Pfizer

Patient mother reported patient began to shake and she was unable to speak or respond. Upon observation patient was pale, awake, and clammy, responding appropriately . Pulse ox placed on patient O2 sats 98-100, pulse 57, BP 87/45. Patient oriented to person, place, and time. Patient reported feeling weak, complains of headache and neck hurting. Patient reported tingling in her left hand and reported her tongue was tingling. . At this time ambulance was called to transport the patient to the ED.

20 minutes after shot. Sharp pain in arm. Daughter said it feels like the needle was left in her arm. Feels dizzy and out of it. 25 minutes after shot having trouble swallowing. No difficulty breathing. Very thirsty. 40 minutes after shot legs feel very heavy. Daughter was sliding them across floor instead of walking regular. She said it was like her legs forgot how to walk. She was very irritable. Two hours after shot she said she was feeling better except for sore arm. Still felt somewhat sick. Next day she said feels like she had the flu but was feeling much better except for sore arm.

Patient had a CVA (stroke) to the R internal capsule and basal ganglia while therapeutic on warfarin. She has a history of Truncus Arteriosus s/p repair and has been anticoagulated for >10 years without issue. Stroke occurred 1 week after vaccine. She now has L sided motor deficits which are likely permanent. Left arm is flaccid. L leg with poor motor function.

Pain in injection area, sharp pain in underarm area, shortness of breath, chest pain, rapid heart palpitations, dizziness, tiredness,

Experienced extreme onset of symptoms 12 hours after the 2nd dose w/ intense headache, severe leg pain, painful chills, fever and extreme fatigue and arm weakness in both arms, lasting approximately 12 hours and then subsiding for 12 hours for 4 days - extreme symptoms for 12 hours and then subsides - severity of the symptoms remains the same and doesn't lessen w/ each 12 hour episode. The leg pain is severe. Alternating Tylenol and Ibuprofen provides minimal relief and doesn't break the fever.

Muscle and joint pain - 9:30pm 04/06/2021 - 6pm 04/7/2021 Headache - 9:30pm 04/06/2021 - 10am 04/9/2021 Chills - 3:30am 04/07/2021 - 6:00 am 04/7/2021 Fever - 3:30 am 04/07/2021 - 12pm 04/7/2021 Nausea - 9:30pm 04/06/2021 - 3pm 04/8/2021 Vomiting - one instance 7:30am 04/07/2021

Within a few hours of vaccine she began to have a very sore arm and headache. Around 1:00 A.M. on 04/09/2021 she began having chills and joint pain, but no fever as the headache continues. The event that concerns us was she began to have tingling in her fingertips both hands. This has been going on since 1:00 A.M. Her NP was notified and they said to watch it over the next few days and report to CDC/ FDA. Patient had Covid December 24, 2020. We waited the 90 days to get vaccinated and had clearance from her doctors.

Pt received first dose pfizer covid vaccine. Approx 1-3 min later pt lost consciousness and experienced upper extremity myoclonic jerks for approx 5-7 seconds before regaining consciousness with fists clenched. Upon regaining consciousness, pt was A&Ox4, reported slight lightheadedness; denied CP, SOB, or cutaneous sx suggestive of anaphylaxis. Pt denies anything like this in the past, denies family hx of seizures, and denies needle phobia. Pt instructed to recline supine in car seat with legs elevated on dashboard, and soon reported feeling better, less lightheadedness.

Patient received first dose of Pfizer covid-19 vaccine on 4/9/2021 at 1800 with her mother in attendance after consent was acquired. At 1805 patient began to feel hot and nauseous. The patient thought she was going to vomit, so she left her chair in the waiting area to head to the restroom at the back of the store. at 1807, Upon rising the patient became weak in the knees and began to collapse. The patient's mother initially supported the patient and I was called to assist the patient to the floor. The patient was very pale in appearance as she was assisted gently to the floor, avoiding any injury. EMS was called shortly after the event around 1810. The patient remained conscious however was a bit disoriented initially while lying on the floor. The patient recovered quickly, however remained nauseous and complained of feeling hot. Upon questioning the patient, she had not eaten since lunch at school at 1300. The patient was given a cold water and a sprite, of which she had a couple of drinks out of each. The patient was relocated back into a chair at 1815 as she was feeling much better. EMS arrived at 1821. EMS performed a general assessment and a blood pressure check resulting in 130/80. The patient's mother dismissed any further treatment from EMS. EMS exited the building at 1827. The patient and mother waited in the store for a while longer. Both patient and mother exited on their own, denying escort from associates at 1840.

15 min after vaccine administration, pt experienced frontal headache, diffuse subjective weakness of LE, and gait instability. Admitted to medical center for monitoring and workup.

