, felt a little blurry for 5 to 10 seconds.
55 2021-03-22 disorientation Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared dia... Read more
Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared diaphoretic with mask down. He flagged down nurse and reported feeling hot/lightheaded. NP asked for BP machine, instructed patient to take slow deep breaths. Pt. reported he felt like he may lose consciousness. His eyes rolled and he became white/pale and appeared to stop breathing. Code assist called; didn't respond to sternal rub, but raspy breathing, weak/rapid pulse palpated; immediately transferred to the ground level without falling, 2 person assist. 9-1-1 called, BP machine didn't immediately work. As soon as his head was low, his face became bright red and he regained consciousness. He was disoriented briefly but then able to answer questions/oriented. BP elevated, HR 80s. BS 257. No s/s anaphylaxis. Hx of syncope r/t blood draw. Wife present and report hx of DM, HTN, Palpitations. He denied CP/SOB or palpitations. He had eaten and took regular medicine the morning. Paramedic arrived and patient was transported to the nearest ER. Pt. was later discharged.
55 2021-03-23 sleep disorder 24 hours post-vaccination, patient developed SEVERE arm pain, such that he has been unable to sleep ... Read more
24 hours post-vaccination, patient developed SEVERE arm pain, such that he has been unable to sleep thru the night and is in near constant pain. Now 6d post vaccination and still very severe pain. Otherwise healthy and fit 55yo. Only able to hold his arm in a couple of positions to get relief from the pain. Feeling numb in entire lower left arm.
55 2021-03-24 disorientation Diarrhea , weakness, sharp pain on back left flank, needles in pelvis and extremities, cold extremit... Read more
Diarrhea , weakness, sharp pain on back left flank, needles in pelvis and extremities, cold extremities, headache, disoriented
55 2021-03-24 memory impairment, confusional state Within 5-minutes of vaccination, the patient reported weakness and confusion. EMS evaluated the pati... Read more
Within 5-minutes of vaccination, the patient reported weakness and confusion. EMS evaluated the patient on-site. No signs of stroke. EKG demonstrated NSR, rate 77bpm, no ST elevation. FSBG was 290mg/dl. EMS transported the patient to Hospital Emergency Department. Enroute, the patient became increasingly confused, forgetting their birthday and location. Patient was hypertensive (178/104) and reported a "crushing headache". EMS crew became concerned for stroke. In ED, the patient remained hypertensive (178/93). ED Physician had high suspicion of TIA versus acute reaction to COVID-19 vaccine. Administerd 650mg acetaminophen and 1mg Lorazepam. Admitted patient to critical care unit where patient stated they had developed a sudden-onset diffuse banding-like headache with associated nausea, diaphoresis, blurry vision, and confusion. MRI was negative and patient was transferred from ICU to hospital. Hospital physician believed the symptoms were likely a vagal mediated response or reaction to his COVID vaccination. Patient was discharged on 3/20 with diagnoses of TIA, Acute encephalopathy, Insulin-dependent type 2 diabetes, Essential hypertension, CAD, Unspecified mood disorder, Dyslipidemia, Obesity, and Mild neuro cognitive disorder
55 2021-03-28 confusional state Symptoms started 3/19/21 and was diagnosed with COVID-19 on 3/21/21. Presented to ED with weakness, ... Read more
Symptoms started 3/19/21 and was diagnosed with COVID-19 on 3/21/21. Presented to ED with weakness, cough, confusion and fever on 3/27/21. He was started on supplemental oxygen, remdesivir, and dexamethasone and was admitted to hospital for 3 days.
55 2021-03-29 impaired work ability Arm started to swell around 3 PM. I had to quit work and go home. I was experiencing some moderate t... Read more
Arm started to swell around 3 PM. I had to quit work and go home. I was experiencing some moderate to severe pain in my left arm where the injection occurred. It is almost 9 PM and the arm still hurts, but not like before. On a scale of 1 to 10 the pain factor was about 5 to 7. I was experiencing some mild shock symptoms (flush face). I couldn't use my left arm for anything, the pain was too great.
55 2021-03-30 impaired work ability I had the chills 101° fever feelings of nausea , muscle weakness , extreme fatigue had to leave wor... Read more
I had the chills 101° fever feelings of nausea , muscle weakness , extreme fatigue had to leave work and slept for 15 hours straight I am currently taking today off to to fully recover
55 2021-03-31 abnormal dreams I was woken up at about 1:15AM with major night sweats and vividly scary dreams of scary faces . I ... Read more
I was woken up at about 1:15AM with major night sweats and vividly scary dreams of scary faces . I opened my eyes and I was still seeing the scary faces that were scaring me and causing me to yell and move around in bed while asleep. I girlfriend said I was yelling and moving around a lot prior to waking up. Once awake, I was still seeing the visions for about 2 minutes until I turned on the light and my eyes adjusted to the brightness. When I turned the light off and tried to go back to sleep, the faces appeared again. I was not able to go back to sleep and ended up getting out of bed and going out on the couch to watch TV to avoid being in the darkness and closing my eyes. I'm not one to dream very often and this was certainly and vividly scary night.
55 2021-04-01 feeling abnormal Dizzy and feels like crap
55 2021-04-02 insomnia The second day I only had a sore arm where I received the injection. Thereafter, and up until 4/2/21... Read more
The second day I only had a sore arm where I received the injection. Thereafter, and up until 4/2/21 PM when going to bed I had fluctuations of hot and cold sweats, difficulty sleeping, daily low grade fever, neck and shoulder pain, mild to medium headaches, and a much lower than usual energy levels.
55 2021-04-06 depression He got the vaccine, no reaction to the vaccine injection site. On coming into work this morning he ... Read more
He got the vaccine, no reaction to the vaccine injection site. On coming into work this morning he feels like he is having a manic episode from his depression. Arthritis is feeling better after the injection. His manic episode consists of being overly active. He has notified his doctor and they told him to call the pharmacy which gave him our number. About 5 years ago he had a hyperactive thyroid disorder and is in remission from that.
55 2021-04-07 confusional state, feeling abnormal I received the vaccine about two - three inches from the center of the muscle and in back of center ... Read more
I received the vaccine about two - three inches from the center of the muscle and in back of center - it was more in back of deltoid than the front of my deltoid. When I first got the shot, I had a burning sensation from the site of needle to back of neck to behind my ear area. It felt like a burning aching feeling. My ear felt like it was clogged up and aching. I told the medical site about it and the doctor on site said that more likely they hit a nerve. My blood pressure was very elevated. They had me stay to be observed for 45 minutes. I went back to work. I still felt it at night. The next day, I started feeling up my neck and my collarbone and my left side of my face and my head - my face felt tight and my lip felt numb on the left side and I had a slight confusion too. I went to Emergency room. They did CAT Scan and exam. After that, I noticed it was going all the way down my arm, all the left side of my body to toes. It felt like numbness - like neuropathy type feeling. It felt like constant pain. I went to the Urgent Care and they gave me Prednisone steroid (5 days of it) 5 mg to help with inflammation. I took that for the five days. I started noticing a little black bruising on my body. After that, I went to the Urgent Care again and they gave me Naproxen and and Dr gave me more Naproxen to take. He took bloodwork, too. I went to the ER and I was still feeling sick and hot. They said it was anxiety. I am still going through it - I feel it on the spot where I got the shot - and on my neck and on my head and on my left eye and down on my legs a lot - some days are worse than others but not as bad as when I had the first symptoms.
55 2021-04-08 anxiety nausea, fever, elevated blood pressure, fatigue all currently resolved. This caused to worsen his an... Read more
nausea, fever, elevated blood pressure, fatigue all currently resolved. This caused to worsen his anxiety which is still presenting effects
55 2021-04-08 disturbance in attention Body aches, fever (101.4F), trouble concentrating, fatigue, listlessness
55 2021-04-09 disturbance in attention Terrible congestion, runny nose that did not stop from Sunday 4/4/21-Saturday 4/10/21 8:00 am, chest... Read more
Terrible congestion, runny nose that did not stop from Sunday 4/4/21-Saturday 4/10/21 8:00 am, chest, lungs hurt, body aches earlier in week, had to stay in bed on and off all week, no energy, forced myself to eat, severe coughing by Wednesday 4/7/21 which has only stopped on 4/10/21. was most severe Thursday 4/8-Firday 4/9 Could not concentrate all week, even watching tv.
55 2021-04-13 feeling abnormal I had very severe vomiting followed by diarrhea and fever that lasted 2 complete days, now I am in ... Read more
I had very severe vomiting followed by diarrhea and fever that lasted 2 complete days, now I am in vaccination +6 days and now my wife is sick and I still have very bad nausea and near vomiting, I also still have sweating and fever but it is getting better, terrible light headedness when I stand and brain fog all day, still continues.
55 2021-04-15 anxiety few mins after vaccine, felt clammy, dizzy. staff notified, assisted patient to floor to put feet on... Read more
few mins after vaccine, felt clammy, dizzy. staff notified, assisted patient to floor to put feet on chair. few mins later assisted to stretcher and taken to obs. in trendelenberg. states was anxious about vaccine. bp 155/71 hr 86 rr 20 sats 95%. water and snacks provided, sat up, bp 172/68 hr 86, rr 18, sats 98% on ra; stated he hadnt taken his noon lisinopril yet and still pretty anxious. after resting, bp 167/81 hr 87, requesting to leave with spouse. escorted to exit with no further issues, instructed to take lisinopril once home.
55 2021-04-15 panic attack, disturbance in attention, feeling abnormal, anxiety, sleep disorder Following day a sore arm and lethargic. 3 days after developed a very foggy mind unable to process ... Read more
Following day a sore arm and lethargic. 3 days after developed a very foggy mind unable to process information, headache severe at times. Severe joint pain throughout body. Nauseous minimal but there. Anxiety very severe at times . 7 days post symptoms remain and elevated anxiety, tired, lethargic, unable to focus, panic attacks, debilitating at times. Woken up from deep sleep still 7 days post of incredibly severe arm pain in arm hat was injected.
55 2021-04-16 feeling abnormal On April 16 had absence seizure. I have not had one in over 7 months and felt no warning or precurs... Read more
On April 16 had absence seizure. I have not had one in over 7 months and felt no warning or precursors. That night fatigue, chills (freezing) headache, nausea, foggy thinking, tense shoulder neck muscles, foot cramps. Day of 17th (ongoing) fatigue, tense shoulders/neck/ lack of hunger, foggy thinking, headache went away with Ibuprofen and Tylenol. Have ate yet so unsure of nausea.
55 2021-04-16 feeling abnormal About five minutes after administering vaccine, patient's spouse reported that patient is not feelin... Read more
About five minutes after administering vaccine, patient's spouse reported that patient is not feeling good and about to faint. Pharmacist on duty immediately attended the patient. Patient was sitting on a chair, started fainting, didn't completely faint though. Patient responded to pharmacist and reported he felt like he was going to sleep and all sudden woke up. Called for emergency help, EMT team checked patient, all the vitals were ok, patient decided not to go to hospital. Patient waited in the store for additional 15 minutes and left the store around 12:45pm
55 2021-04-16 feeling abnormal Feeling pulses, whole arm is numb including fingers are numb
55 2021-04-17 confusional state Facial paralysis on right side; Inability to see or focus and many more serious conditions sppeared ... Read more
Facial paralysis on right side; Inability to see or focus and many more serious conditions sppeared 20-30 approx; Inability to see or focus and many more serious conditions sppeared 20-30 approx; slurred speech; confusion; This is a spontaneous report from a contactable consumer reporting for himself. A 55-years-old male patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at School or Student Health Clinic, via an unspecified route of administration, administered in right arm on 29Mar2021, at 55 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergy to penicillin and sulfa since an unknown date. The patient was not diagnosed with COVID-19 prior to vaccination and he has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. On 29Mar2021 at 12:00 the patient experienced facial paralysis on right side, inability to see or focus and "many more serious conditions appeared 20-30 approximately after injection", slurred speech and confusion, all assessed serious for disability. The patient visited his doctor and was prescribed with unspecified medications and a brain scan. The brain scan was performed on an unknown date and no result were provided. At the time of the report the reported events had not resolved yet. Information on the lot/batch number has been requested.
55 2021-04-18 anxiety, feeling abnormal, sleep disorder A wave came over me that felt like I was going to die, or at least pass out. motor skills were impai... Read more
A wave came over me that felt like I was going to die, or at least pass out. motor skills were impaired, became drenched with sweat and then got the shivers. The worst part only lasted about 15 minutes but it scared the shit out of me. felt like crap the rest of the day, super fatigued. Slept well last night but still feel like I could sleep for another 10 hours. Not quite thinking clearly either.
55 2021-04-19 sleep disorder, feeling abnormal, disturbance in attention, agitation Approximately 48 hours after shot I started feeling very warm flush and experiencing tingling in han... Read more
Approximately 48 hours after shot I started feeling very warm flush and experiencing tingling in hands and feet. No fever, headache or joint pain. Also just not feeling like myself. Lack of concentration, agitated, general fatigue. Hand and feet tingling has been worse and night and causing interrupted sleep. This feeling has not gone away and I'm now past two weeks since shot and Wondering if I should get second dose.
55 2021-04-23 irritability I had pain at injection site, mild night sweats, and increased tinnitus (I have had tinnitus for man... Read more
I had pain at injection site, mild night sweats, and increased tinnitus (I have had tinnitus for many years) the night of / after the first and second shots (03/26/21 and 04/16/21) After the second shot, I had less pain at the injection site, mild body aches, and increased tinnitus the night of the second injection. However, the real reason I am reporting this is because after the second dose, the increased tinnitus continued intermittent, usually in the evenings. The tinnitus became especially pronounced on day 2 or 3, 4, 5 and day 8 - the ringing became so loud on the evening of day 2 that it seemed I was having trouble hearing the television. And on the evening of day 8 after the second dose, the tinnitus again became quite loud, with the additional symptom that external noises were annoying / irritated me. I have had constant tinnitus for at least 20 years, and it almost never bothers me (or is even noticeable.) However, the tinnitus symptoms after the second Pfizer shot were pronounced enough that I thought I would report it. Of course, I can't be sure the tinnitus symptoms - especially those at days 4, 5 and 8 - are indeed side effects of the second dose of the Pfizer vaccine, but since I had increased tinnitus symptoms the night after both the first and second Pfizer doses, it would seem to me to probably not be a coincidence.
55 2021-04-24 feeling abnormal Pain started in left knee, and left hip; discomfort in left ankle; Left leg still weak and feels uns... Read more
Pain started in left knee, and left hip; discomfort in left ankle; Left leg still weak and feels unstable; still achy; Left leg still weak and feels unstable/unstable; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm at the age of 55-year-old on 26Mar2021 09:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Restless Legs Syndrome. No known allergies. No covid prior vaccination. Concomitant medications included ropinirole and statin. The patient experienced pain started in left knee, and left hip. Very severe at times. Some lighter discomfort in left ankle. Left leg still weak and feels unstable. It's gotten a bit better, but still achy and unstable. Events onset date was all on 27Mar2021 11:00. AE resulted in Disability or permanent damage. No treatment received for the events. The outcome of events was reported as resolved with sequel. Information on the lot/batch number has been requested.
55 2021-04-24 excessive sleepiness sleeping a lot; he was tested positive for covid; he was tested positive for covid; experiencing mil... Read more
sleeping a lot; he was tested positive for covid; he was tested positive for covid; experiencing mild congestion in the head/congested in his head; sense of smell is pretty much gone; decided since his throat was scratchy; congestion in his ears; Exhaustion/ Fatigue; This is a spontaneous report from a contactable consumer (patient). A 55 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation, age at vaccination 55 years old. Medical history included Diabetic from 2013 (Diabetes is fairly under control. He has no super high readings. His diet is better); blood pressure (blood pressure abnormal) from 2013; ongoing overweight (obviously he is overweight) from an unknown date; and heart (disorder) from an unspecified date. Concomitant medications included metformin taken for an unspecified indication; lisinopril for blood pressure (abnormal); and lovastatin for heart (disorder), start and stop dates were not reported. Patient is taking an unspecified over the counter multivitamin. There were no other recent vaccinations or started any new medications. The patient is due for the second dose on 9April2021, but he tested positive for COVID-19 on 01Apr2021 with a PCR test described as oral saliva test. Patient was negative on a rapid test on an unspecified date. Patient wanted to know if he could reschedule the shot and when is it recommended. The patient had a coworker who tested positive, he decided since his throat was scratchy that maybe he had got it, then two more employees had gotten COVID-19 so he got a rapid test that was negative. On Mar2021, he stated he stayed home because he was experiencing mild congested in his head/congested in his head, which it still actually was, and he lost sense of smell completely. He was really tired, sleeping a lot, had congestion in his ears, and he can't smell anything. Patient had no fever, and his lungs were clear (unspecified date), so he commented it was deceiving since he feels fine like he can do whatever he wants, then he gets exhausted and sleeps. He stated he can't work for a whole week. He stated he is assuming his first dose of the shot is helping with it. Patient stated he is doing well, he has it (COVID-19), but he feels pretty good. Outcome of congested in his head was not recovered, while unknown for the other events.
55 2021-04-28 disturbance in attention Swollen & painful Lymph nodes under left arm and above left Clavicle, headaches, fatigue and problem... Read more
Swollen & painful Lymph nodes under left arm and above left Clavicle, headaches, fatigue and problems concentrating.
55 2021-04-30 depression, emotional distress, insomnia, anxiety Severe depression; anxiety; deep emotional distress; Fatigue; Insomnia; This is a spontaneous report... Read more
Severe depression; anxiety; deep emotional distress; Fatigue; Insomnia; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 (Lot number: ER8735) on the right arm as single dose for COVID-19 immunization. Medical history included ADHD, hypothyroidism. No Allergies. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (Lot number: EP7534) on the right arm as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not test for COVID-19. The patient did not have covid prior vaccination and did not have covid tested post vaccination. On 09Apr2021, patient experienced severe depression, anxiety, deep emotional distress, fatigue, insomnia. Events resulted in Doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse events. The outcome of events was not recovered. This report was assessed by the reporting consumer as non-serious. No follow-up attempts are needed. No further information is expected.
55 2021-04-30 emotional distress, excessive sleepiness Sever distress, no food, water, sleep four days; Sever distress, no food, water, sleep four days; BP... Read more
Sever distress, no food, water, sleep four days; Sever distress, no food, water, sleep four days; BP 180/120; fever; sweats; body pain; headache; 24 lbs lost 7 days; chills; smell/taste; smell/taste; still sick; This is a spontaneous report from a contactable consumer reporting for himself. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 08Apr2021 at 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. Medical history included chronic pain from an unknown date and unknown if ongoing, and liver issues from an unknown date and unknown if ongoing. Concomitant medication(s) included morphine taken for an unspecified indication, start and stop date were not reported; fluoxetine taken for an unspecified indication, start and stop date were not reported; gabapentin taken for an unspecified indication, start and stop date were not reported; tamsulosin taken for an unspecified indication, start and stop date were not reported; and naproxen (NAPRO) taken for an unspecified indication, start and stop date were not reported. Past vaccination history included the first dose of BNT162B2 on 18Mar2021 as a single dose in the left arm for covid-19 immunization. The patient experienced sever distress, no food, water, sleep four days on 09Apr2021 at 20:00 with outcome of not recovered, blood pressure 180/120 on 09Apr2021 at 20:00 with outcome of not recovered, fever on 09Apr2021 at 20:00 with outcome of not recovered, sweats on 09Apr2021 at 20:00 with outcome of not recovered, body pain on 09Apr2021 at 20:00 with outcome of not recovered, headache on 09Apr2021 at 20:00 with outcome of not recovered, 24 lbs lost 7 days on 09Apr2021 at 20:00 with outcome of not recovered, chills on 09Apr2021 at 20:00 with outcome of not recovered, smell/taste on 09Apr2021 at 20:00 with outcome of not recovered, and still sick on 09Apr2021 at 20:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood pressure measurement: 180/120 on 09Apr2021, sars-cov-2 test nasal swab: negative on 11Apr2021. Therapeutic measures were taken as a result of sever distress, no food, water, sleep four days, blood pressure 180/120, fever, sweats, body pain, headache, 24 lbs lost 7 days, chills, smell/taste, and still sick and included migraine medications, pain control, fluids, and supportive care. It was reported that he was hospitalization in ER twice for supportive care and also reported that Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
55 2021-05-02 feeling abnormal Pain, discomfort at injection site - feels like punched hard in the arm. Numbness, tingling below th... Read more
Pain, discomfort at injection site - feels like punched hard in the arm. Numbness, tingling below the wrist on the injection arm (lasted about an hour or so). Worst side effect was the "brain fogginess" - that lingered for almost 4-5 hours. Felt very odd, out of sorts.
55 2021-05-02 panic reaction Right ear itchy after getting vaccine. Around 3 pm Right ear itchy, throat tight , sore under jaw li... Read more
Right ear itchy after getting vaccine. Around 3 pm Right ear itchy, throat tight , sore under jaw like when you swallow clearing throat .No problem eating dinner.7 pm Trouble swallowing feels stuck when swallows food, esophagus tight. 10 pm took Benadryl . Panicky at 12 midnight. Benadryl helped still feels tight did not want to take second benadryl . Watched until 1:30 am felt tightness under chin but esophagus relaxed. Ringing in ears Saturday all day and still has it. Started Friday but has gotten worse. was told to inform patient to go to PCP.
55 2021-05-05 disturbance in attention, insomnia Approx. 16 days after my Covid-19 shot, I began hearing loud ringing in both ears that doesn't go aw... Read more
Approx. 16 days after my Covid-19 shot, I began hearing loud ringing in both ears that doesn't go away. It has continued and doesn't stop. Volume fluctuates. Sounds like crickets or an electronic hum/buzz sound. Very disturbing and it's hard to concentrate and hard to sleep. The research I've done indicates this is Tinnitus. I don't know yet if this is permanent.
55 2021-05-12 panic attack About 3 days after first vaccine I started experiencing tinnitus, pressure/tension at the base of my... Read more
About 3 days after first vaccine I started experiencing tinnitus, pressure/tension at the base of my skull and symptoms of occipital neuralgia as significant tingling over my scalp and mildly in my face. I did not put this together with the vaccine until is clearly worsened after my second.
55 2021-05-13 feeling abnormal, disturbance in attention Mild overall, but more pronounced than the first vaccination in the series, and definitely the resul... Read more
Mild overall, but more pronounced than the first vaccination in the series, and definitely the result of the vaccination. Reporting just as an FYI. Soreness at the site of injection on my right arm starting several hours after, (Friday), and lasting through two days (Sunday). Took a Tylenol a day. Extreme lethargy/tiredness for several days, and somewhat "off", the first day being the worst. Wasn't really "myself" again until about Tuesday (fourth day). "Off" meaning tired and not 100% clear-thinking. Worst on Saturday and gradually better each day after.
55 2021-05-14 abnormal dreams I felt absolutely fine after eating dinner, but was tired so got in bed around 9:30. I had some ver... Read more
I felt absolutely fine after eating dinner, but was tired so got in bed around 9:30. I had some very vivid dream & woke up at 11:00, the sheet on the bed was wet with sweat, drool on pillow & every muscle in my body was cramped up. I think it was a convulsion/seizure, but was alone in the hotel room. Today, I feel perfectly normal -
55 2021-05-17 disturbance in attention Low fever (100°F), headache, body aches, unusually tired, lack of concentration. This lasted for le... Read more
Low fever (100°F), headache, body aches, unusually tired, lack of concentration. This lasted for less than a day. I took ibuprofen, which helped.
55 2021-05-18 disorientation tested positive for COVID; Disorientated; Difficulty breathing; Fever; cough; This is a spontaneous ... Read more
tested positive for COVID; Disorientated; Difficulty breathing; Fever; cough; This is a spontaneous report from a contactable consumer (the patient's wife) received from a Pfizer-sponsored program. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 02Apr2021 (also reported as 03Apr2021) around 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no adverse events following prior vaccinations. The patient tested positive for COVID on 10Apr2021 and went to the hospital. The patient also experienced fever, disorientated, and difficulty breathing. The patient's wife clarified that the patient went to the emergency room and was hospitalized for four days, from 16Apr2021 to 20Apr2021, for all three symptoms of fever, disorientated, and difficulty breathing. The patient was hospitalized for COVID. It was also reported that fever was from 11Apr2021 to 18Apr2021, disorientated from 16Apr2021 to 17Apr2021, difficulty breathing from 14Apr2021 to 24Apr2021, cough from an unspecified date. On 10Apr2021, COVID test results were positive. On 24Apr21, COVID test results were negative. For treatment at home, the patient took acetaminophen (TYLENOL), ibuprofen (ADVIL), and an albuterol inhaler. When he was admitted to the hospital, he was given IV fluids, TYLENOL, dexamethasone, a blood thinner (did not know the name). He also took cough medicine called guaifenesin at the hospital. When the patient was released from the hospital, he was given 6 days of prednisone to take. The patient did not have an appointment yet for the second dose. All events were considered medically significant. The outcome of cough was unknown. The other events recovered on the following dates: tested positive for COVID- on 24Apr2021, fever- on 18Apr2021, disorientated- on 17Apr2021, difficulty breathing- on 24Apr2021. Information on lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021498996 same drug/similar event, different patients;US-PFIZER INC-2021502035 same drug/similar event, different patients;US-PFIZER INC-2021502065 same drug/similar event, different patients
55 2021-05-24 feeling abnormal, confusional state Metallic taste in mouth after injection; dizziness; nausea; confusion; cold tingling hands and feet.... Read more
Metallic taste in mouth after injection; dizziness; nausea; confusion; cold tingling hands and feet. Pt states he felt really bad and had the urge to defecate.
55 2021-05-25 anxiety anxiety attack; heart racing; intense feeling of heat in body; tired; shortness of breath; This is a... Read more
anxiety attack; heart racing; intense feeling of heat in body; tired; shortness of breath; This is a spontaneous report from a contactable other HCP (patient). A 55-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Apr2021 16:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergy. There were no concomitant medications and the patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient previously took levofloxacin and experienced allergy. The patient reported that approximately three minutes after taking the vaccine 24Apr2021 16:33 (also reported as 17:15), still waiting for the recommended 15 minutes to be released, he started to feel his heart racing and a very intense feeling of heat in body. After reporting to the nurse at the location, she listened to his heart asking him to take a deep breath several times. According to the nurse, he had an anxiety attack, as she did not show any signs of anaphylaxis. However, he felt very tired and the night with a little shortness of breath. He would like to know if he go for the second dose or look for another vaccine. the patient did not receive treatment for the events and the outcome of the events was resolved in 2021. Information on the lot/batch number has been requested.
55 2021-05-25 disorientation first day: fever 100.7, fatigue, extreme thirsty second day: fever 100.8, very disoriented, extreme ... Read more
first day: fever 100.7, fatigue, extreme thirsty second day: fever 100.8, very disoriented, extreme fatigue, I passed out and was unconscious for atleast 2-3 minutes 911 was called.
55 2021-05-25 insomnia Fatigue; sleepless night; This is a spontaneous report from a contactable Non health care profession... Read more
Fatigue; sleepless night; This is a spontaneous report from a contactable Non health care professional consumer, the patient. A 55-Years-old adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EN6207 and expiration date not provided) dose no:1 on right arm via an unspecified route on 13Mar2021 at 11:00(at the age of 55-years-old) as a single dose for COVID-19 vaccination (COVID-19 Immunisation). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Medical history included allergic to Morphine, Dilaudid and the past medical history included bipolar 1 disorder. Concomitant medications included Lithium carbonate, valproate, quetiapine and Pramipexole. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. After the vaccination, on 14Mar2021 at 02:00 AM patient experienced fatigue lasted for 2 days and sleepless night on the first night. The patient recovered from the events Fatigue and Insomnia at the time of this report. No follow-up attempts are needed. No further information is expected.
55 2021-05-28 feeling abnormal Felt bad; has stomach pain; vomiting; This is a spontaneous report from a contactable consumer (pati... Read more
Felt bad; has stomach pain; vomiting; This is a spontaneous report from a contactable consumer (patient's friend) via a medical information team. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 16May2021 (at the age of 55-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Caller says they have a friend put on the Pfizer COVID vaccine on Sunday, 16May2021 and since then has felt bad, has stomach pain and vomiting. He wants to know where to take him, whether to the doctor or a hospital. Advised the caller that they should take the patient to the physician as he could get the medical history of the patient and give medical recommendations and rule out possibilities. The outcome of the events was unknown. Information on the lot/batch number has been requested.
55 2021-06-01 insomnia First dose: soreness in left arm for 1 day. Second dose: Day 1 and 2: Heat sensations from the... Read more
First dose: soreness in left arm for 1 day. Second dose: Day 1 and 2: Heat sensations from the inside of my body. Opposite of a flu like feeling. Day 1 thru 4: Insomnia
55 2021-06-03 anxiety Markedly elevated blood pressure, anxiety, severe body aches, chills
55 2021-06-07 confusional state He had a stroke- sudden onset of weakness,- facial drooping, speech impairment, lethargy, and confus... Read more
He had a stroke- sudden onset of weakness,- facial drooping, speech impairment, lethargy, and confusion obvious symptoms did resolve over 24 hour- he has some residual fatigue and questionable changes post stroke
55 2021-06-14 amnesia I suffered a Subarchnoid brain hemorrhage. The was bleed in the subarachnoid space surrounding the b... Read more
I suffered a Subarchnoid brain hemorrhage. The was bleed in the subarachnoid space surrounding the brain. I went to emergency at hospital with worst headache of my life. After a brain hemorrhage was confirmed by CT-scan, I was rush to hospital were I was treated in the Cerebral critical unit. I suffered through the worst pain of my life for 10 days as the blood from the hemorrhage drained. It 2.5 months later and I am still dealing with the effects of the hemmorhage (headaches, exhaustion, light sensitivity, short term memory loss and speech issues,
55 2021-06-16 feeling abnormal Sniffles/ runny nose; not feeling normal after all; Sinus congestion; cough; COVID-19 PCR test posit... Read more
Sniffles/ runny nose; not feeling normal after all; Sinus congestion; cough; COVID-19 PCR test positive; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 55-years -old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration as single dose on 08Apr2021 at 19:00 into left arm for COVID-19 immunisation. Medical history included pancreatitis. The concomitant medications were not reported. Patient had no other vaccinations the same day as his first dose of the COVID-19 vaccine or in the four weeks prior. On 8Apr2021, patient experienced arm soreness. On 19Apr2021, patient COVID-19 PCR test was positive. Patient stated that he was diagnosed 34 years ago, he has been battling it since then and has numerous surgeries and numerous things since. He had symptoms starting Friday. He says this Friday will have been 7 days, on the 23rd. He says on the following Friday, which is the 30th he was told he could get his second shot, but he was scheduled to get his second shot on the 29th, he wonders if that day made a difference. He says he was symptomatic, so he didn't know where he is at on a timeline to getting the second dose. He says he got the first dose shot the week prior and then that happened to his mom, so going into that weekend he had the allergy symptoms and obviously to play it safely they got tested and they were all negative. He says that following Friday he thought he had normal sinus congestion after cutting the grass, he is also always getting the sniffles from his neighbor's white pollen tree. He says to play it safe he got tested again Monday and that turned out to be positive. He says on the Wednesday the week prior it was negative after the shot they had on the 8th, then this test he had it. He says that his mom passed on the 13th, then on Tuesday which was the 14th they all were tested and all were negative. He says that he got tested again and it was positive after he felt his runny nose and cough that he had originally thought was normal over the course of the weekend was not feeling normal after all, and to play it safe he got tested. He says after his positive test after his first test was negative, because he was positive the second time everyone got tested, and his daughter was the only one who was negative the second test. Enquired ask how they could get information from the facility about when it would be ok to get the second dose, if it was when they had no more symptoms or if it was after a person tested positive or was asymptomatic 10-14 days that they can go get second dose. Enquired when is the best time to get the second dose after testing positive, whether they are symptomatic or asymptomatic.The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
55 2021-06-16 feeling abnormal Brain fog; Nausea; weakness; Weird sensation on [his] tongue 5-10 mins; Weird taste in [his] mouth s... Read more
Brain fog; Nausea; weakness; Weird sensation on [his] tongue 5-10 mins; Weird taste in [his] mouth soon after that/funny taste in mouth; Shortness of breath/difficulty in breathing; Dizziness/Light headedness; Weakness in his upper chest and in both arms; Weakness in his upper chest and in both arms; Diarrhoea; Headache; felt like my throat is gonna close, I won't say I had any difficulty in swallowing, but it was not normal; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on 06Jun2021 at 11:30 hours as 1st dose, single dose (at the age of 55-years-old) for COVID-19 immunisation. Regarding lot number patient stated that it looks like EW, patient thought he was not sure if it was 6185 or 0185, not sure it looks like 0 but it looks like 6 too but patient think it was 0. The patient medical history included shortness of breath, sleep apnea and kidney disease (from an unknown date and unknown if ongoing). Patient sees a doctor for lot of conditions one was for shortness of breath and sleep apnea and sees a neurologist for Bph. The patient concomitant medications were not reported. Patient explained he was reluctant from getting vaccinated and nervous before the shot. On 06Jun2021, after patient took the shot, probably around 11:30 in the morning, patient was same, soon after 5 min maybe more, patient got a sensation on the left side of his tongue 5-10 mins, then kind of a weird taste came to his mouth, patient started to get a little dizzy, a little light headedness, weakness in his chest and both his arms, got shortness of breath but had been seeing a doctor for shortness of breath prior taking the Covid shot and had kind of reluctant of taking the shot but some other issues going on side, patient decided to take it, a couple of hours after the shot, patient had a headache, had the diarrhea. Patient described the weird taste like having a penny in his mouth. Patient explained he consulted a doctor on that Monday (07Jun2021), who said she encountered patients who also had the sensation on their tongues following vaccination, and that it was normal. Today (08Jun2021) patient had feeling just a little bit of nausea and patient kind a feel like a little brain fog, it was just his head doesn't feel right, the major concern was says some things risks factors and some of them had severe reactions, patient had a reaction difficulty in breathing, dizziness and feel little bit weakness, patient kind of a felt like his throat was going to close and he won't say he had any difficulty in swallowing, but it was not normal. Patient developed symptoms which spooked and scared him. Patient did not have his lab test but was constantly going to patient had just had right heart catheter right two weeks ago, you know last for him, patient was supposed to take another lab test to conduct at the end of the month for cholesterol, but patient saw neurologist for kidney disease. Events did not improve, patient just had this brain fog you know. Patient had to call a doctor after he got home, they did not prescribe him anything, patient mean he did bunch of appointment with doctor with the phone as soon as he got home from taken a Covid shot he was little worried. Patient stated he was concerned about getting the second dose of vaccine scheduled on 27Jun2021. Patient stated he will not be able to consult his doctor before the vaccination appointment and was not able to get further assistance from a pharmacist. Patient repeated he does not know what to do about the second dose. Patient was kind of reluctant taking the next shot, if he was going to feel the something like this again, he don't want to, as he already had uneasy you know just had and patient did not had difficulty in breathing all of time this comes and go, from the sentence he described it says on pamphlet that there was severe reaction to the shot and don't want to take the second shot and then end up in hospital because patient had more from it so his question was he was afraid to take the second shot. Patient don't had answer to that he means he would like to talk to somebody who can give him information kind of help me to relax little bit if it was normal and in in response it was responded that decision to receive the second dose for any other reason cannot be made by the company. Patient was referred to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection, as healthcare provider knows his health situation and had access to information that can better help inform this decision. The outcome of brain fog was not recovered and outcome for other events was unknown. Information about lot/batch number is requested.
