Pfizer

I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.

Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold

* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight

generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run down; sleepy; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration on 16Dec2020 08:40 AM at right deltoid, at single dose for covid-19 immunization. Medical history included sleep disorder. Concomitant medication included alprazolam prn (as needed) for sleep, HCTZ; losartan; metoprolol; montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL). On 18Dec2020 the patient had temperature of 98.8 which is low grade fever for her because she runs low. On 18Dec2020, she experienced a low grade fever, chills and was freezing. On 18Dec2020 she had chills and couldn't get warm. She had three layers on and a heating vest. It passed and she was doing fine. Those symptoms passed, but reappeared on 26Dec2020, last Saturday. Since then, she mentioned generally not feeling well, in addition to being freezing cold and experiencing chills every day. She had been monitoring her temperatures, and had no fever. Since 26Dec2020, she had chills, couldn't get warm, and no fever. She was tired and run down. She was sleepy and usually she was very energetic. The patient asked if have heard of such experience in other people. Seriousness Criteria was reported as it was not disabling, but annoying. It was unusual. She had on a thermal shirt that she would wear for skiing and that is not normal. Then on the 26Dec2020 the chills started back again. She felt kind of tired. She didn't feel sick, but not up to snuff. No AE required emergency room/physician office. The outcome of the event fever was recovered on 19Dec2020. The outcome of the events freezing; sleepy; tired and run down was unknown. The outcome of the other events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.

Patient experienced a bit of flushing, itchiness in nose, eyes, tingling in mouth/scalp, and a little throat tightness after initial monitoring period of 15 minutes. Occurred 1-2 hours after dose admin. Resolved with no treatment, though Benadryl was recommended.

Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.

Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."

Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.

Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her history of CA and Immunosupressed state. She went back to her office post monitoring. Around 1535, one of her employees called reporting that she didn't look good and was acting weird - pale; stumbling; slurred speech. The coworker brought employee to the immunization clinic in private vehicle. Dr. along with the CNE and another RN went to the vehicle to asses. It was noted that employee did have slurred/slow speech; droopiness to face. She reported that she started to not feel well while in her office. V/S: B/P 141/102; pulse 108; O2 sat 96% on RA; skin pale. She stated that she felt "loopy". Employees husband was called and her co-worker was instructed to take the employee to the ER where her husband would meet them. At 1540, employee was taken to ER for evaluation.

dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. 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.

Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021   Date: 1/6/2021 MRN: 3274958   Subjective Patient is a 60 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   Pt reports she saw an allergist this am for runny nose, SOB, and sneezing. He determined her symptoms was a neurological response. Previous COVID infection November 30, 2020   PREVIOUS REACTION: Pt reports first Pfzier covid shot she had symptoms of Chills, HA, nausea and fever of 102 that occurred 12 hours afterwards. She states her symptoms lasted 6-8 hours.     ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness       Objective   Vitals Vitals:   01/06/21 1235 BP: (!) 152/82 Pulse: 57 Temp: 99.2 °F (37.3 °C) SpO2: 100% BS 94 at 12:38   Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.       Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.     Pt was observed and given water and food (peanut butter). Felt better within a few minutes. She was released to go home 12:55pm     APRN Electronically Signed 1/6/2021 12:45 PM    

Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.

On day 1 after the vaccine the employee began having muscle aches and sore joints. By day 4 she felt like she had an improvement in symptoms. On day 6 the same symptoms reappeared and the employee was tested for COVID (negative PCR). She reports that all of her joints in bilateral upper and lower extremities are extremely sore, she noted that "even her toes were painful". She is unable to take NSAIDS because of a history of anaphylactic reaction to Motrin in the past.

30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes tingling numbness on hands and feet. Very cold feet couldn't get warmed up till wrapped up on heating pad. Ño fever but felt chills. Sore arm site of injection.

Employee with low grade fever, chills and shaking starting at 2am. Tmax at 5:30 am of 101.2. Self medicated with Motrin with some improvement of symptoms.

Pfizer-BioNTech COVID-19 Vaccine Patient received Pfizer Covid-19 vaccine at 1043. Patient complained of tingling throat, no swelling noted. Patient alert, oriented and talking/answering questions appropriately. Voice noted to become hoarse with continued conversation. EMS alerted and took over care at 1107.

Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD, Benadryl 50mg IM administered with 1 hour in clinic observation. Pt. with improved breathing and relaxation, vitals stable.

Approximately 20 minutes post injection patient felt tingling/numbness in the left pinkie finger, migrated to right pinkie finger with one hours. Acetaminophen

arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach; inherited some type of reaction like a rash, its itchy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1685, Expiry Date: Mar2021, via an unspecified route of administration on left arm from 29Dec2020 to 29Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypertension (verbatim: Blood Pressure High), thyroid disorder (verbatim: Thyroid), cholesterol. The patient's concomitant medications were not reported. The patient stated she got her vaccination on 29Dec2020, that's Tuesday and her arm was sore the next day (30Dec2020) but she have inherited some type of reaction like a rash, its itchy, her hands are itching like crazy, she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach that's not so itchy it's the hands that's itchy. The patient was asking what should she do. The outcome of the events was unknown. When asked for treatment for the events, the patient stated, "I was doing some, I take an Aleve, Aspirin and then I was taking some Benadryl capsule for allergy."

Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.

HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35 PM B/P 185/98 PR 60 @11:45 NO N/V NO CHEAT PAIN

Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of 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.

four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls

COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th approx. 1700. Worsening symptoms through the night. Fever and slight cough on Saturday morning with body aches, joint pain and chills.

She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F

Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms get better.

1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading

Pressure in my head behind my ears. Clear drainage from my nose. Feeling shaky has been going on for past 15 days. Due for second dose afraid to take it.

Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest

the patient began to experience dizziness and flushing; the patient began to experience dizziness and flushing; This is a spontaneous report from a non-contactable other healthcare professional. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The female patient who was seen at (Clinic name) today on 06Jan2021 for her second dose of the COVID 19 vaccination. During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing on 06Jan2021. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness. The outcome of the events was unknown. This case was reported as non-serious. No follow-up attempts are possible. No further information is expected.

Headache, NauseaVomiting, severe migraine, arm pain-sore for 2 weeks, red streak up the shoulder and neck Narrative: Experienced a red streak that went up the shoulder and neck from the injection site. Also felt very foggy, difficulty focusing.

Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown. Information on the lot/batch number has been requested.

developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tylenol, used heating pad

Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started having mild itching in my trunk, arms and left Hand. itching increased so took Benadryl 50 mg PO, stayed for 15 minutes then left work to go home. Once home itching increased, eyes started swelling and started losing my voice. Husband took me to the ER at Hospital, arrived approx. 6.10 pm. Treated with Benadryl, Solu medrol and Pepcid, all thru IV. Condition improved and client sent home with script for Pepcid, Medrol dose pack and Atarax.

Ringing in ears; Triggered to migraine; Cannot hear, Sounded like everything was muffled; Headache; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 04Jan2021 14:56 at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, previously had an allergic reaction to just one antibiotic. Concomitant medication included nifedipine, carvedilol. Consumer stated, "About 15 minutes into after getting the injection, I was sitting to the site they asked me to stay longer because I previously had an allergic reaction to just one antibiotic (Unspecified Medication).So that was within the 15 minute mark I started getting ringing in my ears and at the 20 mark I had migraine. I had them since I was about 9, they were diagnosed, it triggered a migraine. Although the ringing had gotten better in the last year but it is really bad in the right and it is now causing me (incomplete sentence)." Consumer stated, "I am probably say like I am yelling at you. I cannot hear and my son keeps telling me mom you are yelling. I did not see that I am 'ringing to your sheath' ringing in the ear, the headache. I just see my headache is better today. I had a little bit of it but nothing you know Excedrin or something would take care of not enough for me to go take that but it is the ringing and I cannot hear out of that ear. I put my phone up and ringed up. Consumer stated, "Recently my mom had COVID (further not clarified), I barely heard it. On the 23rd of Dec and I keep in contact with my family,they are 13 of us and I picked up the phone and instinctively put it to my right ear, I could not hear and I kept looking at the phone and I thought wait a minute and I put it to my left seems to be okay. It is the right I cannot hear." Consumer further added, "I am a Nurse so you expect this, that is why I waited this long because I got the injection at like 3 O'clock yesterday and I waited even longer thinking maybe it will just go away and So I know you guys want to know everything that is going on. So I said wise better to call." Date of vaccination: Consumer stated, "04Jan2021 (Clarified as 04Jan2021) and the time was 2:56 PM." Consumer further added, "It is the only thing I could think of. It is the only thing that I could think of that I did differently out of my daily habits to go get this injection. I would say within 15 minutes it just started turning my head and I was like wait a minute I am having ringing and then they had music playing above our head, it sounded like everything was muffled then I turn my head to the right I could hear better and they kept turning my head and one of the administrators at the table started looking at me so I get up and I said you know what I am having ringing in my ear so they had me seated there a bit longer." Dose and route of administration: Consumer stated, "I think she pulled up one cc that I saw and I got it in my left deltoid." Treatment: Consumer stated, "No." Causality: Consumer stated, "I would have to say because it started like say in the 15 minute mark and then the headache came in about 20 minute mark." The outcome of the event Headache was resolved while the outcome of the other events was unknown.

The day after my arm was very soar for at least 48 hours, no fever just laying around. I had low energy for about three weeks and I'm just now feeling better. Around the 26th my lymph nodes swelled up (three of them) . I called my PCP, he told me to take Tylenol is painful and to put warm compress if they were uncomfortable. They are still there, they don't hurt or painful.

Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (arm left) on 08Dec2020 (lot unknown) at SINGLE DOSE; and second dose via an unspecified route of administration on 06Jan2021 at SINGLE DOSE (lot number EJ1685) for COVID-19 immunization. The patient medical history was not reported. The patient was taking unspecified concomitant medications (same medications that she usually takes and has not started anything new). Patient reported that she was fine after the first shot. Her arm was a little sore on Dec2020 and that was it. The soreness at the injection site lasted 2 days and then recovered completely. She has no breathing difficulties or anything similar. Outcome of the event "Her arm was a little sore" was unknown while recovered for " The soreness at the injection site lasted 2 days" on Dec2020.

At 4hrs post vaccination experienced extreme muscular pain between shoulder blades. The following week, as far as I can recall, I began to have tingling from the right shoulder blade down to my hand. I thought I may have a pinched nerve and went to the walk in clinic to be seen by the nurse practitioner that is in the same office as my primary. She examined me and thought it sounded like a pinched nerve and said I was swollen in the area of complaint. Cervical and thoracic x rays were taken (normal) and was told to take Flexeril and steroids. Pain was getting worse and primary told me to begin taking Meloxicam and have physical therapy. I have been doing both beginning 1-11-2021. Pain continues with no improvement. Do not know if my symptoms are caused from the Covid shot, but just seemed to me that it was quite a coincidence that muscle pain began on the same day as receiving the shot.

flushing/ felt feverish and it was not a rash, she just felt flushed; hot/ felt really hot; soreness in the arm; little headache; experiencing tingling in hands and feet (mostly in feet); experiencing tingling in hands and feet (mostly in feet) and they feel cold; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route on left upper arm at single dose for COVID-19 immunization on 05Jan2021, 12:30pm at 60-year-old. Medical history included: ongoing diabetes type 2; ongoing gout; went through menopause 10 years ago (2011). She had pulmonary emboli 3 years ago (2018) and had some scar tissue but not on oxygen though she did get short of breath. No relevant family medical history. The only reactions she has ever had was 15 years ago (2006), she had a CAT scan and experienced hives the next day due to the contrast medium. She thought it had since been changed as she had had it twice since then and was given diphenhydramine hydrochloride (BENADRYL) but experienced nothing again. Concomitant medication included: ongoing dulaglutide (TRULICITY) for diabetes type 2 and ongoing oral medication (unspecified) for gout. No additional vaccines administered on same date of BNT162B2. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) single dose for COVID-19 immunization on 19Dec2020 around 12pm and 2 pm. The patient previously got the flu shot (unspecified) every year, 3 years ago (in 2018) she got the shingles vaccine and had also had the pneumonia vaccine (in 2018) but never experienced anything from those products. The patient previously took allopurinol for pulmonary emboli and had had no reoccurrence. She took warfarin for short of breath. The patient had flushing on 05Jan2021, she was hot and turned red like a cherry. She had an episode where she felt really hot like hot flashes or almost like she was flushed. Her face was red as beet and her arm and hands were red, this lasted about an hour and she took ibuprofen (ADVIL) for it. It seemed to be resolved but had come and gone through the night. She was up checking on her puppies so that was how she noticed. She had taken her temperature and it had been 97.6-98.1 which was normal for her, but she was still getting the hot flashes and flushing. She felt feverish and it was not a rash, she just felt flushed. After the vaccine, the patient reported soreness in the arm on 05Jan2021. The patient was experiencing tingling in hands and feet (mostly in feet) on 05Jan2021 and they feel cold. Tingling started about 45 minutes to an hour after the dose. The first time lasted 3-4 hours and then went away. It came back in the middle of the night for a couple hours and then again this morning. This morning it had been going on for 2-3 hours and was still going on right now; it started about 6:30am-7am. They feel cold but her feet were really cold. She had socks and slippers on, but they didn't seem to get warm. She went on to explain that her hands and feet have profusion. During this she had checked her pulse ox (oximetry) related to her cold hands and it had been 92-95% (on unknown date) which was good. She had also checked her pedal pulses even though they were cold, and a little they were a little on white side, they blanch although might be a little slow but nothing alarming. The patient had a little headache on 05Jan2021. Other than that, the patient felt fine. No emergency room or physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events flushing, hot/ felt really hot, soreness in the arm, tingling in hands and feet (mostly in feet) and they feel cold was not resolved; outcome of the other events was unknown. Causality assessment between the Pfizer product (BNT162B2) and the events (tingling, flushing, soreness in the arm) per the reporter was reported as related.

Received 2nd dose Pfizer lot EL0142 in right arm on 1-13-2021. Employee is experiencing body aches and cramping all over.

Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained of head tingling and body itchiness.

reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports weakness,

Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.

Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.

1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heaviness from belly button down to the legs. Advised to go to the EC for evaluation. Update 1/15: Seen in ED and had EKG with inverted T wave. Still has heaviness in legs. Will get a referral to cardiology after speaking with PCP.

left neck moderate to severe pain; pain started radiating down her left arm and down left leg; weakening her joints on those extremities/ shoulder pain; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: unknown), via an unspecified route of administration, on 16Dec220, at a single dose on arm right for COVID-19 immunization. Medical history included diabetes mellitus 2, hypertension (HTN), migraines, back pains, hypothyroidism, and allergies to latex and kiwi. The patient received the vaccine at a military base. She did not receive other vaccines in four weeks. The patient was not pregnant at the time of vaccination. She had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included unspecified medications; she received other medications in two weeks. The patient previously took gabapentin and topiramate (TOPAMAX), in which she experienced allergies. On the second day after receiving the vaccine, 18Dec2020 04:00 AM, the patient started feeling left neck moderate to severe pain, and the pain started radiating down her left arm and down left leg, weakening her joints on those extremities. This continued severely for 3 days. At this time, she continued to feel mild left neck, shoulder and arm pain intermittently. She could not report this immediately due to not having her vaccine documents which she forgot at her workplace as she proceeded to vacation. She had paused in getting the second dose that was due on 07Jan2021, waiting to hear from Pfizer. The patient received NSAIDS and Muscle relaxant medications as treatment for the reported adverse events. Outcome of the events was recovering.

I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in the morning I had high fever, chills, and a very bad headache, and shooting pain like a shock in legs and arms (I had the same when had covid around 04/2020 and was out of work until June 2020 - I developed double pneumonia). It lasted until 11AM the next day. Got a covid test around noon and it was negative and on the 25th I started feeling better. Got second dose on 01/13/2021 had the same symptoms but not as severe.

I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor difficulty breathing. I had an increased you can buildup up in my throat and nose, with coughing. I took two Benadryl; about 45 minutes later my breathing improved. I took the Benadryl at 8:15 AM. It?s now 2:25 PM and my eyes are getting itchy and starting to feel puffy again. My voice is still very hoarse.

Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thyroid medicine before going to before at midnight; very restless night of sleep. The pain in my arm woke me up. I never felt like I fell asleep. I woke up at 530am and took my Thyroid medicine and went back to bed until 6:30am. Felt fine until about 830am. I noticed I was starting to feel lightheaded and had this pressure on my head. I went back to bed and tried to fall asleep but really never did. I noticed that I would lose track of my train of thought often. Got up at 11am and took a shower and still just didn't feel like I had any motivation to do anything, so rested again. I then noticed my face, ear lopes and cheeks felt a little numb. I would pinch them and I noticed they were numb. Also, there was still pressure on the back of my head and on the bridge of my nose. Still light headed. I layed in bed until about 3pm when I did notice the numbness going away and the pressure on the back of my head and on the bridge of my nose getting a little better. Also, no appetite.

Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.

Within 15 mins of receiving the vaccine I had slight tingling in my R cheek. Within 2 hrs of the vaccine I had R facial numbness from maxillary to ear and lower jaw. Within 6 1/2 hrs from the vaccine, I had R lateral calf numbness. Within 8 hrs of the vaccine, I had R hand and arm numbness, R side of mouth and tip of tongue numb, R orbital swelling, scratchy R eye, maxillary tenderness. Advil was taken 9 1/2 hrs after the vaccine. Symptoms improved by next am, and gone by 24 hrs post vaccine.

limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;

Left upper eyelid spasming several times an hour day and night for about 10 days, then starting to lessen to every couple of hours day and night

SORE ARM 8 HRS POST VACCINE. THEN, HEADACHES AND MALAISE. MINOR BODY ACHES UPON AWAKENING THE NEXT MORNING. ALL LASTED UNTIL ABOUT 28 HRS POST VACCINE.

Within approximately 2 hours of receiving vaccine, patient experienced slurred speech, dilated pupils, and was slow to respond to questions. Patient felt "foggy," similar to waking up from anesthesia.

fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension. Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.

Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening

began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and rash to face

Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.

Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart rate increased. Nurses came over and took VS. BP 180/100, P128, Throat scratchy and hard to swallow. Monitored continuously and had epinephrine ready but didn't inject as about 10 minutes later symptoms started to subside. Stayed in hospital for longer period (unsure of exact time) and then went home. Over the next 2 days, felt listless, weak and no appetite.

Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching

Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours

Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.

taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.

received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working afternoon progressed to chills and total body aches. temp 101 through evening up and down after motrin to next day Wednesday. wednesday had some chills but during night into Thursday had joint pain no fever. woken up thursday with joint pain and headache no fever.

INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of both legs- no fever

Sore arm, severe headache- severe body aches, chills, low grade fever. Symptoms started 10 hrs after vaccination and lasted approximately 36 hours.

Patient had stated she felt well. 1-2 minutes later she c/o feeling woozy and was uncertain if her right hand was pale. + tingling. Brought to be evaluated by EMT.

Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days

Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; 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.

12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.

Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed 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 to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/92

The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, she felt dizziness, her head was spinning, weakness of the arms, and slurred speech. Her FS was at 108 (Normal), BP 195/105 (Extremely high), Pulse 91, O2 saturation was at 100%. At 2:48PM, her BP lowered to 167/92. At this time, she can smile, she can put her hands up, she can kick her feet and she can opened/closed her eyes. Due to her high BP, Doctor requested that the should go to the ER via the ambulance.

sore arm; This is a spontaneous report from a contactable nurse (patient). This 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 19Dec2020 for COVID-19 immunization. Medical history included asthma; hypertension; acid reflux; food allergies; known allergies to peanut, shell fish, IVP dye, penicillin and tree nuts. Patient also had known allergies to erythromycin and ceftriaxone (ROCEPHIN). Concomitant medication was not reported. There was no other vaccine in four weeks. On the first dose of 19Dec2020 just a sore arm (date unspecified). The outcome of event was unknown. Information on lot/batch no. has been requested.

Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.

C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids

SUDDEN LOSS OF MOTION OF THE LEFT INDEX FINGER AND LEFT THUMB 9 DAYS AFTER RECEIVING VACCINE. WENT TO ER AND HAD A STAT CAT SCAN TO R/O STROKE AND A CHEST X RAY BOTH NEGATIVE. DISCHARGED FROM ER . SAW NEUROSURGEON FOLLOWING DAY, NECK X RAYS DONE. WAS PLACED ON PREDNISONE FOR 6 DAYS AND REFERRED TO NEUROLOGIST. EMG TO BE DONE IN THREE WEEKS FROM 1/22/21.

There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose on 1/9/21: Approximately 53 hours after Dose #1: Redness on hands and wrist, rash-like small dot appearance on hands and wrists, skin dryness and tightness of hands. I experienced no itching of hands or wrists. Approximately 53 hours after Dose #2: Small, painful red pustule-like occurrence on base of right thumb, with the appearance of a few small dots in it. I experienced no itching of thumb or hand. These events both occurred within the same timeframe following the vaccine doses. Following the first event I was seen in the ER. I checked out fine and they could not say exactly what this was. They said it did not appear to be an allergic reaction to the vaccine because it was not systemic and I had no other symptoms such as trouble breathing. They thought perhaps it was coincidental...I work in the hospital as a radiologic technologist where I hand-wash and hand-sanitize all day. Perhaps I just over-washed that day? However I've worked there for 17 years and never had this happen. The redness and rash dissipated by end of day. Following the second event I did not follow up with any medical provider. This pustule I got happened while I was at home, and otherwise I felt fine so I left it at that. It took several days for the pustule to go away. I hope you don't mind but I am writing to report this information in the event it may be helpful to you and I am also reporting it because I want to know if what I experienced could be considered an immune response to the vaccine? Another words, not an allergic response but an immune response ? I can find absolutely nothing about this on-line and no one knows what to make of it. Thank you.

Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.

First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.

Rash across face, part of her cheeks over her nose; Arm sore; Received two vaccine within 10 minutes of each other and now to be re-vaccinated again the second dose; not enough research can guarantee if that's safe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140, expiry:Mar2021), intramuscular on 12Jan2021 at a SINGLE DOSE then intramuscular on 12Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased, fistula, surgery on 18Dec2020. It was stated, "Sure, I am hoping you can help me. I am one of the legal guardians for our younger sister who has special needs. She is residing in a group home, group home in the city area she is currently been out of it because she has surgery. They have made arrangements for them to still ask for them to receive the first Pfizer Covid 19 Vaccination just this past Tuesday so I go from up there from my home in city and we had a problem in there they screwed up and ended up vaccinating her twice within 10 minutes. I asked the pharmacist, there I asked the RN what does that mean for her I mean I didn't know what that meant but normally we would sat for 15 minutes, they made her sat for 30 minutes. The nurse was there from the group home monitored her blood pressure and temperature and then we got in the car proceeded to drive 3 and half hour. They said just watch for temperature, labored breathing, take her to the emergency room call 911, the only thing she did have about an hour after she broke out that was "malar" (not clarified) rash across her face part of her cheeks over her nose that lasted for about 30 minutes. The next day her arm was sore which was going to happen but here is my question though she received two vaccine within 10 minutes of each other and now they are wanting her to be re-vaccinated again which would have been the second dose, supposedly on 02Feb2021. Nobody can tell me if that's safe or if that's okay, they can't guarantee, they all kept telling me, the nurse says, I called the pharmacist kept saying there's not been enough research to know if it's safe for her to get that next vaccine, so I don't know what to do." The reporter also stated, "IM, Both went for IM, first one went into her left arm and second shot was given in her right arm." The patient underwent lab tests and procedures which included blood pressure measurement: unknown result on an unspecified date, blood test: unknown result on 05Jan2021, body temperature: unknown result on an unspecified date, sars-cov-2 test: unknown results pre-surgery and post-surgery. The outcome of the event rash across face, part of her cheeks over her nose was recovered and arm sore was unknown.

arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.

Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritated sciatic nerve pain. Left left leg numbness. Decreased mobility, difficulty sitting, walking, and even lying in bed. Started very quickly without andy known injury. Pain continued to worsen. Pain even worse after second injection. Now two weeks after second shot, the pain is going away. It is like the nerve irritation is subsiding. The way the irritation is subsiding makes it seem that the vaccination may have caused irritation to the nerve. After receiving 1st and continuing through the second vaccine, started having severe sciatica pain going down left hip and leg. Left leg pain and numbness. Thought I had done something to damage the nerve. Hurt to sit, hurt to stand and even hurt when in bed. The pain was so severe it caused issues with any mobility. Took Advil, Aspiring, Tylenol and nothing helped. Received second vaccine 1/12/2021 the pain continued and even got worse. It was to the point I couldn't even walk. I couldn't figure out how I had damaged the nerve. I am now thinking it was from the vaccine. I believe the vaccine irritated the nerve. The nerve pain is starting to go away. Normally if you have a sciatic nerve issue, it just doesn't go away on its own. I know there have been reports of severe back and neck pain. I believe it can irritate the nerves which cause severe pain. I wanted this reported in cases others complain of similar issues. The good thing it is improving.

day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better. some diarrhea, body aches. pain in my left arm and side around lung area. had chest x-ray on 1-11-21 clear. this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21.... these are all the symptoms i had when i had covid in Nov. it was like having it all over again......

FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT CERVICAL NODES, HOT AND COLD FLASHES AND HEADACHE. NASAL CONGESTION.

Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.

Temperature of 100.7, chilling, tired, brain fog, runny/stuffy nose. Took Tylenol and rested. Felt fine the next morning.

6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.

Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.

10 days after vaccine(1-31-20) I felt flushed in my face and sore throat. My temp was 99.5 which is abnormal for me because my normal is 96.5-97. I called my employer and had COVID test on 1-2-21 negative. Employer instructed me to go to get flu A and B test and strep test which were all negative on 1-3-21. On 1-5-21 had second covid test that was negative. On 1-6-21 video visit at PCP since I wanted to be released to go back to work. Had CXR(negative) and started doxycyline 100mg for possible sinus infection. Flushing sensation stopped on 1-9-21. No flushing sensation until 1-22-21(10 days after 2nd vaccine) but temp 98.5 at highest and I continue to have today. I continued to work through this second episode since I believe it was my body's reaction to the virus.

Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.

Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she developed an itchy rash on her left arm which became panful. She saw her PCP who diagnosed shingles.

Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to calm down. A slight headache was starting. The next morning I had a massive headache all day Saturday, by 8 PM it was a full-fledged nauseating migraine. The severe migraine lasted from 8 PM the previous night to 10 PM on Sunday night. By Monday I was doing better but a bit confused and having difficulty thinking. Now it is Wednesday and I am a bit exhausted and still having trouble thinking but doing so so much better! I am so happy to be feeling better!

Right upper arm/shoulder pain, including pain within joint. Limitations to move arm and weakness continue even after 1 month.

slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupils; "foggy."; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), intramuscular on 19Jan2021 09:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and oedema. Concomitant medication included phentermine hydrochloride (ADIPEX-P), olmesartan medoxomil (BENICAR), furosemide (LASIX), amlodipine besilate (NORVASC), doxycycline (VIBRAMYCIN). The patient previously took Ciprofloxacin, Clopidogrel, Meperidine, Flagyl, Macrobid, Penbutolol and experienced drug hypersensitivity. The patient had the first dose of vaccine on 20Dec2020 (Lot number=EK5730). The patient exhibited slurred speech, dilated pupils and responded slowly to questions within 2 hours of receiving the vaccine. The patient felt like she just woke up from anesthesia and was "foggy" and 19Jan2021. The outcome of the events was unknown.

chills/major chills and could not warm up; was cold all night; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the right arm on 11Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included allergies to sulfa. The patient was not pregnant at the time of vaccination. 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. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included citalopram, topiramate, zinc, and ergocalciferol (VIT D). On 12Jan2021 07:00, the patient started having chills in the morning that was gradually increasing throughout day. At 6:00pm, that patient had major chills and could not warm up. The patient got into the bed with numerous covers. She was cold all night. The last time she woke up was at 3:00am, and then when she woke at 6:00am, and she was fine. No treatment was received for feeling cold. Clinical outcome of the events was recovered on an unspecified date. Information about lot/batch number has been requested.

light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=ELC142) via intramuscular on 13Jan2021 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. Medical history included allergies: Reactive airway to chemicals/perfumes/smoke. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), calcium, fish oil, echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (lot number=EJ1685) via intramuscular on 23Dec2020 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. No other vaccine in four weeks. On 13Jan2021, the patient had a headache in the evening and took Ibuprofen before bed. She woke up about 3:30 AM 14Jan2021 to use the bathroom and had vertigo. She carefully maneuvered to the bathroom and back to the bedroom, drank some Powerade and sat on the bed for a bit before she slowly laid back down. She did feel flushed while experiencing the vertigo. She was able to get back to sleep for a few more hours. When she got up about 7:15 am she felt light headed but did not have any more vertigo. Treatment for event headache included Ibuprofen, no treatment received for other events. Patient did not have COVID prior vaccination, did not test COVID post vaccination, patient was not pregnant. The outcome of events was recovered.

Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache with fatigue and sore throat swollen glands since the vaccine in the evenings.

12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache occurred. The symptoms lasted all day and were mostly gone except for a small headache and fuzzy brain after 30 hours. All clear after about 36 hours.

1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'

Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 97% Lungs clear.Client called family to pick her up and take to her PCP.

High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.

high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; arm was very sore; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 15:15 at single dose for COVID-19 vaccination. Medical history included ongoing coeliac disease diagnosed four years ago in 2017, allergic to dairy and corn, COVID in Nov2020. There were no concomitant medications, no other recent vaccinations and had started no new medications. The patient had a reaction with a high fever, a headache, and her arm was very sore after vaccination, that were similar to how she felt when she had COVID in Nov2020. The patient's arm was swollen and sore that evening on 20Jan2021. Her first fever was yesterday morning on 21Jan2021, probably at about 10:00AM or 11:00AM, and at that time it was 100.1 degrees Fahrenheit then later in the afternoon at 02:00PM it was 100.8 degrees Fahrenheit. She took Tylenol, applied cold moist cloth, drank lots of liquid for treatment, and she did sleep. Tylenol was clarified to be generic pain reliever, Acetaminophen 500mg. Acetaminophen 500mg, EXP Apr2021, LOT P114992, UPC: 1191717759. Her temperature improved after taking this medication, and it was 99.8 degrees Fahrenheit before bed. She hadn't taken any Acetaminophen this morning on 22Jan2021, but she took two tablets the first time yesterday on 21Jan2021 and then one tablet right before bed. She didn't go to the doctor for this. The outcome of events was unknown.

Had trigger finger in right hand lasting 3 days -resolved. Began experiencing tingling and electrical impulses down both legs (no pain). This becomes worse with walking. Comes and goes throughout the entire day and wakes me up at night at intervals. Began 4 days after vaccine and has continued since.

her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.

The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip. The treatment of the reaction was: o Epinephrine: x1 Transferred to ED

02/05/21 Developed headache 3-4 hours after receiving COVID vaccine, along w/ metallic taste in mouth & tingling in right hand. 6 hours after COVID vaccine had tingling in both hands. 02/06/21 4 AM felt chilled. 8 AM had mild headache & fatigue, tingling in both hands continued all day. 02/07/21 Tingling in both hands continued. Then developed tingling in left foot & increased tingling in left hand. 02/08/21 Increased tingling in both hands, worse in left 3rd digit. 6 PM had increased tingling in left hand & tingling up into left elbow. 9 PM had increased tingling in right hand. 02/09/21 Tingling in both hands continued all day. Fingers feel cold off &on. 02/10/21 Tingling in both hands continued all day. Fingers feel cold off & on. Tingling in feet, left leg up to knee in evening. 02/11/21 Tingling in both hands continues, fingers feel cold in both hands. Tingling in feet.

Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.

shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.

2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.

Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.

8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; severe body aches; injection site throbbing; upset stomach and a feeling of nausea. Temperature 100.2 at 8:45. Took temp every hour. By midnight temp reached 102.7. Head ache started. Couldn?t sleep on my left side because of the extreme pain around the injection site and down my left arm. Finally fell asleep around 2:30 and woke at 5:30. Fever was gone. Temp read 98.9. Body aches still present but not as severe. Arm pain had eased but head ache remained most of the day. Felt much better but just very tired.

1/6 1:30 vaccination Later that evening, I had extreme HA. I had 2-3 aura migraines, a day or 2 later. Insomnia. *still experiencing insomnia and anxiety

12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.

Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing 2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen. EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs "Against Medical Advice" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.

facial swelling, facial stinging, flushing approximately 45 minutes after vaccination. Persisted ~12 hours

Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.

lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.

This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to receive bnt162b2 (manufacturer unspecified), lot number: EL4238, via an unspecified route of administration in the left arm, on 21Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included arthritis. Patient's known allergies are Penicillin, Peanut and Dairy. Patient was not pregnant at the time of vaccination. 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 hasn't been tested for COVID-19. There were no concomitant medications. The patient's whole/entire arm was killing her; she was hurting across her shoulder blades down to fingers. Her elbow and wrist were hot and she was feeling a tremble in hand which she has never had before. She later added that her joint in elbow and shoulder was now reaching down to her arm. She couldn't even wear her watch today to her work, it felt swollen, like there was liquid in it. She also can't lift her arm, move and the pain was like going into her back. The patient was taking Aleve and Advil and "it doesn't take away all but it takes away enough that she can function." She also bought a topical ointment to help numb the area and she was wearing a pain patch on my back. The outcome of events was reported as 'not recovered'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

Associate experienced a headache immediately after receiving vaccine. Headache progressed into a migraine that lasted for 1 week.

This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, subcutaneous on 20Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included diabetes, anaemia, blood pressure, cholesterol. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EU9899, in the left arm on 30Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization and experienced swelling and redness at the site. Concomitant medications included liraglutide (VICTOZA), labetalol (LABETALOL), diltiazem (DILTIAZEM), valsartan (DIOVAN), rosuvastatin, metformin, aspirin and iron. The patient thinks that it wasn't given to her intramuscularly. This is a potential inadvertent subcutaneous administration of the BNT162B2. This patient received her second dose on 20Jan2021 on the side of her arm and reported that it was swollen, red, and hot, but has gotten 100 times better' over the last 6 days since administration. She was asking for efficacy of the incorrectly administered dose. It was further stated that in the middle of the night, her arm was red almost like a little bullseye and she said that she was getting burning, and pins and needles down her arm, and a fullness in her hand like her hand was swollen. She said that she still kind of feels it. As the days progressed on day 2, 3, and 4, the swelling got more intense, the circular red swollen area got worse to the size of like a small baseball. She was feeling okay other than that. Today was day 6 and it was not as red and was more black and blue, swelling went down 80 percent, she still feels a little bit of the pins and needles and the fullness in her hand. She said that there was like a big knot that was very hot. It was a hard like knot at the injection site. The injection site was really big, round, hot, red, and had a knot that lasted; adds it is still there but 99% better; and she had tingling down her arm with pins and needles in her hand. She noticed it was little red a couple of hours, like 8 hours later; but by the next day it was circular, more red, swollen, itchy, and burning down her arm. By the third day, the site had a big, red, hard knot; still burning down her arm and with pins and needles down her arm. She added that her hand felt like a fullness in her hand filled with fluid. By Friday the swelling at the site was gigantic. The site swelling is improved but the redness was more of a black and blue now. Her arm has been very dark red, discolored, swollen, painful and has nerve pain described as "hot tingling down the arm like pins and needles" to her hand. She states that she has a very large knot at the injection site. This was in her non-dominant arm. She spoke with two of the pharmacists that she works with and they looked at her arm and both felt like she may have received the injection subcutaneously instead of intramuscularly. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

2-19-21 by 8pm full body aches and head ache 2-20-19 12am woke to severe chilling and temp 101.3, 6am temp 100.8, 5pm temp 99.9, 9:30 pm temp 99.7, slept the whole day with continual aches and pains in legs, arms, and back, with a severe headache 2-21-21 6:30am temperature 97.6, improvement in aches, headache gone, slight ache in legs, arms and back, walking better, feel like getting up and doing something

During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.

Woke up during the night with chills that had my body shivering and a headache. Did not get up until morning because I didn't want to get out of the covers even though I was cold. Took some ibuprofen which helped with both the chills and headache. I had no energy and was very tired. I slept most of the day and woke up to go to the bathroom and take more ibuprofen. Towards the evening I could tell that I was feeling a bit better. I was able to take a bath, more ibuprofen and went to bed. Slept pretty well. Woke up once and took ibuprofen because of headache and body aches. Felt much better on Sunday. Was still tired and slept a good part of the day. My arm continues to ache, but is not really painful unless I try to lift it.

Felt burning towards the ears and cheeks and some numbness, reported not having any difficulty breathing but felt like she had to take off her mask to get "air", slight numbness in the arms and felt flushed.

Other than mild soreness at the injection site she experienced no adverse reactions during the first 24 hours post-vaccine. On the second day after vaccination she developed chills without fever followed by the appearance of rhinorrhea and sinus headache that persisted for about one week. As she has a past history of genital herpes and this resembled her prodrome for recurrence she self-administered valacyclovir for several days. On the eighth day after vaccination she noted mild hand tingling. The following morning she awoke with numbness and hyperesthesia of the left shin that is still present.There was no persistent tingling and no pins and needles sensation

I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway. body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs. I feel fine today

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins

1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order received to administer po benadryl 25 mg po 1030 symptoms resolving continued to monitor for additional 30 min. 1100 pt stable and symptoms resolved left premises this time.

As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level. Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis. Father with Parkinson's disease. I see that COVID-19 biofire came back positive. In light of this, COVID myelopathy is on the differential

Horseness and cough after 30 minutes of monitoring. She has a history of anaphylaxis with bees and 2 antibiotics. She was given 25 mg of benadryl and symptoms improved. She was given instructions to take more benadryl in 4 hours to help with symptoms and to go to the ED if symptoms got worse

About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed. BP was high but otherwise vital signs within normal limits. Symptoms resolved.

Sunday after administration, pt stated she started to feel her hear racing when going to bed, woke up with her heart racing in the am. Pt stated to experience tingling and burning in her feet that later traveled to her hands. Pt has a history of PVCs but noted an increase in the PVC frequency. Chest pain that was intermittent but lasted for 4-5 days. Continues to experience twitches and tingling feet to this day.

Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.

IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever

My upper arm started feeling odd ... numbness in my left upper arm. I liken the feeling to when I?m having dental work done and my mouth/lips are numb. Through the night I developed some aching in my left shoulder. No treatment. Just an annoying feeling of not being able to feel my upper arm. It feels cold as well.

Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Friday night, started coughing and feeling unwell. I had a fever in the morning and had lost my voice but wasn't coughing anymore. Today no fever but no voice and I just don't feel well. No appetite today either.

That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches, headache, sore arm, nausea, 102 fever, joint pain

Swollen and very sore lymph glands in left armpit/chest with pain/tenderness on the underside of arm where injection was given; ice was used to reduce swelling and was alternated with heating pad. soaked in warm bath with epsom salts. relief was finally achieved by taking 1 Aleve liquid gel capsule - 220 mg. Swelling and pain began within 24 hrs after injection and pain increased intensely by hour 36. Some tenderness to touch still in lymph glands in armpit/chest and to underside of arm. minimal tenderness at actual injection site - no more than normal for a injection.

When I received the vaccine, the technician administering the vaccine had a difficult time pushing in the syringe. He moved it around a little bit and pushed hard again. After he pulled the syringe out, he kept tapping it, I guess to make sure all of it went into my arm. When he was administering it, I had a burning sensation as it went in. No one I know had this occur during their vaccine. Due to working environment, I need to know that I received the vaccine, and that something did not go wrong and it failed. Can you let me know if I still received the vaccine after experiencing this during the administration of the vaccine? I am very nervous that it failed and I am not protected. I had a slightly sore arm the evening of the vaccine, but it was gone the next day.

Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level 10. Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2) Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live. Have had arthritis in this thumb but not for approximately 8 years. Entire hand was swollen and not useable.

Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell?s Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid and prednisone 50mg qday x 7 days

I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,

Seizure: Sunday 2/28 @noon Migraines: 2/28 post seizure & 3/1 & 3/2 Pre-seizure symptoms: 3/1 & 3/2 ExtremeMuscle&Joint pain, fatigue, Ubrelvy 100mg 2/28 & 3/2, Ibuprofen 800mg, alt w/Tylenol 2-500mg, Rest/sleep most of days, warm showers, heating pads

5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore throat without SOB or difficulty swallowing. She was able to drink water without difficulty. Her airway was patent and oropharynx was normal on exam. She had no stidor on exam. Patient was advised to seek care at the ED, but she did not.

Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.

At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 16 hours. I reported it to the nurse practitioner but did not want to see her because I knew it would resolve. I am a nurse and expected it would improve on it's own and it did. I did take Tylenol for the symptoms when they began. I work in a clinic.

SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL

Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature was 101 at 0930 this morning. Pt has minimal coughing at this time. Current temperature is 99.9 The pt denies any SOA prior or currently at this time. The pt was informed to eat small amount of crackers as tolerated and fluids as tolerated. Get plenty of rest. Should sx's worsen or SOA occur, then call for an ambulance for assistance.

I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was hard to take a deep breath 15 minutes after receiving the vaccine. I took my pulse. It was 90. I did not tell the medical monitor people. My husband drove me home after the 30 minute watch period was up. At 1:15pm I gave myself an albuterol neb to. Post tx home pulse ox was 95% pulse 96. No n/v, no itching. Breathing felt improved . I did a home peak flow reading which was 240. My personal best baseline is 350. I auscultated my anterior chest. Diminished, clear, no wheezing. I sat calmly. My husband noticed the left side of my face was mildly swollen. Amazing! For him to notice! it was very slight around cheek bone to jawline. I sent him to get otc Benadryl. I took 25 mg po . At 2:20 pm Pam was 300 p02 sat 98% pulse 96. Lips felt tingling, no swelling. Speech clear. Swallowing intact Drank water, low sodium soup. 3:30 pm did another albuterol next. Sat 95% after neb . Pulse 89. 20 minutes post neb peak flow reading 320. Started feeling chills. Temp outside a nice seventy degree day. Wrapped self 6 blankets,winter hoody fleece, heating pad and finally fell asleep. Family watched me sleep. Woke up 7pm. Still felt cold. Had fluids, urinated, breathing ok. Went back to sleep. 11 pm woke up, peak flow 300, did neb, took Benadryl wore my cpap machine and went to bed till today.

COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD

Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.

Approximately 15 minutes after the vaccine was administered, the patient reported feeling lightheaded and tingling sensation of the face; patient also stated that she "feels like tongue is swollen." Patient vital signs were taken by EMS on site. Vital signs were within normal limits.

Swollen arm,unable to lift,unable to lay on,achy arm and wrist,tingly fingers from 7pm same day til 3:30 next day(Friday March 5)Slept all day,made appointment with Primary, took dosages of Ibuprofen

Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.

Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she was unable to swallow while driving home. Used rescue inhaler when she reached home for relief. Symptoms now resolved. H/O asthma

left arm became red and tender 2 days after the shot- and has continued for a total of 3 days without change

Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.

This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.

mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days. Headache, nausea and weakness day after vaccination lasting 24 hours.

On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.

Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction. Itchy red spots all over head, ears and neck, some on lower part of body. Swollen lip. Took two benadryl at 1:45 am Wednesday . This helped to ease the itching. Had a headache so on Wednesday morning I took two Tylenol and made a Dr. appt. Also was weak and faintish on Wednesday when I got up. Dr's said to keep taking anti-histamines and report to ER if tongue or throat starts to swell.

burning itchy red bumpy rash started on left elbow, then spread to right elbow. Went to dermatologist on 2/24 for biopsy (gluten rash, psoriasis) and was prescribed Clobetasol 2x day. Rash dried up with skin flaking and peeling in about 5 days. Second vaccine received 3/4, no rash as of 3/10

acute chest tightness, chest pressure, SOB, severe cough, tachypneic, throat closing feeling hoarse voice, presyncope but epipen administered on site of vaccination location to avert syncope or cardiovascular collapse promptly. Symtoms occurred within 10 minutes of vaccine administration . Vaccine given 12:18 pm or 12:25 pm and symptoms within 10 minutes since in ER 12:30 pm but had received epipen en route before ER arrival since medical building was next to ER

within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.

My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or surgery. Tylenol and Aspirin could not control the intense pain. The pain was excruciating!! I also had aches, fever, chills and tender lymph nodes in my neck. The excruciating pain last 3-4 days. 7 days later I still have tenderness in my breast and arm pit.

Enlarged lymph nodes following 1st shot-- Diagnostic Mammogram and ultrasound; Severe Diarrhea for 48hrs following 2nd shot. Pain in arm for about 4 days following both shots

Tingling/numbness started in feet and then worked it?s way to the top of my head. The tingling/numbness lasted about 10 hours and gradually diminished from my feet up to my head. About 2 hours after the tingling/numbness started I felt my blood pressure or blood sugar start to fluctuate up and down for about 2 hours. I stayed in bed for this time period. I felt light-headed and scared. After about two hours, I felt stable enough to get out of bed and ate some food and drank some liquids. The numbing/tingling sensation seemed concentrated around my head for hours. I couldn?t really focus on anything. It felt like when your foot falls asleep. I felt as if I was having a neurological reaction because of the weird tingling numbness sensation. It felt like my nerve endings were firing all over; like having the chills without being cold. Although the biggest event was on 2/28, I felt the tingling ing/numbness in my arms on and off for at least another week. I?m scared to get the 2nd dose.

Not sure if there was a real adverse affect. It flared up my fiber myalgia in my upper back, shoulders and arms. Took ibuprofen and ultram

Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance 1526: 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.

Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9

2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache

I have a swollen uvula with blood red spot on the side. It is hard to swallow and it burns. I will call my doctor tomorrow morning.

Patient presents with feeling lightheaded after she got the second dose of her Pfizer vaccine about half an hour ago. She is brought over here by staff at the vaccine clinic. She continues to have some shakiness. She denies any pain or shortness of breath. Symptoms are worse when she is sitting up. She has had syncopal episode in the past. Denies any chest pain.

Normal side effects except extreme pain at back and left kidney. Felt like I had been kicked in the kidney by a mule. Lasted Wednesday through Friday. Could not get comfortable.

PATIENT STATED IMMEDIATELY AFTER RECEIVING IMMUNIZATION THAT SHE HAD A "FLUSHING" FEEL, BUT THAT IT IS NORMAL FOR HER TO GET THAT WAY WITH CERTAIN THINGS. PATIENT WAS MONITORED BUT RECEIVED NO MEDICATION.

Fever, nausea, whole body aches, pain in arm, armpit, back, chest, dizziness, palpitations, headache.

Patient reports having a history of anxiety. Stayed for 15 minutes, then went up to her apt. She came back down to report that she was having pain in her right breast (hx of Cancer in it) then it radiated to her right side down to her pelvic region. She reported feeling woozy/dizzy. She did not lose conciousness. HR was 80 regular, BP 164/92, lungs clear.