Pain between the breasts on the ribs. Started out as seconds of slight pain the day after shot until about 9:30pm when the pain became consistent but was a slight pain. I woke up at 2:30am and my chest hurt really badly. It was a constant pain but the amount of pain was back and forth. It hurt more to lay down and if I bent down it was very painful. I stayed up for an hour and a half until the pain went away. When it did I had sweat a lot and was very hot. I then woke up with little discomfort until an hour after I woke up with slight pain. The pain then has gone off and on but not as painful as it was during the night.

After giving the injection the patient had severe pain at the injection site. A few minutes later she struggled to make a fist with her same hand and reported having pain going up her neck. The injection site did swell up a few minutes after the injection as well and she felt tingling in her hands shortly after. Patient was given 25 mg of benadryl after she reported the tingling in her hands. She did not have any difficulty breathing though. She was able to stand up and walk with her parent to the car and was driven to ER by parent to be checked out.

Fever, chills, muscle pain, joint pain, tiredness, headache, injection site pain, injection site redness, nausea

Pain and swelling in both feet and ankles, pain started evening of injection, swelling 2 days later. Still tender/swollen 4 days later. Headache/Nausea on day 2.

Friday : soreness at injection site,3 hours later severe migraines; fatigue Saturday - severe migraines, fatigue Sunday,- -Vomiting, severe migraines, joint aches Monday - awoke with swollen face - centered around eyes and cheeks area, achy headaches, fatigue - went to ER and received Steroid shot.

First experienced heart racing, fatigue, dizziness and heaviness in your legs followed by hives that moved throughout the body including face, hairline, ears, legs, arms for the next 2.5 days.

Accompany minor with dad received vaccine for first time. Pt complain of dizziness, diaphoretic, pale to face, body stiffness and started jerking once on floor. Pt placed to floor for safety precautions. V/s obtained w/ b/p 80/54, HR 92 O2 98%. Jerking stopped with v/s obtained again w/ b/p 82/56 HR 95 O2 99%. EMS arrived and taken over care. Pt was more a/ox3. Taken to hospital via EMS.

While in seated observation area, pt reported feeling faint. Brief loss of consciousness, while supported by pharmacist, legs stiff, arm twitch then relax as regained consciousness, lasting few seconds. Feet elevated, called 911 for care. Evaluated by paramedics in parkinglot, returned back to pharmacy after recovery for checkout.

The complaint is characterized as a skin rash. The onset of the symptoms have been rapid and they have been occurring for 3 days. The course has been decreasing (pain had improved by visit on 5/10). The skin complaint is described as moderate to severe. The location is described as on the right side of trunk. There has been associated itching. She has a history of chronic back pain: aches. She said this is occurring as well as the new and worse sharp pain. It was worst last night. She was achy Wednesday morning into Thursday after vaccine. She felt a little better Friday morning, Friday evening she became tired and her back was hurting again. The rash and itching started on Saturday morning, Sunday was worse. There was burning, sharp pains on her side with the rash. Diagnosis of Shingles (B02.9). Started Acyclovir 5%. Apply 3 times daily for 7 days. Follow up in office if symptoms don't subside or get worse.

pts arm hurt immediately after taking the vax. Later that night her legs were feeling very heavy, her arm still hurts, joint pain in both hands, slight fever, has body aches and pains. On 5/12/21 they contacted her PCP and was told to give them a call back if her symptoms get worse.

7 days of secretory diarrhea, abdominal pain and nausea 5 pound weight loss due to inability to eat/drink regularly

Patient chronic conditions (JIA, UC) previously controlled on adalimumab. Within several days of receiving COVID-19 vaccine dose #2, patient began experiencing worsening/flare of ulcerative colitis symptoms including stomach pain, diarrhea, fatigue, arthritis pain that lasted beyond the reasonable and known duration of vaccine related side-effects. Symptoms treated with dicyclomine and acetaminophen with no relief. Symptoms continued x 2 weeks. Patient ultimately required addition of budesonide to treatment regimen for ulcerative colitis and is currently having relief of symptoms.

The patient felt tired and describes her eyes going dark, then passed out a few minutes after vaccination. She was vaccinated and then left the immunization room to sit down for a 15 minute waiting period. When she went to sit down, she collapsed on the floor. Her mother assisted her into a chair. She continued to be incoherent and have her eyes rolling back into her head for a few minutes. We used a cool cloth on her forehead and the back of her neck. The parents requested that we call 911. EMS arrived shortly and evaluated her. Heart rate, blood pressure, pulse ox, blood sugar and chest sounds were all within normal range. The patient stated that her arm felt heavy and "funny". She then stated that her tongue felt funny. EMS evaluated her tongue and said it looked normal. To err on the side of caution, she was taken to the hospital to determine whether or not she was having a delayed onset anaphylactic reaction. This patient has no history of seizures.