55 2021-06-24 feeling abnormal Yesterday he started to feel bad; Not feeling well; This is a spontaneous report from a contactable ... Read more
Yesterday he started to feel bad; Not feeling well; This is a spontaneous report from a contactable consumer(patient's sister).A 55-years-old adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported ) via an unspecified route of administration on 14Jun2021(at the age of 55-years-old) as 2nd Dose, Single for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported ) via an unspecified route of administration on an unspecified date as 1st Dose, Single for COVID-19 immunization. After 2nd dose of vaccination, on 14Jun2021,the patient reported of not feeling well. On 17Jun2021,yesterday he started to feel bad. She would like to know what kind of side effects are to be expected from the vaccine. Seriousness by the reporter was No. The outcome for the events was Unknown. Information on lot/batch number has been requested.
55 2021-06-29 feeling abnormal Difficult time trying to focus; Low energy; Headache; This is a spontaneous report received from a c... Read more
Difficult time trying to focus; Low energy; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration to left arm on 17Mar2021 at 13:30 (at the age of 56-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 07:00, the patient experienced extreme headache, very low energy and he had a difficult time trying to focus currently (at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. The clinical outcome of extreme headache, very low energy and difficult time trying to focus were not resolved at the time of this report. Information about lot/batch number cannot be obtained. No further information expected.
55 2021-07-07 feeling abnormal after the shots i've had complete sinus pressure in ears in which i've never had before. its been go... Read more
after the shots i've had complete sinus pressure in ears in which i've never had before. its been going on 4months of complete misery. my immune system is going crazy. I've had blood tests and all kinds of test and there's no problems accept severe allergies and ear drum with holes in both. i need help bad. this has never happen even close to what i'm experiencing now.
55 2021-07-08 disturbance in attention, sleep disorder Starting about 14 hours after vaccine administration, patient experienced difficulty concentrating w... Read more
Starting about 14 hours after vaccine administration, patient experienced difficulty concentrating with periods of hyperactivity, pain/soreness in bilateral hands with extreme pain at times with movement, soreness in bilateral feet, soreness across the back in the area of the kidneys, occasional mild dizziness, fatigue, mild nausea, hot flashes, a cold sore, poor sleep quality since vaccine, mild dyspnea on exertion, and increased temperature of about 0.5-1 degree F.
55 2021-07-11 disorientation I started to get severe headaches, burning sensation in my ears, nausea, disoriented. It went away f... Read more
I started to get severe headaches, burning sensation in my ears, nausea, disoriented. It went away for a couple weeks, and has started back.
55 2021-07-20 impaired work ability, feeling abnormal With no history of hearing problems, I lost hearing in my left ear over a two hour period on March 1... Read more
With no history of hearing problems, I lost hearing in my left ear over a two hour period on March 16, and developed acute tinnitus with hyperacusis. With steroid treatments, I recovered some of the hearing in the first week following the loss. The tinnitus and hyperacusis continue unabated, impacting my ability to function and work.
55 2021-07-21 loss of personal independence in daily activities Bilateral pain in shoulders that radiates into bilateral upper arms and elbows and down into wrist ... Read more
Bilateral pain in shoulders that radiates into bilateral upper arms and elbows and down into wrist with associated weakness in upper extremities. Unable to adduct arms without severe pain in shoulders. Unable to perform daily activities without assistance at times due to the pain that debilitates the writer. for appx 5-10 minutes until spasms resolve. Writer is unable to open jars which is a new symptom since receiving the vaccine along the pain in the upper extremities. I feel that I am currently at appx 40% of my usual strength which is causing myself a great difficulty with ADLS and performing my work duties as a clinical nurse. The above symptoms are new since the vaccine and seem to be increasing in frequency regularly. The pain is symmetrical in nature and is on the medial aspect in bilateral elbow joints.
55 2021-07-28 disturbance in attention After first shot on 26 May 2021, light headed and ringing in ears, particularly in the right ear. Li... Read more
After first shot on 26 May 2021, light headed and ringing in ears, particularly in the right ear. Lightheadedness went away after 30 minutes but ringing remained. Faded slightly after a week but intensified immediately after the second shot on 16 June 2021. Had no other reactions after the second shot. Today, 29 July 2021, it is the strongest ringing I have experienced since taking the first shot. Adversely affecting my hearing and ability to focus. My primary care doctor set up a hearing test but says there is no treatment for this.
56 2021-01-07 feeling abnormal patient begin to feel bad that night was admitted into hospital sometime in the next couple of days ... Read more
patient begin to feel bad that night was admitted into hospital sometime in the next couple of days for dehydration, patient discharged home and then readmitted to hospital for positive covid testing after feeling very ill.
56 2021-01-07 loss of personal independence in daily activities Severe chills, fatigue, shivering. Unable to do daily activities. Symptoms started 5 days after t... Read more
Severe chills, fatigue, shivering. Unable to do daily activities. Symptoms started 5 days after the COVID vaccine and have lasted for 7 days so far.
56 2021-01-08 excessive sleepiness Headache & Myalgia Narrative: Employee woke up this morning with a severe headache. He state that h... Read more
Headache & Myalgia Narrative: Employee woke up this morning with a severe headache. He state that he took one capsule of Tylenol and went back to bed sleeping for 5 hours. He states that he feels much better.
56 2021-01-08 impaired work ability Sedation employee reported significant fatigue that required leaving work Narrative: Employee was un... Read more
Sedation employee reported significant fatigue that required leaving work Narrative: Employee was unable to remain at work second to significant fatigue that required him to go home and rest.
56 2021-01-09 feeling abnormal Fever of 102, waxed and waned over 12 hours with diffuse myalgias.
56 2021-01-26 excessive sleepiness, sleep disorder 4-6 HRS post injection loose stool. 8-12 hrs fatigue, body aches. 12-22 hrs flu like body aches, no ... Read more
4-6 HRS post injection loose stool. 8-12 hrs fatigue, body aches. 12-22 hrs flu like body aches, no sleep, comfort at all. 36-48 hrs after, fever > 100 F. Slept 12 hrs straight, woke up soaking wet, 49 hrs after, Fine..... shoveiing snow
56 2021-01-30 euphoric mood, disturbance in attention, impaired work ability, feeling abnormal After being administered with the. Vaccine fist it was a little after taste in my mouth. I felt lik... Read more
After being administered with the. Vaccine fist it was a little after taste in my mouth. I felt like I wasn?t toned off of marijuana. I then became goofy. Started laughing etc. Then in the drive home about 20 minutes later I started to be tired. I was in the phone with a friend and slipped into a deep slumber. The next day Saturday I woke groggy like from a hang over minus the headache. I had a sudden urge to eat , i bacon and egg sandwich with mayo then had a urgency to eat a bowl of cereal. (rice crispies. Then tried to work (remotely from home) but I could not concentrate or focus. Finally I just threw in the towel and went back to sleep. Woke up to send this report. Good night. I still recommend this inoculation to everyone!
56 2021-02-01 feeling abnormal, feeling drunk But like a bit drunk; Felt a little tired; I'm very spaced out; feeling disconnected; This is a spon... Read more
But like a bit drunk; Felt a little tired; I'm very spaced out; feeling disconnected; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received his first dose bnt162b2 (BNT162B2 reported as Pfizer- Biontech COVID-19 Vaccine; lot number: EJ1686; expiration date: unknown), via an unspecified route of administration right arm on 19Jan2021 14:30 at a single dose for covid-19 immunization. Medical history included diabetes and high blood pressure, although both are mostly kept at bay with diet and exercise. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (AMPHET SALTS XR), trazodone, metformin and lisinopril. There was no other vaccine in the last four weeks. The patient received her vaccine in a school or health clinic. The patient reported that on about 30 minutes (19Jan2021 03:00 PM) later, he got home. He felt a little tired and maybe just out of it. It's now 2.5 hours later and he is very spaced out. He mentioned that she's feeling disconnected a bit but mostly just out of it. She was not dizzy but like a bit drunk. No treatment received for the adverse events. The patient did not have Covid tested post vaccination. The outcome of the events was not recovered.
56 2021-02-03 feeling abnormal Right Leg tingling; Strange Feeling; This is a spontaneous report from a contactable consumer (patie... Read more
Right Leg tingling; Strange Feeling; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 via an unspecified route of administration on 20Jan2021 10:00 AM at a single dose as COVID vaccine. There were no medical history and no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had no known allergies. The patient experienced right leg tingling and strange feeling on unspecified dates. Treatment was not received for the events. He had no COVID prior to vaccination. He did not have COVID tested post vaccination. The outcome of the events was unknown. Information on the lot/batch number has been requested.
56 2021-02-03 loss of personal independence in daily activities, impaired work ability Patient has pre-existing arthritis. Patient noticed significant augmentation of joint pain symptoms ... Read more
Patient has pre-existing arthritis. Patient noticed significant augmentation of joint pain symptoms starting two days after vaccination. Augmentation of joint pain symptoms has remained the same or increased in the (2) weeks following. Symptoms are interfering with work and daily activities.
56 2021-02-07 confusional state 1/30/21 patient felt dizzy, had a fever and nausea with some confusion so stayed at work for awhile ... Read more
1/30/21 patient felt dizzy, had a fever and nausea with some confusion so stayed at work for awhile due to not feeling well enough to drive home. Became worse during the night and was sent to the hospital ER.
56 2021-02-25 anxiety Immediately after administration patient seemed red and said he could feel it like he was having an ... Read more
Immediately after administration patient seemed red and said he could feel it like he was having an anxiety attack. Patient said he felt his throat closing up 20 minutes post administration. Said he didn't think he needed an epi-pen. Was offered oral Benadryl, took 37.5mg liquid diphenhydramine (15ml) or 12.5mg/5mL . After 30 minutes post administration patient said he felt he was ok to go and he said he could feel the Benadryl helping. About 7:15p pharmacist called patient cell number and patient said he could feel the Benadryl working and felt sleepy but better than before. He said he thought that maybe he just got nervous.
56 2021-03-04 feeling abnormal On the night of vaccine I had a fever up to 101 degrees, aches and fatigue into the next day. Two d... Read more
On the night of vaccine I had a fever up to 101 degrees, aches and fatigue into the next day. Two days later I started having diffuse sporadic and intermittent tingling on various parts of my body. That lasted about 2 days in its greatest severity. On day 6 post vaccine, I was walking in an airport and developed chest pain, tachycardia, and shortness of breath out of proportion to my level of exertion. This chest pain, shortness of breath and tachycardia with minimal exertion (a flight of stairs. A walk to the end of driveway.) has persisted since then. A cardiac w/u with Echo and treadmill stress ECHO were negative. I also have intermittent fatigue, headaches, and a mild "brain fog."
56 2021-03-10 impaired work ability Uncontrollable chills that night starting at 3am lasted for about an hour and a half; fever and shor... Read more
Uncontrollable chills that night starting at 3am lasted for about an hour and a half; fever and shortness of breath and tightness in the chest the next day; tightness in the chest on Saturday. Patient had previously recovered from Covid in August 2020. First positive test for Covid was at the end of July 2020. Out of work, sick with Covid for over a month.
56 2021-03-16 feeling abnormal, anxiety Patient states he "felt weird", tingly all over and extremely anxious. Patient was brought to observ... Read more
Patient states he "felt weird", tingly all over and extremely anxious. Patient was brought to observation for continued care. vs: P-92 r-16 b/p 174/92. Repeat b/p after 15 minutes was 124/90. Patient feeling much better. Now states he had been very anxious about receiving vaccine. B/P cuff recycled it did not measure correctly- air in cuff. Repeated and up to 170/90, patient states it went up because he was worried about the cuff. Refused to have any more vital signs. Ambulated in unit, did well. Discharged home after 30 minutes.
56 2021-03-17 sleep disorder discomfort; did not sleep a wink last night; Nauseous; blood pressure elevated/139/94; heart rate el... Read more
discomfort; did not sleep a wink last night; Nauseous; blood pressure elevated/139/94; heart rate elevated/His heart rate is currently 139; This is a spontaneous report from a contactable consumer (patient). A 56 -year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9264), intramuscular (on left arm) on 28Jan2021 12:30 (at the age of 56 -years-old), single dose for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. Patient is calling about the first dose of the Pfizer covid19 vaccine which he received on Thursday. Yesterday, he started getting nauseous, it is terrible and very strong. The nausea has been continuous since yesterday. His blood pressure and heart rate is pretty elevated. Declines any treatment. The nausea was bad yesterday and stayed bad, he did not sleep a wink last night. His last blood pressure taken about 10 minutes ago was 139/94. His blood pressure is normally 125 over 65 or 70. His heart rate is currently 139. His heart rate and blood pressure became elevated yesterday. States it might have to do with how much discomfort he is in. When querying other medications and medical conditions, he reports nothing out of the ordinary. The outcome of the events sleep disorder and discomfort was unknown, other events was not recovered. No Prior Vaccinations (within 4 weeks).No AE(s) following prior vaccinations.
56 2021-03-30 feeling abnormal fatigue, brain fog, mild headaches, serious TMJ - Jaw - left side only (same side as vaccine in left... Read more
fatigue, brain fog, mild headaches, serious TMJ - Jaw - left side only (same side as vaccine in left arm)
56 2021-03-30 feeling abnormal Excess energy immediately following the vaccine; diarrhea starting about 16 hours after the vaccine... Read more
Excess energy immediately following the vaccine; diarrhea starting about 16 hours after the vaccine; general metal fogginess (as expected). But NOTHING SERIOUS.
56 2021-04-03 feeling abnormal, confusional state At 8:35pm on 3/30, sudden onset severe vertigo while lying down - lasting only a minute - followed b... Read more
At 8:35pm on 3/30, sudden onset severe vertigo while lying down - lasting only a minute - followed by severe nausea and cold sweat. Couldn't open eyes or move head for fear of repeating episode. A few hours later, a repeat episode lasted a few minutes and triggered vomiting. Around 7am the next morning, a third episode violent enough to trigger vomiting again. The severe nausea and headache lasted around 12 hours, but the mild nausea and severe headache lasted 48 hours. At 5 days after vaccination, still feel lightly dizzy with a sense of confusion or fogginess.
56 2021-04-05 anxiety headache, anxiety, lethargy, shortness of breath with minor exertion. 2 days after vaccination; felt... Read more
headache, anxiety, lethargy, shortness of breath with minor exertion. 2 days after vaccination; felt better, but got tired after a couple hours of desk work. Slept 2 hours, did more desk work, got tired again. 3 days after vaccination; no symptoms.
56 2021-04-06 disturbance in attention Swelling of throat. Difficulty with memory and recalling (cloudy/foggy mind).
56 2021-04-06 sleep disorder Sudden onset diarrhea followed within a few minutes by body aches that became severe within 1 hour. ... Read more
Sudden onset diarrhea followed within a few minutes by body aches that became severe within 1 hour. Severe chills and sweating that lasted into the early morning hours. I awoke around 3 AM soaked with sweat and still with chills. I got up at around 8 AM and felt much better. Still having periodic diarrhea that is not explained by my diet.
56 2021-04-07 feeling abnormal, disturbance in attention First Day my head was in a fog, struggled to concentrate. Day two and three I feel like I have a ha... Read more
First Day my head was in a fog, struggled to concentrate. Day two and three I feel like I have a hangover with headache. still struggling to concentrate.
56 2021-04-08 feeling abnormal double pneumonia; body aches/I started aching; headache; tired/fatigue/exhausted; I got the chills; ... Read more
double pneumonia; body aches/I started aching; headache; tired/fatigue/exhausted; I got the chills; my skin felt like it was sunburned; cough; fog; no appetite; sweating; my arm hurt/sore arm; he had a previous flu like symptoms after the shingles vaccine.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10.30 (at the age of 56-years-old) as single dose for covid-19 immunisation. Medical history included hypertension diagnosed 20 years ago, blood cholesterol diagnosed about 7 years ago, Covid-19 in Dec2020 which hit him pretty hard, double pneumonia, he was wiped out, patient had a shingles vaccine a couple of years ago he had a fever and it felt like he had the flu, for about 48 hours he was wiped out. This happened with both doses of the shingles vaccine. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) and vitamin C (ascorbic acid) (VITAMIN C [ASCORBIC ACID]). On 24Mar2021 (Wednesday), patient experienced double pneumonia, body aches/i started aching, my arm hurt, headache, tired/fatigue/exhausted, i got the chills, my skin felt like it was sunburned, cough, fog, no appetite, sweating, sore arm, he had a previous flu like symptoms after the shingles vaccine. It was reported that all the same symptoms the patient had with COVID, the caller had after the vaccine. The next morning was much worse and through that next day. Patient describes his side effects like a mini Covid 19 reaction. The symptoms were very similar to the symptoms he had 4 days into his Covid-19 diagnosis. It was reported that on Friday (26Mar2021) he felt normal and was able to workout on Saturday (27Mar2021) as usual. The patient believes his antibodies are strong following his virus and then the 1st Pfizer vaccine dose. The patient doesn't think he had a fever, but he didn't have that with covid along with no loss of taste and smell. The patient was very grateful for the vaccine. Patient had no other vaccinations within 4 weeks prior vaccination. The patient underwent lab tests which included blood cholesterol and blood pressure whose results are reported as high on an unknown date. The outcome of the event double pneumonia was unknown, and for all other events it was recovered.
56 2021-04-14 sleep disorder Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, ... Read more
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Unable to Sleep-Medium, Additional Details: Patient reports experiencing numbness in both arms, has doctor's appt scheduled for further follow-up
56 2021-04-15 loss of personal independence in daily activities, disturbance in attention Mild headache and severe tinnitus in the right ear after waking the morning after the exam making it... Read more
Mild headache and severe tinnitus in the right ear after waking the morning after the exam making it difficult to concentrate on work or enjoy normal daily activities.
56 2021-04-17 feeling abnormal Dizziness, Brain Fog
56 2021-04-17 feeling abnormal Bell's palsy; Foggy brain; Loss of feeling in lips and tongue; This is a spontaneous report from a c... Read more
Bell's palsy; Foggy brain; Loss of feeling in lips and tongue; This is a spontaneous report from a contactable consumer (patient, self-reported). A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 30Mar2021 at 17:30 (age at vaccination was 56 years), as a single dose for COVID-19 immunisation. Patient's medical history included diabetes and cancer survivor. The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 09Mar2021 at 03:00 PM (age at vaccination was 56 years), as a single dose for Covid-19 immunisation. On 31Mar2021 at 09:00, the patient experienced bell's palsy, foggy brain and loss of feeling in lips and tongue. Patient did not receive other vaccines within 4 weeks or prior vaccination. Patient's treatment medications included unspecified steroid for the adverse events. The patient was hospitalized for the events on an unknown date in 2021 (for two and half days). Seriousness of the events was reported as hospitalization. Outcome of events was not recovered. Information on the lot/batch number has been requested.
56 2021-04-17 feeling abnormal Tingling, nausea, headache day of vaccination. Brain fog for following 36 hours.
56 2021-04-19 loss of personal independence in daily activities A few days after my first dose I started feeling mild light headed when standing that would not go a... Read more
A few days after my first dose I started feeling mild light headed when standing that would not go away. I checked my standing blood pressures and notices that it was very low 83/56 with a heart rate of 110. This went on for several weeks with standing blood pressures in the 80-90's/50-60's . I was having difficulty with daily activities where I would get tired just going up and down steps. I was very concerned and made an appt with my Dr. He did not think it was related to the vaccine. I was treated with chemo and radiation in 1984 for Hodgkins disease (MOPP and ABVD) were the chemo agents. This treatment as left me with mild orthostatic hypotension which I have been dealing with for over 10yrs however I have
56 2021-04-22 feeling abnormal Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: warmness in chest,tighte... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: warmness in chest,tightening of throat, no difficulty breathing but \"funny feeling\", able to complete sentences, able to answer questions, patient is alert-Mild, Additional Details: patient describes tightening of throat, warmness of chest, no difficulty breathing but \"funny feeling\" (cottony feel according to patient) when swallowing. patient is alert, able to answer questions and able to complete sentences. pharmacist on duty immediately called 911, have epipen ready. per 911 dispatcher, rph must answer some questions first, but paramedics arrived immediately to the scene and took over. patient interviewed by paramedics and patient walked with paramedics out of building.
56 2021-04-22 feeling abnormal Systemic: throat thigtness, warmness in chest, no difficulty building but\"funny feeling\" when swal... Read more
Systemic: throat thigtness, warmness in chest, no difficulty building but\"funny feeling\" when swallowing, patient is alert, able to answer questions, able to complete sentences-Mild, Additional Details: patient describes tightening of throat, warmness of chest, no difficulty breathing but \"funny feeling\" (cottony feel according to patient) when swallowing. patient is alert, able to answer questions and able to complete sentences. pharmacist on duty immediately called 911, have epipen ready. per 911 dispatcher, rph must answer some questions first, but paramedics arrived immediately to the scene and took over. patient interviewed by paramedics and patient walked with paramedics out of building.
56 2021-04-24 disorientation disoriented; Fever; Headache; swollen lymph node under left armpit for 4 days; body aches; tiredness... Read more
disoriented; Fever; Headache; swollen lymph node under left armpit for 4 days; body aches; tiredness; mild nausea; This is a spontaneous case is received from a contactable consumer (patient). A 56-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 23Feb2021 15:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes mellitus, high cholesterol and acid reflux. It was unknown if the patient had known allergies. The patient's concomitant medications were not reported. On 24Feb2021 at 02:00, the patient experienced disoriented, fever, headache, swollen lymph node under left armpit for 4 days, body aches, tiredness and mild nausea. Therapeutic measures were taken as a result of fever. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
56 2021-04-27 anxiety Respiratory, labored breathing, wheezing, anxiety
56 2021-04-27 feeling abnormal, disturbance in attention Dizziness exactly 7 days after shot. I NEVER have dizziness. And suddenly, I am feeling dizzy at ... Read more
Dizziness exactly 7 days after shot. I NEVER have dizziness. And suddenly, I am feeling dizzy at time throughout the day. It's worse when getting up out of a chair or bed, but also feel it when just staying still. I can still function, but it is strange. Also: a day after the second shot (Day 2), I got "sick" for two days (Day 2 and 3)-- sluggish, exhausted, unable to focus. Spent two days in bed. But was fine by Day 4.. Then the dizziness started on Day 8.
56 2021-05-01 confusional state Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, S... Read more
Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
56 2021-05-01 sleep disorder When I got home from receiving the vaccination, my shoulder felt very sore. When I removed my shirt... Read more
When I got home from receiving the vaccination, my shoulder felt very sore. When I removed my shirt, I noticed that the injection site (as indicated by the location of the bandaid) was in an unusual location. Instead of in my shoulder muscle, the injection site was further back toward the back side of my shoulder joint. My shoulder pain got worse throughout the day and I continue to experience pain when I lift my arm over my head or when I put weight on it while laying down. I have trouble sleeping with this pain.
56 2021-05-03 feeling abnormal States that he feels like BP is elevated, VS obtained (BP 142/75, HR 88, RR 97%) - felt better
56 2021-05-10 impaired work ability Sporadic nystagmus within days after 1st shot. 12 hours after second dose, dizziness started. Had n... Read more
Sporadic nystagmus within days after 1st shot. 12 hours after second dose, dizziness started. Had nystagmus and vertigo episodes for a week, then full vertigo at 2am for 9 hours, , vomiting could not keep in solid or liquid. In ED for CT scans and medications. After that, dizziness and severe headache for 1 week. Treated one week of meclazine. Sent to DPT for nystagmus. . After ~ 4 weeks, dizziness, headache, and nystagmus still occur. Daily ibuprofen. occasional Dimenhydrinate. Can not work, on short term disability. Unknown if there will be permanent damage
56 2021-05-10 mental status changes WEAKNESS AND COUGH COVID-19 pneumonia and urinary retention
56 2021-05-11 insomnia, feeling abnormal Soreness in arm soon after shot. Fatigue, mental fogginess, body aches at joints and back, insomni... Read more
Soreness in arm soon after shot. Fatigue, mental fogginess, body aches at joints and back, insomnia, night sweats. All began that evening and continued. I expected them to moderate but they continue. Also experiencing stomach queziness intermittently.
56 2021-05-12 excessive sleepiness Extreme Fatigue for 6 days Unable to stop sleeping. First 24 hours of the event was sleep with only ... Read more
Extreme Fatigue for 6 days Unable to stop sleeping. First 24 hours of the event was sleep with only brief wakings (5 to 10 minutes). The following 5 days 16 to 20 hours of sleep each day.
56 2021-05-13 sleep disorder After several days my knees began to hurt. They continued to worsen until i was unable to use stairs... Read more
After several days my knees began to hurt. They continued to worsen until i was unable to use stairs in my home and severely reduced my ability to ambulate anywhere. Pain was severe and constant and caused me to sleep very poorly and very little.
56 2021-05-20 sleep disorder LUQ Abdominal Pain: Patient reports that he was in his usual state of health until last week when he... Read more
LUQ Abdominal Pain: Patient reports that he was in his usual state of health until last week when he received his COVID 19 vaccination. He received 1st dose of Pfizer vaccination. Prior to this he was healthy. He reports 10 minutes after injection, he felt a knot/burning sensation in the LUQ of his abdomen. He states that it progressively worsened to the point where he couldn't sleep the following night. Over the weekend, he felt like he was improving. However, last night it was significantly uncomfortable. He feels an achiness/bruising sensation over his LUQ. He reports that there is a baseline discomfort but then it will become so bad that he has a hard time walking. He states that if he gets in a certain position he will feel improved but if he moves the wrong way it feels like it pinches. No changes with food. He reports decreased appetite. No fever, chills, nausea or vomiting. He had diarrhea x 1. No constipation.
56 2021-05-21 insomnia Caller has previously been diagnosed with arthritis, fibromyalgia and acid reflux. On Sunday, 09 May... Read more
Caller has previously been diagnosed with arthritis, fibromyalgia and acid reflux. On Sunday, 09 May 2021, at 4:00PM, at that time, all three activated at once; Caller has previously been diagnosed with arthritis, fibromyalgia and acid reflux. On Sunday, 09 May 2021, at 4:30PM, at that time, all three activated at once; Caller has previously been diagnosed with arthritis, fibromyalgia and acid reflux. On Sunday, 09 May 2021, at 4:30PM, at that time, all three activated at once; his arm pain became sever; Caller had pain at the injection site; He felt his arm shutting down from his shoulder to his fingers, becoming paralyzed; felt shaky inside; did not sleep at all; This is a spontaneous report from a contactable consumer (Patient) The 56-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot number unknown), via an intramuscular route of administration (standard 0.3mL according to patient) on 07May2021 at 02:30 PM (at the age of 56-years), for COVID-19 immunization. The patient had a family and medical history of hypertension but was not on any medications. He was on blood pressure medication (unspecified) but they took him off because he was doing fine. He had been diagnosed with arthritis, fibromyalgia and acid reflux. The patient was allergic to Tetracycline: His arm shutting down, and being paralyzed after taking tetracycline happened years ago and the paralysis was much more severe. They told him no more tetracycline for him, and he has not taken it since. He got a flu shot 26 years ago, and it put him in the hospital. He has not had a flu shot since. The patient did not receive any vaccines within 4 weeks prior vaccinations. Patient had no history of other previous immunization with the Pfizer vaccine or additional vaccines administered on same date of vaccination Concomitant medications were not reported. After first dose on 07May2021, patient had a rough time from it and felt some pain in the injection site, right after he went down to rest and felt shaky inside. Shakiness occurred right after the injection, it was subtle and at 8:00 PM his arm pain became severe, as it went on, he did not sleep at all. Patient arm pain went through out Friday night, and into Saturday morning. His arm pain was gone by 5:00 AM on Saturday morning. He felt his arm shutting down from his shoulder to his fingers, becoming paralyzed. At 8:00 AM Saturday, the paralysis sub-sided partially and at 5 pm that day he was perfectly fine. On Sunday, 09May2021, at 4:00 PM, all three: arthritis, fibromyalgia and acid reflux activated at once with no warning. That morning he had no symptoms except from the arthritis pain. He made a VAERS report and that his doctor recommended taking Ibuprofen right after taking his second dose. Event did not require Emergency Room/ Physician Office visit. He was scheduled to receive the second dose on Friday 28May2021, but due to his doctor suggestion he would like to know if he can reschedule it for Thursday 27May2021. The outcome of the events of arm shutting down from his shoulder to his fingers, becoming paralyzed; his arm pain became severe; pain at the injection site; did not sleep at all was recovered on 08May2021, and events fibromyalgia and acid reflux on 11May2021, felt shaky inside was recovered on an unspecified date in May2021, while that of arthritis was unknown. Information on the lot/batch number had been requested.
56 2021-05-22 nervousness 5/21?severe headache and shaky feeling 5/22?vomiting, headache better but still bad, hot flashes, sw... Read more
5/21?severe headache and shaky feeling 5/22?vomiting, headache better but still bad, hot flashes, sweating, shaky feeling, tongue feels ?thick? 5/23?vomiting, shaky feeling, tongue feels ?thick? and this feeling is worse today
56 2021-05-26 irritability, feeling abnormal, memory impairment, excessive sleepiness couple pains in the left chest area behind the breast; his stomach was feeling sick and his body was... Read more
couple pains in the left chest area behind the breast; his stomach was feeling sick and his body was hurting; His whole torso hurt and his stomach; The pain now is not like where it hit him with the back. He has back pain every day but more than he used to. the back pain was just the one day.; his arm was a little sore; He was lethargic and had no energy; He was lethargic and had no energy/weakness; diarrhea; Responding strangely to people/but is still there and is so weird; dizzy; getting really irritable; Slept all day for several days; Arm started hurting where he got the shot; been sick pretty much everyday; not feeling good in his stomach; he passed out for 2 days; breathing hard; wouldn't feel good; a fast heartbeat; chills; nausea; headache; he gets really short and impatient; forget a little something still, but just once in a while; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:30 (Lot Number: WR8783) as 1ST DOSE SINGLE for covid-19 immunisation. Medical history included ongoing sciatica, back problems, stomach was sensitive, lower back pain, bone spurs down his spine. He was a medical marijuana patient, he had Shigella when he was a baby. He was 2 or 3 and almost died but came out of it; His mom had cancer from smoking, he got the worse flu sick of his life. His stomach was sensitive all of the time. If he was too happy or too nervous get upset. He can eat spicy food, not super hot, but he can eat anything and it doesn't go crazy. He has a little bit of a sensitive stomach sometimes. He can't take a multivitamin or supplements because he would get sick to his stomach, this was before the vaccine. He was getting that same sick feeling now that he would get if he was taking a multivitamin. He had his blood drawn a week before he had the vaccine to check his kidneys with the pills he is on. It was perfect and normal, and he has had nothing since then. In his 20s he had the flu vaccine, and he had never had the flu in his life. That year he got the worse flu sick of his life. He never got the flu vaccine or other vaccines after that. That was probably between 1987 to 1990. His folks passed away. He had been in the hospital when he was little.Concomitant medications included acetaminophen taken for back pain, sciatica from an unspecified start date and ongoing; nabumetone taken for sciatica, back pain from an unspecified start date and ongoing. The patient experienced he passed out for 2 days (medically significant) on Apr2021 with outcome of unknown, been sick pretty much everyday (non-serious) on 07Apr2021 22:00 with outcome of not recovered, not feeling good in his stomach (non-serious) on 07Apr2021 with outcome of not recovered, slept all day for several days (non-serious) on 08Apr2021 with outcome of unknown, responding strangely to people/but is still there and is so weird (non-serious) on 12Apr2021 with outcome of not recovered, his stomach was feeling sick and his body was hurting (non-serious) on 15Apr2021 with outcome of not recovered, his whole torso hurt and his stomach (non-serious) on 15Apr2021 with outcome of unknown, diarrhea (non-serious) on 12Apr2021 with outcome of not recovered, getting really irritable (non-serious) on 09Apr2021 with outcome of not recovered, he had no energy (non-serious) on 12Apr2021 with outcome of recovering, he was lethargic/weakness (asthenia) (non-serious) on 12Apr2021 with outcome of not recovered, dizzy (non-serious) on 10Apr2021 with outcome of not recovered, couple pains in the left chest area behind the breast (non-serious) on 17Apr2021 with outcome of not recovered, breathing hard (non-serious) on Apr2021 with outcome of not recovered, wouldn't feel good (non-serious) on Apr2021 with outcome of not recovered, arm started hurting where he got the shot (non-serious) on 08Apr2021 with outcome of not recovered, headache (non-serious) on Apr2021 with outcome of unknown, his arm was a little sore (non-serious) on 13Apr2021 with outcome of unknown, a fast heartbeat (non-serious) on Apr2021 with outcome of unknown, chills (non-serious) on Apr2021 with outcome of unknown. Patient got sick around 10:00 at night. He was supposed to get his second dose but he was so sick and they said lets give it a week. Then he talked to his doctor and he said to wait 2-3 weeks to make sure he is back to normal. So he is scheduled for the second dose next week at 6 weeks. He asked if it was okay that the shot was given in the sunlight. He stated that he saw that it was in an ice chest but the person had to walk it over to him 20 feet and deal with his sleeve for a second or two so it was in the sun. He said all that walking it was 100% in the sun and he has read that it should not be in the sun. He asked if this could have caused bacteria and caused his symptoms. He stated his doctor was only concerned about giving him antibiotics for bacteria if it was in the sun and if that was a problem. He just read from CDC, once mixed the vaccine can be left at room temp for 6 hours and mixed vaccine does not need to be protected from light. So it sounds like his first shot was good. He had gotten the shot at about 1430 in the afternoon. He was like he is going to get the shot and everything will be great. He didn't think there would be an effect. Then strangely enough at about 2200 he was about to eat dinner and he got to not feeling good in his stomach. It had been close to 8 hours. The next day he slept all day, got up and had coffee, and Saturday he was in the chair in the living room. He is never in the chair during the day because he works. He slept all day and all night and the next day. He was responding strangely to people, and he was in and out of it. He had the shot on Wednesday and then his stomach was feeling sick and his body was hurting. He has back pain anyway and bone spurs on his spine. He was telling his wife whatever pain he is normally in was enhanced. His whole torso hurt and his stomach. The following Monday he had diarrhea. Then he started getting really irritable and didn't want to talk and was impatient. He was lethargic and had no energy. That was the second week. By the end of the second week he had a couple pains in the left chest area behind the breast. He thought it was a heart attack, then thought it was just pain not a heart attack. Every time he wouldn't feel good he would start breathing hard. Once in a while he gets pain through his chest area. His stomach would start and he would breath hard every time he didn't feel good. The third week he was supposed to get the second shot. He called the department of health for New Mexico. The nurse called back and said not to do the shot that week but to wait a week. He rescheduled for a week later. By the third week he was still not feeling good and called the doctor. He asked about the pain in his chest 3 times and he said it seemed to be okay. His arm started hurting where he got the shot in the second week. He still had no energy and he told the doctor this. Patient started taking 2 extra Tylenol during the day for pain. Lately he has been good until one little thing and then all of a sudden his stomach is hurting and he is holding his stomach. He was good today, all he did was eat a cookie and he didn't get sick. He was worse for a little while in the first or second week, he was really bad. It came and went over the next 2 weeks and now it is coming and going less frequently. He slept through 2 or 3 days. Thursday, Friday, and then Saturday he was in and out. He woke up to take the garbage out on Friday then saw he already took it out and forgot it was out there. And it was Saturday. He was kind of out of it. When he would respond strangely he would respond with a question he just asked and someone answered. It is like brain fog or like he is on something. It started after the weekend, more on 12Apr2021. Once in a while he will forget a little something still, but just once in a while. He would walk and hold his rib cage with both arms when he was hurting. He wrote down that it felt like somebody had hit him in the back with a bat in the lower back. One day it was that bad. His back pain was on Thursday 15Apr2021. The pain now is not like where it hit him with the back. He has back pain every day but more than he used to. The sore like he was hit in the back pain was just the one day. He had diarrhea 12Apr2021, 13Apr2021, and 14Apr2021 then it left for probably a week. Then it came back last week one day. Instead of every day it was every 3 or 4 days. He has not had it in the last 4 days. He hopes it is done. He noticed any time he has salad or lettuce he feels bad in the morning so he stopped eating those. He felt irritable more when he started not feeling good. The last 5 days or so more towards the evening at 1800 or 1900 he starts not feeling good and gets irritated. His wife will ask him something and he gets really short and impatient. He felt irritable more when he started not feeling good. The last 5 days or so more towards the evening at 1800 or 1900 he starts not feeling good and gets irritated. His wife will ask him something and he gets really short and impatient. The irritable feeling started right away the Friday of the week he got the shot. He is still struggling some, it will come and go. Yesterday he was zonked. With having no energy it is a big thing. He has to do something instead of what he would be doing. He works all day and takes long orders and stuff. Now he does like one order when normally he did 10. One for him is a huge little sore so he will lay on his right side. His left arm still hurts like a pulling hurt from his neck to his arm. It has been every day from 13Apr2021. It is much better and he will move and it will relax a little bit. It was really weird. The whole time he held the phone with his left hand up until one second he moved his phone and it was the same pain. At night the left side where he had the injection pulls on his neck muscle coming from his arm. He was actually taking two Tylenol in the morning and two at night when he went to bed. With the pain he takes 2 during the day, 650mg each. He was just taking 500mg and then his wife said take these. It seems to have gotten a little better. He always took them 2 times a day and now he takes them 3 times a day. After the first dose he experienced difficulty breathing dizziness, weakness, a fast heartbeat, chills, nausea, headache, he passed out for 2 days and has been sick for 5 weeks. He started having some dizziness a couple of days later and reports, it's like I would stand up too quickly and get a head rush, that kind of dizzy feeling. He confirmed that his dizziness did not start until a couple of days after he received his first dose.