This patient was vaccinated approximately 1 hour prior to presentation here with her first dose of the Pfizer COVID-19 vaccine. She felt fine right after her vaccination but as she drove to her destination where she was going to take a walk, she started to develop left-sided facial burning and swelling. That prompted her to call her PCP in that office recommended she come back to the vaccination clinic to be evaluated. I evaluated her at approximately 2 PM.. She was feeling well for the most part with the exception of left-sided facial burning and swelling and a little bit of redness over her left cheek. She denied fevers, chills, itching, other areas of rash, difficulty speaking, difficulty swallowing, tongue swelling, lip swelling, wheezing, chest pain, or difficulty breathing. She recalls a penicillin allergy at age 5 or 6 but cannot remember the reaction. She has never reacted to a vaccine before. Initial vital signs included a blood pressure of 134/73, a pulse that was 70 and regular, and an oxygen saturation of 100% on room air. She had normal mental status and her lungs were clear. The left side of her face was slightly swollen over her left cheek as compared to the right with some slight increased flushing on the left side. There was no stridor, she was speaking comfortably, and her lungs were clear with good airflow. Her heart demonstrated S1 and S2 with regular rate and rhythm. I administered 2 doses of Benadryl, 25 mg with each dose about 15 minutes apart with her last dose at approximately 2:25 PM. I rechecked her vital signs at 2:50 PM and her blood pressure was 138/79 with a pulse of 70 and regular and an oxygen saturation of 99% on room air. Her lungs were clear and she was moving good air. I did take a relook at her face which was improved with decreased swelling. At 3 PM, because she was doing much better, I discharged her to home with instructions to use Benadryl 50 mg when she got home and then 25 to 50 mg every 4 hours today. If she develops any respiratory symptoms such as difficulty swallowing, cough, breathing difficulty, swollen tongue or swollen lips, as well as increased facial swelling, she will call 911 to be evaluated. She should not get the second Pfizer COVID-19 vaccine.

Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.

About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.

3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat and upper chest. It got a bit worse and then improved over the next few hours. I also experienced a scratchy/itchy sensation in my throat and a slightly itchy feeling on the skin of my neck and upper chest. No wheezing or swelling. Took 25 mg Benadryl at bedtime. 3/13 ? Sensations continued, still fairly mild, but with occasional tingling on lips in addition to other symptoms. Took 25 mg Benadryl at bedtime. 3/14 ? Feeling about the same; still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime. 3/15? Symptoms continue to improve, but I?m still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime.

my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow water; my tongue was tingling and was slightly swollen; I felt some tingling in my face; I felt light headed right after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EM9810), via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 vaccination. Medical history included depression, anxiety and the patient was diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included 6 prescribed meds daily plus vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Upon vaccination on 04Feb2021 at 16:15, patient felt light headed right after the shot. She waited 15 minutes and started driving home. she felt some tingling in her face. By the time she got home, 35 minutes after the shot, her tongue was tingling and was slightly swollen. She had some difficulty swallowing saliva but could swallow water. Her tongue was still slightly swollen the next morning but did not tingle. No seriousness criteria was reported. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date of Feb2021.

15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fever that climbed to 102.7 and lasted 24 hours. Took acetaminophen. Fever back to normal on 3/16/2021, four days after the vaccination.

Approximately 5 minutes post injection my blood pressure plummeted and I began to feel faint. I also started shaking uncontrollably particularly hands and arms. Vaccine administrator was immediately notified and they summoned the closest EMT. Emergency Services took my BO and pulse oximeter. A few minutes after the start of the symptoms. They explained that since my HR was at 84, BP was 110/68 and oxygen saturation was at 98% and I wasn't having difficulty breathing that I was not having an allergic reaction to the vaccine but a parasympathetic response instead. They sat with me until the shaking stopped approximately 15minutes later.

Pt in COVID-19 Observation Area complained of weakness to body. Per pt felt dizzy and anxiety earlier but better now. . B/P @ 141/92 02 Sat. @ 96-99%. Doctor evaluated pt rechecked B/P @ 100/50 02 @ 96-99%. After evaluation pt states less wekness to body. Pt keep in Obsrvation area.Pt felt better and wants to go home Doctor notifed. Instructions given to pt to go to Urgent care or E.R. @ Medical Center if sympyoms worsen and return tomorrow if s/s continue. Can be discharged. Pt accompanied to vehicle to daughter. Instruction given to daughter verbalized all discussed.

The event began with me feeling extremely cold and unable to warm up. It later progressed to needle like sensations where ever touched. I do not remember the next week. Per my husband I had a sustained temp of 102 and was difficult to keep hydrated. My O2 sats remained stable. The following week I became unable to drink anything thicker than water. This has improved but continues to this day. My husband is a physician.

Pt. at the observation area felt a heat flash and dizzy, paramedics assessed pt. Once pt. was feeling better, paramedics released her to home.

As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vaccine. A tingling feeling up my left arm to back of my neck. My neck stiffened and then my throat started to close. Not to where I can't swallow but just like when I eat food that I'm allergic too, it closes up. The nurse that was overseeing me was holding the umbrella over my car window with the rainfall. All of a sudden their was lightning & thunder. The nurse threw the umbrella because she was shocked from the lightning. She started to talk to all the other around her and forgot about me. Since I could still swallow I didn't get her attention. When she returned she asked me the time so I had to pull my phone out. She didn't know the time of my 15 minutes and sent me away. As soon as I got out of the parking area but still inside amusement park, I started to feel my cheeks becoming numb and my right eye was blurry. I quickly moved over to the side lane still inside of amusement park and waited. I called my husband and told him that with the heavy rain I didn't feel safe driving with my right eye being blurry. I waiting another 15 minutes before driving home. That evening the blurriness came back, my eye's & forehead was tender to touch but no headache. Only pressure in my head. My symptoms of closed throat, swollen cheeks, pressure in my head and blurriness continued on Friday, March 12th, Saturday, March 13th, Sunday, March 14th and Monday, March 15th. As of today, no other systems other than feeling my body has inflammation.

Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick at my stomach, started have Diarrhea, Severe Headache, My arm hurt really bad could not use it for a Day and 1/2. Just felt like I had been run over by a Bulldozer.

Left side of left arm became numb, down side of arm and three fingers. Left side of left leg also felt numb but half as much as the arm. No treatment. It went away by 10 am the next morning.

Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed 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 to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Face begin to itch, then neck. About 20 minutes later started to notice large hives on face and neck. Very red and itchy. Went to pharmacy to get Benedryl and pharmacist suggested to go to ER immediately. Went to ER and was evaluated and kept for observation. No swelling of tongue or difficulty breathing. Stayed for observation and given prednisone (deltasone) . Given an epi pen and instructed to take benedryl. Hives subsided. No reactions since that night. Arm a bit sore but nothing severe. Seeing an allergist next week as followup.

/o sore arm & fatigue since receiving the vaccine on Friday. Deveolped low grade temp on Monday, taking tylenol & ibuprofen PRN, No other complaints at this time. Advised to continue with Tylenol/ibuprofen and contact PCP if symptoms worsen.

This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea. Patient received her initial COVID vaccine 2 days ago. History is obtained from urgent care chart. As per notes patient started nausea vomiting 6 hours post COVID vaccine administration. Patient was seen in urgent care for epigastric pain and nausea vomiting. Patient was found unresponsive at 0902 by tech. No carotid pulses palpated. CPR was started. Patient was brought into the emergency department with Lucas on. Patient was given 5 epinephrine prior to arrival. CPR was in progress. Patient was asystole. Resuscitation was continued in the ED. Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED. Cardiac Ultrasound didn't show any cardiac activity. Asystole on the monitor. No corneal reflex people are fixed and dilated. Patient was pronounced at 1007 am

I had no side effects except a sore arm with both doses of the vaccine. Only this week I started to experience ringing in my ears (tinnitus) and I have never had that before. The only reason I thought it was related to the vaccine was that my husband experienced the same symptoms recently as well and he received both doses of Moderna vaccine in January. I find it very strange that we are experiencing these symptoms now after more than a month of getting a second dose of the vaccine.

Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone

Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired the day after. I was incredibly sore everywhere - back,chest, hips, legs, neck... very hard to move. Around 5 PM the day after the vaccination, I became violently ill. Diarrhea, chills, feverish, sweating. etc. This lasted until about 3 AM on the 18th.

5 minutes after the shot, a feeling of warmth went through my upper body to my head & my tongue was tingling. It lasted about 30 seconds. It happened again about 1/2 hour later (11:12 am) but not as strong or as long.

Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache

Pfizer-BioNTech COVID-19 Vaccine EUA Date of Tuesday, Mar 16, 2021. Intense neuropathy pain in both feet and both lower legs mainly at night. Difficulty sleeping. This continued each night but during day of Friday, Mar 19, 2021 the neuropathy continued and the numbness and tingling migrated up into my legs and into my arms and hands but not as intense as in my feet and lower legs Tingling, shakiness felt in muscles is continuous now, not just at night. I was scheduled to have 2nd dose today but decided not to go through with getting it. Consulted with my APRN on phone and they advised to get 2nd dose and we would follow up if needed on neuropathy. I decided I did not want the 2nd dose.

I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. Around 10 am I developed chills and just did not feel great. My husband took my temp and the highest it got was 102.6 which is high for me since my baseline is 97.6 or so. I did not have a great appetite and felt very stiff when I moved around. I pushed fluids and took 3 naps Saturday. I have a low grade fever of 99 today but feel much better. Did take 2 naps and slept well last night. Took Advil with each meal and doing so today.

COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance, attempted to located on site MDs. 1526: No MDs on site, 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.

03/19/2021 - 4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD WITH COLD CHILLS. LAID DOWN WITH TWO BLANKETS AND WAITED FOR THE SHAKING TO STOP...THEN FELL ASLEEP. I AM GUESSING SHAKING WENT ON FOR A GOOD 1/2 HR TO HOUR. i WAS VERY WEAK TO GET UP TO GO THE BATHROOM. MY HUSBAND HELPED ME.

8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.

Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started afternoon. 99.4. Took Tylenol but it gradually rose to 102.3. Took 3 hours for fever to go down. By 5:30 fever was gone & I was feeling better. Next day I felt great but by three days later I had a fever blister & very sore, dry and stuffy nose which lasted two weeks. And headache as well. I?m thinking because of stuffy nose. I did have Covid last March/April 2020 so I have heard that I would have side effects.

By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me up. I could not raise my arm up past 6 inches. My left arm and side down to my waist was hurting. I took some Ibruprofen. Used a heating pad on my shoulder. Finally got back to sleep for a few hours. When I woke around 7:30 am, most of the pain had moved under my arm and to the front of my shoulder. I sat in my hot tub (100 degrees) for an hour and took more Ibruprofen. I was able to raise my arm up about half way. Was very tired. Went back to bed around 10 am and slept until 2:30. Had a headache and fatigue. Napped off and on the rest of the day. Today I can raise my arm all the way up, slowly. It is still painful to do so. The headache and fatigue are minimal.

Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; Tingling; prickly sensation on tongue when eating; cold items felt opposite of what they should, more like burning sensation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 12:45 as single dose for COVID-19 immunization. Medical history included known allergies to Sulph. The patient was not pregnant. Concomitant medications included aceclofenac (BIOFLEX [ACECLOFENAC]), calcium (CITRICAL [CALCIUM]) and vitamin D (VITAMIN D [VITAMIN D NOS]). On 01Mar2021 08:00, the patient experienced sialadenitis (salivary gland inflammation), glossitis (tounge inflammation), inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips. Tingling, prickly sensation on tongue when eating, cold items felt opposite of what they should, more like burning sensation were also reported. Onset of symptoms Monday morning, symptoms peaked Wednesday evening through midday Thursday, greatly improved by Friday morning. The patient had a COVID test on Friday to be sure and it was negative. There were no treatment for events. No COVID prior vaccination. The patient had a COVID test type post vaccination-Nasal Swab (Covid 2 PCR) on 05Mar2021 which was negative. The patient had The outcome of the events was recovered on unspecified date in Mar2021.

Started out with mild muscle pain with certain movement. Effects ability to drive and work. Saw Dr on 3/16/2021 Steroid cream, tylenol, and Xrays done. Informed that they might need to do an MRI. At this time she does not feel like it is getting any better. Sometimes hurts more than other times depending on activity, feels heavy and week. Can feel it poping and grinding with movement.

Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a plane and was blocked as you would feel by altitude change. I kept trying unblock by swallowing etc. That last 15ish minutes followed by a constant sound in both ears as if someone was rubbing sand paper back and forth in front of each year. That lasted 40-50 minutes. Approximately 32 hours after feel like I have to keep swallowing to unblock my ears. That altitude flucuation again feeling but not as bad as the first encounter. This was related to the vaccine. No doubt in my mine. Never had anything like this before unless on an airplane. Sand paper sound, never. I let my physician know tonight via email. In addition I felt dizzy within 5 minutes of receiving the injection. Subsided within 15 -20 minutes. Felt aloof the remainder of the day. Also arm hurt so bad the next day I had to cancel golf. Low grade fever plus headache

Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning the evening of injection. All symptoms, except sore arm, gone by morning. No treatment given.

I could actually feel the vaccine entering my blood stream above and below injection area. I had sharp pain on right upper side of my chest that came and went for several hours along with dizziness. Arm hurt so bad later that night from my elbow to my neck it woke me up and I took aspirin until pain died down some.

At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.

As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vaccine admin. Was discharged from ER, but returned later for general weakness/lightheaded, heart racing, felt throat was closing.

Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next day, I had diarrhea and stomach upset starting by mid day. Since then, I have had daily diarrhea, lethargy, weakness, off and on headache, body aches (especially joints) and overall feeling of unwell.

Patient presented to emergency department at Hospital 30 minutes after receiving vaccine, complaining of tingling in tongue/lips. Patient was evaluated and given diphenhydramine and famotidine. Symptoms were improved and patient was discharged. Patient returned to emergency department approximately 4 hours later with general weakness/lightheadedness, rapid heartbeat, feeling of throat closing. Solu-medrol and IV fluids were administered. Patient felt much better and was discharged with a prescription for oral prednisone. **Note, this information was reported from patient's primary care office. An event have already been reported to VAERS for this patient by Hospital**

Patient complained of numbness to her left hand. She reports "like hand is asleep but very faint." Reported the sensation began around 15 minutes after the injection. Patient stated that she is "not afraid and the sensation is still present but is barely noticeable." Patient did not have difficulty breathing and declined vital signs. Patient was advised by staff to login to report further symptoms and to go to the ER for worsening reactions.

received the Pfizer COVID vaccine dose 1 (lot ER8732, expiration 7/2021) at 0915. Patient reported to at 0920 that she was experiencing a bitter and metallic taste in her mouth and cramping in her wrist. Vital signs: O2 98%, pulse 73, blood pressure 140/82, respirations 16. Patient reported the taste had disappeared but the cramping radiated up her arm to the axilla. Medical conditions include: diabetes mellitus type II, pacemaker, status post stroke in 2017, hysterectomy in 2012, breast cancer in 1998 in remission, hypertension. Patient reported her normal blood pressure is 140s/80s. Medications: synthroid, levothyroxin, novolin, Humulin R, niacin and fish oil. Allergies include corticosteroids, codeine, sulfa, citric acid. Patient denied edema, tingling, pain, or dizziness. Patient reported she had not eaten breakfast and only drank a few sips of water with her morning medications. EMT advised patient to move arm and wrist continuously to promote circulation. At 930, offered Benadryl that patient declined, also advised patient to notify provider and signs when to contact 911. Patient drank approximately 8 oz of water, ate a small snack of pistachios, and reported improvement in cramping and taste resolved. At 940, vital signs: O2 97%, pulse 65, respirations 16, blood pressure 142/86. Patient reported symptoms had resolved. At 0952 vital signs: O2 99%, pulse 64, respirations 16, blood pressure 140/82. Patient left walking with steady gait.

I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.

Patient complained of feeling dizzy and hands tingling. One set of vital signs taken but patient refused a second set of vital signs. Patient felt fine after speaking with the medical doctor and went home.

After I left the facility, driving home I notice that my back was starting to hurt, so I turned on the heat on my back . When I got home, I had difficulty getting out of my car. I sat in a chair and within the next few minutes I was not able to stand. My husband had to come help me get up and stand, there was pain across my lower back like pin needles and up part of my spine. I took Motrin and it helped it subside somewhat not much. The second day it continued but later started to ease a little but I was not able to walk upright. Third day, 3/24, it is starting to ease up and I am able to walk upright, there is still discomfort. I have contacted my physician to report the issue.

this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.

After coming into the observation post vaccination, the patient told the nurse that she was itchy. The nurse assessed her and did not note any hives but did see scratch marks. Soon after, the patient stated she felt hot and had a headache. She quickly noted that her throat had begun to also hurt at that time. EMT's came over to assess her, per the nurses request the EMT's at that time suggested to the patient that she be further evaluated at the hospital. She accepted the transport to the ER.

neurothopy for 1-2 days; bone pain; Exhaustion; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified route of administration on unspecified date at age of 60 years old at single dose for COVID-19 immunisation. Patient had chemotherapy for ovarian cancer in 2020. Concomitant medications were not reported. Patient experienced exhaustion, bone pain, neurothopy for 1-2 days post first vaccine. Event took place after use of product. Outcome of events was unknown. Information on the lot/batch number has been requested.

sore arm, started to hurt in the afternoon treating it at home with cold pack, trying to avoid OTC medications

things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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.

seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I felt dizzy and then had diarrhea this continued off and on for several hours...in the ER they gave me steroid, saline solution for dehydration and pepcid. I had a headache and chills while in the ER. Went home and felt fine that night other than mild headache.

Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021

The first day body discomfort, arm pain, today vomiting and diarrhea chronically, mild stomach pain. Discomfort all day from the morning and vomits and diarrhea from 3 in the afternoon. Body pain.

On 3/18 Started out with arm and shoulder feeling hot. Then Excruciating pain in shoulder and all down the arm from 3/19 and still continuing today 3/27. Took Tylenol and used ice on shoulder and arm. Had a massage and stretching done on 3/23 didn?t help much. Contacted my doctors office on 3/23 and have an appointment for 3/31. The symptoms I?m feeling is that of SIRVA. Went to urgent care on 3/26 and was told that ?that is a symptom of the vaccine, give it another day?. Told them it was over a week and the pain I?m feeling is nerve pain. I was told there was nothing they can do for me there. Still feeling the pain today. Still icing and using Voltaren gel to help with inflammation.

Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.

Severe cramping, bloody diarrhea, dry heaves. It calmed for a week, now I have cramping and bloody diarrhea again.

soreness in arm. Chills, fever as high as 101.8, body aches, fatigue. Fever continued the entire next day along with fatigue. Today, March 27th, I have woken up feeling better, no fever.

1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12midnight My arm was sore and in pain and very warm to the touch 2- on Tuesday morning I was very cold and very tired . 3- Around none or so I notice my self cleaning my mouth the left side , it feel like you just where out of the Dentist , like went you anesthesia from the dentist is running out. I have feeling but it almost feel like my drooling like my saliva is out of my mouth and also my left eye felt heavy and at first very watery and the dry . My left side of my mouse feel different and I?m connately cleaning my mouth.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

Patient walked to medical tent complaining of itchy, blotchy skin chest and hand; voice breaking; throat uncomfortable, shaking BP 164/74 P 111 02 97%. Epi 0.3mg IM administered transferred to EMS for hospital transfer.

Patient received 2nd Pfizer COVID vaccine today; completed 15 min RN observation; however, described to nursing staff she was starting for feel dizziness, tingling of hands, feet and " sudden odd, metallic taste" in mouth. A/O x 4 VS stable; reports dizziness, tingling to hand and feet bilaterally. Patient was assisted w/transfer from chair to wheelchair and transported to UC department accompanied safely by RN. RN/COM advised of incident.

Heart rate increase Blood Pressure increase Chills Fever Headache Body Ache Tight Chest Lethargy Weakness

The next day I felt it was allergies, sneezing etc. I was told go to take a test took pcr and it came back two days later positive for covid. 24 hours after 3nd vaccine. Also have pain in left breast Under arm where shot was given

Headache, fever, lethargy, entire body ached, very increased neuralgia which I haven't experienced for a very long time (stemming from Shingles years ago) took lots of Tylenol, slept for about 12+ hours straight, lots of water Outcome - still a bit feverish on 2nd day and tired but no headache

first dose gave me hot flashes night sweats, put me back into meno pause hasn't stopped, yet second dose gave me frequent urination going on the 6th day, blood in urine

felt nausea and dizziness on day of vaccine. 2-3 days after sore throat, hard to swallow, 5 days after vaccine lost voice and/or voice change. no fever at any time

Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot EN5318) via an unspecified route of administration in left arm on 09Mar2021 at 10:00 AM (at the age of 60-years-old) at single dose for COVID -19 immunisation. Medical history included systemic lupus, asthma, rheumatoid arthritis, thyroid cancer. She had allergies for antibiotics, pneumovax and morphine. She had taken other medications in two weeks. No other vaccine in four weeks was received. She experienced urticaria, bronchospasms, itchiness, shortness of breath, flushing/redness on 09Mar2021 at 10:15 AM. The adverse event was resulted in emergency room/department or urgent care. She was treated with IV fluids, benadryl, decadron and solumedrol. She did not have COVID prior vaccination and COVID tested post vaccination. Outcome of events was ecovering. No follow-up attempts are possible. No further information was expected.

patient states a few seconds after receiving the vaccine she was light headed, and had a low grade headache. Later on that evening she began to have 1/10 central abdominal pain. C/o coughing spasm in the middle of the night that went away after a few minutes. Also c/o moderate fatigue.

Chills, body aches, fatigue, lack of alertness, mucus secretion in nasopharynx and upper airways for ~10 days

Pt. stated she felt nauseous 10 Minutes after getting vaccinated. She also stated she suffers from migraines and when she is about to get a migraine she feels nauseous. She stated she has her migraine medication at work and she will take it as soon as she gets there. At 9:30am she stated she feels better. At 9:33am pt. stated she was ready to go.

her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell like she had the flu/sick; nose running; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 60-years-old), as single dose for COVID-19 immunisation. Medical history included lupus from 2018 to an unknown date, Cushing's syndrome from 2018 to an unknown date and ongoing Hashimoto's disease. The patient had also allergies. Concomitant medications included ibuprofen (ADVIL). Patient reported that within 2 minutes of getting the vaccine her nose was running. Two hours later she started to feel unwell. Her nose was still running. She was not sure if this was from the vaccine or because of her allergies. She felt unwell like she had the flu. She was sick and progressively getting worst. She was having reaction to the injection. On 26Feb2021 she woke up around 3:00 am and was unable to move the left side of her neck or her left arm. She still has some neck stiffness. She had small incidences for 3 days after. She felt paralyzed. She was unable to move her arm because it was completely painful. She didn't panic that her arm was extremely sore. She was able to move it. Caller added that she though she had Covid when she got the vaccine and didn't know it. She was sent t an EMS station to be tested. She was given the rapid test on 03Mar2021. Within 15 minutes she was told the result was negative. They sent out another test the same day. On 06Mar2021 she received negative results. She was scheduled to get the second dose on 18Mar2021 at 11:00am. The outcome of events 'she felt unwell like she had the flu/sick' was not recovered, nose running was resolving, unable to move left side of neck was resolved on 28Feb2021, unable to move arm was not resolved, the outcome of other event was unknown.

Muscles around hip replacement were affected for 2-3 days. Sore muscles in the buttocks, hip and quad. It only affected this site. It went away but I found it odd. I got the usual bit of nausea, wooziness, fatigue and sore arm, but those were expected

My face started tingling 15-20 minutes after vaccine and then my lips and tongue went numb. It felt like I had been to the dentist .

Patient administered 1st dose Pfizer COVID 19 vaccination. Approximately 10 min after receiving vaccination, patient became dizzy and tremulous. Tremors increased for left arm to more generalized and more significant. Denied shortness of breath. ED and on site physician notified and patient transferred to ED for further treatment. .

That night felt tired with chills and body aches. The next day I had a fever of 102.2, horrible body aches, joint pain, chills, headache, nausea, zero appetite, fatigue. Felt like a bad flu. By Monday the fever was gone but was very weak, nauseous, with joint pain. Didn?t feel like myself for several days-almost a week.

BP 100/100 mmHg, HR 72 History of Orofacial granulomatosis, neurofibromatosis type 2 and Sjogren's and trigeminal neuralgia Around 10 minutes after receiving the vaccine developed tinnitus, severe vertigo and left sided facial pain in typical character and pattern of her trigeminal neuralgia and then at 14:24 some lower lip swelling typical of what she develops with her orofacial granulomatosis patient took 1200 mg of her own IR gabapentin. Symptoms progressively worsened.

History of orofacial granulomatosis, neurofibromatosis type 2, Sjogren's and trigeminal neuralgia. Around 10 minutes after reaching vaccine developed tinnitus, severe vertigo and left sided facial pain in typical character and pattern of her trigeminal neuralgia and then at 14:24 some lower lip swelling typical of what she develops with her orofacial granulomatosis patient took 1200 mg of her own IR gabapentin. Symptoms progressively worsened

3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of face, nausea and vomit once. Went to ER around 12:30am on 3/30/21. Admitted to the Hospital from 3/30/21-3/31/21.

Patient received vaccine and in the waiting area after waiting for 6 minutes began to complain of lightheadedness. She stated that she has had a migraine for a few days. Patient's BP readings were 196/110, 195/107, 191/114. EMS was contacted and came to assess the patient. Her BP was 190/120 . She did not go to the hospital but was strongly advised to follow up with her doctor.

I felt OK for the first 3 days and then I started having worse symptoms of my MCAS and POTS condition. Note, I had NOT had POTS symptoms for 7 years. I was originally diagnosed with POTS in 2010 but slowly got better over 3 -4 years time and have not had issues with POTS since until after the 1st dose of the Covid 19 vaccine. Once my mast cell issues seemed to improve after the first week or so then the POTS symptoms kept getting worse. I am now one month out from the first shot and my heart rate and blood pressure are so bad I'm mostly couch ridden. I'm seeing a cardiologist on Monday. Heart rate even when sleeping at night is shooting up to 125-136 without exertion, just sleeping or standing. I have almost passed out while driving 5 times. Until I improve I won't be driving on major freeways. My vision has also been severely effected. Very blurry and one time all I could see were prisms blinding my view of almost everything. Also very weak all of the time and a lot of pressure in my head, it feels like someone is pushing my head forward. Some ringing of the ears as well.

she thought she was getting Bell's Palsy; Lymph nodes swelled; This a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 17:30 (at the age of 60years) as single dose for Covid-19 immunization. There was no medical history; no known allergies. The patient is not pregnant at the time of vaccination. Concomitant medications included colecalciferol (VITA D); ascorbic acid (VITAMIN C); fish oil; ubidecarenone (COQ10); magnesium; and zinc; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph nodes swelled on the same side where she received the shot. Also, the left side of her checks down to neck and shoulders felt weird, she can't quite explain the feeling; she thought she was getting Bell's Palsy which is one of the adverse reactions. She was alarmed as she was unaware of the swelling of the lymph nodes. The adverse events occurred on 19Mar2021 (16:30). There was no treatment received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering. Information about lot/batch number has been requested.

Extreme chills, shaking, then slept 3 1/2 hours, woke up sweating and extremely hot. Went between hot and cold for 24 hours. Very weak, couldn't eat.

Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported vitals from ER BP=107/70, Liver tests were off due to dehydrated per ER , had fever ,sweats then chills and Headache followed by fatigue for a few days. Patient did notify her PCP

The day after the vaccination, there was pain on my left side (my vaccine shot was in my right arm). By Saturday 3/27/21 (day 4), a localized rash appeared on my left side (midriff area) which looked like herpes blisters. The area was sensitive to touch and painful. The pain had spread to my left back area. Started 1000 mg Valacyclovir 3 times a day on 3/30/21, after I saw the doctor and she confirmed it was probably shingles. The rash and sensitivity/pain are still present today, 4/2/21, on day 10 after the vaccine.

Flushing /redness of face starting 50 minutes after vaccine Hot feeling of face & mouth & slight tingling in mouth that lasted 3-4 hours Low grade fever 99.4 about 3-4 hours after vaccine All resolved within 5-6 hours

Tachycardia, hypertensive episode within 2 minutes. Diarrhea, flushing, and palpitations about an hour later, and later that afternoon. Diarrhea, dizziness, fatigue, and palpitations the afternoon of 4/2/2021.

Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a spontaneous report from a contactable Pharmacist. A 60-years-old female patient received BNT162B2 ( BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) first dose via an unspecified route of administration, administered in left arm on 18Feb2021 9:15 as single dose for COVID-19 immunization. Vaccination administered facility Workplace clinic. The patient medical history included Osteoporosis; irritable bowl syndrome. The patient concomitant medications included : Citracal; Centrum; Vit D (ergocalciferol); Colace; Evening Primrose (oenothera biennis), ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium borate, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, panax ginseng root, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium metavanadate, sodium molybdate, sodium selenate, stannous chloride, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM ENERGY). On 18Feb2021 10:00 patient experienced with sore left arm at injection site (vaccination site pain), tingling feeling on forehead, slight headache, and sore neck on left side. The outcome of the event was recovering. Follow-up information was received on (25-MAR-2021): No new medically significant information was received on this case.

Sore arm within 8 hours. Headache within 24 hours which became increasing severe. At 32 hours after the vaccine, severe headache, chills, nausea and vomiting. The headache lasted up to 47 hours after the vaccine and then started to become better. By noon 48 hours after the vaccine, I felt better but still a little shaky.

12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.

Sharp stabbing stomach pain without nausea or diarrhea. Burning, achy joint pain followed by chills, fever ,headache and general weakness. Lack of appetite due to stomach pain. Continued for 48 hours. Slow improvement on 4/4. Still having moderate, intermittent stomach pain and now diarrhea. Poor appetite, feel flushed, without fever. Still headache,weakness and fatigue

Even though taking Tylenol - had fever the next day that became increasingly higher. Highest Fever 101.5 first day after with bad chills all day, achy joints, dull headache and no energy. Low grade fever 100.5 second day after with Dull headache and low energy.

Scratchy throat, cough within 10 minutes of vaccine administration; some nausea, abdominal cramps and headache. Also felt burning during vaccine administration. Given oral benadryl with improvement. Observed one hour total after vaccine. Called 2 hours post vaccine with almost complete resolution of all symptoms. instructed to not get second dose and follow up with PCP/allergist.

Nausea - Not Diaphoretic Reports being "lightheaded" No Emesis No Syncope No rash Reports being cold Reports tightness in throat - EMS activated

Started feeling unusual burning in right arm ( opposite from vaccine side), from wrist to elbow then elbow to shoulder. Attributed it to tennis elbow from strenuous hitting, then got raised welts like hives following evening on right shoulder. Rash appeared and I started to suspect shingles. ( have never had before) saw doctor on 3/30/2021 and got shingles diagnosis. I believe it is due to the vaccine and have spoken to multiple medical professionals that believe there is a connection. I have had racing heartbeat, numbness on right side of face, severe pain in right ear.

Massive headache at front of head, dizziness, ringing in ear, nausea, restless, diarrhea, stomachache, shallow breathing, hearing sensitivity, exhaustion, sleep sweat, lack of appetite.

She got the vaccine, only had the real sore arm. She went to bed and trying to get ready to go to work, had a slight fever, headache, chills, aches, stomach didn't feel right. Felt like she had the virus again. She was in bed all day on Friday, and then that night she still had chills and 101.1 fever. Did not feel well on Saturday and was out of work for 2 days. She is feeling better, tired. The arm is still sore to touch, but not as bad. She just felt sick, and is feeling better today. Her stomach is still not right, but overall feeling better. She did take Tylenol which helped and a couple of other times for the symptoms.

Woke up at 2 AM with severe chest pain, no dyspnea, but she felt like she was going to die. Chills, back pain (from the front of the chest to the back), slight nausea. Sore arm the next day, chest continued to hurt over the next 24 hours, developing lower right groin pain ~ 32 hours after injection onset. Diaphoretic 36-48 hours afterwards, severe abdominal pain when waking up in the morning . 53 hours s/p injection, pt now feeling queasy.

Cold Feet, Nausea, Vomiting, Diarrhea/abdominal cramps. The diarrhea and abdominal cramps/stomachache are still happening as I write this report today April 5, 2021.

Pt got a pfizer COVID vaccine on Saturday 3/27 States that she was out in the sun over an hour to get a vaccine and then waited another 40 mins inside a warm building before she got her vaccine States that she had nothing to drink and barely anything to eat and prior to her appt she had been doing yard work States that about 10 mins after she got her vaccine she blacked out, clinic staff noted seizure like activity which resolved prior to EMS arrival. States that this is not the first time she was outside in the sun without water and she passed out before States that the vaccine site thought that this was a reaction to her getting the vaccine but she thinks it was due to her being in the sun for over an hour waiting to get the vaccine States that she has never had any reaction to any vaccines before States that the vaccine site informed her to call her PCP to inform them of what happened States that once she got a few sips of water she felt normal again. Was refereed to PCP who felt most likely related to orthostasis and clearred patient to receive dose # 2.

12 hours following injection, nausea leading to vomiting and heat flush. Fine immediately following vomiting.

TINGLING IN THE CHEST ABOUT 1/2 HOUR AFTER SHOT, FEELING OF SWOLLEN LIPS STARTING ABOUT 2HRS AFTER SHOT LASTING ABOUT 4 HOURS..THEN TONGUE AND FACE FELT TINGLING ..TONGUE FELT SWOLLEN METAL TASTE IN MOUTH AND A VERY FUZZY FEELING FOR THE DAY OF AND DAY AFTER SHOT WENT TO WALK IN CLINIC AT 620 PM ON 4/3. RECOMMENDED BENEDRYL RATHER THAN STEROID METAL TASTE AND FEELING OF SWOLLEN TONGUE SUBSIDING....FACE TINGLE REMAINS ON 4/6/21

My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested.

The evening after I got my last pfizer covid 19 shot , I felt a red , hot rash, on my right buttock. It was not raised. I did not seem like hives. I took Benadryl . I slept the night. It was a little less red the next day. Then, around 2pm the next evening (4/7) I had another red patch on my other buttock.

Patient reports of feeling flush. She reports she feels she has a rash on her hands. Reports of shortness of breath, Blood pressure elevated and elevated Heart rate. Duration: 30+ minutes.

After about 30 minutes experienced a warm flushing feeling and shortness of breath. Lasted about 8-10 minutes and then started to subside. Pulse oximetry 99%, HR 72, BP 144/84, RR 20. States she has had anxiety reactions to vaccines in the past. Monitored for an extra 30 minutes. Refused Benedryl or Epinephrine. Refused a visit to emergency room. Advised when leaving if symptoms increase to search out medical care. States she feels back to her normal self upon leaving.

Hives including 1 that was blister like; Redness on arm; itching; arm soreness; This is a spontaneous report received from a contactable consumer. A 60-year-old (age at vaccination) female consumer reporter for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; ER8727) via an unspecified route of administration on 23Mar2021 at 11:45 am at single dose on left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital facility. Patient's medical history included COPD mild (Chronic obstructive pulmonary disease) and allergies to medications, food, or other products (unspecified). Concomitant medications included (received within two weeks of vaccination) inhaler and vitamins (drug name unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Hives including 1 that was blister like, redness or arm, itching and arm soreness on 23Mar2021 at 01: 15 pm. Self- warm compression initially then iced was the treatment given. It was unknown if the patient was diagnosed with covid-19 prior to vaccination. Patient was not tested for covid-19 since the vaccination. The outcome of events was unknown. information on lot expiry has been requested.

On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then there was a rash all around my thigh. The pain is still present and the rash has gotten worse. I went to my doctor on 4/6/21 and he says the event is caused by the vaccine. He said the symptoms resemble shingles but also varies from shingles.

pt says that her right arm became very sore. The muscles in her right knee became sore. Her knee seemed to have locked up. By the next day it became very painful and still. The pain is going up towards the thigh and then going down the calf muscle. Pt has taken Advil and used ice compressions for the pain. She says the pain and swelling seem to be less present today but is still there and will see an orthopedic doctor if she doesn't improve.

I didn't even feel the shot, but there was soreness up my arm, across my shoulder and up the left side of my neck in the occipital region. There was no redness, rash nor was it hot to the touch. It was still painful for about 3 days and I took Ibuprofen as directed by my doctor (via telehealth), but stopped taking it. Today, even turning my head is really painful and I still have a headache. It isn't throbbing or debilitating, but it's there. I am getting my 2nd dose on 4/14/21.

3/10/21?first shot. Felt fine. 3/19/21?started to get rash on upper left arm?shot arm. 3-20-21?rash spread to upper right arm and a few spots on my knees 3/23/21?blood draw. Platelets almost doubled since my last count three weeks prior. Increase anagrelide to two pills twice a day. 3/31/21?second dose. Shot again the left arm Felt fine that day. 4/1/21?felt tired. 4/2/21?really feel tired and skin feel tingly like a rash coming on. Had chills. By evening upper arms were red, sore, swollen, rash covered and warm to the touch. 4/3/21---Slept a lot of the day and still in a fair amount of pain. Upper arms and hands red, sore and swollen. Took an over the counter antihistamine Zyrtec, which helped with the swelling. 4/4/21?Continued with Zyrtec 4/5/21?Continued with the Zyrtec. Skin in my arms seems to be ?drying out? a bit and swelling down. 4/6/21?Arms and hand still red but swelling down.

shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital and discharged on 4/2

Severe headache unresponsive to OTC analgesics, body aches, chills, coughing, burning sensation in central chest, severe fatigue, nausea continuing for 5 days starting the second day after the initial dose.

March 28: Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (continued through entire series of symptoms) March 31 - April 2: Fever, Chills, Excrutiating muscle and joint pain, nausea, severe headache. Unable to function, think clearly, or eat/drink. No vomiting April 2 - April 5: Severe upper stomach pain and burning/soreness under right side rib cage. Uncontrollable watery diahhrea. Unable to eat the first two days of this. Able to drink some. April 5 to current: Still fighting the diahhrea but pain stopped. Have been on the BRAT diet since April 4th. Began taking a prescription from doctor to help with diahhrea on April 8. Still experiencing dizzyness, lack of clarity.

I started with a headache the next day on my right eye. That lasted for two days and then developed into a swollen eye. By the forth day I started getting a rash on my forehead and scabs which was finally diagnosed on the 5th day as shingles. The Shingles lasted about a week, but the side effects of the shingles now is terrible. It has developed in to neuralgia. Right side of face is still numb and my eyes are very sensitive to light.

Pt c/o tingly feeling to hand s/p 2nd vaccine . states had similar reaction after 1st vaccine. Pt also informed paramedics that she had a "metallic taste" in her mouth also.

Got extremely cold day after. On Saturday 4/3 I woke up and mouth was numb. As morning went on I went to Urgent care and they diagnosed me as having Bell's Palsy. Followed up with my personal doctor and she said it was from the Covid shot

Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along her heart, collar bone area, and ribs; Hot flash on the left side of her head preceded the headache; Headache; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 12Mar2021 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included sickle cell anaemia diagnosed when she was a baby from an unknown date unknown if ongoing. The patients concomitant medication included unknown injectable medication the patient stated she was given injectable medication for 2 tests, 1 on 23Feb2021 and 1 on 26Feb2021. She said she didn't know the name of the medications given to her and the tests were ordered by her cardiologist. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient experienced sickle cell crisis on 18Mar2021 headache on Mar2021, she said she was unable to touch her collar bone because of the pain on an unspecified date, pain along her heart, collar bone area, and ribs on an unspecified date, hot flash on the left side of her head preceded the headache on an unspecified date. The patient was hospitalized for sickle cell crisis from 19Mar2021 to 20Mar2021. The patient was still had sickle cell crisis pain along her heart, collar bone area, and ribs. She said she was unable to touch her collar bone because of the pain. She said she also had a headache. She clarified the headache started a couple days after she had the COVID-19 Vaccine. She said a hot flash on the left side of her head preceded the headache. She said she still had a headache, and some days her headache was better. She said yesterday (24Mar2021) her headache was so strong. She said the headache was on the left and back side of her head, but particularly strong on the back side of her head. The patient went to the Emergency Room after midnight on 19Mar2021. She said she spent the night at the hospital as an inpatient, and then was discharged by Saturday (20Mar2021) afternoon, around 14:30-15:00. She said she was given Morphine for pain, and was on an IV, and took her regular medicines. She said she did not know the name of the IV fluids that were given to her. The patient underwent lab tests and procedures which included cardiac stress test and electroencephalogram result was unknown. The outcome of event hot flash on the left side of her head preceded the headache was unknown and outcome of all other events was not recovered, Information on the lot/batch number already available. Further information has been requested.

tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both knees; numbness in both thighs; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 21Mar2021 14:30 (Batch/Lot number was not reported) at the age of 60 years old, as single dose for covid-19 immunization. Medical history included sleep apnea, history of breast cancer left side lumpectomy, chemotherapy, radiation, asthma, osteoarthritis, vestibular disorder, allergies to unspecified medications and food, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL); hydrochlorothiazide; hydroxyzine; and meloxicam (MELOX); 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. On 21Mar2021 03:00, the patient experienced tightness in chest, headache, dizziness, shortness of breath, nausea, itching, severe pain in both knees, and numbness in both thighs. The events resulted in: doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events were treated with Benadryl, solution medrol pf, sodium chloride. The patient has not recovered from the events. The patient has not been tested for COVID post vaccination. The events were reported as non-serious. Information on the lot/batch number has been requested.

vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.

Pfizer-BioNTech COVID-19 Vaccine EUA I had normal pain at the injection site after the shot, which went away after a couple of days. A few days later a different part of that upper arm and shoulder became painful to move certain ways. I saw my primary care physician and he said the shot must have nicked the bursa under the muscle. He diagnosed bursitis and prescribed diclofenac gel.

Thursday April 8, 8:15pm arm starts to ache; 8:30pm feel a little nauseous; 11:30pm feel dizzy (like the bed is moving under me) while I'm laying down. Friday April 9: 5:20am headache, body aches, nausea and fatigue; stayed in bed. 4:15pm went out to feed the cats and felt dizzy and kept loosing my balance; 5:30pm feel bad again: dizzy, headache and exhausted; That night my head ached and I felt mildly unwell. Saturday April 10: I feel better all around but I'm still getting dizzy and loosing my balance; also I still have a slight head ache. By 11:00 am, I'm feeling much better - just about normal.

pt c/o tingling hands and arms, chest pain 6/10 described as tightness and pressure; pt self medicated with Nitrogycerin SL 1 tab 0.6mg; advised by on site physician to go to the hospital, pt did not want to and sign AMA

1) I hour after 2nd dose was dizzy 2) 2 hours after had vertigo, hands felt like vibrating for 2-3 minutes, nauseous, vomiting, diarrhea, elevated tinnitus 3) taken to ER at Hospital and sat there with no treatment for several hours. Symptoms were resolving on own. Given an IV and Benadryl. 4) started again (similar to after 1st dose) on Meclizine 5) after light exercises this morning got dizzy, vertigo and nauseous- lasted for over 4 hours!!

Mild to moderate hallucinations for about 10 hours, starting about 6 hours after vaccine. insomnia & restlessness - at its worst during first 24 hours, then tapering off in severity but continuing for 48 hours. Both were tolerable but uncomfortable. These were very unusual symptoms that were not listed as expected symptoms so I thought they should be reported.

Dizziness, achy all over, fever, sick to stomach, hot and cold, extremely weak and fatigued, still upset stomach and weakness today but getting better

Feeling feverish and achey, hot but not registering any high temperature. Headache. Nauseous and itching at injection site. This all started at 12 hours after the shot, almost to the minute. I have been taking Ibuprofen for the aches and headache, drinking water and eating small meals, trying to rest.

Almost immediately felt flushy and a bit hyper and then started to develop numbness (not pins and needles) of the front of my face. Somewhat milder than for the first dose, both of my upper arms started to feel discomfort within a few minutes. The numbness dissipated within an hour and a half, by which time I started to feel achy and have some of the common side effects. Next day was very achy and did not have much stamina. Was feeling much better in the morning of 04/11/2021. In the evening of 04/11/2021 started to feel some numbness in my nose again.

itching to face and facial flushing. hypertensive 151/108,78, 16,99% RA. After some time the patient Blood pressure improved 146/92. refused transport

Numbness (not pins and needles) developed in left middle finger immediately, then developed on left side of nose, left upper gums, left ear within 30-45 minutes. Tightness in head , sight headache and sticky eyes which dissipated quickly. The numbness subsided in about 2 -3 hrs. Slightly elevated temp in the evening which abated by bedtime. All better next day.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Thirty minutes after shot, patient passed out and urinated on herself. Plus, had what she discribed as a seizure.

My arm was sore immediately. As the hours progressed after the shot, my left upper arm became very swollen, hard, and painful enough to wake me in the middle of the night. The hard lump was as big & wide as my right hand and began 2 inches above my elbow up to the place of injection. When my morning alarm went off, I was very fuzzy and extremely weak. I was unable to go to work or remember a lock combination I use every day. My energy began to return the next day enough to work a half day but returned to bed for the afternoon. The tiredness was all but gone by 8:30 pm. Reaction began Sunday morning and was gone by Tuesday night.

Within 12 hours of receiving the vaccine, I became very nauseous and remained so through the next day (4/7). I could not eat anything and by 3pm on 4/7 I threw up. I could not keep food down through 4/9 - my stomach was acidy and I was throwing up bile. I did not have a fever. On 4/9 I went to the Urgent Care and was advised to take an anti nausea medicine and get some Pepcid and try electrolyte drinks until I could keep down solid food. I slept and only had liquids on 4/10 and 4/11. Today - 4/12, I am able to keep down crackers. I have never had a reaction like this (except when I had stomach flu - and then I had a fever). Even today I am very weak. I believe it is related to the COVID vaccine.

18 hours after receiving shot, experienced extreme sweating, chills, diarrhea, dizziness, passed out in my husbands arms. Husband shook me awake, applied cold compresses, and took two Ibuprofen tablets. Chills and sweating continued for several hours. The following day I was very weak and had a head ache. Next day was better.

9 minutes after vaccination patient developed chest discomfort with burning sensation and anxiety. BP 151/86 HR 75 RR14 Sat 98% 0.9 % NSS to keep vein open Benadryl 50 mg IV one dose stat

Feeling EXTREME dizziness and nausea that does not let up or subside. Unable to stand. feeling dizzy. Sudden whole body heating up. Face turns red. Symptoms do not get better.

Arm pain immediately afterwards. Beginning at 18 hours after vaccination: excruciating headache, nausea, diarrhea, elevated temperature/flushing, chills, fatigue, swelling and redness at injection site. Unable to eat or drink anything for 12 hours. Symptoms started to ameliorate after taking 1,000mg of acetaminophen around 28 hours after injection. 48 hours after vaccination, most symptoms had passed except for some residual headache and fatigue. Short fainting spell at 49 hours but did not pass out.

Extreme pain from top of left shoulder to the elbow. Unable to stretch, scratch my neck, wash my back or put on my seatbelt. The are aches so much that I can not sleep at night. I am unable to lay on my left arm. I have a large hard lump on my left arm at the injection site. Weakness in left hand. Unable to raise my arm to remove my shirt. The pain seems to be getting worse. Left inner leg bruises and pain.

Very bad sometimes extreme pain in my left breast area that radiates into my chest area. Hurts to touch my left breast area and the pain is a shooting pain that is constant and feels like a stabbing pain. Hurts to move my left arm. I've been taking 3 Advil at a time and the pain subsides for a couple of hours but comes back. It doesn't matter if I'm sitting up or lying down the pain is always there. I sometimes feel like I've had the wind knocked out of me when the pain radiates to the front of my chest area. There is no longer any pain at the injection site.

Pt calling to report a vaccine reaction to the 1st dose of covid vaccine. Pt describes about an hr after the shot she experienced dizziness, flushed face, tightness in throat, feeling of obstruction in her throat.

Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient said she experienced left side numbness, slurred speech, severe neck pain, and a headache. She said she had stroke like symptoms but after being hospitalized for 3 days and having a CT scan performed stroke was ruled out.

very bad migraine, nausea, chills, overall very sick feeling, could not get out of bed Took migraine meds & some Tylenol, did not help to counter symptoms and migraine The entire day, starting at 4am, I was unable to get out of bed For the past 1 1/2 weeks I feel very run down and my brain is foggy Will not take a booster vaccine ever! These entire after effects are not worth the taking the vaccine.

pt states after receiving vaccine about one minute after pt states she felt arm tingling and pins and needles feeling in left arm and metallic taste in mouth, and very anxious pt shaking and was unable to sit still in stretcher, refused wheelchair to observation area and ambulated self without difficutly. pt also very guarded and did not want to talk about health history or meds upon assessment. pt state feeling hot and cold chills as well. pt anxious about previous anaphylaxis had in past with darvocet. denies feeling symtpoms of anaphylaxis, site of injection healthy no observed hives or redness in area. vs as noted, pt feeling better and wanting to be sent home pt ambulated to exit with husband at 1438 vs: 1410 bp123/81 hr 84 rr 18 o2 97 1415 bp 140/96 rr 18 hr 78 o2 98 1420 bp 137/80 hr 80 rr 18 o298 1425 131/89 hr 80 rr 18 o2 99

Immediate trigeminal nerves triggered, mouth tingled, slightly dizzy, blurred vision. 1/2 hr later felt like skin burning on face and arms looking like a sunburn, small fiber neuropathy kicked up throughout body. Next morning slight headache and slight dizziness, slight sweating. Subnormal temp all day. Burning feeling, sunburned skin continues as it comes and occasionally lessens.

Swelling of the Left Side of the Brain Encephalitis, Herpes Simplex Virus Encephalopathy Spinal Tap Removed Cerebrospinal Fluid (CSF tests for infections) Aciclovir Drip for about 10-21 days

In 15 min I felt my tongue was numb I left and my face on the right side was drupping My eye was cold because the bottom lid was dripping so I held it closed 3 hour later it went back to normal.

Patient vaccinated and complained initially of tingling sensation in fingertips at 1025. Patient went to bathroom 10 minutes later. At 1045 patient began complaining of coughing, throat was "tight", face was visibly flushed. RN called Pharmacist requesting Benadryl. Patient declined the liquid Benadryl offered by the pharmacist. Patient had her own Benadryl 25 mg tablets in her car. She agreed to take one 25 mg Benadryl po at 1050. Patient normally takes 50 mg po every day and wanted to take another dose so she did at 1053. Pulse was 60 and regular. Patient did have relief of symptoms, decreased flushing, decreased throat tightness, and more calm after 30 minutes. Patient agreed to wait awhile longer. She was encouraged to follow up with her primary care doctor to discuss reactions and to determine how to proceed regarding getting a second dose of Pfizer vaccine. At 1215 patient felt fine to drive home. She was accompanied by her son. RN to call patient later to see how she is feeling.

In addition to common symptoms listed on the CDC website ( soreness in arm, muscle and body aches, fatigue) I experienced tingling and numbness in hands and feet, and tingling in the face. It got progressively worse over the next few days, and started getting better each day after Sunday 4/11/20. I went to my doctor?s office yesterday, and since he was not available, I saw the nurse practitioner. She checked me out and did a needle test as well. She said that although this is not listed on the common side effects, that it appears to be a side effect. She said since I am getting better each day, it will likely resolve itself in a week or two. She feels that my nerves are inflamed. I was not prescribed anything, and since I do take a dose of gabapentin each day, this should help.

throat numb; coughing, clearing throat; HX seasonal allergies- take zyrtec and allegra; no HX: anaphylaxis

Lightheaded, dizziness, feeling warm developing after patient discharged from clinic prior to leaving facility, approximately 0825-0830. Returned to COVID vaccine clinic for assessment. Provided water, snack. Vs 0840: 163/86, HR 56, RR 18, 02 100%. States had not eaten this am, history of hypoglycemia. 0850: 160/75, HR 48-52, RR 18, 02 100%. States not feeling as warm but with increased dizziness. PT advised ER for further eval. Transferred to ER with staff.

Numbness in arms and tongue. She self medicated with 25mg of benedryl. Appeared well, no acute distress, no difficulty breathing. Declined ER transport. Had support person to drive her home. Instructed to report to ER if throat swelling or difficulty breathing occurred.

She stated that after vaccination, she was feeling numbness in arms and tongue. No difficulty breathing, appeared well, in no acute distress. No throat swelling. Heart rate 70, SpO2 99%. She medicated herself with 25mg of Benedryl PO. Instructed to go to ER if difficulty breathing or throat swelling occurred. She was accompanied by support person to drive her home.

Extreme arm pain began 4/7, Shingle rash outbreak on 4/9, diagnosed with Shinges on 4/11. Prescribed Valtrex for 7 days

Pt was given second dose of vaccine on 0412/2021. She developed severe pain of forearm and wrist. She had applied ice to site and today noticed a bruise on her inner wrist (4 x 2 inch). Denies taking any blood thinner and denied trauma. No warmth or pain at this time. She took 800 mg Ibuprofen night before vaccine for back injury. She applied ice to site. PCC: Advised to FU with pcp, urgent care or ED for cbc and coags. Although Pfizer vaccine has not been known to cause clotting issues and sx could be unrelated it is best to r/o. Caller will be going to home on Friday and said she might wait to fu with pcp there.

Bruising; Soreness and pain in left arm at site; Soreness and pain in left arm at site, under arm pit; Soreness and pain in left arm at site, under arm pit and around breast; This is a spontaneous report from a contactable other HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot Number: EL9261) as single dose for covid-19 immunisation (age at vaccination was 60 years). No other vaccine in four weeks and other medications in two weeks were reported. No Known allergies and no other medical history were reporter. Historical vaccine included dose 1 via an unspecified route of administration, administered in Arm Left on 05Jan2021 at 07:45 AM, (Batch/Lot Number: EK4176) as single dose for covid-19 immunisation (age at vaccination was 60 years). Following mammogram 26 days after (as reported) second dose the patient experienced bruising and soreness and pain in left arm at site, under arm pit and around breast on 19Feb2021 at 16:00. The patient recovered with lasting effects. No treatment was received for the events. No covid reported prior vaccination. Covid wasn't tested post vaccination. The patient underwent lab tests and procedures which included mammogram: unknown result. Outcome of events was recovered with sequelae on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; difficulties to sleep and walk; difficulties to sleep and walk; Superficial Thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 61 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9263, expiry date not reported), at the age of 60 years old, via an unspecified route of administration, administered in left arm on 02Feb2021 09:00 at a single dose for covid-19 immunisation. The patient then received the second dose of covid-19 immunisation on 23Feb2021 08:00 AM (lot EN6200), via an unspecified route of administration, administered in the left arm. Medical history included rheumatoid arthritis and multiple sclerosis, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and the events. The patient no covid prior to vaccination. The patient's concomitant medications were not reported. The patient was not tested for covid post vaccination. Soon after COVID-19 vaccination, on 21Feb2021, patient experienced extreme pain on inner thigh on left leg. It was hot to the touch, very red and swollen causing difficulties to sleep and walk. Patient then saw a vascular doctor for the pain on 16Mar2021 and was advised that patient have superficial thrombophlebitis (since 21Feb2021) and was prescribed to take Xarelto 15 mg for two weeks. Therapeutic measures were taken as a result of the events reported which included Xarelto 15 mg and had a venous ultrasound of area on an unknown date (unknown results). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events reported was recovering.

Pt felt her heart racing and a flushed feeling over her body. After a few minutes, symptoms resolved without any intervention.

itchy lips, then itchy scalp and feet. started 45min after shot. lips may have been swollen or may have seemed that way because of itchiness. I could not see them. lips issues ended within an hour from starting and the rest of itchiness ended after 2-3 hours. headache next day and lifting arm soreness next day.

Nausea Chill - Bone Chilling/Chattering Teeth/Cold more at extremities/cold to the touch Headache Achy All over Achy joints Exhausted/Extremely Tired Diarrhea

Bells Palsy right side of face; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient (patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number En6208), via an unknown route on 15Mar2021 at 12:00 pm (at the age of 60-years-old) at single dose on the left arm for COVID-19 immunization. Medical history was none. The patient did not have allergies to medications, food, or other products. Relevant concomitant medications patient received within 2 weeks of vaccination included pantoprazole 40mg. On 15Mar2021 at 12:00, the patient had Bells Palsy right side of face. 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. No treatment received for the event. Outcome of the event Bells Palsy right side of face was recovered in 2021. Follow up attempts are needed. Information on the lot/batch number has been requested.

This was my first shot. sore arm that hurts to move. 7am on 4/16 work up made cup of coffee, too exhausted to drink. Went back to sleep. Slept until 5pm. Eat soup, exhausted, fell back to sleep until 10pm. Talked on phone a bit, exhausted. Had chills, very hot feeling in head, ears, mouth when I was awake. Got body aches 10pm. I literally could not keep myself awake all day. Went back to sleep until 6am Saturday. arm still sore but a little better. Stayed awake all day. Still have hot feeling in head, ears, mouth. Dizziness. Fatigue, but better than Friday. Sunday, still the same as Saturday. I read people who get first shot side effects may have gotten covid and not known it. Oddly, On 1/3/21 I went to ER. Had pain in abdomen for days, winded walking in kitchen and out of breath when using stairs. Had high white blood on blood test. Was not tested for covid. If I had covid, that was probably it. It took a while to get better and I had the same hot feeling in head, ears, mouth like I do now. I hope I don't get worse reaction with 2nd shot

13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613), via an unspecified route of administration, administered in arm left on 28Mar2021 at 12:00 as single dose for COVID-19 immunization. Medical history included breast cancer from 2013 and blood cholesterol increased. The patient had allergy to sulfa. The patient previously received first dose of bnt162b2 (lot number: EN6202), in left arm on 07Mar2021 at 15:30 as single doses for COVID-19 immunization. Concomitant medication(s) (received within 2 weeks of vaccination) included atorvastatin, colecalciferol (VITAMIN D [COLECALCIFEROL]), ascorbic acid, betaine hydrochloride, boric acid, calcium carbonate, calcium citrate, calcium lactate, calcium pantothenate, calcium phosphate, citric acid, colecalciferol, copper gluconate, cyanocobalamin, folic acid, fumaric acid, magnesium aspartate, magnesium oxide, malic acid, manganese aspartate, menaquinone-7, nicotinamide, oxogluric acid, phytomenadione, pyridoxine hydrochloride, riboflavin, silicon dioxide, sodium molybdate, sodium selenite, strontium chloride, succinic acid, thiamine, zinc picolinate (OSTEOPRIME ULTRA). 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 29Mar2021 at 03:00, the patient experienced 13 hours after receiving second dose, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage. The patient did not receive treatment for the events. The outcome of events was recovering. No follow-up attempts are possible. No further information expected.

Abdominal cramp/diarrhea on day of injection and 2 days later 4/17/21, 4/18/21, 4/19/21 Headache and feeling of weakness and foggy head day after injection 41/18/21 subsided by third morning 4/19/21.

appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.

Shingles-left shoulder blade and left breast (vaccine in left arm); began two days after vaccine with tingling on shoulder blade, then red rash, then painful blisters; stinging/stabbing pain; inability to sleep due to discomfort Lymphadenopathy-swelling in my left breast and chest; much discomfort

Patient had her first covid vaccine injection at 0722 this am. She was escorted to the observation room where she told her nurse that she was experiencing tingling and numbness on the right side of her face from the nose down to the middle of her lip including half her tongue at 0730. Patient verbalized she had a TIA 10 years ago and this is how she felt when she had that event. She states she has a history of hypertension and a recently diagnosed aneurysm in her spleen. vital signs were obtained blood pressure 168/121, Heart rate 68, O2 sat on room air 99 % She denied any pain. Asked patient to stick her tongue out and it was midline before vitals slightly deviated after vitals were finished. Patient then states she feels like her face is swelling on the right side. ER was called. Patient taken to ER by wheelchair for follow up evaluation. Event documented on patient consent and event reported. Patient later admitted to hospital.

Following my first Covid 19 Pfizer vaccine 03/11/21: **Note, I went through 1 1/2 days dull ache in arm no concerns > days 2--5 went through a HYPER-WELL (no age aches, prior-hurt finger didn't ache, energy, ladies room habits back to what I reported to daughter "age 20!" for these four days, amazing, enjoyable, then > day 6 very early am woke up with swollen neck lymph nodes half-palm sized rocks on neck, breathing difficulties (lungs not neck), bad dull intrusive headache (different pain from Migraine, or low-hydration pain), cough dry and have called this my HYPER-CRASH because I could barely walk, backward C-shape abdomen hurt (dull ache big always + frequent stabbing pains from below bra bottom line to left abdomen down side then curving to my right across bottom abdomen at both leg-attaches-to-abdomen locations. Difficulty breathing, pain, extreme swelling over upper abdomen when I even drank water to swallow morning Hydrochlorothiazide pill and would stay swollen for 4-8 hours with continued surprise to me gulps of air throughout period, weak, nausea but not vomiting, dizzy, unable to walk more than a few steps at a time, fever taken and wavered from 95 to 99 degrees (my usual body registered 97.8 degrees) but never over 99 degrees, and only over 97.8 degrees perhaps three times very little above it and only for a few hours. >>I went to Urgent Care in person no better at all on 3/24/21/roughly day 12 after vaccine shot 3/11/21 (Urgent Care) which took blood and urine tests determining roaring infection and blood in tests and a CT CONTRAST scan should be ordered by my PCP asap at appt PCP already scheduled 3/26/21 but she couldn't order CONTRAST version the PCP would need to and she prescribed three antibiotics to take over next 2 weeks >> I went to PCP 3/26/21/day 14 after vaccine shot and he ordered CT Scan but insurance required pre-auth and they refused it at first so PCP referred me to GI SPECIALIST who again referred me for CT CONTRAST test, which I did have on Friday afternoon 4/16/21 (Clinic), and I await the results today 4/19/21. Today I continue to have pain abdomen, though softer and throbbing, same C-shaped region, HUGE issue even drinking water with Hydrochlorothiazide pill only for many hours as abdomen swells at bottom bra-line center in a palm size mound for hours, and back hurts badly, solid headache which may be only right side of head more than left but I am taking nothing for any symptoms afraid of GI issue. NOTING AGAIN: Yes I was diagnosed roughly 2015 with a single incidence of diverticulitis/osis by GI SPECIALIST in Town and went through series of Colonoscopies and tests, but tests only determined incidental few polyps removed over all tests and no incidents at all since that. Knowing what I know of my body and health, the trigger seemed to be the first shot of Covid 19 Pfizer vaccination which remarkably seemed to react first with a few days of better health than I have had for decades (eating, moving, energy etc. for my age), where after days of extreme great health and energy (where I went nowhere, and still did not push myself much) my body then crashed to unable to move much or even breath normally for many days after and with a multi-level infection in my gut that needed three antibiotics and after those I still hurt in the same locations. I cannot confidently rule out the Vaccine as the cause, and what I know of my body suggests in fact some "overdrive" function in my system was triggered and then caused the crash that resulted in infection and that continues to interfere with my walking, eating, moving, breathing, and even drinking a small glass of water today. Final note: PCP confirmed I should take the second Vaccine Pfizer shot, which I did on 4/1/21 - same site, Lot #EW0150, after which second vaccine shot I had the same two days of dull arm pain, and I continued to finish the antibiotics until finished (but pain though softer continues to today). I did not experience a #-Days HYPER-WELL episode then HYPER-CRASH after this second vaccine shot, only the arm ache, but throughout was still very unwell (breathing, pain, no activity, weak, unable to eat, swelling, headache, cough intermittent, back hurts, etc.) throughout, and same to this day 4/19/21 as I await CT CONTRAST results. I felt compelled to share I feel this was triggered by the first Vaccine shot, and would not have happened had I not had the Vaccine shot. Thank you.

Pain in left shoulder/ arm started approximately two hours after vaccine. Pain Consistently getting worse into Wednesday evening to where I was having trouble moving my arm up down behind me a crossed my midsection and out away from my side, pain getting worse intoThursday morning. Called off work Thursday/Friday. Other symptoms subsided after 48 hrs but not the pain in Site area and shoulder. Saturday not improving went to clinic in afternoon.

Three hours after receiving the 2nd dose, right arm begin to ache. Felt ache down the arm into the hand and fingers. Body aches and chills through out the night ache across the shoulders, neck and up toward the base of the neck and lower back. Next day symptoms were slightly worse I developed a slight headache became very listless had to go to bed. Friday night, the injection site arm developed a red rash that was warm to the touch.

Felt burning sensation in left pinky finger while driving on hwy. then numbness in both hands and legs . Then going to a shock not feeling my body and weakness in jaw and loss of motor skills, like paralysis, not able to walk or speak. Loss of speech for about 90 minutes.

Small lesion appeared under right shoulder blade on back, thought it was a bite and put triple antibiotic cream on it, radiating pain through right breast - took 200mg Advil every 6 hours for 3-4 days. Made dr appt after a photo taken looked to me like shingles. Dr diagnosed herpes/varcella zoster. No further treatment.

Received the shot about 1:30. Everything was fine. By evening, the arm was sore and left armpit hurt. Went to bed about 10. Woke up about 1:30/2:00 with left arm hurt a lot. Took Advil and went back to bed. Woke up at 4 am to get ready for work and felt awful. Noticed was out of breath on short horizontal walk from bedroom to bathroom, chest tight, acting like an asthma attack. Took a puff of albuterol inhaler and went back to sleep. Got up just before 7, still sore to breath. Grabbed oximeter (being asthmatic, I have one) and noticed )s level down to 94/95 when normally it reads 98/99 on this one. Called allergist to cancel allergy shot scheduled for that morning. Took another puff of albuterol. (Waiting to see if need nebulizer.) Breathing becoming easier and reading now about 97/98 with pulse lower, more normal. Lungs a bit touchy this time of year anyway. And I have had allergic reactions in the past take place as an asthma attack. (For instance, if I eat a small quantity of something with yellow dye 5 in it, I will notice that my breathing is more difficult.)

Sat (4/17): severe chills for two hours starting at 11:55 pm Sun (4/18): woke and could not walk across the room without falling down due to dizziness, was nauseated, strong headache, fever of 102 all day, bedridden Mon (4/19): Fever was reduced but nausea, headache still persisted all day, continued chills. Right middle finger began to swell and turn purple Tues (4/20): Lost feeling/sensation in right middle finger, head feels off, nausea still persists, stomach pains. Called doctor and had televisit with nurse practitioner

Onset of severe chills and headache approximately 8 hours after the injection of the second vaccine. Extreme fatigue, nausea and chills lasted 24 hours plus after injection. Still feel weak, nauseated and have headached 48 hours after injection.

DIZZINESS, ATAXIA, WEAKNESS FOR 1 WEEK, THEN DEVELOPED HYPERGLYCEMIA AND DEHYDRATION AND ACUTE DELIRIUM AND HYPERTENSIVE EMERGENCY REQUIRING ICU HOSPITALIZATION

I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.

Right facial/injection site numbness Vital Signs: BP 150/100 HR 76 (84) Resp 20 O2Sat 98 Skin Signs: Clammy, diaphoretic Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Observation, patient remained AOx4. Assessed/evaluation by Doctor. 12:10 PM Vital Signs: BP 138/90 HR 74 Resp 20 O2Sat 93 Skin Signs: Clammy (mild), Diaphoretic Circulation: Cap refill <2sec Follow up Treatment: Patient states numbness in face has lessened in severity Notes: Encouraged patient to continue hydration at home Disposition: Home with friend

Patient received her second Pfizer COVID vaccine yesterday. She reports today she has a sore arm (no redness, warmth or swelling), a headache, feels tired, and has some muscles and joint aches. She is using Tylenol (advised to not exceed 3000mg in 24 hours), gatorade, water, rest, and ice. She questioned how long these symptoms will last and was advised that generally they lessen within the first 24-36 hours. She was advised to call if she did not start to feel better within that time frame.

her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.

The following morning,, back pain/sciatica began after waking. As the day went on, it got worse. Night-time ... difficult to sleep. Next morning (today) very painful ... difficult to stand (at times) and sit. All similar to my back condition in December that I thought was under control. Taking over the counter medications haven't helped yet. Alternating heat / ice / bacx-brace.

On 4/10/21 I had fever and severe chills. On 4/11/21 the fever broke. I was fine but weak. On the night of 4/11/21 (9:00pm) fever returned. I took advil and went to sleep. On 4/12/21 I woke up with my arm very swollen and it was hot to touch. By the afternoon I was worse and the area was turning red so I went to the Urgent care and diagnosed with Cellulitis (which I have never had and didn't understand at first what this was about). I was treated and returned to my regular Doctor for follow up. I still have this thing and although it's better it's not gone as of this report and it is causing me distress in typing, cleaning and so on.

1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of both legs. 2) Sharp breast pain, on the left breast,

15 minutes after vaccine, I felt a sudden burning, warm feeling spread through my arms and head. I checked my Watch and heart rate was 127. I had a similar reaction with the first shot on 3/24/21 and was told by staff that it was probably due to hyperventilation and panic after they took my vitals. I did not seek medical attention the second time as the burning sensation disappeared quickly and I was able to lower my heart rate through breathing exercises. I left the medical location about 15-20 minutes after the episode and drove home without incident. I had moderate arm pain and fatigue the rest of the day. On the morning of 4/22/2021, I woke up feeling well except arm pain. At around 7:45 that morning, I had a sudden shaky episode where my watch registered heartrates from 105 up through 153. My hands tingled and they developed a significant tremor. These symptoms are typical for me during a panic attack. I took 1/2 of a Clonazepam and did some breathing exercise and was able to get my heart rate back to normal (in the 70s) within 10 or 15 minutes.

3-12-21 5 minutes after eyes began to feel warm/hot latsted about a minute 3-13-21 Early afternoon neck and shoulders began to ache followed sharp pains to my right eye and right foot 3-14-21 Morning began to feel a tingling sensation throughout whole body.. Pins and needles. 3-17-21 Went to primary physician. No knowledge of this side effect left with no real information and or treatment. 4-22-21 Symptoms have subsided, but still very present and activates upon anxiousness do to condition of sensations.

I really don't know if this is at all related to the second vaccination but we were encouraged to report any odd experience. About 27 hours after receiving the second shot, what appears to be a menstrual cycle began. I last had my period in 2015. For additional context, I have a history of fibroids and still have a good sized one. In late February I had a spotting issue but what I'm experiencing now is a full on period. I was already in contact with my PCP and an OB/GYN for testing related to the Feb. spotting event and as a result of that will be having an endometrial biopsy and hysteroscopy. Outside of the above, I had a sore arm and bruising at the injection site. Thank you

The day following the vaccination, I had a fever, intense chills, and a mild headache. I have had an upset stomach since the second vaccination, with intermittent stomach pain. Last night (04/22/2021, starting around 7:30 PM), I had intense lower abdominal pain, loose stool, vomiting, and an intense chill. The symptoms came on suddenly (over the period of a half hour). After vomiting, I was seized by sudden, intense, lower-back pain immediately followed by full-body tremors. The tremors started with my legs, then went to my hands and finally my arms. I have never had a problem with tremors or seizures before. The back pain and tremors fully subsided after 10 minutes. I did not visit a doctor, since it is doubtful that they would definitively blame the Covid vaccine, and I would be stuck with a large hospital bill. However, the symptoms were too peculiar to be attributed to a random illness. I do believe they are a side effect from the second vaccine dose. This morning I feel tired and am a pound lighter, but I am quickly recovering.

At time of injection- immediate warm sensation in stomach, neck and face. Slight flush color in face. Itching in face and forehead however NO signs of hives or labored breathing. Intake if fluids. No Benadryl or Epi-pen required. Symptoms diminished and left facility in 10-15 minutes. 2-3 hours later- body aches, mild nausea and mild headache. NO Tylenol 1 am- woke from sleep- Headache . Took 2 Tylenol. Went to sleep. Woke at 6 am- string body aches, nausea, and very sore arm. NO headache. Took Tylenol. Stated in bed with fluids until 2 pm. Little appetite. Slight headache in evening. Achey feeling subsided . Next day - Mild body aches and nausea. Took one Tylenol. No appetite.

Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Severe, Error: Incorrect Reconstitution

Cause I am past menopause for several years now and all week since the injection I?ve been experiencing hot flashes. I have not had hot flashes from menopause in several years. I find this quite unusual. It?s lasted nearly a week so far. It concerns me that the vaccine can impact hormones.

severe headache- took Maxalt, went away vomiting- began 12 hours after injection painful arm, especially when lifting arm up

Injection site pain, extreme tiredness, ?hangover? headache/awful headache, joint pain, 101 degree fever, feeling unwell, no appetite (but not nauseous) X 1-1/2 days Sore arm/difficulty raising arm X several days; tolerable

Arm was sore within an hour after the injection & is still sore today (the 23rd). I woke up on the 22nd with total body aches comparable to the flu & those have lasted even until now (10:00am on the 23rd). I had a fever (100-degrees) beginning late afternoon on the 22nd & it finally broke early in the morning of the 23rd. I also have a slight headache that came on early this morning.

Systemic: Allergic: Itch Generalized-Medium, Additional Details: Administered second dose on right arm. Client reported no reaction after first dose except for sore arm. No history of allergies or adverse reactions from vaccine. Reported generalized itchiness. Gave 50 mg Benadryl. Client's husband drove her here and back home. First dose of vitals: 97.7 degrees F, 82 bpm, 98% O2, 130/94 BP, RR 16 at 1756. Second dose of vitals taken 1815: 72 bpm, 98% O2, 97 degrees F, BP 120/80. Client left approx. 1830 reports decreased generalized itchiness.

Day after shot (Saturday 10 April) - nausea, headache, 101.5 fever, body aches, arm soreness, tiredness 2nd day after shot (Sunday 11 April) - slight headache, tiredness, red rash around injection site and itching. My arm was also swollen and more sensitive to touch than movement. The itching wasn't bad enough that I needed to take any meds. I just wanted to report this adverse reaction to the second shot.

3/19/21: patient is a 60yo female who presented with complains of facial droop. The sister reports the patient complained about headache in the left temporal area around 8-9pm, reports having the same pain throughout the week but today was stronger, and the sister noticed she had facial droop and was unable to open her left eye. The patient also reports abdominal discomfort the the epigastric region and LUQ that started today and was associated with nausea. She denies diarrhea or fever. Of note patient reports having Covid Pfeizer vaccine yesterday and 5 minutes later being were unable to speak with edema in her lips and tongue, associated with SOB. She was taken to a ER, was given epipen, albuterol, benadril, prednisone and was discharged home at night with improvement on her symptoms. Patient discharge note on 3/22/21: Admitted for facial paresthesias in setting of arnold-chiari malformation, HTN, HLD, after covid vaccine, neuro work up neg, discharged home on 3/22/21.

Bell's Palsy; right side of mouth felt numb; freezing cold; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6207), via an unspecified route of administration administered in right arm on 01Apr2021 15:15 (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included high blood pressure. The patient had known allergies with Allegra. Concomitant medications included pravastatin; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); and bupropion. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), administered in the left arm on 14Mar2021 at 04:00 PM for COVID-19 immunisation. On 02Apr2021 at 13:00, the patient got freezing cold. The patient was cold for several hours. On 03Apr2021, the patient woke up and right side of mouth felt numb. The patient went to urgent care and was diagnosed with Bell's Palsy on 03Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy, freezing cold, and right side of mouth felt numb. The patient had not yet recovered from the events.

Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) lump in my throat; turned red on my face and neck and chest and arms; when I get nervous; between my eyes on my forehead felt like a round circle (no bump) (past the bridge above eyebrows). It didn't hurt, but I felt something; felt odd; felt like my eyes were moving back and forth; very very cold; hands were ice cold; This is a spontaneous report received a contactable consumer, the patient. A 60-year-old adult female received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not reported) as a single dose via unspecified route on 14Mar2021 (at 60-years-old), for COVID-19 immunisation. Relevant medical history included high blood pressure, and diabetes. There were no concomitant medications or past drug history reported. The patient reported that she had a couple of reactions the first day, so she was afraid to take the second one. The patient stated that within eight minutes she had a lump in her throat, which she gets when she is nervous and was unsure if from shot or nervousness. The patient reported that then she turned red on her face, neck, chest, and arms. The patient reported that the redness lasted about six or seven hours and did not bother her at all. The patient explained that then between her eyes on her forehead felt like a round circle (no bump) past the bridge above eyebrows. The patient stated that it did not hurt but felt like something. The patient also stated that she felt like she was going to get headache, though did not. The patient reported that it just felt odd. The patient also stated that she felt like her eyes were moving back and forth. Though when she looked in the mirror, they were fine. The patient stated that the eyes happened three times but by the time she looked in the mirror they looked fine. The patient added that she never felt sick or anything though about six or eight hours later she got very very cold which only lasted about a minute. The patient stated that her hands were ice cold and then it all went back to normal. The outcome of the events turned red on my face and neck and chest and arms was recovered on an unspecified date in Mar2021 after 6-7 hours. The outcome of the event she got very very cold was recovered on an unspecified date in Mar2021 after one minute. The outcome of the events hands were ice cold, and felt like my eyes were moving back and forth was recovered on an unspecified date in Mar2021. The outcome of the events, lump in my throat, get nervous, between my eyes on my forehead felt like a round circle (no bump), felt something, and felt odd, was unknown. Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Stroke - Cerebellar hemorrhage. Had to have brain surgery to relieve the pressure and a drain placed. She has a history of low blood pressure, never high. They did an angiogram that came back normal and an MRI as well. They have been unable to find a cause of the stroke at this time. She was in ICU for four days then Neuro PCU for about 4 days and now she is in inpatient rehab. She is currently learning to walk and has weakness on her whole left side. Vision issues. And motor control issues of the left arm. The stroke came on very sudden and she felt fine before her sudden ?worst migraine ever?. Luckily my brother was with her and took her to get help straight away before she became unconscious.

Swelling lower left arm and hand. Intensified to include entire left arm. Deep bruised ache feeling. Heaviness. Could not fit arm through sleeve. Became difficult to use hand due to swelling. Due to swelling now have carpal tunnel in left hand with numbness & painful tingling.

possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.

60 y/o female, with past medical history HTN, anxiety, high cholesterol, and artery stenosis seen today for report of feeling lightheaded, hot flashes, tremors and the feeling of something cold running through her legs going to her stomach about 5 minutes post vaccination. Patient also reports that she took her medications this morning. (amlodipine 5 mg, HCTZ 12.5 mg, Atorvastatin 40 mg, metoprolol ER 100 mg, and escitalopram 10 mg. Patient states that this is her second dose in the series. NP and Paramedics at patient side. Patient is hypertensive despite taking all blood pressure medications. B/P 184/88, HR 78, 99% RA, 19 Resp, bs 108). Bottle of water provided to patient and her legs were elevated on a chair. Repeat BP obtained. Patient BP decreased to 187/82. Patient blood pressure is still elevating 152/76 and still complains of coldness feeling that moves to her abdomen. Patient advise to go the hospital. Patient and her husband agree to go the hospital. Patient transferred to the hospital accompanied by her husband.

Headache started after 2nd dose?started Wednesday evening. Diarrhea on Thursday. Headache continued. Night sweats on Thursday to the point of waking up soaked. Friday headache continued, no energy. Saturday felling slightly better and by Sunday appetite returned. Treated with IBP and Tylenol plus rest.

Within an hour, dizziness. That night, fatigue, pain in arm, bad,bad headache, neck ache. Fever around 100 degrees. Morning after, bad headache, fever over 100 but less than 101. Within 24 hours, headache, shoulder, back, neck ache. Fever with Tylenol 101.6. Sore throat. Possible swollen glands. Waiting to see if better at 48 hrs.

Exactly ONE WEEK after I had the 2nd dose of Pfizer, both my arms began to tingle and hurt by 2 pm on a Monday. Within a few hours, this spread to my entire body; every joint and muscle was in severe pain and discomfort. I went to bed around 5 pm and had the chills, but no fever. I continued with this pain for Monday night and could barely sleep. It continued but not as severe on Tuesday and Wednesday. By Thursday, I forced myself to take a shower. By Thursday, the pain in the upper body was gone, but I still had severe pain in both lower legs from the knees down. It was unbearable if I stood for more than 20 seconds, however, if I lifted each leg and then alternated legs, the pain would go away. This felt like enormous pressure in my legs and at one point, I thought maybe I had blood clots, but my legs were not red or swollen. The lower leg pressure finally went away on its own by Sunday, April 25th, 2021. At no point did I have a fever and I could get some relief by taking Ibuprofen, but not a lot of relief.

her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.

Body aches, skin feels like its burning but no fever, psoriasis flared up on my legs and it had been cleared up, frequent chest pains.

Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccination site.

Tingling in lungs, mouth for 15 minutes Tingling and numbness in jaws for over a month Tinnitus for 2 weeks Migraine/headaches: a week

This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.

She had a slow infection in her chest; She was breathing fine, but she got out of breath every now and then; her immune system was not too good; no sleeping; She was so tired; she woke up on Thursday (08Apr2021) sick; She had a cold all year long, but normally doesn't have a color from her chest and nose (mucus). She said she now had a color to her chest and nose mucus; Has had a bad cold after the vaccine and an infection in her lungs; She had no energy, and couldn't work; This is a spontaneous report from a contactable consumer, the patient. This 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration in the left arm on 07Apr2021 around 12:15 (at the age of 60 years-old) for COVID-19 vaccination. Medical history included smoker since 1976 pack-a-day of cigarettes since 16, quit for 11 months, she went back to smoking, x-rays done in the 1990's and the patient was told that the lower part of her lungs were flat and was told she had chronic obstructive pulmonary disease (COPD) and emphysema at that time. She said her lungs were pretty bad. Family Medical History Relevant to adverse events were not provided. Concomitant medications included ascorbic acid, rosa canna fruit (VITAMIN C PLUS NATURAL ROSE HIPS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had a slow infection in her chest on an unspecified date (also reported as her doctor told her she had a little bit of an infection), a bad cold after the vaccine and an infection in her lungs on Apr2021, she woke up on Thursday 08Apr2021 sick, was so tired on 08Apr2021, had no energy and slept for 5 hours, couldn't work on Apr2021, had a cold all year long, but normally clear drainage from her chest and nose, she now had a color to her chest and nose mucus on Apr2021, she was breathing fine, but she got out of breath every now and then on an unspecified date and her immune system was not too good on an unspecified date. She reported that on 11Apr2021 to 13Ap2021 she has been fine, no sleeping. The patient had been told by her doctors that her immune system was not too good, and she should quit smoking. She said her sister was a licensed practical nurse (LPN), and her sister told her that she thought she (the reporter) may have had a cold when she got her first COVID-19 Vaccine. She said she had felt good since Sunday (12Apr2021). She said she felt stronger, but her cold was not better. She said she was breathing fine, but she got out of breath every now and then. The patient reported that she would get a lung infection if she had a bad cold. She said her doctor told her she took way too many antibiotics in the past, and now her body was used to the antibiotics It was also reported that she said she doesn't take antibiotics. She reported that her second COVID-19 Vaccine dose was scheduled for 05May2021, which was 4 weeks after the first COVID-19 Vaccine dose. There were no relevant laboratory tests done. There were no emergency room (ER) or physician office visits. Nature Made Vitamin C 1000mg yesterday (12Apr2021). She said she was taking 1 Nature Made Vitamin C (Lot Number: 2370401, Expiration Date: Feb2024) 1000mg a day. Adverse events following prior vaccinations were not applicable. The clinical outcome of no sleep, chest infection, no energy, couldn't work, out of breath, immune system was not too good was unknown, not recovered for cold, sick, color to her chest and nose mucus and recovering for tired. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure high diagnosed about 7-8 years ago. The patient's concomitant medications were not reported. The patient got her first dose of the Pfizer Covid vaccine on 09Apr2021. On Saturday, 10Apr2021, she got this severe cramp in her left leg below the knee to her toes and it is extremely painful and thought she was having stroke. She stated that she was treating with a warm cloth and was going to go to the emergency room; rubbing down in case there is a blood clot. She wanted to know if this could be from the vaccine. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

1) Slight redness in neck/chest area approx. 75 mins after shot 2) Tingling, pins&needles on both sides of face between jaw and cheekbones approx 90 minutes after shot that lasted for about 10-15 minutes. This was followed by numbness around cheekbone area that gradually went away by 4/29/2021 Emergency room doctor gave me antihistamine and I took antihistamine 6 hours later before bedtime and twice the following day. I also used a coldpack on my face. 3) Two days after shot 4/29/2021, slight numbness at tip of my little finger on right hand started in the morning.

1/11/2021: Within 40 minutes of receiving 2nd dose Pfizer vaccine, began having tingling bilateral arms proximal & distal. Following day, developed a temperature to 102F which remained x4 days. Since this time, has had continued tingling of the arms & low grade temperature (99F) & has begun having weakness of her upper extremities only with hypersensitivity to heat, as well as touch, but interestingly having decreased sensation to touch of her fingers, feeling as though she wears gloves, with no weakness anywhere else on her body. She has also beginning to develop a sense of decrease cognition. She has been seen by Neurology who felt this was a neurologic hypersensitivity reaction. Initially when she began having complaints following injections/day 1, she was given Benadryl with no improvement beyond causing her to sleep. Since this time she has also been placed on prednisone with no interval improvement. Relates no cutaneous lesions beyond mottling of her arms/no frank urticaria dermatitis etc., and has had no GI complaints or cardiovascular sequela. 4/19/21: This 60 y.o., female is referred by MD for evaluation of bilateral hand pain, weakness and numbness starting shortly after the 2nd dose of her COVID vaccine (5 her). The patient has generally been in excellent health. On Monday, January 11th at 9:20 a.m. she received the 2nd dose of COVID vaccine (Pfizer), in the left deltoid. She had no immediate reaction but while driving about 45 min later developed numbness and tingling bilaterally in her face, lips, tongue and hands. She awakened at about 3:00 a.m. with fever of 102, no abnormal sensations in her face but pain, redness and sensitivity in both hands. Systemic symptoms resolved in several days. Hand symptoms have continued to date. Pain can range as high as 8/10. She has marked sensitivity such that if she or someone else touches her hands it is extremely painful. She sleeps with opera gloves to protect them. She has not had neck pain but has developed grip weakness and has to use 2 hands to hold a cup of coffee. She has never had adverse reactions to vaccines in the past. She has had no immunologic disorders. She initially saw Dr. who tried a short course of steroids without benefit. She took gabapentin 200 mg followed by 100 and slept for hours without a change in the pain. NSAIDs have been ineffective. No other medications have been tried. She has had nothing to suggest a symptomatic COVID infection. 4/23/21: The patient continues to have bilateral hand sensitivity and temperature lability. The EMG showed diffusely slow sensory conductions, consistent with the non correctable low temperature of her hands. Motor conductions were notable for slowing in the right median motor with drop in amplitude proximally but with waveforms that did not suggest conduction block. All motor terminal latencies and F response latencies were normal. Overall the study is probably normal within technical limitations but if necessary should be repeated in about a month with her hands warmer. The nortriptyline was just approved yesterday and the blood tests 2 days ago. She will start the nortriptyline over the weekend and let me know if it is tolerable or effective. She will get the blood work done early next week and I will review the results with her. HISTORY: This patient with bilateral hand dysesthesias and temperature lability following COVID vaccination comes in for neurophysiologic testing. Notably the nortriptyline was just approved and she has not yet started taking it. Similar the blood test were just approved 2 days ago and she will have them drawn next week. Her symptoms have not changed since he was here last.

After 1st vaccine it was just like I had COVID all over again - severe headache lasting 48 hours, sweaty/cold, diarrhea. After 2nd vaccine severe body aches, extreme fatigue, sweaty/cold and diarrhea.

pt said her arm hurt immediately after taking the vax and she experienced strange pains in random spots. She got home and was very dizzy. She was stiff and achy. Today she woke up feeling wiped out, very fatigued. She has a slight fever, chills and pains. She has taken 2 Bayer aspirin.

Cerebral venous sinus thrombosis Patient received vaccine in March (exact date is unknown but around March 8-12 per husband); in mid-April patient started reporting intermittent low intensity headaches. On April 23, patient had severe headache and vomiting, went to urgent care and was thought to have sinusitis and started on antibiotics and discharged home. On April 24th, patient became more drowsy with worsening headache and unresponsive. On April 25, she was taken to outside hospital and was noted to have abnormal brain MRI. She was transferred to our facility on April 26 after clinical worsening. Imaging revealed venous sinus thrombosis in deep cerebral veins and patient was intubated due to worsening mentation. Imaging also revealed a venous stroke with hemorrhage in her left thalamus and diffuse brain edema. Treatment includes extraventricular drain placement, anticoagulation (heparin), hypertonic saline to manage brain edema. We also did extensive workup but no history of hormone therapy, contraceptive pills, underlying cancers. Tumor markers are negative. Hypercoagulable panel and rheumatologic panel are negative. Body imaging did reveal multiple uterine fibroids but no other cancer. Patient remains in the ICU, on the ventilator, heavily sedated for management of refractory intracranial hypertension.

Chest pain/dizziness/throat swelling/weakness. 0.3 autoinjector EpiPen and 50mg IM Benadryl given while patient was observed for acute life-threatening changes. EMS came and took the patient in a distressed but stable condition to the nearest ER.

Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. 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.

Bell's Palsy; I started to have sharp pain behind my ear; sinus congestion; deep sore throat; dry left eye; This is a spontaneous report from a contactable other healthcare professional (HCP; patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 at 16:00 (Lot Number: ER8733, expiry date not reported) at the age of 60-years-old at a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was facility. The patient received no other vaccine in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. Medical history included penicillin-rash; high cholesterol being treated with Repatha; slightly high blood pressure being treated with lisinopril; cysts in pancreas, thyroid and kidneys-all benign. Concomitant medications included evolocumab (REPATHA) for high cholesterol; lisinopril for slightly high blood pressure; spironolactone for an unspecified indication and testosterone for an unspecified indication, all start and stop dates were not reported. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 27Mar2021, 4 days later on 31Mar2021 20:30 she developed Bell's Palsy. She would like to know if in the clinical trials those who experienced this adverse event was after the first or the second dose of the vaccine. She already reported this adverse event to Safety, online and verbally. She would like to know if Pfizer recommends for people who develops Bell's Palsy after the first dose of the vaccine not to receive the second dose and if there's information about the cases of Bell's Palsy after receiving the vaccine during the vaccination to larger populations. She's also wondering if there is information about how long it takes to resolve. Patient reported that four days after vaccination on 31Mar2021 at 20:30, she started to have sharp pain behind her ear, sinus congestion, deep sore throat, and dry left eye, went to bed, next morning she woke up with Bell's palsy on left side of face (also reported to have occurred on 31Mar2021 20:30). These resulted in a doctor or other healthcare professional office/clinic visit. The patient was treated with high dose prednisone and Valtrex. The outcome of the events was not recovered.; Sender's Comments: Bell's palsy is not uncommon in general population, however the causal association between bell's palsy and the usage of the vaccine BNT162B2 cannot be excluded because of strong temporal association. 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.

C/o facial fullness, jaw/facial heaviness, dizziness, and slight speech slurring 5 mins after vaccine. No CP, SOB, dyspnea, blurry vision, HA, redness, swelling, rash noted. A&O x 4, able to speak full sentences. VS stable: 88. 97%, 144/86, BS: 116. EKG: NSR. Neuro exam normal, muscle strength intact, facial symmetry, no facial droop noted. Advised pt to transport to hospital but pt refused transport. Observed for total 45 mins.

Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she is just a little uncomfortable, just a little today, not too bad; She adds that she is having a hard time focusing; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8731 and expiry date unknown, Solution for injection), via an unknown route on 12Apr2021 at 15:05 (at the age of 60-years-old) at single dose on left arm for COVID-19 immunization. Relevant medical history included allergies, asthma, she had anaphylaxis in the past to allergies. (Unspecified allergens). The patient added that she had issues for about a year before her surgeon had to do a surgery on her throat. She added she was fortunate because her thyroid was in her airways 14 years ago and her body exploded with allergies and her throat closed a lot. When the doctor did the surgery, the doctor opened her throat up more so that if she had another anaphylaxis it would not result in death. Concomitant medications was not reported. On the same date, after the vaccination the patient had anaphylactic reaction. She stated that happened 62 minutes, it might have been 64 minutes and also stated a few minutes after 60 minutes. The vaccination facility released her after 30 minutes at 15:35 and when she realized something was happening it was 16:10 when the patient realized what it was that she was experiencing. The vaccine facility held onto her for 30 minutes, so she got the vaccine around 15:05 and they watched her for 30 minutes. She believed it was around 65 minutes later that she started noticing something was happening. The patient started like a flushed feeling. She does not know to describe it, it was like she had a drink or something like she felt flush or something over her system like a wave or something. It was like a strong drink or something. She does not drink a lot but it was like woohooo, a wave of something, and then she felt woozy. It was not too bad at first, she was at a bank drive through and she was not driving. The patient was going to pick something up so she stopped for 5 to 10 minutes. She was on the phone with a friend. She felt woozy. The patient asked her husband to buy diphenhydramine (Benadryl). Her husband called back when she got done at the bank, and she was only 10 minutes from her house. The patient had her EpiPen with her. The patient was feeling better and she still feels a little tight in her throat and the way she explained it yesterday was that it was like someone had their finger down her throat, it was uncomfortable. She was just a little uncomfortable, just a little today, not too bad. She added that she was having a hard time focusing. Today, the patient felt tight, scratchy, and hoarse. It was not like it was last night. The patient did not receive any treatment for the events. Outcome of the events were unknown. Description of Product Complaint: Description of complaint: Consumer reporting an AE for the Pfizer COVID 19 vaccine mentions that they told her not to take the flu vaccine because she would get sick. Her flu symptoms would go on for 2-3 months. If she got the flu shot in September or October, she would not feel well through Christmas. Caller adds that she never got the flu again when she stopped the vaccine. Caller does not know manufacturer, NDC, lot or expiration date for the flu vaccine she had that made her sick Caller does not have any information about the Benadryl - and she does not have the bottle that she took that made her sleepy because she added that the only bottle she had was the one that her husband bought yesterday and it was not opened and she had not taken it. Caller added that she had not taken Benadryl in 14 years since before her surgery. Caller adds it might have been 15 years, she would have to remember that. AE identified after call completed. No NDC, lot or expiration date provided for Benadryl caller took 14 to 15 years ago. Follow-up attempts completed. No further information is expected.

Injection site arm pain for 5 days, followed by pain in left neck and left collarbone lymph node approximately 1 week after injection. 10 days after injection pain in collarbone increased, area tender and discomfort when bending forward and shrugging.

Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.

flushed; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), dose 1 via an unspecified route of administration, administered in left arm on 24Mar2021 as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated that she did get flushed after the first and second vaccine. She stated that she noticed the flushed feeling after the first dose (24Mar2021) when she went back to the car and took off the mask. She stated she thought was she flushed, was it the mask or the vaccine? She stated that she got her first dose on 24Mar2021 and that the flushed feeling started a few hours after the injection. She confirmed that she recovered completely from it on the same day. She stated that she has been on medications for a long time and she has never had this reaction like she was having now. There is no history of all previous immunization with the Pfizer vaccine considered as suspect, no additional Vaccines Administered on Same Date of the Pfizer Suspect. AE did not require a visit to emergency room and physician Office. There is no prior Vaccinations (within 4 weeks). The outcome of the event was resolved on 24Mar2021. No follow-up attempts are needed. No further information is expected.