12 hours post vaccine she had severe myalgia, rash on both arms and legs, headache, nausea, stomach pain, and mild swelling in legs. Over the next 48 hours the rash darkened and spread to the entire body causing pain in her skin. The myalgia became nearly unbearable and both Ibuprofen and Acetaminophen didn't put a dent in the pain. One side of her face swelled so that one eye could only partially open. The nausea and stomach pain worsened so that she couldn't eat. Headache became intense. By 48 hours post vaccine she became delirious - her speech was slurred and difficult to comprehend. She would fall asleep for a few minutes and wake up unaware of where she was or what was happening. She never got a fever but did have chills. Around this time I called a relative who is a doctor to seek advice and Diphenhydramine was recommended. Benedryl helped immensely. 30 minutes after taking it she could speak clearly, was more alert, pain became tolerable, and her appetite returned. Symptoms and swelling returned when the Benedryl wore off so she continued taking it every 4 hours for the next two days until it wasn't necessary any more. The myalgia, stomach pain and headache persisted for 7 days. At 8 days post vaccine (today) a mild headache, mild and intermittent stomach pain, and mild fatigue are her only remaining symptoms. Her pediatrician cannot see her until next week but we have an appt for the 22nd.

Child was complaining of pain and knot on the left side of her chest and her left shoulder and arm as well. Parent took child to the doctor on May 12, 2021 because the pain was unbearable. The doctor stated to the parent that she needs to consulted with the infections disease doctor to get his opinion on what it is and how to treat it. The infections disease doctor stated to the other doctor to treat it with antibiotics. The doctor wanted to do a follow-up with child in two to three days to see if the antibiotics is working. Childs follow-up is schedule for May 15, 2021. Child was saying that she cannot sleep on her left side because it hurts so much.

Immediately after the shot she had a bad headache and approximately 30 to 35 minutes later dizness, chills, and throat restriction (anaphlaxis), extreme muscle soarness( any sort of touch was extremely painful, and she couldn't move her neck, it hurt to move from side to side. Her legs began to feel extremely heavy and hard to move. These symptoms seemed to last for approx 30 minutes. Headache didn't subside until later in the day, it did lighten up.

PT HAD A SEIZURE APPROX. 30 MINS AFTER RECEIVING THE COVID VACCINE, PT FAINTED, STIFFENED UP, AND BEGAIN TO CONVULSE. PT WAS PLACED ON COTT IN THE RECOVERY POSITION, 911 WAS CALLED AND VS OBTAINED. P74, R22, BP118/80, O2SAT 98% ON RA. SEIZURE LASTED APPROX 10 SECONDS, AMBULANCE ARRIVED WITHIN 10 MINS, AND TOOK OVER PT'S CARE. PT'S COLOR REMAINED PINK THROUGHOUT, AND SHE WAS SLEEPY BUT ABLE TO ANSWER QUESTIONS APPROPRIATELY. VS: P83, R24,BP116/80, POX99% ON RA. PT TAKEN IN AMBULANCE TO HOSPITAL FOR FURTHER EVALUATION

Patient started experiencing numbness and tingling on her right side and then all over on Sunday evening 5/2/21. It affected her gait and the numbness and tingling in her legs caused her to have to catch herself and hold on to something to keep from falling. She described that her legs felt weak for a few seconds when walking. This sensation gradually decreased in intensity and duration. When I saw her at 5 pm on 5/3, she had normal gait and only felt the numbness and tingling very briefly. Her exam including her neuro exam was normal on 5/3 when I saw her. The sensation of numbness and tingling completely resolved by 5/4. She also experienced HA, nausea and fatigue, but did not have syncope, dizziness or fevers.

arrhythmia, heart palpitations, pain in left arm, pain in chest (particularly left side) radiating into shoulder blade, fatigue, muscle aches

48hrs post-vaccine began with polyarthralgia, progressed to myalgias, arthritis, weight loss, abdominal pain/diarrhea, mucosal ulceration, and dyspnea, now admitted for evaluation which is suggestive of systemic lupus erythematosus.

Pfizer-BioNTech COVID-19 Vaccine EUA I woke up at about 4:30 AM and couldn?t fall back asleep, I kept feeling sleepy until I would get jolted back awake over and over. My joints were hurting, I had somewhat severe nausea, my head started throbbing. At about 6:40 AM my migraine started, my arm felt hot to the touch, and I got dizzy so I took some acetaminophen. At 10:00 PM I noticed the area under my left armpit was a little swollen and really sore, my throat and right tonsil was also sore and it hurt to swallow. The next day (today) I have another migraine, my throat and left armpit are still sore, and my muscles hurt. I?m getting better though.