56 2021-05-31 feeling abnormal scalp hurt; everything hurts. Brushing his teeth hurts.; couldn't move his body; wasn't feeling like... Read more
scalp hurt; everything hurts. Brushing his teeth hurts.; couldn't move his body; wasn't feeling like himself; rapid test and he came positive/yesterday (29Mar2021), he started having chills, shivering, and fever; butt cheeks hurt; This is a spontaneous report from a contactable consumer (patient's wife). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 26Mar2021 11:15 (at the age of 56-year-old) (Batch/Lot Number: ER8730) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Penicillin allergy, pain, arthritis, was hospitalized when the patient was small for 15 days in a bubble following an allergic reaction, and had knee surgery. Concomitant medications included ongoing vitamin c [ascorbic acid] taken to make sure he doesn't catch a cold; acetylsalicylic acid (ASPIRIN BAYER) taken for pain, arthritis, and as a preventative to make sure he doesn't get any clogs; and ongoing ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN) taken for multi-vitamins, after a certain age you need to take a multi vitamin. On 29Mar2021, the patient experienced couldn't move his body, wasn't feeling like himself, he started having chills, shivering, and fever yesterday (29Mar2021) then had a rapid test and he came positive, and butt cheeks hurt; on an unspecified date, scalp hurt, and everything hurts. Brushing his teeth hurts. It was further reported that they went to take a rapid test in the morning of 30Mar2021 and he came positive. The patient didn't have problems Friday/Saturday/Sunday. Yesterday (29Mar2021), he woke up and he felt like he's been having aches and pains and when he took a shower, washing his head hurt. And his butt cheeks hurt from sitting down. He's allergic to penicillin and they kept them there for 30 minutes. Everything was fine. No side effects from Friday through Sunday. But yesterday (29Mar2021), he started having chills, shivering, and fever. Additionally, it was reported that the patient was tested for Covid-19 prior to getting vaccinated and the results were negative. The wife also clarified that last night, 29Mar2021, the patient had chills, couldn't move his body, and had a temperature of 101-102. Therefore, they both made an appointment to get tested at 09:30 this morning (30Mar2021) to get tested. The patient's test came back positive. The wife again states they are going back tomorrow for a rapid and mouth Covid-19 test. Furthermore, it was reported that yesterday (29Mar2021), her husband woke up and wasn't feeling like himself. In the night, he was hot, shivering, and his temperature got up to 101. The patient's temperature was not so high this morning but that he still wasn't feeling himself. He began not feeling like himself yesterday morning, 29Mar2021. The patient confirmed that he still feels unlike himself today. The wife also reported that every time her husband would move he said that everything hurts. Brushing his teeth hurts. He even said his butt cheeks hurt. When her husband was taking a bath and passed the soap over his head, his scalp hurt. The wife makes the comment that this isn't like her husband. The patient works like a mule and doesn't complain about anything. That's why the wife got worried. For example, the patient had knee surgery and walked out limping but did not use a cane because that was the kind of man he is. He was not whiner so when he tells you something's wrong, something's wrong. The patient's second dose was scheduled 16Apr2021. The patient was allergic to the penicillin class in generalized. When the patient was small, he was hospitalized for 15 days in a bubble following an allergic reaction. The wife reported that the patient drinks (takes) every day religiously one Centrum for men, one Vitamin c, and an aspirin. She clarified all the medications that her husband drinks (takes) he has been on for at least 10 years, since he was 35 or 40 years old, tops. All of these medications are approved by the doctor. She mentions when she try and give her husband a pill, he just looks at it. He won't even drink (take) a Tylenol. Her husband works construction and was around a lot of dust. Sometimes, he will work with Clorox and stuff like that cleaning towers, so he just takes Vitamin C to stay safe. Their son was a vet and when her husband helps their son with the animals, he takes it to make sure he was clean. She also clarified that her husband drinks (takes) the aspirin that was for arthritis because he's 57 and has worked very hard. She believes the dose was 325 or 500, she was not sure. She clarified further it's the aspirin that's for body and aches. His doctor doesn't let him take any more than one tablet daily in case he gets cut, he could bleed. The patient takes the aspirin daily because both his dad and mom died of aneurysms so he was told to take an aspirin daily to make sure his arteries and everything are clean. It's a preventative to make sure he doesn't get any clogs and for the pain. She makes the comment unfortunately, their son that's 35 had to have 2 open heart surgeries. She and her husband have not been in contact with anyone. They have 3 small grandkids and a son with a history of open heart surgery. The wife reported that she and her husband live in a bubble. The patient underwent lab tests and procedures which included body temperature: 101-102 on 29Mar2021 and COVID-19 test which was negative on an unspecified date in Mar2021 and then became positive on 30Mar2021. On an unspecified date, the patient recovered from COVID-19 while outcome of the rest of the events was unknown.
56 2021-06-02 depressed mood Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Numb... Read more
Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Back hurts; Severe fatigue; He feels dizzy; Does not feel well; Coughing; Sore throat; Wasn't eating/Not eating; Body aches; Feeling down; Weak; Eyes burning; Headache/a very bad headache; This is a spontaneous report from a Pfizer sponsored program, report from a contactable consumer (patient). A 56-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0186), via an unspecified route of administration on 24May2021 (at the age of 56-years-old) as single dose for COVID-19 immunisation.The patient medical history included COVID-19 in December 2020. The patient concomitant medications were not reported. On 25May2021, the patient experienced numbness and pain in his armed where the shot was given and then continued to his left shoulder and body aches, feeling down, weak, a very bad headache, eyes burning, backed hurt, severe fatigue and he felt dizzy and he had a coughed and fatigue, sore throat, not ate. Patient states that he did some construction worked yesterday before receiving the vaccine and next day he have had been experienced the same symptoms when he had covid-19 in december 2020. Patient states he knew that the vaccine has not had anything in it that would caused him to got covid-19 so he would liked to knew if his side effects were normal. Patient would also liked to knew what could've he took to eased his headache. Patient took Tylenol and it hadn't worked. He also put ice and cold watered on it. Patient states if his symptoms were not better by next day then he would contact a health care provider. Patient states when he had covid-19 in december he was a little sick but hadn't require hospitalization and his oxygen level was between 90-92. He was not experienced a fever or chest pain as he did when he had covid-19. He was positive for covid 19 in december and had coughing, sweating, sore throat, wasn't ate, body aches, feeling down, feeling weak, eyes burning, backed hurting, headache, chest pain, and sweating. After reading the side effects that had been reported patient states he was experienced everything he mentioned except a fever, rash, itching, hives and swelling of the faced. He was fine after the covid vaccine. Next day he have had all the symptoms that he listed that he had when he had covid 19 except for the chest pain and sweating. Patient states that he just wants to knew what he could've took and did. Patient took Tylenol. He have had Tramadol but he hadn't taken it. Patient states he has not wanted have been on the phone long because he has not felt well. He stated that he knew he hasn't had covid 19 again and stated that he may did a report later. The outcome of the events was unknown. PSCC Communication: Warm transfer to (withheld) at company attempted. INT-#. Caller disconnected right before the transfer. (withheld) from company, caller states that she will reach out to the caller.
56 2021-06-02 feeling abnormal Patient stated he was encouraged by friend to call health dept now because his effects after the sho... Read more
Patient stated he was encouraged by friend to call health dept now because his effects after the shot didn't seem normal. He stated appx 50 minutes after shot #1 (4-1-2021), he had c/o of H/A that lasted 1 wk, brain fog for 1 wk, stomach cramps for 2 days & achy x1 wk, sore arm. He stated 90 minutes after 2nd shot (4-23-2021) he had c/o pounding H/A, arm fatigue, feverish off n on for 1 wk, all 4 extremities (hips to toes, shoulders to fingers) went numb for 2 hours & head fog for 2 days. No vaccines prior to covid vaccine. No issues with health history. Advised to call PCP with his complaints of side effects after the covid vaccine to decide about future booster doses, if they are offered in the coming months.
56 2021-06-05 anxiety, feeling abnormal, impaired work ability 5 minutes after vaccine stomach and sides felt heat, upset stomach, lightheaded and blood pressure e... Read more
5 minutes after vaccine stomach and sides felt heat, upset stomach, lightheaded and blood pressure elevated way up. felt very sick, went thru 3 extended observations that lasted about 1 hour and things started to calmed down except light headed and anxious. Finally felt like I could drive home then while driving home my temple and side face started tingling and went numb, pain in the back of my right eye this lasted about 20 minutes and the numbness went away however I had a sensation for a week in my temple and forehead. Could not go to work the next day, felt bad on and off for 8 days. Triggered anxiety for several days, did not get second dose..
56 2021-06-09 agitation, nervousness felt a "rush" and shakiness as if I just had a cup of coffee; felt a "rush" and shakiness as if I ju... Read more
felt a "rush" and shakiness as if I just had a cup of coffee; felt a "rush" and shakiness as if I just had a cup of coffee; felt nervous; This is a spontaneous report from a contactable consumer (patient's himself). A 56-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration in the left arm (Batch/Lot number unknown) on 06Mar2021 at 09:30 AM at the age of 56-year old as single dose for Covid-19 immunization and alprazolam (XANAX) 0.25 mg two hours before the vaccine (06Mar2021 at 07:30 AM) Relevant medical history included high blood pressure. Concomitant medications were not reported. The patient reported that he was very relaxed and calm and had taken less than 0.25 mg of alprazolam two hours prior. In less than two minutes after receiving the injection he felt a "rush" and shakiness as if he just had a cup of coffee. He was not short of breath and had no other symptoms. The patient tried to remain calm. The symptoms subsided in less than 30 seconds. He still felt nervous but may have been out of concern after the "rush" feeling. The site monitor approximately 8 mins. after the injection asked him how he was doing. He told him he was shaky but may have been nervous. He said he was free to leave. The patient took alprazolam that morning because he had prior Emergency Medical experience and was aware of potential anaphylaxis. The outcome of the events was recovered. No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
56 2021-06-09 feeling abnormal So I have, Tinnitus both of my ears. It was a constant ringing. Which is still going on. I went to ... Read more
So I have, Tinnitus both of my ears. It was a constant ringing. Which is still going on. I went to the Dr. and he prescribe prednisone. The following day I felt very funny for about 3 hours.
56 2021-06-09 insomnia Fever, shortness of breath, chest pain, bloody nose, heart AFIB, lack of sleep, Diarrhea, and nausea... Read more
Fever, shortness of breath, chest pain, bloody nose, heart AFIB, lack of sleep, Diarrhea, and nausea.
56 2021-06-13 sleep disorder Ears ringing or tinnitus on a constant basis. This is affecting my sleep and life in general and def... Read more
Ears ringing or tinnitus on a constant basis. This is affecting my sleep and life in general and definitely as a result of the second dose of the Covid vaccine.
56 2021-06-20 insomnia Admitted to ER with complaints of generalized weakness and report of insomnia for 4 days to getting ... Read more
Admitted to ER with complaints of generalized weakness and report of insomnia for 4 days to getting his second covid shot. He reports having one episode diarrhea and emesis pta. He reports there was no blood in his stool , no black stool, no blood in emesis tonight pta. He reports he saw blood in emesis one day prior
56 2021-06-21 insomnia I caught a kind of flu the middle of May and was sick for a couple of weeks. COVID test came back ne... Read more
I caught a kind of flu the middle of May and was sick for a couple of weeks. COVID test came back negative. After my second vaccination, on 6/8/2021 I started to experience gastric distress that caused pain and caused me to lose sleep. After 2 nights I checked into the ER. Thursday 6/10/2021 they determined I had an infected gallbladder and removed it immediately. I was discharged 6/11/2021.
56 2021-06-22 loss of personal independence in daily activities Two days after the shot I was very ill with nausea, bad headache and was very lethargic. Four day l... Read more
Two days after the shot I was very ill with nausea, bad headache and was very lethargic. Four day later I went to an urgent care for treatment for nausea and the headache. Two days later I was in the emergency room in the Medical Center for treatment of the same symptoms. Eventually the headache got better so I could function but I was very lethargic and had a constant cough for the next 6-7 weeks.
56 2021-07-08 poor quality sleep flu (fever, fatigue, headache, ache and pain); poor sleep; 100+ degree (F) fever; headache.; just fa... Read more
flu (fever, fatigue, headache, ache and pain); poor sleep; 100+ degree (F) fever; headache.; just fatigued; general aches; This is a spontaneous report from a non-contactable consumer. A 56-year-old adult male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: UNKNOWN), via an unspecified route of administration on 25Mar2021 (at the age of 56-year-old) as single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: EN 6205), via an unspecified route of administration on 04Mar2021 (at the age of 56-years-old) as single dose for COVID-19 immunisation. The patient was not tested with COVID-19 prior to the vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 26Mar2021, the patient experienced 100+ degree (F) fever, the night of receiving 2nd dose of the vaccine for several hours during the night, along with some general aches and pains and headache, generally, characterized the symptoms as mild flu symptoms. The fever was gone by morning, felt better, just fatigued, likely from poor sleep due to the flu symptoms. No treatment was taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of flu like symptoms, poor sleep, generalised body pain, headache and fatigue was resolved. No follow-up attempts are possible; information about lot number cannot be obtained.
56 2021-07-11 memory impairment, confusional state Peripheral vision loss the morning after the first covid vaccine, confusion over the weekend (approx... Read more
Peripheral vision loss the morning after the first covid vaccine, confusion over the weekend (approximately 4/2/21-4/6/21), Went to hospital Tuesday 4/6/21. Did MRI and determined patient had a stroke. Doctor said event was "fairly new." Patient was hospitalized almost 3 weeks. Doctors called it "embolic shower," said he may have had more than one stroke. They are calling in a stroke of "unknown origin" Patient currently still has short-term memory problems, blindness in right eye, and had to start dialysis treatments when in hospital, is still on dialysis.
56 2021-07-13 sleep disorder Started to develop tinnitus which would wake me up at night and increase in intensity and tone upon ... Read more
Started to develop tinnitus which would wake me up at night and increase in intensity and tone upon arising. This happens every night. Workup revealed hypothyroidism which was treated but tinnitus has not abated once becoming Euthyroid. Neurology and ENT workup revealed no specific reasons for tinnitus and possibly for hypothyroidism. Discussion with ENT provider lead to possible CoVid vaccine related cause from inflammatory reaction. Decided that this might be reportable.
56 2021-07-15 disturbance in attention, insomnia Migraines, dizziness, Tinnitus, Vertigo. Fatigue, Difficulty concentrating, difficulty sleeping
56 2021-07-17 feeling abnormal Pemphigus; Nose bleeds; Globus sensation; Swelling left breast; Blood blisters in my mouth; Mouth ul... Read more
Pemphigus; Nose bleeds; Globus sensation; Swelling left breast; Blood blisters in my mouth; Mouth ulcers; Skin ulcers; This is a spontaneous report from a contactable physician (Patient himself). A 56-year-old male patient received bnt162b2 (Manufacturer: Pfizer, Formulation: Solution for injection), dose 2 single via an unknown route of administration, administered in left arm on 08Jan2021 09:00 (Batch/Lot Number: Ek9231) as dose 2, single for covid-19 immunisation in the hospital. Medical history included reflux from an unknown date and known allergies were none. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Manufacturer: Pfizer Formulation: Solution for injection), dose 2 single via an unknown route of administration, administered in left arm on 20Dec2020 10:45 (Batch/Lot Number: Ek5730) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not since vaccination. The patient reported that he started with some nose bleeds which he assumed was dry winter then developed shotgun 2to 3 weeks globus sensation. Then developed swelling left breast then started with blood blisters in his mouth. Then mouth ulcers. Then started with skin ulcers. All this was due to pemphigus on 15Jan2021. The patient underwent lab test which included biopsy proven with IF on 04Jun2021. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested. Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal association between the event pemphigus and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-07-21 amnesia, confusional state Developed what we believe was an encephalitis with confusion, memory loss, fever. MRI with abnormal... Read more
Developed what we believe was an encephalitis with confusion, memory loss, fever. MRI with abnormal enhancement of the mesial termporal lobes bilaterally. No other obvious etiology found. Slowly over several weeks improve.
56 2021-07-24 feeling abnormal After the first shot I felt like I had Covid again. Fever, body aches, rapid heart rate, generally j... Read more
After the first shot I felt like I had Covid again. Fever, body aches, rapid heart rate, generally just miserable.
56 2021-07-27 feeling abnormal Besides sore arm feeling a little dazed I Noticed a rash on left arm few days after vaccine, they we... Read more
Besides sore arm feeling a little dazed I Noticed a rash on left arm few days after vaccine, they weren?t to itchy, but blotchy and spreading.contact my physician at the time and he saw me same day. I was diagnosed with shingles. Very uncomfortable and painful on my left side. Waited longer before 2nd vaccine . Got that on 5/10/2021
57 2021-01-06 insomnia After receiving the vaccine within 15 mins I had a metallic taste in my mouth. I exp fatigue and cou... Read more
After receiving the vaccine within 15 mins I had a metallic taste in my mouth. I exp fatigue and couldn't sleep I went to ER HR 180/10, elevated HR/BP, muscle joint pain and tremendous back pain. After I followed up with my PCP still elevated BP 140/70 as a result I'm on blood pressure medication. I was advised to stay on this new medicine until I receive the second dose of the vaccine. Also was told to take Benadryl and Tylenol before taking 2nd Covid vaccine.
57 2021-01-08 impaired work ability Developed significant headache following dose resulting in one day missed work; now feeling better
57 2021-01-10 depression Depression, Headache, Myalgia & Arthralgia Narrative: chills, sweats, fatigue, lymph node swelling
57 2021-01-11 impaired work ability this 57yo Male ret. He received his first Pfizer covid vaccine on Jan 7th to left arm at hospital (n... Read more
this 57yo Male ret. He received his first Pfizer covid vaccine on Jan 7th to left arm at hospital (not where he works). He went home and reported was fine, but tired. Stated his fatigue and onset of shortness of breath began day 1 post vaccine kept him from working. As his symptoms worsened, on day 4 (1/11/2021) he obtained a pulse ox and O2 sats were in the "80's" with normal heart rate. He went to ER on 1/11 1507 with body aches, fatigue, chest discomfort and SOB where he was ultimately admitted with diagnosis of COVID-19 pneumonia. Is on O2 support via NC.
57 2021-01-12 sleep disorder A terrible headache made me awake in the morning. Toothache as if I have a gum problem. Drinking col... Read more
A terrible headache made me awake in the morning. Toothache as if I have a gum problem. Drinking cold water was a problem. All teeth are causing pain Tooth ache during chewing. Overall body ache
57 2021-01-15 impaired work ability 24 hours after the second vaccine I had crushing, tightness in my chest. It felt like a myocardial i... Read more
24 hours after the second vaccine I had crushing, tightness in my chest. It felt like a myocardial infarction. It lasted 24 hours. I had difficulty doing my job. I considered going to the ER to rule out a myocardial infarction not related to the vaccine. I also had bone pain in right forearm and hand which lasted 24 hours. In addition, I had muscle pain in my entire upper body but not lower body. On day 2 I had right axillary swelling and pain.
57 2021-01-16 impaired work ability Dose 2 of Pfizer Covid vaccine on 1/12/2021 4:53 pm 1/13/2021 827 am Temp 99.3 , pulse 82/min sittin... Read more
Dose 2 of Pfizer Covid vaccine on 1/12/2021 4:53 pm 1/13/2021 827 am Temp 99.3 , pulse 82/min sitting. Feeling tired and very sleepy. Left work to go home 1/13/2021 350 pm temp 100.2 pulse 81 supine headache, tired, myalgias, run down 1/13/2021 554 pm 101.6 f 1/13/2021 815 pm 102.1. F chills after dinner. 1/13/2021 830 pm diaphoresis starts intermittently. Chills and sweating. 1/14/2021 temp at 8 am 99.7 F 1/14/21 11 pm 97.1 F, symptoms resolved. Missed two days of work
57 2021-01-16 impaired work ability On Friday--four days after shot--I had fatigue and slight sore throat. This continued thru Tuesday w... Read more
On Friday--four days after shot--I had fatigue and slight sore throat. This continued thru Tuesday when at work I felt the fatigue get much worse. The next 3 days I stayed home from work (Wed to Fri). I started improving at home on Wednesday and by Friday I felt good (no symptoms).
57 2021-01-23 feeling abnormal Chills lead to severe shaking / seizure-like activity for approximately 1 hour. Condition abated af... Read more
Chills lead to severe shaking / seizure-like activity for approximately 1 hour. Condition abated after taking 1000 mg apap, 200 mg Motrin and 10 mg prednisone. This occurred about 12 hours post vaccine. Reaction preceded by brain fog.
57 2021-01-27 disorientation Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but we... Read more
Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but went away after half hour. At 12 am on 1/27/21, I felt extremely dizzy, very low blood pressure (80/50), sweating, disoriented and lightheaded which lasted approximately an hour. Also developed a large swelling/lump on the lower part underneath my right armpit. (soft to the touch but noticeable.)
57 2021-01-27 disorientation Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but we... Read more
Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but went away after half hour. At 12 am on 1/27/21, I felt extremely dizzy, very low blood pressure (80/50), sweating, disoriented and lightheaded which lasted approximately an hour.
57 2021-01-27 impaired work ability, confusional state Too large dose injected. Bolus was 1ml. Initial metallic taste and mouth 15 min after injection. Num... Read more
Too large dose injected. Bolus was 1ml. Initial metallic taste and mouth 15 min after injection. Numbness, tingling, muscular weakness in the left arm radiating to fingers along C7 dermatome. Severe fevers, chills, mental confusion, muscular weakness, exquisite tenderness at injection site, severe fatigue. Had to leave work. Slept 12 hours. Lingering muscular pain and fatigue for 48 hours following injection.
57 2021-01-31 disturbance in attention Within 12 hours i started having shallow breathing and labored. The next day i found it hard to focu... Read more
Within 12 hours i started having shallow breathing and labored. The next day i found it hard to focus and stuttered a couple times and a co worker said my eye was twitching. Today my breathing is worse.
57 2021-02-01 feeling abnormal Woke up in the middle of the night of the 2nd day after 2nd covid vaccine with body aches, chills, f... Read more
Woke up in the middle of the night of the 2nd day after 2nd covid vaccine with body aches, chills, fatigue, slight nausea overall felt yucky....lasted for 3-4 hours.
57 2021-02-04 feeling abnormal migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it... Read more
migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; This is a spontaneous report from a contactable 57-year-old male other health care professional reported for himself. A 57-years-old male patient started to receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration at Left arm on 07Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included pinched nerve in left leg and kidney stones (recovered). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) Intramuscular at Left arm on 17Dec2020 04:00 PM for covid-19 immunization. The patient experienced migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it. it had been going on since second dose and got worse, not sure if can continue work. The event started on 08Jan2021 02:00 AM, no treatment received for the adverse events. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies to medications, food, or other products. The outcome of the event was not recovered.
57 2021-02-05 feeling abnormal Chills, strong pain in left arm and left shoulder, light headed, foggy thinking.
57 2021-02-21 feeling abnormal Day after vaccine arm was very very sore, with a hard lump on arm at injection site. He states he fe... Read more
Day after vaccine arm was very very sore, with a hard lump on arm at injection site. He states he felt hot flashed and then cold flashes that continue to this day. States ' I feel like I have critters crawling up my skin starting at my legs and going through my body. Has headaches that start at the top of his head then pain radiates down the left side and then head feels very warm. At times he feels "like I am in a tunnel " and "everything slows down (mental/cognitive)" Continues s to this day to feel like there are "lumps within soft tissue areas on inner thigh, back and burning sensations. Chills on and off daily Exceptionally tired, no energy, feels drained. No changes in blood pressure
57 2021-02-28 impaired work ability Developed diarrhea, joint aches and fever leading to being unable to work for the next two days
57 2021-03-11 confusional state, feeling abnormal 5 minutes after receiving immunization he became confused and foggy, complained of being faint, fogg... Read more
5 minutes after receiving immunization he became confused and foggy, complained of being faint, foggy, and having issues with his cognitive processing, he was also cool and clammy. He stated that he was feeling light headed and dizzy. He was monitored for about 5 more minutes in the pod and his symptoms continued . He brought back to the observation area, vital signs 119/78, oxygen 92% on room air and heart rate 63. He was given apple juice and applesauce and his mask removed, he was also placed on a liter. He was continued to be observed and follow up vital signs were 125/85, heart rate 66 @ 0849. Patient skin was less clammy and patient reporting symptoms improved. patient was able to move to sitting and standing position without any issues he was escorted to the site exit without incident.
57 2021-03-11 excessive sleepiness, impaired work ability Pfizer-BioNTech COVID-19 Vaccine EUA. On Friday morning, at 6-7am, less than 24 hours from the time... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. On Friday morning, at 6-7am, less than 24 hours from the time I received my vaccination, I was experiencing chills and could not get warm. I tried to go to work...well, I did go to work. When it became apparent that I was not going to get warm, I left work. When I got home, my wife made me breakfast between 8:30 & 9:00am. After i eat, I slept under a sheet and two blankets...fully dressed for 5 hours. When I came to, it was the first time all day that I felt some warmth.
57 2021-03-15 sleep disorder We had to call 911 at 2:00am. He \woke up from sleep with Uvulitis and sore throat with swelling in ... Read more
We had to call 911 at 2:00am. He \woke up from sleep with Uvulitis and sore throat with swelling in his throat. He felt like his throat was closing. His wife gave him 2 Benedryl while waiting for the paramedics to arrive. They arrived quickly, within 10 minutes. The medical team monitored him at home for about 30 minutes. During this time had high Blood Pressure. They offered to take him to the hospital but he declined. He wanted to monitor himself at home to see if it would resolve itself. He spent the rest of the night in a recliner to help him breath, with his wife by his side. He did not follow up with any medical professional. He did NOT get the 2nd vaccination and will NOT.
57 2021-03-22 loss of personal independence in daily activities Fatigue, injection site pain, use of prescription pain reliever or prevents daily activity Dizzines... Read more
Fatigue, injection site pain, use of prescription pain reliever or prevents daily activity Dizziness, lightheadedness Myalgia, diarrhea, vomiting Non-prescription medication use
57 2021-03-29 feeling abnormal Per ED Provider Report, the patient collapsed while outside on 3/25/21. Ambulance was called to the ... Read more
Per ED Provider Report, the patient collapsed while outside on 3/25/21. Ambulance was called to the scene where patient was found unresponsive. Patient was transferred to Hospital. Patient was in full cardiac arrest upon arrival. CPR was initiated. Patient deceased. Patient's mother stated the patient had been feeling badly for 2-days, but refused to seek medical treatment.
57 2021-03-29 sleep disorder After both doses, I could not sleep well the night after. I had no other adverse reactions, other th... Read more
After both doses, I could not sleep well the night after. I had no other adverse reactions, other that a sore arm.
57 2021-03-30 impaired work ability On the evening of 3/21 I started to feel like I had a sore throat. Morning of 3/22 it felt like a f... Read more
On the evening of 3/21 I started to feel like I had a sore throat. Morning of 3/22 it felt like a full blow cold with soar throat, swollen glands. Symptoms became worse throughout the day. Reported sick at work on 3/23 because symptoms were worse. (measured temperature 98.9 to 99.9 throughout the say, normal temperature for me is 97.5) Had covid test that came back negative. Started taking cold relief medications. Conditions slowly improved over next few days but still don't feel 100% as of this report.
57 2021-04-02 confusional state Lethargy, erythema at site, fever to 104.2, loss of ability to stand or walk, confusion, reduction i... Read more
Lethargy, erythema at site, fever to 104.2, loss of ability to stand or walk, confusion, reduction in speech ability. Symptoms started during the evening of 3/30/21 after vaccination. PCP was contacted on 3/31/21 and we were told the effects would only last 48 hours. Fever was reduced with Acetaminophen 1000 mg q6h x 2 doses, oral fluids, and icing the axillary. 911 was called on 4/1/21 when pt lost ability to stand and and was minimally vocal but alert. Pt was hospitalized and remains in that situation at this time.
57 2021-04-04 feeling abnormal, anxiety Pt stated he felt light headed, cloudy. EMT informed to evaluate Pt. VS BP 132/100, HR 86 regular... Read more
Pt stated he felt light headed, cloudy. EMT informed to evaluate Pt. VS BP 132/100, HR 86 regular, OxSat 96% on RA. Pt stated BP runs high when he experiences anxiety which he was today. D/t rushing to site to receive vaccine but he said once he was evaluated by EMT he was feeling much better.
57 2021-04-04 motion sickness About two weeks after the first injection I experienced significant dizziness/motion sickness when I... Read more
About two weeks after the first injection I experienced significant dizziness/motion sickness when I got out of bed. It felt like I was on a ship in heavy seas. I don't think I could have driven a car. I laid down around noon and slept for about 90 minutes. Upon waking the symptoms had lessened. I had another occurance (about the same severity as my post-nap symptoms from previous incident) on April 4th.
57 2021-04-06 feeling abnormal Stomach felt queesy and then my face began to tingle and feel very strange. This lasted about 2 hou... Read more
Stomach felt queesy and then my face began to tingle and feel very strange. This lasted about 2 hours and then went away. I went to bed and slept it off and have not had any other affects.
57 2021-04-07 feeling abnormal all body tingling, foggy mind, unable to fully focus eyes, SOB and pain in lungs. Gave benadryl 25mg... Read more
all body tingling, foggy mind, unable to fully focus eyes, SOB and pain in lungs. Gave benadryl 25mg. and monitored. Resolved 70 minutes following start.
57 2021-04-07 feeling abnormal Day 1 - Fatigue beginning about 6pm, then foggy feeling about 7pm, then mildly headachy about 8pm Da... Read more
Day 1 - Fatigue beginning about 6pm, then foggy feeling about 7pm, then mildly headachy about 8pm Day 2 - Fatigue, fog, and headachy continued through the day easing somewhat in evening Day 3 - pretty much back to square
57 2021-04-08 sleep disorder Severe nausea, hard time sleeping, dizziness
57 2021-04-12 feeling abnormal fever up to 102 x 2 days; body aches; headache. Currently has headache and brain fog.
57 2021-04-12 loss of personal independence in daily activities Adverse event #1: Flu-like symptoms, severe headache, vision blurriness, lasting roughly 10 days. ... Read more
Adverse event #1: Flu-like symptoms, severe headache, vision blurriness, lasting roughly 10 days. Adverse event #2: Deep Vein Thrombosis in the left Popliteal vein with moderate associated edema and pain. Required Emergency Room visit, diagnosis, and treatment with Eliquis. This event prevented normal daily work activities for 5 days, after which edema and pain has mostly subsided.
57 2021-04-12 sleep disorder I had my first Covid vaccine (Pfizer - Lot ER2613) on March 17. No issues other than a soar arm the... Read more
I had my first Covid vaccine (Pfizer - Lot ER2613) on March 17. No issues other than a soar arm the next day. In fact, I went on a hard 7 mile run the next day as part of my normal training routine (currently training for a half Marathon.) This past Thursday, April 8, at 6:00 pm EST, I had my 2nd shot (Lot EW0161). For about the next 18 hours, I was fine other than the arm being a little sore in the morning. Late in the morning I noticed my back was getting very stiff and a bit sore when I moved around. I have a desk job and spend a lot of time in front of the computer, but I normally stretch and move throughout most days, so I don?t have many back issues. This was a bit worse than normal. Usually, when I feel something like this, my go to remedy is an easy run. I had a 5 mile easy run planned for that day, so later in the afternoon, after some dynamic stretching, I went for a run. As I started, I felt some of the worse back pain I could remember and stopped running after about 50 yards. I stretched a little more, questioning if I should continue, but decided that movement would be better than doing nothing. I started running again and although the first mile was much more uncomfortable and painful than normal, I continued on for the 5 miles with everything eventually loosening up as the blood starting flowing. I felt pretty good the rest of the day and into the evening. In the middle of the night, I awoke numerous times with a bad ache in my back, which is very unusual for me. I tossed and turned all night from side to side, from front to back but could not stop the burn and pain in my lower back. I took 2 Advil, but that did little to help. I got out of bed about an hour earlier than normal and after a little light stretching, my back felt fine again. I went for my weekly long 14 mile run an hour later and everything was good again and for the rest of the day. The next 3 days / nights have been similar. I continue waking each night with a burning and aching in my lower back and it continues all night long. Once I stand up, get out of bed and start moving around, the pain and burning go away almost immediately. I?ve never felt anything like this before. I?m 57, male, am very healthy and fit (aiming for a 1:30 half marathon in 10 days.) Never had issues with sleeping before this and haven?t experienced any back pain in a very long time. I can?t think of anything I?ve done recently to trigger this other than the coincidence of the 2nd Pfizer vaccine shot.
57 2021-04-13 sleep disorder *Pfizer-BioNTech COVID-19 vACCINE eua, Patient complained of pain and tingling starting 7 days post... Read more
*Pfizer-BioNTech COVID-19 vACCINE eua, Patient complained of pain and tingling starting 7 days post vaccination from the knees down to the bottom of the feet. The pain and tingling in his feet is most severe. The pain wakes him up at night during sleep to the point that he is unable to fall back asleep, and the pain and tingling is still there when he wakes . The tingling and pain is not noticeable once the patient is working, and once he wakes he still has the symptoms, but it is not as bad as it is during the night. He had not experienced this pain or tingling ever before having the vaccination.