Client received her first Pfizer-BioNTech COVID-19 Vaccine at about 12 noon on 04/09/2021 with lot number ER8731 exp. 07/2021. Client's daughter reported to EMT that her mother's arm was twitching at the site of the injection. Patient has a history of Carpal tunnel syndrome for the last 10 years, stroke in 2010, and asthma requiring an albuterol inhaler. Vital signs at 1232pm revealed: blood pressure of 172/120, pulse of 64, and respiratory rate of 16 breaths per minute. Vital signs at 1242pm were 168/132, pulse of 62. Blood pressure at 1256pm was 190/110. EMS was offered to client but was declined, client was alert and oriented. No medications or interventions were indicated or administered. Client stated would follow-up with medical provider on own. At 1300 client and daughter left the site, reporting feeling fine, however, symptoms noted were not resolved. Client stated would go to Hospital for further evaluation as that is where medical records are.

anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.

real tired; legs felt heavy and aching; legs felt heavy and aching; I have a MTHFR mutation; This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date (at the age of 60-year-old, not pregnant), at single dose, for COVID-19 immunization; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198 and expiration date not provided), via an unspecified route of administration, in right arm, in Mar2021 15:45 (at the age of 60-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included MDD (major depressive disorder), allergies to IV contrast dye. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication included sertraline. The patient previously took oxycodone hydrochloride;oxycodone terephthalate;paracetamol (PERCOCET) and ketorolac tromethamine (TORADOL), both had allergies. The patient stated the first dose made her real tired, and after 2 weeks her legs felt heavy and aching (but no redness or swelling). Patient had a MTHFR mutation (Methylenetetrahydrofolate reductase gene mutation) so she was scared about clots. After the 2nd shot on 04Apr2021 patient feel better. Patient thought COVID is in our bodies already and the shot just stimulates antibodies which somehow create the clotting. No treatment received for events. No COVID tested post vaccination. The outcome of the events was recovered. Information on the lot/batch number has been requested.

First symtom occurred after shot while driving home: I can only explain it as as 'rush' in my head; some kind of dizziness I've never had. 1:30 am on 2/28/21: Chills and fatigue. The next day and since then I have had: extreme fatigue, malice, headache, extreme joint pain, dizziness. I still have it today on 5/2/21. I cannot search for a job, I feel debilitated.

C/O FACIAL FULLNESS, HEAVINESS, JAW, HEAVINESS, DIZZINESS, SLIGHT SPEECH SLURRING 5 MIN AFTER VACCINE

soreness in the arm; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (the patient) reported that a 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 22Apr2021 at age of 60-year-old at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the vaccine today (22Apr2021), she was currently (22Apr2021) experiencing soreness in the arm but not severe. She would like to confirm if she can take Tylenol to have a nice sleep tonight. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

I woke up 4/26/21 with what looked like 2 bug bites on my left cheek. By morning of 4/27/21, it was completely swollen. I experienced itching, pain & vibrating pulses in this area. The swelling enlarged over the next several days. On 4/22/21, I had gone to my annual dermatology appt at Derm. I had to have 2 spots frozen off my face. One on my left cheek & one on my forehead. Since the swelling was occurring near the area I had frozen on my left cheek, I called Dr at Derm & was seen by them for a wound check follow up on 4/28/21. She did not know what it was but did not think it was related to her procedure. She took a culture & had it tested. Her best guess was that it was either an infection or Shingles. Since the results of the culture was going to take several days, she gave me a RX for ValACYclovir. This was just in case it was shingles. Even with this medication, the swelling, itching, burning & pulsating continued. On 5/4/21, I woke up & noticed a significant reduction in the swelling on my left cheek. I also received a follow up message from Dr that the results showed negative for Shingles. However, they have no idea what caused the issue on my left cheek. She recommended that I notify CDC as it may or may not be related to the Covid shot.

Patient stated she felt warm after getting the vaccine and demanded we called EMS. She did not faint or have any extreme acute symptoms that we could note. When EMS arrived they were familiar with the patient and brought her in to be checked on.

When the shot was administered into my left arm, I immediately felt pain down my left arm and into my left hand began to tingle. After waiting 15 minutes, my arm stopped hurting and my hand stopped tingling. At 3:00 AM 4/13/2021, I woke up to my left arm numb and a light purple color and my left hand was numb and my finger tips were tingling. I got a heating pad and placed the heating pad on my left arm, at the injection site, and then began to massage left hand and left arm. After 15 minutes my left hand stopped tingling and the numbness in my left arm stopped and the color to my left arm came back to the same color as my right arm. There is continued soreness and some swelling at the injections site of my left arm.

Client describes a tingling in her legs, feet and arms that started about 6-8 hours after receiving the shot. She also felt her face getting red and feeling hot and took Tylenol after going to bed. The next day, she had a rash on her forehead, scalp, neck, arms (elbows to hands) and ankles - red and a little itchy. She used soap and alcohol which had helped previously with other sensitive skin issues. This did not help for this and she starting using hydrocortisone cream, which helped some, but the rash returns. The rash which appears on her forehead has blisters.

Pt arrived to med obs #1 via wheelchair with ODI c/o dizziness, lightheadedness, and diaphoresis. Pt has holter monitor in place, placed yesterday (5/3/21) by pt cardiologist for ongoing s/s of palpitations and dizziness per her report. Pt also c/o tingling to bilateral hands and abdomen, and "strange sensation" in throat. Denies difficulty swallowing, soreness, or tightness of throat. Pt cannot elaborate further on the way her throat feels. Pt accepted water, declined snack. Pt began c/o worsening dizziness, placed in trendelenburg position with relief. Orthostatic VS obtained. Pt reports her BP tends to run low at baseline. VSS. Pt declined wheelchair to exit, escorted by staff with pt son to exit. VS are as follows: 1640: BP 128/55, HR 81, RR 12, O2 sat 96% on RA 1650: BP 117/60, HR 74, RR 14, O2 sat 96% on RA 1655 (lying): BP 110/55, HR 72, RR 16, O2 sat 95% on RA 1657 (sitting): BP 119/62, HR 83, RR 16, O2 sat 97% on RA 1659 (standing): BP 115/55, HR 77, RR 16, O2 sat 97% on RA

1/7/2021 vaccination 1/8/2021 bruise/pain R lower leg, hard warm to touch. Painful and sore. Progressively got worse; red, bluer. 1/10 or 1/11 ER . Ultra sound on leg. 10cm clot. Put me on aspirin, warm compresses. Had to increase aspirin up to 2x day. It eventually cleared. Referred to surgeon. Found some other veins their inspecting further. *have not had any more clots

sickness to her stomach; fibromyalgia flared up; heaviness in the muscle of her arm; vomiting; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, lot number: EN6206), via an unspecified route of administration in left arm on 08Mar2021 at single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia, diabetes diagnosed almost 10 years before, obese, knee replacements 10 years before on both knees, and Sjogren's disease. Concomitant medications included loratadine from 13Mar2021, hydrochloorthiazide for Sjogren's disease from little over a year before, fluoxetine, cetirizine hydrochloride (ZYRTEC) for years like 20 years for asthma, and montelukast sodium (SINGULAIR) for years for asthma. Patient previously received varicella zoster vaccine (shingles shot) 2 years before. The patient experienced sickness to her stomach, fibromyalgia flared up, heaviness in the muscle of her arm and vomiting within 24 hours after the vaccination. After the 1st dose she was really sick and it affected her fibromyalgia and rheumatoid arthritis and she was just a mess and ended up vomiting and this took about three days which was normal. Patient was on a lot of medicines that counter act anything the Pfizer COVID Vaccine could do to her regarding side effects and thought the vaccine was too much for her body. Patient took several different asthma medicines and made the reported event not as severe. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Noticed Paresthesias on left side of face Tuesday evening at 9:30pm. It dissipated over the next hour. However, I woke up at 3:00 am and then the numbness was all over the left side of my face. I went to the ER.

blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back had some excruciating pain; Nauseous; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I got a mark on my arm, my arm started swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0164/expiration date: 30Jun2021), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6208/expiration date: not provided), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced a headache. Relevant ongoing medical history included Diabetes Type II from about 5 years ago in 2016, fibromyalgia diagnosed about 6 years ago in 2015, and high blood pressure. Concomitant medication included gabapentin from an unspecified date at 600mg 3x/day for fibromyalgia, empagliflozin (JARDIANCE) from an unspecified date at 10mg 1x/day for Diabetes Type II, clonidine from an unspecified date at 30 mg, 2x/day for high blood pressure and labetalol from an unspecified date at 200 mg, 2x/day for high blood pressure. On an unspecified date in Mar2021, the patient experienced her blood pressure (BP) went over 269/149, it made my blood pressure go up, which required hospitalization overnight. Also on an unspecified date in Mar2021, the patient experienced a mark on her arm, and her arm started swelling. On 16Mar2021, the patient experienced major body ache, described as it started hurting the minute she put it in her arm, excruciating pain and pain in the neck down the arm, and she was nauseous. She described that she couldn't get out of the bed because of so much body pain. On 21Mar2021, the patient experienced her left side of middle back had some excruciating pain. The clinical course was as follows: I had a major body ache with the second vaccine. I did not have any problem except the headache with the first one but I took second one on this past Friday, I got very nauseous, it started hurting the minute she put it in my arm, which is on the left side. I got a mark on my arm, my arm started swelling. Saturday morning I couldn't get out of the bed because of so much body pain, Sunday my left side my middle back I had some excruciating pain I rushed to the doctor to the ER, my BP went over 269/149 and they had to give me pain medicine and BP medicine to reduce the blood pressure. I made it to the doctor and I'm getting medicine for the pain. I woke up in the morning there's pain in the neck down the arm and it's aching, the side I got the shot, the side is hurting, excruciating pain in my arm. I had to go to the ER straight to my doctor's office, they wouldn't let me drive or anything straight to the ER where they administered 2 doses of pain medicine and 3 doses of blood pressure, the pain was so intensive it made my blood pressure go up, the doctor said all of this was coming from the vaccine." Relevant lab data on an unspecified date in Mar2019 included blood pressure 269/149. The patient received treatment for the events blood pressure high, body pain, neck pain, pain in arm, and back pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446955 same reporter/patient/drug, different event in separate dose

Facial drooping on right side of face, began after shot, about 10:30pm was the first indication. Still couldn't spit out my toothpaste properly in the morning, doctor's office told me to go into the Emergency room, which I did. Diagnosis of Bell's Palsy.

After the first shot on March 6 but much worse right after the second shot I developed hot feet, numb, and prickly sensation up the lower leg. the left arm also feels numb. It is worse at night. I did blood work, EKG and went to emergency room but all seems normal. Still suffering from the same issues.

Severe flu-like symptoms. Chills, fever, headach, body aches. Arm is red from vaccine site to almost elbow. Very sore arm.

SORE THROAT, COUGH, NASAL CONGESTION, LEG SWELLING, BURNING FEELING TO BOTTOM OF BILATERAL SOLE OF FEET

Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.

PT STATES SHE HAS 'TINGLING TO BOTH FEET AND RT HAND. ALSO HAS WEAKNESS TO BOTH LEGS FROM VACCINE. HAS SEEN A NEUROLOGIST AND HAD MRI X3 - NEGATIVE.

Bronco spasm, cough, throat swelling, inability to speak-treated with solumedrol,epinephrine,Benadryl, Pepcid, resp neb(pulmocor and Duoneb),

I started feeling worst anymore and woke up and my arm was sore; little sore onthe injection site; I started feeling worst anymore and woke up and my arm was sore; Rigorous, just shaking uncontrollably; Fever; profuse sweating; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 60-years-old female (non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: en6201), dose 1 via an unspecified route of administration on 20Feb2021 13:30 (at the age of 60-years-old) as SINGLE DOSE for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 to vaccination. Medical history included drug hypersensitivity, seasonal allergy, blood pressure increased, vascular device user from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the Covid vaccine on Saturday afternoon and didn't feel anything. She was really impress the way it went. Sunday, on an unspecified date, she started feeling worst anymore and woke up and her arm was sore. It was not that big deal. Then by Sunday night on 21Feb2021 , she started to have a severe not chills but rigorous she meant just rigorous, just shaking uncontrollably and then her fever went up. This was same thing Monday and sweat so bad so profusely (on 21Feb2021). But it was such a violent reaction, she was wondering was that normal. She was enquiring that she should get second dose or what. She meant it was, she better today. She felt like she had been drunk to (statement incomplete). She had not none of today but that was terrible. She asked was that normal. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the adverse event rigorous, just shaking uncontrollably, fever and profuse sweating. The outcome of event i started feeling worst anymore and woke up and my arm was sore, little sore on the injection site was unknown. The outcome of rest event was not recovered. No follow-up attempts are needed. No further information is expected

12 hours after the 2nd injection I developed sudden severe nausea that lasted 24 hours non-stop. I was also very thirsty and had chills. The nausea stopped as suddenly as it started but I had fatigue for a few days afterward. I had slight left arm pain. I had fatigue for several days after I recovered from the nausea.

Onset less than 30 minutes. She felt hot (opened windows), light headed, mentally obtunded 'goofy' and observed flushing to head and neck. Her throat felt sore, but did not note swelling, or difficulty swallowing. She denies CP, wheezing, dyspnea, cough, n/v/d. She is unsure about voice change, red/watery eyes, rhinorrhea. She was the driver and asked her husband to switch spots. She denies pruritis, urticaria. Staff on site did lung exam which was normal. She does not recall VS except temperature check. She was instructed to go to ER. They instead got a coke due to her increased warmth and did not feel there was urgency, so instead drove around for about an hour when symptoms resolved.

Immediate feeling of pain that shot down arm of left arm ("tendonitis-feeling") after receiving vaccine. Developed odd lower back and abdominal cramping 4 days later accompanied with loss of appetite. Provider thinks possible colitis but unsure.

Chest pain and couldn't hardly breathe and hard to get up off the bed; Chest pain and couldn't hardly breathe and hard to get up off the bed; Sweats; Hot and Cold; Chills; Sweats; Hot and Cold; Chills; Sweats; Hot and Cold; Chills; Body Aches where can't walk; Body Aches where can't walk; Fatigue; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Dehydrated and Dry Mouth and Mucous; Dehydrated and Dry Mouth and Mucous; Dehydrated and Dry Mouth and Mucous; Fever 102F; Weak and Can't Hardly Walk; Diarrhea; Blurred Vision in Both Eyes; Right Arm Pain; Headache; Lightheadedness; flu bug, virus in her body; This is a spontaneous report received from a contactable consumer (patient). A 60 years old female patient received the first dose of bnt162b2 (Pfizer COVID 19 vaccine) via unspecified route of administration in right arm on 09Apr2021 09:10 AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as no. No history of all previous immunization with the Pfizer vaccine considered as suspect ad no additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No family medical history. The patient experienced diarrhea on 18Apr2021, blurred vision in both eyes on 18Apr2021, sweats; hot and cold; chills on 19Apr2021, body aches where can't walk on 19Apr2021, really bad fatigue on 19Apr2021, nauseated and can't eat; vomiting dry heaves on 19Apr2021, dehydrated and dry mouth and mucous on 19Apr2021, fever on 19Apr2021, weak and can't hardly walk on 19Apr2021, chest pain and couldn't hardly breathe and hard to get up off the bed from 20Apr2021 to 20Apr2021, right arm pain from 09Apr2021 to 12Apr2021, headache from 09Apr2021, lightheadedness comes and goes from 09Apr2021. Right after the shot her headache started and the soreness in the arm. The patient stated she didn't know how to ride out her headaches, they were so severe like bricks in her brain. For diarrhea, the patient stated it is like water and she is going to the bathroom right now. For Nausea, the patient stated if she eats or drinks anything she is throwing up, further clarifies that nothing comes up but dry heaves. For fever, the patient stated her temperature was 102F 19Apr2021 night, 100F 20Apr2021 morning, and it is 101F at the reporting time. The patient stated she had a cold rag on her forehead. For weakness, she has to use a cane to get up and move around because of the weakness. The patient received none treatment. The events did not require a visit to Emergency Room or Physician Office. The PCP stated he is treating it like flu bug and said she just has to ride it out. The patient stated she was supposed to go back for her second shot 28Apr2021, but she is hesitant because she can't take care of her children because she is sick. The patient stated she didn't know if she was going to take the second vaccine and didn't know what to do for her side effects. The patient asked, with these symptoms, if recommended she get the second shot, because it is like a virus in her body. The outcome of the events sweats; hot and cold; chills was resolving. The outcome of the event chest pain and couldn't hardly breathe and hard to get up off the bed, right arm pain was resolved. The outcome of the other events was not recovered. Diarrhea, blurred vision in both eyes worsened. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

pain in her right arm; there is pain in her right breast and under arm.; there is pain in her right breast breast and under arm; there is pain in her right breast breast and under arm; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for 60-year-old female patient (reporter wife) that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) On 07Apr2021 administered at right arm as a single dose for COVID-19 immunization. The past medical history and concomitant medication was not reported. On 07Apr2021, patient had experienced pain in her right arm where she received the vaccine. Patient reported that she could hardly lift up the arm because of the pain, there is pain in her right breast breast and under arm. The patients second dose was due today 29Apr2021 but she did not want to get it because of the pain. Patient is going to see an MD tomorrow for treatment. The clinical outcome for the events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

24 hours after second shot I had a sever migraine, nausea, pain in joints/bones, and fatigue. My lungs also had a minimal amount of pressure/discomfort

Right arm did not hurt immediately after shot. By 12:30 am arm hurt extensively and I started with chills that were so bad my teeth were chattering. By approx 2am I had a fever of 103.2 and every single part of my body felt like I had been beaten with a baseball bat. I hurt so badly that I was unable to sleep at all that night. I took two 500mg Tylenol at approx 2:15 am but it was vomited right back up. Nausea continued through the night. Started vomiting every time I had to get up for something. Was not able to take my morning meds or more tylenol until approx 11:00am. even with tylenol, fever hovered between 101.6 - 102.5. Unable to do anything all day. Now, at 5:54pm on day 2 I still hurt all over, though not as badly. My fever is 100.9.

My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I am allergic to them/ Severe reactions and had to be hospitalized overnight; had problem swallowing a little bit and voice changes after talking; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. Medical history of the patient included anxiety, depression, nerve pain, ongoing blood pressure (hypertension), change in personality and cardiac disorder. Concomitant medication of the patient included levothyroxine, atorvastatin calcium (cholestat [atorvastatin calcium]), pantoprazole, 1300mg fluconazole (Fluxizol), 81mg aspirin, lubiprostone (Amitiza), alpha lipoic acid, baclofen, linezolid (Zenix [linezolid]), centrum silver, 10mg rosuvastatin calcium (Crestor), 100mg docusate sodium (stool softener), amlodipine and magnesium oxide for blood pressure. Patient was on Benazepril HCTZ for heart, Pristiq for anxiety or depression, citalopram for pain (something to do with pain I can't remember), Effexor for Anxiety, Lexapro, Levaquin, and Sulfa for rashes. Patient got it from her bladder infection. Cyclobenzaprine (I can't remember), Gabapentin, change in personality and nerve pain. Metoprolol for heart. Patient was not taking any of these medications now she got several allergies from them. Patient had a lot of allergies. She was on lot of medications. But it was not what she was taking any these medications on the same, so she was like what was going on. Patient not taking the medication (Unspecified Medication), she was allergic to them, but she was taking other medication. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number, PF12ER6200), via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. On 15Mar2021, the patient had severe reactions and had to be hospitalized overnight. Within mild reaction for 15 minutes and within 40 minutes severe. Patient went to have it done at the hospital they walked her down to the ER they get to give her an epi Pen injection into IV." When again probed for the concern, Patient stated, she had it done at the hospital, they after 15 minutes her throat was itchy they may say another half hour in between that half hour her voice started to change and her throat felt worse they walk her down to the ER her throat was hurting then slowly they gave her Epi Pen and they injected in an IV with steroids. Patient had wheezing in her lungs and she spent the night in hospital for observation. Patient stated that she still had problem swallowing a little bit and voice changes after talking. Patient wanted to know it was like how she supposed to find out what she was allergic. Patient further stated, "Because she want to you know she need an update how was it bad so she want to had to go all this what she was allergic. Event outcome for the events swallowing difficult and for voice alteration it was not recovered and for other events it was unknown. Information about lot/batch number has been requested.

Client reports she began to experience muscle twitching to vaccinated arm about 20 minutes after vaccination. Client reports she told the EMT during her observation. Client was guided to private observation room and evaluated by EMTs. Client reports upon assessment EMTs found that she had a blood pressure of 190s systolically. Client cannot recall exact blood pressure. Client denied any other symptoms at this time other than muscle twitching. Client was taken to the Emergency Room where she was evaluated. Client reports her blood pressure went down on its own without the need of medications. Client denies history of hypertension.

This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no pregnant) patient received 2nd dose of BNT162B2 on 14Apr2021 03:45 PM on Left arm at single dose for covid-19 immunization. Medical history was Myasthenia Gravis. Past drug was allergies to Z pack. Historical Vaccine was 1st dose of BNT162B2 on 24Mar2021 03:45 PM on Left arm for covid-19 immunization. No other vaccine in four weeks. Other Medications in Two week included Olmesartan, Calcium. On the second day of the second dose of Pfizer (15Apr2021), she had the expected side effects, such as chills, muscle pain during the day. But, around 11 p.m. she suddenly started having abdominal pain, then throwing up, cold sweats, shivering, dizziness. She was taken to ER that night. The ER doctor did a CT, lab work but didn't find anything remarkable, so she was sent home. The next day (16Apr2021) she found blood in the toilet when she had bowel movement, so she went to see family doctor. He confirmed it's blood. He then set up an appointment for her to see a specialist the next Monday, since it's Friday afternoon. The bleeding got worse at night (16Apr2021), so she went to that ER again. She was then admitted to the hospital due to the big drop of red blood cell count. Later, the specialist did a colonoscopy on her and the result showed ischemic colitis. She was released from the hospital on 18Apr2021. This is very surprising to her as she had never had GI problems before. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days). Outcome of the event was Recovering. No covid prior vaccination. No covid tested post vaccination. Information on the lot/batch number has been requested.

extreme muscle spams in both legs unable to walk went to ER twice and was administered steriods, norco, vallium time course 2 days

Night sweats; Fever; This is a spontaneous report from a contactable pharmacist. A 60-year-old female patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), via an unspecified route of administration on an unspecified date at the age of 60 years old (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced Night sweats and fever for 2 days before subsiding. Events took place after use of product. The outcome of the events was recovered on an unspecified date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

1 week after my second Covid Vaccine I developed sudden bilateral foot and hand tingling and numbness . This occurred around Jan 30th/ my second Covid was given on 01/22/2021. The numbness and tingling in my hands has resolved but my toes remain numb.

The morning after the vaccine, despite sleeping on my right side, I woke up with my vaccine arm (left) numb and tingling all the way down to the fingertips. It's a "pins and needles"-y feeling. The vaccination site itself wasn't unusually painful. The pins and needles feeling has diminished somewhat over the past three weeks but continues. It is not exactly painful and it does not affect my movement; it is more weirdly uncomfortable.

severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Mar2021 10:30 (Batch/Lot Number: unknown) as single dose for 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. The patient medical history was not reported. Concomitant medications included chlorthalidone; diltiazem; doxepin; famotidine (PEPCID AC); fexofenadine hydrochloride (ALLEGRA). The patient experienced severe systemic itching, facial swelling, hives on back, flushing on chest, face, arms, hands on 18Mar2021 10:45. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment received for the adverse events included diphenhydramine (BENADRYL) and steroids. The outcome of events was recovered in 2021. Information on the batch number has been requested.

Twelve days after 1st covid vaccine dose profuse sweating and increased heart rate 148. Two days later no energy or appetite and decreased exercise intolerance

Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the eyes; She got some bumps that are itchy on the ankle; Bell's palsy; facial paralysis; Lyme disease/had a bunch a symptom and flare up; Lyme disease/had a bunch a symptom and flare up; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:00 (Batch/Lot Number: EW0158) at single dose for COVID-19 immunisation. Medical history included High Blood pressure, Chronic Lyme's Disease, Rocky mountain spotted fever, Psoriasis. She had Bells Palsy with her Lyme's disease 15 years ago. She also added that she was diagnosed about a year with rocky mountain spotted fever. Lyme's disease and rocky mountain spotted fever are both tick born diseases. She also had Bells palsy with the rocky mountain spotted fever. She had mild psoriasis, once a year she got little spots on both arms little patches of skin that were scaly, other then shots been. Concomitant medications included routine blood pressure medication .Patient stated she reported the side effects to the nurse on the other line. she wanted to know if you have information on the vaccine given to individual with Lyme disease. she received the first shot of the Pfizer COVID-19 shot on 15Apr2021. she had a bunch a symptom and flare up. she had facial paralysis which began 24 hours after receiving the vaccine. she worried about getting my second shot. Patient also wanted some clarification on the reported Bell palsy post vaccination. Patient stated that she was calling about the covid vaccine, she had had chronic Lyme disease for a long time and when she got the vaccine it triggered a lot of old symptoms. She was trying to call doctor and health department. She was scheduled for the second dose on this coming Monday 03May2021. She wanted to question if there was research on people with Lyme's diseased. The symptoms she experienced was bells palsy, noticeable numbness in lips to nose to cheeks that occurred about an hour and a half after shot, the bells ballsy was in the center of her face clarifying on both sides of the face. She spoke for a living and her face went numb that didn't make sense. She also still had a headache for 2 weeks every day, she saw white flashes in front of the eyes, some dizziness, extreme fatigue, and muscle aches. She also went to the chiropractor once a week for back pain and it hadn't been helping. The Chiropractor said that a bunch of patients have been complaining since the shot that the chiropractic wasn't working as well. She got some bumps that are itchy on the ankle, no bugs are outside yet, it's a couple itchy bumps, she didn't know if it's related. Patient clarifies that the bumps she had was 1 on ankle and 1 on hip, and 1 below belly button, it started a couple days ago. No follow-up attempts are needed. No further information is expected.

Rash on face; Rash on neck; swollen tongue; swollen lips; swollen face; itchy hands/Itchy; Lip tingling; Swelling of the arms; swelling and tingling; swelling and tingling; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (patient) reported that a 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206, Expiry Date of Covid-19 Vaccine: Unknown), via an unspecified route of administration on 05Mar2021 03:00 PM in the left arm at 1st dose, single for COVID-19 immunisation. The patient age at vaccination was 60 Years. Medical history included vertigo, migraines, Sjogren's syndrome (diagnosed about 10 year ago), thyroid cancer, diabetes and high blood pressure. known allergies included Latex, daptomycin, ceftaroline fosamil, doxcycline, fremanezumab-vfrm. The patient had second shingles shot with Shingrex and she got a few chicken pox rash around the shot itself but that's pretty normal, the onset age was 58 years and at the age of 60 years old at the time of the last flu vaccine, and has received multiple flu shots in the past with unknown brand of flu vaccine. On 05Mar2021 03:15 PM, the patient experienced rash on face, rash on neck, swollen tongue, swollen lips, swollen face, itchy hands/Itchy, lip tingling, swelling of the arms and swelling and tingling. The report received as, on 05Mar2021, received her first Pfizer Covid vaccine dose. 10 minutes later patient had an allergic reaction which included swelling of her lips and tongue, rash on her body, and swollen and itchy hands. The patient reported a second reaction on 07Mar2021, which were the same symptoms as the first and then another (3rd) reaction on 12Mar2021. She has been to the ER 3 times and was prescribed oral steroids and was given a steroid injection each time. She feels that each time the steroid injection wears off, the symptoms return. She wants to know how long this side effect could last. The patient had allergic reactions to it and patient as now had three allergic reactions to it and was wondering have you had other people that have had multiple allergic reactions if the steroid they were given has run out. The patient was given Decadron on day 1 and it ran out in a couple of days because it's a short-acting steroid, then they gave her the longer-acting five-day steroid, betamethasone, patient was taking oral, but it's not as good as the beta methasone shot, patient was asking to have we had other people who have needed more steroids even though the shots have stayed in their system. She wants to know if she is going to have more allergic reactions down the road as the steroids' run out. The patient had three injectable rounds of steroid shots on 05Mar2021, 07Mar2021, and 12Mar2021 and had two courses of oral steroids on 05Mar2021 and 12Mar2021. The patient said 10 to 15 minutes after receiving the shot, had lip swelling and tingling, rash on face, then within a half hour started to swell up. The patient stated that at the center where she got her vaccination, they gave her Benadryl but noticed her symptoms getting worse, packed her up in an ambulance to hospital, and there they gave her Decadron and Pepcid and more Benadryl. The patient states it wasn't anaphylaxis but was an allergic reaction. This was on 05Mar2021, right after getting the shot. It is explained the events improved when given the medications at the ER. She still gets a little itchy once in a while but she is on oral steriods and 50 mg of Benadryl every day. This is her third injectable and second round or oral steriods. Caller has not NDC, Lot, or Expiry for those product as they are from the pharmacy. She also has no NDC, Lot, or Expiry for the Benadryl being used, it is also from the pharmacy. The patient informed as, this was her first Covid vaccination and she was not getting the second one. The patient husband and daughter have had their Covid vaccines and had no reactions at all. The patient was not had covid prior and post vaccination. The patient was not received other vaccine in four weeks. Abd received many daily prescriptions and supplements medications in two weeks. Adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and treated with Benedryl, Steroids, Pepcid. Outcome of the events itchy hands/Itchy, swelling of the arms, swelling and tingling was unknown, for remaining events outcome was recovering. Follow-up attempts are required. Further information was expected.

I have been sick; couldn't eat anything down; lost consciousness; Trigeminal neuralgia attack; Trigeminal neuralgia attack; massive vertigo attack; eye was so swollen; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Apr2021 (at the age of 60-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history included trigeminal neuralgia, head injury, pulmonary problems, severe migraine and tumor in lymph node. Concomitant medications were not reported. On 09Apr2021, the patient lost consciousness; in Apr2021, she experienced trigeminal neuralgia attack, massive vertigo attack and eye was so swollen; on an unspecified date she experienced also sickness and couldn't eat anything down. The patient specified that right after she got the injection, they make you to sit there for 15 minutes to see. She lost consciousness, it was like they gave her a shot before you go on for surgery and the doctor had come over, they had to wake her up. She didn't know what happened, so that was the first thing and the doctor said that's out of all the 1000's of people they vaccinated she was the first one that passed out right after the injection. So, she thought may be that should be noted somewhere and she didn't get a headache that she has a condition called Trigeminal neuralgia which was extremely painful and it's like only 3% of the population get it and it's usually caused after major head injury, was the very next day her shot was on the Friday and then Saturday the pain was terrific and she had the trigeminal pain for a week, took a week to go away and then right after that the next week she had a massive vertigo attack. And she really didn't know all these things or side effects from her head injury. But her conditions are pretty rare, you only get them if you've got massive concussions and fractured skull and stuff like that which happened a long time ago. So she didn't know if the shot had anything to do with it. She has pulmonary problems so she was getting it no matter what because she can't go anywhere hery Pulmonologist won't let her leave the house unless she has to go to a doctor or an emergency room. And she did go to the emergency room because her pain medication wasn't working at all (Unspecified medication). She used to have migraine but after the head injury the migraine went away which she was very happy because she had severe migraine. What she didn't know was this Trigeminal neuralgia the nerve pain. The consumer further specified that she was so happy with the vaccine and she mean she doesn't care what the normal side effects are, she didn't have any other side effects her arm never hurts, she never had any fatigue or headache but she didn't know it was odd, the very morning she woke up Saturday she was in excruciating pain, its nerve pain that went down to the jaw, right under her eye and over the forehead and it's the most extremely painful thing that people get. She takes medication (Unspecified medication) daily to try to control it but sometime the pain is really really bad. She had been sick for the 3 weeks, she did not think anything had to do with the vaccine except the trigeminal. But it could have caused a massive vertigo attack which lasted 8 or 9 days. Today was the first day she was eating food in a week because she couldn't eat anything down. The patient was on a lot of steroids, she was reducing but she was still very plump so she thinks it's about 270 pounds right now. At the time of the report, the outcome of the events was unknown. The information on the batch number has been requested.

BP 169/101; HR 109; tongue and throat itching; tongue and throat itching; chest pain; discomfort; This is a spontaneous report from a non-contactable pharmacist. A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), at the age of 60 years-old, dose 2 intramuscular, administered in Arm Left on 14Apr2021 (Batch/Lot Number: ER8733) as a single dose for covid-19 immunisation. And dose 1 Lot number: ER8727Administration route: Intramuscular, Administration Date: 24Mar2021, Vaccine location: Left arm. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination was given in a hospital. on 14Apr2021, at 1557: Pt went up to nursing staff 15minutes after vaccine administration to report tongue and throat itching. VS assessed: BP 169/101, HR 109, O2 99%. Pt then c/o chest pain and discomfort, was seen gripping chest for relief. Code MET called 1602: Code MET team transported pt to ER for higher level of care. Pt received diphenhydramine 50 mg PO and methylprednisolone 125 mg IV in the ED as well as cardioversion (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19, nor was tested after vaccination. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

With the 1st shot arms got heavy; Couldn't move arms for about 4 min; The next 2 days I felt like an oven door was opened inside me. Very hot inside but outside body was cool; This is a spontaneous report from a contactable 60-year-old female (Nurse). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot no: EL1283) via intramuscular administration, administrated in right arm on 12Jan2021 11:15 AM, as single dose and second dose (Batch/Lot no: EL3302) via other route administrated in right arm on 02Feb2021 12:15 PM as single dose for COVID-19 immunization. The patient medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. The patient concomitant medications included Simvastatin 40mg, Duloxetine 30-60mg, Raloxifene 60mg, Chlorthalidone 25mg, Levothyroxine 0.88mcg, Calcium 600mg with 500IU Vitamin D, Folic Acid 400mcg, Fish Oil 1400mcg, B12 5000mcg, Vitamin D 2000IU and Tumeric 1000mg. The patient had second dose on 02Feb2021. After the first dose patient experienced patient arms got heavy and then pateint couldn't move them for about 4 min. The next 2 days patient felt like an oven door was opened inside. Very hot inside but outside body was cool, no redness or sweating. patient 2nd shot on arms didn't get heavy, just felt a weakness going from shoulders down to hands. Couldn't move or feel them for 15 min. Slowly patient could move fingers then hands then lift arms. The next day patient brain felt kind of fuzzy. Still a little "off kilter" on 2nd day. Patient did not have any anxiety about either shot, even with what happened with the first one. (patient the one reporting - it says patient from a healthcare professional reporting for a patient and patient couldn't change it). Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, the patient had been not tested for COVID-19. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021136873 Same patient, same drug, different vaccine date

about 1+ hours ago, she came down with a massive headache; it as a "bright, red, rashy and blotchy"/her (left) arm was bright red with a (blotchy) rash (across her left arm); it was "hot as hell"/her (left) arm was hot as hell; She had a blotchy rash across her left arm; She had injection site soreness for 3 days after receiving her first COVID-19 Vaccine; couldn't move her arm at all; left arm was a little tender to move; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 27Apr2021 (lot number: EW0171) at single dose for COVID-19 immunization. The relevant medical history included ongoing multiple allergies, ongoing peanut allergy, ongoing reaction to sulfites (sulfites in wine gave her a headache), ongoing reaction to preservatives (She said she would become anxious & then turn bright red & become short of breath. She said sometimes her tongue would turn pale & white looking & she would faint. She said she carried Benadryl with her & the Benadryl took care of her reactions. She said Benadryl had been her "MO" for treating reactions. She said the doctors don't want to give her an EpiPen unless her reaction is a documented as an anaphylactic reaction) and sensitive to the epinephrine (used in dental treatments caused her to become short of breath, and faint). Concomitant medications included potassium acetate from Apr2021 and ongoing for an unspecified indication. The patient previously took Benadryl from unspecified date to treat her peanut allergy and won't help her allergic reaction to peanuts; also took Benadryl from unspecified date for reaction to preservatives. The patient said that 8 days after the injection, she experienced a massive headache and the left arm where she received the vaccine had a red "circle" around the injection site. She described it as a "bright, red, rashy and blotchy" and said it was "hot as hell". She explained her son and husband were vaccinated right after her, by the same person, and they didn't develop anything. She explained she thought her reaction was due to the preservative in the vaccine as she had a lot of allergies. She expressed her concern about potentially developing anaphylaxis to the second dose of the vaccine after her reaction to the first. She asked for the risk associated with taking the second dose of the vaccine after such reaction to the first. The nurse furtherly reported that about 1+ hours prior to the report (clarified as the time of the report, 06May2021), she came down with a massive headache. She said her husband brought her home something for her headache. She said her (left) arm was bright red with a (blotchy) rash (across her left arm). She said her (left) arm was hot as hell. Reported she had a hesitation to take the COVID-19 Vaccine because she had a lot of allergies to begin with, but nothing that caused an anaphylactic reaction. On 27Apr2021, she had injection site soreness for 3 days after receiving her first COVID-19 Vaccine and her left arm was a little tender to move at that time, but not as bad as after receiving a TB (vaccine) shot. She said after the TB vaccine shot, she couldn't move her arm at all. She reported her symptoms came out of nowhere, and she believed her headache and left arm rash were directly related to the COVID-19 Vaccine. She said her son and husband went immediately after her for their COVID-19 Vaccines, and had the same exact person administer the COVID-19 Vaccine. She said neither her son, nor husband, had a reaction from the COVID-19 Vaccine. No further details provided. The events did not require a visit to Emergency Room or Physician Office. Treatment for headache included 1 Extra Strength Tylenol 500mg caplet. Treatment for left arm blotchy rash included a cold compress on her left arm. She said she also took Benadryl (clarified as Walgreens Children's Dye Free liquid "Wal-Dryl" Diphenhydramine). She said she preferred to use the children's liquid Diphenhydramine because when she had a reaction, sometimes her throat felt like it was swelling. The outcome of the event left arm was a little tender to move and couldn't move her arm at all were recovered on an unspecified date, for event injection site soreness for 3 days after receiving her first COVID-19 Vaccine was recovered in Apr2021, while the other events were not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events headache, Vaccination site erythema, Vaccination site warmth, and Vaccination site rash and the suspect drug. 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.

On May 16th after the shot I got a slight headache then 3 days later was feeling very tired and went to bed, woke up a few hours later with numb legs and feeling very faint with numb lips..became unresponsive and Fire Rescue responded and took me o the hospital where they said all test were ok.

Felt pinpoint pressure 1 minute after receiving the vaccine in the middle of the back of her head. Resolved within 24 hours. Felt pressure building up that she thought was a headache developing although she does not really get headaches. Does not take any medications regularly. While driving home, she began to feel very woozy and developed vertigo. 10 minutes after getting home developed pressure in head that was very intense between ears - ears were popping like she was on a plane. Lasted on and off for over a week. Pressure has diminished a lot but still present - about 25% of what it initially was. She realized that she could not focus when she sat down at the computer soon after that. Any time she looked at her devices could not focus and device would blur out. When she tried to focus her eyes would get woozy and pressure in head would get more intense. Currently can only spend about 1/2 the amount of time she normally can at her computer. Reports that I appear blurry to her on video visit. When she went to lay down that day had tingling and numbness of R side of face. Could not go to sleep because there was a sensation change. Did not improve with position change. Still present about 80%. No facial droop.

Shingles. Right arm, hand, shoulder Was given antiviral medication, lidocaine cream, pain medication for 14 days. As of 4/23/2021 symptoms of rash, scabbing, burning sensation still present.

Swollen injection site, red itchy, hard, painful. Whole arm pain. Tylenol and also Benadryl at night.

incredible chest pressure; shortness of breath; anxiety; chest started hurting; pain across her breasts; concentration levels are off; but being that sick makes her so weary.; She goes to the bathroom 12 times a night to urinate; body aches; feet hurt/top of her feet hurt really super bad/legs hurt; pressing under her arm and she had pain really bad there; pain went around her back /whole back started hurting; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in right arm on 27Apr2021 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunisation. Medical history included ongoing congestive heart failure, diabetes, high cholesterol and high blood pressure. Concomitant medication(s) included aripiprazole (ABILIFY) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported, noted as on of the 2 new heart medication; and another unspecified heart medication. No other vaccine within 4 weeks. The patient received the first dose of the COVID-19 vaccine on 27Apr2021, then 2 days later on 29Apr2021 she developed side effects of body aches and couldn't get comfortable sitting, laying down, or standing, and her feet hurt, the top of her feet hurt really super bad and her legs hurt. She stated she was feeling "fair to partly cloudy" and "this is just beyond anything". She stated she literally didn't want to exist anymore the pain was that horrible, that when she was experiencing adverse effects she couldn't get comfortable in any way, nowhere to go, nothing to do, no warm bath, no hot warm or cool compresses, it was just her whole body. She said there was nothing that would help and she just didn't know if she could do that again. She only had relief through paracetamol (TYLENOL) and she took so much that she felt her liver was in jeopardy. She stated it was a really bad experience. The patient was also having incredible chest pressure and shortness of breath, onset date unspecified. She had a diagnosis of heart failure/a history of congestive heart failure, with the body aches she was having, she thought she was going into heart failure. She did call an ambulance twice (maybe 29Apr2021 then 01May2021; she didn't remember exactly which days) and the emergency medical technicians (EMT) took an EKG each time. The first time she called the ambulance the EMT's offered to take her to the hospital. Her EKG did look abnormal but it could have been attributed to her history of heart related issues or anxiety. The second time her chest started hurting it was hard to distinguish between pain and pressure. There was definitely pressure. There was also pain across her breasts (onset date unspecified) and underneath her arm (on 29Apr2021; initially she was pressing under her arm and she had pain really bad there), she was questioning her lymph nodes. Then the pain went around her back and then her whole back started hurting and her whole body was hurting, onset date 29Apr2021. She had never experienced anything like this before, as stated. She also reported that her concentration levels were off (onset date unspecified). She couldn't listen to music or do anything like that. She spoke with her doctor but being that sick made her so weary (onset date unspecified). The patient reported she didn't know if her symptoms were because of the COVID-19 vaccine or because of her new heart medication, but she said it's stupid to think her symptoms could be caused from her new pills. Her doctor wanted blood work on 27Apr2021 primarily because of all the medical diseases she had. She's guessing maybe blood work would give her an indication of why the vaccine made her feel the way it did. She went on 05May2021 to get bloodwork. She went to the bathroom 12 times a night to urinate (onset date unspecified) and she asked her doctor to put her on Lasix so she could just get the urine out. The doctor told her that her heart and her lungs sound good. The patient asked if she should still get the second dose of the vaccine as she was worried that the symptoms could be worse after the second dose. She was supposed to return for her second COVID-19 vaccine on 14May2021, but she was not going (though she knew she needed to get the second dose), she did not want to get it. The events body aches, feet hurting/legs hurting, pain underneath her arm, back pain, were ongoing but lessened in severity. As of the time of reporting, she had started to feel better, these events (body aches, feet hurting/legs hurting, pain underneath her arm, back pain) were resolving. The outcome of the other events was unknown.

Tongue swelling, facial numbness, rash to both arms, tachycardia, headache, eye pain, elevated b/p 210/103, dizziness, and shaky. Epinephrine given with relief of swelling within 20 min. Two hours later reports vomiting and diarrhea.

I began experiencing severe muscle pain and stiffness near the injection site beginning 8 days after vaccination. Pain is in my shoulder and bicep and radiates all the way down my arm and up to my neck. I experienced moderate muscle pain for about 24 hours beginning about 8 hours after vaccination with both doses (first on was April 24), but that resolved both times and did not return after the first vaccination. When I was receiving the injection on May 12 I felt a sharp pain deep that radiated to my back as the injection was given. I did not have that experience with the vaccination on April 24.

Upper arm pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 19Feb2021 at 08:30 AM (Lot Number: EN6201), as single dose, for COVID-19 immunisation. Medical history was none. Patient had no known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included rosuvastatin (unknown manufacturer) and colecalciferol (VITAMIN D). Patient did not receive any other vaccine in four weeks. The patient experienced upper arm pain (non-serious) on 19Feb2021 at 07:00 PM with outcome of recovered. Patient has not been tested for COVID-19 post vaccination. Follow-up attempts are completed. No further information is expected.

Sweating profusely; could not even move her body it was so sore; flushed/this is like a hot feeling in her face; tingling feeling on the side of her face, above the eye; tingling feeling on her lip; numb feeling on the side of her face, above the eye and on her lip; numb feeling on her lip; fever of 100; arm started hurting really bad; felt really tired/exhausted; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03May2021 (Lot Number: EW0171; Expiration Date: Aug2021) as 2nd dose, single for covid-19 immunisation. Medical history and concomitant drugs were reported as no. The patient previously received 1st dose, single of bnt162b2 on 12Apr2021 (Batch/lot number - ER8729, Expiry Date: Jul2021) for covid-19 immunisation, and she was fine but then the next day her arm was a little sore if she touched it. Caller stated she just needs to ask a question because she is getting concerned. Caller stated then she went Monday to get the second dose and right after the shot her arm started hurting really bad which is a common side effect and she felt really tired so when she got home she went to bed. Caller stated then she noticed on the side of her face felt like she had Novocaine where she had this tingling and numb feeling on the side of her face, above the eye and on her lip and she was also still sore on her arm on Tuesday. Caller stated then Wednesday she was still experiencing a little bit of this tingling and numb feeling, was exhausted, and her arm was killing her. Caller stated on Thursday she was like ok she is feeling really good and starting to get back to normal. Caller stated and she just wanted to let this DSU agent know she has not been sick with anything not even a cold for over three years so this is not common. Caller stated then last night (was early this morning on 07May2021) she woke up sweating profusely and she could not even move her body it was so sore like she got beat up as it was just like an ache from her head to toes (this was like she had exercised and was really sore like that type of soreness) and also her arm was killing her still and she had a fever of 100. Caller stated she was calling because she is not sure if this is common? By Thursday she started feeling better from tired and made it through the whole day until last night she got really tired again and is still tired now. Caller stated she is just flushed (like a hot feeling in her face) now since the sweating had stopped. Caller stated she had a fever the first day on 03May2021 and then went away on Tuesday and she had recovered completely. But then she and woke up early this morning in the middle of the night on 07May2021 and the fever had started back. Caller stated she still has a fever as of now and it has stayed the same since she first noticed it early this morning. Treatment included: Tylenol and Ibuprofen. The outcome of sweating was recovered. The outcome of arm started hurting really bad, could not even move her body it was so sore and flushed was not recovered. The outcome of fever was unknown. The outcome of others was recovering. Information on Lot/Batch number was available. Additional information has been requested.