Vaccine administered at outside facility. Patient is a 16 yo girl, admitted on 4/19 with myocarditis, s/p IVIG (4/19) after presenting with progressive new onset chest pain. She was in usual state of health up until 2 days ago when she started developing body aches, and chest pain. Patient received her 2nd Pfizer COVID vaccine last week (4/15). No known history of COVID infection. Parents brought her to the ED yesterday after she complained of dizziness, SOB, chest pain, and had a near syncopal event. EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, normal CXR, negative COVID PCR. Denies fever, GI symptoms, GU symptoms, headache, rash. Once transferred to our PICU, she was worked up for myocarditis vs MIS-C. Troponin has been trended q6 and is trending up (now 11). Of note, there have been no fevers. Patient is a 16 yo girl, s/p admission (4/19-4/23/21) with myocarditis, s/p IVIG (4/19), has now been readmitted on 5/10 with myocarditis after presenting with headache and neck pain for 2 days. Following discharge from the PICU on 4/23, patient states that symptoms have lingered (low grade fevers, feeling tired, on and off chest pain). After developing a progressive headache and neck pain, she came back to the ER for re-evaluation. Upon readmission, her troponin was elevated (2.06 on 5/10). Her CBC and CMP were reassuring. Blood culture collected on 5/11 and urine culture collected on 5/10. ID consulted for workup.

103 degree fever, migraine, severe joint pain, GI got significantly worse (pain in stomach); went to ER; admitted overnight to hospital since they could not get the fever and migraine resolved; spent two days in the hospital treated with various medications including Tylenol and magnesium

Presented to ED on 5/13/21 with trouble breathing, chest pain, back pain and numbness. Had been exposed to boyfriend with flu like symptoms 3 weeks prior and had had some symptoms around that time but had been improved. SARS-CoV-2 PCR negative in ED. patient afebrile but workup in ED revealed troponin of 0.71, no EKG changes. Symptoms resolved in ED but given troponin was admitted to the hospital for further evaluation. Echo performed and normal. Troponin trended in hospital and patient discharged without events.

Patient experienced seizure activity after receiving 2nd dose of pfizer vaccine. Sx started approximately 5 mins after receiving injection. fell and hit head. B/L upper extremity contractures noted that did not resolve and was associated with extreme pain and muscle rigidity.

Patient went stiff/possible seizure 5 minutes after getting the vaccine. She came back after approx. 30 seconds. EMS was immediately called and her blood pressure and pulse were both taken prior to EMS arrival. Blood pressure was 91/51 with a pulse of 48. PER EMS, the patients blood sugar was low.

arm pain, mild chest pain, mostly around the sternal area, more with on palpation, extremely elevated troponin levels (high normal is 0.04 for our labs, patient had 20) echocardiogram negative transferred to a more complex center, Hospital

Patient reports immediately after receiving the vaccine she developed chest tightness and pain that has continued to wax and wane the past two weeks. Has some intermittent difficulty breathing and fast heart rate that each last about 20- 30 minutes. Also accompanied by dizziness or lightheadedness. Reports her whole right leg feels tingly and her joints hurt, but denies weakness, redness or swelling of the joints or right foot. Also has a continuous headache that started within an hour of receiving the vaccine and worsened over the next few days. This too has waxed and waned.

delerium; Severe myalgia; full body rash; swollen legs; facial swelling; slurred speech; stomach pain and cramping; nausea; headache; injection for vaccine received same date; injection for vaccine received same date; injection for vaccine received same date; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 15Apr2021 (Lot Number: EP7533, at the age of 16-year-old) as single dose, and second dose via an unspecified route of administration, administered in right arm on 15Apr2021 (Lot Number: EW0171, at the age of 16-year-old) as single dose for covid-19 immunization. Medical history included post streptococcal reactive arthritis and bee sting allergy. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced severe myalgia, full body rash, swollen legs, facial swelling, slurred speech, delerium, stomach pain and cramping, nausea, headache. Headache and stomach pain have lasted 7 days. Rash and myalgia lasted 5 days. Delerium, facial swelling, leg swelling and slurred speech lasted 12-24 hours and were relieved by Benedryl. The treatment for the event included Ibuprofen, Acetaminophen, diphenhydramine. The injection for vaccine received same date on 15Apr2021. 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 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant. The outcome of the events severe myalgia and full body rash was recovered on 21Apr2021, for events stomach pain and cramping and headache was recovered on 23Apr2021, for other events delirium, swollen legs, facial swelling, slurred speech, nausea was recovering.

Fever 37.5C, fatigue, headache, swollen lymph nodes, back of the neck pain, stomach ache, pale complexion. Missed school, stayed in bed at home until symptoms resolved.

1st dose: fatigue, slight headache, pain in left arm. during arm circles, would be pain during movement pain for a day or two. Took Tylenol 2 tablets 500mg each on the night of the vaccine. 2nd dose: received vaccine at 5pm, during night of vaccine day, got a fever and headache and chills. flu-like symptoms for 24 hours. fever of 101F. soreness of muscles. on second day, fever was almost gone. lasted 2 days total. most severe symptoms on first day. Took Tylenol 2 tablets 500mg in the morning, 2 tablets 500mg in the evening. Took 1 tablet of Advil 200mg on day 2.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: blurry vision-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient reported leg weakness and blurred vision and dizziness/slight difficulty breathing upon getting ready to leave observation area. Said she hadn't eaten in a while and felt cold due to A/C in the store as well. BP was low and HR high, so called 911 to get her emergency help as she didn't feel like she could walk out of store safely. Felt strange and that her legs might give way. EMS arrived, vitals looked good, pt refused ambulance.