57 2021-04-14 feeling abnormal Dizzy, fuzzy feeling starting within about 5 minutes, lasting approx 1 hour. Major headache focused ... Read more
Dizzy, fuzzy feeling starting within about 5 minutes, lasting approx 1 hour. Major headache focused behind the left eye. Starting about 2 hours later, lasting about 2 - 3 hours.
57 2021-04-17 restlessness, confusional state Pt developed fever as high as 104.2; confusion, inability to form sentences; restlessness; inability... Read more
Pt developed fever as high as 104.2; confusion, inability to form sentences; restlessness; inability to ambulate.; inability to form sentence; This is a spontaneous report from a contactable nurse. A 57-year-old male patient received the first dose of BNT162B2 (lot no. and expiry date were unknown), via an unspecified route of administration, administered in right arm on 30Mar2021 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included Cancer Stage 4 - renal with mets. The patient's concomitant medications were not reported. The patient previously took ciprofloxacin (CIPRO) and sulfamethoxazole, trimethoprim (BACTRIM) in which he experienced allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, the patient developed fever as high as 104.2, confusion, inability to form sentences, restlessness, and inability to ambulate. He was hospitalized on unspecified date due to the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient had nasal swab on 01Apr2021 with negative result. The outcome of the events was not recovered. Information on lot/batch number has been requested.; Sender's Comments: The information currently available is extremely limited and does not allow a meaningful case assessment. However, based solely on an implied temporal association, a causal relationship between events fever,confusion,aphasia,movementdisorder adverse events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
57 2021-04-20 insomnia, impaired work ability, feeling abnormal Slight discomfort in left arm injection site by 6PM and went to bed 9:30PM. Woke up 12:30AM with ch... Read more
Slight discomfort in left arm injection site by 6PM and went to bed 9:30PM. Woke up 12:30AM with chills and did not sleep well for the remainder of night. Got up 5:30AM ate something and had some coffee. What was noticeable initially was fatigue, followed by chills. My temperature was 99.2 and 99.4. I never took any medication until going to bed. I reported in sick to work and went back to bed for 4 hours approximately. I felt bad all day even as I went to bed.(chills and very fatigued). I tried to keep very warm and took Tylenol PM to sleep. 100% recovery 1 day later
57 2021-04-20 mental status changes patient received Pfizer covid vaccine on 4/12. On 4/13 patient presented to ER with purple fingers ... Read more
patient received Pfizer covid vaccine on 4/12. On 4/13 patient presented to ER with purple fingers and toes. bilateral feet numb and tingling. patient admitted to hospital. by morning 4/14 patien resp status declined, ciwa score 15, afib rvr, ams, low bp. septic shock. source unclear.
57 2021-04-21 anxiety patient waited about 15 minutes after his vaccine. Upon leaving patient began to feel light headed. ... Read more
patient waited about 15 minutes after his vaccine. Upon leaving patient began to feel light headed. patient was then asked to take a seat and vitals were check. patient showed hypertension (which he states was due to not taking his blood pressure medications x 3 days) and patient also showed mild tachycardia (102BPM), patient states increased heart rate is due to his anxiety. Other vitals stable. patient was then monitored for an additional 10 minutes and states he is no longer light headed. patient is given advice to follow up with his doctor about his high blood pressure and encouraged to call 911 if he experiences any symptoms after leaving.
57 2021-04-23 nervousness, insomnia Uncontrolled hypertension, injection site pain, increased myalgia pain, headache, sinus congestion, ... Read more
Uncontrolled hypertension, injection site pain, increased myalgia pain, headache, sinus congestion, nervous, tiredness, back pain, hip pain, increased heart rate, shortness of breath, shoulder pain, muscle soreness, sleeplessness. All ongoing.
57 2021-04-24 memory impairment This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiration date not provided), via an unspecified route of administration, on 06Apr2021 10:30 (at the age of 57-year-old), at single dose, for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) from 2018 and ongoing, and had a shot, a steroid for COPD; high blood pressure from 2016 and ongoing, and patient took medication for it; 7 heart attacks; 8 stents in his heart; patient was a smoker (ongoing, had been smoking for a long time. He was a walking post card for don't smoke. He stated that he can only walk twenty feet before he was out of breath); and patient was allergic to penicillin and Lortab. Family history included patient had a family member die of cancer and lupus. Patient had two biopsies for skin cancer (unknown date) within 4 weeks prior vaccinations. Concomitant medications were not reported. On 07Apr2021, the patient experienced extremely high blood pressure, arm aching, body aches, night sweats, and headaches. The patient stated since receiving the vaccine, that his blood pressure was very high and his medications were not bring it down. He stated that one of his blood pressures was 197/121 and this morning it was 181/130, which was extremely high for him. He stated that he went through the aches and his arm was hurting. He even had sweats last night. Patient stated that his blood pressure still hadn't come down and he could feel headache from the pressure. He stated he already called the doctor, and the doctor told him that if it persisted to go to the emergency room. He stated that he took a couple of medications for his blood pressure and he declined giving medication information. He said that one started with an R and he took another one twice a day. He said that all the names of them, remembering them at his age was hard. He stated that he could read that small writing he had to get a magnifying glasses. Patient was scheduled for next vaccine on 04May2021. He stated that his blood pressure was not so unbearable but it was pretty high, he checked his blood pressure twice a day for everyday. He stated whatever he was lucky if he remembers if he had breakfast in the morning, until he remembered that he hadn't had breakfast. He stated that his arm started aching on 07Apr2021, it had improved but was still ongoing. He stated that it felt pretty good. Patient's blood pressure had been constant since today was the 8th it's only been a little over 24 hours now. On 07Apr2021 he had night sweats. He woke up pillow was soaking wet. He stated that his body aches still ongoing started about the same time. His headache started at the same time and was still going on. Patient stated he had a heart attack in 2016 and he hadn't had a normal blood pressure since. He hadn't been able to keep it all in check since the vaccine. His blood pressure medicine had been changed from 20 mgs to 40 mgs. He was under constant doctor care. The patient underwent lab tests and procedures, which included blood pressure was 197/121 (unknown date), 181/130 (08Apr2021), and 165/116 (08Apr2021). Patient's heart rate was 85 (unknown date). Patient stated his normal blood pressure was 135/85, his normal heart rate was 75. The outcome of the events "extremely high blood pressure", "body aches", "headaches" was not recovered; of event "arm aching" was recovering; of other events was unknown. No follow-up attempts are needed. No further information is expected.
57 2021-04-24 sleep disorder 2 days after my initial vaccine injection, my lower body joints/muscles/tendons were extremely painf... Read more
2 days after my initial vaccine injection, my lower body joints/muscles/tendons were extremely painful to move. The pain was evident after sitting or laying down for 10+ minutes. During nighttime sleep, the pain does not allow me to move my lower extremities without intense pain keeping me awake and only allowing less than 2 hours of sleep a night. Prior to March 12, I was physically fit and active. I was able to ride a stationary bike, treadmill and attend fitness classes. Now, I need to walk with a cane and I was diagnosed with "arthritis" symptoms as well as micro tears in my left knee. My left knee swells so much that I am unable to bend it without great pain.
57 2021-04-26 sleep disorder Tinnitus much worse than before 2nd shot (or first). Very loud pulsing that is annoying when trying ... Read more
Tinnitus much worse than before 2nd shot (or first). Very loud pulsing that is annoying when trying to sleep (3 weeks after 2nd shot there is no improvement in the tinnitus). No treatment yet.
57 2021-04-28 excessive sleepiness Fever, muscle pain all over the body, joint pains all over, especially kidney area, strong headache... Read more
Fever, muscle pain all over the body, joint pains all over, especially kidney area, strong headache, sleeping all day.
57 2021-04-29 amnesia transient global amnesia - started within hour of receiving vaccine - pt became lost driving, was su... Read more
transient global amnesia - started within hour of receiving vaccine - pt became lost driving, was subsequently admitted and had amnesia that lasted approx 24 h then resolved, negative CVA workup
57 2021-04-30 insomnia Muscle aches; head aches; injection site soreness; hypertension; tiredness; increased back and shoul... Read more
Muscle aches; head aches; injection site soreness; hypertension; tiredness; increased back and shoulder pain; increased back and shoulder pain/ hip pain; sleepless; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in right arm on 07Apr2021 at 13:45 (lot number: ER8737; expiry date: unknown) at a single dose, for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma, fibromyalgia, and hypertension. Concomitant medications included meloxicam, rosuvastatin and lisinopril. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient had no known allergies. On 08Apr2021 at 12:00 AM, the patient experienced muscle aches, headaches, injection site soreness, hypertension, tiredness, increased back and shoulder pain, sleepless, and hip pain. The events resulted in emergency room visit, physician's office visit, and one day hospitalization on unspecified date. The patient received unspecified treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 15Apr2021. Outcome of the events was not recovered.
57 2021-05-03 amnesia Six days after receiving the Pfizer vaccine, patients developed transient ischemic attacks. Had a f... Read more
Six days after receiving the Pfizer vaccine, patients developed transient ischemic attacks. Had a full evaluation at Medicine Center. Work up negative and symptoms resolved; atorvastin dose was doubled. He has had some short term memory loss and decrease in neurocognitive function. He had the second dose of the vaccine as scheduled, following which he had a severe unilateral headache but he did not seek care/evaluation.
57 2021-05-03 nervousness approx 20 minutes post vaccine administration - pt felt lightheaded and c/o palpitations. initial BP... Read more
approx 20 minutes post vaccine administration - pt felt lightheaded and c/o palpitations. initial BP 220/100, pulse 65, pulse ox normal. given water and allowed to rest. 15 minutes later BP 195/96, HR 56. his lungs were clear, no SOB or wheezing. on tongue/facial swelling or tingling/itching. pt's heart was sinus regular to brady with frequent PVCs. denies chest pain. pt then noted blurry vision in addition to lightheadedness and feeling shaky. continued palpitations. he was escorted to ER. in ER, his BP is 145/84. EKG shows SB w/ PACs. he felt better and was dc'd home. no medications administered. to f/u with PCP.
57 2021-05-04 insomnia Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few mi... Read more
Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few minutes.I experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time; Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few minutes.I experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time; Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few minutes.I experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time; Was unable to sleep for longer than an hour at a time for 5 days; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at school or student health clinic on 15Mar2021 16:45 (at the age of 57-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient had no medical history. The patient had no allergies to medication, food, or products. Concomitant medications included finasteride and morniflumate (FLOMAX [MORNIFLUMATE]). On 15Mar2021 at 19:15, approximately 3 hours after injection, the patient became very dizzy, lightheaded, and passed out for a few minutes. The patient also experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time. There was no treatment for the events. On an unspecified date, the patient recovered from all events. Information about batch/lot number has been requested.
57 2021-05-04 poor quality sleep he doesn't go to sleep well; having pain at the injection site/like a burning sensation inside like ... Read more
he doesn't go to sleep well; having pain at the injection site/like a burning sensation inside like where the shot was; This is a spontaneous report from a Pfizer sponsored program COVAX US support from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Mar2021 14:10 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. Patient didn't drink, didn't smoke, didn't do anything. Maybe the end of the year, he got a physical and nothing, everything came back normal. The patient's concomitant medications were not reported. Patient experienced pain at the injection site and stated it was like he had like a burning sensation inside like where the shot was on and he still had it. It began about 2 days after the shot (27Mar2021). Sometimes he didn't go to sleep well because he woke up every hour or so. He didn't sleep well because of the pain. He was supposed to get the second one this coming Saturday (24Apr2021). Outcome of having pain at the injection site/like a burning sensation inside like where the shot was not resolved. Outcome of didn't go to sleep well was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-05-06 feeling abnormal, impaired work ability, confusional state Day of Vax: At about 2pm....I had a severe reaction forcing me to lay down for several hours....bod... Read more
Day of Vax: At about 2pm....I had a severe reaction forcing me to lay down for several hours....body aches and pains, mental confusion, really weird feelings throughout my body. I had to take sick time from work. I felt better in the evening. Day 2(wed): woke up with moderate/extreme fatigue....body did not feel good...could not work took more sick time...spent most of day in bed. Day 3(thurs): Was going to try to get back to regular schedule.....worked in the morning...did my usual lunch time hike.....in the afternoon suffered from another bout of moderate/extreme fatigue...could not work..took more time off....in the evening had chest pain in my back between my shoulder blades. Day 4(fri): I am filling out this form...woke up with pain in between my shoulder blades....that seems to be feeling a little better now....I am trying to get back to my regular routine and have been working this morning. I believe that I will continue to get fatigued for a few more days....and I'm very sensitive between my shoulder blades.
57 2021-05-07 feeling abnormal stroke like symptoms; on his left side he had face droop; he had a speech slur; he couldn't move his... Read more
stroke like symptoms; on his left side he had face droop; he had a speech slur; he couldn't move his left arm/couldn't lift his left arm; low blood pressure; his face was numb; his lip was twitching; bad headache; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 21Apr2021 14:00 (Batch/Lot Number: EW0169) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included stroke from 02Feb2020 to 02May2020 (not ongoing). The patient had 3 stroked last year and he was put on ELIQUIS and baby aspirin and a regimen for his strokes. The last one he had was 02May2020 and he has had no problems since then. Last year when he had strokes it wasn't because of his heart it was because of an artery in his brain that went 90 degrees. In Jun2020 they found out that the problem was an artery and that's when the doctor to do the double dose baby aspirin and then everything was fine and he had no episodes at all. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), lot number: P116218, expiration date: Jan2022 taken for stroke from 02Feb2020 to an unspecified stop date; and apixaban (ELIQUIS), lot number: 1796050, expiration date: Sep2023 taken for stroke from 02Feb2020 to an unspecified stop date. The patient had no additional vaccines on the same date as Pfizer vaccine and had no prior vaccine within 4 weeks. The patient had his first shot of the Pfizer COVID vaccine on 21Apr2021 at 14:00 and stated that they made him go wait for 15 minutes in his car. 10 minutes into waiting after the COVID vaccine, he had to call over the EMT because he had stroke like symptoms. On his left side he had face droop, he had a speech slur and he couldn't move his left arm. The patient was transferred to the hospital and was hospitalized. His CT scan was fine, the CT scan with dye was fine, his MRI was fine, and his heart was fine. The patient wanted to know if he should get the second COVID vaccine because of the reaction that he had from the first COVID vaccine. The patient got the COVID vaccine on 21Apr2021 and on 23Apr2021 he was still having a bad headache, brain fog and there was a deficit on his left side. He can't grab and hold something in his left hand and he has a slight deficit on the left side corner of his mouth. The patient was planning on seeing the provider in the first week of May2021. The patient added that he was told to wait 15 minutes and then 10 minutes in he could feel his face was numb and his lip was twitching and he couldn't lift his left arm. He laid on the horn and the EMS came over and they said that he had stroke like symptoms so they transferred him out of his car and into an ambulance where he had vitals taken and he had another episode of stroke like symptoms. They took him into a different ambulance and had another episode in that ambulance when they were on the way to the hospital. He didn't have anything after that except a bad headache and a slight deficit on his left side, according to them, and just a brain fog like when he was trying to figure out how to put things together and he was still having those at the time of the report. The patient was discharged from the hospital on 22Apr2021. The patient stated that his last stroke was on 02May2020 and he has had no headaches since until he had the COVID vaccine on 21Apr2021. According to the doctors and the neurologist at the hospital he could've had a stroke, he could've had low blood pressure from the vaccine or he could've had a multitude of other things but they recommended him to call Pfizer and CDC for the report. While in the hospital, he had a CT scan without contrast, a CT with contrast on 21Apr2021; an MRI without contrast on 21Apr2021; an echocardiogram without dye and with dye on 22Apr2021 and they did another MRI but of his neck on 22Apr2021; all were normal. The patient was hospitalized for stroke like symptoms, on his left side he had face droop, he had a speech slur and he couldn't move his left arm from 21Apr2021. The event stroke like symptoms resolved with sequel on 22Apr2021. The patient recovered from on his left side he had face droop, he had a speech slur, and he couldn't move his left arm on 22Apr2021. The patient has not recovered from bad headache, brain fog. The outcome of his face was numb was unknown, his lip was twitching and low blood pressure was unknown.
57 2021-05-07 sleep disorder Pain on the three joints I have had tendinitis due to sports injuries (left hip, left knee, left elb... Read more
Pain on the three joints I have had tendinitis due to sports injuries (left hip, left knee, left elbow). I had felt fine from after the shot at 10:30am that day (Thursday 5/6/21) until that evening, where I did feel some soreness in those joints. I took two Alleve pills an hour prior to bedtime. I woke up in pain at 2:00AM that night (5/7/21) on the said joints, about a level 6-7 out of 10. By morning the pain had subsided a bit, but I was in pain walking for the next day (Friday) and today (Saturday).
57 2021-05-10 abnormal dreams Extreme headaches in the back of my head, then radiating to the frontal lobe. Second stage was dizzi... Read more
Extreme headaches in the back of my head, then radiating to the frontal lobe. Second stage was dizziness/ vertigo seemed like my brain was going to explode. Ringing in ears and then intense vivid dreams. It?s been two weeks since the second shot and I am still dealing with the dizzy spells. The headaches have gone . Also another symptom was I would get weak at times not for long but in spells. Still trying to over come this pressure and dizzy feeling other than that now I am getting better.
57 2021-05-10 insomnia A male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19... Read more
A male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Apr2021 13:50 (Lot Number: EW0169; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. There was no relevant medical history and concomitant medications. There was no Additional Vaccines Administered on Same Date of bnt162b2. The patient previously received the first dose of bnt162b2 on 29Mar2021 (Lot Number: EP6955; Expiration Date: 30Jun2021) for covid-19 immunisation. The reporter stated he thought he was having side effects. He thought he had a cold, sore throat so he took Nyquil and Tylenol PM. His side effects were nausea and threw up. his whole body was sore from arm to back. Time of Onset was Morning 05:45 on 20Apr2021. The patient also experienced up all night on 19Apr2021. The outcome of Nausea and Threw Up was resolved on 20Apr2021. The events did not require a visit to emergency room or physician office. The outcome of Whole Body is Sore from Arm to Back was not resolved. The outcome of Feels like he has a cold; Sore Throat was resolving. The outcome of up all night and Nausea and Threw Up was resolved on 20Apr2021. No follow-up attempts are needed. No further information is expected.
57 2021-05-13 feeling abnormal Aches and pains, feeling weak, foggy head Symptoms started 18 hours after injection, 36 hours after ... Read more
Aches and pains, feeling weak, foggy head Symptoms started 18 hours after injection, 36 hours after injection symptoms were gone.
57 2021-05-17 feeling abnormal 24hrs post 2nd Dose Pfizer. Bradycardia, chest pain, fever, skin patches heat sensation, swollen te... Read more
24hrs post 2nd Dose Pfizer. Bradycardia, chest pain, fever, skin patches heat sensation, swollen testicals, lymph nodes swollen, entire body joint pain, severe headache, foggy, extremely tired. At 9:25am (24hrs after 2nd dose) I was able to muster enough energy to text. 15 minutes later my heart was beating so slow I was unable to move my hand to grab my phone. It was like I was paralyzed for a couple hours other than my heart beat hurt and below 30 bpm for a couple hours. In and out of being awake. After a couple hrs I was able to move and my heart was beating faster. My chest hurt significantly for 12 days. May 13th, (9days post) I went to Emergency Room in evening. Fear of blood clots with chest hurting and extreme fatigue. ER preformed an XRAY for heart size and lungs, Blood work for blood clots and markets for heart attach. All came in negative to a heart related event causing pain.
57 2021-05-18 mental impairment after shot, his mind suddenly went blank, followed with the inability to move his legs at all; Legs ... Read more
after shot, his mind suddenly went blank, followed with the inability to move his legs at all; Legs became weak. Within 15 minutes of the shot. Went home and rested with weakness in left leg; after shot, his mind suddenly went blank, followed with the inability to move his legs at all; slight numbness; tingling; pain; legs have been heavy; central vestibular disorder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 10:15 (Lot Number: ER8731) as 2nd dose, single for covid-19 immunisation. Medical history included Epilepsy, Migraine, Central Vestibular Disorder, and Known allergies: Sulpha Drugs and Shellfish. Historical Vaccine included first dose of bnt162b2 (lot number:ER8727, Administration date= 26Mar2021, Administration time= 12:15 AM, Dose number= 1, Vaccine location= Left arm) for COVID-19 immunisation; Adacel (DTAP) PMC (Sanofi) (vaccine date=11Mar2021, lot number=C5667AA, dose number=1, vaccine location=Left Arm) for immunisation. After bnt162b2 first dose, the pateint had Legs became weak; Could move them, but not stand up on them; Lasted approximately 2-3 hours; Reaction occurred within 15 minutes after the shot; Nurses made her go to the emergency room (ER). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clonazepam taken for an unspecified indication, start and stop date were not reported; lacosamide taken for an unspecified indication, start and stop date were not reported; lamotrigine taken for an unspecified indication, start and stop date were not reported; omeprazole taken for an unspecified indication, start and stop date were not reported. After bnt162b2 second dose, the patient experienced Legs became week. Within 15 minutes of the shot. Went home and rested with weakness in left leg. Day after shot, his mind suddenly went blank, followed with the inability to move his legs at all. He could feel them. There was slight numbness, tingling, and pain, but he was not able to move them. He was transported to the ER via ambulance. This reaction lasted about 4 hours. Since then his legs have been heavy and the progress he had made with his central vestibular disorder has thrown him back to almost square one and his physical therapy is now not helping as it did. The adverse events (AE) resulted in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered with sequelae. Information on Lot/Batch number was available. Additional information is expected.
57 2021-05-30 feeling abnormal Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), f... Read more
Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), fatigue (day 1 forward), mild cough on/off, eye pain (? day 4 forward), achey (day 1 forward), chest rash (? day 3 forward), fever (? day 5 forward 101.9 day 5), back pain (? day 5 forward), labored breathing (? day 5 forward), diarrhea (? day 5 forward), sore throat (? day 5 forward) vomit (day 7). Symptoms of chills and miserable feeling increased day 4 on. Tylenol, Albuterol on day 6, Day 8 hospitalized, antibiotics and oxygen, Sepsis and shock, less than one day in hospital - passed on 3/2/21 am.
57 2021-06-07 sleep disorder Reports pain in left arm since second shot, pain progressed 2-3 days after injection. Unable to use... Read more
Reports pain in left arm since second shot, pain progressed 2-3 days after injection. Unable to use his arm at his doctor visit on 5/4/21. Diagnosed with shoulder injury related to vaccine administration. F/U appointment on 6/7/21 reports able to use his left arm, still has pain off/on . Has been going to PT for three weeks and has shown increased range of motion. Improved but still not back to normal, still unable to sleep on left side. Continuing PT.
57 2021-06-10 sensation of foreign body slight difficulty swallowing; feeling of something stuck in my throat; This is a spontaneous report ... Read more
slight difficulty swallowing; feeling of something stuck in my throat; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered in the left arm on 12Mar2021 11:45 (at the age of 57-years-old), as first dose, single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight difficulty swallowing and feeling of something stuck in my throat on 13Mar2021 00:30. Patient did not seek consult to physician or urgent care. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-06-22 feeling abnormal This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of BNT162B2 at 57-year-old, via an unspecified route of administration in arm left on 31Mar2021 at single dose, and the second dose at 57-year-old via an unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunisation, and testosterone, via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020, and left arm bothered him. There were no concomitant medications. Patient reported his tongue and taste buds were "screwed up" and it had been painful to eat which had resulted in weight loss of 50 pounds in the last 5 months and this had gotten worse since being vaccinated. He was fatigued and his whole body hurt and sports injuries from past were very painful. He had previous Covid infection in Dec2020. He had seen many doctors and had an appointment with neurologist coming up. He didn't have much hope. He felt like he had 75% Covid all the time and his body felt like he had been hit by a truck. Not really that bad but like his taste buds were screwed up and it kind of progressed since he received the vaccine. Ever since the patient got the vaccine, the arm that he got the vaccine in it killed him, every joint in his body hurt, and he had seen lots of doctors about this and no one could figure it out. The patient was 250 pounds before this started. Patient was having something wrong with his tongue and taste buds, it was hard to explain. It was painful to eat, the patient had been to an ENT and they were sending the patient to neurology to figure it out. The tongue thing went away they thought it was thrush, then talked to another ENT and thought it was something neurological. The patient's whole body hurt. The patient was unsure when all of this started but he stated that it had worsened over the last couple of months. The patient's mouth was in pain. The patient was fatigued. The patient's left arm bothered him before the vaccine but it had progressively gotten worse over time. All of the symptoms that the patient had from COVID got progressively worse after the vaccine. The patient's arms were really lose and it felt like the arms wanted to come out of the socket. The pain could be a 9/10 and nothing touched it. The day after the first shot, the patient got testosterone shots, they found and erratic heartbeat which freaked out the patient. They did and EKG and said it was okay but couldn't determine what it was. Patient was tested and it showed hypothyroid and they did an intake test. The doctors thought it was thyroiditis but that got better but then it snowballed into what it was. Investigations: The patient was tested for cancer, rheumatoid arthritis and all sorts of different things which were all negative. The patient was a healthy guy otherwise, besides these symptoms. Action taken in response to the events for testosterone was unknown. Outcome of events his tongue and taste buds were "screwed up", the arm that he got the vaccine in it kills him/left arm bothered him before the vaccine but it had progressively gotten worse over time, every joint in his body hurt, and erratic heartbeat was not resolved, and of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-06-23 sleep disorder I have developed arrythmia for the first time in my life. On some days, the arrythmia has prevented... Read more
I have developed arrythmia for the first time in my life. On some days, the arrythmia has prevented me from sleeping overnight. I have visited a cardiologist for the first time in my life, though i have had annual normal EKGs each year for my annual physical. Dr. currently has me wearing a Zio Patch heart monitor to help determine what is happening.
57 2021-06-29 confusional state Patient presents to the hospital with constant left sided chest pain, intermittent left arm tingling... Read more
Patient presents to the hospital with constant left sided chest pain, intermittent left arm tingling, nausea, vomiting, confusion and shortness of breath. Chest pain is worse with deep inspiration. Tests ran include EKG/CXR, chest CT, and labs. Admitted to hospital for observation work up. Serial EKG, serial troponin, CT head Patient was discharged AMA with cardiology and pulmonary consults. Medications on discharge: Aspirin 81, Spiriva, and albuterol HFA. Symptoms likely a result of exacerbation of other disease processed, but cannot rule out contributory effects of the vaccine
57 2021-06-29 disturbance in attention 3 bowel movements in 8 hours; Unfocused Mind; This is a spontaneous report received from a contactab... Read more
3 bowel movements in 8 hours; Unfocused Mind; This is a spontaneous report received from a contactable consumer, the patient. A 57-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in right arm on 20Mar2021 at 09:15 (at the age of 57-years) as a single dose for COVID-19 immunisation. Medical history included obesity, renal insufficiency and fatty liver. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 09:45 (35 minutes after injection), the patient had unfocused mind (easily lost his train of thought) for the duration of 6 hours. On 21Mar2021 (day after injection), the patient was ok in the morning and then had 3 bowel movements in 8 hours. The patient did not experience diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for these events. The clinical outcome of the event unfocused mind was recovered on 21Mar2021 and outcome of the event 3 bowel movements in 8 hours was unknown at the time of this report. No follow-up attempts are needed. No further information was expected.
57 2021-07-01 abnormal dreams Lightheaded; Fatigued/ very tired; Nosebleed; Sweaty feet; intense dreams; This is a spontaneous rep... Read more
Lightheaded; Fatigued/ very tired; Nosebleed; Sweaty feet; intense dreams; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 08:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient was allergic to unspecified medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 22Mar2021 at 08:00, after the injection the patient felt lightheaded and fatigued. The patient waited and monitored for 45 minutes before leaving. The patient had breakfast afterwards but very tired, went home and slept solid for 3 hours with intense dreams. The patient slept well the night before. The patient felt better as the day progressed. On 22Mar2021, at night, the patient went to bed early and woke up with a nosebleed, blood pooled in mouth from the nose bleed and sweaty feet. The patient underwent lab test which included blood test on an unknown date in Feb2021 and the result showed negative. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. Therapeutic measures taken for the adverse events included water and blood pressure check (result not provided). The clinical outcome of events lightheaded, fatigue, nosebleed, intense dreams and sweaty feet was recovering. No follow-up attempts are needed. No further information is expected.
57 2021-07-04 anxiety, fear I've been experiencing intermittent sensations in my upper and lower chest [lung and heart] area sin... Read more
I've been experiencing intermittent sensations in my upper and lower chest [lung and heart] area since I received my 2nd Pfizer vaccination shot on June 22, 2021. It?s been happening for two weeks, today but I?m only now reporting it because I?m getting concerned. Each time it?s happened, it lasts for a couple of hours and it's scaring me. I feel pressure in there like something?s not right. I?m not paranoid but I am concerned and want to report it.
57 2021-07-10 sleep disorder Woke up at 3:36 am on May 27th. I was feeling lightheaded when I got up to pee. Laid down and the fe... Read more
Woke up at 3:36 am on May 27th. I was feeling lightheaded when I got up to pee. Laid down and the feeling didn?t go away. Went into another room to put my head between my legs and the feeling did not go away. And then began to feel a pressure sensation in my chest and feeling clammy. Woke up my family and I went to the ER. When I arrived at the ER my heart rate was 32 bpm.
57 2021-07-11 depression, crying Chief Complaint covid since last friday, getting more SOB, was 88% RA History of Present Illness ... Read more
Chief Complaint covid since last friday, getting more SOB, was 88% RA History of Present Illness Patient is a 58-year-old male with a history of ADHD, Depression, sleep apnea on CPAP, hypertension, hypercholesterolemia, and type 2 diabetes presenting for concerns of shortness of breath after being diagnosed with Covid. Patient first started having symptoms 10 days ago with fevers, diarrhea, and malaise. He tested positive for Covid 8 days ago, despite being vaccinated with the Pfizer vaccine in February. He states that he has been getting progressively more short of breath, to the point where he is having to take breaks while going upstairs to his bedroom. He called EMS to the scene, who state that when they arrived that he was saturating 88% on room air, so he was placed on a nonrebreather. Patient states that his fevers have stopped and the biggest issue that he is having is his shortness of breath. He does endorse some intermittent swelling in his lower extremities, which he takes furosemide for. Furthermore, patient started crying thrice during the interview, seemed depressed but had no thoughts of hurting himself. He denies any history of heart failure or heart attacks. He also denies any chest pain. Chest Xray was done in the ED and it showed severe diffuse bilateral lung consolidation, consistent with Covid 19 pneumonia.
57 2021-07-12 impaired work ability Constant lower extremities related pain unable to repair from day to day. Missing a ton of work. I ... Read more
Constant lower extremities related pain unable to repair from day to day. Missing a ton of work. I am currently awaiting scheduleing for nerve compression surgery on both arms with possible transposition. Numbness in both arms.
57 2021-07-22 feeling abnormal Extremely sore Arm, fatigue, migraine and cloudy mind starting 12 hours after injection
57 2021-07-27 feeling abnormal brain fog; Tiredness; Spike in blood pressure/High very high Blood pressure, needed treatment to bri... Read more
brain fog; Tiredness; Spike in blood pressure/High very high Blood pressure, needed treatment to bring down 210 over 109.; immediately ringing in ears; Facial stiffness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm (reported as left shoulder) on 29Mar2021 09:30 (Batch/Lot Number: ER8730) (at the age of 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient had no relevant medical history and no known allergies. There were no concomitant medications. On 30Mar2021, the patient experienced spike in blood pressure, immediately ringing in ears, and facial stiffness. On 31Mar2021, the patient experienced brain fog and tiredness. It was further reported that after tracking O2, blood pressure, heart rate and exercise for one and half years with all being under normal, the patient almost immediately had ringing in ear, facial stiffness, high very high blood pressure, needed treatment to bring down 210 over 109 (blood pressure medicine). The events spike in blood pressure, had ringing in ear, and facial stiffness were considered as serious important medical event. The events spike in blood pressure, brain fog and tiredness resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: normal in 2020, blood pressure measurement: needed treatment to bring down 210 over 109 in 2021, heart rate: normal in 2020, oxygen saturation: normal in 2020, and physical examination: good (released for sports) on 30Sep2020. Therapeutic measures were taken as a result of all events. The patient received the second dose of bnt162b2 administered in left shoulder on 19Apr2021 09:30 (Batch/Lot number: EW0153). The patient was recovering from spike in blood pressure, immediately ringing in ears, and facial stiffness while outcome of brain fog and tiredness was not yet recovered. Follow-up attempts are completed. No further information is expected.
57 2021-07-28 sleep disorder Hard bump directly under the the injection site.; Trouble sleeping; red area about 3-4 inches around... Read more
Hard bump directly under the the injection site.; Trouble sleeping; red area about 3-4 inches around site injection,; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received unknown dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, blood pressure high, ascending aortic aneurysm, COVID-19 started on an unknown date. The patient received an unspecified medication within 2 weeks of vaccination. The patient previously received trimethoprim; sulfamethoxazole (bactrim) and amoxycillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 06:00, appx. 40 hours after shot, the patient had a red area about 3-4 inches around site injection (not a rash), hard bump directly under the injection site and was not itchy and also had a trouble sleeping. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received the treatment with cold compress for the reported adverse events. The clinical outcome of the event hard bump directly under the injection site, trouble sleeping and red area about 3-4 inches around site injection was recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
58 2021-01-01 loss of personal independence in daily activities, feeling abnormal Injection site pain and tiredeness day after injection. Severe left sided low back pain centered in ... Read more
Injection site pain and tiredeness day after injection. Severe left sided low back pain centered in sacroiliac joint, next day radiating into left leg and left thorax on Sunday, five days after injection. Severe disruption in all ADLs necessitating narcotic pain medication and an emergent visit with chiropracter. This pain is somewhat better but still persists today 14 days after onset!! This is absolutely miserable. I think I'd rather have COVID
58 2021-01-05 sleep disorder Aches, Dizzy, Chills, high pulse rate, cant sleep
58 2021-01-06 anxiety Fever, chills, headache, body on day after vaccination. The persistent ventricular ectopy and anxiet... Read more
Fever, chills, headache, body on day after vaccination. The persistent ventricular ectopy and anxiety days 2-4 after vaccination.
58 2021-01-07 insomnia, restlessness CoughWheeze, NauseaVomiting, restlessness/no sleep
58 2021-01-10 anxiety Taste of the vaccine in my mouth as soon as administered followed by full body flushing and sweating... Read more
Taste of the vaccine in my mouth as soon as administered followed by full body flushing and sweating and hypersensitivity to sound and touch sense of depersonalization, anxiety Next morning, severe muscle and joint pain
58 2021-01-12 poor quality sleep fatigue; threw up a little; patient received the second dose of BNT162B2 on 06Jan2021; soreness in h... Read more
fatigue; threw up a little; patient received the second dose of BNT162B2 on 06Jan2021; soreness in his right arm/soreness in his legs/legs were hurting; did not sleep good; sick to his stomach; This is a spontaneous report from a contactable consumer (patient himself). A 58-year-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via intramuscular on 06Jan2021 15:00 in right arm at 0.3 mL (30mcg), single for preventative. There were no medical history and concomitant medications. Patient had the first dose of BNT162B2 vaccine on 19Dec2020 for covid-19 immunization. No investigation assessment was received. Patient had the second Pfizer COVID19 vaccine shot yesterday around 15:00 on 06Jan2021. He was asking if it was normal to be sore, patient had a little fatigue on 07Jan2021 and be sick to his stomach in Jan2021. The soreness in his right arm started last night (06Jan2021). He experienced soreness in his legs. He did not sleep good and his legs were hurting last night through the night. As of now his legs do not seem as bad. Patient went to work this morning and then he left work to go back home. He ate a cake and milk before he left for work. He threw up a little on 07Jan2021. It did not take much for him to gag, he even gags when brushing his teeth. Right now and within the last hour, he had not felt sick to his stomach. Outcome of soreness in his right arm/soreness in his legs/legs were hurting was not recovered, of fatigue was recovering, of sick to his stomach was recovered on 07Jan2021, of other events was unknown.