Chills; fever; shaking; Diarrhea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no. EN6208) via an unspecified route of administration in the right arm on 12Mar2021(at the age of 60 years old as a single dose for COVID-19 immunisation. The patient's medical history not reported. Concomitant medications for an unknown indication. The patient did not have any allergies to medications, foods or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19. On12Mar2021 The patient was experienced diarrhea and vomiting 15 hours after the vaccination which continued for 12 hours. The patient also experienced chills, shaking and fever that climbed to 102.7 from 24 to 48 hours after the vaccination. The patient also reported that it took another 48 hours for the fever to end. The patient did not undergo any lab tests and procedures. The patient had not received any treatment for the events Diarrhea, vomiting, chills and shaking were recovering and the event fever was recovered at the time of report. No follow-up attempts are needed. No further information is expected

It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling really sick; Her arm was hurting/Sore arm; I did have COVID, the virus; Slight headache; Weak; I don't even feel that well right now with the first shot; So I think this was an allergic reaction to the medicine because its not real clear; She was pale and dizzy/kind of dizzy; She was pale and dizzy; Nauseated; She's tired/I just feel tired; I just feel like I am dragging; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) dose 1 via an unspecified route of administration in the left arm on 04May2021 (at the age 60 years old), as single dose for COVID-19 immunization. The patient's medical history included patient had a pulled tendon for which she was wearing a boot, hypothyroidism for which the patient was taking Synthyroid since 1991, COVID-19 in Dec2020 and was sick from Dec2020 to Jan2021, it took patient a month to get over it. The patient's concomitant medication included Diclofenac Sodium delayed release tablets 75mg, two times a day for 2 pulled tendons in her foot. On 05May2021, patient's arm was hurting/Sore arm. On 06May2021, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle, feeling really sick. On an unspecified date in May2021, patient did have COVID, the virus, patient was pale and dizzy/kind of dizzy, felt nauseated, tired/ just feel tired like patient was dragging, slight headache, weak, patient didn't even feel that well right now with the first shot and patient thought that this was an allergic reaction to the medicine because it was not real clear. Patient was started on Diclofenac Sodium 75mg two tabs daily- started on Tuesday, the same day she got her Pfizer Vaccine. On an unspecified date, patient had ultrasound of the leg to check for clots, but she did not have any. The patient reported that her arm was still really sore, and she was not as nauseous and pale as she was last night but then was tired and slept all night. She just felt tired. The patient did not receive any treatment for the adverse events. Patient wanted to know if this could be a reaction between the medication (Diclofenac Sodium) and the vaccine and also wanted to know if she was allergic to something in the vaccine and how many days side effects might last, patient did not know anyone who got sick after the first dose. Patient was scheduled for the second dose of the vaccine on 26may2021. Outcome of the pale and nauseated was recovering, patient's arm was hurting/sore arm, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle not recovered was not recovered while for the other events was unknown. Patient reported that her 83-years-old mother got Moderna and her arm was a little sore after the first dose and nothing after the second shot. No follow-up attempts are needed. No further information is expected.

headaches; weakness; chills; This is a spontaneous report received from a contactable consumer (the patient). A female patient (Age: 60, Units: unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday (unspecified date). She has been having headaches, weakness, and chills. She asked what she should do. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diarrhea; Extremely tired; headache; Nausea; her blood pressure was taken and it was 165/40.; her blood pressure was taken and it was 165/40.; throwing up; dizzy; Numb on body on right side; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 04May2021 08:30 (Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as none. There were no concomitant medications. Patient had investigation assessment. No additional administered vaccines. No Prior vaccinations within 4 weeks. The patient had an allergic reaction to the first dose of the Pfizer covid 19 vaccine and wanted to know if she should take the other one. The patient had throwing up, numb on body on right side, dizzy, nausea on 04May2021; headache and extremely tired on 05May2021; diarrhea on 06May2021; rash all over, swelling in arms and legs, chills on 08May2021; her blood pressure was taken and it was 165/40 mmHg on 04May2021, she couldn't get warm on an unspecified date. Events did not require a visit to emergency room or physician office. The outcome of events rash all over, swelling in arms and legs, chills was not recovered; event throwing up was recovered on 04May2021; numb on body on right side was recovered on 06May2021; events diarrhea, headache and extremely tired was recovered on 07May2021; events dizzy and nausea was recovered in May2021; of other events was unknown.

Neuropathy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 15Apr2021 10:45 (Batch/Lot Number: EP7534) as 2nd dose, single for covid-19 immunisation. Medical history included hypertension, diabetes type 2, and known allergies to any antibiotic with sulfur. The patient was not pregnant. Concomitant medications included lisinopril, metformin hcl and ezetimibe. The patient previously took vancomycin and experienced allergies. The patient received first dose of bnt162b2 for covid-19 immunisation on 25Mar2021, 10:45. On 15Apr2021, at 21:00, the patient experienced neuropathy and had burning pain in legs. The event resulted in doctor or other healthcare professional office/clinic visit. There was no therapy for the event. The patient had no other vaccine in 4 weeks. The patient had no covid prior vaccination and was not covid tested post vaccination. Outcome of event was not recovered.

no energy; Sore arm; spike of asthma; chills; tiredness; fever; body ache; headache; nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Lot /Batch Number: EN6205), Dose 2 via an unspecified route of administration on left arm on 04Mar2021 at 10:15 (at the age of 60 years) as a single dose for COVID-19 immunization. Medical history included heart attack, diabetes, obesity, asthma and Sulfa allergic. The patient's past medical history included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: EN6201) dose 1 on 13Feb2021 at 10:00 as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took Nasal swab test for COVID-19 and was tested negative at 04Feb2021. Concomitant medications include Meloxicam ER (Manufacturer Unknown), Metformin (Manufacturer Unknown), Spironolac (Manufacturer Unknown), Pantoprazole (Manufacturer Unknown), Metoprolol tartrate (MANUFACTURER UNKNOWN), Atorvastatin (Manufacturer Unknown), Clopidogrel (Manufacturer Unknown), Losartan (Manufacturer Unknown), Montelukast (Manufacturer Unknown). The patient experienced no other adverse event except for sore arm until 11Mar2021. On 11Mar2021 around 03:30am it started with chills but moved on and would cycle through between chills, fevers up to 102.4, headaches, body aches, tiredness, spikes in asthma, nausea, and just an overall feeling of feeling bad and 6 days later the patient feels ok, just no energy. Patient not taken any treatment for reported events. Therapeutic outcome of reported events was recovering at the time of report. No follow-up attempts are needed. No further information is expected.

It's like eczema in skin/patches like an eczema; Itchy; little blots of red; Allergic reaction; Pain Whole Left arm; Headaches; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Deltoid Left on 03Apr2021 12:00 (Lot Number: EN6198) as 1st dose, single, and via an unspecified route of administration, administered in Deltoid Left on 24Apr2021 12:00 (Lot Number: ER8737) as 2nd dose, single for COVID-19 immunization. Medical history included Crohn's disease and immunodeficiency from an unknown date. The patient is not on other medication and doesn't take anything. On 04Apr2021, the next day after vaccination of the first dose, the patient had pain whole left arm and headaches and took Tylenol. On 05Apr2021, patient experienced it's like eczema in skin/patches like an eczema, little blots of red, that is really itchy, and allergic reaction. The patient took an antihistamine. On 25Apr2021, after the second dose, the patient again had pain whole left arm and headaches and on an unspecified date after the second dose had the same patches like an eczema not clearing still itching. Patient was still taking antihistamine. No emergency room and physician's office visit was done. The outcome of the events was not recovered.

Within about 15 minutes of administration of the 2nd dose of the Pfizer COVID vaccine, the patient experienced arm numbness / tingling that radiated between the elbow and her hand.

Patient is a 60-year-old, female. Alert, oriented X4, clear speech, able to answer to questions. Patient has history of smoking and elevated blood pressure. No history of allergies. At 11:14 am, the patient received her second dose of Pfizer (lot number EW0187, expires on 08/2021) on left deltoid. Patient walked with a steady, balanced gait to EMT observation area. At 11:30 am, patient notified EMT that she was experiencing numbness in left fingers. EMT assisted patient to anti-gravity chair. Patient states she has not eaten. Patient was given a granola bar and water bottle. Patient remained A&Ox4 and talking to EMT. Lead RN was notified of reaction. RN requested vitals Q5 minutes for 30 minutes. At 11:33 am: BP of 137/91, HR 88. At 11:35 am, patient states numbness is ?improving?. At 11:40 am: BP of 132/99, HR 77, SPO2 99%. At 11:44 am, patient states numbness in fingers is ?almost gone?. Patient denies any additional adverse symptoms, such as dizziness, lightheadedness, and shortness of breath. At 11:50 am, patient sat up with a BP of 152/94, HR 80, SPO2 99%. Patient states she is "feeling better" and requested to leave facility. Patient was A&Ox4 with no reports of dizziness and lightheadedness. Lead RN provided patient with education concerning when to call 9-1-1, including worsening of symptoms and trouble breathing. Patient was instructed to follow up with PCP. At 11:52 am, patient stood up from chair, denied lightheadedness and dizziness. Patient walked to car with steady, balanced gait. Patient's husband drove patient home.

Released from ER after receiving 2nd Pfizer vaccine. 1 mile down the road, I could no longer drive. I had to pull over on the highway. I had a tingling in my face, immediately followed by a combination of severe headache, hard to breath, rapid heartbeat and feeling like I was going to pass out. I wasn't able to even dial my phone. A construction worker on the side of the highway called for the ambulance and I was transported back to the ER.

60 y/o female with past medical history of HTN who presents with leg left numbness post vaccination. Patient states that this is her second vaccine in the two-dose series. Patient states that she had fever, weakness and right arm difficulty moving 8 days post vaccination, lasting 4 days. Patient states that she received the first vaccination to the left arm and experienced the symptom of difficulty moving post vaccination to the right arm. Patient states that she received todays vaccination to the left arm. NP and Paramedics at patient side. Patient was able to stand and sit in wheelchair without difficulty. Patient was able to ambulate from wheelchair to cot without difficulty. Within in 2-3 mins patient states that numbness to left leg improved. NP questioning if numbness was due to the way that patient was sitting post vaccination. Patient able to move all digits of her left foot, normal color and temp of left lower extremity. No swelling visualized. Patient initial vitals with hypertension noted, 170/77 BP R arm, 80 HR, 98% RA, 12 Resp. Patient monitored for blood pressure normalization. Patient BP decreased to 151/79, which is described as normal for patient. Patient able to ambulate without difficulty and states that she feels better and ready to go home. Patient discharged in stable condition with numbness resolved. Patient aware that if symptoms worsen or persist, to seek further medical care.

aching all over; her arm hurt very bad where she got shot, right arm, "her arm was killing her; shooting from her arm up to her neck; chills; feeling really unwell; heart started beating a little bit fast; shortness of breath; tiredness; headache; muscle pain; joint pain really bad; really weak; Back Pain; Throat Hurting; injection site pain; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the right arm on 12May2021 08:30 (at the age of 60-year-old) as single dose for COVID-19 immunization. Medical history included allergic to dye (last time she had black dye, her head was itching and burning like fire and her head is still red and her hair is falling out by handfuls), back injury ongoing since 2004, and ongoing diabetes mellitus that started 14.5 years ago. The patient was tested negative on the COVID Nasal swab on 08Nov2020. The patient was hospitalized for 7 days for COVID-19 from 07Feb2021 or 08Feb2021 when she had "diarrhea coming out both ends", and when she had come home, she had on/off head spinning for 2 weeks and in a month her head stopped spinning. She waited 90 days before getting the vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not enrolled in a clinical study or a program. Concomitant medications included naproxen (NAPROSYN E) taken as needed for back pain. On 12May2021, the patient experienced injection site pain. On 13May2021, she started experiencing aching all over for about 8 hours and has been hurting all morning from 08:00, "her arm hurt very bad where she got shot, right arm", "her arm was killing her; shooting from her arm up to her neck", tiredness, couldn't hardly walk legs were hurting started today worse, headache, muscle pain, really bad joint pain, chills, feeling really unwell, really weak, heart started beating a little bit fast and shortness of breath. she has no swollen lymph nodes. She stated her back wasn't hurting yesterday and now today (13May2021) she has back pain so much so that she can't hardly get out of bed. She also stated throat hurting. She reported that the persistent/significant aching all over for about 8 hours & "her arm hurt very bad where she got shot, right arm" were serious due to disability/incapacity. If it keeps up like this, she doesn't know if she will take the second one. She is scheduled for her second one on 02Jun2021. Later, she stated, "I was aching about 8 hours. After that I think I had took a Tylenol" but she can't be sure. The clinical outcome of the event "aching all over" was resolved after 8 hours on 13May2021 around 16:00. The clinical outcomes of the events chills and heart started beating a little bit fast were resolving, the events injection site pain, "her arm hurt very bad where she got shot, right arm", "her arm was killing her; shooting from her arm up to her neck", tiredness, headache, muscle pain, joint pain really bad, really weak, throat hurting were not resolved, while the events feeling really unwell, shortness of breath and back pain were unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Headache; Achy legs; This is a spontaneous report from a contactable other healthcare professional. A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), intramuscularly in left arm on 23Feb2021 at 08:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included diabetes, asthma, known allergies: Penicillin. Concomitant medical included diabetes meds plus other medicines prescribed by my doctor, received within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), intramuscularly in left arm on 02Feb2021 at 14:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. No COVID prior vaccination. The patient has not been tested for COVID post vaccination. On 24Feb2021 at 06:00, the patient experienced achy legs, headache, only lasted the next morning until about noon. No treatment medications was received for the adverse events. The outcome of the events was recovered on 25Feb2021. No follow up attempts are possible; information on Lot/batch number cannot be obtained.

body and headache; chills; body and headache; low grade fever; nautiated for 48 hours; Very weak for 2 days after.; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old non pregnant female patient received second dose of BNT162B2 (Formulation: Solution For injection, Batch/Lot Number was not reported) via an unspecified route of administration, administrated in left arm on 17Feb2021 as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medications included in two weeks Lisinopril was taken.No known allergies.The patient previously took first dose of BNT162B2 (Formulation: Solution For injection, Batch/Lot Number was not reported) via an unspecified route of administration, administrated in left arm on 28Jan2021 13:30 as 1ST dose, single for COVID-19 immunization and experienced chills, headache and 101 fever. Took some Ibprofane temp went down and was fine the next day. 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.On 17Feb2021, the patient experienced with 8 hours later, chills, body and headache, low grade fever and nauseated for 48 hours. very weak for 2 days after. No treatment was received for the events. The outcome of the events was recovered in Feb 2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Muscle twitching in Right Arm; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN 6206), via an unspecified route of administration, administered in left arm on 09Mar2021 (at the age of 60-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Medical history included mitral valve prolapse, osteopenia, skin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included calcium citrate (CITRACAL); fish oil; sertraline; raloxifene; 'aspiri'. The patient's known allergies included erithomyicine, codeine, skin allergy, Propylene Glycol and other skin allergens. The patient experienced muscle twitching in right arm, not the arm vaccine was given in. Began on 13Mar2021. Since the vaccination, the patient was not tested for COVID-19. No treatment was received for events. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected

shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips; Because of the blisters she had a hard time breathing and couldn't can't eat; had a fever of 102°F; weak; tooth throbbing; body aches; food tasted like crap for anything that she could get into there; Because of the blisters she had a hard time breathing and couldn't can't eat; Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling; injection arm was "swollen so bad" from her neck to her fingertips; vomiting; lightheaded, dizziness; Migraine headache/migraine; her arms swollen down to her fingertips which she could not sleep on her left side; could not get out of bed; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EWO182) as single dose for COVID-19 immunisation. Medical history included allergic reaction to back yard tree and had sniffles and watery eyes prior to shot. There were no concomitant medications. The patient received her first Pfizer Covid vaccine dose on 18May2021. That evening she began to experience side effects. Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling. She had Migraine headache and vomiting. At 5 AM the following day 19May2021, she was vomiting, had diarrhea, a migraine, and then developed blisters in her mouth. Because of the blisters she had a hard time breathing and couldn't can't eat, had a fever of 102 degree F, was feeling weak, had to crawl to bathroom. She reported that 24May2021, was the first day that she felt ok. It was reported that her arms swollen down to her fingertips which she could not sleep on her left side, blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips, stated that she could not go to her dentist appointment the following day because of blisters and her tooth was throbbing on 19May2021. Stated that she had migraine headaches with vomiting, diarrhea, heart palpitations, weak, 102 fever, food tasted like crap for anything that she could get into there. The patient is supposed to go on 08Jun2021 for her second shot and was told that the second is worst than the first. Stated that she refused second shot. Stated that she could not get out of bed. Stated that she has a 7 and 8 year old to take care of by herself. Stated that the shot entry is the size of an apple on 24May2021. Clarified that she had the shot in her left arm. Caller stated that she had the Covid shot 18May2021 and she still does feel well today. Clarified that the blisters all started at the same time. Stated that she has had no heart palpitations since 5am this morning (24May2021). Stated that her fever is 99.9 Caller keeps rambling on; unable to clarify details with each event. Stated that the migraine is now a headache. She wants to know what would happen if she doesn't get the second dose of the vaccine. The patient received no treatment. Outcome of the events could not sleep on her left side, could not get out of bed was unknown; peripheral swelling was recovered with sequelae on 23May2021, vomiting was recovered with sequelae on 24May2021; Heart palpitations was recovered on 24May2021; Fever, migraine, couldn't lift up her arm, hard time breathing was recovering; all other events was not recovered. Follow up attempts needed. Further information is expected

One week later (overnight Apr 18/19) I woke during the night with fever (highest 101F) and lower right side abdominal pain. I called my primary care dr on Apr 19 at 10.15am. Due to prior history of intestinal surgery and resection July and Aug 2015, Dr advised me to go to Hospital ER for a CT scan. During some 7 hours in the ER, blood work, urinalysis, EKG and CT scan were done. The urinalysis showed possible UTI (though no other symptoms) and appendicitis was suspected from the CT scan. I also got a migraine during the hours in the ER. IV antibiotics and med for migraine were started and I was moved to a room. I saw surgeon and his team over the next two days. Another CT scan - with contrast drink - was done on Apr 20, and from this Dr advised the inflamed appendix was visible. Again due to my prior abdominal surgery and potential scar tissue Dr advised that removing the appendix in this state was at a bit higher risk. He suggested continuing IV antibiotics in the hospital for 48hrs and if the appendix responded well to finish oral antibiotics at home and then schedule appendectomy in approximately 6-8 weeks. This is now the plan. I am going for another CT scan with contrast drink next week in advance of potential appendectomy the week of June 14.

Upset stomach; Sore arm; Headache; Tired; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 11:15 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 11.45 as a single dose for COVID-19 immunisation. Concomitant medication included Celebrex for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient was not diagnosed with covid-19 prior to vaccination. Since the vaccination, patient had not tested positive for COVID-19. On 16Mar2021 at 19.00, patient experienced sore arm, headache, tired, upset stomach. Clinical outcome of the events sore arm, headache, tired, upset stomach was recovering. No follow-up attempts are needed. No further information is expected.

The caller's heart was really fast and heart pressure went up; has been experiencing runny nose, has the flu; has been experiencing runny nose, has the flu; Only pain on arm for two or three days; got a panic; got a panic; The caller's heart was really fast and heart pressure went up; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0182) via an unspecified route of administration in right arm on 10May2021 at 11:30 (age at vaccination 60-year-old) at single dose for covid-19 immunisation. Medical history included tachycardia from 12Apr2021 and ongoing, transient global amnesia from 25Mar2021 and ongoing, anxiety from 25Mar2021 to an unknown date, panic reaction from 25Mar2021 to an unknown date, amnesia from 25Mar2021 to an unknown date. Concomitant medication included cannabidiol (CANNABIDIOL) taken as needed for amnesia from 28Mar2021. The patient is not taking the CBD oil right now, only takes when needed. Has not taken in two weeks, was not she should take it. Suspended for four or five days before first dose. Really does not need it. No other vaccine in four weeks. On 26May2021, patient experienced runny nose, on 25May2021 patient experienced flu like symptoms, on 10May2021 patient got a panic after receiving the first dose Pfizer Covid Vaccine on, the caller got a panic and had to stay at the vaccine facility for half an hour. The patient's heart was fast and heart pressure went up. The patient stayed at the vaccine facility like thirty minutes after receiving the first dose Pfizer Covid Vaccine. The patient stated this went away. The patient knew every time she has anxiety her heart goes up, it is something that happens. The patient let the persons know at the vaccination facility it is not the Pfizer Covid Vaccine, because the patient has that problem right now. Patient's heart was fast and heart pressure went on, on 11May2021 patient experienced pain on arm for two or more days. Patient also experienced cardiac discomfort. The patient stated that the side effects were only pain on arm for two or three days and this began on 11May2021, the day after receiving the first dose Pfizer Covid Vaccine. The patient is experiencing a runny nose right now had the flu but doesn't have any high temperature. The patient states she does not speak English that well HCP: the caller does not wish to provide name, address, telephone number or email. The physician stated she doesn't have a primary care physician yet. The patient was experiencing a runny nose right now began on 26May2021 and is persisting. Had the flu but doesn't have any high temperature: The patient states this began on 25May2021 is ongoing and is improving a little bit. The patient states she is taking CBD oil because she had an issue back on 25Mar2021 of amnesia. The patient has tachycardia and has issues with anxiety and panic. The patient stated after receiving the first dose Pfizer Covid Vaccine on 10May2021, the caller got a panic and had to stay that the vaccine facility for half an hour. The caller's heart was really fast and heart pressure went up. The caller stayed at the vaccine facility like thirty minutes after receiving the first dose Pfizer Covid Vaccine. The caller states this went away. The caller knows every time she has anxiety her heart goes up, it is something that happens. The patient let the persons know at the vaccination facility it is not the Pfizer Covid Vaccine, because the caller has that problem right now. The caller states this went away in thirty minutes. Anxiety and panic not diagnosed, she can just feel it. This started after problem of amnesia the caller had on 25Mar2021. Transient Global Amnesia, had a problem of amnesia on 25Mar021. The patient is not taking the CBD oil right now, only takes when needed. Hasn't taken in two week, wasn't she should take it. Suspended for four or five days before first dose. Really doesn't need it. The patient received the first dose Pfizer Covid Vaccine on 10May2021 and is scheduled for the second dose on 31May2021. The patient has a runny nose right now and had the flu. The caller is asking if they should get a Covid test prior to receiving the second dose Pfizer Covid Vaccine. Only pain on arm for two or three days The patient states the side effects were only pain on arm for two or three days began on 11May2021, the day after receiving the first dose Pfizer Covid Vaccine. She has recovered from the arm and everything. The patient mentioned she was scheduled to receive the second dose Pfizer Covid Vaccine next Monday, 31May2021. Patient did not undergo lab tests and procedures. The outcome of event was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.

pt received pfizer at outside location. Reports day after receiving vaccine had rash for 5 days. Rash: bright red indurated splotches. Located on buttocks, truck thighs, arm. Pruritic and tender. Resolved 5 days later, except for erythematous patch on left medial thigh.

soreness on her arm/ sore arm; felt very cold; weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body; heart rate went a little fast, recorded at 110-112; could not sleep; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: EN6205; Expiration Date: Jun2021) as 1st dose, single dose for covid-19 immunisation. Medical history included covid-19 from 27Nov2020 to an unknown date and aggressive fever. The patient's concomitant medications were not reported. The patient previously took albuterol, tylenol and mucinex for covid-19. The patient reported that she was fine after 1st dose of the Pfizer vaccine but experienced some soreness on her arm and took tylenol. When she got home, she felt very cold but did not have a fever and had a normal temperature. As she was laying down, she felt a weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body. Her heart rate went a little fast, recorded at 110-112 while her normal is 100-110. She could not sleep because of this. She woke up today and mentioned that her symptoms are lessening, not as intense as they were last night, and there is a little improvement. She took Tylenol for her symptoms and did not go to work. She received the vaccine amidst having a previous COVID Diagnosis last thanksgiving, 27Nov2020 and stated that she may still have antibodies from her infection and that the vaccine might be interacting with it. She knew that the Pfizer vaccine was not tested in people with previous COVID Diagnosis and just followed the CDC's recommendation to get vaccinated after 90 days after the infection and inquired for information, Pfizer may have on these topics and if she should receive the 2nd dose on 22Mar2021. She had covid around thanksgiving being about 3 months ago, so she waited the 90 days to get the vaccine. She reported that since she was a covid patient, she was thinking is it because she had antibodies. She was checked 2 weeks in Feb2021 and she was positive for antibodies and wanted to know the relationship between antibodies and the vaccine. Therapeutic measures were taken as a result of soreness on her arm/ sore arm. The patient underwent lab tests and procedures which included heart rate: 110-112, heart rate went a little fast, recorded at 110-112 while her normal is 100-110, sars-cov-2 antibody test: positive on Feb2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

odd sensation in her mouth; difficulty swallowing; mouth full of saliva; Her face, neck and chest were all very red and flushed; Her face, neck and chest were all very red and flushed; This is a spontaneous report from a contactable consumer (patiemt). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on 04Mar2021 13:00 (at the age of 60-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included shellfish allergy from 2011 and ongoing (patient had an Epi-pen prescription on her patient portal information but she has never filled or used that prescription), pneumonia in 2017 and 2018 (occurred 2 years in a row, probably around 2017 and 2018), bronchitis from 2016 (one year bronchitis without Pneumonia, may have been 2016), prediabetic (Onset date: Probably 2015), obesity (Onset Date: Probably 2000), compromised immune status, blood pressure and thyroid. Concomitant medications included lisinopril taken for blood pressure from 2016 and ongoing; atenolol taken for blood pressure from an unspecified start date and ongoing; amlodipine taken for blood pressure from an unspecified start date and ongoing; hydrochlorothiazide taken for blood pressure from an unspecified start date and ongoing; levothyroxine taken for thyroid from 2016 and ongoing. On 04Mar2021 about at 13:50 the patient experienced odd sensation in her mouth, difficulty swallowing, mouth full of saliva, and her face, neck and chest were all very red and flushed. The patient stated that it was a slight reaction. The patient reported that she received her first dose of Pfizer COVID-19 Vaccine on 04Mar2021. She waited the 30 minutes and then left. As she was driving home felt she felt an odd sensation in her mouth, had difficulty swallowing and her mouth filled with saliva; so she pulled over and she looked in the mirror she was all red, her face, neck and chest were very flushed. She just did some breathing and tried to relax. She called her doctor and waited to hear back from her but didn't yesterday. She tried to drink water and just relax; she did not feel like she had to go to the emergency room. Her doctor got back to her today and had a teleconference. The patient did not have other vaccinations within four weeks prior to the first administration. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

I was unresponsive, he could not wake me up; Had pain in my neck on the same site of the shot; Had pain in my neck on the same site of the shot.; Nerve pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration, administered in left deltoid (left arm) on 17May2021 (at the age of 60-year-old, Batch/Lot Number: EW0177) as a single dose for Covid-19 immunization. Medical history included the patient had a child arrhythmia; she believed it was from 1996 but it pretty much controlled and prior to vaccine. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This report was not related to a study or programme. The patient stated that she had a concern because she took the first COVID vaccine on the 17May2021 and she was due to get the second one on the 07Jun2021 however she had some concern today. The patient stated that she had some changed episode of reactions on 17May2021, she started having pain, after she took the first one, on the same day, she had pain in her neck on the same site of the shot and had some effect of pain, a nerve pain and it had devastated to the back of her neck where she had her thick neck and she had to use warm pack on the back of my neck. It would be about 4'O clock in the morning which would be on the 18May2021 her husband was observing her because he is a nurse and he could not wake her up, he tried everything possible to wake her up and he attempted to perform cardiopulmonary resuscitation (CPR) on her, so she was concerned about putting herself again such an event taken place. The patient went to the emergency room. They took her to the emergency room however she got her name administered in 'first a clinic' and he was able to stabilize her. The patient went to the emergency room and when she got there it was like a concerning so when she got there, she was not seen by the doctor because she was feeling little better but the context person, and they did concern that some of the episode she had, she saw the effect after COVID vaccine, she was concerned because she was due for the second vaccine and this was the first episode which she had, and she was concerned whether not should, she take the second shot, she went on her and she reported. The patient could not get this anyone, all she got was the worst. They took her to late but whatever she never got a chance to speak with anyone in her life, you know she do consult with her doctor has followed her so she was concerned now that she would have a second shot, she did not know if she could really take it. When concern confirmed the patient stated that she did have adverse reactions to the Covid-19 shot. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.

A little soreness in her arm; Metal taste; This is a spontaneous marketing program report from a contactable consumer or other non hcp (patient herself). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient's medical history included Multiple sclerosis from an unknown date patient taking Immunosuppressant Ocrevus. Historical vaccination included the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunization.The patient's concomitant medications were not reported. On an unspecified date the patient experienced with A little soreness in her arm, Metal taste patient state that it was like I ate hot soup. The patient enquired about the information about the individuals with MS or taking immunosuppressants who received the vaccination. The outcome of the event Metal taste patient state that it was like I ate hot soup was not resolved and while "A little soreness in her arm was unknown. Information on Lot/Batch number has been requested.

needle was put in and burned like hell and her head kind of exploded; arm was throbbing; pain rotated out everywhere after 30 minutes; burn a little regarding; incapacitated; injection site swelled and turned red; injection site swelled and turned red; non-anaphylactic reaction; nightmare; Bruise; This is a spontaneous report from a contactable consumer (patient). A 60-year-old (age at vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 22Feb2021 (lot number: EN6198; expiration date: 30Jun2021) as 1st dose, single, dose 2 via an unspecified route of administration on 15Mar2021 (lot number: EN6204; expiration date: 30Jun2021) as 2nd dose, single for COVID-19 immunisation and varicella zoster vaccine rge (cho) (SHINGRIX), via an unspecified route of administration, administered in left deltoid on 01May2021 (lot number was 9NH54 and expiration date was 14Oct2022), at an unknown, single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient family history included shingles (caller mother had shingles). On an unspecified date, the patient experienced needle was put in and burned like hell and her head kind of exploded, arm was throbbing, pain rotated out everywhere after 30 minutes, burn a little regarding, incapacitated, injection site swelled and turned red and non-anaphylactic reaction. The clinical course of the event was reported as: caller stated that her pharmacist told her to report because she had Shingrix vaccine injection on 01May2021 and had a non-anaphylactic reaction but her reaction was epic and her pharmacist said that the company would want to know this information for the numbers related to the product. It was reported that her weight was when she was fully dressed. The caller stated for Shingrix vaccine, the needle was put in and burned like hell and her head kind of exploded and that was epic. The nurse said it did burn a little regarding the patient stating Shingrix vaccine burned upon administration; stated the nurse let her go but she wanted to stay in the store for a few minutes and it felt really awkward; her head settled down and her arm was throbbing and started screaming; stated the pain began in her lower back and her arm, head and right side of her hip and moved throughout her body and the pain rotated out everywhere after 30 minutes the pain settled down and she just had the pain in her arm. She stated the area where Shingrix was injected was almost like a baseball sized circle and was read and she had to drive to care for her parents and that made this a nightmare. She removed the band aid from the injection site because the band aid caused a bruise and the injection site swelled and she remembers taking the band aid off and not being able to put ice on it and could not bear the pain. She could not put ice or clothes on top of the injection site and could not take it. She reported her head was just killing her and it was ridiculous to had to use that arm and to lift it like a disabled arm, she would say she was incapacitated and only if forced could she do something under those conditions. She stated the injection site swelled and turned red and just continued to swell, turn red and was burning and hurting and did not go farther and was the size of a baseball. She reported that the other symptom was she had her head back down and no pain in her back anymore, no pain in her chest anymore, and no pain in her legs anymore. She stated the pain after Shingrix vaccine was localized but gave her a headache; states using that arm was insane and if she was not forced to use the arm she could not use it effectively and this was not an anaphylactic reaction and the reaction was not moving anywhere else; stated the area of the injection site is now black all around it like the nurse gave a bad vaccine but she did not do a bad job; stated she could see the dot where the Shingrix vaccine went in. Stated the indication for which she had Shingrix vaccine was that her mother had shown up with shingles and they took her to the emergency room on Sunday (as reported) with a rash that began to bubble so the caller called for her mother; stated her mother was transported to the hospital and the caller had been wearing gloves and thought it was contagious and it was shingles; states the six doctors for her mother in the ER pressed the caller to get Shingrix vaccine. Caller stated the reported reaction for Shingrix vaccine lasted 11 days and sort of calmed down and all she could see now was the red dot where the vaccine was administered; stated she was sure she would have to do Shingrix again due to her reaction and did not have an anaphylactic reaction but wanted to report this as she was told. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

60-year-old Female was found by EMT sitting upright and complaining of being lightheaded. Client was alert and tracking with her eyes while nervous. Client had a chief complaint of anxiety post vaccination. Client stated she began to feel anxious shortly after her vaccination and requested to lie down for the duration of her observation. Client has a history of anxiety for which she is taking CBD oil. Client also has a history of new onset tachycardia and periodic irregular heart rate for which she sees a cardiologist. Client was recently diagnosed with transient amnesia. She denies any allergies. Assessment revealed no swelling, hives, discoloration, shortness of breath or other signs of anaphylaxis. Airway, breathing, and circulation were intact. Client denied any pain throughout her body. Client's initial vitals were a heart rate of 76 and irregular, blood pressure 160/98, respirations 20 and regular, alert and oriented to person, place, date and event, eyes equal and reactive to light, lung sounds clear bilaterally and SPO2 100% on room air. Client was shaking while anxious but consolable. Client consented to an additional 30-minute observation after her first set of vitals. She was provided water during her observation. Her remaining vitals at 1152 - 158/98, pulse 86, O2 99% respirations 16. After approximately 5 minutes, client reported that she felt much "better" and remained calm for the rest of her observation. Client's vitals improved at the completion of her observation with a heart rate of 80 and regular, respirations 16, blood pressure 140/88 and O2 98%.. Client departed vaccination site after 30mins of observation feeling "better".

2nd dose: Stinging a few minutes after shot, I felt really woozy, and then started shaking all over having a hard time processing and talking. Went home the next day (Wed) fever, chills, headache, 24 hours better, returned to work on Thursday, day (2). Day (3), Friday, I noticed a red rash at the site of the injection earlier in the day, but no symptoms, just a little tender. Friday evening I noticed a little SOB, a little burning sensation under my skin on both forearms, and a couple times felt a little dizzy, but I didn't think much about it. Day (4) Saturday morning, I went to spin class, I felt a little off, halfway through spin class I noticed I was struggling with some breathing, thought it was because I was wearing mask, but pushed through. Ran a couple of errands afterwards and then noticed the SOB was continuing, my skin started burning again under forearms and now my legs with tingling into my feet. At this point I decided I probably needed to go home. On my way home my chest started to hurt in the very center of my chest, and slowly felt like some pressure, with squeezing sensation. Then starting at the center of my chest I could almost feel what felt like a numbness creepy from my chest to my throat. I went to the ER. My legs felt really wobbly and had a difficult time walking, and was feeling dizzy. They ran a variety of blood work and tests. They noted my D-dimers were elevated and (4) lymph nodes enlarged. They ran an additional series of test and released me at 10pm with follow-up to cardiologist. I am still experiencing SOB, not as bad, and the burning sensations under my skin.

After first shot - felt severe flu-like symptoms. Very lethargic, no energy, boy ached ALL over. Lasted two days. After second shot, at 1 am, I woke up with EXTREME convulsions. Entire body was shaking all over, looked like I was being electrocuted. Conditioned worsened over next 30 minutes. I then asked my husband to hold me as tight as possible to stop the shaking. He did so and it took over 30 min. for the extreme convulsions to cease.I was not "hot nor cold", meaning no fever. The next two days I had the same symptoms as after the first vaccine - felt severe flu-like symptoms. Very lethargic, no energy, boy ached ALL over

developed a "severe reaction"; body aches; constant rash; burning sensation on the back; fever; she feels uncomfortable; has stomach issues; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number was not reported expiry date was not reported) dose 1 via an unspecified route of administration on 04Mar2021, as FIRST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient developed a severe reaction, with body aches, constant rash, burning sensation on the back, fever, she feels uncomfortable, tired, and has stomach issues. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

a week after the 1st dose, i start having a migraine behind my left ear for a while and then it moves at the back of my head and after on the right side. I also have body ache at night and lower back pain. it comes and goes until the time come for the second dose. at first, I simply take tylenol and green tea. After the second dose, the next day, i discover a swollen lymph nod between my neck and my shoulder but closer to my neck area. The following day, I went to my doctor who prescribes a steroid and an antibiotic. However the med is over and i am still having the migraine from time to time and when have it, i also have lower back pain. This week i also feel pain in my ears

aches and pain in the left side of body that went away; aches and pain in the right side of body; pain in right and left side joints,elbow,knee,wrist,shoulder; right arm and forearm pain; its effecting my gripping power; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on 19May2021 as, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in May2021, 1week after vaccination the patient experienced aches and pain in the left side of body that went away. From the second week patient experienced right side of body pain in joints at the wrist, shoulder, elbow joints, now it's started in her right knee. She states right side is very different symptoms, it is problematic, but improving, she don't think it's going away anytime soon. Patient stated If her body has not returned to normal, it's also in the forearm, its effecting her gripping power and she was concerned about getting the second shot before this resolves. it's gonna take a while, she hoped to delay the second dose to the 4th week. She stated it was weird because her body was split in two, on left side one week and then the right side started and it was so different, it seems to be all in her right arm until today it started in knee. She felt vaccine was working and her body reacting to the first dose, don't want to make things worse, just curious about the switching side, starting in one side and then going to the other, it was isolated on one side and then switched to the other side. The side it started on was not the side she got the shot. It's like some one drew a line down the middle of the body, and one week was on one side and then the next week the other side. Patient enquired whether will it be effective if she delays second dose to the fourth week". The outcome of the event aches and pain in the left side of body was recovered on unspecified date of May2021. The outcome of the event aches and pain in the right side of body, arthralgia, pain in extremity, grip strength decreased was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Hypersensitivity; I feel like I have a arthritis like rheumatoid arthritis in my hands; little tender on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm/ feet are swollen; mild chills; body aches; weird muscle; fatigue; Diarrhea; had marking on my legs actually in elbow area; had like ulcers in my mouth; I lost in the meantime, currently now I am 108 pounds; Bone Ache; blistering in the mouth; blisters; sandpaper like rash on the hands and the feet's; mild rash and itchiness on the arm; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 17Feb2021 Arm Left at the age of 60-year-old as 2nd dose, single (Lot # EN6201) for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Anatomical location: Left Arm for covid-19 immunisation. The patient had it, 2nd one was then on 17Feb2021, 10 days later had a guess what you call hypersensitivity because that is the thing can relate to and the they had at the urgent care (emergency room visit) and then the hospital (further not clarified) because had therapy in multiforme. Symptoms on 27Feb2021 and then had gone through an urgent care that following Tuesday and Thursday went back. So, thought it was from that. She had the initial little tender on the arm and it is swollen and little itchy and then had mild chills and body aches initially and did not take, that is better than other people are having with headaches and everything else but it was 10 days later that had this multiforme beginning of this blisters (27Feb2021), sandpaper like rash on the hands and the feet's (27Feb2021), blistering in the mouth (27Feb2021) and had that everything multiforme all over body it is in neck and head. After the 2nd shot on 17Feb2021. She have been mild rash and itchiness on the arm and then little bit of mild chills and mild body ache, it was nothing serious or anything took a steroid and then 10 days later have little bit of sensitivity on index finger and middle finger and then from the next day had marking on legs actually in elbow area, thought it was mosquito bit because of the experienced of itchiness and then it progressed and migrated upward had sandpaper and blisters on face, hands and feet. The rash was on under, it progressed from the ankle and up through the shoulder and had the blister and sandpaper, rash feeling on hands and on feet and then had like ulcers in her mouth. She also had weird muscle and bone aches, body aches and fatigue and diarrhea and everything but she still had she felt like she had a arthritis like rheumatoid arthritis in hands and feet are swollen. She lost in the meantime, currently now was pounds. Treatments included a corticosteroid shot (Further not clarified) and took steroid for the 5 days at the hospital (further clarification unknown) they give her the shot, corticosteroid shot and then took the pills for the 5 days. Outcome of the events was unknown.

She could not sleep the whole night; Right hand is swollen; She has a sprained wrist; Her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; Her left knee was hurting her a lot worse; Sore arm; First dose: sore arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6206) via an unspecified route of administration (age at vaccination 60-year) in Left Arm on 09Mar2021 as single dose for COVID-19 immunization. Medical history included accident (The accident was 25 years ago, and they told her that she had shrunk an inch from the accident. It is hard for her to say) and cardiac disorder (Her dad has heart disease) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 09Mar2021 the patient experienced sore arm after receiving first dose; On 30Mar2021 her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; her left knee was hurting her a lot worse; sore arm; her right hand is swollen and she has a sprained wrist. On 30Mar2021 09:30 she reported she could not sleep the whole night. The seriousness of all the event was reported as non-serious. Her left knee was hurting her a lot worse was recovering. The clinical outcome for all other events was unknown. No follow-up attempts are needed. No further information is expected.

severe headache; major rash with prickle feeling on face, chest, both arms; major rash with prickle feeling on face, chest, both arms; lethargic; This is a spontaneous report from a contactable other-healthcare professional (patient) reported for herself. A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6202, Expiration date: Unknown) via an unspecified route of administration, in the left arm on 03Mar2021 11:45 AM (at the age of 60-year-old) as 2 ND DOSE, SINGLE for COVID-19 immunisation at public health clinic. The patient medical history included tachy-Brady syndrome, thyroid, gout and umbilical hernis. The patient had no known allergies. The patient previously received her first shot of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN9810, Expiration date: Unknown) via an unspecified route of administration, in the left arm on 10Feb2021 (at the age of 60-year-old) as 1 ST DOSE, SINGLE for COVID-19 immunisation and had severe chills, severe soreness in shot area, lethargic. The patient received the medication within 2 weeks included Synthroid, Allupurinol and Digitex. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 03Mar2021 at around 15:00, the patient had experienced severe headache, major rash with prickle feeling on face, chest, both arms and lethargic. The patient did not received treatment for adverse events. The outcome of all events was resolving. No follow-up attempts are possible. No further information is expected.

I had a headache, chills, and a fever. Then I had tingling in my head. I started breaking out in a rash all over my face, especially on the right side and near my eye. My face swelled up completely. I went to the ER. I was diagnosed with Shingles. I was given nerve pain medication. Later I saw another ER doctor and I was given an antiviral & steroid medication, but I was nervous to take it. I then visited my PCP, where they checked my eye.

feeling a bit woozy; weak; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6199, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date in Mar2021 at 10:45 (at the age of 60-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history included asthma and arthritis. The patient had known allergies to sulpha drugs, keflex, levoquin, and codeine. Concomitant medications included desloratadine (CLARINEX [DESLORATADINE]), montelukast sodium (SINGULAIR), lansoprazole (LANSOPRAZOLE), diltiazem (DILTIAZEM), and estradiol (ESTROGEN). The patient received no other vaccine in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient was not tested for COVID post vaccination. On an unspecified date in Mar2021 at 11:00 reportedly, the patient started feeling a bit woozy and weak about 5 min after the shot and that feeling continued 2 hours later. No treatment was given for the events. The outcome of the events was reported as not resolved. No follow-up attempts are possible. No further information is expected.

hurt more; rash itching; redness; Developing the short sight like a rash and it's you know kind of puffy and hot; Developing the short sight like a rash and it's you know kind of puffy and hot; at the injection site is itchy, rash and swollen; at the injection site is itchy, rash and swollen; at the injection site is itchy, rash and swollen; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female consumer (patient) reported that: A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0177; Expiration date: Unknown), via unspecified route of administration injected in upper left arm on 27May2021 as single dose for covid-19 immunization. The patient medical history included immediate allergy to penicillin. The patient's historical vaccine included first does of bnt162b2 on 06May2021. Past drugs included penicillin and fexofenadine (ALLEGRA). The patient called to inquire that she had taken fexofenadine (ALLEGRA) in the past and whether she can put diphenhydramine (BENADRYL) on it. She was responded from the attached CONS. The patient stated that she had received the second dose of bnt162b2 on 27May2021. She stated that on an unspecified date in 2021, it hurt more, and she was experiencing rash and itching. She said, the week prior to that little bumps on legs which was last Tuesday and dose was given on Thursday. She was asking if this was a reported adverse event greater than Day One post vaccination. The patient was responded from attached and Full EUA Prescribing Information 6.1 Clinical Trials Experience LAB-1457-9.0 Revised: 19May2021. The patient stated that she had called three times and was given VAERs information. The AE was E-transmitted and she was referred to HCP. The report was not part of study or program. The patient stated that she had developed short sight like a rash and it was kind of puffy and hot on an unspecified date in 2021. The patient did not specify seriousness of the events itchy rash, puffy skin and feeling hot. The patient stated that she got her second shot last Thursday, which was on 27May2021 and she noticed some redness and stuff, but she didn't get sick at all after the next day or anything like that, but today she was developing the short sight like a rash and it was kind of puffy and hot. She did not know if that was normal. She inquired whether most people will get the reaction right away. She confirmed that it was Pfizer COVID-19 vaccine. When informed about the Pfizer medical information department for the concern, the patient stated that they gave her a number and said to press 3 already. She was informed that after dialing the number, she needs to press option 3 to reach the department. The patient stated that that's what she did and then they asked her for another option and then another option. So, she pressed option 3, then option 2 and then option 1. The patient was informed that in order to reach the Pfizer Medical Information Department she needs to press option 3 and if she pressed option 1 then she would reach Department. The patient stated that she did exactly the same and that's how she got connected to the Pfizer Department. She was informed the role of Pfizer drug Safety Department and asked for permission to probe questions, upon which the patient replied that she just wanted to talk to somebody who could tell her whether it was okay. She wanted to check if anybody has had it and said that she was actually at work and was trying to get to the Pfizer drug Safety Department before 8 o' clock. The patient was provided with timings of Pfizer medical information department as 8 AM to 8 PM on Monday to Friday and 9 AM to 3 PM on Saturday and Sunday, EST. The patient was unwilling to complete the report. Hence, limited information was available. The patient called again and stated that she experienced "injection site is itchy, rash and swollen" on an unspecified date in 2021. She was unsure about the lot number whether it was EW "O" 117 or EW "zero" 117. Expiry date of the covid-19 vaccine was unknown. The patient stated that she called because she had the second shot on last Thursday, and she did not know because she did not have any reaction to it, but today (on an unspecified date in 2021) "at the injection site is itchy, rash and swollen". She wanted to know whether it was normal. She confirmed that the shot was of Pfizer Covid 19 vaccine. She confirmed her second shot was on last Thursday, on 27May2021. She stated that the first shot was three weeks apart to that. She did not recall the exact date, but believed it to be Thursday. She stated it was 06May2021, which was 21 days apart. She was unsure of the lot number whether it was EW, zero or O, 177. The outcome of the events were unknown. Further probing was not done hence limited information available over the call.

Right away the vaccine made my arm tingle and it was painful. I woke up that morning and I had chills and I felt very nausea. I had body aches and I was breaking out into sweats. I took some Tylenol , I had a headache. The nausea was very horrible, and I didn't have much dizziness. The brain fog is the worst thing that I have experienced. I have severe brain fog . I have no appetite and certain smells will bother me and make me more nausea. When I am sitting still , I feel a dizziness where I feel like I am seeing stars. After the vaccine I wasn't able to keep up anything not even ginger ale or water.

vomiting; fever; chills; diarrhea; dizzy and shaky; dizzy and shaky; she "felt [her] gut and pieces of tissues from [her] gut were coming out; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Jun2021 (at the age of 60-year-old) as single dose for COVID-19 immunization. Patient medical history included COVID-19 in Nov2020 and long haulers before getting the vaccine. Concomitant medications were not reported. On an unspecified date in Jun2021, after receiving first dose of vaccine, patient experienced violent vomiting, fever at 101.9F, chills, diarrhea, felt dizzy and shaky. Patient explained she was sitting on the bowl, had diarrhea, and had her "head in a bucket" but the force at which she was vomiting was unbelievable. Patient described she felt [her] gut and pieces of tissues from [her] gut were coming out; and the content sprayed on her walls, even 6 feet away reaching the shower. Patient specified she didn't vomit when she was infected with COVID-19. Patient explained that she feels better this morning but would like to know if she was contagious. Patient asked if she should quarantine for 14 days after experiencing side effects from the Pfizer-BIoNTech COVID-19 vaccine. Outcome of the events was unknown. Information about lot/batch no has been requested.

auditory hallucinations; Initial extreme fatigue; weakness; worsening tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: not reported), via an unspecified route of administration in the left arm on 15Apr2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to cashews and pine nuts; back pain associated with herniated discs, major recurrent depression severe, generalized anxiety disorder. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lamotrigine (LAMICTAL), calcium levomefolate (DEPLIN), acetylsalicylic acid (ASPRIN), celecoxib (CELEBREX). There were no other vaccinations within four weeks of the vaccine. On 16Apr2021 at 23:45, the patient experienced initial extreme fatigue and weakness which had been replaced by auditory hallucinations and worsening tinnitus. It was unknown if the patient was treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of initial extreme fatigue, weakness, auditory hallucinations, and worsening tinnitus was not resolved. Information on the Batch/Lot number has been requested.

After 18 hours of 2nd dose. Symptoms: cold, temperature degrees from 37.8 C to 39.9 C. 6/8 around 12:00AM, I had headaches, muscle pain, shortness of breath, cough, muscle pain, weakness, dizzy. Sleeping until 1:00pm on 6/9. The body temperature was down to 37.8C?but still dizzy and no energy at all. I feel better today, and body temperature has down to 37.4, and the shortness of breath is getting better, but not as normal, and had cough sometimes, but not too bad.