Fever, urticarial rash to face, neck trunk, and extremities, arthralgias and swelling to hands, feet, ankles, left knee and left elbow occurring 4 weeks after vaccine lasting for 4 days in hospital after 2 days at home. still resolving slowly

Patient admitted with myocarditis s/p dose #2 of the Pfizer COVID-19 vaccine. At the time of the report, she is still hospitalized. From EHR note: Patient was in her usual state of health when she received her second dose of the Pfizer mRNA Covid vaccine on 6/3. She experienced mild myalgias in the day following the vaccine. However, on 6/5 she developed new severe substernal chest pain, dizziness, and dyspnea. Pain radiated to her throat. Given severity of pain, she presented to the emergency department. In the ED she was afebrile, tachycardic, and initially hypertensive. Labs demonstrated WBC 10.9 (N 49, L 27), Hb 11.7, PLT 315. ESR 25, CRP 7.61. Troponin T was mildly elevated at 0.08, consistent with mild cardiac inflammation. SARS-CoV-2 PCR and antibody testing were negative. An EKG was normal. However, an echo demonstrated low-normal LVEF (55%). Otherwise, patient denies nausea, vomiting, diarrhea, cough, runny nose, conjunctivitis, new rashes, arthralgias. Patient was admitted to the cardiology service for further monitoring. Following admission, she was started on ibuprofen. She notes that her substernal chest pain has improved somewhat since admission. Differential for patient's presentation includes infectious, post-infectious, and non-infectious causes of myocarditis. Although post-vaccination mild myocarditis seems likely, we agree with the infectious workup already undertaken, and recommend additional EBV and CMV PCR testing.

Pain in her chest, lungs, and ribs; Costochondritis; Myalgia; This is a spontaneous report from a contactable physician (patient's father). This is one of the 2 reports from same patient. A 16-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 21Mar2021 as single dose for covid-19 immunization. Patient received first dose of bnt162b2 on unknown date in 2021, 3 weeks before the second dose for covid-19 immunization. Medical history included asthma (Diagnosed when she was 5 years old), allergies (Pollen, dust, walnuts, coconut, diagnosed when she was 3 years old) and migraine from Sep2019. Concomitant medications included Amitriptyline 25 mg for migraine, Macrogol 3350 (MIRALAX) daily for constipation and salbutamol sulfate (VENTOLIN HFA) asthma pump taken as needed for asthma which patient had not used this for a while before the vaccine. The patient received the second dose and then 5 days later she had to be taken to the emergency room. The patient was only 16 years old but was able to be vaccinated because she had asthma, so she is high risk. In Mar2021, 5 days after the second dose, the patient had horrible pain in her chest, lungs, and ribs. On 26Mar2021 or 27Mar2021 the patient woke up with this pain, then that night it hurt when the patient breathed or talked. The patient was taken to the emergency room at that time and was diagnosed with costochondritis, the patient was not ever admitted to the hospital. The patient was given ibuprofen 600 mg prescribed but it didn't help. Unknown lot, NDC, and expiration date for the Ibuprofen. The pain was still there so the patient was given naproxen and she has been taking that for almost 2 months now. Sometimes the pain gets better but sometimes it gets worse. Unknown lot, NDC, and expiration date for the Naproxen. The first 4 weeks the patient had to lay down because she couldn't sit or stand for more than 15 minutes because of the pain. The patient was fine and then 5 days after the second dose she got the pain, and it doesn't go away. The pain is under the breast like 4 fingers under it and in the middle near the sternum. The pain hurts more when the patient moves and changes positions. It was reported that "Two days ago, the pain was a 2 out of 10, but randomly it goes to 5,6, or 7. Today the pain is a 4 out of 10". The caller said this event was ongoing and persisting. When the patient went to the emergency room on 26Mar2021 or 27Mar2021 they checked her for inflammation and rheumatoid arthritis, but it was negative. The patient's blood work was normal, the chest x-rays were normal too. The patient also went to the emergency room on 05May2021 and was not admitted. The care team checked the patient again and they said it was myalgia or something. The patient was not resolved from the events. The causality assessment with suspect vaccine reported as Related to the events pain in her chest, lungs, and ribs. Follow up attempts are needed. Further information has been requested.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Pulmonary pain, Costochondritis and Myalgia. 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.

She experienced severe chest pains within the first 24 hours of the vaccine. The pains have lingered on and off for a week after. She has severe fatigue, headaches, nausea, and bilateral arm pain in both arms like pain in her bones. They are giving her Zofran for the nausea which also causes headaches.