58 2021-01-13 impaired work ability He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effe... Read more
He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered. Unknown if any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension. Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
58 2021-01-20 depressed mood Came down with cold chills and sweats. And feeling run down
58 2021-01-28 anxiety Pt reported to Covid-19 vaccination clinic for Pfizer lot #EL3302 first dose.Reported allergy to sul... Read more
Pt reported to Covid-19 vaccination clinic for Pfizer lot #EL3302 first dose.Reported allergy to sulfa drugs and was in observation for 30 minutes. At approximately 25 minutes post vaccination at 10:15am, Pt signaled that he wanted to leave & was instructed to stay 5 more minutes. Pt anxious and began to shake, saying he could not breathe. Vitals were 147/88, HR 86, O2 98% on RA. Pt was reclined on floor and reported being cold and was striking his head on the blanket; head stabilized. Patient was alert and oriented x3, but complained of chest pain. EMS called, arrived at 10:25, Vitals: 144/92, HR83 O2 99% on 2L. Pt stable & transported to hospital by EMS at 10:35am
58 2021-02-01 disturbance in attention I developed a headache and very mild difficulty concentrating about 16.5 hours after the injection.
58 2021-02-01 sleep disorder I started getting ringing in my ears several days ago, waking me up at about 2 am. Today while at wo... Read more
I started getting ringing in my ears several days ago, waking me up at about 2 am. Today while at work in my office, the ringing became very loud, and has stated that way all day. I?ve never had this before in my life, other than if because of loud concert or such 20 years ago.
58 2021-02-04 feeling abnormal I've had both the first and second shot, with the second shot initial side effects occurring 10 minu... Read more
I've had both the first and second shot, with the second shot initial side effects occurring 10 minutes sooner and lasting about 6 hours longer. 2nd wave effect occurred 3-4 days after shot; it's only been 2 days since the 2nd shot, so that effect hasn't hit yet. Note that I had similar reactions to the flu vaccine's for 17 straight years , with the exception of the brain fog. Flu shot reactions stopped when I started taking Amway Double X multivitamins and tripling up on Vitamin A, C, Zinc and echinacea 3 days before through after the vaccine. Shot 1 - initial side effects: 40 minutes after shot within a mile of returning to work from hospital, I suddenly got lightheaded and very tired with brain fog creeping in. Since that was closer than home, I continued on to work hoping it would soon pass. Brain fog, dizziness and fatigue all continued to worsen, and I was taken home. Effects lasted 9 hours. 3-4 days later the symptoms all came back and lasted 2-3 days, with the addition of temperatures in mid to high 96 range. My normal temperature is a degree low at 97.8.
58 2021-02-13 impaired work ability Significant stomach pain and distress, pronounced fatigue, headache. Most concerning was the emergen... Read more
Significant stomach pain and distress, pronounced fatigue, headache. Most concerning was the emergence of a long dormant auto-immune disorder (Bullous Pemphigus) that I have. None of these problems were present prior to the vaccination. I missed several days of work at the onset and have sought medical treatment three times.
58 2021-02-18 disturbance in attention Vaccine given by vaccinator at 1pm, pt being monitored by RN at 115pm pt had eyes open but did not r... Read more
Vaccine given by vaccinator at 1pm, pt being monitored by RN at 115pm pt had eyes open but did not respond to nurse commands, Breathing normal even, no distress noted, vitals 181/105 HR 98 96%on room air. Director of Nursing in room w/ pt &. called 911 for evaluation at 117pm pt responds to verbal command slow to move head in direction called prior to EMS arrival bp 171/105. EMS arrival at 127pm Paramedic at bedside for evaluation
58 2021-03-01 disorientation Nausea, diarrhea, body aches, headache, disorientation. Severe to moderate for 48 hours, light or in... Read more
Nausea, diarrhea, body aches, headache, disorientation. Severe to moderate for 48 hours, light or intermittent for another 12 hours. Tylenol, liquids, and bed rest.
58 2021-03-01 disorientation Pt reported he got the second COVID vaccine at 8:33 am at the Center at an event run by Health Clin... Read more
Pt reported he got the second COVID vaccine at 8:33 am at the Center at an event run by Health Clinic. At 10 am he began to feel unwell describing "disorientation" which upon further explanation seems he is describing difficulty with his proprioception, ie not able to tell where his body is in space, and disequilibrium, ie having to stop and hold on to something while walking. This lasted most of the day and subsided by evening. He has continued to have ongoing shorter episodes 3-4 times per day lasting 5-10 minutes. In addition he has noted increasing weakness in his right thigh, particularly when going from sitting to standing and the through swing while walking. He describes these as "paralytic attacks" that occur once or twice per day and last hours. Both symptoms are similar to those he had post CVA in 2019 and greatly improved with PT and home exercises. In addition he has noted fecal urgency and fecal incontinence in the last couple of weeks, he is unsure if this is directly related to the vaccine.
58 2021-03-02 excessive sleepiness Achy after day 1. Big fibromyalgia flare days 2-8, unable to pursue normal activity but not bed-ridd... Read more
Achy after day 1. Big fibromyalgia flare days 2-8, unable to pursue normal activity but not bed-ridden. Very tired, lots of naps. On day 9, nausea began. Day 12, fever (100 degrees), nausea, vomiting, diarrhea
58 2021-03-06 sensation of foreign body Within a minute of receiving vaccine I felt a very cold lump/ feeling in my throat that got worse ov... Read more
Within a minute of receiving vaccine I felt a very cold lump/ feeling in my throat that got worse over the next few minutes making it difficult to swallow. At the same time I felt very fuzzy and numb all over my face and body and very light headed. My arms and legs felt very heavy. The EMT took my blood pressure and told me it was 174/125. My normal BP is 110/60. I have had my BP taken once a month over last 20 years at my monthly pain center appointments. They hooked me up to a 4 lead cardiac monitor and said I had A -Fib. They then hooked me up to a 12 lead ekg monitor and said I didn?t have A-Fib. I have had 3 EKG?s in last year because I was scheduled to have total knee replacement surgery which was rescheduled 2 times and all 3 EKG?s were completely normal. After about 1 hour my symptoms improved to the point where I could go home. I Have had between 20-30 knee procedures over the last 40 years and my reaction to the vaccine felt exactly like I was being put to sleep by sodium pentothal or a very high dose of Versed.
58 2021-03-09 confusional state Shaking, Confusion, Head Ache
58 2021-03-11 feeling abnormal First started feeling upset stomach and severe headache, then a couple hours later, the body aches a... Read more
First started feeling upset stomach and severe headache, then a couple hours later, the body aches and joint pain set in. He said his lower body felt like he'd been in a car accident. He couldn't keep anything down to take pain medicine all day long so was miserable all day until about 4pm when he was able to drink some water and take some Vicodin, which did not help. He was up and down all night long with the headache and body aches, and I gave him Excedrin about 6am and that finally started alleviating the headache. He took it again at 11am and was able to eat then, and is gradually been feeling better throughout the day. He was finally able to take his regular meds so now the body aches have subsided (48 hours after injection/36 hours after onset of symptoms).
58 2021-03-22 disorientation pt passed out about 2 minutes after receiving vaccine. Pt was seated when he lost consciousness, pt ... Read more
pt passed out about 2 minutes after receiving vaccine. Pt was seated when he lost consciousness, pt was initially disoriented but was fully conscious and lucid within seconds. Pt stated that he did not hit head when falling from chair, blood pressure was normal at two separate readings minutes after the incident, pt was sweaty with loss of color but was more embarrassed than anything, wife and son returned from shopping, pt felt much better and left with his wife approximately 30 minutes after receiving the vaccine. A follow-up call 4 hours after the event was made. Pt stated he was at work and felt fine.
58 2021-03-22 sleep disorder Right Foot started hurting the night after the vaccine. The next day, it hurt to walk on it. Mainly... Read more
Right Foot started hurting the night after the vaccine. The next day, it hurt to walk on it. Mainly around the base of my 2nd and 3rd toes. The next day it hurt so bad I couldn't walk on it and saw the doctor. A red area had developed on top of my foot at the base on my toes. Doctor though could be Gout but didn't really look like it and usually that is in the big toes. Plus the timing of this issue and my vaccine were suspect. Had X-ray on that Friday, two days after vaccine and everything looked fine they said. I was prescribed Celebrex and over the weekend took two per day due to the pain. I stayed in bed all weekend and pain got worse before taking another dose of medicine which helped for a while. Swelling continued to be about the same or a bit more and the redness moved over to my big toe and then up my foot around towards the right side. Today my right side of foot is really soar now as well and still can't walk on it and still swollen. Doctor at a urgent care sports medicine location prescribed me Prednisone steroid to see if that helps. But so far 5 days after vaccine and my foot is still swollen, red across the top and so painful it keeps me up at night and I can't walk on it. I'm hoping the steroids work.
58 2021-03-23 feeling abnormal On 3-11-21 at 0930, I developed low grade headache up neck over top left side of head in morning, by... Read more
On 3-11-21 at 0930, I developed low grade headache up neck over top left side of head in morning, by 1300 hours I felt very crappy similar to how it feels days after a fever breaks when having the influenza. At bedtime 3-11-21, I had a fever 100.1. At 0100, fever rose to 101.1. At 0500 fever rose to 102.6. During day on 3-12-21, I felt like I had the flu, fever broke mid-morning. on 3-13-21, I felt OK. On 3-15 and 16, I felt like I generally like I had a flue bug. I felt better days later and then around March 21-24th I've had a pretty continuous headache and neck ache which I have not had before the vaccine. Lack of energy and feeling crappy. Scheduled for second vaccine April 2nd.
58 2021-03-24 sleep disorder, feeling abnormal I have had Post Acute Covid-19 syndrome since Nov 4, 2020. The first night after receiving my firs... Read more
I have had Post Acute Covid-19 syndrome since Nov 4, 2020. The first night after receiving my first vaccine I got the chills about 16 hours after my shot went away after a few hours. Woke of the next day with my post acute syndrome symptoms much worse than I had prior to shot, my fatigue in my legs were to the point I could hardly walk, my brain fog and tremors were much worse, that lasted about 1 day then the next two nights I woke up in the middle of night with severe sweating. I was then felling like I had before the shot. Then about 4 days after receiving the vaccine the post acute syndrome symptoms again were much worse than before. This last for about 2 weeks then gradual worked back the my original feeling of fatigue, brain fog and tremors that I had prior to vaccine
58 2021-03-26 nervousness Pfizer COVID-19 Vaccine EUA Was shaky and lightheaded sent to medical obs and provider kept for 30 ... Read more
Pfizer COVID-19 Vaccine EUA Was shaky and lightheaded sent to medical obs and provider kept for 30 mins. Felt better after juice and crackers. Patient presents today for medical monitoring of complaint of being dizzy, sweating s/p COVID - 19 vaccine # 1. Past medical history is significant for intermittent vertigo and asthma. Patient reports previous history of vasovagal episodes with blood draws. Patient was monitored for a total of 30 minutes. Patients vital signs remained stable. Patient reported improvement in symptoms prior to being discharged.
58 2021-04-02 confusional state Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Syste... Read more
Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild
58 2021-04-03 feeling abnormal Joint aches and pains, headache, fatigue, coldness in my hands and feet. Symptoms lasted about 20 h... Read more
Joint aches and pains, headache, fatigue, coldness in my hands and feet. Symptoms lasted about 20 hours, with a bit of residual fatigue and odd feelings for about 1 more day.
58 2021-04-03 sleep disorder rash, very mild just itching a little bit on right arm just inside the elbow/rash on both arms; took... Read more
rash, very mild just itching a little bit on right arm just inside the elbow/rash on both arms; took some Benadryl, it helped him sleep; Swelling in eyes; Eyes watering a lot; eyes red, itchy, and swollen/he deduced that he was having an allergic reaction; eyes red, itchy, and swollen/he deduced that he was having an allergic reaction; eyes red, itchy, and swollen/he deduced that he was having an allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 21Jan2021 (Batch/Lot Number: EL9262) as a single dose for COVID-19 immunization. Medical history included cannot see well out of right eye. There were no concomitant medications. Patient had a rash that appeared a couple days after, very mild just itching a little bit on his right arm just inside the elbow. Patient received the vaccine in the opposite arm in the left arm. Patient is going back on 11Feb2021 for the second dose. It was reported that it is better than being on a ventilator. Patient ruled out everything else the rash could have come from, he didn't change his laundry soap, or anything else. He haven't changed anything since he took the vaccine. He didn't speak to his MD about the rash, because he didn't think about it. He is going to be talking to his Doctor on Monday (unspecified date). He is going to get some calamine lotion but he took some Benadryl, it helped him sleep. It was also reported that the patient had a rash on both arms and swelling in his eyes and he went to the eye doctor who has prescribed him some medication and cream from family doctor. He noticed the rash a couple days after the vaccine and the issues with his eyes too, they were also watering a lot, can hardly see out of the right eye, he had this problem prior to vaccination. The cornea specialist prescribed him some drops, that his eyes were red, itchy, and swollen, he deduced that he was having an allergic reaction. Outcome of the event "took some Benadryl, it helped him sleep" was recovering and of the other events was not recovered. Follow-up attempts are completed. No further information is expected.
58 2021-04-04 sleep disorder I had surgery for spinal stenosis on 07/09/2020, including a decompression and fusion at L4/L5. I r... Read more
I had surgery for spinal stenosis on 07/09/2020, including a decompression and fusion at L4/L5. I reported the following symptoms, which I attribute to the COVID-19 vaccination, to my spine surgeon. I had my second dose of the Pfizer COVID-19 vaccine on Monday, March 29th at 5:45 PM. Lower back pain in the general area of my surgery (07/09/2020) woke me up from sleep around 4:30 AM Tuesday (03/30/2021) morning. Being woken up from sleep had never happened previously - not before surgery, following surgery, ever. I recall the pain being a dull throbbing ache, nothing sharp. I recall being generally pain free Tuesday during the day and went for a mile and half walk Tuesday evening and hit about 20 40-yard (or less pitch shots) Tuesday evening. I woke up Wednesday at my usual 6:45 AM. Although I don't recall being in pain getting out of bed, I do remember being in excruciating pain the remainder of the day. It hurt to walk (landing either foot) and the only position that I had any relief was sitting at work. The pain was frequent, sharp, and up to a 6 on a scale of 1 to 10. I felt exhausted and feel asleep at 7:30 PM Wednesday night. I was in significantly less pain Thursday, although it was still uncomfortable rising from a seated position and bending at the waist (to assume a putting position in the office) caused pain to the extent that I chose not to fully bend. Thursday night was generally OK but there was one point, while seated on a couch, where I felt a sharp stabbing pain in the general area of my surgery. I tried to change positions to alleviate the pain, but it persisted for 30 seconds before finally subsiding. The pain felt like I was being stabbed and it was a 8 or 9 on a 1 to 10 scale. Friday was a repeat of Thursday. Generally, I have very little pain except when I stand from a seated position (1 or 2 on a 10 point scale) or bend slightly at the waist (3 or 4). The pain is dull but the pain from bending does prevent me from bending comfortably. All of this pain is new this week since Monday. This past weekend I worked in the yard, including some heavy lifting and digging. Is there any chance this is a side effect of the vaccine? Should I schedule an office visit to evaluate the pain? NOTE: I was generally symptom free by Saturday, 04/03/2021 and totally symptom free by 04/05/2021.
58 2021-04-06 disturbance in attention, confusional state, disorientation I woke at 6:30am on 04/07/2021 in a state of complete confusion and disorientation. It was a level ... Read more
I woke at 6:30am on 04/07/2021 in a state of complete confusion and disorientation. It was a level of disorientation I have never experienced before in my lifetime. I fainted one time and was having extreme difficulty getting my bearings and walking and was simply in total "mental disarray". I was having difficulty producing words, a prolonged stutter, you might say. I was shaking. The local paramedics came and I was taken to the local ER. Because I was having difficulty speaking, the paramedics (and later the physicians) thought I might have had a TIA. An MRI on 04/07/2021 at 5pm produced a negative result. So i can only attribute my reaction to the vaccine. It was very significant, and i thought it made sense to report it.
58 2021-04-06 insomnia Fever, fatigue, headache,lung congestion,eye pain,hand and feet pain(cramps needle/pins poking)eyes ... Read more
Fever, fatigue, headache,lung congestion,eye pain,hand and feet pain(cramps needle/pins poking)eyes blurred,sleepness
58 2021-04-09 amnesia, hallucination, feeling abnormal 11 hours after shot (Sat 3/27/21 2:00am): Chills, high temp & hallucinations, then hot, neck, back, ... Read more
11 hours after shot (Sat 3/27/21 2:00am): Chills, high temp & hallucinations, then hot, neck, back, arms & legs muscles tightened, freezing for a few hours. 8:00a: wiped out. 1:00pm (Sat): chills, hot, body aches, upset stomach, slept on/off until 4 or 5pm when I started shivering, vomiting, some hallucinating. Armpit glands felt twisted and pulled. I felt worse & asked my wife to call 911. Paramedics came, took vitals, blood, offered to take me to hospital (didn?t go). They stayed an hour until I felt stable. Sun 3/28/21am, exhausted, slightly better but my mind was spacey, body achy & armpits hurt. 12:00pm: noticed short term memory loss, ate a few crackers, drank water, napped on/ off, went to bed around 900pm. Mon, 3/29/21, still achy and mentally fuzzy. Side effects diminished over a few days.
58 2021-04-09 confusional state, feeling abnormal About 12 hours after vaccine, I experienced severe, intense, terrible diarrhea, lasting for several ... Read more
About 12 hours after vaccine, I experienced severe, intense, terrible diarrhea, lasting for several hours. I had red rash across my arms, legs and belly. My blood sugar crashed. I had "brain fog" and was very confused.
58 2021-04-09 feeling abnormal passed out/unconscious; feel weak; dizzy; not normal; This is a spontaneous report from a contactabl... Read more
passed out/unconscious; feel weak; dizzy; not normal; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 26Mar2021 09:45AM (Lot Number: ER8730) as single dose for COVID-19 immunisation. The patient had COVID prior vaccination. The patient had no other medical history or known allergies. The patient's concomitant medications were reported as none. The patient did not have COVID test post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking the vaccine the patient waited for 15 minutes prior to departing the facility in order to make sure there was no adverse reactions. At approximately 10:15 10:30 AM the patient drove back home. After driving for about five minutes while stopped at a traffic light the patient completely passed out at 10:45, he was unconscious for approximately 2 to 3 minutes, almost crashed his car and EMT support had to be called. The patient regained his conscience but it took him over a half hour to feel 50% better. Until 8:30 PM 26Mar2021, the patient still felt weak and dizzy and not normal. No treatment was received for events. The outcome of events was recovering.
58 2021-04-12 feeling abnormal, loss of personal independence in daily activities, impaired work ability Day 2 Extreme fatigue and foggy head. I had to leave work as I was extremely tired and just driving ... Read more
Day 2 Extreme fatigue and foggy head. I had to leave work as I was extremely tired and just driving home was as if I was under the influence. Day 3 - Extreme fatigue and sever body aches Day 4 - Slightly better, but still not able to resume normal activities Day 5 - Tried to resume normal activities (bike ride), but I have to stop due to extreme fatigue and severe muscle cramping. Day 6 - Actually felt normal Day 7 - Back to 100%...
58 2021-04-13 insomnia March 10, 2021: 1st dose of Pfizer COVID-19 vaccine March 11: pleurisy-type symptoms and difficulty ... Read more
March 10, 2021: 1st dose of Pfizer COVID-19 vaccine March 11: pleurisy-type symptoms and difficulty urinating began March 19: still symptomatic, urgent care visit with chest x-ray and blood draw March 20: told to go to ER, concern for pulmonary embolism. Sent home the same day, told to take pain medications and tamsulosin prescribed from urgent care visit. Received chest x-ray, blood draw, and CT scan. March 25: another doctor visit, still symptomatic, prescribed prednisone and hydrocodone for pain and trouble breathing April 1: Seen by renal specialist, blood pressure medication dose changes, elevated potassium As of April 12, 2021, still symptomatic with pain (in the back), unable to sleep and taking pain relievers every 4 to 6 hours
58 2021-04-15 insomnia Headaches, body aches, exhausted feeling, diarrhea upset stomach, insomnia
58 2021-04-15 sleep disorder Became like a case of pleurisy with debilitating pain & chest pain -many labs taken, X-rays , CAT S... Read more
Became like a case of pleurisy with debilitating pain & chest pain -many labs taken, X-rays , CAT SCAN, for lungs, In ER.... over $7.000 with more expenses for 5 dr. Appt. post vaccine Difficulty with breathing - unable to sleep - continued pain-dr. Called today - 4/16/21 Begin antibiotic
58 2021-04-16 feeling abnormal Exhaustion / Fatigue - significant exhaustion at about 5:30 PM. It came as a wave while standing up... Read more
Exhaustion / Fatigue - significant exhaustion at about 5:30 PM. It came as a wave while standing up talking to someone. I fell back against wall. I went home and fell asleep at about 8:30pm for 13 hours. Felt tired the entire next day and went home and fell asleep at about 8:30 pm and slept for 14 hours. Felt tired most of the day. Felt exhausted and went to bed at 9:30 on Saturday night (the 3rd night) and slept for about 12 hours. This is very unlike me because I normally stay up and watch a movie with my wife on a Saturday night. This pattern of feeling exhausted by 6:00pm continues and we are now at about 3 weeks after the vaccine. It?s improving a bit but it?s still outside the normal pattern for me. I?m still feeling quite tired early in the evening and going to be much earlier than Normal. Additionally, I feel like I?m not myself. At times, my brain feels a bit foggy in that I?m not as aware or clear in my thinking as I normally would be.
58 2021-04-19 confusional state, impaired work ability Day after first vaccine (Tuesday March 30) was administered, developed severe headache, chills, neck... Read more
Day after first vaccine (Tuesday March 30) was administered, developed severe headache, chills, neck pain, and slight abdominal cramp. By Friday April 2, severe abdominal cramp, headaches, nausea, slight high temperature. Persisted throughout the whole weekend. Called in sick Tuesday April 6 for abdominal cramp, temperature, confusion - admitted to ER.
58 2021-04-21 emotional distress After vaccination approximately 10min, client was noted to have reddened face and stressed appearanc... Read more
After vaccination approximately 10min, client was noted to have reddened face and stressed appearance and then post administration monitor called for health care assistance. Nurses responded with O2 and emergency cart. Client reported unable to swallow. Client status changed deeper reddened/dusky skin and assisted to the floor. At 3:27pm administered epipen and O2 also applied via simple mask at 10L/min. VS continuously monitored. At 3:32pm administered 2nd epipen due to client status continuing to decline. Client reported yes to question of chest pain with deep breaths, unable to speak. 911 was called at 3:26pm. EMT arrived at 3:35 and assumed care. Client transferred to facility. Spouse present throughout event and Additional information for Item 18: ambulated off floor with EMT.
58 2021-04-22 confusional state, memory impairment, disturbance in attention 4/14/21 Patient is a 58 y.o. male who presented for confusion, fatigue and dizziness since the past ... Read more
4/14/21 Patient is a 58 y.o. male who presented for confusion, fatigue and dizziness since the past couple of days. Patient was getting lost on the train and forgetting his work duties. 4/14/21Neurologic exam: MS - awake, alert, oriented to name, -age, hospital, -time, speech fluent and without dysarthria, naming & repetition intact, follows commands, attention and concentration are impaired, clock drawing is impaired and shows L sided neglect, line bisection test is impaired, remote and recent memory and fund of knowledge are impaired CN - PERRL, EOMI and without nystagmus, visual fields are intact to confrontation but there is extinction on the L to double simultaneous stimulation, facial sensation is intact to PP V1V2V3, no facial droop, hearing is intact to finger rub B, palate is not well visualized due to his palate/tongue anatomy, head turn is 5/5 B, tongue protrudes symmetrically. Fundoscopy is deferred due to the COVID-19 pandemic and need for PPE which precludes exam. Motor - Normal bulk/tone, 5/5 B UE and LE, curling of the L fingers on pronator drift testing Sens - Pinprick is intact B UE and LE. There is extinction to double simultaneous stimulation on the L DTR's - 1/4 B bi/tri/BR and patellar/ankles. No clonus. No Hoffman's. Babinski is down B. Coord - finger-to-nose is without dysmetria B, there is dysmetria of the L leg on heel-to-shin
58 2021-04-24 confusional state Full blown seizure; Fatigue; Confusion; Breathing was off; breath was heavier; patient's blood press... Read more
Full blown seizure; Fatigue; Confusion; Breathing was off; breath was heavier; patient's blood pressure was very low; Real sluggish/get slow; Speech started to get slow; This is spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734) via an unspecified route of administration in left arm on 04Apr2021 12:00 at age of 58-year-old at single dose for COVID-19 immunization. It also stated the patient was one of the most vulnerable against virus so he took the Covid-19 Vaccine. Medical history included ongoing cardiac failure congestive diagnosed probably 10 years ago, ongoing diabetes mellitus diagnosed probably 20 years ago, ongoing dialysis for 3.5 years. Concomitant medication included ongoing unspecified blood thinner. Caller reported that the patient didn't take any blood pressure medications and that she knew the patient took a blood thinner. Caller unable to provide further detail for the patient's medications as she doesn't have the patient's list of medications with her. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7534) injected in left arm in Mar2021 at age of 58-year-old for COVID-19 immunization and experienced fatigue after the first dose of the Covid-19 vaccine. Caller reported that it was hard to determine the cause of the fatigue because the patient was on dialysis, but that the patient has been more fatigued since he received the first dose of the Covid-19 vaccine. The patient was a compromised fellow with a host of pre-existing conditions as far as heart disease, diabetes, and dialysis. Caller was calling in regard to the Pfizer Covid-19 vaccine. Caller reported that she was calling to report a bad reaction that her husband, the patient, received on Sunday, 04Apr2021, following his second dose of the Covid-19 vaccine. Approximately 3 hours after receiving the Covid-19 vaccine, the patient had a full blown seizure at 15:00 on Sunday, 04Apr2021. Caller reported that she had to call emergency responders following the patient's seizure. The patient was doing better but the experience with his seizure was quite traumatic. Caller stated that if it was going to happen, it was going to happen to us. About 3 hours after receiving his Covid-19 vaccine on 04Apr2021, the patient became real sluggish and his speech started getting slow before the seizure occurred. Caller reported that the patient made a gradual descent downwards. Caller reported that she swears the patient has not been the same as far as fatigue goes since the patient received his first dose of the Covid-19 vaccine 3 weeks prior. Caller reported that she thought the fatigue was maybe from dialysis. The patient started to get slow just before the seizure, about 2.5 hours after he received the second dose of the Covid-19 vaccine. The patient was laying down following the second dose of the Covid-19 vaccine. Caller reported that the patient's breathing was off. The patient's breath was heavier. Caller reported that after she noticed the patient's breathing was off, she asked the patient if he was ok. Caller reported that this is when she noticed that the patient's speech was really slow and that he was experiencing confusion. The patient has had no more seizure activity. The patient was still being monitored in the hospital. Caller reported that the patient didn't remember any of it. It's hard to say if the patient's sluggishness and fatigue were ongoing. Caller reported that she couldn't go see the patient while he was in the hospital but that the patient's voice sounds much stronger. For Confusion and Speech: Caller reported that the patient seems to be back/ returned to normal. Caller reported that she knew that the patient's cardiologist went to see the patient. The patient's cardiologist said that there was nothing that happened to the patient's heart, that what the patient experienced was not a heart issue, and that the event had no effect on the patient's heart. The medical staff stated that the seizure the patient experienced was related to a blood pressure drop. Caller reported that the patient's blood pressure was very low on 04Apr2021. The patient required a visit to Emergency Room for event seizure, no visit of physician office. Admitted on Sunday, 04Apr2021 for seizure, and still hospitalized. For investigations: Caller reported that the medical staff at the hospital definitely did lab work but she was not sure if any imaging was performed. Caller reported that she has no results available for tests that were performed. The outcome of events confusion and "speech started to get slow" was recovered in Apr2021, the outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021380129 same patient, different product(dose)/event
58 2021-04-24 feeling abnormal Caller reports having a Covid infection after receiving the first dose of the Pfizer Covid vaccine/d... Read more
Caller reports having a Covid infection after receiving the first dose of the Pfizer Covid vaccine/diagnosed with COVID-19 virus; Headache; Cough; feeling ill; Fatigue; feeling bad; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program COVAX Support. A58-year-old male patient received first dose BNT162B2 (Solution for injection, Pfizer-Biontech Covid-19 Vaccine, lot number: EN6208, expiry date: 30Jun2021) via an unspecified route of administration in left arm on 20Mar2021 at 10:05 AM at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Reports having a Covid infection after receiving the first dose of the Pfizer Covid vaccine on 25Mar2021. He wants to know if he should get the second dose of the vaccine. He states he got the first shot and then he got the COVID virus. He says he doesn't know if he got the virus before or after shot. He states he contracted the virus 4 or 5 days after getting the shot. He started feeling bad on an unspecified date in Mar2021. He has gone through the 14 days of quarantine and is suppose to get his second shot. He wants to know was it smart to get second shot on top of getting COVID? He states he was 6 foot or 72 inches. States he got the first shot 3 weeks ago, on Saturday 20Mar2021. He states that he started feel ill on the 25Mar2021 and went and got a COVID test. His results came back positive on Thursday 26Mar2021. On 25Mar2021, he states that he has a cough and a headache, and a few other symptoms as far as fatigue and things like that. He does not have a fever. He states that he has gone through the 14 day quarantine and was planning on going back to work tomorrow. He states that he was due to take the second shot this Saturday and he doesn't want to get sick all over again. He doesn't want to feel like this after being gone for two weeks. His headache, cough, and feeling ill started on 25Mar2021. He states that his symptoms are improving everyday seems like it is a little better. He left his vaccine card in his truck because he figured he would need it when he went back, and it was better than putting it in his wallet and loosing it. He got the vaccine because he didn't want to get the virus and then he got it anyway. He was tested for COVID on 25Mar2021 and got a positive result on 26Mar2021. Reported, as he had 1st shot 20Mar2021, but was diagnosed with COVID-19 virus. He was concerned about getting the 2nd shot scheduled on 10Apr2021. He was not yet getting better, and the caller still has the symptoms. (Name) calling also about his wife, named (Name) was in quarantine and also experiences an adverse reaction after the 2nd shot. Outcome of events was recovering. No follow up attempts are possible. No further information is expected.
58 2021-04-24 feeling abnormal Four hours later he passed out/ Four hours after getting vaccine he was on the floor and out like a ... Read more
Four hours later he passed out/ Four hours after getting vaccine he was on the floor and out like a light; Sore right arm; goofy; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 58-years-old intramuscular, administered in Arm Right on 04Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation and prophylaxis. Medical history included high cholesterol, allergy (When pollen is heavy, it is worse) from an unknown date and unknown if ongoing, fractured his shoulder in 05Feb2021, sinus jacked up from an unknown date and unknown if ongoing, covid-19 from Nov2020 to an unknown date, anemic from Dec2020 to an unknown date, nasal surgery on an unknown date, fever blisters from an unknown date and unknown if ongoing, immune system disorder from an unknown date and unknown if ongoing. Concomitant medications included zolpidem tartrate (AMBIEN) taken to help sleep; atorvastatin (LIPITOR) taken for high cholesterol; loratadine taken for allergy; cetirizine hydrochloride (ZYRTEC) taken for allergy; mometasone furoate (FLONASE) taken for allergy; start and stop date were not reported for all; fish oil (OMEGA 3) and selenium (SELENIUM) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D3 1000) taken for immune system disorder; iron (IRON) taken for anaemia; lysine taken for fever blisters ; zinc taken for immune system disorder, start and stop date were not reported for all and multivitamin. It was reported that four hours after getting vaccine on 04Mar2021, he was on the floor and out like a light. This is the first one he received and his doctor said not to get second one. He had the first one and about 4 hours later, he was on the kitchen floor and out like a light. He doesn't know if it was connected to shot or not. He never had problems before. He got the vaccine around 09:30 and around 13:30, his friend came in for lunch and found him on the floor. She freaked out. She said she liked to never got him awake and said he was goofy for a good half hour. He does not know how long he was on the floor. His arm was sore on 04Mar2021 09:30 for about 4 days. The patient underwent lab tests and procedures which included blood iron: so low on an unspecified date. The patient was recovering from passed out and sore arm while recovered from goofy on 04Mar2021.
58 2021-04-28 loss of personal independence in daily activities Following the first dose of the Pfizer vaccine, about 2 days later he started having bilateral shoul... Read more
Following the first dose of the Pfizer vaccine, about 2 days later he started having bilateral shoulder pain which progressed over the following few days to include proximal muscle weakness. The symptoms seemed to slowly improve by the time he received his second dose on 4/20 but then he had worsening of symptoms again. Symptoms included difficulty with movement of the arms for routine daily activities, difficulty ascending stair or getting out of chairs. Pain and weakness is more severe in proximal muscles, particularly the shoulders and hips.
58 2021-05-04 sleep disorder Immediately following the injection, my right shoulder, elbow, forearm and wrist started to get sore... Read more
Immediately following the injection, my right shoulder, elbow, forearm and wrist started to get sore. Each day thereafter my shoulder was really sore, I am having these burning sensations in my right forearm and my wrist is in pain. It has been 5 days since my second vaccine and each day has been very rough to get through. I have 2 jobs and the pain is interfering with my job duties. And when I'm trying to sleep, it's very uncomfortable and I haven't been able to get a full night's rest. I haven't seen any doctors or taken any medication because I thought that the symptoms would go away but they haven't. I don't know what to do
58 2021-05-07 disturbance in attention, feeling abnormal Extreme Fatigue , Blurry Vison, Inability to Focus/Concentrate - Brain Fog
58 2021-05-07 disturbance in attention, feeling abnormal Extreme Fatigue, Inability to Focus, Concentrate , Brain Fog
58 2021-05-07 feeling abnormal I don't know it is stroke or something; heart burn something; its like I am having a heart attack; f... Read more
I don't know it is stroke or something; heart burn something; its like I am having a heart attack; feeling crappy/ feeling funny/ I can feel like the drug was inside me like something was changing/ something happening with my body; Headache/ slight headache; Chest pain/ I can feel a pain where my heart is; arm was sore; heart burn; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 09Apr2021 at a single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 18Mar2021 for COVID-19 immunisation (left arm). Patient stated, "the second was really bad my arm was sore for like over a week I mean it was sore. I don't know I have not felt the same since. I can feel like the drug was inside me like something was changing and I never had no problem for anything but now its been like at the last when I got the shot was 9th of April of this month, its been like 2 weeks now almost and it is like I feel crappy. I have headache I have like a chest pain u know in my chest. I have like my heart is I don't know its like I am having a heart attack or something I don't know it is stroke or something. I do not know it is feeling funny. I have no problem I do, may be I have may be heart burn something. I don't know because on every single day everyday I have chest pain my heart, headache I have slight headache now. I don't know why I can feel a pain where my heart is on left side now I got the pain on right side you know I have the pain there and I wondering what's going on so I don't know". Consumer stated, "First its both side that is what I am saying now right now so as I am talking to I have pain in my heart and like it feels the heart u know I don't know there is a weird thing in my heart. I feel like you have a heart attack or so, I you feel like a chest pain or you had a heart burn or something and then on my right side has started it is like something happening with my body you know now its the right side. I don't really know, I can feel me liver, my kidneys are like something is like I can feel something is going I don't know what's going on with my body. You know after getting the shot right now I have the slight headache. I took a quite couple of Tylenol as stuff but that seems like no. This every single day you know that you I thought it will go away but it did not go away". Consumer stated, "Yes, it is the first time. Like I said I thought it will go away but it is not getting any better. I am getting concerned. I do not know I have to be admitted to hospital. I do not have no insurance or anything. I am really worried." The patient hasn't been to the doctor, he was calling first for help. He has no insurance so he cannot just go to the doctor. Consumer stated, "It never improved no. Persisting." Outcome of the events was not recovered. Information on the lot/batch number has been requested.