Approximately 10 minutes after receiving vaccine, patient became very hot and sweaty, nauseous, and dizzy. We laid her down flat on the floor with a pillow and got her some water. We checked her blood pressure, and it was approximately 90/58. Patient says her BP usually runs very low. She stated she had just been for a 4 mile run in 90+ degree heat, had not eaten much that morning, and had not drank much water. After about 20 minutes, she began vomiting. After about 40 minutes from time of vaccine, her son picked her up and took her to a nearby ER at her request. I called her the following day, and she had recovered.

Erratic blood pressure. Decreased heart rate. Weakness. Fatigue, increase in PVC?s. I am an athlete and was simply unable to workout due to response. I did workout the two days after the vaccine and perhaps I shouldn?t have done that. The following week I was exhausted and ended up I?m emergency room with dropping pulse rate and erratic blood pressure, swelling in my face and ankles.

throat swelling/numbness; throat swelling/numbness; lips feeling numb; Her face up to below her eyes was starting to feel numb; the rest of her left side of her head, and her ear was feeling numb; Her left arm was feeling a little bit less sensation than her other arm; a little tired; short of breath; Her esophagus going down the first few inches of her chest was feeling numb; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6200, Expiration date: Unknown) via intramuscularly administered, in left arm on 09Mar2021 at 07:10 am (At the age of 60-years-old) as 1 ST DOSE, SINGLE for Covid-19 immunization. The patient medical history included Asthma, gastrooesophageal reflux disease (GERD), Hypertension, Migraines, Anxiety, Hypothyroidism. The patient concomitant medications were not reported. The patient has seasonal allergies and often rashes and reactions to drugs. Patient makes the comment that patient was canary in a coal mine. It was reported that all medical history were long-term and patient has had them all for more than 20 years, and some conditions, she has had longer than 20 years. It was reported that there were no prior vaccinations within 4 weeks of vaccination. It was reported that the patient received the vaccine on 09Mar2021 at 7:10 am in the morning and she felt fine until the afternoon. By 1:00 pm, patient started feeling a little tired, may be a little short of breath, very slightly. At about 3:00 pm, patient started feeling like her throat was swelling, like it might swell shut. It was only on her left side. By that time, patient drove herself to the (emergency room) ER and when she got there, it was 3:45 pm. Patient's throat felt numb, and it felt like it was swelling. Her face up to below her eyes was starting to feel numb and lips were feeling numb. Patient clarifies the numbness was only on the left side and esophagus going down the first few inches of her chest was feeling numb. It was all on the left side. Then, the rest of her left side of her head, and her ear was feeling numb. Her left arm was feeling a little bit less sensation than her other arm. Patient was checked out and looked at the ER and was told, there was no swelling, no muscle weakness, no drooping or swelling of her face or mouth. Patient just had that feeling of numbness. She confirms all of the numbness was on the left side which is where patient received the vaccine. Patient confirms that she was not admitted into the hospital. She was only seen and discharged from the ER. They checked patient to make sure she did not have a stroke, or bells palsy. On 09Mar2021, the patient had blood test and EKG showed unknown. Patient was seen at the ER and treated with Benadryl, Pepcid, and sent home last night. About midnight, patient took a couple of Benadryl because it had worn off and patient was feeling numbness again. Patient took 20 mg of Pepcid AC which she takes for reflux anyway this morning. Patient was only experiencing a little bit of numbness, very slight. The outcome of all the events were recovering. Description of product complaint was as follows: When probed for any product information for the medication patient has taken in treatment of her symptoms, patient explains she doesn't know what they gave her in the hospital. Patient took Benadryl last night at home and clarifies its probably a generic that came from pharmacy . Patient clarifies its out of the package so she cannot provide a specific name for what she was taking. (Manufacturer: , Lot: P120251, Expiry date: May2023). Patient clarifies she took a pharmacy Generic of Pepcid AC, 20mg (Lot: 0CE2921A, Expiry date: Jan2022). No further details were provided or obtained. No follow up attempts were possible. No further information was expected.

had soreness in my left arm where the vaccine was administered; she felt a little more soreness; feeling lethargic; experienced dizziness, weakness and tiredness; experienced dizziness, weakness and tiredness; experienced dizziness, weakness and tiredness; This is a spontaneous report from a contactable consumer. This 60 (and a half)-year-old female consumer (patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 05Jun2021 10:00 (at the age of 60 (and a half)-year-old) as 1st dose, single for COVID-19 immunization. The patient's medical history included blood pressure. The concomitant medications included unspecified basic blood pressure medication (no further details provided). No prior vaccination was taken within 4 weeks. The patient stated that her last vaccine she got as child. The patient believed she took her blood pressure medication that morning and that she wasn't told not to take anything. It was reported that on 05Jun2021, within 15 minutes after getting the vaccine the patient started to feel the dizziness. It wasn't severe. She felt a little week from it and those didn't start until probably 30 minutes after the injection and lasted for about 1 hour. The patient did not eat that morning. She did get up and before she left and she grabbed something to eat and drink (had a fruit smoothie). The patient took a car service there. The patient still felt it but not to a great degree. The patient reported that she sat there at the site for about 15-20 minutes and as she went to get up and started walking toward the door, she did feel slightly dizzy. The patient was asking if this was common or not. She stated it was not really dizzy, like faint dizzy, but she felt dizzy and weak. She stated that about 2 hours after the vaccine she felt tiredness and that lasted most of the afternoon for a good couple of hours and nothing else. The patient kept moving and pushing and stopped within a half hour after she got home and in the next hour, she started to feel tired. She was moving around getting things done (she was doing renovations at her house) and hour and half she got home she started to feel a little tired and sat down. In the evening hours she was feeling ok, not feeling as tired, feeling lethargic. It just lasted that Saturday. The patient stated weakness wasn't as bad as the feeling tired. On 06Jun2021, Sunday morning the patient had soreness in her left arm where the vaccine was administered. Most of the day she felt soreness no dizziness and not feeling tired. Today she was feeling fine and back to normal. Maybe a little tenderness at the site. The patient considered dizziness and weakness as severe allergic reaction and not just a side effect. The patient did not have emergency room visit or physician office visit for events. The patient came across the report. Her daughter and her husband got the Moderna: they had no side effects, and they were younger than the patient. The patient had scheduled her second dose on 26Jun2021, and she was wondering if what she experienced with the 1st dose is it possible to experience it to a greater degree with the 2nd dose. The patient reported that she was seen by her primary care for a complete physical before and did consult with her to discuss having the vaccine administered and she got the go ahead. The outcome of the event "feeling lethargic" was reported as resolved on 05Jun2021. The outcome of the events "experienced dizziness, weakness and tiredness", "had soreness in my left arm where the vaccine was administered", and "she felt a little more soreness" was reported as resolved on 07Jun2021. Information about lot/batch number has been requested.

Started out as joint pain and heaviness. Progressed to extreme swelling in both hands. Progressed to upper arm pain. Treating with steroids. Treating with occupational therapy. So far refractory to steroids.

May 1, 2021 ? Received 1st Covid19 shot around 3:00PM at a Pharmacy. No concerning reaction. May 2, 2021 ? Arm a little sore at site of shot. Not a problem. Later afternoon some posterior leg muscle pain. Not severe. May 3, 2021 ? Bowels are hardened and a little difficult to push out. In the afternoon definite pain in various places in the large posterior muscles of both legs. In the evening abdominal cramping. A little tired feeling. May 4, 2021 ? Bowels hardened. Abdominal cramping. Deep specific areas of pain in both my posterior leg muscles including: calves, hamstrings, gluteals ? felt like someone sucker punched me up and down the backs of my legs. Right thigh is going numb while I work. Forearms and hands are going much more numb. Extreme fatigue by afternoon, to the point I had to sleep for a while. Diarrhea by early evening. May 5, 2021 ? Hardened bowels. Pain in legs is less severe but still there plus pains in inner thigh. Slight headache (I very rarely get headaches), extreme fatigue by afternoon, Debilitating, I had to take a nap. Thigh continues to go numb off and on while I work. My forearms and hands are tingling and going numb at times. May 6, 2021 ? I am noticing mild headache comes and goes, am experiencing ringing in head like I had with past concussion. Extreme fatigue by afternoon and have to lie down. My bowels are less hardened but still not regular. Still have deep pains in legs muscles but not as severe. Joints are achy: wrists, elbows, hips, knees. May 7, 2021 ? Same as day before. Also realize my blood pressure is running high. May 8, 2021 ? One Week Since Shot. Have noticed I am not able to focus in on specific things as well as normal. The fatigue is debilitating at times. It is affecting my daily chores. I have definitely gained weight, joints continue to be achy and stiff. Less headaches and leg pains are much less. No more abdominal cramping. Bowels are still a little hard. May 8, 9, 10, 11, 12 ? Still more tired than usual but not as debilitating. Bowels are better. My joints and muscles are still sore but not as bad. I am noticing swelling in my arms and legs and face ? feels like I am retaining fluid. I have occasional periods where I am not mentally focused/ forgetting things/ not as observant. Ringing in head happens from time to time. Blood pressure is higher than normal. May 13, 14, 15, 16, 17, 18 ? No more leg muscle pains but continue to have fluid retention. My joints are more sore than normal. Thigh and forearms are no longer going numb. Still more tired than normal but no longer need naps. Mental clarity is better but still feel ?off.? May 19, 20, 21 ? Exhausted. Completely exhausted. Legs and arms and face swollen. Bowels are hardened again. I feel like I have regressed. No deep muscle pain. Joints are stiff again. Mentally out of it. Not able to intently focus. Blood Pressure is up again. May 22, 23, 24 ? Body edema continues. On Sunday the 23rd my face literally swelled up! I took a benedryl and did lymph drainage massage on myself. It eventually went down after several hours. Never experienced difficulty breathing, my parotid glands did not seem to be swollen. May 25 to June 13 - Some days I feel okay, other days I am having swelling in legs, arms / seems like I am still retaining fluid, still more tired than I was before the Covid shot/ still have times a don't focus in as well as normal / joints are stiff at times from swelling and right thigh goes numb off and on when standing.

Pain in my left arm and shoulder. I cannot raise my arm above my head. I have sharp pain in my arm, I cannot put any weight on that arm. I went to a shoulder specialist who prescribed Physical Therapy.

white blood cell count being lowered/ WBC down to 8.6; arm was sore; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207), dose 2 via an unspecified route of administration, administered in Arm Right (right upper arm, as reported), on 27Mar2021 14:00 as, single for COVID-19 immunisation. Medical history included airborne herpes simplex pneumonia (started and stopped eight years ago, WBC remain chronically elevated, as reported), joints started swelling (patient states with the virus she has fogginess, joints started swelling, arthritis, and a rash on her neck, as reported), arthritis, a rash on her neck, Hep C vaccine (she knows they gave her Hep C vaccine in the hospital but she had no reaction), She did have reaction to a flu vaccination (She did have reaction to a flu vaccination and her arm swelled up; in 1996. She has no NDC, lot or expiration date for that flu vaccine). Reportedly, she thinks it was injection error because a nursing administrator gave it to her and she had not worked on the floor in a long time. The patient's concomitant medications were not reported. Patient took first dose of bnt162b2 (Batch/Lot Number: EN6202), on right upper arm, on 05Mar2021 14:00, for COVID-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Reportedly, Patient would like to know when will another dose of the Pfizer COVID vaccine will need to be administered such as a booster dose. Patient stated her HCP did not know this information and stated that no one knew at this time. Response reported was, need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On 25Feb, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine is not approved. Patient stated she would like to know if the Pfizer COVID vaccine is suppose to help your immune system. Patient stated 8 years ago she almost died from a virus they called airborne herpes simplex virus pneumonia. Caller states with the virus she has fogginess, joints started swelling, arthritis, and a rash on her neck. Patient stated when she had pneumonia it was in all 5 lobes of the her lungs and she was out of it for days and the doctors did not think she was going to make it. Doctor said she had no damage to her lungs. She didn't know what was wrong and the doctor's didn't know either until she went to a convenient care on a Saturday and was put on 6 L of oxygen and they got her oxygen saturation up to 80%. Caller states she was completely shut down. She found out that this condition was found mostly in patients with a tracheostomy and she used to work around trach patients but not direct patient care she worked in admissions and along side nurses. After receiving the Pfizer COVID vaccine second dose two months later she had some blood work done and her white blood cell count was 8.6. Caller states that this is the lowest her white blood cell count has been in 8 years. She couldn't believe it and was wondering if the vaccine helps the immune system. She also experienced arm soreness when she touched her arm after the second dose of the vaccine but if she didn't touch it then it didn't hurt. She had no side effects with the first dose. She was not saying that she feels any better due to her white blood cell count being lowered. The vaccine worked for her and it helped her body. She wishes they would come out with more vaccines because otherwise our world was going to be in trouble. On 27Mar2021, the patient experienced arm was sore, on unspecified date of May2021 white blood cell count being lowered/ wbc down to 8.6 and event was serious (medically significant). Patient did not visited emergency room or physician office. The patient underwent lab tests and procedures which included blood immunoglobulin a: normal and white blood cell count: 8.6 on May2021. Therapeutic measures were taken as a result of arm was sore. Outcome of the event white blood cell count being lowered/ wbc down to 8.6 was unknown, for arm was sore recovered. History: Caller states she has tried to stay away from people and she doesn't go anywhere. When she first heard about the COVID 19 virus she had an N95 mask on that day. Reports the virus she had eight years ago, they called it airborne herpes simplex pneumonia. She called the CDC and they had never heard of it; she also called the state health department who didn't know it. Adds even the librarian at the hospital had not heard of it and all she can find out is a lot of trach patients have it. Adds one infectious disease doctor she knew said she had a patient that had this virus and it got in the doctor's eye. Caller adds she remembers the doctor's eye was messed up. Caller adds after having had the airborne herpes simplex pneumonia, the caller was told never to work in the hospital again or even to visit. Since then when she has done that she will get sick. Adds she was told she had pneumonia in all five lobes and they didn't expect her to live. The pulmonologist said there was no scarring in her lungs but some way it shut her down but she survived. Tests: Reports she had an IGA that was fine. Adds now for some reason her WBC will go up. The doctor told her even though it is over 10 or around 10 it is still okay. Caller adds before she got sick with the airborne herpes simplex pneumonia her WBC would never be that high. Information on the lot/batch number has been requested.

Migraine, Seizure, Grand Mal, could not move out of bed, low awareness for 2 weeks. Took 3 months to get to walk. Dizzy and off-balance, nausea

Right arm pain, swelling and redness starting 5/28 lasting 3 days. Chills x2 days starting 5/31/21. Constant cough starting 5/31/21 and continues.

was in bed for 2 weeks. She could hardly move around; Since taking first vaccine, was ill for several weeks; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (had for about 6 years), hypertension from Apr2021 and ongoing, ongoing depression (had since teenager), nephrectomy from 06Jul2020 to an unknown date, ongoing blood cholesterol, ongoing hypersensitivity. Concomitant medication(s) included montelukast sodium (SINGULAIR) taken for hypersensitivity from an unspecified start date and ongoing; pravastatin (PRAVASTATIN) taken for blood cholesterol from an unspecified start date and ongoing; venlafaxine hydrochloride (EFFEXOR) taken for depression from an unspecified start date and ongoing; losartan potassium (COZAAR) taken for hypertension from Mar2021 and ongoing. Caller reported that she got the first shot at 9:30 in the morning at work. She had an appointment at 14:00 with the diabetes specialist. It was about a 20 minutes drive. Caller said that about 10 minutes into the appointment, she had to cut the appointment short and call her son to come get her. She was in bed for 2 weeks. She could hardly move around. Then for the last week before the second shot, she was better but it persisted. It was reported that since taking first vaccine, was ill for several weeks (29Mar2021). She was scared to get the second shot. She had seen her doctor. Treatment was received for the event since taking first vaccine, was ill for several weeks (illness) was to drink plenty of liquids and rest. Outcome of the events were reported as unknown. Information regarding the lot/batch number has been requested.

feeling like legs were made of jello.; Very hot; flushed face; weak; Merely nauseated; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 05Mar2021 at 12:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included hashimoto's thyroiditis. Patient had allergies to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) for an unknown indication. On 05Mar2021 at 13:30, patient experienced very hot, flushed face and weak and feeling like legs were made of jello. This lasted for approximately 3 hours. On 05Mar2021, patient experienced merely nauseated. On 17Mar2021, patient underwent lab tests nasal swab (PCR) and result was negative. No therapeutic measures were taken for the reported events. The clinical outcome of the events very hot, flushed face and weak, feeling like legs were made of jello and merely nauseated was recovered/ resolved on 05Mar2021. No follow-up attempts are needed. No further information is expected.

lost sense of taste; felt really tired; Her whole face and neck was really red and felt like it was on fire; trouble breathing; face felt like it was on fire; headache; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 19May2021 09:00 (age at vaccination: 60 years) as 1st dose, single dose for covid-19 immunisation. The patient's medical history included ongoing multiple allergies. She has had allergies her whole life. Concomitant medication included rosuvastatin calcium (CRESTOR OD) taken for blood cholesterol increased which she has taken it for 15 or 20 years; fenofibrate (LIPOFEN) taken for blood cholesterol increased, which probably she has taken it for 15. On 19May2021, she experienced multiple symptoms 15 minutes after initial vaccination including, trouble breathing which started maybe an hour after she had the vaccine, face felt like it was on fire which lasted for 2 or 3 days, headache, felt really tired and her whole face and neck was really red and felt like it was on fire; on 21May2021, the patient lost sense of taste. Her sense of taste is back now. She thinks her tiredness has gone away. The adverse events did not require emergency room visit or a physician's office visit. The patient did not get other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient feels hesitant about getting her second dose of the vaccine tomorrow and would like some guidance, asking if she should get her second dose or not. The outcome of the event dyspnoea was reported as not recovered; burning sensation, erythema was unknown; headache was recovered on 24May2021, Ageusia was recovered on 23May2021 and tiredness was recovered on May2021. Information on Lot/Batch number was available. Additional information has been requested.

When she took her Pfizer vaccine on 5/29/2021, she had a feeling of pressure around her heart that made her anxious on Day 2 and Day 3, Lymph node under her left arm was swollen the size of a credit card for Days 3 & 4 post vaccine. Had a fever on Day 4 & 5 after the Covid Vaccine. Would wake up in the night with her bed soaked with sweat and she would have to change her clothes. She had a horrible smell in her nostrils. Had diarrhea.

numbness on the top of the lip and bottom lip and my nose; numbness on the top of the lip and bottom lip and my nose; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration, in left arm on 15Mar2021 17:30, at 60 years of age, (Batch/Lot Number: EN6208) as single dose for COVID-19 immunization. The patient medical history included allergy to sulfamethoxazole/trimethoprim (BACTRIM). She didn't receive any other vaccine in the prior 4 weeks. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included magnesium sulfate taken for an unspecified indication, since an unknown date. On 15Mar2021 she waited for 15 minutes and maybe a few minutes after she left (also reported at 18:00) the patient experienced a mild reaction: numbness on the top of the lip and bottom lip, around the outside of her mouth and nose. The area around her mouth including the mustache area and below her lower lip and nose went numb. She had already left the pharmacy, she was in traffic so it was hard to go back to the pharmacy. It didn't get worse. The numbness lasted for 4-5 hours and gradually started to get better. By 10 o'clock that night it had dissipated without any treatment. The events resolved on 15Mar2021. No follow-up attempts are needed. No further information is expected.

I am having muscle cramping all over my body within 24 hours; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 17Mar2021 at 14:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient medical history included COVID-19 prior to vaccination. Concomitant medication included Levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in left arm on an unknown date, as a single dose for COVID-19 immunisation. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 18Mar2021 at 12:00, the patient experienced muscle cramping all over her body within 24 hours. The patient did not receive any treatment for the event. The clinical outcome of event muscle cramp was not recovered at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.

Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Pain in the right side of her leg and in her stomach; Caller stated she has been vomiting mainly from the draining that is choking her.; Throat tightened up and glands swell; Barely able to breath, shortness of breath; Pain in right side, below her breast; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; She was so sick; Caller stated she has been vomiting mainly from the draining that is choking her.; Headaches; Pain in the right side of her leg and in her stomach; Burning in her chest and throat/ pain was in the right side of the chest; Burning in her chest and throat/ throat has been like its on fire; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Jun2021 (Batch/Lot Number: EW0177) as 1ST DOSE, SINGLE for covid-19 immunisation. Time the Vaccination Was Given: Between 12:00 and 1:00pm. Medical history included when she was a child, she had bronchial asthma. Has not had any problems in years. Prior Vaccinations (within 4 weeks): No, has been years. Has not even had the flu shot in 3 years. The patient's concomitant medications were not reported. Caller stated she had the first dose of the Pfizer covid 19 vaccine and stated she is having a reaction. Caller stated it feels like she has covid. Caller stated she got the vaccine 3 days ago and within 1 hour had tightness in her chest, wheezing and her throat started to tighten up. All she could do was wheeze. Her throat started tightening up and her glands started swelling. Caller stated she then had draining down the back of her throat. Caller reported burning in her chest and throat. Caller reported pain in the right side of her leg on 02Jun2021 and in her stomach. Caller stated she has been vomiting on 02Jun2021 mainly from the draining that is choking her. Caller stated she is still draining but not vomiting. Caller reported she is having headaches. Caller was concerned about what she should do, go to her doctor or go to the ER. Caller wanted to know how long the symptoms should last. Caller stated she is 52 hours out from the vaccine, Throat tightened up and glands swell, Barely able to breath, shortness of breath, pain on 02Jun2021. She was so sick. She was barely able to breathe within an hour and has been in pain. It is now a struggle, with shortness of breath. Her throat has been like its on fire, and lungs filled with a huge amount of drainage in the back of her throat. Is having right leg pain and pain in her stomach. It is not severe pain, but there is some pain there, is having a lot of burning sensation with the drainage. It now feels like she has Covid now. She read in the paperwork that this could not cause Covid. She was perfectly fine when she had the vaccine. She has no allergies. Does not know what to do. It has been 48 hours. She was perfectly fine until an hour later. She contacted the pharmacy and they didn't do anything. She then contacted this number to report this. Her biggest concern was the severe drainage. There were globs of drainage down the back of her throat. Her chest tightened prior to that and she was wheezing. She has not had bronchial asthma since she was a child. Has had no flus, or nothing. Had the pain after the burning in her chest, the pain was in the right side of the chest. Pain in right side of leg: Hasn't stopped completely. Still has pain in the right leg and in the chest. It is barely any better. It is probably because it is in one spot in the calf on her right leg. The pain in the right side, below her breast. The pain seems to be in the right side. Pain in stomach: Seems to be both sides. Has gotten better some, in the stomach. Vomiting: Was vomiting from all the drainage, it was choking her. It started within 2 hours. She is still experiencing the drainage, but not the vomiting. Has also been experiencing headaches. Shortness of breath: Was the same time as the tightness in the chest. It was within an hour after she left. They kept her there 15 minutes and she was fine when she left. Within the hour, she could barely breathe. She didn't know if she should go to the emergency room or if it would get better in a few days. The shortness of breath and wheezing is not worse, but is constant and really hard. Her breathing is really labored. She is not having pain, other than the tightness and wheezing, which she can hear. It is like she had asthma for years, or pneumonia. Outcome of events Wheezing, Chest burning, Throat burning sensation, headache, and Shortness of breath, pain of was not recovered, of Pain in leg, Stomach pain was recovering, of Vomiting was recovered in Jun2021, of others was unknown.

Heartbeat 120 on April 27 and May 18 at night after both shots went away the next day. Dizziness and Nausea right after 1st shot. Sore arm 1st shot.

On the morning of April 8, 2021, dull, achy lower back pain woke me up and did not subside throughout the day. The next morning, April 9, 2021 (2 weeks to the day of my 2nd Pfizer vaccine dose), I noticed a few spots on my lower left to middle torso. The pain was increasingly unbearable. I immediately suspected possible shingles and went to ER where I was diagnosed with shingles. I was prescribed a 10 day dose of antiviral acyclovir along with Percocet. As of this date, despite various OTC remedies as well as completing all medications prescribed, I still have inflammation, pain that intensifies throughout the day, as well as periodic numbness, primarily on my left side (which was the site of the original shingles attack).

Sudden and unusual passing of a slight blockage, much blood, and blood clots in urine lasting a few hours one month after the second vaccine. This was in addition to other symptoms following the vaccine, which included struggling with dehydration, especially for 2 weeks following the second vaccine dose, and tingling in feet that started a few days following second dose of vaccine and still comes and goes with varying intensity as of today (6 and half weeks following 2nd dose). The blood in urine was followed up with the following tests, in which results all were negative (no cause of hematuria found): cystoscopy, blood and urine cultures, comprehensive metabolic panel, cat scans of abdomen and pelvis.

couldn't lift arm or lay on it; red hematoma at injection site for weeks; burning from head to toe; Arm hurt; Neuropathy and Small Nerve Fiber Neuropathy; worst headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05May2021(at age of 60 years old) (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunisation. Medical history included Hashimoto's, Fibromyalgia, Small Nerve Fiber Neuropathy, surgeries for defective veins and valves, poor circulation problems and kidney infection 10 years before shortly after undergoing cath lab procedure. The patient's concomitant medications were not reported. Consumer call with questions regarding " I had side effects after the first dose of the vaccine. Should I get the second dose?" Side effects included "worst headache on 05May2021 for 2 days continued for weeks, couldnt lift arm or lay on it, red hematoma at injection site for weeks, burning from head to toe." Caller also reported that her arm hurt after the vaccine. Also reported she had to receive prednisone (her doctor put her on steroids) after first vaccine dose, also reported that her doctor gave her Methylprednisolone, which she took for 6 days, the medication did help somewhat with her symptoms, specifically, the burning from her neuropathy, headache and she couldnt lift her arm, the medication was not a miracle drug, but she did have some relief. She tapered the medication, she had less relief of her symptoms. The symptoms have subsided somewhat and it has taken several weeks. Caller just wanted to ask a medical professional if that ingredient (propyl ethlene glycol as provided and spelled by Caller) contributes to Small Nerve Fiber Neuropathy, Patient reported she went on vacation in January of 2020, after returning home she was very sick but was never diagnosed with Covid-19. Caller reported that she had some type of neuropathy that had come back after she got the first vaccine, she had a splitting headache within 30 minutes of getting the vaccine, and it was really bad, for two days after the vaccine. Caller was concerned to take the second vaccine, because of her previous bad reaction, and her doctor told her to take her second dose and Second dose of vaccine scheduled for 10Jun2021, 36 days after the first dose of vaccine. Outcome for events was recovering. Information regarding the lot/batch number has been requested.

her voice feels a little weak; having problems breathing; lot of Phlegm; coughing a lot; fingers started tingling; waves of nausea; light headedness; She started to itch; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN8203 and expiration date 30Aug2021), via an unspecified route of administration in left arm on 01Mar2021 at 14:30 (age at vaccination 60-year-old) as single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus, hashimoto's disease, high cholesterol and high blood pressure. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. On 01Mar2021, with a few minutes just driving to the waiting spot she was having problems breathing. There was plenty of staff there in the hospital parking lot to help. They were monitoring her oxygen and her heart also on 01Mar20210, patient experienced lot of phlegm, coughing a lot, fingers started tingling, waves of nausea, light headedness and on 03Mar2021, patients voice felt a little weak. She was treated with Benadryl and an inhaler. The outcome of event having problems breathing, fingers started tingling, light headedness, waves of nausea was recovered on 01Mar2021. The outcome of event lot of Phlegm and coughing a lot was recovering at the time of reporting. The outcome of itching and her voice feels a little weak was unknown. No follow-up attempts are possible. No further information is expected.

Patient having worsening tingling and numbness of hands and feet. Patient also having weakness of all extremities

Arm & hand numb during night after injection; lymphadenopathy in left armpit (injection given in left arm); This is a spontaneous report from a Non-contactable Nurse (Patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 02Feb2021 (at the age of 60-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included allergic to penicillin and Imipramine, and hypertension. Concomitant medication(s) included Elderberry Syrup, Zicam, HCTZ, lisinopril; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 12Jan2021 as 1st dose, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021, patient experienced arm and hand numb during night after injection, lymphadenopathy in left armpit. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

The dizziness was incapacitating; Had 100.6 temp and body aches; Had 100.6 temp and body aches; Sore arm; Temporary shortness of breath; This is a spontaneous report from a contactable other hcp. A 60-years-old female patient received BNT162B2 (COMIRNATY) (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, (Lot Number: EL3248 expiry date was not reported) dose 1 via intramuscularly administered at Arm Right on 13Jan2021 11:30 as 1st Dose, Single for Covid-19 immunization.The patient's procedural history included tonsillectomy and adenoidectomy, total abdominal hysterectomy, salpingo-oopherectomy and cholesytectomy (01Jan2004). The patient's medical history included mononucleosis (from 01Jun2020 to 01Mar2021). The patient's concurrent conditions noted hypertension (from 01Jan2013) and hot flashes. The patient family history included hypertension for maternal grandmother.Concomitant medications included . The patient had reaction immediately after 1st vaccine and she felt short of breath that evening on 13Jan2021. The patient had a sore arm 14Jan2021 (the next day). On an unspecified date, the patient had dizziness which was incapacitating and could not drive and also had 100.6 temp and body aches. The patient unable to stand without passing out.The patient received Dramamine for dizziness and Nyquil for fever and body aches and temperature.The patient received Nyquil (doxylamine-DM-acetaminophen) and went to bed. The patient reported that she was okay. The outcome of all the events was resolved on an unspecified date in 2021. Causal relationship:Is there a reasonable possibility that the event is related to suspect product: Yes No follow-up attempts are possible. No further information is expected. Comments/narrative: Reaction immediately after 1st vaccine. Felt short of breath that evening, took Nyquil went to bed. Besides a sore arm the next day, I was okay. Approximately 12 hours after second vaccine, I was achy, dizzy and had temperature of 100.6. Did go to walk but by the afternoon, felt bad enough and went home. The next day, was still dizzy, achy and was vasovagal with standing.Stayed home from work. The 3rd day, I felt ok, went to work.

that the second dose appointment was cancelled, she thought they did not have enough of the vaccine; that the second dose appointment was cancelled, she thought they did not have enough of the vaccine; eye pain and turned out to be viral infection, clarified that herpes in her eye; pain in arm; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1282), via an unspecified route of administration in the left arm on 15Jan2021 (afternoon) as 1st dose, single dose for COVID-19 immunisation in hospital. Medical history included diabetes mellitus from an unknown date in 1985, blood cholesterol increased (diagnosed in the past, unknown exactly when), hypertension from an unknown date in 2001 (about 10 years ago), coronary arterial stent insertion from an unknown date in 2015, Glaucoma (twice she has had surgery for glaucoma once in 2019 and in 02Dec2020), hysterectomy (uterus removed) from an unknown date in 2000 (uterus removed in 2000 and then got a tumor) and oophorectomy (ovaries removed) from an unknown date in 2001 and cataract. The patient has no family medical history relevant to adverse events. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports, she was supposed to get second one on 19Feb2021, states she got the first on 15Jan2021, clarifies it was the Pfizer Covid vaccine, states the second dose appointment was cancelled, she thinks they did not have enough of the vaccine. States she was supposed to go on Monday, 1Mar2021 to get the second dose, appointment had been rescheduled but she had to go to the emergency room for eye pain and turned out to be viral infection, clarifies herpes in her eye and the ER doctor recommended her not to get the second dose of the vaccine. Asks if it is safe to have the vaccine because she is taking the medication for the eye infection, taking acyclovir 400mg 1 tablet 5 times daily for 10 days. States she also tried to reach out to her primary care, and they are going to send a message to him to see what he had to say about getting the second dose. Clarifies she had a stabbing pain in her eye, above eyebrow, and on side of eye, it stung and was itching and watering a lot for 2 weeks prior to going to the ER on 28Feb2021. Thinks maybe it started around the 12 or 13 of Feb2021. States her doctor said his second gave him body aches. States she had surgery in Dec2020 for glaucoma and for cataracts was wondering it if was her pressures going up or what is going on to make sure she was not going to confuse it with actual side effects of injection. States she also was a little painful in her arm for a day or so on 15Jan2021. Patient reported that she was not hospitalized but waited in emergency room from 12:00 (12 noon) until 23:00 (11:00 PM). No relevant tests were provided. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Patient states loss of apatite, flatulence, burping, feeling hot and sweating since day after Vaccine

I walk daily in hills around my neighbor with my dog. I noticed it being more taxing to walk uphill after having the vaccination. Also I do daily dance exercise classes for an hour. I could do it fully no issues but after vaccination I have a harder time completing the class with 100% participation all the way to the end. I noticed my feet feeling numbness in toes after lots of walking as well. Never had this happen before though I walk daily and occasionally all day at the local adjustment park.

Patient reports having a sore arm that is warm to the touch after getting her second Pfizer COVID-19 vaccine. She also reports some continued soreness and itchy feeling in her left arm which is about the size of a hand. She reports that this adverse reaction has improved since it started on 6/23/21 but it is still present ~5 days later. She will continue to monitor, and will report back to us and her primary care physician.

Day of First shot: headache, sore arm, extreme exhaustion, feeling that some virus or illness was coming on, intermittent chills. 36 hours after first shot: sore arm, headache, stomach ache (upper and lower), cramping, swollen gland on front of neck (just one gland). Had all of these symptoms on my second shot too, but not as bad. I did not have a swollen throat/neck gland, BUT had shortness of breath/asthma reaction on my second shot, and chest & sinus congestion. The intermittent asthma/shortness of breath, (haven't had in a long time), was without wheezing. I used my albuterol rescue inhalor and it seems to help me get through these boughts. The asthma came on at about 29-36 hrs and has lasted 6 days so far.

I do not think this is an adverse reaction at all. My lower back started swelling and having pain. My chiro is caring for me. I reported this on my form because it asked for new symptoms. The only reaction I have had is my left arm has remained and still is very painful and the pain is deep into my arm at the exam site. I have not told my PCP.

Acute onset of myalgia, polyarthraglia, cramps, weakness, stiffness, fatigue, edema, decrease mobility of small joints of hands, feet, wrists and ankles. Difficult to write and grasp items starting a few days after the first dose. Symptoms increased after second dose and continue to persist.

Pt was on 15 min observation following injection. After approximately 10 min pt began to complain of feeling like her heart was racing, dry mouth and feeling "Jittery", dizzy and weak

About 20 minutes after right cheek started twitching intermittently then became more frequent.; Right cheek feels numb; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 22Mar2021 at 07:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, COVID-19, shellfish allergy, penicillin allergy and angiotensin-converting enzyme (ACE) inhibitors allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included BYSTOLIC, CLARITIN and BENICAR, all for unknown indications from unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination. the patient had not been tested for COVID-19. On 22Mar2021, about 20 minutes after, the patient's right cheek started twitching intermittently then became more frequent and about an hour later, the patient's right cheek felt numb. It was unknown if patient 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 facial twitching and numbness facial were unknown. No follow-up attempts are needed. No further information is expected.

Swelling and pain under the arms; Swelling and pain under the arms; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 02Mar2021 at 8:45 as a single dose for COVID-19 immunisation. Medical history included thyroid. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), metoprolol ER succinate (MANUFACTURER UNKNOWN). The patient had a history of drug allergy to hydrocodeine. 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 24Feb2021, the patient underwent lab test included a nasal swab and the result was negative. On 02Mar2021, the patient developed swelling and pain under the arms. No treatment was received for the events. The clinical outcome of the events swelling and pain under the arms was resolved on an unknown date. Information about lot number cannot be obtained. No further information is expected.

Fever; Body aches; Shakes; Fatigue; Joint pain; Headache; Weakness; Chills; Sore arm; Nausea; Stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 19Mar2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had only known allergy with z-pak. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR), estradiol (ESTRACE), simvastatin (ZOCOR) and multivitamins, all for unknown indication received within 2 weeks of vaccination and was unknown if ongoing. The patient experienced fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea on 20Mar2021 at 06:00. The patient did not receive any treatment for 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 fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea was resolving at the time of reporting. Information about lot/ batch number cannot be obtained. No further information expected.

This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: 9W0187), intramuscular, administered in upper Arm Left on 17Jun2021 14:15 (Age at vaccination: 60 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she don't know if she has high blood pressure or diabetes at that time. Patient did not received any vaccinations prior to COVID vaccine. It was reported that she haven't took any medicine since Thursday morning (further not clarified). On 17June2021 the patient experienced fever went highest as 104 but it's down to 101 today, lot of pain, headache, muscle ache, tiredness, chills, joint pain, Feeling unwell, severe nausea, pain in her ear, severe vomiting, really draining she haven't eaten anything since Thursday at 6 pm, everything keeps 'coming', diarrhea, pain in 'neck area'. Consumer stated that I don't have my, the card with me, I am downstairs on the couch I don't have the card in front of me and I don't have enough energy to go upstairs to get it. Consumer stated, "I got the Pfizer shot (COVID Shot) on Thursday and Thursday evening I have been having the problems and it's still going today 20Jun2021 and I got the call from the pharmacist and he concerns about the side effects, I am not sure what caused all of this 'up again', I was fine before the shot and now that evening different things started happening, not feeling well." Patient did not had swelling. Consumer was suggested to share information and a safety report will be filed by the call handler which is going to be forwarded and if consumer want to speak to someone then call back attempt can be done in order to get a person. The patient underwent lab tests procedures which included body temperature was 104 , body temperature was 101 on 20Jun2021. Patient did not received any treatment for the events. last night something to control diarrhea Ammonia AD, that was the only thing that she took, to stop the diarrhea. But the pain was still there, diarrhea stopped. The patient was recovered from diarrhea in Jun2021,Outcome of Lot of pain was not recovered ,the outcome of the rest of the events was unknown.. Consumer was informed about the role of Pfizer Medical Information and offered the number. Information on the lot/ batch number has been requested.

Pfizer-BioNTech COVID-19 Vaccine EUA: After receiving dose 1 on 5/19/21 & 2nd dose on 6/9/21, I noticed daily, low-grade headache and continued muscle soreness in my left arm at the injection site that was used for both vaccines. I had frequent flushing/burning in my cheeks. As of 7/1/21, these symptoms linger but are becoming lesser. I treat the headache as needed with OTC ibuprofen. Note: When I contracted & was treated for Lyme's disease in or @ 2010, I had severe daily headaches for 1 year & then they went away. The covid vaccine side effects seem to be similar to the Lyme disease side effects.

Feb 3, 21 I was at work, around 8:20 PM I was standing at my computer, all of a sudden my legs felt aches and pains, it was so excruciating that my legs collapsed. My supervisor had to hold me, assist me to my car and leave work. While I was driving my sciatic nerve down to my legs and toes tingling, burning sensation, pain radiated. My arms, hands and fingers went numb and tingling. Trigeminal neuralgia.

Headache; Dizziness; Fatigue; Nausea; Swollen lymph node; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included losartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and labetalol (MANUFACTURER UNKNOWN), all for unknown indication within two weeks of vaccination. 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 positive for COVID-19. On 20Mar2021, at 19:00, the patient experienced headache, dizziness, fatigue, nausea, swollen lymph nodes, sore arm. Adverse 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 events. The clinical outcome of the events headache, dizziness, fatigue, nausea, swollen lymph nodes and sore arm was resolved on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.

In the week after receiving the second vaccine, I developed various joint pains and muscle pains, at times severe. The first event was both knees becoming very stiff and sore. It lasted about 24 hours. A day later, both my hands became swollen and stiff. Ibuprofen seemed to alleviate the problem. Since that time, at approximately 3-4 day intervals I developed pains in hands and knees again as well as ankles, bicep muscles, wrists, and jaw. This has continued for the last 3 months, and is now only in one of the pair of joints at a time, as in just one knee, not both at the same time. My right wrist is most commonly affected.

I am so confused; There is a sore there where I got it; I got a burning sensation in my whole body, like a hot flash almost.; I got a burning sensation in my whole body, like a hot flash almost.; I am not taking the second shot; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, in Left Arm on 28May2021 (at the age of 60-years-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included Fibromyalgia syndrome; Diabetes; Conversion disorder; Arthritis; and consumer stated, "I have a Pacemaker. The patient's concomitant medications included insulin aspart (NOVOLOG) taken for diabetes mellitus; gabapentin (GABAPENTIN) taken for neuropathy peripheral; tizanidine (TIZANIDINE) taken for muscle relaxant therapy; meloxicam (MELOXICAM) taken for inflammation; and Klonopin. Consumer stated, no prior vaccinations within 4 weeks of prior vaccination. On an unspecified date, the patient reported that she was so confused, there is a sore there where she got it, she got a burning sensation in her whole body, like a hot flash almost, and she supposed to get the second shot on 07June2021but she was not taking it. She further stated that she had a bad reaction to the Pfizer shot. They had to put her in a nursing home. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown, and sars-cov-2 test: unknown. The outcome for all the events was unknown. Information about batch/Lot number has been requested.

Bottom of both feet were very blue/purple, bottom of my feet became very red and eventually returned to the normal color; Numbness in my hands and feet; Became very cold; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot number: ER2613) via an unspecified route of administration in left arm on 23Mar2021 (at the age of 60 years) at 11:00 as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included CRESTOR for an unknown indication. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination the patient had not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 23Mar2021 at 19:00, the patient became very cold whereas the temperature remained 97.3 (unspecified units) and bottom of the feet turned blue/purple. The patient took a warm bath after which the bottom of the feet became red and eventually turned normal. The hands and feet had numbness. No treatment was received for the adverse events. The clinical outcome for the events feeling cold, feet turned blue/purple and numbness of hands and feet were recovering. No follow-up attempts are possible. No further information is expected.

Possible anaphylactic shock, acute kidney injury, shock liver, hypotension, rash, thrombocytopenia. Full body rash, abdominal pain, vomiting, diarrhea, RLE pain, fever, dizziness, body aches, headache. Sx onset 06/26/2021 after receiving COVID vaccine #2 the same day. Pt went to medical facility on 06/30/2021 and was sent to ED. Pt admitted to ICU 06/30 - 07/02. Transferred to general medical floor on 07/02/2021.

Itching on the arm (started within the first hour) and sore and my arm felt heavy (injection site arm). Hard to lift my arm. I noticed my fingers were swelled up. The itching never has gone away. I still get it. The swollen fingers took about two weeks to go away. I hadn't been able to take my wedding rings off. Heaviness didn't go away. When I got the second shot that got worse (heaviness). March 28 was date of second Pfizer vaccine - LOT# ER8730. The itching felt more prominent and I couldn't scratch by that time so I would try to rub it lightly to calm it. I would put warm compresses on my arm jus to fall asleep. I went to the doctor - I had to see a resident doctor in the office - that might have been 6/2/2021. He prescribed me to take two Aleve's morning and night. And he prescribed a muscle relaxant and Naproxen but none of that worked. I can't extend my arm unless I use my other arm to do it. It wakes me up at night. They also prescribed physical therapist and I had my second Physical therapy appt yesterday but it just hurts - they have scheduled me for12 sessions. I had realized there was a lump on the arm on the first week of May. Now the lump is bigger and you can feel hardness inside. Doctor could see it. The lump is a little lower to the right of the injection site. If I put my three middle fingers together it kind of covers the size - so it's the width of three finger. And that hurts - it wakes me up at night even if I'm not sleeping on it. I'm usually pretty tolerant of pain and I don't usually have time to go to the doctor but this is how bad it hurts - I had to go to the doctor. My physical therapist says they have had patients come in with those same symptoms after their vaccines. I also get lightning bolt pain on the left side of top of my hand - on my left hand. It feels like a neurological issue.

Complete brain fog for an entire day; Sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3248, Expiration Date- 30Jan2021) via an unspecified route of administration in left arm on 30Jan2021 as dose 1, single (at the age of 60-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9809) via an unspecified route of administration in left arm on 20Feb2021 as dose 2, single for COVID-19 immunization. Patient medical history included high blood pressure, diagnosed 20 something maybe 30 years ago, underactive thyroid, diagnosed 20 something maybe 30 years ago. The concomitant medications included atenolol at a dose of 25 mg and 75 mg taken for high blood pressure, patient started taking it years ago, levothyroxine at a dose of 0.075 taken for underactive thyroid, taking since 20 years ago, fish oil. Vaccination facility type was reported as hospital. Vaccine was not administered at Military Facility. Patient stated that she received the vaccine on 01Feb2021 and 20Feb2021. She was having abdominal pain and she did not know if that was related. She was also having very high blood pressure and palpitations. She felt like she was having neuro symptoms in her head, like she was having a stroke. The reason she went to the emergency room was she felt like her blood pressure was very high, and it was extremely high, they had to bring it down with a beta blocker. She reports that after, she was unable to get her blood pressure under control. She was on blood pressure medication prior to this but her blood pressure was under control, it then became uncontrolled. She had to start seeing a Cardiologist. She reported having extreme anxiety, since all of this happened, she had become an extremely anxious person. She reported her D-dimer was high. She stated that due to SOB and pulse ox and all, he did CAT scan to determine if she had pulmonary embolism, she did not. She stated her D-dimer was still high so he changed blood pressure medicines, increasing and manipulating them. Now she felt her blood pressure was under control. She was perfectly fine until she took the vaccine. The real issue was neuro symptoms. Her feet had gone numb, she has tingling in her feet, fingers, face, arms, legs, and head. She has a nerve conduction test on 12Jul2021 (as reported). She hoped that will show some things on the status of her nerves. She did not know where all of this came from as she was perfectly fine before the vaccine. She went through a bout of extreme anxiety, which she was a little better from now. Waking up in the morning felt like the petal was to the metal, felt everything is revved up. She could not control that, that went on for awhile. She tried different antidepressants which did not work. Since she has gotten off these she feels a little bit better now. The main reasons she was calling were for the cardiology, neurology, and anxiety issues. These are the adverse reactions she has had since the vaccine. She mentioned she still had to work and her feet and legs were not the best. She reported they put her on gabapentin, a nerve drug and it was helping her nerve problem. It was explained, regarding her blood pressure, the beta blockers worked to bring her blood pressure down. The cardiologist had manipulated her medications, increased them, and that had brought her blood pressure under control. She tried 2 antidepressants for extreme anxiety and that did not help, it made it worse. Since she got off of them she had improved. She still had it but it is not as bad as it was. She was on blood pressure medication and also on thyroid medication. Patient did not have a blood clot in her lung. She reported that after receiving the second dose she was sick with had fever, shaking, chills and flu-like symptoms and fogginess in the head. On an unspecified date in 2021, after the first dose she had total and complete brain fog for an entire day, also she had a sore arm. She stated for the neuro symptoms she woke up, put her feet over the side of the bed and could not feel her heels. Description of complaint included she was on blood pressure medication prior to this but her blood pressure was under control, it then became uncontrolled after the vaccine. She stated she was taking atenolol. She tried 2 antidepressants and that did not help, it made it worse. Since she got off of them she had improved. She still had anxiety but it was not as bad as it was. No additional information was provided regarding this statement. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

sore arm; headache; Fatigue; feeling drugged; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via unspecified route of administration in the left arm on 22Mar2021 at 14:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included mild osteoporosis and herpes. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. It was unknown if the patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced fatigue and feeling drugged on 22Mar2021 at 19:00. The patient experienced sore arm and headache on 23Mar2021. No therapeutic measures were taken for the reported events. The clinical outcome of the events fatigue, feeling drugged, sore arm and headache was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected

Sick with had fever; flu-like symptoms; She felt like she was having neuro symptoms in her head, like she was having a stroke; Palpitations; Blood pressure high; Tingling in her feet, fingers, face, arms, legs, and head; She reports having extreme anxiety; D-dimer is still high; She says her feet have gone numb; Waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. She couldn't control that; Abdominal pain; Fogginess in the head; fever; Shaking; Chills; This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EM9809, Expiration date: Unknown), dose 2 via an unspecified route of administration, in Left Arm on 20Feb2021 (at the age of 60 years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included high blood pressure Diagnosed 20 something maybe 30 years ago, underactive thyroid Diagnosed 20 something maybe 30 years ago, autoimmune thyroid disorder. Patient previously received first dose of bnt162b2 (Solution for injection, Lot number EL3248, Expiration date: Unknown) via an unspecified route of administration, in Left Arm on 30Jan2021 (at the age of 60 years-old) as 1 ST DOSE, SINGLE for Covid-19 immunisation. The patient concomitant medications included Atenolol years ago, she doesn't know taken for hypertension, Levothyroxine taken 20 years ago, a long time ago for thyroid disorder. The patient experienced abdominal pain on 01Mar2021. Patient had, palpitations, blood pressure high , tingling in her feet, fingers, face, arms, legs, and head, she reports having extreme anxiety, d-dimer is still high, she says her feet have gone numb, waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. she couldn't control that, She flu-like symptoms, she felt like she was having neuro symptoms in her head, like she was having a stroke in Apr2021. she was sick with had fever on an unspecified date. she had fever, shaking, chills, had fogginess in the head in 2021. She stated she was at the emergency room 3 times since receiving the vaccine. The reason she went to the emergency room was she felt like her blood pressure was very high, and it was extremely high, they had to bring it down with a beta blocker. She was on blood pressure medication prior to this but her blood pressure was under control, it then became un-controlled. She had to start seeing a Cardiologist. she has become an extremely anxious person. She states that due to SOB and pulse ox and all, he did CAT scan to determine if she had pulmonary embolism. She did not. She states her D-dimer is still high so he changed blood pressure meds, increasing and manipulating them. Now she feels her blood pressure is under control. The cardiologist has manipulated her medications, increased them, and that has brought her blood pressure under control. She is seeing a neurologist. She states she was perfectly fine until she took the vaccine. She hopes that will show some things on the status of her nerves. She does not know where all of this came from as she was perfectly fine before the vaccine. Waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. She couldn't control that; that went on for awhile. She tried different antidepressants which didn't work. She tried 2 antidepressants and that didn't help, it made it worse. Since she has gotten off these she feels a little bit better now. she was calling were for the cardiology, neurology, and anxiety issues. still has to work and her feet and legs are not the best. She reported that going to the ER on 17Apr2021, and she also thinks she went on the 25th and 29th. She reports they put her on gabapentin, a nerve drug and it is helping her nerve problem. states she does not have results of the tests other than she does not have a blood clot in her lung. After the first dose she had total and complete brain fog for an entire day, also she had a sore arm. Patient was working with the elderly in nursing home type of environment. The patient underwent lab tests and procedures which included computerised tomogram results unknown, fibrin d dimer was high, magnetic resonance imaging showed mri of brain it was ok. She has a nerve conduction test on 12Jul2021. The Outcome of event abdominal pain was recovered on an unspecified date in 2021. Outcome for the events palpitations, blood pressure high, She reports having extreme anxiety, Waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. She couldn't control that, fever, Shaking, Chills, flu-like symptoms, She felt like she was having neuro symptoms in her head, like she was having a stroke was recovering. Outcome for the other events tingling in her feet, fingers, face, arms, legs, and head, She says her feet have gone numb, fogginess in the head was not recovered. The outcome of D-dimer is still high, Sick with had fever was unknown. Information on Lot/Batch number was available. Additional information has been requested. No Follow-up attempts completed. No further information is expected.