Patient states she had a loss of sense of smell and taste after receiving both doses of the Pfizer vaccine. She states that foods taste like gasoline or urine and she has lost a lot of weight from not being able to eat. She has not tried anything to fix the loss of taste or smell, but is frustrated that it has been over one month and the symptoms have not resolved

headache, ataxia, weakness, loss of DTR in lower extremites, treated with steroids. clinical improvement over 7 days. discharged home to follow up with pediatrician, pediatric neurology, pediatric infectious disease, and pediatric rehab. patient also found to have coronavirus (NOT COVID 19) acute infection during illness as well.

16-year-old one day status post Pfizer vaccination #2. Other than the typical, known side effects of the vaccination, patient has right sided and fasciculations at rest and with movement. Additionally she reports numbness of the hands and feet although sensation is intact to light touch and remainder of exam is reassuring. The exam is not consistent with tardive dyskinesia, however in order to give patient symptomatic relief she was given Benadryl 25 mg by mouth ×1 with resolution of the fasciculations. Incidentally, the patient did develop a fever while in the urgent care, was given 650 mg of Tylenol. Patient was discharged from the urgent care in good condition, reassuring vital signs, well-appearing with instructions to take Tylenol and Benadryl as below as needed. Peds follow-up Monday

After receiving her 2nd shot of Pfizer about 8 hours later her left ankle became weak and numb and her left toes became numb, tingling and in pain. It was painful to wear a shoe or even a sock. She had trouble even walking (putting weight on her ankle). This went on for almost 1 week. By May 6th her ankle was still weak and she still has numbness in her left big toe and the one next to it. To this day, she is still in the same condition.

My daughter had been battling migraines and joint pain and generalized fatigue for over three years. We started seeing a functional medicine specialist in April and radically altered her diet due to food sensitivities. Approximately two weeks prior to the Covid vaccine she had been free of migraines for over four weeks and free of generalized fatigue and joint pain for over two weeks. Within two hours of receiving the Covid vaccine her generalized fatigue and joint pain was back and has not yet resolved as of today.

felt exhausted; Blood pressure low, after the seizure: 73/49 and 68/42; skin pale and sweating, after the first vaccine; skin pale and sweating, after the first vaccine; Tired and weak, with some lightheadedness, after the first vaccine; Tired and weak, with some lightheadedness, after the first vaccine; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; felt funny; This is a spontaneous report from a contactable consumer(mother, a nursing assistant, years ago) reported for a patient(daughter). The 16-year-old female patient received bnt162b2 (BNT162B2, Pfizer vaccination, Covid vaccine) at the age of 16-year-old, dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 11:52 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included seizure from 28May2021 to an unknown date (doctor wants to schedule an EEG, for further evaluation of the seizure ,because they did not do that test in the hospital.), ongoing Feels down at times (Consumer states the doctor originally prescribed her daughter another medication. Because all the appointments were by video, Consumer felt the doctor was not understanding her daughter's issue. Consumer states the original medication for ADHD was helping her daughter, but it made her daughter uncomfortable, as her daughter had no problems with attention, or school. Caller states then the doctor changed the medication to Zoloft. Name of previous medication was Zenzedi.). No family Medical History. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for depressed mood from 19May2021 and ongoing. Consumer states that her daughter is not depressed, but just feels down at times, and it is not severe. Consumer states the doctor had her daughter on another medication before Zoloft, that is used for ADHD. Consumer states that her daughter has not been diagnosed with ADHD, and the doctor switched the medication once her issues were further understood, as clarified in later part of report. The patient experienced seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine on 28May2021 with outcome of recovered, felt funny on 28May2021 with outcome of recovered , blood pressure low, after the seizure: 73/49 and 68/42 on 28May2021 11:52 with outcome of recovered , skin pale and sweating, after the first vaccine on 28May2021 with outcome of recovered , skin pale and sweating, after the first vaccine on 28May2021 with outcome of recovered, tired and weak, with some lightheadedness, after the first vaccine on 28May2021 with outcome of unknown, tired and weak, with some lightheadedness, after the first vaccine on 28May2021 with outcome of unknown, felt exhausted on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 73/49 on 28May2021 low , blood pressure measurement: 68/42 on 28May2021 low , blood pressure measurement: normal on 28May2021, heart rate: 55 on 28May2021, heart rate: 70 on 28May2021. The clinical course was reported as follows: Consumer states she took her daughter Friday, to have her first Pfizer vaccination, later reclarified as the Covid vaccine. Consumer states her daughter had a seizure after the vaccine. Consumer states Height maybe 5'8" or 5'9". Consumer states her daughter was weighed at the hospital. Consumer states that the experience was terrifying for her, to watch her daughter have the seizure. Consumer states her husband got the vaccine, and was fine. Consumer reports that her daughter got the vaccine at 11:52 am and within 30 seconds, her daughter said she felt funny, and then rolled her eyes and passed out. Consumer states after a minute, her daughter was conscious and the staff was rushing to her aid, as the Consumer called 911. Consumer states that for the next 25 to 30 minutes, her daughter was talking like a toddler, and was pale and sweating. Consumer states that the paramedics, told her daughter that she had a seizure, as they took her to the hospital. Consumer reports her daughters blood pressure, around the time of the event. Consumer states the first blood pressure, when her daughter awakened, after the seizure about 2 minutes later was 73/49, pulse 55, and a few minutes after that it was 68/42 and her pulse was 70. Seizure: Time: 11:52 am, almost immediately after the vaccine. Outcome: caller answers as she is monitoring her daughter closely. Consumer states that during her seizure, her daughter started to stare, and then passed out. Consumer states her daughter did have some stiffening of the arms with the seizure. Blood pressure low: Consumer states he daughter's blood pressure, began to elevate, before they transported her to the emergency room. Time: 11:52 am, almost immediately after the vaccine. Outcome: Consumer answers as her daughter's blood pressure was stabilized enough by the time she was transferred to the hospital, where it normalized. Consumer reports later that her daughter's skin was pale and she was sweating, at this time. Reclarified, Consumer states that when her daughter was talking to the medical staff, she was talking like a toddler, and giddy. Consumer states she was trying to tell the staff that this is not normal for her daughter. Consumer reports her daughter feels tired and weak after all the events. Consumer states she signed up for VSafe. Time: Consumer states sometime, after the vaccine. End: Consumer answers as her daughter is not as tired and weak, as she was the first day the event happened. Caller states that the next day, her daughter relaxed all day, and the day after that, her daughter went to work and felt exhausted, but felt that she could still go to work. Consumer states that yesterday at work, her daughter said she felt weak, and lightheaded. Consumer states that after having a snack and a break, her daughter felt better and worked the rest of her shift. Outcome: Unknown. Reclarified, Caller states she does not want to assume anything, and is monitoring her daughter, and that this event may be due to another reason, as well. Consumer clarifies her daughter went to the emergency room and then was released. Vaccination Facility Type was pharmacy. No Vaccine Administered at Military Facility. 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).No additional Vaccines Administered on Same Date of the Pfizer Suspect. The event Seizure required a visit to Emergency Room, not Physician Office. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. No AE(s) following prior vaccinations. Caller reports some prior vaccinations that her daughter had without any events. Consumer states that her daughter is not going to get the second vaccination. Consumer states that she does not know the potential risk, if her daughter gets another vaccination. Information about lot/batch number has been requested.