58 2021-05-08 feeling abnormal Severe vertigo, nausea and vomiting. Could not stand up for over 24 hours. Could not eat or drink wa... Read more
Severe vertigo, nausea and vomiting. Could not stand up for over 24 hours. Could not eat or drink water without vomiting for over 24 hours. Symptoms subsided after 24 hours, but almost a week later I still wake up dizzy in the mornings. Dizziness subsides as I start moving around, but still do not feel fully normal.
58 2021-05-09 feeling abnormal I continue to struggle with these re-awakened symptoms from my Covid infection 11/2020 * Headaches ... Read more
I continue to struggle with these re-awakened symptoms from my Covid infection 11/2020 * Headaches * Spiking blood pressure * Brain fog/light headedness * I often smell a campfire, i.e. wood burning smell
58 2021-05-10 disturbance in attention, feeling abnormal Muscle/ body aches (back, leg and arm pains) and joint pain (wrists), even feet difficulty bending a... Read more
Muscle/ body aches (back, leg and arm pains) and joint pain (wrists), even feet difficulty bending and pain back and hips sitting low-grade fever Brain fog; trouble focusing/ concentrating.
58 2021-05-15 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild
58 2021-05-15 feeling abnormal Patient received the 2nd COVID vaccine (Pfizer, lot #EW0182, use by date 05/17/21 at 1515) at 1438. ... Read more
Patient received the 2nd COVID vaccine (Pfizer, lot #EW0182, use by date 05/17/21 at 1515) at 1438. The patient reported feeling dizzy to EMT, who immediately moved him to the anti-gravity chair. RN assisted in positioning him in a Fowler's position and ice packs were placed on his back and behind his neck. Patient's face mask was removed and his vital signs were taken at 1459, the patient was wearing a thick jacket, so the palpable radial pulse on the left forearm was 145, HR 83, RR 16, oxygen saturation was 97%., and pupils were equal. The patient denied any shortness of breath, difficulty breathing, difficulty swallowing, chest pain, or loss of consciousness. The patient was alert and oriented to person, place, time, and situation. The patient was speaking in full sentences and immediately responsive to questions. The patient was given a bottle of water and reported last eating around 1300. The patients color slowly reappeared when he was placed in Fowler's position. Reported being allergic to penicillin and taking Seroquil, 400mg, daily and Hydroxyzine, 25 mg for anxiety. Denied any chronic medical disorders other than general anxiety. Vitals were retaken at 1459, BP: palpable radial pulse, 140, RR 16, HR 79, and oxygen saturation at 98%. The patient stated that he felt flushed in his face, and the patient was immediately offered Benadryl but he stated, " Let's wait a few minutes, I don't like taking anything if I don't have to."The patient denied any shortness of breath, difficulty breathing or swallowing, lip tingling, or facial swelling. The patient decided to take the oral Benadryl at 1503 and was given Benadryl, 50mg oral suspension, PO. At 1505 we attempted to position him to a sitting upright position in the gravity chair and he stated, " I feel lightheaded, can we place me back how I was?" EMT and RN repositioned the patient in the anti-gravity chair to a Fowler's position and assisted the patient with removing two layers of shirts, as he was wearing multiple layers. Vitals were retaken at 1506: 120 palpable radial pulse, RR 16, HR 78, and oxygen saturation at 97%. The patient was alert and oriented to person, place, time, and situation. The patient was able to follow commands, had strength equal bilaterally in the upper extremities, and had a symmetrical smile. Vitals were retaken at 1515, BP: 120/82 (R arm), HR 81, RR 16, oxygen saturation at 97%. The patient was given juice and repositioned to a semi-Fowler's position. Denied dizziness or lightheadedness. The patient stated, " I'm usually pretty sensitive to medication, now I just feel like I could go to sleep." Denied experiencing shortness of breathing, difficulty swallowing, or difficulty breathing. Vitals were retaken at 1528, BP 120/85, HR 66, RR 16, oxygen saturation at 98%. The patient was able to follow commands, and stated, " I feel a pressure in my head." RN was going to call 911 to have EMS transport the patient to a hospital, but the patient denied EMS services and did not want 911 to be called when it was offered at 1528. The patient was repositioned to a Fowler's position. Patient reported no longer feeling flushed on the left side of his face at 1535. At 1540, vitals were retaken, BP 120/85 ( R arm, sitting upright), HR 79, RR 16, and oxygen saturation at 97%. The patient's color returned and he denied feeling lightheaded or dizzy. RN instructed the patient about emergency precautions and to follow up with his primary care provider. RN educated the patient about not operating machinery as the patient was given Benadryl and this may cause him to be drowsy. The patient contacted a friend to pick him up from the site. RN gave the patient reporting information. Vitals were retaken at 1550, BP: 120/82, HR 76, RR 16, and oxygen saturation at 98%. The patient's mouth was moving with regular movements and the patient was rapidly responding to questions. Patient called friend to coordinate his ride home. RN educated him about ER precautions again. The patient was alert and oriented to person, place, time, and situation, and his facial color had returned to baseline. EMT was instructed to stay with the patient until patient's friend arrived on site. At 1610 EMT reported to RN that patient reported feeling flushed and lightheaded again. EMT immediately placed him in a Fowler's position and RN called 911, EMS. The patient stated, " It's hard for me to recall things, like my head is really foggy." Patient's speech was slower than baseline, no facial swelling was observed and patient denied any difficulty breathing, shortness of breath, chest pain, or loss of consciousness. Patient was alert and oriented to person, place, time, and situation. Fire Department assumed care at 1615, RN gave report to the responders. The responders completed an EKG on site and completed a set of vitals. Patient denied transportation by EMS to hospitaland signed AMA paperwork given to him by the responders. Patient's friend arrived on site at 1618. RN educated patient's friend about transporting patient to hospital, as patient stated, " I'm going to have my friend take me to the hospital." RN quickly educated patient's friend that if while transporting patient to hospital, he began to experience shortness of breath, loss of consciousness, or difficulty breathing, to immediately pull over and call 911. Patient's friend verbalized understanding and patient was pushed in a wheelchair to the friend's vehicle, as he was very lightheaded. EMT, EMT, and RN assisted patient into the vehicle. Patient and friend stated that they were going to pick up a few items from patient's car and then go to the hospital immediately. Patient left the site at 1621.
58 2021-05-22 sleep disorder 2021.05.20, 11:30PM felt unusually tired after my daily evening 3-mile walk. Muscles all over my bod... Read more
2021.05.20, 11:30PM felt unusually tired after my daily evening 3-mile walk. Muscles all over my body ached. 2021.05.20 12 midnight - 2021.05.21 8:00AM - slept very poorly with several interruptions, lots of sweating, mattress and bedding damp by the morning. I did not feel hot like when I have a fever. 2021.05.21 - 8:00AM - 9:00PM - Felt weak and lethargic. Muscle pain all over body continued. I needed to nap for two hours during the day. My heart rate was elevated about 15 percent above normal. After the nap I still felt tired. Food helped a little, but I went to be early, at 9PM. 2021.05.21 - 9:00PM - 2021.05. 22 - 8:00AM - Slept poorly with several interruptions, chills, and night sweats. Again awoke with damp mattress and bedding. For the first 10 minutes after rising I felt a little better, but then the muscle pain intensified and the lethargy too. I spent several hours of the day lying down in bed. Ate normally, which improved my overall feeling and energy level. Also consumed electrolytes and water. In the evening I started to feel not fully recovered, but a lot better than 24 hours prior. I went to bed at 11PM. 2021.05.22 - 11PM - 2021.05.23 - 10AM - I had some chills on preparing my bed, but overall slept better. Some sweating still. 2021.05.23 10AM - present 8PM - Felt much better. 95 percent of normal.
58 2021-05-25 confusional state Patient received the vaccine on 3-31-21. Then at 4:00 am on 4-1-2021, he became lightheaded and rep... Read more
Patient received the vaccine on 3-31-21. Then at 4:00 am on 4-1-2021, he became lightheaded and reports passing out. He had several weeks of general malaise and mild headache. He does not recall head trauma and had no bruising, "goose egg", etc. He felt generally unwell with a mild headache since then. Then on May 16th, 2021, while traveling with his wife, his left hand and arm and left side of tongue became numb and week. He was mildly confused. His wife took him to the ER and he was transferred to hospital for neurosurgery admission. Hospital records note that they presume the subdural bleed was triggered from the fall the morning of May 5th.
58 2021-05-26 confusional state Approx 5 min after receiving the 2nd Pfizer COVID vaccine the patient fainted hitting head against w... Read more
Approx 5 min after receiving the 2nd Pfizer COVID vaccine the patient fainted hitting head against wall, scraping knee from falling and biting his lip. Pt was unconscious for approx 45 secs to 1 min. Vitals remained within normal limits during entire encounter except for increase in respiration rate of about 26-28. After regaining consciousness the pt was confused, nauseas, vomiting, diaphoretic and clammy to the touch. EMS arrived un scene approx 5-10 minutes after pt hitting his head and was transported to Hospital
58 2021-05-26 confusional state Patient received their 2nd Pfizer COVID vaccine and about 5 minutes afterwards in the observation ar... Read more
Patient received their 2nd Pfizer COVID vaccine and about 5 minutes afterwards in the observation area the patient became lightheaded and collapsed hitting his head against the wall, EMS was called. While collapsing the patient bit his tongue, scraped his knee, and developed a visible bump on his head. Patient was unconscious while collapsed lasting approximately 45 seconds to 1 minute. When he regained consciousness he was confused and unaware where he was or what happened. Vitals were taken throughout being unconscious every 5 minutes until EMS arrived which was about 5-10 minutes after the patient collapsed. After regaining consciousness patient was cold, diaphoretic, nauseas, and emesis x 2. Report was given to EMS and transported to Hospital.
58 2021-05-31 anxiety Saying he could not breath; anxious; reported being cold; complained of Chest pain; began to shake; ... Read more
Saying he could not breath; anxious; reported being cold; complained of Chest pain; began to shake; This is a spontaneous report from a contactable other hcp reported that a 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3302 and expiration date: unknown), via intramuscularly in Arm Left on 29Jan2021 at 09:45 (at the age of 58 years old) as a single dose for COVID-19 immunisation. Medical history included allergies to Sulfa drugs from an unknown date and unknown if ongoing, Cardiac stents from 2004 to an unknown date. Concomitant medications included Lipitor, Aspirin, Plavix, Nitroglycerine for an unspecified indication from an unspecified date. No other illness reported at the time of vaccination and up to one month prior. The patient was in observation for 30 minutes. At approximately 25 minutes post vaccination at 10:15am, Patient signaled that he wanted to leave and was instructed to stay 5 minutes. Patient anxious and began to shake, saying he could not breathe. Vitals were 147/88, HR 86, O2 98% on RA. Pt was reclined on floor and reported being cold and was striking his head on the blanket; head stabilized. Patient was alert and oriented X3 but complained of Chest pain. EMS called, arrived at 10:25, vitals: 144/92, HR83 O2 99% on 2L. Pt stable & transported by EMS at 10:35am. The patient underwent lab tests and procedures which included heart rate: 86, 83, investigation: 147/88, 144/92, oxygen saturation: O2 98% on RA , oxygen saturation: 99 % on 29Jan2021. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
58 2021-05-31 feeling abnormal Patient reports shortness of breath, headache and dizziness 15 minutes after received COVID-19 vacci... Read more
Patient reports shortness of breath, headache and dizziness 15 minutes after received COVID-19 vaccination. Patient stayed in observation area for 1 hour. Patient reports "brain fog" for 4 days after vaccine and 1 week after vaccine experienced tinnitus.
58 2021-06-01 sleep disorder, loss of personal independence in daily activities Severe tinnitus ( ear ringing) started at 4:20 a.m. ,(woke me up), on Tuesday April 13th, 2021, less... Read more
Severe tinnitus ( ear ringing) started at 4:20 a.m. ,(woke me up), on Tuesday April 13th, 2021, less than 48 hours after receiving the 1st dose of the COVID Pfizer vaccine injection. It's been so severe it's got to the point that I've contemplated considering suicide. It has totally turned my life upside down as it relates to sleep, working, daily functioning and living. On a scale of "1 to 10" I'd rate my tinnitus a "7" in severity. It's a very high pitched tone, it sounds like the test pattern the TV stations used to broadcast at midnight. It's maddening. It's torture. The first 4 weeks were really hell. Now it vacillates between a 7 and a 4. It gets worse at night when I lay down. So as of today it's been 7 weeks and 1 day since the onset of this tinnitus. I called Pfizer Thursday April 15th, they were no help. I had a zoom call with an MD who recommended not taking the 2nd Pfizer dose and to see and ENT asap. I saw Dr. who prescribed Prednisone tablets. I am still suffering greatly from this. Never in my life have I had tinnitus. Never in my life have I been around loud work environments. This is a direct result of taking the Pfizer vaccine. I am certain of this fact.
58 2021-06-02 feeling abnormal Left arm was only sore for 36 hours; Within 1 minute throat got ice cold; Difficult to swallow; Fuzz... Read more
Left arm was only sore for 36 hours; Within 1 minute throat got ice cold; Difficult to swallow; Fuzzy feeling over entire body; Numb face; Tingly feeling; Heavy arms and legs; Light headed, felt very woozy; Blood Pressure went up to 170/120; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple (20 to 30) bilateral knee surgeries and total right knee joint replacement on 02May2020. Concomitant medications included oxycodone 5mg (MANUFACTURER UNKNOWN) as needed, aspirin 88mg/day (MANUFACTURER UNKNOWN) for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 05Mar2021 (within 1 minute of vaccination), the patients throat got ice cold and more difficult to swallow, fuzzy feeling over entire body, numb face, tingly feeling, heavy arms and legs. Light headed, felt very woozy. It felt exactly like patient had been administered general anaesthesia right before surgery. The patient blood pressure (BP) went up to 170/120 (unspecified unit). As symptoms started getting better after 1 hour, BP went down to 140/70. On an unknown date, the left arm was only sore for 36 hours. It was reported that, emergency medical technician (EMT) did multiple blood pressure checks and electrocardiogram (EKG) at the vaccine site. The patient did not received treatment for adverse events. The clinical outcome of events throat discomforts, swallowing difficult, fuzzy, numbness in face, tingling, heavy feeling in arms and legs, light headed and blood pressure increased was recovered on 05Mar2021 (symptoms were gone after 3 to 4 hours from onset of reaction) and the event pain in arm was recovered on an unknown date (left arm was sore for 36 hours). No follow-up attempts are needed. No further information is expected.
58 2021-06-03 disturbance in attention, confusional state Body aches Loss of mental clarity - extreme confusion lasting for the first 5 days Very extreme head... Read more
Body aches Loss of mental clarity - extreme confusion lasting for the first 5 days Very extreme headaches lasting for 9 days, then recurring on Apr 27 for another 7 days Intolerance to heat or temperatures above 72F lasting 30 days Positional dizziness lasting 30 days
58 2021-06-03 loss of personal independence in daily activities Prior to receiving the vaccine I had mild sciatica. I was able to walk a mile before it bothered me.... Read more
Prior to receiving the vaccine I had mild sciatica. I was able to walk a mile before it bothered me. The pain was perhaps a 3 on a scale of 1 to 10. After receiving the vaccine it became so severe that I was unable to walk or stand for more than a couple minutes, the pain was a 7 on a scale of 1 to 10, and it therefore interfered with daily tasks such as cooking, cleaning, showering, shopping and so on.
58 2021-06-07 anxiety sore arm; chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs; chest pain... Read more
sore arm; chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs; chest pain/muscle pain in the rib in the chest ribs; teeth pain; teeth sensitivity; anxiety; When I take a death breathe it hurts and sometimes it doesn't; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 58-year) on 07Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Advil 12 hours back for arthralgia. The patient stated, she received the first dose of her Pfizer vaccine that morning at 9:45am or 10am. she was fine. she just had a sore arm. About 2 and 1/2 hours later experienced: chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs. Minor issue: teeth pain/sensitivity there. she talked to her PCP and he said she had anxiety, so took CBD oil. She stated "When I lie down the pain wakes me up because of the pain. When I take a death breathe it hurts and sometimes it doesn't. It's been almost 8 hours, there's no gas that I'm passing. I'm eating very light food (it's not due to the food I'm eating). It's a unique experience. Something new. not very severe. Question asked whether to take Advil or pain medicine. I was taking Advil for my joint pain, yesterday last night around 10:30 I took the last dose. Today I didn't take anything. Question asked if I should monitor for anything else." On 07Mar2021 the patient experienced sore arm, chest area feels like gas, chest pain/muscle pain in the rib in the chest ribs, teeth pain, teeth sensitivity, anxiety and when I take a death breathe it hurts and sometimes it doesn't. Therapeutic measures were taken as a result of anxiety. The clinical outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
58 2021-06-07 anxiety I waited 10-15 minutes after receiving the shot and I started to get an overwhelming migraine headac... Read more
I waited 10-15 minutes after receiving the shot and I started to get an overwhelming migraine headache. I was at the center, so I went to the ER. They put me in a dark room I received a Toradol shot and another shot to get rid of my headache. I was in the hospital for 3 days so they could monitor my migraine. While I was in the hospital, they changed my medicine. I was on 40 mg of Lexapro and they moved me down to 20mg. The first night I was in the hospital was horrible, but I feel that was from the vaccine. I kept pacing back and forth and didn't want to sit down. I do have anxiety and depression. Nothing has really helped with the headaches. I was given medications to take, but I don't remember to take them.
58 2021-06-08 disturbance in attention recently diagnosed with suspected autoimmune disease Sarcoidosis but no coughing involved - mainly s... Read more
recently diagnosed with suspected autoimmune disease Sarcoidosis but no coughing involved - mainly skin; a slight headache; a month after the 2nd shot I ran a fever that lasted 3 weeks. the first week the fever would reach 103.5 and second week 101 and 3rd week between 99.5 and 100.5; A week after the 2nd shot I felt lethargic and without ability to focus - eyes also were achy. This lasted for a few weeks but no fever.; A week after the 2nd shot I felt lethargic and without ability to focus - eyes also were achy. This lasted for a few weeks but no fever.; A week after the 2nd shot I felt lethargic and without ability to focus - eyes also were achy. This lasted for a few weeks but no fever.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 26Mar2021 13:00 as 2nd dose, single for COVID-19 immunisation. Medical history included autoimmune disease suspected. Concomitant medications included losartan; hydrochlorothiazide; atorvastatin and tadalafil (TADAL). The patient previously received first dose of BNT162B2 on 06Mar2021 for COVID-19 immunization (first dose, administration time: 11:00 PM, anatomical location: arm left). A week after the 2nd shot (Apr2021), patient felt lethargic and without ability to focus - eyes also were achy. This lasted for a few weeks but no fever. Event resulted to a Doctor or other healthcare professional office/clinic visit; no treatment received. A month after the 2nd shot (26Apr2021 01:00 AM) patient ran a fever that lasted 3 weeks. The first week the fever would reach 103.5 and second week 101 and 3rd week between 99.5 and 100.5. Eyes still hurt and fever was controlled by aspirin during day. It was not a normal fever and he did have a slight headache. Recently diagnosed with suspected autoimmune disease Sarcoidosis but no coughing involved - mainly skin. He felt fine now. Note extensive blood tests and sonograms/xrays turned up nothing that would cause such a prolonged fever. "I've never run a fever for more than 4 or 5 days. I also hardly ever get sick". Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Covid test post vaccination: Nasal Swab negative and blood test negative both on 26Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event sarcoidosis was unknown, while recovered on an unspecified date for the other events. Information on the lot/batch number has been requested.
58 2021-06-16 feeling abnormal After 2nd. shot on Tuesday: early on Thursday morning woke up 102+ degree temp, extreme nausea, swe... Read more
After 2nd. shot on Tuesday: early on Thursday morning woke up 102+ degree temp, extreme nausea, sweating, severe headache, joint stiffness and head felt like I was in a fog. Severe systems lasted for four days. Today (6/17/21) still having headaches, head fog, and severe joint stiffness in hands elbows and ankles. Taking Tylenol and Advil for relief.
58 2021-06-22 feeling abnormal About 17 hours after the shot, preparing to go to my office I suddenly became dizzy in a way similar... Read more
About 17 hours after the shot, preparing to go to my office I suddenly became dizzy in a way similar to an episode of vertigo I had 15 years prior. I notice I had a headache that got worse in minutes. I sucked down 3 and 1/2 two hundred mg Aleve pills and hit the sack. Four hours later I drank 14 oz of water and took another 2 Aleve since the headache was still strongly with me. My body had a general soreness and an ache. I went back to bed thinking I might need to call my MD. About 3 hrs later, I took more water, ate nothing, took 2 more Aleve, and my wife made a call to schedule an appointment with Dr. I was awakened by my wife for dinner. I had an appetite but was foggy and sluggish. I took two more Aleve skipped any alcohol - and went to bed for the evening. The following morning - Jan 18th, 2021 - I awoke with no headache, no soreness, no vertigo.
58 2021-06-23 amnesia Minor memory loss
58 2021-06-24 feeling abnormal DOSE 1 12/20/2021, began to feel sick. 12/24/2021 I had a high fever, called the CDC, a physician sp... Read more
DOSE 1 12/20/2021, began to feel sick. 12/24/2021 I had a high fever, called the CDC, a physician spoke with me, then on Christmas day I called into work sick, I went to ER, and I tested positive for COVID. DOSE 2 01/07/2021, I had shortness of breath, high heart rate, fatigue, brain fog, body aches, some coughing, some nasal congestion. Testing on Feb 1st, 2021 visited ER.
58 2021-06-30 feeling abnormal, loss of personal independence in daily activities Joint pain hands and feet; severe pain in feet and knees, not in hips, but more in extremities; musc... Read more
Joint pain hands and feet; severe pain in feet and knees, not in hips, but more in extremities; muscle fatigue; Joint pain hands and feet; severe pain in feet and knees, not in hips, but more in extremities; almost arthritic feeling; severe pain in feet and knees, not in hips, but more in extremities; Couldn't open jar of pickles; Making fists not a normal reaction anymore; thumbs feel like they're dislocated; Clicking going on in hands and wrists; Muscle pain in every part of his body; Hands and wrists painful, swollen and inflamed; Pain in hands when going to bed and making contact with mattress; Hands and wrists painful, swollen and inflamed; Hands and wrists painful, swollen and inflamed; This is a spontaneous report from a contactable consumer. A 58-years-old male consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8735) via an unspecified route of administration in right arm on 27Apr2021 in the afternoon around 13:30 or 14:00 hr (at the age of 58-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history (including any illness at time of vaccination), prior vaccinations received within 4 weeks, adverse events following prior vaccinations, family medical history relevant to adverse events, additional vaccines administered on same date of the Pfizer suspect and concomitant medications were reported as none. Patient stated that he took nothing, not even over the counter. This report was not related to a study or programme. Investigation assessment was not reported. Patient stated he took vaccine as he was trying to be a good human. Patient didn't know but he believed he was having a reaction and said nothing else was going on in his life and the timeliness to the first and second shot was there. He was having joint pain in his hands and wrists. It was almost arthritic feeling. Patient said that with shot number one, he had muscle fatigue. And wanted to know if anyone else had been reporting this. Patient said that he was certainly not a doctor. He was having muscle pain in every part of his body. It started in the feet, knees, and hands. He couldn't open a jar of pickles. When he was going to bed, he put his hands down to migrate to put his body down. It was painful making contact with the mattress. Patient said he had nothing in his hips or lower back. It was slightly in his neck. He described his elbows as wow. They were pretty extreme. He had clicking going on in his hands especially his wrists. They were painful, swollen and inflamed. There was no redness. It felt like a bee sting reaction. He could feel the inflammation. Making fists was not a normal reaction anymore. Shaking hands, he could not do anymore as it was painful. Patient clarified how it was when he got into bed. He stated that people ease themselves down with their hands. It was painful for him. Patient stated that he got the vaccine so this nonsense would go away and it was the convenience of the supermarket. He was on the government waiting list, but his time was not being called. Patient stated that he was not a hypochondriac or complainer. The injection site where he went told him to call. He wanted to know if anyone else was having this kind of reaction. Patient said that he had not gone to the doctor or ER. He had not gone to the doctor yet. He said the ER would be a waste of time. They would do lots of tests. He had a call into his doctor. He would get in in a few weeks. He had been negligent, and his symptoms were not getting any better, they were getting worse. He would call and get in as soon as possible. He was thinking this would go away. He stated that if events went on for 6 to 8 weeks, he would probably get into his doctor. He did not like running to the doctor. Patient said that if he cut off his leg, he would probably not go for 3 days, he did not like the process. He reported that all of his family had been vaccinated with no issues at all. Relevant tests were reported as none. On additional follow-up on 23Jun2021, patient stated that after dose 1, he had some muscle fatigue. Says it is progressing to the point where he gets in bed and has severe pain in feet and knees, not in hips, but more in extremities. Also stated that thumbs feel like they're dislocated. He did not require emergency room and physician office visit. He stated that had not been to doctor yet but considering getting an appointment. He had not gone to the doctor or ER as it would be a waste of time because if there was a .0001 percent chance of a reaction, he doesn't want unneeded tests and procedures. He asked if it's common, and if it was, he might wait a little longer to see his HCP. He wanted to know how long the effects had lasted with others that reported similar effects. Patient was directed to cvdvaccine.com for further reading at his discretion. Referred to HCP for ongoing management of symptoms. Patient stated that he felt better knowing he was not the only one that has experienced theses side effects. The outcome of all the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021764854 similar report from same reporter
58 2021-07-01 anxiety Woke up with anxious feeling, heart was beating faster than normal, hands/fingers cold. Tested ecg ... Read more
Woke up with anxious feeling, heart was beating faster than normal, hands/fingers cold. Tested ecg with Watch and it indicated Atrial Fibrillation. I didn?t believe it and retried several times over the next hours and finally went to ER.
58 2021-07-01 feeling abnormal Head ache for about a week and felt bad Ringing ears- started after first shot and got worse after ... Read more
Head ache for about a week and felt bad Ringing ears- started after first shot and got worse after the second shot
58 2021-07-05 sleep disorder About 3 weeks after the 2nd dose vaccination, at night my joints started to feel painful in my knee... Read more
About 3 weeks after the 2nd dose vaccination, at night my joints started to feel painful in my knees and elbows. The pain would keep me up at night. I took over the counter ibuprofen to help relieve the pain. The pain was about an 8/10. After a few days, I went to see my doctor. The doctor did blood work and it came back positive for indicators for autoimmune disease. I was prescribed a steroid Prednisone for 3 weeks to alleviate the pain. I was referred to a rheumatologist for follow up. My appointment is in November 2021. The pain is resolved and I was advised that it may flare up at any time in the future.
58 2021-07-10 poor quality sleep headache; chills; warm forehead; sore left arm; second shot on 21Apr2021; he has not been able to ge... Read more
headache; chills; warm forehead; sore left arm; second shot on 21Apr2021; he has not been able to get good sleep; tiresome.; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8729), via an unspecified route of administration in Arm Left on 21Apr2021 as single dose (at the age of 58-year-old) for precautionary measures. Medical history included left eye surgery for cataracts on 20Apr2021 and cataracts, had for over a year. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0158), on 09Apr2021 as single dose for precautionary measures and experienced Sore left arm. Reported that patient had second vaccine shot from Pfizer yesterday. Was on way to work and was tiresome. Stated that he has not been able to get good sleep. Stated that he woke up at 3am with a headache and warm forehead. On 28Apr2021, the patient had chills. Stated that he had no effects from first vaccine but a left sore arm. Stated that his left arm is sore from the second one. Later clarified as Pfizer Covid 19. Stated that he had cataracts before the vaccines. Stated that when he picks something up, strains or moves his left arm that its sore. Stated that the first time he had a sore left arm that it went away in 4-5 days. Stated that he did not take Ourezel and Besivence today. Started using Ourezel and Besivence on 18 Apr or 19 Apr. The outcome of events headache, chills, warm forehead, sore left arm was not recovered, and for other events it was unknown. No follow-up attempts are needed. No further information is expected.
58 2021-07-12 loss of personal independence in daily activities 6/4/2021 5:00PM first dose Pfizer EW0182, the second day (6/5/2021) morning, eyes see objects were... Read more
6/4/2021 5:00PM first dose Pfizer EW0182, the second day (6/5/2021) morning, eyes see objects were very blurry, and double images for a whole day, cannot do anything that day, then it seemed okay. (6/6/2021 morning is ok, recovered). The second dose at 7/2/2021 5:00PM Pfizer EW0181 , and the next day until now (already 10 days) , see things blurry and double images. but the blurry degree is less than the first time (6/5/2021)
58 2021-07-17 confusional state Headache; Vision problems; Fever; Night sweats; Bodyaches; Confusion is turning yellow again; This i... Read more
Headache; Vision problems; Fever; Night sweats; Bodyaches; Confusion is turning yellow again; This is a spontaneous report from a contactable consumer, the patient. A 58-years old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) as a single dose on left arm via unspecified route on 22Mar2021 at 03:00 PM (at the age of 58-years old) for COVID-19 immunisation. The patient medical history included major cirrhosis of the liver needs a liver transplant. The patient was allergic to morphine cipro and motto patch.Concomitant medications was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, at 20:00 the patient experienced major headache vision problems as well both on left side of head, fever night sweats body aches confusion was turning yellow again. The patient did not receive treatment for the reported events. The clinical outcome of major headache vision problems as well both on left side of head, fever night sweats body aches confusion was turning yellow again was not recovered. No follow-up attempts needed. No further information expected. Amendment: This follow-up report is being submitted to amend previously reported information: Verbatim of Relevant Med History updated as same as source document, note added, "Concomitant medications were not reported" updated as "Concomitant medications was reported as none", "on left arm", "The patient did not receive treatment for the reported events " added in narrative and Reference No. added.
58 2021-07-28 feeling abnormal feeling achy and joints ache especially in his neck and shoulders and where he broke his shoulder it... Read more
feeling achy and joints ache especially in his neck and shoulders and where he broke his shoulder it really aches; felt a lump on his collar bone next to his carotid artery, can move it around and it is tender; Dizzy spells; feeling achy and joints ache especially in his neck and shoulders and where he broke his shoulder it really aches; feeling achy and joints ache especially in his neck and shoulders and where he broke his shoulder it really aches; Tiredness; eyes were burning; head ached and was foggy and he was not feeling like himself; head ached and was foggy and he was not feeling like himself; This is a spontaneous report from a contactable consumer (Patient)or other non Health care professional. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported ), dose 2 via an unspecified route of administration on 26Mar2021 as dose 2, single (Age at vaccination: 58 years) for covid-19 immunisation. Medical history included, diabetes mellitus from Mar2020 and ongoing, hiatus hernia from 1992 and ongoing, Acid Reflux from 1992 and ongoing. Patient did not had prior vaccinations within 4 weeks. Concomitant medications included METFORMIN taken for an unspecified indication, he States that he did not have the bottles with him and that he has been taking it for a year; OMEPRAZOLE taken for Acid Reflux, he States that he did not have the bottles with him and that he has been taking it for 15 years, TAMSULOSIN taken for prostate infection States that he did not have the bottles with him and that he has been taking it for 3-4 years. Patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT: EN6202) on 05Mar2021 as dose 1, single for covid-19 immunisation states that he was sick for three days from the first vaccine, and still feels ill, everything smelled like cigarette smoke and every he ate tasted nasty like stale cigarettes, really sick to his stomach, he couldn't go to the bathroom, his stomach was all bloated and he lost his appetite, every joint in his body ached, eyes were getting a burning sensation like someone was taking a blow torch to both eyes. Patient received second dose on Friday. He reports that "a little knot showed up on his collarbone like a cyst. He was not sure what it was. It was tender to the touch. It's by his carotid artery to his head Caller states that he has experienced two weekends from H due to the vaccine. The patient experienced tiredness, his eyes were burning, headache and was foggy and he was not feeling like himself on Saturday 27Mar2021 Morning when he woke up. He was, feeling achy and joints ache especially in his neck and shoulders and where he broke his shoulder it really aches on, felt a lump on his collar bone next to his carotid artery, can move it around and it is tender, dizzy spells on 28Mar2021. He states the first day, he had about the same things a gnarly headache, his eyes were burning and then his stomach hit yesterday. He states that the shoulder that he got the shot in on his right side, that morning he felt a lump on his collar bone next to his carotid artery. States that he can move it around and it is tender. he never had it before and it appeared after the second shot. He states it was like a cyst appeared, he can move it around over his collar bone. He states that it is weird because it happened where he broke his collar bone 10 years ago. Clarifies that he is calling to report his reactions and he has questions about the lump on his collar bone. His doctor doesn't know about it [the lump] because it appeared over the weekend. He tried to call last night but he was on the phone for 2 hours and he fell asleep and when he woke up he hung up because he figured no one calls that late on a weekend. States he was debating getting it as bad as a reaction he had to first one, but he went ahead against his instincts, he thought he needed to finish what her started and went in and got the shot and it didn't bother him right away. He states that Saturday morning when he woke up, he didn't get a lot of rest and he woke up early, he was tired, his eyes were burning, his head ached and was foggy and he was not feeling like himself. States as the day progressed as he was basically getting things done he had to stop and take a nap and he was sleepy and went to bed early. He states that he woke up yesterday feeling achy especially in his neck and shoulders and where he broke his shoulder it really aches and so he started rubbing it and felt a little knot and it moves around and it is really tender. He states that he was also having dizzy spells and he was having it right now. States that it was all ongoing but it was hard to say if it has improved, worsened or persisted until he gets moving around because that was when he really notices it. He states right now he doesn't feel that bad except his joints were achy. States that he woke up with not such bad headache. He took Excedrin for headache. He states that it helps some but not completely. Patient did not visit emergency room or physician office. The outcome of the events Tiredness, eyes were burning, head ached and was foggy and he was not feeling like himself, feeling achy and joints ache especially in his neck and shoulders and where he broke his shoulder it really aches was not yet recovered. The outcome of felt a lump on his collar bone next to his carotid artery, can move it around and it is tender, Dizzy spells was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-01-04 nervousness Itching; Little bit nervous; This is a spontaneous report from a contactable consumer reporting for ... Read more
Itching; Little bit nervous; This is a spontaneous report from a contactable consumer reporting for himself. A 59-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced itching and little bit nervous on an unspecified date with outcome of unknown. The information on the Lot/Batch number has been requested.