Vagina Bleeding and cramping; Vagina Bleeding and cramping; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6203, Expiry date: not reported, age at the time of vaccination: 60-year-old), via an unspecified route of administration, administered in Arm Right on 17Mar2021 08:15 as dose 2, single for covid-19 immunisation in facility. Medical history included High Blood Pressure, known allergies include Penicillin, Menopause (I have been post menopause for over 15 years.) Concomitant medication within 2 weeks included metoprolol succinate (TOPROL XL) at 50 mg. Previously the patient received first dose of bnt162b2 (Lot number EN6198), in Arm left on 25feb2021 12:00 for covid-19 immunization. On 17Mar2021 20:00, patient experienced vagina bleeding and cramping and the patient had received a treatment as she had contacted her physician. 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 since the vaccination. The outcome of events was not recovered.

face/hand sensation/Tingling; Elevated tinnitus; Night sweats; Sweats; light-headed; Vertigo; Dizzy; Nausea; vomiting; diarrhea; hands sizzling; chills; Tinnitus/Tinnitus in other ear; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP letter sent in cross referenced case. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EP7533, Expiration Date: not reported) via intramuscular, administered in left arm on 05Apr2021 at 13:00 as dose 2, single for COVID-19 immunization. Prior vaccination within 4 weeks was none. Medical history included vitamin d deficiency, dry eye, and Injury. Concomitant medication included vitamin d [vitamin d nos] taken for vitamin d deficiency and ciclosporin (RESTASIS) taken for dry eye. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) on 08Mar2021 at 13:00, and experienced vertigo, dizzy, hearing loss, tinnitus, nauseous, diarrhea, chills, sweating, Hands felt like vibrating, and vomiting. The patient experienced vertigo, dizzy, nausea, vomiting, diarrhea, hands sizzling, chills and tinnitus/tinnitus in another ear on 05Apr2021 at 14:00. On 10Apr2021, the patient experienced light-headed. On 15Apr2021, the patient experienced sweats and on 19Apr2021, night sweats. Elevated tinnitus on 20Apr2021, face/hand sensation/tingling on 24Apr2021. The patient underwent lab tests and procedures which included blood test: all else normal, eosinophil count: low Eosinophil absolute- low, full blood count: normal, lymphocyte count: low and neutrophil count: high on 05Apr2021. The events recovered but reoccurred again. The patient did not received treatment for the events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

AFTER RECEIVING MY FIRST DOSE I WENT TO WAIT IN THE WAITING ROOM AND BEGAN HAVING A RACING HEARTBEAT ABOUT 10 MINUTES AFTER THE SHOT. I BEGAN TO FEEL DIZZY, MY HEART WAS RACING, MY PULSE SHOT UP FROM 64 TO 154 PER MY WATCH AND MY MOUTH GOT DRY. I ASKED FOR A NURSE AND THEY ESCORTED ME BACK TO A ROOM. I WAS FEELING LIKE I WAS GOING TO PASS OUT SO THEY LOWERED ME ON THE THE TABLE. THEY CHECKED MY PULSE AND 02. MY MOUTH WAS DRY AND MY LEGS AND HANDS WERE TINGLING. MY HEART WAS POUNDING AND I FELT SICK TO MY STOMACH. THEY CHECKED MY BP WHICH IS USUALLY LOW AND IT WAS REALLY HIGH. I WAS FEELING WEAK AND UNABLE TO STAND SO THEY TOLD ME THEY WERE TRANSPORTING ME TO THE ER. I WAS SHAKING, FREEZING, MY MUSCLES WERE CRAMPING IN MY ARMS AND LEGS. MY HEART CONTINUED TO RACE, I WAS DIZZY AND REALLY WEAK. I HAVE CONTINUED TO HAVE A RACING HEART BEAT AT RANDOM TIMES DURING THE DAY, STILL FEEL DIZZY AND FATIGUED. MY HEART ALSO POUNDS AT RANDOM TIMES DURING THE DAY. I AM NOT FEELING WELL.

Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Sore arm; Extreme chills; Body and muscle ache; Body and muscle ache; Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EW0182), via an unspecified route of administration in left arm on 10May2021 10:45 as single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included COVID-19. Concomitant medication included (paracetamol) TYLENOL. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via unspecified route in left arm on 19Apr2021 24:00 (Batch/Lot number EW0171) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 11May2021 23:00 the patient experienced with felt like COVID pneumonia all over again, sore arm, extreme chills, feels like ice in blood, Body and muscle ache and diarrhea. Treatment received was reported as no. The outcome of events was recovering.

Swelling in glands/lymph nodes; earache (right ear); burning and tightness in chest; burning and tightness in chest; Aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60- years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep6955) via unspecified route of administration in the left arm on 15Mar2021 at 15:15 (at the age of 60-years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling in n glands/lymph nodes, earache (right ear), burning and tightness in chest, aches and fatigue on 19Mar2021. The patient underwent lab tests and procedure which included COVID test (Nasal swab) on an unknown date and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of events swelling in n glands/lymph nodes, earache (right ear), burning and tightness in chest, aches and fatigue was not resolved. No follow-up attempts are needed. No further information expected.

temporary partial paralysis.; During my hospitalization my creatinine levels elevated and I was diagnosed with Kidney Failure.; During my hospitalization my creatinine levels elevated and I was diagnosed with Kidney Failure.; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:30 PM (at the age of 60 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Diabetes, High Blood Pressure, Asthma, Lupus, Fibromyalgia, Bipolar, PTSD from an unknown date and unknown if ongoing. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), lisinopril (LISINOPRIL), gabapentin (GABAPENTIN), tizanidine (TIZANIDINE) taken for an unspecified indication, start and stop date were not reported. The patient has allergy to Sulfa, Ibuprofen, Heaprin, Lisinipril. 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 been tested for COVID-19. On 14Apr2021 at 01:00AM the consumer stated that she had the Pfizer first vaccine 02Apr after which I was hospitalized for back surgery. During my hospitalization my creatinine levels elevated, and I was diagnosed with Kidney Failure. Which doctors attributed to an allergy to my blood pressure medication Lisinipril. I also experienced temporary partial paralysis. I have taken Lisinipril for 5 years with no side effects. I had previous blood test with normal findings. The adverse event resulted in life threatening illness (immediate risk of death from the event). The outcome of the events was recovering. Information on Lot/Batch number has been requested.

On May 27th 2021 At approximately 10 Am I was walking and I stumbled and I stumbled I noticed that I noticed my left foot was dragging.. I then started to walk again and I could not control or pick up my left foot. The following day may 28th again I was walking And stumbled because I had no control over my left foot . I continued to monitor my foot checking pulses for periodically for circulation galation doing exercises But no changes.. Appointment made with made with PCP Referral given bro given for brain MRIMRI results results negative referral referral given to C neurologist see neurologist. Appointment with neurologist Is in office test completed Referral given for spine spine MRI along with along with 2 prescriptions for pregnant for prednisone 10 mg tablets Start off taking 10 pills A-day pills A-day every other day decrease is their day decreased by one pill is pill also omeprazol oh omega prazal 40 mg 40 mg 1 A-day times A-day times 30 days then return to C earn to see neurologist Still under doctor's care.. Experiencing no experiencing numbness bilaterally to this early to the souls of feet cat is feet calf thigh and knee Unable to balance independently periodically fall down when is he fall down when walking Is feet in pain continuously.

soreness in arm; chills; fever 101.8; extreme fatigue; body aches; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the right arm on 25Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Concomitant medications included ascorbic acid (VITAMIN C) started on an unknown date for an unspecified indication. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced soreness in arm, chills, fever (101.8), extreme fatigue and body aches. The patient had tested for body temperature on 26Mar2021 and resulted 101.8 (unspecified units). Therapeutic measure was taken as result of events and included treatment with Tylenol. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness in arm, chills, fever (101.8), extreme fatigue and body aches were resolved on 27Mar2021. No follow up attempts are needed. No further information is expected.

Hi I got my second Covid shot on Saturday July 10. Shot was in the left arm. Severe headache within five minutes like last time. Felt like a migraine. After an hour the worse pain was in my left breast & armpit. My left armpit was swollen significantly & my breast felt like I was punched or stabbed. I couldn?t lift my left arm. I applied heat & ice alternately & took Tylenol. Then whole body ached like the flu. No worries there, it?s the swollen left armpit & pain in breast that is bad. Yesterday it got worse. I continued with heat, ice & Tylenol. I took today off because the pain is severe & I can only lift my arm half way up. The severe pain feels like how you feel after a surgery when pain meds start to wear off. Do you know how long this will last?? Thanks & have a great day.

rheumatoid arthritis; was really sick and it affected her fibromyalgia; she was just a mess and ended up vomiting and this took about three days; feeling sick; This case has been considered invalid initially upon follow up information case was processed as valid file The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting Medical Information. Upon receipt of follow-up information on (20Apr2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of two reports. This 60-year-old female consumer reported for herself that: a 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6206, Expire Date: unknown) via an unspecified route of administration, in the left arm on 08Mar2021 as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8734, Expire Date: unknown) via an unspecified route of administration, in the left arm on 29Mar2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing Diabetes, Sjogren's disease, obese and knee replacements like 10 years ago on both knees and she did not know the exact dates of the knee replacements. Concomitant medications included loratadine taken for rash from 13Mar2021 and ongoing; hydrochlorothiazide taken for sjogren's syndrome, fluoxetine taken for antidepressant therapy; montelukast sodium (SINGULAIR) taken for asthma, cetirizine hydrochloride (ZYRTEC ALLERGY) taken for rash. No additional vaccines administered on same date of the pfizer suspect. The patient did not receive any vaccines within four weeks prior to the vaccination. Caller stated she had a reaction to the Pfizer COVID vaccine and had the 1st dose on 08Mar2021 and after the 1st dose she was really sick and it affected her fibromyalgia and rheumatoid arthritis and she was just a mess and ended up vomiting and this took about three days which was normal. Stated after the 2nd dose within 24 hours she started feeling sick again on 30Mar2021 and she could not move and ended up throwing up and got a rash that appeared on her left arm; stated she had both doses of the Pfizer COVID Vaccine in her left arm and the rash was a little above where the vaccine doses were administered. Stated she had the 2nd Pfizer COVID vaccine on 29Mar2021 and had been coming in and out of feeling good and bad since then and for the rash she had, she used the Triamcinolone Acetone cream and the rash seems to subside and then flares back up and when the rash flares back up she got sick again. Stated the Triamcinolone Acetone cream is 0.1% with lot 0LT0435, expiry date Sep2022 and NDC number. Stated the rash has gotten larger than when it first appeared and when it did flare it itches and was hot and she also has Sjogrens disease in that rheumatology thing and has had the shingles shot 2 years ago; stated she had no name of the shingles shot to provide but had it 2 years ago in September and it was at Walgreens. Stated she just got over this weekend and was sick on Friday, was ok on Saturday and then on Sunday she could not move and was sick. Caller stated the 1st dose of the Pfizer Vaccine was administered on 08Mar2021 with lot EN6206; 2nd dose administered on 29Mar2021 with lot number ER8734; states the patient card has no expiry date or NDC written on it; stated she has had no treatment for the reported events and had not gone into the HCP office but wanted to. Stated her husband got nervous when he looked on the site and saw there were problems with the Pfizer COVID Vaccine in Israel about bringing up shingles in people and he read this in an article; caller stated her husband was concerned about her and thought maybe she had shingles and caller stated this was not shingles and she had the shingles shot and this did not look like shingles to her. Caller stated her husband himself had shingles and he got a little nervous and she herself was going to go to urgent care and did not feel like going that route; stated she had no other treatment. Stated she was having a bad reaction and sees enough doctors and went often enough if this was a real problem she would bring it up and the further away from testing the longer the distance was between her feeling ill; no further details stated by the caller. Stated she took quite a bit of medications and takes Hydrochlorothiazide for her Sjogrens disease and began taking that a little over a year ago and takes 300mg once per day by mouth. Stated she was on an antidepressant and takes Fluoxetine 60mg once per day by mouth and all the names of these medications a was going crazy in her head; stated she began taking Fluoxetine about 10 years ago. Stated she was on a lot of medicines that counter act anything the Pfizer COVID Vaccine could did to her regarding side effects and thinks the vaccine was too much for her body; no further details provided by the caller except she states she took several different asthma medicines and made the reported event not as severe and the rash was not as severe. Caller clarifies to state the medications she took for asthma that made the reported events less severe are Zyrtec 10mg tablets and she took it once per day and had been on it for years like 20 years; she takes Singulair 10mg once per day and had been on that for years and had two new medications just prescribed to her that was Loratidine 10mg once daily that she started taking on 13Mar2021 and then clarified this was the only new one prescribed and she also used nose sprays; no further details provided by the caller. Caller asks that based on what she had told medical, was she doing the right things for this and was she treating this the right way by letting it run its course; caller aware that Pfizer cannot offer medical advice or treatment recommendations and she was referred to her HCP. Adverse events not required in a visit to ER or MD office. Outcome of all events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076803 same reporter/drug/event, different patients

LA- 1st Covid Vaccine. IMMEDIATELY after Vaccine: Tingling & NUMBNESS to my fingertips. By Nine PM the night of vaccination, arm pain 10/10 with severe swelling, no mobility and feeling of a dislocated shoulder and elbow. Severe pain the next day accompanied by loud "Cracking" of my L Shoulder and L Elbow. Ongoing Shoulder/Arm pain with decreased mobility and numbness to the fingertips along the ulnar nerve & "cracking". Taking Motrin. Rotational shoulder pain. Consult Dr. 4/22/21. Consult Dr. (orthopedics)-- Prednisone prescribed. Pain improved a bit for 4 days- then pain and rotational problems continued. On 07/12: Visit to Dr., Orthopedics at hospital-- 2nd Prednisone dose pack. Continued from 1st page: 2nd Prednisone dosepak prescription. Was told my Dr. that I had probable improper administration (wrong location- too high) of Covid vaccine and severe, prolonged inflammatory response. I have been referred to physical therapy to improve mobility. Physical Therapy will call me for consult. Problem ongoing... I am tired of filling out this form and keeping it on my desktop.

I had a severe headache like a migraine the night before and then in the morning it was really severe. I couldn't stop throwing up. The night before I took the butalb-acetamin-caff. I went to an urgent care facility, and they sent me directly to the emergency room.

Burning , kneedle pain in left hand, chest pain, paralysis, not able to move or talk for hours, was taken to ER, was kept at the hospital overnight, released next day. Follow up with cardiologist & Neurologist, EKG test, Nuclear cardio test, angiogram of the heart , medication.

Was unable to walk, pain in uterus, severe pain in lower extremities, constant urination, dehydration.

I woke up around 2:30 in the morning of the 18th and I was having pain that went across my shoulders. In half an hour, it was going down both arms, up my neck and in my jaw. I started having chest pains. I went to the ER and they sent me to another hospital where they gave me blood thinners. They think something affected my heart or I had a blood clot. I was discharged two days later and was given an MRI of my heart. They determined that the lining of my heart was swollen. I am now on blood pressure meds and cholesterol meds and am not allowed to spike my heart rate for the next 3-6 months. The doctors believe it was caused by the vaccine.

Sore Right Arm and swollen vein ; ultrasound confirmed a blood clot in Right Arm. Trip to ER 6/30/21; put on blood thinner. No history of blood clots.. self or family. 2nd vaccine shot was 6/22/21 LOT EW0217

Headache; Chills; Fatigue; Muscle ache; generalized weakness; unable to stand for minimal amount of time due to chills and generalized weakness; This is a spontaneous report from a contactable Nurse, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration on 27Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included AFib, rheumatoid arthritis (RA), migraine, asthma, congestive heart failure (CHF), prosthetic heart valve, allergies, hyperlipidemia and pacemaker. Concomitant medications included warfarin (MANUFACTURER UNKNOWN), digoxin (MANUFACTURER UNKNOWN), verapamil (MANUFACTURER UNKNOWN), abatacept (ORENCIA), prednisone (MANUFACTURER UNKNOWN), leflunomide (LEFL); all from unknown date for unspecified indication. The patient had known(Unspecified) allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199), via an unspecified route of administration on 06Mar2021 at 15.45 (at the age of 60-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-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021 at 06.30, the patient experienced headache, chills, fatigue, muscle aches and unable to stand for minimal amount of time due to chills and generalized weakness. 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 clinical outcome of the headache, chills, fatigue, muscle aches and unable to stand for minimal amount of time due to chills and generalized weakness was not resolved. No follow-up attempts are needed. No further information is expected.

Hands and feet were burning, very painful and felt locked up. By the end of the day the extreme pain had subsided but now, hands, feet, ankles, back and arms hurt. So much so it?s keeping me up at night. Prior to the shot I did have hand pain due to RA. But not like this. Shooting pains start from wrists and go down into palms. Those come and go. Mornings are terrible. The pain is getting worse. Taking over the counter pain pills reduces the pain a little bit.

feels hot to touch; Swollen; Having the redness on the arm/tiny redness; Arm feels hard inside like its inside the muscle; Redness on her arm (where the injection was given)/bit of redness, tiny redness, the size of a penny; This is a spontaneous report from a contactable consumer or other non-HCP. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Left Arm on 27Jun2021 10:00 as DOSE 2, SINGLE (at the age of 60-year-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180) administered in Left Arm on 06Jun2021 at 12:00 for covid-19 immunization and had a little bit of tiredness and sleepiness. On 27Jun2021 the patient experienced redness on her arm (where the injection was given) and bit of redness, tiny redness, the size of a penny. On 28Jun2021 the patient experienced feels hot to touch, swollen, having the redness on the arm/tiny redness, arm feels hard inside like its inside the muscle. The patient's arm feels hot to the touch and swollen: The next morning, 28Jun2021, in the morning, the caller finds out that her arm is swollen, not the whole arm, but the area where the caller received the second dose Pfizer Covid Vaccine, it was maybe 5 to 6 centimeters that it was swollen. The patient arm feels hard inside like its inside the muscle. Her arm was hard when touching the muscle, will feel hardness inside when touching arm. Her arm feels hot to the touch and swollen: The arm felt hot, warm, and swollen. Her arm feels hot to the touch and swollen: In the night hours, maybe about 2000, the callers arm swelling was already 9.5 centimeters, the swelling grew. All day on 28Jun2021, the caller was putting a little ice pack and wet and cold things onto the arm. Today, 29Jun2021, in the morning the caller finds out the size is the same. Her arm feels hard inside like its inside the muscle: The hardness in the caller's arm muscle is a little less. The caller doesn't feel the big chunk inside of the arm. There is a little less hardness. Her arm feels hot to the touch and swollen: The swelling is the same. The size is the same on the arm. Her Has redness on arm where the second dose Pfizer Covid Vaccine was given: The color is the same on the arm. Therapeutic measures were taken as a result of swollen. The outcome of event arm feels hard inside like its inside the muscle was recovering. The outcome of rest all events was not recovered.

Throat clearing; fleeting hot flash; This is a spontaneous report from a non-contactable consumer. A 60-years-old non-pregnant female patient received BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via an unspecified route of administration on 24Mar2021(at the age of 60-years-old) as a single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. It was unknown, if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The Patient was not tested for COVID-19 since the vaccination. On 24Mar2021, the patient experienced throat clearing and fleeting hot flash. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the reported event. The clinical outcome of the Throat clearing and fleeting hot flash was recovered on unknown date. Information about lot/batch number cannot be obtained. No further information is expected.

Pain/heaviness in left arm; Sweats; Chills; Diahrea; Nausea; Weakness; Fatigue for 3 weeks; This is a spontaneous report received from a contactable health care professional (patient). This is the 1st of 2 reports, for the 1st dose. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231) via an unspecified route of administration on the left arm on 07Jan2021 at 17:00, as single dose for COVID-19 immunisation (age at vaccination 60-years-old). Medical history was reported as asthma, hypothyroidism, neuro damage in spine and wrists, vertigo, migraines (none in past 5-6 years), arthritis, and mood disorder. Concomitant medications included bromide, vilanterol trifenatate (ANORO); levothyroxine sodium (UNITHROID); paliperidone; valproate semisodium (DEPAKOTE). The patient previously took Darvon [dextropropoxyphene hydrochloride] and was allergic to it. 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 4 weeks prior to the COVID-19 vaccine. On 08Jan2021 at 14:00, the patient experienced pain/heaviness in left arm, sweats, chills, diarrhea, nausea (nausea for 3 days), weakness, and fatigue (fatigue for 3 weeks). The patient received treatment for the reported events as an injection of a medication with high NSAID (non-steroidal anti-inflammatory drugs) levels. Patient visited the doctor or other healthcare professional office/clinic visit for adverse event. The events outcome were recovered with sequalae. No follow-up attempts are needed. No further information is expected.

chills; Headache; fatigue; Sorearm; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6203) via an unspecified route of administration in the left arm on 18Mar2021 at 14:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included sulphonamide allergy and bee sting allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 25Feb2021 at 14:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient had not been tested for COVID-19. On 18Mar2021, the patient experienced chills, headache, fatigue and sore arm. No therapeutic measures were taken as a result of the event. The event 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 chills, headache, fatigue and sore arm was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-year-old female patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8729, Expiration Date: UNKNOWN), via an unspecified route of administration, in left arm, on 19Apr2021 (at the age of 60-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included atrial fibrillation from Jun2020 and ongoing patient stated she was diagnosed after the heart surgery, heart surgery on 20May2020 patient stated she had a new Tricuspid valve placed and she was in the hospital for two weeks during the surgery and she was still having some problems from the heart surgery, ongoing BP elevation patient stated about two weeks ago, her heart doctor kept her on a blood pressure medication, and she cannot provide the name, stroke on 27Feb2020 and ongoing, had hole in heart from birth and unknown if ongoing. The concomitant medications of the patient included apixaban (ELIQUIS) taken as blood thinners from Jun2020 and ongoing and metoprolol (METOPROLOL) taken for heart issues from Jun2020 and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER2613, Expiration Date: UNKNOWN), via an unspecified route of administration, in left arm, on 26Mar2021, as single dose for COVID-19 immunisation and she also received flu shot on an unspecified date in Oct2020 (at the age of 59-years-old) and reported arm sore. There was no investigation assessment. There were no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The family medical history relevant to AE(s) was not provided. The relevant tests were reported as none. AEs prior vaccination was reported as arm sore. On 04May2021, the patient reported she's had severe arm pain on the arm with the injection (left). She stated she is still having the pain. it's like someone punched you in the arm with their fist, the pain was running my blood pressure so i had to go to the hospital/blood pressure elevated, 212/109 and atrial fibrillation on an unspecified date. The patient reported that her arm hurt so bad, pain, cannot put her arm behind her back, after second vaccine, it had been over 2 months since her arm hurting her, and she went to the emergency room and her blood pressure went way up and she had some heart issues and had atrial fibrillation two to 3 weeks after the second shot, and it lasted one day. She asked how long the pain will last and was anyone else reporting arm pain for this period of time. The patient was hospitalized as a result of events from 06May2021 to an unknown date. The patient visited emergency room. The patient underwent lab tests and procedures which included Blood Pressure elevated: 212/109 on 06May2021. Therapeutic measures were taken as a result of events that included, she took Tylenol. She reported that she was given medication in the hospital, cannot provide the name and the medication did help to bring her blood pressure down and she also did get a shot of a steroid states the steroid did help to relieve some of the arm pain. The outcome of the events having the pain. it's like someone punched you in the arm with their fist and the pain was running my blood pressure so i had to go to the hospital/blood pressure elevated, 212/109 was reported as unknown and the patient recovered from atrial fibrillation on an unspecified date in 2021. Follow-up attempts are completed. No further information is expected. ; Sender's Comments: A causal association between BNT162B2 and the reported events atrial fibrillation, blood pressure increased and pain in arm cannot be completely excluded based on information provided. However, patient's underlying medical conditions atrial fibrillation, septal defect, heart surgery, hypertension and advanced age were confounders. 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.

Painful blisters and rash on left side, starting as small boils, diagnosed as Shingles, after second vaccine.; Painful blisters and rash on left side, starting as small boils, diagnosed as Shingles, after second vaccine.; Painful blisters and rash on left side, starting as small boils, diagnosed as Shingles, after second vaccine.; Sore, reclarified as left arm after the first and second vaccine; Fever, after the second vaccine; Muscle pain, after the second vaccine; Itching, left arm at the injection site, after second vaccine; Left side of body aching, after the second vaccine; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8735, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 03May2021 17:00 (at the age of 60-years-old) as dose 2, single for covid-19 immunisation in pharmacy. No vaccines administered on same date of the Pfizer suspect. The patient did not have prior vaccinations within 4 weeks. The patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Medical history included glucose tolerance impaired from 2020 and ongoing (patient stated probably last year), blood cholesterol increased from 2020 and ongoing (patient states at about the same time as diagnosed with prediabetes). Family medical history was none. Concomitant medication(s) included naproxen taken for arthralgia from an unspecified start date to 10May2021; valaciclovir hydrochloride taken for herpes zoster from 12May2021 and ongoing. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8729, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 11Apr2021 17:45 (at the age of 60-years-old) as dose 1, single for covid-19 immunisation in pharmacy and experienced she fell in the office and she had knee pain, Sore, reclarified as left arm after the first and second vaccine. On May2021, the patient experienced, muscle pain, after the second vaccine, itching, left arm at the injection site, after second vaccine, left side of body aching, after the second vaccine. On 04May2021, the patient experienced sore, reclarified as left arm after the first and second vaccine, fever, after the second vaccine. On 10May2021, the patient experienced painful blisters and rash on left side, starting as small boils, diagnosed as shingles, after second vaccine. The events resulted in physician office visit. Patient stated she was not sure if she had to call, but she still was in pain, and she wants Pfizer to know, so she can help other people. Patient stated she had her second dose of the vaccine and then the following day she was sore in morning. Patient stated she had a fever for 3 consecutive nights. Patient stated because she had normal effects, the vaccine was probably working. Patient stated on the third night she had muscle pain. Patient stated her left side of her body was aching and she used a pad on it for the muscle pain. Patient stated on 09May2021 or 10May2021, she had blisters that were painful on her left side. Patient stated that the blisters were diagnosed as Shingles. Reclarified, patient stated she had a video visit with her primary care doctor. Patient stated that and she noticed the rashes and blisters on the left side of her body. Patient stated they started as small boils and then blistered. Muscle pain started probably on morning of 05May2021 or 06May2021. Itching, left arm at the injection site, after second vaccine started on 05May2021 or 06May2021 and confirmed the itching is not like it first started. Left side of body aching, after the second vaccine started on noon of 05May2021 or 06May2021. Patient stated when she went to the urgent care for her knee pain, they gave her Naproxen Patient stated she stopped taking it when the rash and blisters appeared. Patient was thinking she was allergic to the medications, not the shingles. Patient stated she has high cholesterol and diabetic medications that she doesn't take. Patient stated she checks her blood sugar, and they are normal. Therapeutic measures were taken as a result of muscle pain, after the second vaccine with a pad on it and Motrin. Patient stated that when she takes Motrin it helps with the pain, but then it comes back when the medication wears off. The outcome of the event sore, reclarified as left arm after the first and second vaccine was recovered on an unspecified date of May2021. The outcome of the event fever, after the second vaccine was unknown. The outcome of the events muscle pain, after the second vaccine and itching, left arm at the injection site, after second vaccine was recovering and not recovered for other events. Information about Lot/Batch number is available. Further information has been requested.

Pain; shoulder and armare still sore; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old female non-pregnant patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202), via an unspecified route of administration in arm right on 12Mar2021 at 12:15 (at the age of 60-years) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medication included unspecified herbal supplement/vitamins taking from over 5 years. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EM9809), via an unspecified route of administration in arm left on 19Feb2021 at 9:15 (at the age of 60-years) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine 4 weeks prior to 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 12Mar2021 at 13:45, the patient experienced pain less than one day later the vaccination, waited for the pain to resolve but it had not, and it was continuing to get worse, the patient shoulder and arm are still sore, the pain is getting progressively worse and not it hurts to lift the arm when comb the hair or to put dishes in the cabinet but it hurts to lift arm up and it hurts when the patient pick up objects of 8 ounces or more. No therapeutic measures were taken 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 clinical outcome of the event vaccination site pain and pain in arm was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Day 3 woke up with dizziness; Vertigo; Feel soreness in arm almost right after shot. Moved arm and massaged.; Developed a red rash at site for next 12 hours.; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 25Mar2021, (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was allergic to amoxicillin and erythromycin. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021, at 07:00, the patient felt soreness in arm almost right after shot, moved arm and massaged and also developed a red rash at site for next 12 hours. Developed a red rash at site for next 12 hours. On 27Mar2021, the patient woke up with dizziness and vertigo. The adverse 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 soreness in arm, vertigo and dizziness was not resolved, while the clinical outcome of red rash was resolved. No follow-up attempts possible. No further information expected.

Massive headaches; very bad arm pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the arm right on 22Mar2021 at 13:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer and diagnosed COVID-19. The patient had no allergies to medications, food, or other products. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) and venlafaxine (MANUFACTURER UNKNOWN) taken for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 the patient experienced massive headaches and very bad arm pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of events massive headaches and very bad arm pain were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Client reported nausea, tingling in her left hand, and slight dizziness at 6:45ish. Vitals obtained at 6:53PM PM were as follows: BP 120/78, HR 71, O2 96%. The client reported a history of nausea when she is nervous. Client was provided an emesis bag. Vitals obtained at 6:58PM were as follows: BP 120/68, HR 65, and O2 98%. The client reported a history of hypotension. The client stated she has to be sure to stay adequately hydrated or she notices a decrease in her blood pressure. Current medications include Avapena. The client denied any s/s of anaphylaxis. At 6:55PM the client reported a headache. The client did eat today. At 7:02PM RN provided the client a cotton ball with peppermint oil on it to smell.. The client stated her headache was very light at 7:05PM. The client left at 07:10PM.

Diarrhea. No appetite. Flu-like symptoms: Headache; Weak; No energy; I am currently having digestive issues.

The morning following vaccination, the patient reported pain and heaviness in middle portion of her left arm (the arm that received the vaccine). The patient stated that the pain was fairly localized around the elbow area, with the area of the pain starting about six inches below the elbow and stopping about six inches above the elbow. The pain made normal activities uncomfortable and became more intense as the day progressed. The patient also reported noticing occasional shooting pains originating at her shoulder and traveling down her left arm. She did not mention any systemic signs or symptoms nor did she report any areas of redness or swelling. After about a week of the elbow-area pain, the patient sought care at an urgent care provider who ordered x-rays of her arm, which did not show any detectible damage. After that visit, the patient saw her primary care doctor for the arm pain as well as for routine care. The patient noted that the provider suggested possible nerve involvement due to the vaccine and/or its administration and mentioned to the patient that the arm pain should improve over the next few months. The patient regularly sees her primary care doctor and a cardiology due to poorly controlled hypertension.

Pain seems to be in shoulder area and bicep area; aching/ stabbing pain; Bump reappeared with red itchy rash; Extreme pain and mobility issues with left arm that lasted from time I received vaccine but really worsened on 4/2/21./ Could not even lift my arm any distance from body in any direction; mobility issues/ did not had full mobility; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 30Mar2021 at 12:30 (Lot Number: EN6208) at the age of 60-year-old as single dose for COVID-19 immunization. Medical history included allergies to medications and food. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included estradiol, antihistamines, vitamins and progesterone. The patient experienced extreme pain and mobility issues with left arm that lasted from time received vaccine but really worsened on 02Apr2021. On 04Apr2021, the patient went to urgent care. Went again to primary care doctor 4/8/21. It was gotten better each day but still did not had full mobility and had some pain. The patient could not event lift arm any distance from body in any direction. Extreme pain on scale of 1-10, a definite 10. Aching, stabbing pain. Bump reappeared with red itchy rash on the 07Apr2021, but was not severe. And improved today the 10Apr2021. Still not able to fully extend arm up above head. Pain seems to be in shoulder area and bicep area. At 2nd application, they prescribed Prednisone as treatment for events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.

Sore arm; chills; body aches; pain under left arm pit; headache; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 (at the age of 60-years) as a single dose for COVID-19 immunisation. The medical history of the patient included high blood pressure. The patient did not receive any concomitant medications with in 2 weeks of vaccination. The patient had no known allergies to food, medications, or other products. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via an unspecified route of administration in the left arm on 10Mar2021 at 10:00 (at the age of 60- 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-19 vaccine. 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 31Mar2021 at 17:00, the patient experienced the events sore arm, chills, body aches, pain under left arm pit and headache. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore arm, chills, body aches, pain under left arm pit and headache was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.

3/23 Arthritic flare up w/ painful numbness. NSAIDs, Voltaren, referred to Rheumatologist, Physical therapy.

Sore arm; This is a spontaneous report from a contactable consumer (patient reported for herself). A 60-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jun2021 (Age at vaccination:60 years) as DOSE 1, SINGLE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient medical history was penicillin allergy and concomitant medications were not reported. The patient previously took allergyx. 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 vaccine within 4 weeks prior to covid-19 vaccination. The patient had not received other medications in two weeks. On an unspecified date, after the 1st shot she experienced mild side effects of sore arm. The event outcome was unknown.

pain/heaviness in left arm; pain/heaviness in left ram; pain/heaviness in left arm; sweats; chills; diahrea; Weakness; nausea; fatigue; low tolerance to sound and light; low tolerance to sound and light; vertigo; feeling cold; headaches; muscle/joint pain in all extremities; muscle/joint pain in all extremities; diminished sense of taste; blurred vision; confusion; mood changes; increased sleep; physical agitation; difficulty breathing; Aggravation/exacerbation of underlying neurological/ pulmonary conditions; Pain in injection arm persists; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 60-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9261) via an unspecified route of administration in Arm Left on 29Jan2021 07:00 (age at vaccination 60 years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, vertigo from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing None in past 5-6 years, arthritis from an unknown date and unknown if ongoing, affective disorder from an unknown date and unknown if ongoing, nervous system disorder from an unknown date and unknown if ongoing. The patient had unknown allergies Darvon. 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. Concomitant medication(s) included umeclidinium bromide, vilanterol trifenatate (ANORO); levothyroxine sodium (UNITHROID); valproate semisodium (DEPAKOTE); paliperidone (PALIPERIDONE). All taken for an unspecified indication, start and stop date were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EK9231) via an unspecified route of administration in Arm Left on 07Jan2021 17:00 (age at vaccination 60years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced after second dose pain/heaviness in left ram, sweats, chills, diahrea, nausea 3 days. Weakness and fatigue for 3 weeks, low tolerance to sound and light, vertigo, feeling cold, headaches, muscle/joint pain in all extremities, diminished sense of taste, blurred vision, confusion, mood changes, increased sleep, physical agitation, difficulty breathing. These lasted 5 weeks. Mood changes, breathing difficulties, vertigo, muscle and joint pain persist. Aggravation/exacerbation of underlying neurological/ pulmonary conditions. Pain in injection arm persists on unspecified date. Therapeutic measures were taken as a result events which included injection of a medication with high NSAID levels. AE resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was recovered with sequelae in 2021. No follow-up attempts are possible. No further information is expected.

Similar to allergic/immunity response; Intense and long term hives; rash; itching; burning on neck, back of neck (top of back), chest, arms, legs; Unable to sleep; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: 8727) via an unspecified route of administration on 29Mar2021 (at the age of 60 years old) as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Known allergies was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced similar to allergic/immunity response, intense and long term hives, rash, itching, burning on neck, back of neck (top of back), chest, arms, legs, unable to sleep on 08Apr2021. Event reported as intense and long term hives, rash, itching, burning on neck, back of neck (top of back), chest, arms, legs. Similar to allergic/immunity response. Nothing at injection site or on torso or face. Unable to sleep, work, leave house. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included prednisone, antihistamines, steroid oil, EpiCeram. Since the vaccination, the patient has not tested for COVID-19. Outcome of the events were not recovered. Follow-up attempts are completed. No further information was expected.

New onset eczema- Filed earlier report about being bitten by fire ants two weeks after second covid shot and having anaphylactic reaction with no prior history of insect bite allergies and have been bitten alot including the harvester ant. Now have epipen. Then started fire ant shots in June and developed butt tingling/numbness and muscle and body aches after 2nd fire ant shot. By third shot on on July 1st, I had fatigue, extreme musculoskeletal pain and developed a rash. It was really scary so went to the allergist who referred me to my GP. She thinks it is serum sickness. Saw the dermatologist today about the rash and it started about 3 to 4 days after the third fire ant shot. I have never had eczema in my life either. After three weeks from July 1st, am starting to feel better. Not sure if serum sickness caused by molecular mimicry hypersensitive immune syndrome caused by Covid vaccine or not, but there are a lot of immune mediated things happening to me in less than 3 months. My brother developed pericarditis after the second Pfizer shot and I told him to file a VAERS as well.

Splitting headache; Extreme fatigue; Hot flashing; Felt nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: PAA16596S/06/2022), via an unspecified route of administration in the left arm on 15Mar2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Meniere's disease. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), multivitamin (MANUFACTURER UNKNOWN), ubidecarenone (COQ10) and vitamin D not otherwise specified (NOS) (MANUFACTURER UNKNOWN) all since an unknown date for an unknown indication. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 15Mar2021 at 11:05, within 5 minutes of vaccination, the patient felt nausea and had nausea all day for 48 hours. Four hours after the shot, at 15:00, extreme fatigue had kicked in and experienced hot flashing. On 16Mar2021, the morning the patient woke up with a splitting headache that lasted for 24 hours. On 17Mar2021, the patient felt great and free of symptoms. The adverse 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 felt nausea, extreme fatigue, hot flashing, and splitting headache were recovered on 17Mar2021. No follow-up attempts are needed. No further information is expected.

Endorses significant painful swelling of multiple joints including hands, wrists, legs, ankles, decreased mobility of the small joints of her extremities. Symptoms worsened after the second dose of the vaccination. Since then, her symptoms have worsened. Endorses hand swelling daily, worse overnight and in the mornings. States that she wakes up with her hands paralyzed into a claw position, painful, right worse than left. Endorses fatigue, myalgias, weakness. States her fingers feel that they are on fire. Is starting to drop things -having difficulty with sustaining grasp and having difficulty writing.

Slight sore arm; Severe headache; chills; nausea; vomiting; This is a spontaneous report from a contactable healthcare professional, the patient. A 60-year-old non-pregnant female 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 01Apr2021 at 10:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis, alopecia areata (not chronic but recent) and penicillin allergy. Concomitant medications included loratadine (CLARITIN), ascorbic acid; calcium; minerals nos, retinol; tocopheryl acetate; vitamin b nos; vitamins nos; zinc (CENTRUM SILVER) and others (unspecified). 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 02Apr2021 at 08:00, the patient experienced slight sore arm, severe headache, chills, nausea and vomiting. The headache started within 24 hours of the vaccine. It became worst and most severe approximately around 32 hours after the vaccination. The severe headache and chills lasted for approximately 26 hours after they started. 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 patient did not receive any treatment for the events slight sore arm, severe headache, chills, nausea and vomiting. The clinical outcome of the events slight sore arm, nausea and vomiting was resolved on an unspecified date in Apr2021. The clinical outcome of the events severe headache and chills was resolved on 03Apr2021 at 10:00. No follow-up attempts are needed. No further information is expected.

On March 30 2021, she received her second Pfizer Covid-19 vaccination. Four days after receiving the vaccine she started losing her vision, it was hard to focus and she had double vision. She went to the ER where they did an EKG, chest x-ray, cat scan and lab work and was told to see an ophthalmologist. On April 6 the ophthalmologist told her she had Six Cranial Nerve Palsy on the right side of her eye. She was referred to a neurologist. An MRI was performed on the head to look for additional causes, where nothing additional was found. She has a past history of Bell?s Palsy on both sides of her face. She was not able to tolerate a steroid, so she was seen every 4 weeks for 3 months. After the 3 months her vision started to return during the daytime with double vision still at night. Her sight returned after another 2 to 3 weeks.

pressure in head , slight tingle in right hand and spine at 3 am , noticed veins on hands and legs are all I can see , green in color , back to normal in the morning. tired and sleep for 4 days

Headache; Tiredness; Muscle pain; Chills; I am so painful in my joints, all muscle ache; I was so tired and weak; I am not feeling well; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number: EW0167, Expiration date: Aug2021), via an unspecified route of administration, administered in Arm Left on 20May2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus from 26Apr2021 to 26Apr2021. Concomitant medications included metformin, lisinopril and glipizide. Historical vaccine included first dose of BNT162B2 (Lot number: EW0171) via an unspecified route of administration, administered in left arm for COVID-19 immunization. Patient got the vaccine second dose and patient was not feeling well. patient got the vaccine in the morning and midday patient was having like headache, tiredness, muscle pain and last night, patient was not shivering but patient was feeling chills inside her body like patient was under the layers of blanket, but patient did not have fever. My temperature patient kept taking it was last 98 to 97.9 something like that. Patient kept taking her temperature, but patient so painful in her joints, all muscle aches. Patient was so tired and weak on an unspecified date in 2021, for headache patient have taken Tylenol (Treatment) it comes in and goes. The outcome of the events headache, tiredness was not recovered while unknown for another events. Information on Lot/Batch number was available. Additional information has been requested

pneumonia; loss of consciousness; difficulty in breathing; feeling weak; diarrhea; Arm fracture; Fall; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer. (MFR Control No. # 21K-163-3955081-00). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 26Apr2021 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation; adalimumab (HUMIRA 40MG/0.4ML, Solution for injection in pre-filled pen), subcutaneous from 03Apr2020 (Batch/Lot number was not reported) to Mar2021, at Citrate Free (40 mg,1 in 2 wk), subcutaneous from Mar2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for Ulcerative Colitis. Medical history included tobacco user: one pack of cigrette per day (Started 1978), abstains from alcohol. Concomitant medications included tizanidine; carvedilol (COREG); pregabalin; atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS). The patient previously took hydrocodone. The patient experienced loss of consciousness on May2021 with outcome of recovered on May2021, pneumonia on 05May2021 with outcome of recovered in 2021, feeling weak on 27Apr2021 with outcome of unknown, difficulty in breathing on 27Apr2021 with outcome of unknown, diarrhea on Mar2021 with outcome of recovered in 2021, arm fracture on 27Feb2021 with outcome of recovering, fall on 27Feb2021 with outcome of recovering. Clinical course: In 2021, the patient experienced chest tube had been drained and removed. On 27Feb2021, the patient experienced broken right arm in two different places and fell. In Mar2021, the patient experienced diarrhea. in May2021, the patient experienced loss of consciousness. on 05May 2021, the patient experienced pneumonia. in May 2021, the loss of consciousness resolved. in 2021, the pneumonia and diarrhea resolved. Covid-19 vaccine was also considered suspect. the patient shared that she fell in 27Feb2021 and broke her right arm so she went to the emergency room. Her x-ray revealed that she broke her arm in two different places. she was then asked to meet with an orthopedic surgeon and was scheduled for an out-patient procedure to repair her broken arm with pins and plates on the second week of Mar2021. she was sent home and was given hydrocodone for pain. she also added that the physician placed her humira on hold two weeks prior and after the procedure. because of humira was placed on hold, she experienced diarrhea for a week until it resolved. she received her first dose of her covid-19 vaccine in 26Apr2021. she noticed that she started feeling weak and had difficulty in breathing the next morning. she was rushed to the hospital in 05May2021 because her weakness and difficulty of breathing worsened. a series of unrecalled tests had been performed including chest x-ray which showed that she had pneumonia. she was then admitted and was hooked up to a machine because she had difficulty in breathing. she added that she could not recall any other treatments or diagnostic tests that was done to her because she was unconscious for three weeks and was monitored in the intensive care unit. she added that her chest tube had been drained and removed the day she got released in the hospital. she was sent home in 25May2021. alternative etiology of pneumonia, weakness, loss of consciousness, difficulty breathing were reported as covid-19 vaccine.it was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown. Causality for humira 40mg/0.4ml(adalimumab)-the reporter's causality for the event(s) of loss of consciousness, broken right arm in two different places, pneumonia, fell and diarrhea with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of chest tube had been drained and removed was not provided. Programs opinion is that there is no reasonable possibility that the events of loss of consciousness, broken right arm in two different places, chest tube had been drained and removed, pneumonia, fell and diarrhea are related to humira 40mg/0.4ml(adalimumab). COVID-19 VACCINE (COVID-19 VACCINE)(Injection) (COVID-19 VACCINE), Causality: Loss of consciousness-Causality as per reporter (Drug/Vaccine): Probable; Arm fracture-Causality as per reporter (Drug/Vaccine): Not Related; Pneumonia-Causality as per reporter (Drug/Vaccine): Probable; Fall-Causality as per reporter (Drug/Vaccine): Not Related; Diarrhea-Causality as per reporter (Drug/Vaccine): Not Related. The reporter's assessment of the causal relationship of the events (feeling weak, difficulty in breathing) with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the plausible temporal relation, the association between the events of loss of consciousness, pneumonia, asthenia and dyspnoea and the suspect product of BNT162B2 cannot be completely ruled out. The confounding factor for the event of pneumonia is the co-suspect drug Humira Due to implausible temporal association, the events of diarrhoea, arm fracture and fall are assessed as unrelated to 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.

the aches and pains were severe and affected all of her joints; cramping up in her calves and it hurts; sight issues; She could barely move; arthritis; she has real sensitivity to light; She still has pain in her knees when she walks, it's almost like her knees want to give out. Severe pain in hips; severe pain was also in her back, hips and neck; severe pain was also in her back, hips and neck; aches and pains; Diarrhea; Severe fatigue; a little bit of swelling; pain at the site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169; Expiration Date: Aug2021, at the age 60-year-old), dose 1 via an unspecified route of administration, administered in arm left on 27Apr2021 13:00 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Prior vaccinations (within 4 weeks), adverse events following prior vaccinations, patient's medical history (including any illness at time of vaccination), family medical history relevant to adverse events and relevant tests: none. Caller stated she had the shot and a reaction with the first shot and haven't had the second. She clarified she was referring to the covid 19 shot. On 27Apr2021, she had the first vaccine. The day of the vaccine, she experienced normal swelling, a little bit of swelling (not much), and pain at the site, which was normal. The pain went away but she doesn't know it went away. No treatment received. Then, after a few days, she started out with aches and pains but then it got to the point, the aches and pains were severe and affected all of her joints. She could barely move. Her husband had to help her on and off the toilet and that lasted a good week. She also mentions she had diarrhea. She doesn't know. It was probably a couple days later after receiving the vaccine. She was still having diarrhea, but it had improved. She has been taking Imodium. Patient reported that 2 days after she got the shot, she was severely fatigued and that's when the aches and pains started. Caller doesn't know the exact date. If she stands for more than 5 minutes, she has cramping up in her calves and it hurts. She confirms she has recovered with lasting affects. She adds she also has arthritis which might be a factor. She clarifies the aches and pains started on third day. She believes the third day, she is not exactly sure. The aches and pains got worse. When she says severe fatigue, she means she was in bed all day. Time of onset: She would say the fatigue started the 2nd or 3rd day. She provides the start date as: 29Apr2021. The severe fatigue is better than it was but hasn't gone away. She makes the comment she doesn't know why she reacted so bad to the first vaccine. She mentioned she was supposed to go on 18May2021 and get second shot, but she cancelled it. She explains this is one of the reasons she is calling. She needs to know should she get the second shot. Patient wanted to be protected against covid the best she could, her husband has major heart issues and she can't have him being exposed to the virus and she needs to get a shot. She's scared. DSU agent stated we suggest caller reach out to her primary care provider if she has questions on whether or not to get the second vaccine we wouldn't be able to provide her with any medical advice over the phone. Caller stated her doctor said not to take the second shot because she had such a severe reaction to the first one. Her main problem is that she is having sight issues. She has her husband read off the product information from her vaccine record card because she can't really see it. She has always been near sighted but this is to the point, she has real sensitivity to light, that's her main concern right now. First, she had severe pain and then had sight issues. She explained the sight issues started about two weeks in after receiving the first dose, it was right after the severe pain. It has persisted. She has an appointment on Thursday to see her ophthalmologist. She mentions its hard to get into her ophthalmologist. The severe pain started on the 4th day after receiving the first dose, around 30Apr2021. The severe pain lasted a good week, week and a half. She still has pain in her knees when she walks, it's almost like her knees want to give out. Other than that, it's better. She mentions the severe pain was also in her back, hips and neck. Her doctor prescribed diclofenac, 50 mg. She mentions she can see this dose because its bolded and its bigger. No emergency visit. The doctor said to call and see what Pfizer had to say about the second shot because she is really nervous. The outcome of event a little bit of swelling was resolved, diarrhea, fatigue was was not recovered and outcome of all other events was unknown. No follow-up attempts are needed. No further information is expected.