16 y/o F with hx of autoimmune disorder and Tourette's syndrome BIB mom for dizziness s/p Pfizer COVID-19 vaccine received yesterday. Pt endorses muscle pain, nausea, sinus pain, throat pain, and HA. Pt with fever (Tmax 100.2F) onset this AM. Denies chest pain and difficulty breathing. Pt reports she feels a little out of breath. Mom has a heart rate monitor at home and states pt's HR has been in the 140s. No medications taken. NKDA. Differential Diagnosis: vaccine reactions, myocarditis, pericarditis. After physical assessment and management, pt is well appearing, explained to mom on reassessment symptoms have improved, no longer dizzy or having trouble breathing. Pt still feels a little myalgia. Explained symptoms likely from vaccine reaction, explained normal heart enzymes and normal EKG, strict return precautions given including chest pain and persistent fever.

Sharp chest pain and left shoulder blade/back pain with difficulty taking deep breaths. Did not report initially because it went away after a few days, but after reading the studies wondering if she had the myocarditis/pericarditis side effects.

Patient began to notice her arm was extremely heavy, red, and swollen approx. 27 hours after the vaccination. Ice and Ibuprofen were used to control the swelling and discomfort.

L distal internal jugular venous thrombus found on 6/29 after pt had three days of squeezing sensation on upper arm followed by acute pain on day of presentation to ED. In ED upper extremity Doppler demonstrated clot. Pt transferred to our hospital where she started on anticoagulation therapy for treatment.

sore muscles all over entire arm in pain when used Extreme chills fever mood swings extreme fatigue muscle pains headache dizziness hyperventilating

After about 1 week after taking her first vaccine, she started to have rashes on her legs along with her feet swelling and hurting. And after her second vaccine which was given on May 15 (Lot # EW0168) her whole body had rashes and her feet pain got worse. Her joints (knee and elbow) started to hurt her too. I took her to her pediatrician and her doctor thought it was an allergy but the allergy medicine didn?t work so we did blood extraction and they said to take her to hospital immediately. After staying for 5 days, the doctors were suspicious with the diagnosis Lupus so they prescribed her Hydroxychloroquine 200 Mg Tablet, Phytonadione 5 MG Tablet, and PresniSONE 10 MG Tablet. Now she is sick at home and taking the medication. She has never been sick or diagnosed with anything before the vaccination. I told the hospital my concerns and everything should be there too.