59 2021-01-05 sleep disorder, impaired work ability "I've got 1st vaccination shot at 11 am 12/21/2020. Got moderate (3 to 5 on 10-steps scale) pain ... Read more
"I've got 1st vaccination shot at 11 am 12/21/2020. Got moderate (3 to 5 on 10-steps scale) pain in left upper arm/shoulder around 9 pm, limited mobility. Took 2 extra-strength Tylenols. Between 2 and 3 am woke up because of severe headache (7 to 8), couldn't normally sleep because of that. Temperature 99.6 F. Another 2 Tylenols about 4 am. Not effective. Drinking a lot of water. Decided to stay home. Contacted my supervisors by text and e-mail, left a voice message for EH. 8 am - another 2 Tylenols. Tried to sleep - slept till 1 pm. Headache improved (3-5), 99.3 F. Water and tea, minimal activity. Received instructions from EH - to stay at home if any symptoms will take place, to get COVID test upon returning to the hospital. Condition was improving during the day. Low pain and discomfort in the evening (2-3). Sleeping normally during the night. No symptoms in the morning. No reason to delay returning to work. Took COVID test at 9 am. Negative. No symptoms since then"
59 2021-01-07 impaired work ability Dizziness, Constipation, Extreme Fatigue, pain in arm form shot Narrative: Significant impact on li... Read more
Dizziness, Constipation, Extreme Fatigue, pain in arm form shot Narrative: Significant impact on life as he missed work due to this
59 2021-01-10 confusional state, feeling abnormal Vaccine recipient developed headache, dizziness, fogginess, feeling flushed, cold sweats and a weird... Read more
Vaccine recipient developed headache, dizziness, fogginess, feeling flushed, cold sweats and a weird tingling sensation hours after receiving the vaccine. He also noted developing mental confusion. He did not have to go to the ED and went home for the rest of the day. For 1.5 days, he was home resting. On a follow-up call on 1/11/2021, vaccine recipient reported feeling better. Pfizer-BioNTech COVID- 19 Vaccine EUA.
59 2021-01-12 depression Chills; nausea; dizziness; fatigue; Epi-gastric pain; racing heart; depression; This is a spontaneou... Read more
Chills; nausea; dizziness; fatigue; Epi-gastric pain; racing heart; depression; This is a spontaneous report from a contactable healthcare profession (HCP) (patient). A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly on 23Dec2020 11:00 at a single dose in left arm for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), COVID-prior-vaccination: Yes. No allergies to medications, food, or other products. Concomitant medication included ibuprofen in two weeks. On 24Dec2020, the patient experienced chills, nausea, dizziness, fatigue, epi-gastric pain, racing heart, and depression. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for adverse event. The outcome of events was recovered on 24Dec2020. This is a non-serious report. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
59 2021-01-12 nervousness Symptoms were first noted on 12/22/2020 in 15 minutes after getting the Covid Pfizer vaccine. He had... Read more
Symptoms were first noted on 12/22/2020 in 15 minutes after getting the Covid Pfizer vaccine. He had numbness of his face and right hand. It resolved in two hours. He did have soreness for two days after the vaccine. He did not have any other symptoms like rashes or difficulty breathing. He could lift his arm. It made him a little nervous. It was bad enough that he pulled over from the freeway and rested for a few hours. He used an ice pack that helped the soreness, but this was after then numnbness resolved.
59 2021-01-13 mental status changes, agitation altered mental status, hypoxic, fever 39.3, agitated
59 2021-01-16 insomnia Diffuse body and joint aches, pleuritic chest pain, malaise, insomnia due to pain- started ~12 hrs a... Read more
Diffuse body and joint aches, pleuritic chest pain, malaise, insomnia due to pain- started ~12 hrs after vaccine and got worse over next 1-1/2 days then plateaued. Body aches and chest pain lessened 3rd day but rheumatoid arthritis flared up in hands and feet especially on 4th day
59 2021-01-17 sleep disorder, impaired work ability Had my 2nd COVID vaccination shot at 2 pm on Monday, January 11, 2021. Next morning - moderate pa... Read more
Had my 2nd COVID vaccination shot at 2 pm on Monday, January 11, 2021. Next morning - moderate pain in upper left arm/shoulder (place of injection). Working full shift. Around 4 pm on Tuesday (after almost 3hrs OR case) - feeling very tired. Completed the working shift at 6 pm. Minor to moderate headache started to develop later in the evening. Two pills of Tylenol at 9 pm, another two around 2 am - while headache was getting worse. @6:30 am Wednesday - informed managers that I'll have to stay off work because of bad headache (7 to 8 from 10), called EH as well. During the day - mostly staying in the bed. Tylenol, water, tea with lemon, apples for hydration. Headache -- up and down (between 4 and 8), occasional fatigue and nausea (after staying upright more than 10-15 minutes), left upper arm pain, moderate pain in joints (knees, hips, low back). No fever. Troubled night-time sleeping because of headache. 7 am - informed managers and EH about my condition, Got approval for another day off - with request to have a C-Test after that. Similar feeling and treatment. Slow improvement during the day. Around 5 pm - feeling good enough to start moving more actively, headache and shoulder pain on low level, though getting tired quickly still. Much better sleeping. No symptoms in the morning. Had a COVID test before returning to work.
59 2021-01-20 poor quality sleep next day was very tired with a slight headache; next day was very tired with a slight headache; 12 h... Read more
next day was very tired with a slight headache; next day was very tired with a slight headache; 12 hours after the injection I got the chills while I was in bed trying to sleep; I did not sleep well that night; 4 hours after the injection my arm was very sore; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 09:00 at single dose at left arm for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient reported 4 hours after the injection/reported as 30Dec2020 14:00, my arm was very sore. On 30Dec2020 21:00, 12 hours after the injection, "I got the chills while I was in bed trying to sleep. I did not sleep well that night. The next day (31Dec2020) was very tired with a slight headache. The patient only rested all day. The next day he felt better but was slightly fatigued all day. The day after that the patient was back to being himself. His arm continued to be sore for a total of 5 days. The patient did not receive treatment for the events. The outcome of the events was recovered. Information on the Batch/Lot number has been requested.
59 2021-01-20 restlessness Had first injection in the upper left arm and now arm is still extremely sore and makes for restless... Read more
Had first injection in the upper left arm and now arm is still extremely sore and makes for restless sleep. Second injection done in right arm and know soreness except slight at injection site if touching it.
59 2021-01-25 disorientation On 1/4/21 Client had what appeared to be a seizure and went unresponsive. He foamed from the mouth a... Read more
On 1/4/21 Client had what appeared to be a seizure and went unresponsive. He foamed from the mouth and turned blue. O2 Sat was in the 60's, O2 was applied previous to paramedics arrival. BP was high. Unresponsive for 30 minutes. When he woke he did not recognize anyone, did not know where he was at or what day of the week it was. He was transported to the Hospital. Multiple tests were ran and nothing out of the ordinary was found. Started seizure medication.
59 2021-01-29 panic attack Approximately 60 seconds prior to emergency, patient felt a sense of panic (first time ever). State... Read more
Approximately 60 seconds prior to emergency, patient felt a sense of panic (first time ever). Stated to me (wife) "I feel like I am having a panic attack" as we walked on to a parking garage elevator at 12:30 pm on 1.22.21. As I turned to push the button to go down, leaned against the wall of the elevator. His eyes fluttered and back, he was a little pale. When I turned around, again, he fainted and fell face down on the elevator floor. He never stopped breathing and had no convulsions. He was out for less than 30 seconds. When he came to, he got up by himself with minimal assist from me (911 was already on their way). He did not remember saying that he felt like he was having a panic attack; but he remember the fear/panic he felt just prior to. He was oriented x3. I had him smile, stick his tongue out and speak to make sure it was not a TIA or stroke and there were no symptoms of that. His bladder did release. He went by ambulance to the ER (we were on a mini vacation to celebrate his birthday). They did a CAT scan, checked his blood sugar twice, EKG twice, complete blood work panels and urinalysis All tests were either normal or negative. They found nothing. His BP was normal for the first 30 minutes at the hospital, then increased. But has been normal ever since (he checks it daily). Absolutely no other symptoms since that episode. He met with our PCP on 1.29.21 as a follow-up and she directed us to complete this form. She has ordered a consult with a Neurologist and that is scheduled for 3.10.21. His second shot for the vaccine is due on 2.9.21.
59 2021-02-08 disturbance in attention Seem to have lapse in categorizing or focus on task; This is a spontaneous report from a contactable... Read more
Seem to have lapse in categorizing or focus on task; This is a spontaneous report from a contactable consumer (patient). This 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3248), via an unspecified route of administration on 14Jan2021 15:00 at single dose on the left arm for COVID-19 immunization. The patient medical history included COVID prior vaccination, high blood pressure and cholesterol. No known allergies. The patient's concomitant medications were not reported. Facility type vaccine was hospital. No other vaccine received in four weeks. The patient experienced seem to have lapse in categorizing or focus on task on 14Jan2021 16:00, reported as disability. AE resulted in Emergency room/department or urgent care, Disability or permanent damage. No COVID tested post vaccination. AE treatment included emergency room call and treatment to left hand. Outcome of the event was not recovered.
59 2021-02-09 feeling abnormal vomited; felt sick; very loose stool; fever; felt like beat with baseball bat; body aches; muscle jo... Read more
vomited; felt sick; very loose stool; fever; felt like beat with baseball bat; body aches; muscle joints hurt; flu like symptoms; head pounding; this may have been a bad batch or something; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3302 , via an unspecified route of administration on 22Jan2021 10:00 (at the age of 59-years-old) as a SINGLE DOSE in the left arm for COVID-19 vaccination. Medical history included potentially had Covid prior to receiving the vaccine from an unknown date and unknown if ongoing, he had antibodies prior to the vaccine from an unknown date and unknown if ongoing. The consumer reported he must have had Covid in the Spring because he got sick, took a Sudafed and had Afrin nose spray and was fine after that. The patient previously took pseudoephedrine hydrochloride (SUDAFED) for he got sick, oxymetazoline hydrochloride (AFRIN) nasal decongestant for he got sick. They were giving shots out to the military. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Jan2021, the patient experienced flu like symptoms, body aches, head pounding, muscle joints hurt, felt sick, fever, felt like beat with baseball bat, vomited, very loose stool. The consumer reported that this may have been a bad batch or something in Jan2021. The consumer reported that the body aches started at 8AM and resolved at 6PM. The consumer reported that he recovered from all other events late afternoon on Saturday. The consumer reported he vomited from noon-1PM. The consumer reportedhad body aches at 08:00, muscle joints hurt at 08:00, felt like he was beat with a baseball bat 08:00, felt sick at 10:00, vomited 12:00, loose stool 09:00 and fever 08:00 .The events did not require a visit to the emergency room or physician office. No treatment was received for the events. Outcome of the events flu like symptoms, body aches, head pounding, muscle joints hurt, felt sick, fever, felt like beat with baseball bat, vomited, very loose stool was recovered on 23Jan2021. Outcome of the event this may have been a bad batch or something was unknown.
59 2021-02-18 insomnia, feeling abnormal Dizziness, mental fog, insomnia, severe fatigue, chills, bodyaches, delayed onset (3rd night) muscle... Read more
Dizziness, mental fog, insomnia, severe fatigue, chills, bodyaches, delayed onset (3rd night) muscle/joint pain, delayed onset (day 5) rash at injection site and swollen mass (supraclavicular lymph nodes, larger on left side).
59 2021-03-10 euphoric mood, feeling abnormal Joint pain, fatigue, felt weird. Felt spacey. Light headed.
59 2021-03-16 sleep disorder Some time after my first dose on 2/19/2021, I began to notice an increase in ringing in both of my e... Read more
Some time after my first dose on 2/19/2021, I began to notice an increase in ringing in both of my ears. It has increased subsequent to my second dose on 3/4/2021. I had no other significant symptoms after my first dose, but did have sufficient pain at the injection site in my left upper arm the day following my shot to wake me up at night. That went away within 48 hours, but the tinnitus effects have not decreased to date.
59 2021-03-17 disorientation Pfizer-BioNTech COVID-19 Vaccine EUA Pt chronic schizophrenia with subsequent mild cognitive impairm... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Pt chronic schizophrenia with subsequent mild cognitive impairment over the past year who was brought to hospital after 4 days of food/medication refusal, withdrawal from care and more recently disorientation and tremor. Pt was recently transitioned from haldol decanoate to clozapine. Last dose haldol decanoate was on 2/16/21. First dose clozapine 12.5 mg was on 2/24/21. Increased to 12.5 BID the following day. Increased to 25 mg BID on March 2, without reported side effects or other issues. Pt got his first dose of Pfizer COVID vaccine on March 4, and that night was less engaged with staff, felt feverish. Did not spike a temp per bedside accompaniment who was with him that day. The following day, he barely ate any food and did not get out of bed all day. This continued for the entirety of the weekend - bed bound, turning to look at staff when called but did not engage/respond verbally. He was incontinent of urine over the weekend. Treated for Neuroleptic malignant syndrome 2/2 clozapine Uncertain if vaccine contributed to event, but recent case report published relating clozapine toxicity and Pfizer COVID vaccine, so submitting to VAERS for evaluation
59 2021-03-19 impaired work ability, feeling abnormal At 7:00 pm I started experiencing sinus drainage & stuffiness. When I went to bed at around 8:30 P.M... Read more
At 7:00 pm I started experiencing sinus drainage & stuffiness. When I went to bed at around 8:30 P.M. I Noticed some difficulty getting enough air into my lungs ( 11/2020 Ablation for A fib, compromised phrenic nerve Not usually SOB unless high physical demand ) At 9: 30 P.M started moderate shacking/Chills until around 3 A.M. with little sleep. Then some sleep until 5:00 A.M. woke up with 102.4 temp and felt lousy with joint pain in various joints that do not typically hurt. Did not go to work spent most of the day in bed until 4:00 P.M. Feeling somewhat better now
59 2021-03-22 euphoric mood 11:38am Patient states "I feel palpitation and shortness of breath". Pt. stated "I feel better". ... Read more
11:38am Patient states "I feel palpitation and shortness of breath". Pt. stated "I feel better". Vital signs 11:38am 152/80 92 18 O2 99%; 11:43am 122/78 64 16 O2 98%; 11:48am 118/72 67 16 O2 98%; Patient in the passenger seat, went home calm and cooperative. Disposition: Patient left the parking lot by car, calm and cooperative.
59 2021-03-24 confusional state Pt with witnessed ground level fall from chair due to syncopal event after receiving vaccine. Pt sus... Read more
Pt with witnessed ground level fall from chair due to syncopal event after receiving vaccine. Pt sustained blunt trauma to his head that included a contusion over his right forehead and laceration to posterior right ear. Pt was AOx2, not oriented to time, confused and repeating himself. Pt was also diaphoretic and hypotensive after the event. Due to altered mental status pt was transported by EMS to a local hospital for further evaluation.
59 2021-03-24 impaired work ability Severe fever lasting still on day 5 most days over 100 brought down only with ibuprofen, dizzy and l... Read more
Severe fever lasting still on day 5 most days over 100 brought down only with ibuprofen, dizzy and lightheaded that prevents me from working and driving. I've missed 2 days of work so far. Soreness continues in my arm as well. I've also had nausea at times and appetite that varies.
59 2021-03-24 impaired work ability Very sore arm. Cold sweets. Elevated temp for 2 days reaching 101.5 degrees. Sick stomach. Nearly pa... Read more
Very sore arm. Cold sweets. Elevated temp for 2 days reaching 101.5 degrees. Sick stomach. Nearly passed out one evening when I got up out of bed. Nearly didn't make it back to bed. Body aches. Used cold compresses and took extra strength Tylnol and Aspirin. Lots of water and Ensure. Dressed in layers to stay warm. My wife and I are sick at the same time from vaccine injection. Missed 2 days of work. Also had skjn hypersensitivity in my upper back. Had fatuque, but not as bad as my wife.
59 2021-03-25 anxiety Dizzy, vertigo, difficulty breathing immediately after shot. Dizziness subsided after a few hours, t... Read more
Dizzy, vertigo, difficulty breathing immediately after shot. Dizziness subsided after a few hours, typical arm pain at the injection site a few days after. Fatigue and difficulty breathing increased over the next few days. On the third day after injection, experienced cognitive difficulty using words, vertigo. Went to emergency for possible stroke symptoms. Cognitive testing, Brain CT scan w/contrast, MRI, Echocardiogram, 24 hour in patient observation. All negative. Still experiencing shortness of breath and anxiety a week after injection.
59 2021-03-27 feeling abnormal, anxiety, impaired work ability Heart Palpitations (appear to be premature ventricular contractions), foggy head. on and off for tw... Read more
Heart Palpitations (appear to be premature ventricular contractions), foggy head. on and off for two weeks. Anxious feelings and foggy brain accompany palpitations. Feel normal part of the time.
59 2021-03-30 feeling abnormal I tested positive for covid back in August, and experience the same symptoms , fever 100.8 joint ach... Read more
I tested positive for covid back in August, and experience the same symptoms , fever 100.8 joint aches, fatigue and brain fog
59 2021-03-31 insomnia He will keep him up until 3 in the morning and he stays awake; headache; it is really frustrating; p... Read more
He will keep him up until 3 in the morning and he stays awake; headache; it is really frustrating; pain in his joints and his bones and it was getting worse; pain in his joints and his bones and it was getting worse; pain all over; Any place in his body, his muscles, joints, and bones have had pain previously/ pain in his joints and his bones and it was getting worse/ pain all over on the day after his COVID vaccine; body is so weak/ doesn't have any energy to move; tired; a little bit of small itching, not much, just a little bit that made him feel not comfortable with it; a little bit of small itching, not much, just a little bit that made him feel not comfortable with it; ribs moving quicker; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2, via an unspecified route of administration (left arm) on 06Mar2021 at a single dose for COVID-19 immunisation. Medical history included pain, high cholesterol, and testosterone low, joint pain, bone pain, muscle pain, any place in his body had pain, and doesn't have good memory, all ongoing. Concomitant medications included ongoing hydrocodone for pain, ongoing atorvastatin for high cholesterol, ongoing clomiphene citrate for testosterone medication because it was low because of his age, ongoing colecalciferol (Vitamin D), ongoing ascorbic acid (Vitamin C), ongoing oxycodone for pain, and unspecified eye medication. He had many different medications that he was taking. Historical vaccines included chicken pox vaccine for immunization and shingles vaccine in Jan2020 for immunization and experienced pain all over. The patient stated that he was a torture survivor and he has been taking pain medication because of him being tortured previously. He was taking medications for the pain, clarified to be hydrocodone and oxycodone. These medications kept his body stable. He was able to sleep and relax. One day after he received his Pfizer COVID vaccine (07Mar2021), he started feeling the pain in his joints and his bones and it was getting worse but the pain used to be stable with the way he was using his medicines. But now his body was not stable. Any place in his body, his muscles, joints, and bones have had pain previously because of the damage of torture but now it all came up after the COVID vaccine. Every piece of his body hurt even if he takes his medications. He still had the pain and his body was so weak for about 4 to 5 hours. He used to be able to do his business all day but now after about 3 to 4 hours on his feet he got so tired and he needed to sit. He didn't know why this happened. He has talked to others that have received COVID vaccines and none have had this kind of reaction like him. He has asked them about it. It was very frustrating to him on an unspecified date. Every month he sees a physician. He would like for Pfizer to contact him with further questions, he can't understand the pain. This was really killing him especially when the pain goes to his bones. He will keep him up until 3 in the morning and he stays awake on an unspecified date. He then took medicine and he had to wait for 30 minutes for it to start working and then he will be able to sleep. But other than that, the pain jumped. He has had the chicken pox and the shingles vaccines and none did like that. The pain was not going away in his muscles or joints. And now he was getting a headache on an unspecified date, it was really frustrating. He didn't have good memory from the torture. This morning, when he woke up, he had the pain in his joints and his bones. He didn't like to use too much medication. He liked to use it only as he needs it. Pain medications are strong. But this COVID vaccine somehow made him need to use more medication and then that caused him to have a headache. His pain should get better with his medications but today, he had pain all over him and he didn't have any energy to move. He didn't know how to explain it. The COVID vaccine had really kind of made him weak. Sometimes he drinks a lot of cranberry juice to try and take the vaccine out of his system and it was frustrating because he hasn't ever been like this. When he had pain like this it reminded him of his torturing and what had happened to him. When the pain came on strong was when it reminded him of that. The medications he was taking were supposed to kill the pain. That was the reason he got so pissed and was trying to ask what was going on. This COVID vaccine is not safe he believed because it has been almost 10 days and it was not helping him. He was still not good. After he got his COVID vaccine on 06Mar2021, he had a little bit of small itching, not much, just a little bit that made him feel not comfortable with it. That was why they kept him for 20 minutes after his vaccine. When he got back home, he was okay, it was nothing serious. But then the day after his COVID vaccine on 07Mar2021, his joints, his muscles and his bones had pain. On 06Mar2021 the itching lasted about 20 minutes. He felt like he was chewing his lip, he was a little uncomfortable and he felt his ribs moving quicker. Nothing happened but he could feel it. He tried to chew his lips a couple of times, but not that much. But after that, he had pain all over on the day after his COVID vaccine, 07Mar2021. By the time this vaccine started getting into his body, it was really hurting and getting worse. He had the shingles vaccine and for 1 1/2 to 2 days, he had pain all over and then 2 days after it was all gone, he was back to normal life. The pain was gone. With this COVID vaccine he thought that maybe it was going to be the same but it was not the same and it was hurting. The shingles vaccine was last year in 2020, 3 months before people knew about the coronavirus that was when he got the vaccine for shingles, so maybe Jan2020 was when he had the shingles vaccine. He had no medical conditions or heart and chest problems. No other vaccine he has taken has ever had this type of side effect to him. He took his shingles vaccine in his right arm and the COVID vaccine was in his left. With both he had the same start of having the bad pain. This COVID vaccine goes deeply to the body. The vaccines job is to wake the body. The vaccine's job is to wake up the body for the virus. The body has to make some kind of soldiers to stand up on the virus and this COVID vaccine had actually made his body weak. After the vaccine is supposed to wake the body, little by little the side effects are supposed to go away. His body was not learning this vaccine. It kept fighting to learn whatever was in this COVID vaccine, his body can't learn it and fight it. That was the reason his body got weak and the pain has not gone away. His body is still in alert and that's why the pain was still there. His body was still fighting. Somehow it didn't match the inside of the body. Maybe for some people that this will happen to, they will be okay but for some they will not be okay. It is not because some people have nothing wrong with them. The patient recovered from itching and discomfort on 06Mar2021; not recovered from any place in his body, his muscles, joints, and bones have had pain previously/ pain in his joints and his bones and it was getting worse/ pain all over on the day after his COVID vaccine; while outcome of other events was unknown. Information about lot/batch number has been requested.
59 2021-04-01 sleep disorder, disturbance in attention Day of shot, 9 hrs later chills, 18 hrs later fever of 103 Day 2, fever 102, chills, fatigue, body a... Read more
Day of shot, 9 hrs later chills, 18 hrs later fever of 103 Day 2, fever 102, chills, fatigue, body aches Day 3, fever 101.3, chills, fatigue, body aches, rash at injection site, arm pits, feet, headache, unable to sleep, stomach ache Day 4 , no fever, very weak, headache, same rash, can not concentrate, stomach ache
59 2021-04-04 mental impairment, anxiety voices, paranoia, anxious, difficulty thinking and processing thoughts, light sensitivity, very leth... Read more
voices, paranoia, anxious, difficulty thinking and processing thoughts, light sensitivity, very lethargic
59 2021-04-05 confusional state Fever, Dizziness, Weakness, confusion for 3 day. racing heart and sore throat. Ladder brought patien... Read more
Fever, Dizziness, Weakness, confusion for 3 day. racing heart and sore throat. Ladder brought patient to Doctor office for treatment. Antibiotics treatment for sore throat to no effect. 2nd dose started and to date same effect. Patient is in pain.
59 2021-04-06 excessive sleepiness Side effects began the morning after ? severe headache and body ache (back and abdomen muscle pain),... Read more
Side effects began the morning after ? severe headache and body ache (back and abdomen muscle pain), followed in the afternoon by severe fatigue (I slept two hours in the late afternoon before dinner), then by evening mild nausea and chills. I ended up going to bed at 9pm and slept nearly 10-1/2 hours after, for a total of 12-1/2 hours.
59 2021-04-08 feeling abnormal Began feeling a little warm and flushed and tired. I felt off overall. On the 8th around 12pm. I cam... Read more
Began feeling a little warm and flushed and tired. I felt off overall. On the 8th around 12pm. I cam e home from work around 4:30 and laid down til 5:30 and I woke up feeling a little better but around 6:15 I felt the same as earlier that day and then it got worse. My ears were ringing loudly and I had shortness of breath, I had difficulty breathing, and my chest was tight and I had pain in the center of my chest and I was nauseous and hungry but really couldn't eat anything. I checked my BP at home and it was 189/127 and then 192/122. I was well hydrated but I drank 2 16 ounce glasses of water and sat down to try and relax. An hour later the ringing stopped and I was feeling much better. I took my BP again and it was up to 202/126. I decided to go to the ER at this time. around 11pm it was 143/89. Ringing and flushed still present with some stomach issues (4/9)
59 2021-04-08 sleep disorder Date and time adverse event started: Approx. 2-3 days from date 2nd dose rcvd (3/29/2021) approx. ti... Read more
Date and time adverse event started: Approx. 2-3 days from date 2nd dose rcvd (3/29/2021) approx. time unknown. Patient reported that with the first dose he had a mild headache which went away. Reported that from the second dose rcvd (3/29/2021), same day had left shoulder soreness and stiffness which went away two days later without any treatment. Reported that the headache felt worse from rcvding the 2nd dose, which occurred 2-3 days later. Pt is still experiencing the headache which has not gotten better, there's pain and stiffness in the back of his neck and skill area (lots of discomfort in the neck and skull area from trying to rotate his head). Also reported that he can't sleep, and the chills are still coming off and on (chills also started approx. 3 days from 2nd dose rcvd). Patient reported since his headache started 2-3 days from rcvding 2nd dose, he has been taking Tylenol 650mg tablet (dosing approx. 2-3x per since headache started) which helps alleviate the headache for approx. 30-45 minutes and then the headache would return. He had tried to reach out to his PCP but his PCP has moved. Patient advised will go to urgent care today to get check out. ***NOTE*** Counseled patient to stay hydrated (recommend water or fluid with electrolytes, and avoid caffeine to prevent dehydration) and can continue to take Tylenol as needed just a long as he does not exceed 4,000mg per day. Counseled patient to avoid consuming alcohol while taking alcohol to prevent drug interaction with Tylenol. Recommend patient to seek medical care since his headache his not gotten better and he has been taking Tylenol for almost a week now. Patient called back 4/6/2021 at 9:09am: Patient reported that he felt much better today headache, pain or stiffness in the back of his neck or skull areas, and slept fine last night. Patient stated he did not get a chance to go to urgent care. He stated he took Tylenol last night. Recommend patient to continue to stay hydrated, and if his headache comes back to contact his PCP for further follow up.
59 2021-04-10 nervousness dizzy, shakey, hot nausea
59 2021-04-11 depression, feeling abnormal After my first shot, my brain has felt fuzzy or foggy and heavy. I have also felt some depression an... Read more
After my first shot, my brain has felt fuzzy or foggy and heavy. I have also felt some depression and weird thoughts (lot #ER 2613). My ears also felt heavy. After my 2nd shot yesterday, I awoke this morning with ringing in my ears and it has not gone away and my brain fog is still there as well.
59 2021-04-11 feeling abnormal within 2minutes i felt my feet and toes get hot. whole body. thot it was just a reaction. later that... Read more
within 2minutes i felt my feet and toes get hot. whole body. thot it was just a reaction. later that day and overnite feet very hot. now its 5days later its so much worse. very numb in whole leg, right foot the most, very tingly-painful, asleep type feeling, But Way Worse. im very scared. hands and fingers, and whole body feels real bad. . feels like dead nerves happening.
59 2021-04-17 sleep disorder Pfizer-BioNTech COVID-19 Vaccine EUA 4/14/21 12:45 pm - vaccination - no issues 11:00 pm - Chills, c... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 4/14/21 12:45 pm - vaccination - no issues 11:00 pm - Chills, chattering teeth, nausea 4/15/21 1:00 am - loose bowels, minor headache 8:30 am - Vertigo, unable to stand, collapse on floor, major nausea, dizziness - go straight to bed 8:30 am - 8:30 pm - Sleep off/on entire period, arm pain, drink water, take tylenol, chills, nausea, lethargy 8:30 pm - Midnight - profuse sweating soaking clothes, major headaches, nausea - continue to sleep 4/16/21 Midnight - 6:00 am - Restless sleep, loose bowels at times All day - Awake, tired, occasional nausea. limited appetite 4/17/21 Limited appetite - occasional nausea
59 2021-04-18 mental status changes 1- Pfizer vaccine on 4-14-21 @10am monitored family clinic. 2-Thursday 4-15-21 Acute febrile events ... Read more
1- Pfizer vaccine on 4-14-21 @10am monitored family clinic. 2-Thursday 4-15-21 Acute febrile events at 1pm temp 40 degree C. Altered mental status, went to ER. work up included CSF-NL, D/C's on 4-18-21
59 2021-04-19 confusional state Fever (102.6 x 48hrs), Mialgia, Nausua, Diahrrea, severe weakness, dizziness, confusion. Abominal pa... Read more
Fever (102.6 x 48hrs), Mialgia, Nausua, Diahrrea, severe weakness, dizziness, confusion. Abominal pain & cramps. Left upper arm pain. Symptom course lasted total 5 days and completely resolved by Sunday evening(4/18/21)
59 2021-04-20 anxiety Worsening anxiety with chest tightness and feeling of trouble swallowing
59 2021-04-20 impaired work ability, feeling abnormal I had minimal reaction to the 1st dose, slightly sore arm at injection site for 3 or 4 days. 2nd dos... Read more
I had minimal reaction to the 1st dose, slightly sore arm at injection site for 3 or 4 days. 2nd dose, I was feeling off by 3:30pm, mild headache and extremely tired. By 5 I was exhausted, and paranoid about a work situation, paranoia is not part of my normal state of being. By 6pm my left upper arm was very painful from shoulder to elbow. Took aspirin and went to bed at 7pm. Woke at 8am Friday with mild headache an very tired, by 10am was back in bed, slept 4 hours, Repeated the Friday pattern for 2 more days. Monday the extreme tiredness and arm pain abated. Tuesday, the paranoia abated. Now just Brain Fogged.
59 2021-04-20 insomnia Pfizer-BioNTech COVID-19 Vaccine EUA: 2nd dose Took 5 weeks after 1st dose. Feel very tired, but t... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: 2nd dose Took 5 weeks after 1st dose. Feel very tired, but trouble sleeping; achy, especially headache
59 2021-04-22 confusional state Headache, confusion, fever, body aches
59 2021-04-23 insomnia Increased insomnia
59 2021-04-24 sleep disorder, restlessness, disorientation Left arm, shoulder, and upper body severe pain. I couldn't lift my left arm. It felt as if I had the... Read more
Left arm, shoulder, and upper body severe pain. I couldn't lift my left arm. It felt as if I had the flu. Body aches, disorientation, difficulty breathing, severe body weakness, nose running. I used 8hr Tylenol for the pain. I was restless and couldn't sleep Friday and Saturday night. On Sunday, the symptoms began to subside, but the general weakness and disorientation remained.
59 2021-04-25 memory impairment 1-5 days swelling and rash, pain in arm at injection side Day 3-4 Throbbing leg - felt artery flutte... Read more
1-5 days swelling and rash, pain in arm at injection side Day 3-4 Throbbing leg - felt artery flutter. 1-12 days recurring headache 3-18 days pain in shoulder and armpit near injection site Day 12-18 swelling in hand Day 2-18 - extreme fatigue, lack of energy Day 2-18 - higher blood pressure Day 4-18 ? Nausea and forgetfulness
59 2021-04-28 feeling abnormal severe allergic reactions; strep throat; joint pain; Pain; that's how foggy his brain is with what's... Read more
severe allergic reactions; strep throat; joint pain; Pain; that's how foggy his brain is with what's going on his thinking is not straight from the pain; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER8727, Expiration Date: Jul2021) via an unspecified route of administration on 19Mar2021 at 14:30 (at 59-year-old) at single dose in upper left arm for COVID-19 immunization. Medical history included depression, anxiety, high blood pressure, high cholesterol, and high triglycerides. Concomitant medication(s) included hydrochlorothiazide/ lisinopril (LISINOPRIL/HCTZ) hypertension; citalopram; trazodone for sleep disorder; zolpidem for sleep disorder; simvastatin for blood cholesterol; alprazolam for anxiety (doctors said high dose which he needed to be stable, at least 7 years ago); and fenofibrate for blood triglycerides increased. No prior vaccinations within 4 weeks. E-transmitting possible duplicate AE as caller stated they already reported AE to previous agent. He had near all the side effects listed as well as severe allergic reactions listed. He hasn't been able to get out of the house since, felt like he had the flu. He has had the symptoms since; tiredness, headache, pain, terrible chills every day, joint pain, nausea, he was a hearty eater and he did not have a good appetite/ no appetite; he felt unwell, completely unwell, a sick feeling and it's pronounced; and particularly swollen lymph nodes, difficulty breathing at times, definite swelling of face and throat, dizziness and weakness. Caller provided these all started 2 weeks after he got the shot. Started on Saturday, 03Apr2021, and same thing happened everyday (going on). He called the weekend and after a couple weeks he called, the on call doctor and after his second call he was ordered to get to a medical facility/ urgent care facility (went to the doctor and it wasn't his regular doctor) in the weekend of 11Apr2021 and he has one nearby and they ran a test for COVID and it was negative, also tested for strep throat positive. He was given amoxycillin 30 tablets, 500mg tablets to be taken 3 times a day for 10 days for the strep throat, although he has not had any symptoms of strep throat which for him it is pronounced and painful, he can swallow, has no pain, no cough, nothing, he has nothing. His soreness and everything here was exactly what was in the manual was what he has going on and nothing else, no mucous, nothing like that. Confined to his house, has no energy to do anything chills and hot flashes. He has been taking ibuprofen 800mg tablets with food, 1 in the morning and 1 in the evening and got some relief from the chills and symptoms but not totally and it was waning in it's effectiveness after the first 3-4 days. All his symptoms were persisting and they had worsened after he started getting then for he guesses 4-5 days and then they kind of leveled as bad as they are now and haven't tailed off. He was ordered not to take the 2nd dose until he finishes all the amoxicillin and was told quite sternly not to get the 2nd dose until he finishes it. He has 12 pills left so next week sometime Tuesday or Wednesday and his concern was he finished that medicine and feels he would still have these side effects and doesn't know if he would build up immunity and maybe the 2nd shot won't be as bad. The nurse practitioner who worked with him at the urgent medical care place said the 2nd shot is a doozy and not to mix it with Amoxicillin as it might have a bad effect on the effectiveness of the strep throat. States he has had strep before and doesn't feel like that at all and nothing is wrong with his voice, throat or upper respiratory at all. He is supposed to get the 2nd shot tomorrow (16Apr2021), he was scheduled. He was afraid to do it as he hears it's worse than the 1st one and he is already relegated to his house and has to order in and not risk driving that's how foggy his brain was with what's going on his thinking is not straight from the pain. The outcomes of the events were unknown.