Nauseous; Night sweats; Chills / more of the chills; Headache; Aching all over; Off balance/ head felt like it was swimming off balance; Throwing up; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), buspirone (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and fluoxetine (MANUFACTURER UNKNOWN) all for unknown indications from an unknown dates. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00, the patient started experiencing chills and headache. By the night, the patient experienced aching all over, throwing up and off balance. On 01Apr2021, the patient experienced more of the chills, nauseous and head felt like it was swimming off balance. On an unknown date in Apr2021, the patient experienced night sweats. The patient experienced headache the whole time. The patient did not receive any treatment for the events. The clinical outcome of the events chills, headache, loss of balance, night sweats and nauseous was resolved on an unknown date in Apr2021.The clinical outcome of the events general body pain and vomiting resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Dizzy immediately following injection; Tired; Nauseous; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 29Apr2021 at 11:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included scoliosis. The patient did not receive any medication within two weeks of vaccination. The patient previously received unspecified medication. 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 29Apr2021, the patient experienced dizzy immediately following injection, tired, nauseous and sore arm. The clinical outcome of the events dizzy immediately following injection, tired, nauseous and sore arm was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Right arm sore; left knee/shin/calf pain; left knee/shin/calf pain; left knee/shin/calf pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm right on 30Apr2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), rabeprazole (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously took Avelox, penicillin and sulfa on unknown date 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 four weeks prior to the vaccination. On 01May2021 the patient experienced right arm sore, left knee, shin and calf pain. The patient stated that she had right arm sore but was not bad. However next morning she woke up with left knee/shin/calf pain and she could not put weight on it throughout the day and night. She further stated that her knee and shin got better on second day morning but calf was still stiff and sore. The clinical outcome of the events right arm sore, left knee pain and shin pain and calf pain was unknown. No follow-up attempts are needed. No further information is expected.

In May I went to Primary Care because of right arm pain. She said it was Bicep Tendonitis, and take rest it and take Advil. It is somewhat better, but still painful. I don't know what I did to cause this, I've never had any kind of injury before. Now, July 28 I'm scheduled to see an Orthopedic Specialist on Aug 4.

Tired; Achy; Runny nose; Cough; 98.3 Fever; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the arm left on 31Mar2021 at 12:15 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, metabolic syndrome, hyperlipidaemia and coronary disease. Concomitant medications included acetylsalicylic acid (ASPIRIN), metoprolol succinate (METOPROLOL), losartan potassium (LOSARTAN), atorvastatin calcium (ATOR) and multi vitamin. The patient had no known 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 22:00 the patient felt tired, achy, runny nose, cough, fever of 98.3, headache and sore arm. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events tired, achy, runny nose, cough, fever of 98.3, headache and sore arm was recovering at the time of the report. No follow-up attempts are needed. No further information is expected.

Numbness on face; Fast heartrate; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the right arm on 15Mar2021 at 16:00 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history included migraine, allergies and the patient had a history of several foods allergy and environmental allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC) on 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 15Mar2021 at 16:00, the patient experienced numbness on face, headache, fast heartrate and fatigue about 45 minutes after the first dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcomes of the events numbness on face, headache, fast heartrate and fatigue were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

I was so sick on 03Jun2021; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; sweating; migraine; Headache; nausea; hair still falling; shaking; I was aching worse on 2nd shot; This is a spontaneous report from a contactable Nurse (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0172), via intramuscular route of administration on 03Jun2021 at 09:10 AM (at the age of 60-year-old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from 18Feb2021 to an unknown date (my hairs still falling out after had covid by hands full as of 18Feb2021. I had Covid & so sick. I could not get out of bed). The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP753), via intramuscular route of administration on 12May2021 at 09:00 AM (at the age of 60-year-old) as dose 1, single for COVID-19 immunization and experienced shaking, I was aching all over. The patient experienced shaking, I was aching worse on 2nd shot, hair still falling on an unspecified date in 2021, sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed on an unspecified date in Jun2021, I was so sick on 03Jun2021. Pertinent Details: shaking, I was aching worse on 2nd shot & had to go to bed when got up at 10 AM and sweating, migraine, headache & nausea. Could not eat, had to stay in bed & whole Day & Night. My hairs still falling out after had covid by hands full as of 18Feb2021. Family medical History: Patient husband (withheld) took Moderna & no symptoms at all. But patient was so sick on 03Jun2021. Patient never want to take that shot again because patient felt like I did when I had Covid & so sick. Patient could not get out of bed. The patient underwent lab tests and procedures which included COVID test: had covid (my hairs still falling out after had covid by hands full as of 18Feb2021) on 18Feb2021, blood test was kidney, liver, heart all good and thyroid good (everything good & doctor still don't know why my hair is falling out in hands full) on 01Jun2020. The patient received Tylenol, Chicken soup as a treatment for the event shaking. Outcome of the events I was aching worse on 2nd shot, hair still falling was not recovered; sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed was unknown; shaking was recovered on an unspecified date in 2021, I was so sick was recovered on 03Jun2021. Follow-Up: Follow-up attempts are completed. No further information is expected.

lymphadenitis; gland swelling; periorbital edema; severe muscle cramping; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 21May2021 08:00 am (batch/lot number EW0161 and expiry date unknown) at 60 years of age as dose 1, single for covid-19 immunization. The patient informed that the facility where the most recent COVID-19 vaccine was administered was in the hospital. Medical history included graves disease. The patient had no covid prior vaccination/was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine for unspecified indication from unspecified. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In May2021, the patient experienced lymphadenitis, gland swelling, periorbital edema, severe muscle cramping. The events resulted to emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The patient was hospitalized for 1 day due to the events. The patient underwent lab tests and procedures which included COVID-19 (BP) (nasal swab) on 24May2021, 01Jun2021, 10Jun2021, 15Jun2021, 21Jun2021, 29Jun2021, and COVID-19 (RAPID) (nasal swab) on 24Jun2021; all negative. The patient received treatment of prednisone w/taper, magnesium. The outcome of the events was not recovered.; Sender's Comments: The contributory role of the suspect product bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), (batch/lot number EW0161 and expiry date unknown) to reported events is possible based on temporal association and known profile of the product.

very sore arm; soreness spread to my whole body/My pain right at the moment is at a 7; Erythromelalgia/Since the shot, this rare condition has not stopped flaring; Erythromelalgia/Since the shot, this rare condition has not stopped flaring; My blood sugar has stayed over 250 with a top number on the evening of the last shot of 419; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Apr2021 18:30 (Batch/Lot Number: EW0171) (at the age of 60 years old) as single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HBP), ongoing erythromelalgia, overweight. Patient was not pregnant at the time of vaccination. Patient did not have Covid prior to vaccination. No known allergies. The first dose was administered on an unknown date for covid-19 immunisation where patient felt nothing. Concomitant medication included oxycodone taken for erythromelalgia, start and stop date were not reported. After the second dose, on 28Apr2021, her blood sugar has stayed over 250 with a top number on the evening of the last shot of 419. On 29Apr2021 01:00, she developed a very sore arm, unlike the first shot where she felt nothing, her soreness spread to her whole body. Patient would be in more pain than the level 5 she was at but she took Oxycodone 10.05-325 for a rare condition called erythromelalgia. Since the shot, this rare condition has not stopped flaring. Her pain right at the moment was at a 7 (29Apr2021). Therapeutic measures were taken as a result of all the events. Increased insulin. Patient was not tested for Covid after vaccination. Outcome of the events was not recovered.

Lips and left side of face numbness and tingling about 10 minutes after first dose of Pfizer COVID-19 vaccination. Started first on the lips and then spread to left side of face and continued for 45 minutes to an hour after vaccination.

About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation

development of rash on arms, itchy feeling on arms and torso; feeling of increased warmth all over body--temp 96.8 temporal but felt very, very warm took Benadryl rash faded, decreased itchiness

Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills; feeling a little warm/ She is cold, too; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm, near the top (in the muscle), at single dose for vaccination on 29Dec2020 at 12:45 pm at 61-year-old. Medical history included: hay fever allergies, allergic to prochlorperazine maleate (COMPAZINE). Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer vaccine. On 30Dec2020, the patient stated her headache started about an hour and a half ago. She started having the muscle aches and pains when she woke up this morning. She felt like she was getting a fever, but she was at work and couldn't take her temperature. She was feeling a little warm, she was cold, too. She was having the chills. The patient confirmed all of these symptoms just started happening this morning (30Dec2020). No emergency room nor physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.

aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.

Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.

I went to the emergency room which after the Pfizer injection I had numbness sensation to my face and upper lips, nose and mouth. I feel a pulling sensation to her lips and nose. I have brain fog. I feel the injection affected a nerve in my face. She went to see her primary doctor put her on anti-histamine medication. She states she has no itching at the moment.

Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscular on left arm at single dose for COVID-19 immunization on 23Dec2020 at 61-year-old. No medical history or concomitant medication. Yesterday (30Dec2020), the patient woke up with a sore throat, it was like getting cold with a sore throat, congested, the patient had cold like symptoms, seemed like the patient was getting a cold. The patient just took decongestant medication. After waking up this morning (31Dec2020) the patient did not have taken anything. The patient got tested for COVID (for antigen not a PCR) yesterday (30Dec2020) and was negative. The patient did not have got any fever, just sore arm a week ago (Dec2020). She was hurting for a day and then she was good, everything good. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.

left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe

Immediately after receiving the vaccine, patient developed sensation of throat numbness in the back of the throat. Patient denied SOB, wheezing, throat swelling, stridor, rash, chest pain, tongue swelling. One dose of diphenhydramine 25 mg PO suspension and referred to the Mount Sinai emergency department. Sensation resolved after a total of 30 minutes (10 minutes after receiving diphenhydramine). Vital signs and physical exam were WNL with the exception bilateral submandibular adenopathy. Patient was observed in the ED for approximately one hour with no clinical change and was subsequently discharged home.

Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes 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.

Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.

1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM

pain in her whole arm; numbness in right cheek/numbness in arm/hand; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 12:12 at SINGLE DOSE at right arm for covid-19 immunisation. Medical history included SVT this was recognized at least 20 years ago, around the age of 30, she started to deal with high blood pressure, allergic to penicillin. The patient's concomitant medications were not reported. The patient previously took codeine, levothyroxine: allergic to codeine, levothyroxine. The patient also previously took Tylenol with Codeine and that was horrible and she can't ever take it again, when she was around the age of 40 years old. The patient received the COVID vaccination around Wednesday 30Dec2020 at 12:12 p.m. She was perfectly fine until late Thursday afternoon 31Dec2020, around 3:30-4:00 pm. She started to have swollen lymph nodes. It was only a little bad at first and then she started getting more and more swelling. She spoke with her facility's RN who suggested she use some cold and warm packs/compresses and also take some Tylenol to deal with it. She has had the swelling for this many days now. It's not bad swelling but she her lymph nodes are still so swollen. She thought it was a regular reaction, but now it's been too long. Her lymph nodes are not swollen humongous. There is no redness. Her lymph nodes are not hard, just swollen. The swelling was a little bit better on Friday and Saturday but yesterday, it started bothering her again. She has had pain in her whole arm on an unspecified date. On 03Jan2020, her face also started to feel funny. She clarifies by "feeling funny", she meant she started to experience numbness in her right cheek, only her cheek, like when one gets a vaccination when they go to a doctor's office/dentist office and it starts working and one can feel it getting numb. She also experienced numbness in her arm. She clarifies when she puts pressure on her arm (like putting her arm on the desk), she feels numb in her hand. She verifies the numbness in both her cheek and arm started occurring on 03Jan2020 around 7-8pm. She is fine today and then she'll start to feel the numbness again in her cheek and arm. She clarifies the numbness comes and goes. It comes in the morning and then goes away and then the numbness starts again. She started to feel numb in her face and cheek, like when one gets a Novocain at the dentist office and it starts working- it's like the same feeling. The outcome of the events Swollen lymph nodes and numbness in right cheek/numbness in arm/hand was not recovered, while unknown for the other event. Information on the lot/Batch number has been requested.

Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one hour, headaches, fatigue, abdominal pain that cleared 1/7 in the afternoon. The nausea was so bad I could not eat. Vomited only one time. I missed one day of work, slept the whole day, and night, too.

muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blistering; redness on left should blade and over left breast

About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.

First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.

Numb hands, numb face, lightheaded, almost passed out, spike in blood pressure, unsteady walk. Ambulance called, tested to rule out stroke and blood sugar issue but tested ok. Determined I had allergic reaction to vaccine.

I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a few days after.

24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 hours- more chills, more wheezing, LA still sore Took Tylenol twice, using inhaler 72 hours- LA still sore, skin red over deltoid and biceps with tenderness, still wheezing, using inhaler throughout day Symptoms somewhat controlled with repeated doses of Tylenol and Proair

Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to touch.

Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.

After patient had received vaccine, a vaccinator was called by a member of the healthcare facility to assess the patient. The patient was jittery and exhibited signs of confusion approximately 20 minutes (3PM) after her vaccination. The vaccinator asked if she was diabetic and the patient replied "yes" and takes metformin. Further questioning revealed that the patient had not eaten since 9AM - it was then around 3PM. The ambulance was called and the patient went to the hospital. Probe revealed that she had not taken her diabetic medication and that the patient had not eaten or drink. Patient was encouraged by vaccinator to eat on time and take her medicine as prescribed.

Arm pain post injection Severe pain in shoulder joint, down arm, pain elbow, pain firearm and hand on left side. Diagnosed as reactive arthritis due to vaccine

Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills and extreme fatigue lasted 4 hours. Low grade fever lasted 12 hours.

On my drive back to work after getting the vaccine the left lower part of my face when numb and tingly. Then it focused on my left nostril. The overall effect didn't last long but my nostril still doesn't feel right. Somewhat numb but not always. The left side of my face feels strange at times as well. Hard to explain.

Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!

Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.

Woke with chills & shaking. Temp was only 99.3 oral at that time. Took Motrin 800mg. Significant body aches & pain. The next day, 1-13-21, Temp 100.4, continued body aches, very tired & sleepy. Sore right arm, body aches from head to toe. Taking Motrin again.

Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at midnight the same day. The following day shew had a fever a high as 103. She continued to feel fatigued, achy, headache, slightly nauseated and weak. Her symptoms improved over the course of the last 2 days. She is fever free today

About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I also started feeling lightheaded like I might faint. I pull over into a parking lot and had a family member come get me to drive me home. I was extremely thirsty and drank a lot of water at home. Eventually, my redness went away and my face did not feel as hot. I did feel other more typical symptoms too such as painful arm, and flu like symptoms. I am mainly concerned about the reaction I had when driving home since it was similar to what happens when I take cortisone or Doxycycline. I am needing information as to whether it is safe for me to take my second dose of the covid vaccine.

At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested for about 45 mins before I felt well enough to drive. All better after about 2 hours.Next day, tired, sweaty, nauseous, lightheaded when standing.

Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determine if anaphalaxis or panic attack, patient experienced facial weakness, chest tightening, tremmors, inability to breathe, and fainting within 10 min of administ

Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating; Abdominal cramps; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 07Jan2021 07:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient experienced abdominal cramps on 07Jan2021 13:30, diarrhea and chills for 20 or 30 minutes and then it all went away on 08Jan2021. Again today 24 hours later, she had abdominal cramping that was almost debilitating. Had Covid 19 Test up the nose test, thinks it was PCR that was negative on 06Nov2020. The outcome of events was recovered on 08Jan2021.

Patient instructed to wait 30 min post vaccine administration. After 30 min patient reported feeling flush and cheeks were slightly red. O2 sats 98%, HR 62 bpm, denies shortness of breath. Notified Dr. who gave a telephone order for Benadryl 25mg PO now. Instructed patient to stay 30 additional for observation post Benadryl administration.

Shingles type reaction without a rash or redness; Extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site.; This is a spontaneous report from a contactable pharmacist (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included diabetes and hypertension (HTN). It was also reported that the patient had allergies with quinolones. Concomitant medications included metformin (METFORMIN), cetirizine hydrochloride (ZYRTEC), semaglutide (OZEMPIC), simvastatin (ZOCOR), levothyroxine sodium (SYNTHROID) and "elav". On 01Jan2021 19:00, the patient had extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site. The patient also had shingles type reaction without a rash or redness. 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 treatment for the events. Outcome of the events were not recovered.

Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, I had a painful swolle lymph node on left side of neck. That same evening I developed pain, swelling, in my right armpit radiating to the right upper breast and down my right arm with a swollen lymph node under the right arm pit. The pain was about a number 7 on a scale of 1 to 10. The pain and swelling still persist today on 1/15/2021 Still painful, especially to touch. Still radiating down the arm. Lymph node still swollen The pain is about a 2 on a scale of 1 to 10

DEVELOPED SORE ARM THAT LASTED 1 DAY. ALSO HAD BAD FATIGUE AND HEAD PAIN LASTING UNTIL MORNING OF 1/10/21.

Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.

but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; Got the vaccine early Friday afternoon and had a sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine early Friday (08Jan2021) afternoon and had a sore arm but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever. The patient asked if that normal for side effects to occur 2 days later. The outcome of the events was unknown. Information on the lot/batch number has been requested.

immediate metallic taste in mouth accompanied by tachycardia to 120 (usu pulse is 65) followed by unusual feeling in mouth, not itchy, but tingly-type sensation. lasted about 1 1/2 hours, same reaction happened with both first and second doses, the second time was a little more intense and longer lasting.

2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout muscles, tongue felt thick, mild tongue coordination alteration. Left 2nd and 3rd branch trigeminal nerve mild numb sensation though unclear if I have mild paresis too. Mildly reduced tongue coordination continues.

Hands are hurting, looks like I have some bleeding under the skin on my left hand, middle finger, hands are swollen and have a spotted look on the underside. Tried taking over counter meds, nothing is helping with pain.

Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.

she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.

DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 THRU 01/19 SORE ARM 01/09 THRU 01/19

Though I had pain and soreness in the arm after both the shots I am left with a residual weakness and ache in the arm almost a month later. I find I am not able to lift items that I was able to lift last month and there is a lump in my left upper arm that is new as well.

Severe Left Leg Pain, thing started about three hours after the shot and it so severe screaming and needed pain medicine . The next morning left work due to pain . 12/28/2020. Physical Exam and called it sciatica but not what it was It was inflammation of left fascia lata the Tramadol 50mg and Percocet 5 mg and Prednisone 5 days and it was better by 90% after receiving second shot worsened for a day then back 90%

After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to develop difficulty swallowing by the time I reached my car. Waited a few minutes and it did not abate and continued worsen,. Went to hospital's ER and was seen by Dr. At that time, my voice had become coarse and gravely. Was given oral steroid and a Benadryl. Symptoms lessened a bit and were gone after about 2 hours. While at first I thought my breathing wasn't affected, after symptoms cleared, I realized that my breathing was easier. Symptoms did not reoccur.

Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.

I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.

Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and needles in arms, hands, and feet b/l, with "slight tingle" in lips. Unusual taste in mouth (that happened after 1st dose as well). Small wave of nausea. Sensation of heat in chest. At 1301 on 1/20/2021, 50 mg of IM Benadryl administered to RD (Lot # 080010, Exp 8/20/2022) by NP. At 1320, arms were less flushed, however b/l pins and needles persistent in both arms and feet, with "tingling" still in lips. Pt will wait until symptoms improve further to d/c to home. NP checking in continuously.

Due to hx of allergic reactions, pt was told to wait for 30 minutes in observation prior to vaccination. At 1208 on 1/20/2021 pt received 2nd dose of COVID Pfizer vaccine. Immediately after vaccination, pt experienced unusual taste in mouth, flushing, and feeling of heat in chest. At 1232, pt noticed flushing on arms and feelings of heat and pins and needles in both arms, hands, chest, both feet, and back. Sensation was persistent, so at 1301, 50 mg of IM Benadryl administered to RD by NP. By 1320 flushing on arms and chest subsided, feeling of pins and needles persisted but was not as severe as initial reaction. By 1345 flushing on arms returned, pins and needles sensation worsened again in all locations noted prior, spread to scalp, and tingling sensation occurred on lips. Pt communicated with Dr advised to stay under observation, but transfer to ED not medically necessary. At 1415, pt was advised to go home with supervision of partner and monitor symptoms from there.

felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."

Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6 to touch and on abduction. About 11 hours after vaccination, I became increasingly uncomfortable, feeling warm, chills, muscle aches. I could not sleep. 22 hours after vaccination, my temperature was 101 F (did not take it before this time). Temperature waxed on waned from that point (day #2). About 36 hours after the vaccine, my temperature stabilized to normal. 48 hours after the vaccine, I felt better and better with each hour.

sensitivity to cold; feeling chilled; short of breath (SOB) with minimal exertion; This is spontaneous report from a non-contactable nurse reported for herself. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular in the left arm on 08Jan2021 12:00 at single dose for Covid-19 immunization in a hospital. Medical history included COPD, hypothyroidism and allergies to penicillin (PCN). The patient was not pregnant. The patient has no COVID prior vaccination. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), montelukast sodium (SINGULAIR), oxybutynin, and azelastine; all from unspecified date for unspecified indication. The patient previously took Celebrex and experienced allergies. Historical vaccine included first dose of BNT162B2 intramuscular in the left arm on 20Dec2020 09:15 (61 years old) at single dose for Covid-19 immunization in a hospital. The patient has no other vaccine in four weeks. On 08Jan2021 15:45, the patient experienced sensitivity to cold, or feeling chilled for 48 hours post dose, short of breath (SOB) with minimal exertion for 72 hours post dose. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not COVID tested post vaccination. The patient did not received treatment due to the events. The outcome of the events sensitivity to cold, or feeling chilled, short of breath (SOB) with minimal exertion was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.

STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)

I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.

Rash in my chest, under my breast and some in the side. Experience some tingling, itching in my legs.

Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.

Left fingers tingling 10 minutes post vaccine. Next day felt it spread to whole left side and left eye felt "weird." Took Advil, got better after no difference with Tylenol. Then stopped the Advil and symptoms persisted. Then had tingling of head and neck. Saw her physician and Carotid flow study was normal. Waiting for MRI approval. Has been working with the symptoms.

Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 11 pm to use the restroom and when I returned to bed I had a cough and SOB. This continued with copious secretions with worsening over time until I was fighting for air at 4:30 am. My husband called the ambulance because he did not feel he could get me to the hospital in time. In the ambulance I was started on 4L of O2. Upon arrival at the ER I was given a breathing treatment and started on the BiPap. I was admitted to the hospital and received 3 more breathing treatments and recovered to be on room air by 11:00 pm. The tests and observations, the doctor reported that there was no other cause than the vaccine.

Patient seated in observation area for a 30 minute observation after injection of Covid 19 vaccine. Patient after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was A&O x4, lungs clear to auscultation, patient stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on RA and B/p of 130/80. at 1016 covering provider ordered to give patient given 12.5mg of Benadryl liquid with 16oz of Water intake during observation period. Continued to monitor patient and noted that was able to ambulate at 1025 to bathroom with assistance but still experiencing dizziness. Patient monitored for a total of 45 minutes then discharged home.

Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.

felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; This is a spontaneous report from a contactable consumer report self. This 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL4176), via an unspecified route of administration at left arm on 12Jan2021 14:30 at single dose for covid-19 immunization. Medical history included COVID in Nov2020 (Patient was tested for Covid on 23Nov2020 and found out the 25Nov2020 the result was positive), she just quarantined herself at a hotel (They gave her Benzonatate, but she was also taking Tylenol 500mg and Robitussin DM). Concomitant medications not reported. Patient did not get any other shots or 4 weeks prior. No problems with vaccines in past that she can remember. No additional vaccines administered on same date of the Pfizer suspect. Patient received the Pfizer BioNtech vaccine on 12Jan2021 and after that on 12Jan2021 night she didn't feel anything but mild pain in arm, it was so painful, but not as bad on 13Jan2021 even though she still has it. She can't move her arm up and down. On 13Jan2021 morning at dawn she had a fever and it is now 101.2. Has taken Tylenol 500mg (Lot number: SLA071, UPC number: 30047112, Expiry Date: Aug2024). Patient had body aches started 12Jan2021 at midnight (12:00) that is start date of 13Jan2021. She felt cold and chilly and not sure if it was the weather or her. No Emergency Room or Physician Office visit. The outcome of "felt cold and chilly" was unknown, of else events was not recovered.

Monday afternoon, January 25, I started feeling achy and chilly. Just not well. I work 5 a.m. to 1:30 p.m. I went straight home from work. I took shoes off and got in bed. I was very cold and felt that the coldness was from inside out especially in my hands. I covered with a sheet and 3 blankets with an extra blanket to my feet and used winter gloves on my hands. I got up at 5 p.m and felt better. Tuesday morning, January 26 at 3 a.m. when I got up to shower, I noticed a soreness and large swelling under left armpit, ? lymphadenopathy. All others symptoms had passed. Continues to be the same on today, January 27. Seeing MD on Thursday, January 28.

After first dose I felt an overall odd feeling . no shortness of breath etc, just odd. I was thinking it may have been just some anxiety. I left the center after 15 minutes and came back to Pediatric office where I work. I did take a Zyrtec and felt completely better after approx. an hour. After the 2nd dose I did mention I had felt odd after 1st dose and decided to sit for 30 min. I felt about the same as I did after the 1st dose so I left. when I got to my car my face was flushed. I was not tachycardia just a very odd felling in my head and then my tongue did start to itch (or feel funny) . I took a Zyrtec and went home. I never had any swelling of lips or tongue, no trouble breathing. Pulse stayed constant around 80. This time the symptoms lasted approx. 4 hours. I I did continue to take Zyrtec for 3 days after injection.

unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. 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.

Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for 30 min. Hx of allergies. Very anxious, anxiety causing increased HR and Sweating. throat itching/tightness. Legs elevated, 50 mg of Benadryl given.

10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; trouble swallowing : elevated blood pressure Told nurse 25 minutes later.given benedryl injection Things improved and an hour later tongue began to swell again and blood press increased Paramedics called and they transported me to the ER where I was given an Epi injection and steroids. Monitored for three hours and sent home with prescription for steroids: epi pen; and zyrtec Still experiencing fatigue , headache and lots of drainage off and on

A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headache, no appetite, and tired/achy. I slept for 3 hours and woke up a little after 8 p.m. Temperature was 100.5. After calling work and notifying my doctor, I drank a Powerade and went to bed. This morning, I feel almost normal. Slight headache (maybe from lack of food) and my stomach is still a little upset.

headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3249) via an unspecified route of administration in the left arm on 12Jan2021 09:15 AM at a single dose for COVID vaccine. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide, paroxetine, and ergocalciferol (VITAMIN D) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA) and mefloquine. It was reported that the patient had 4 days of headaches and achy feeling on 12Jan2021. During her 30-minute wait after the injection, she experienced some nausea and felt hot on 12Jan2021. Treatment was not received for the events. The patient had no COVID prior vaccination. She did not have COVID tested post vaccination. The outcome of the events was recovering.

tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe nausea/nauseous light headed when standing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Lot number: 3302), via an unspecified route of administration in right arm on 13Jan2021 13:00 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included escitalopram, vitamin d. At the time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested about 45 mins before feeling well enough to drive. All better after about 2 hours. Next day (14Jan2021), tired, sweaty, nauseous light headed when standing. No treatment received. No pregnant at the time of vaccination. The outcome of the events was unknown.

about 30-45 minutes later started feeling numbness on left side of face; left lower lip remained slightly numb; This is a spontaneous report from a contactable nurse. A 61-year-old female nurse reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1686), intramuscular at single dose into the left arm on 08Jan2021 at 03:30 PM for COVID-19 immunization. First dose of BNT162B2 was received on 18Dec2020. Medical history included rheumatoid arthritis, coronary artery disease and hypertension. Past drug history included NSAIDS which caused bleeding. The patient's concomitant medications were not reported. The patient reported that about 30-45 minutes after vaccination she started feeling numbness on left side of face and left lower lip remained slightly numb. The events were reported as non-serious. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.

Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contactable nurse (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 13:00 at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 01:00, the patient experienced fever 101, pain in both thighs, chills, nausea and headache. No treatment was received for the adverse events. Clinical outcome of the events was recovered with sequelae on Jan2021.

Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been resolved on the date of her death which occurred 01/27/21, She was found unresponsive by staff, 911 contacted, and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate.

Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol for relief. still feeling weak. can't stand up long without feeling dizzy.

day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around the shot area.

Bells Palsy Signs and Symptoms Right Side for the last 72 hours with ear pain and eye twitches. noticeable onset this morning 1/30 with right eye right and upper lip involvement.

in first half hour, heat/flush came up the left side of neck and face up to eye. inside of ears felt warm. extreme tinnitus. took Benadryl and slept. after 5 hours, symptoms came back. feels like lower jaw is pulling to right. took more benadryl.

alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.

12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)

Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting

Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to do anything, very tired.

Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.

thrush; weak; tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunisation. Medical history included ongoing COPD (chronic obstructive pulmonary disease) (not really diagnosed with COPD), ongoing smoker (smokes about 10 cigarettes a day; has smoked 40+ years), cough. The patient's concomitant medications were not reported. It was reported that on 31Dec2020, the patient tested positive for COVID from which she went to the doctor and was treated on 14Jan2021. The patient was given SOLU-MEDROL injection just to help her because she has mild COPD to bring up all of the junk. She is clear now. She doesn't have pneumonia. Her labs were good. She feels 80% back. The patient also experienced weak and thrush on unspecified date. Therapeutic measures were taken as a result of the event tested positive for COVID which included antibiotic and a cortisone injection, and for the event thrush which included NYSTATIN mouth rinse. Outcome of the event tested positive for COVID was recovering. Outcome of the remaining events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (10 days in this case). However, a causal relationship between event "tested positive with Covid " (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.

I'm not sure if this is related; Was at work in out patient hospital facility and placed a mask on from a new box. I noticed my nose was itching a bit (I'm very sensitive to certain masks and usually air them out) A little while later I had an intense itching / prickly, sensation in my nose and started itching on my face under the mask. I took it off and found a different brand and took some benedryl. Seemed to get some relief and later that evening, I started to itch again including my head and inside ears, face had flushed with hive like rash. This continued throughout the weekend on and off eventually my whole body was randomly itching/tingly. No problems breathing. Took allergy meds and felt good but noticeably annoying. Called our covid info line on Monday and they gave me a few numbers for allergists. Mine retired. Had an appointment Tuesday morning. Dr felt it probably was reaction to mask not vaccine. Did a patch test with a piece of mask and did itch some but had a reaction to the tape that held the piece of mask in place so results not good. Took medrol dose pack and increased allergy meds. Still itching on and off randomly all over body, not as severe Delaying second vaccine by a week or two until this resolves per DR

sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache; arm hurts; The initial case was missing the following minimum criteria- No Adverse Effect. Upon receipt of follow-up information on 19Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided - "has not received information card "), via an unspecified route of administration on 17Jan2021 at single dose on the left arm for COVID-19 immunization (reported as "Why was the patient taking Covid-19 vaccine (Verbatim): works in a group home "). Medical history included ongoing heart murmur since 2019. There were no concomitant medications. There were no investigation assessment. The patient experienced low-grade fever, chills and a bad headache on 17Jan2021. Patient was sluggish and wanting to sleep all day on 18Jan2021. Patient took Tylenol for a headache. It did not work so she took sumatriptan. The patient was also sneezing on 18Jan2021. Patient reported that she sweated the fever out. She had chills at night. The headache was lingering off and on but was mild. She sneezed all day on Monday (18Jan2021). She has not sneezed yet today but she has a stuffy head on 18Jan2021. Patient clarified that she took Acetaminophen Rapid Pain Relief instead of Tylenol. She took two 500mg tablets (UPC: 3225152303, Lot: 91670159AA, Expiry: Aug2022). Patient also reported that her arm hurts on 17Jan2021. She was unable to provide the Lot number. She will receive the information card after she receives the second dose. She had a picture of the card but it was not very clear. Outcome of the events arm hurts, headache, stuffy head was recovering (also reported as ongoing), for chills, low grade fever was recovered on 18Jan2021, for sluggish and wanting to sleep all day was recovered on 19Jan2021 while for other event was unknown. Information about batch/lot number has been requested.

Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hurt/ her hips were really sore; Chills; Arm pain; Headache/ pain at the base of the head/ pain in her head; Neck pain; Shoulder pain; pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ16R6), intramuscular in the left arm on 17Jan2021 09:30 at single dose for COVID-19 prophylaxis. The patient medical history was not reported. There were no concomitant medications. The historical vaccine included the first dose of BNT162B2 on 26Dec2020 at her 60-year-old for COVID-19 prophylaxis. The patient was a physical therapist (non- Healthcare Professional), she received the second dose and was having almost every side effects. She experienced arm pain started night around 17Jan2021 17:00; headache, pain at the base of the head, neck pain, shoulder pain, pain everywhere on 17Jan2021; chills that she couldn't get rid of on 17Jan2021 19:00; slight fever, and overall feeling tough, joint pain because her hips hurt on 18Jan2021. At 17:00-19:00 on 17Jan2021 and stated that she could not tolerate her head being upright. She stated that she went to bed at 19:00. Pain in her head, neck, and shoulders is a little better because she can actually sit up now and hold her head up. She said that her temperature usually ran 97 and currently was 99.4. She said that she did not take her temperature on 17Jan2021 and did not get up until 13:00 and stated that she took it when she got up on18Jan2021. She noticed joint pain when she got up on 18Jan2021, her hips were really sore. Chills started at night, when she went to bed she had the chills around 19:00 17Jan2021. The outcome of pain in her head, neck, and shoulders was recovering, of the other events was not recovered.

C/O "TINGLING PIN PRICKS" WITH SLIGHT ITCHING SENSATION, NO SOB, NO HEADACHES B/P 136/100 SYMPTOMS SUBSIDED 10 MIN. LATER

12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation. Interpreter RN assisted with interpreting. Another RN assessed pt, negative wheezing &/or stridor, pt accepted bottle of water ingested/tolerated sips of water. Pt ambulated with RN w/o issue to have IM Benadryl 50 mg Right gluteus. Pt tolerated well. Pt prior hx allergies to PCN & NSAID?s w/side effects of laryngeal edema. 12:55 pm called over to pt, RN for 61 yo F with hx of laryngeal edema with PCN & NSAID?s. Pt states her throat feels scratchy, primary Spanish speaking w/interpreter at side. Assess pt no ins/exp wheezing. No stridor, no SOB on O/A 98% O2 sat, HR 67, with 90 SBP palp. Pt also, hx of anxiety. Pt given bottle of water with sips occasional clearing throat. No mouth/oral swelling visualized, however pt is requesting Benadryl. Pt does not have Benadryl on her & discussed with option of IM injection if pt feels she needs it. Pt not flushing, talking with staff & continues with no stridor. Pt again states she would like to have Benadryl. 1300 Per standing order with pt?s stated feels like her throat is having swelling/itching Benadryl 50 mg IM R gluteal with band aid applied. 1305 Per adm ALS called for f/u, pt continues with no distress, no stridor, no ins/exp wheezing. Pt sips on water & is talking with staff without distress. 1308 ALS on scene with update status, PMH & allergies with Benadryl 50 mg given @ 1300 IM, HR 67, O2 sat 98% RH, B/P 161/80 RA. Pt not in distress & is stating she feels much better, no throat swelling, just feels sleepy. Pt has husband in personal vehicle to assist pt home. Pt denies need for transport. 1323 Pt sitting in chair, calm & no distress, cont. to re-assess. 1330 Pt tolerated well & cleared for discharge to home with husband. Pt I/S to f/u with PCP if needed. Any SOB, increased anxiety d/t possible reaction, call 911 & will be re-evaluated. Pt consents to go home with husband driving.

Redness numbness and tingling in both hands Increases when hands are pointed down improves when lifted above the heart Is lessening but is clearly not listed as a side effect It is improving however is concerning more information and direction needs to be addressed several other coworkers have experienced or went to the ED with the same adverse effect. It is clearly not life threatening but I hope it will not increase with the second dose or continue in the future

Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.

sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all day; congestion; severe headache; severe cough; achy/was in such pain all over; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249, expiration date unspecified), intramuscular on 18Jan2021 12:00 at single dose (left arm) for COVID-19 immunization. Medical history included slight hypertension and allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included losartan. The patient took first dose of bnt162b2 on 28Dec2020, at 10:00 (lot EL1284) at left arm for COVID-19 immunization. When the patient went to bed that night about 10 hours after the shot, I was just achy on 18Jan2021, at 22:30. When she got up at 02:30, she was in such pain all over and had chills and was hot with a slight fever, was dizzy, and tired on 19Jan2021. When she woke up later and had to call off, she had all of that (worsening), plus congestion and severe headache on 19Jan2021. The patient slept all day, but developed a severe cough by that night and she took nighttime cold medication to sleep and when she woke up on Wednesday, she took the daytime ones. The patient reported that she still have achiness, was tired, and a sore throat and some cough on Thursday, 21Jan2021. The patient received therapy for the event severe cough; and patient did not received treatment for the rest of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovering.

Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache and muscle aches the next day on 1/22/21. Some fatigue and nasal congestion that next day as well. Some fatigue and headache on 1/23/21. Took Tylenol once on 1/22 and 1/23.

I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day

Patient began to have chest pains, SOB, feeling flushed and tingling down both arms. EMS began with heart monitor on patient. EKG WNL B./P 140/97, HR 57 o2 Sat 100 %Ambulance transported patient to Hospital.

facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.

She had significant fatigue the day after the injection along with a sore arm and intermittent headache. Starting about 72 hours after the vaccine she noticed a swollen lymph node at the base of her neck on the side of the injection. The lymph node, sore arm and intermittent headache are still present.

arm pain; This is a spontaneous report from a contactable Health Professional. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Jan2021 (at the age of 61-years) as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain from vaccination on an unspecified date. The clinical outcome of the event was unknown.

Tingling upper and lower extremities, tingling left lower lip and cheek, weird feeling in head. Symptoms started February 1 at 6 PM were intermittent until 6 AM February 4. No symptoms until 6 AM February 6, again they were intermittent. Virtual visit with nurse practitioner at MD office February 6 at 11 AM. No symptoms since 6 AM on February 6.

Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more than 80 and was regular). Discomfort in arm began, progressed to inflammation and difficulty in movement of arm especially to lift arm. Used Tylenol or Motrin PRN for relief as well as heating pad intermittently. After 1/23 injection discomfort seemed to lessen but on 2/9 (4 days before second injection due) discomfort still persists. Due to persistence of symptoms seen in Urgent Care diagnosis Adhesive Capsulitis of right shoulder and acute pain of right shoulder. Treatment, Physical Therapy and Ibuprofen. Unable to use steroids due to diabetes. Follow up scheduled 2 weeks 2/16/2021.

Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated with 50 mg diphenhydramine as well as her morning cetirizine 10 mg before the second dose. Approximately 10 minutes s/p second dose the patient experienced dizziness, facial tingling, anxiety, hard and soft palate numbness, and flushing. She was helped to a stretcher and her BP was 204/94. The patient was taken to the ED for further monitoring. In the ED, she denied any throat swelling, tongue swelling, or difficulty breathing on arrival. She also denied any chest pain and palpitations. She received methylprednisolone 125 mg IV x 1 and a liter of normal saline, underwent observation, then discharged home uneventfully.

Feeling like I'm being pricked from the waist down. It's in varying spots and doesn't last long in any one spot. Assuming this is a nerve reaction.

Facial flushing and light headed immediately after vaccine. Provided Juice and granola bar at 17:50. Improved after a few minutes.

Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneous report from contactable Pharmacist (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)Lot number EL1284, expiration date 30Apr2021, Intramuscular on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 on unknown date. The patient received her second dose of the Pfizer vaccine a week ago on Wednesday, '2 days ago' (not clarified), so it's 9 days ago and she was wondering if she could still have, she felt fine for over a week and then yesterday (22Jan2021) she woke up feeling terrible, just over all body ache, 'cramps' (voice feeble not clarified further) like no energy and she was wondering that. She was getting a headache now from this conversation. She did take Acetaminophen yesterday and she was ready to take it now, that's a bad headache. The outcome of all events was unknown.

30 minutes after injection: severe headache, general feeling of illness. Following day in the morning, headache, left arm in extreme pain, facial numbness, disorientation, inability to talk, confusion, difficulty breathing

Fever,chills and uncontrollable shaking. Lymph nodes enlarged. Under layers of bedding and couldn't get warm. Fever got up to 102.5 on that Saturday about 25 hours after vaccine. Also, felt weak and very tired. Early Sunday morning about 2am, I woke up to my gown dripping wet from sweating. I changed went back to sleep and woke up again about 7am to the same thing. I did take Tylenol and Ibuprofen for the fever. I spent all Sunday in bed, no more shaking but chills and Fever persisted through out the day. Monday, I felt better initially until about 8 pm and symptoms started all over but harsher because know my Lymphedema flared up

I received the first vaccination of pfizer at 10:00am Friday, February 12, 2021. I felt fine most of the day, only right arm hurt at the site of the vaccination. Then around 7:00pm at night the right side of my nose went numb, as the night went on, the right side of my mouth was numb. No changes upon waking Saturday morning. As the day went on the numbness subsided on the nose and mouth and moved down onto my chin. Today Sunday, very little numbness on nose and mouth, some on chin. Site of vaccine feels fine.

Twitching in left arm of shot in the lower part of arm by elbow crease. Almost constant when resting. Not when moving. Thought it had stopped yesterday afternoon but then woke up this morning with the twitching. Very localized.

I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a bad reaction to a flu shot and I have never had another one. I didn't think this vaccine would be similar. I am not someone who gets very sick often and I don't miss days of teaching for illness. Note that my first vaccine on 1/21 had no effects. I did not even get a sore arm. I even sort of bragged about it. The 2nd vaccine on 2/11 seemed fine until I woke up the following morning feeling like I had been hit by a truck. I yawned for 3 hours straight, but still made it to school and worked and taught 6 online classes. I took an ibuprofen that morning because I was feeling so odd. By 3:00 I was driving home (40 minute drive) and I cried uncontrollably the whole way home while my hands and feet were shaking. Not normal for me. When home I went almost immediately to bed. I had a slight temperature and was dizzy. I thought I had the chills but it didn't feel like any chills I have had before. Usually my teeth would chatter and I would feel hot and cold at the same time. The hottest temperature I had was 100.5. But by 9 I started shaking so profusely that I couldn't pick up the thermometer any more, I couldn't use my phone, or take a sip of water. I stumbled to the bathroom holding onto things all the way. My husband was not home, or I imagine he would have called 911 at that point. I kept shaking a lot through the night and kept praying that it wouldn't happen to my heart. I fell asleep eventually and dreamed of fish flopping inside me and my neighbors coming over to to see why the bed was knocking against the wall. Saturday morning I woke up and all the shaking had stopped, but I found I was too weak to get up much. Today is Monday and I mostly feel normal, except a little dizzy when I move and the top of my head is tender to the touch.

Severe migraine headache with pain behind eyes with uncontrolled tearing, ringing in head, pain and pressure lasting about 12 hours. No treatment. Dull headache with numb forehead lasting several days. Took Advil for 3 days Wheezing and shortness of breath lasting 6 hours and the same symptoms the following day lasting about 6 hours. No treatment Did call the doctor with my reaction and concerns for second dose recommendation.

Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and continuing nausea.

Patient felt moderate hand pain following injection. was evaluated by clinician on site and instructed to take routine pain medication once patient was home.