59 2021-04-28 hallucination Nightime hallucinations upon waking (All of them are realistic, but some of them are disturbing). Th... Read more
Nightime hallucinations upon waking (All of them are realistic, but some of them are disturbing). This began a couple of days after my first injection, and occurs approximately every two days.
59 2021-04-28 insomnia He is not sleeping because he is constantly chocking and coughing every second.; having excess mucou... Read more
He is not sleeping because he is constantly chocking and coughing every second.; having excess mucous/ He has fits where he is trying to cough up mucous/ having a mucous coughing spell/He is not sleeping because he is constantly chocking and coughing every second.; He is not sleeping because he is constantly chocking and coughing every second.; He is not sleeping because he is constantly chocking and coughing every second.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EM6208), via an unspecified route of administration, administered in Arm Right on 15Mar2021 11:00 (received at 59-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history and concomitant medications were not reported. The patient just got his second Pfizer shot Monday 12Apr2021 10:45 am (lot number: EW0162) administered in Arm Right, and he got his first one on 15Mar2021. He wants to report what he thinks is a side effect. He does not know if it is related or not, but at the end of Mar2021/ beginning of Apr2021, he started having excess mucous. He has fits where he is trying to cough up mucous for 45 minutes. Ever since it started there has been a lot of mucous. He has been taking Benadryl and stuff like that. He headed to urgent care on 11Apr2021 but decided to go to the ER (emergency room) instead because he was having a mucous coughing spell. They checked for pneumonia, but it was negative. The chests x-ray was clear with no pneumonia. They are saying it is allergies, but he has never had a reaction like this with mucous. He has been wearing his mask too. He knows the allergy season is supposed to be bad, but they said on the news the masks were actually helping with the allergies. That people were having less symptoms. They were contributing it to allergies, but he has never had them this way before. He wants to report because he is thinking maybe it was something from having the vaccine. He thinks the mucous first started the end of Mar2021 or the first day of Apr2021. He went to ER on 11Apr2021. He also went back and forth with the doctor. They gave him allergy medicine. The ER gave him codeine cough syrup and Allegra D. His GP has him on Sudafed now, Flonase, Allegra, and Benadryl. He has fits at night nothing seems to change. He is not sleeping because he is constantly choking and coughing every second. Last night, 13Apr2021, he finally fell asleep at 3 am and woke up at 9am. They do not want to give him prednisone yet. He would have to wait 2 weeks after his last shot for it. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-04-30 feeling abnormal Angioedema. Pt felt lip feeling funny around 0300 and went back to sleep. Woke up at 0600 with a swo... Read more
Angioedema. Pt felt lip feeling funny around 0300 and went back to sleep. Woke up at 0600 with a swollen lower lip. Presented to ED at 0838. Given IV medications and monitored. Symptoms improved.
59 2021-04-30 insomnia, feeling abnormal has fits at night nothing seems to change/ constantly chocking and coughing; has fits at night nothi... Read more
has fits at night nothing seems to change/ constantly chocking and coughing; has fits at night nothing seems to change/ constantly chocking and coughing; excess mucous was reported as worsened; he is not sleeping because he is constantly chocking and coughing every second; Feeling funny; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the right arm on 12Apr2021 at 10:45 (batch/lot number: EW0162) as a single dose for COVID-19 immunization. The patient has no medical history and no concomitant medications. Historical vaccine included BNT162B2 first dose on 15Mar2021 at 11 am (lot number: EM6208) for COVID-19 immunisation and experienced excess mucous (started at the end of Mar2021 or beginning of Apr2021), has fits where he was trying to cough up mucous and allergies. The patient reported that he just got his second Pfizer shot Monday 12Apr2021, and he got his first one 15Mar2021. He wanted to report what he thinks was a side effect. He doesn't know if it was related or not, but at the end of Mar2021 or beginning of Apr2021, he started having excess mucous. He has fits where he was trying to cough up mucous for 45 minutes. Ever since it started there has been a lot of mucous. He has been taking Benadryl and stuff like that. He headed to urgent care Sunday 11Apr2021, but decided to go to the ER instead because he was having a mucous coughing spell. They checked for pneumonia, but it was negative. They were contributing it to allergies, but he has never had them this way before. He wanted to report because he was thinking maybe it was something from having the vaccine. He thinks the mucous first started the end of Mar2021 or the first day of Apr2021. He went to ER on 11Apr2021. He also went back and forth with the doctor. They gave him allergy medicine. The ER gave him codeine cough syrup and Allegra D. Her GP has him on Sudafed now, Flonase, Allegra, and Benadryl. They were saying it was allergies, but he has never had a reaction like this with mucous. He has been wearing his mask too. He knows the allergy season was supposed to be bad, but they said on the news the masks were actually helping with the allergies. That people were having less symptoms. On an unspecified date, excess mucous was reported as worsened. He has fits at night nothing seems to change. He was not sleeping because he was constantly chocking and coughing every second. Last night, he finally fell asleep at 3 am and woke up at 9 am. They don't want to give him prednisone yet. He would have to wait 2 weeks after his last shot for it. The patient also experienced "feeling funny" on an unspecified date. The patient underwent lab tests and procedures which included chest X-ray: negative for pneumonia on 11Apr2021; the chests X-ray was clear with no pneumonia. Vaccine was not administered at military facility. No additional vaccines administered on same date of the Pfizer suspect. The adverse events excess mucous, cough and not sleeping required a visit to the physician's office. No prior vaccinations (within 4 weeks). The outcome was not recovered for the events "has fits at night nothing seems to change/ constantly chocking and coughing", "excess mucous was reported as worsened" and "he was not sleeping because he was constantly chocking and coughing every second"; and unknown for the event "feeling funny". No follow-up attempts are needed. No further information is expected.
59 2021-05-02 feeling abnormal Male patient (date of birth: 02/05/1962) received the 1st COVID Vaccine (Pfizer, Lot #: ER8731 and e... Read more
Male patient (date of birth: 02/05/1962) received the 1st COVID Vaccine (Pfizer, Lot #: ER8731 and expiration date: 08/2021) on 04/09/2021 at 12:45PM. Client returned to the vaccine site on 04/30/2021, for his second dose. Client was checked in by the ancillary staff and then sat down with a nurse vaccinator at one of the vaccination stations. As the vaccinator screened the client, some medical concerns came up so the vaccinator went over to the lead nurse for a consult. Nurse received a brief report from the vaccinator, and then walked over to the vaccination station to talk to the client. The client explained to Nurse that he received his first dose on his left arm and about 2 days later, he developed "numbness and tingling" in that same arm and it has not resolved. As Nurse asked further questions, she discovered that the client also started to develop that same sensation, of numbness and tingling, in his right hand. The client described that it is painful, if poked in those areas. Nurse also asked if this feeling radiates anywhere else and the client explained that, if he sits for a prolonged period of time, the numbness and tingling will develop in both of his lower extremities and he needs to get up and walk around. Client reported that it is not painful in a way that he can rate it on a pain scale of zero to ten, but he did describe it as being "abnormal for him" and "not comfortable." Client denied any known drug allergies as well as denied any past medical history. He stated he had his left index finger amputated "years ago, but that is it." Nurse explained to the client that there are some concerns regarding the new onset of symptoms after receiving the vaccine and that she would like to get a medical consult before deciding how to proceed with the second dose. Client agreed. Nurse sent a text message for a medical consult received an answer about 45 minutes later. The medical team recommended waiting to give the second dose until the client is assessed by either a primary care provider or neurologist. They also gave the client the option of receiving the JOHNSON and JOHNSON vaccine 28 days after the first dose, if the client does not wish to receive PFIZER again. Nurse then educated the client on the recommendations. The client expressed to Nurse that he is "very healthy and does not go anywhere," so he does not wish to be seen by a medical provider right now. The client asked questions regarding vaccine efficacy in the first and second doses and Nurse addressed them. The client told Nurse that at this time, he would like to hold off on getting a medical assessment and did not wish to reschedule for a JOHNSON and JOHNSON vaccine. Nurse respectfully acknowledged his decision and educated him on V- safe and how to proceed if he changes his mind later down the road.
59 2021-05-04 feeling abnormal Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot... Read more
Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot; Threw up; This is a spontaneous report from a contactable consumer (the patient) and then from a contactable consumer (the patient's wife). A 59-year-old male patient received the first dose of BNT162B2 (lot number not provided), via an unspecified route of administration in the left arm on 31Mar2021 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included: fish oil (OMEGA 3 FISH OIL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient felt ill shortly after receiving the shot. Told to sit down. Passed out. Awoke on the floor. Told possible seizure. Sat up. Threw up. Told to lie back down. Ambulance came and took him to the hospital. He spent 90 minutes in the Emergency Room. He was unable to work for a couple of days. He had extreme fatigue and brain fog. He was not back to relatively normal for at least 10 days. Treatment received was reported as yes: ran tests including 3 EKGs, on an unspecified date. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
59 2021-05-04 sleep disorder ringing in the ears flushed face cough dizziness waken at night in a cold sweat
59 2021-05-05 depression A few days after the second dose, my depression inexplicably worsened despite my ongoing medication ... Read more
A few days after the second dose, my depression inexplicably worsened despite my ongoing medication routine (supplements were stopped). Had to stay home from work on Wednesday 5/05/21 due to severity. Nothing else in my life has changed that would explain this. To date, I am experiencing the same intensity.
59 2021-05-09 feeling abnormal After about 10 hours, pain at injection site. By 12 hours, pain is considerable, cannot move arm ar... Read more
After about 10 hours, pain at injection site. By 12 hours, pain is considerable, cannot move arm around without wincing. Went to bed and woke up about 3 hours later (e.g. 15 hours after injection). Suffering from full body aches, headache (even my teeth and eyes hurt), chills, uncontrolled shaking, followed by uncontrolled sweating, muscle spasms, nausea, severe pain at injection site, swollen and painful lymph node in left armpit. Little to no sleep that night. In a fog all day Sunday, low grade fever just below 100. Went to bed early (around 8:30pm) with similar but reduced symptoms. Pain at injection site has subsided by now. Shakes and chills are far less but still there. Still sweating, really bad body aches, headache, swollen and tender lymph node under left arm. Challenge sleeping but did a little better. Today, Monday, still in a serious fog. No energy. Other symptoms appear to be subsiding
59 2021-05-13 insomnia About 13 hours after the shot, at about 12:45 am of 5.5.21,, I had severe shaking while getting read... Read more
About 13 hours after the shot, at about 12:45 am of 5.5.21,, I had severe shaking while getting ready for bed. This happened while standing up. The shaking was so bad that I could not use my phone to search the side effects. The shaking started to subside after I laid down. Other symptoms after this event: unable to fall asleep for about 4 hours; feeling warm at times, with some minor chills; thirsty during this 4 hour period.
59 2021-05-18 disturbance in attention, mental impairment, irritability, disorientation 1ST Day , severe body aches , tired . 2ND day severe headache , disoriented , could not think clearl... Read more
1ST Day , severe body aches , tired . 2ND day severe headache , disoriented , could not think clearly and very tired. This headache condition has persisted for the last 7 days. At times it is mild and at other times severe . It makes you on edge ,causes loss of focus and disoriented. I rarely ever get a headache , maybe a handful in my lifetime. As of today 5/19/21 @8:40 AM my headache is painful even after taking 2 Tylenol hours ago. i am still dizzy and disoriented and moody. The headache is focused on my front left side , it feels as if someone is sqeezing my head tightly. Today I may go to clinic . Not sure what they will do except say to stay in bed.
59 2021-05-19 confusional state 1. (Day of injection) minor headache, pain at injection site; confusion/wooziness 2. (Following da... Read more
1. (Day of injection) minor headache, pain at injection site; confusion/wooziness 2. (Following day) 30 minutes severe shaking of right hand followed by 30 minutes minor shaking; headache; fatigue, sense of a sharp instrument like an ice pick being pressed hard into the inner surface of my ankles and my lower thighs - but only felt this in one location at a time as it there was a ghost poking me in those locations intermittently with just one ice pick; wooziness; pain at injection site 3. (2 days after injection) morning still had wooziness but subsided by evening.
59 2021-05-19 impaired work ability May 17, 2021: Severe Inflammatory arthralgia within 30 days of 2nd dose of Pfizer Covid-19 Vaccine (... Read more
May 17, 2021: Severe Inflammatory arthralgia within 30 days of 2nd dose of Pfizer Covid-19 Vaccine (received elsewhere). Has had 2 weeks of symmetrical, severe, constant stiffness in "every joint of my body", especially all 30 finger joints (equally), bilateral wrists, and bilateral shoulders. Not improving. Affecting his ability to work (despite his very high pain tolerance). No fever during this time. T 98.6 today. No synovits on exam. He is a construction worker, and he has been requiring 4 advil every 2 hours to even move at all. His work is severely curtailed from the pain and stiffness. (continued)May 19 update: Patient slightly better after medrol/ketorolac injections, but still with severely stiff and achy joints as before. Affecting his work ability. But he is still trying to work. -- > He reports that he had the Pfizer vaccine Lot EP6955 on 3/24/2021 at the Vaccine Clinic, and 2nd dose of Pfizer LOT EP7533 on 4/14/2021 at the same clinic -- > On April 23, 2021 he developed abdominal cramps, bloating, pain and diarrhea that lasted for a few days. -- > On Aprl 29, 2021 he developed the the current arthragia symptoms, which are severe, persistent and disabling
59 2021-05-23 confusional state Three minutes following receiving the vaccination I experienced rapid heart beat, confusion, burning... Read more
Three minutes following receiving the vaccination I experienced rapid heart beat, confusion, burning in lungs, blood pressure increase. Wheeled down to emergency room. Given anti nausea medication, exrays on heart and lungs, saline IV, heart monitored
59 2021-05-25 insomnia low grade fever (99+); pain in joints; pain in muscles; swollen lymph node under the arm that was va... Read more
low grade fever (99+); pain in joints; pain in muscles; swollen lymph node under the arm that was vaccinated; difficulty sleeping; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) as a single dose via unspecified route of second dose on 15Mar2021 at 11:30 AM for COVID-19 immunization. The concomitant medications included multi-vitamin (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) for unknown indications. The Medical history included Ibuprofen allergy. Past medication included BNT162b2 had taken as a single dose via unspecified route of 1st dose on 22Feb2021 at 11:30 AM (lot number: EL3247). Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, 11 hours after dosing patient woke up with low grade fever (99+), pain in joints, muscles and swollen lymph node under the arm that was vaccinated. He had difficulty sleeping the rest of the night and still 22 hours after dosing) had sore muscles. The therapeutic measures taken were not reported. The clinical outcome of all the events were reported as recovering/resolving at the time of report. No follow-up attempts are possible. No further information is expected.
59 2021-05-28 feeling abnormal Headache; Brain fog; Stomach cramps; Diarrhea; Chills; This is a spontaneous report from a contactab... Read more
Headache; Brain fog; Stomach cramps; Diarrhea; Chills; This is a spontaneous report from a contactable consumer. This consumer reported for 59-year-old male patient (age at vaccination: 59 Years) received a dose of (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that the patient had headache, brain fog, stomach cramps, diarrhea, and chills which was started 24 hours after vaccination on 27Feb2021. The patient did not receive any treatment for the adverse events. The reporter responded to the query that the reporter became aware of the occurrence on 01Mar2021. The reporter was not the patient in this case and the patient was not a Pfizer colleague. Outcome of the events was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
59 2021-06-03 disturbance in attention, memory impairment onset of fatigue, headache, within hours of vaccine, difficulty with concentration, cognition, memor... Read more
onset of fatigue, headache, within hours of vaccine, difficulty with concentration, cognition, memory, headaches 1 month after vaccination
59 2021-06-03 feeling abnormal This is a spontaneous report from a contactable other Health Care Professional (patient). A 59-years... Read more
This is a spontaneous report from a contactable other Health Care Professional (patient). A 59-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: En6198, Expiration date: Unknown), via an unspecified route of administration, in Arm Left on 05Mar2021 at 13:30 (at the age of 59-year-old) as 1ST DOSE, SINGLE for Covid-19 immunization at Public Health Clinic/Administration facility. The patient medical history included thyroid disorder from an unknown date (Low thyroid numbers), migraine from an unknown date (Chronic), hypotension from an unknown date (Low blood pressure), raynaud's phenomenon from an unknown date (Raynauds syndrome). The patient had no known allergies. The patient had received concomitant medications within 2 weeks included nifedipine (NIFEDIPINE), levothyroxine (LEVOTHYROXINE), trazodone (TRAZODONE) and tamsulosin (TAMSULOSIN) were taken for an unspecified indication, from an unknow start date. The patient did not receive other vaccines within four weeks of vaccination. The patient was not diagnosed with COVID-19, prior the vaccination. The patient was not tested for COVID-19, post vaccination. On 05Mar2021 at 12:00 AM (approximately 6 hrs post vaccination), the patient felt extreme weakness, dizziness, brain fog. The patient woke up for work but had to call in sick sure to extreme weakness and dizziness along with severe pain at injection site. The patient did not receive treatment for the events. The outcome of the event was reported as recovering. No follow-up attempts are possible. No further information is expected.
59 2021-06-08 disturbance in attention Starting on the day of the vaccine (2nd dose)- I felt "a warm, chemical and electrical sensation" in... Read more
Starting on the day of the vaccine (2nd dose)- I felt "a warm, chemical and electrical sensation" in my chest a few hours after the vaccine. The next morning, I was unable to have a bowel movement, when usually I am very regular. I was not able to have a bowel movement for a couple of days. I felt very constipated and would try to force myself to have a bowel movement. I ate more fiber and fiber pills and drink more water, which was uneffective. I was finally able to have a bowel movement but it took a lot of force and would push the point of exhaustion and almost passing out. On 2/19/2021, I decided to seek medical care for my constipation, stomach cramps, fatigue, difficulty concentrating and shortness of breath. The doctor diagnosed me with Covid long hauler (I had a previous covid infection in 11/2020). I was prescribe probotics (for constipation) and rest for 2 months. I am still feeling fatigue and having heart palpitations. They order ECG(normal) and blood work (normal).
59 2021-06-09 disturbance in attention Beginning two days after the vaccination, dizziness, joint pain, difficulty falling asleep, difficul... Read more
Beginning two days after the vaccination, dizziness, joint pain, difficulty falling asleep, difficulty concentrating, difficulty with balance. Symptoms became less severe slowly over 2 months. Currently, 6/10/21, symptoms are dizziness, difficulty concentrating, fatigue, stuffiness in left ear, and some difficulty falling asleep. Below, you ask about disability. I don?t know yet.
59 2021-06-15 memory impairment, feeling abnormal Vaccinated at 3:10 pm. Went for a walk at about 5pm for 40 minutes. Resting heart rate that day was ... Read more
Vaccinated at 3:10 pm. Went for a walk at about 5pm for 40 minutes. Resting heart rate that day was 55. O2 was 98%. For the walk my average heart rate was 98. AM BP reading was 87/55. The longer I walked the more I felt a mental fogginess. By the end I could not even remember prayers I have known my entire life. Yes, I was praying or trying to. I honestly wondered if I was having a stroke. I got home and rested and it seemed to go away. I walk every day and for the next 7 days I had the same effect, but to a lesser degree each day. I got the first dose on March 18, 2021. Lot number 2613. Same location. Just felt lethargic and run down for 3-5 days.
59 2021-06-17 feeling abnormal, confusional state lost so much weight; there it inflamed the places where you have bumps; dry skin; had fungus things ... Read more
lost so much weight; there it inflamed the places where you have bumps; dry skin; had fungus things push under the nail; fever, says 98.6 is about a half point to a point high; passed out; dead for a while; Itching; Stomach a little bit bad/Sick to his stomach; Really, really tired; Brain is scrambled a little bit/Brain things get a little not right/Brain things get a little not right/Fogged up a little bit more lately/ Feeling kind of crummy/ Feeling a little bit bad; Dry mouth; Judgement is off; Falling a bunch of times; Slept and slept and slept; This is a spontaneous report from a contactable consumer reported for himself. This 59-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Deltoid on 13May2021 (Lot Number: EW0167; Expiration Date: Aug2021) at single dose for COVID-19 immunisation. Medical history included ongoing cardiac failure, ongoing hypoxia (Hypoxia, brain injury), Kidney problems , ongoing myoclonus (he has several different things, says stuff comes from the brain injury, and from medicines they gave him), hepatitis C (he had treatment for Hepatitis C when it first came out, says it's cleared up and has never had bad liver function. States he was diagnosed 15 years ago), ongoing attention deficit hyperactivity disorder (ADHD, combined type), ongoing ventricular fibrillation, ongoing gastrooesophageal reflux disease (GERD, he has had GERD all his adult life), ongoing back pain (chronic back pain, he has had chronic back pain since he was about 15). Handicapped/ disabled, depression, heartburn and acid reflux, cardiomyopathy, pain, urine flow decreased. Concomitant medications included ongoing acetylsalicylic acid (ASPIRIN (E.C.)) taken for cardiac failure, he has been taking this medication for years; ongoing atorvastatin (LIPITOR [ATORVASTATIN]) as heart medicine, he has been taking this medication for years; ongoing clonazepam (CLONAZEPAM) taken for brain injury; ongoing escitalopram oxalate (LEXAPRO) taken for depression, he has been taking this for 25 years; ongoing esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for heartburn and acid reflux; ongoing furosemide (FUROSEMIDE) taken for heart failure and fluid, he has been taking this somewhere between 5-10 yrs; ongoing isosorbide mononitrate (ISOSORBIDE MONONITRATE), he doesn't know what he takes these for, something for added heart; ongoing levothyroxine sodium (SYNTHROID) taken for thyroid disorder; ongoing losartan (LOSARTAN) taken for cardiomyopathy; nystatin (NYSTATIN), he doesn't know why he takes this, says it's probably for his heart; ongoing primidone (PRIMIDONE); ongoing promethazine (PROMETHAZINE); ongoing spironolactone (SPIRONOLACTONE); ongoing trazodone (TRAZODONE) taken for sleep disorder, he uses it as a tranquilizer, uses it for pain, they say he's a drug seeker and won't give pain medicine.; ongoing morniflumate (FLOMAX [MORNIFLUMATE]) taken for urine flow decreased. The patient experienced passed out on May2021 with outcome of unknown , dead for a while on May2021 with outcome of unknown, itching on May2021 with outcome of recovered in 2021, stomach a little bit bad/sick to his stomach on May2021 with outcome of recovered on May2021, really tired on May2021 with outcome of unknown, brain is scrambled a little bit/brain things get a little not right/brain things get a little not right/fogged up a little bit more lately/ feeling kind of crummy/ feeling a little bit bad on May2021 with outcome of recovering , dry mouth on May2021 with outcome of recovered in 2021, judgement is off on May2021 with outcome of recovered in 2021, falling a bunch of times on May2021 with outcome of recovering , slept and slept on May2021 with outcome of unknown, lost so much weight on unspecified date with outcome of unknown, there it inflamed the places where you have bumps and dry skin on unspecified date with outcome of unknown, had fungus things push under the nail on unspecified date with outcome of unknown, fever on unspecified date with outcome of unknown. The clinical course was reported as follows: This past week he has been feeling kind of crummy, says he's disabled, and can lose track. He says his brain is scrambled a little bit since he got hit, says he passed out, was dead for a while, states that affects him quite a bit, and he says he loses track. He says when he tells about that, he didn't know he got the first shot and it had a little place that hopes it didn't mess up. He states he put on small wounds, corcetin. States when they did the shot, says usually they'll make you hold, ask you to hold the cotton ball in place, says they get a Band-Aid on tight and push down, says they put compression so it doesn't leak. He states this was loose when he got home, it was leaking like a little bubble, a little fluid. When he washed it, he washed it off. Right close to it, there were two other places. He states when they gave him some steroid cream, he put that on there it inflamed the places where you have bumps and dry skin and a cut and looks like a little cut. Says when he put cream, it got inflamed and angry. He stated he was watching Dr, and when she calls it a cyst or something is infected, she calls it angry. He says there was a bunch where they put the Band-Aid, and he put just a dab of corcetin, believe that's what he had when he put, took it off the first time, and it had two bigger places that were a scab. He says once he put 2 by 3 Band-Aids and left it on for a couple of days, says he did this several times since last year or two, says to try to clear some of this stuff up, don't scratch, says he did get an itch in that location when he got the shot. He didn't scratch, said he wanted to pull Band-Aid off and scratch but didn't do it. He says it cleared up but he's been feeling a little funny, just maybe a little sick to his stomach, dry mouth, stuff like that. He says he didn't think it's a problem, says he had that problem like after 3, 4, or 5 weeks and all of a sudden he has a little episode where he gets to feeling funny, says his judgement is off and the brain things get a little not right. He stated he then fell a lot, says he's been falling a bunch of times in the last week, he'll feel better and it won't bother him. He says it's a cycle he's gone through since he lost oxygen. He doesn't think it's anything, it's confusing, says it has so many symptoms, and when he read this it has so many symptoms. Confirmed patient was referring to COVID vaccine. He states he hasn't had eczema then most of it, sometimes he'll scratch, it will build up like a scab and he'll scrape it off, put some of the ointment on there. but a band aid on top, leave it down for a couple of days, after a shower, a couple of showers, it comes off. He says it clears it up, says if it doesn't, just wash, wash it hard, it scrubs the scab off. He states the worst thing he had was his toenails, he had to work on them, had fungus things push under the nail, under the side, and he cut it. He used cortisone 10 on it, says they always quit making something that works well, states you know how you get a yellow toenail. He says he's been putting Neosporin on it. Clarified corcetin is Cortizone 10, it is pretty strong stuff. He says he puts it on these places on his arm using Neosporin. Attempted to clarify that itching began after use of Cortizone 10, states nothing like that, says it did itch a few days after still a little bit, there were three little places under that Band-Aid where they put the shot. He ended up putting Neosporin right when he took that band aid off it was itching, says he washed it good, then put Neosporin on it, says it's cleared back up to its normal roughness. For event itching, he states at first it was almost a scab, but it was not quite a scab, it was wet like a little bubble. After the scab, when he got ready to take, it was itchy after the band aid was on there a couple of days, he took a shower, washed it, and put more ointment on it. Each time he took the Band-Aid off, he washed it, washed his arm, and put the Band-Aid back on. He did the same again and it's gone away. He states he is feeling a little bit bad, his stomach is a little bit bad. He hadn't checked it lately, when he gets a fever, says 98.6 is about a half point to a point high. He was really, really tired, says he slept and slept and slept. Says this is similar to the cycle that he goes through with his brain injury, says it's the same cycle he goes through. He also stated he lost so much weight laying in bed.
59 2021-06-25 excessive sleepiness, nightmare, loss of personal independence in daily activities, feeling abnormal Symptoms immediately started on Sunday, June 20, 2021. These effects are exactly like Walking Pneum... Read more
Symptoms immediately started on Sunday, June 20, 2021. These effects are exactly like Walking Pneumonia: fever, headache, muscle & bone aches, no appetite (have not eaten a full meal since that Sunday), no bowel movement, 18 hours of sleep per day, with constant run on nightmares that make me feel as if I am going insane. I have no mental health issues whatsoever. I will not drive since my brain is clouded. This is affecting my school time since I cannot focus because of this vaccine. I will not lose earning my degree over experiment.
59 2021-06-26 amnesia Tinnitus increased greatly after 2nd shot, within the same day. Tinnitus is still very bad 2 months... Read more
Tinnitus increased greatly after 2nd shot, within the same day. Tinnitus is still very bad 2 months after shot. Slight headaches started within a week of 2nd shot, would happen a couple time a week. After two months they have mostly gone away. Moderate Short term memory loss started after 2nd shot. This has greatly improved after 2 months.
59 2021-07-08 feeling abnormal My arm is sore; my arm was sore, it is still sore; I wasn't feeling right, my breath was not right/s... Read more
My arm is sore; my arm was sore, it is still sore; I wasn't feeling right, my breath was not right/shortness of breath; Chills; I wasn't feeling right, my breath was not right; temperature was 101; This is a spontaneous report from a contactable Consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208) via an unspecified route of administration in left arm on 11Mar2021 as single dose for covid-19 immunization. The medical history included acid reflux. The concomitant medication included Pantoprazole taken for acid reflux (40 mg, Once every other day for acid reflux) and Patient had been taking it from past 3 years. In Mar2021, the patient experienced that his arm was sore and it was still sore, patient wasn't feeling right, his breath was not right, shortness of breath, don't feel good, went to the bathroom a lot and chills. Patient further explained his arm was just a little sore other stuff went away. It was also reported, that was all until last Monday, after Monday I still have sore arm, my arm is still sore but I don't have shortness of breath anymore. patient is supposed to go back on the 2nd of Apr for his shot. Patient reported that he took some Tylenol and NyQuil for the chills and all. The patient underwent lab test of blood test and diabetes check-up and temperature was 101, SWAB test and it was positive 22Feb2021. The outcome of the event arm was sore was not recovered, wasn't feeling right, breath was not right, chills was recovered. No follow-up attempt are needed. No further information expected.
59 2021-07-08 impaired work ability, feeling abnormal, sleep disorder, restlessness, disturbance in attention Within a couple hours of the vaccine, in addition to expected arm soreness, I felt tingling up and d... Read more
Within a couple hours of the vaccine, in addition to expected arm soreness, I felt tingling up and down arm, then odd feeling throughout my body and head by the afternoon (just very odd, not pain). I did not have any cold fever or flu-like symptoms. But, within the next day or two, more concerning symptoms appeared: I felt, for lack of a better way to describe it, very "twitchy" from my chest, like a flutter. I've felt restless and fatigued at the same time nearly all the time, like excess energy and exhaustion both at once. I feel an uncomfortable feeling, like irregular heartbeat or arrhythmia in chest especially at night lying down, which as been interfering with sleep. I have felt the restlessness and fatigue off and on night and day, interfering with focus and work. This has gone on for over two months now since the first vaccine dose. My overall health and how I felt were excellent the day prior to the vaccine. There is definitely something off with my metabolism, in particular my cardiovascular and aerobic function, since the vaccine that has not yet resolved itself. I can still exercise and feel better by doing so, but, it always feels at a lower performance level than before the vaccine. The feeling in my chest, like a harder heartbeat than normal, and sometimes what fits some of the symptoms of congestive heart failure or possibly myocarditis, is most concerning. I experience some periods where it feels like almost a wheezing in the back of my throat when I breathe. This was persistent for awhile and now seems to be more off and on, becoming less often. I am slender, exercise regularly and eat fairly healthy, am fit, and have never had any major health problems. There definitely seems some kind of cardiovascular, aerobic and/or respiratory effect from the vaccine.
59 2021-07-10 excessive sleepiness Since the first shot I've been experiencing some fatigue and oversleeping .; Since the first shot I'... Read more
Since the first shot I've been experiencing some fatigue and oversleeping .; Since the first shot I've been experiencing some fatigue and oversleeping .; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730) dose 2 via an unspecified route of administration in Arm Left on 09Apr2021 14:00 (at the age of 59 years old) as single for COVID-19 immunisation at pharmacy or drug Store. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient received other medications within 2 weeks of vaccination. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0151) via an unspecified route of administration in Arm Right on an unspecified date as single for COVID-19 immunisation. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced as, since the first shot i've been experiencing some fatigue and oversleeping. I normally sleep 4-6 hours but now after the shot I sleep a lot more 14-18 hours daily intermittently I thought I might sleep it off but it's taking longer than normal on 12Apr2021. Since the vaccination, the patient did not tested for COVID-19. No treatment was given. Outcome of the events were not recovered. Information on Lot/Batch number was available. Additional information has been requested.
59 2021-07-11 nervousness Real tightness in chest, nervousness, not able to breath ,deep breath. could not go up stairs. after... Read more
Real tightness in chest, nervousness, not able to breath ,deep breath. could not go up stairs. after 2nd day went to urgent care.
59 2021-07-15 sensation of foreign body, anxiety At approximately 7:00pm on 7/7/2021, I started to show signs of an anaphylaxis reaction. Those inclu... Read more
At approximately 7:00pm on 7/7/2021, I started to show signs of an anaphylaxis reaction. Those include: lip swelling, facial swelling, moderate difficulty breathing, anxiety, and severe diarrhea. Since it was late in the evening, I treated with an Albuterol inhaler, which provided very little relief. On 7/8/2021, I went to Urgent Care and was given a course of Prednisone, starting at 60mg and tapering down. Lip and facial swelling and diarrhea continued to be moderate to severe. On 7/9/2021, my breathing condition improved while still on 60mg of Prednisone. Facial and lip swelling continued. Additional diarrhea continued, but not as severe. On Sunday, 7/11/2021, as I reduced to 40mg of Prednisone, my condition deteriorated starting at 10:00am. Facial and lip swelling worsened, there was quite a bit of difficulty breathing and more diarrhea. However, I started to feel a lump in my throat as well. An on-call nurse asked me to take 25mg of Benadryl-- which I did. On 7/11/2021 at approximately 3:00pm, I went to the Emergency Room. O2 Sat levels ranged from 88 % to 95% and my BP was in the normal range. At 5:00pm, I was given additional Prednisone orally to increase that daily does to 60mg. I remain on a tapering dose today-- at 40mg and decending.
59 2021-07-20 anxiety, sleep disorder, insomnia, feeling abnormal Vision loss; Severe Vertigo; Headaches; insomnia; High blood pressure; Tinnitis; Sleep issues; Anxie... Read more
Vision loss; Severe Vertigo; Headaches; insomnia; High blood pressure; Tinnitis; Sleep issues; Anxiety; Absolutely feel horrible/Had not feel himself in 90 days; Possible diagnosis of post vaccine psychosis.; Migraine; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (BNT162B2) at the age of 59-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:30 (Batch/Lot Number: ew0162) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The COVID-19 vaccine was administered in Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination included Trilogy, Flownase Sensimist. Historical Vaccine included BNT162B2 for COVID-19 immunization on 18Mar2021 at the age of 59-year-old (dose 1, product=COVID 19, brand=Pfizer, lot number=ER2613, administration time=16:30, vaccine location=Left arm). The patient experienced vision loss, severe vertigo, headaches, insomnia, high blood pressure, tinnitis, sleep issues, anxiety, absolutely feel horrible, possible diagnosis of post vaccine psychosis on 11Apr2021 07:30, migraine in 2021, with outcome of not recovered. Detail information was as following reported Event: Severe Vertigo, headaches, insomnia, high blood pressure, vision loss, Tinnitis. Vertigo just about 3 days after 2 nd vaccine. Had not feel himself in 90 days. Still experiencing headaches, sleep issues, anxiety. Absolutely feel horrible. Blood pressure up significantly over historical levels. Being treated for high blood pressure, sleep, anxiety, headaches. Currently seeing a neurologist. Possible diagnosis of post vaccine psychosis. The report was reported as non-serious. The events resulted in Doctor or other healthcare professional office clinic visit Emergency room department or urgent care. Treatment received included Vertigo treatment, Migraine treatment, Ongoing. Since the vaccination, the patient has not been tested for COVID-19.
59 2021-07-28 impaired work ability Extreme fatigue, constipation, lower muscle pain down legs, severe pain in knees, difficult to climb... Read more
Extreme fatigue, constipation, lower muscle pain down legs, severe pain in knees, difficult to climb stairs. Out of work for 5-6 weeks. Went to primary care doctor and a cardiologist. Still experiencing severe fatigue