Blisters on elbow that has spread to her legs, ankles and feet; Elbow pain; it looks like she has some red things maybe on her face; This is a spontaneous report from a contactable consumer or other non hcp. A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration on 27Jun2021 11:00 (at the age of 16-year-old) as dose 1, single for covid-19 immunisation. Medical history included none. Family medical history relevant to AE included none. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within four weeks prior to vaccination. On 27jun2021, patient experienced elbow pain. Patient woke up with the blisters on her elbow 28Jun2021. Reporter clarified they were covered on both elbows with blistery things. Patient this morning blisters covered new areas and spreading on her arms legs ankles and feet. Reporter said it has worsened because it is now in other places. Reporter said that the actual elbow pain has persisted about the same but the worsened is the blisters in other areas. On an unknown date in 2021, reporter stated that "it looks like she has some red things maybe on her face". Reporter stated that "She had called paediatrician and trying to find recommendations and she can not find anything other than to take Benadryl and Advil, she is trying to find what to do for it, does Pfizer have any recommendations for when the reaction is blisters". The events did not result in emergency room/physician office visit. patient's father and the patient's brother and sister all had the vaccine as well and no one had this reaction. The outcome of the events were not recovered.

Migraine with aura; Burning pain along her right side; prolonged nosebleed; bruise developed under right eye; mouth ulcer; Joint pain; Stiffness; Stomach pain; headache; arm soreness; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patients medical history included Bechet's disease. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 since having the vaccine. The patient experienced normal headache and arm soreness after 48 hours of vaccination and severe fatigue on 22Mar2021 and prolonged nosebleed, a bruise developed under her right eye, mouth ulcer, joint pain, stiffness, and stomach pain on 23Mar2021 and had another nose bleed on 24Mar2021 and migraine with aura and unusual burning pain along her right side on 25Mar2021. The patient did not receive any treatment for the reported events. The clinical outcome of the events headache, arm soreness, fatigue, nosebleed, bruising, mouth ulcer, joint pain, stiffness, stomach pain, migraine with aura and burning pain was not recovered. No follow-up attempts are needed. No further information is expected.

Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on the back, her back is all rash, her legs all rash and her face is just swollen.; The rash is stopped right away but her face is still swollen.; She loose 8 pounds within two weeks because of after, she fell sick.; The pain is just after the first vaccine and it gets worse, after the second one.; Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on the back, her back is all rash, her legs all rash and her face is just swollen.; She loose 8 pounds within two weeks because of after, she fell sick.; This is a spontaneous report received from a contactable consumer. This consumer (mother) reported for a 16-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172) via an unspecified route of administration on 24Apr2021 (at the age of 16-year old) as dose 1, single for COVID-19 immunization. Relevant medical history was reported as none. The patient's concomitant medications were not reported. It was mentioned that patient did not receive other products and no investigation assessment was done. On an unknown date in Apr2021 the patient had a problem with vaccine, reporter just thought that this was because of the vaccine but after the second one it got worse. She had rash in her legs, by the knee and all joints had pain and she had it on the back, her back was all rash, her legs all rash and her face was just swollen. The rash had stopped right away but her face was still swollen. Reporter stated that she lost 8 pounds within two weeks after, she fell sick. Right after her first vaccine, about a week after patient start facing pain in her joints. The pain was just after the first vaccine and it got worse, after the second one. When probed for lab test: Reporter stated, she had not yet got them and was going to go tomorrow, because two weeks ago, the doctor said, it was allergy and was prescribed Zyrtec and Benadryl. It did not work so that was why they going to do blood work tomorrow because she took her again. It was mentioned that patient received Zyrtec one in the morning and Benadryl one in the night but she took like 3 days and it gave her headache (Further not clarify hence not captured as event) so she start taking it the other, she does not take it. The reported took her again and doctor took her blood to see what was wrong because they could not really tell, what could be better. The reporter mentioned that her daughter was a completely normal kid and after this vaccine just everything had become like another world. The split case was identified after the call hence no further relevant information for the patients could be probed. Limited information was available over the call. Follow-up attempts were completed. No further information was expected.

Developed Postural Tachycardia Syndrome (POTS) with vomiting and diarrhea, 20 lb weight loss. She was evaluated by pedi GI, who made the diagnosis based on labs, EKG, vital signs, and clinical presentation. Symptoms started 3 days after the 2nd Pfizer COVID vaccination was administered. She was treated with supportive care (fluids, salt, compression stockings), omeprazole 20 mg BID, cyproheptadine 2 mg BID. She received a single dose of decadron (for croup on June 25,2021). Her symptoms have improved though they have not fully resolved. she continues on omeprazole and cyproheptadine.

after 15 minutes started to feel light headed, had patient lay down with feet up, VSS - 120/68, pulse 78 strong and regular, Resp 18 non labored, skin warm and dry, sat up to take a drink of water as she was laying back down she started to have mild tremors of both arms and legs and then became rigid, pupils were dilated and non responsive to light, no verbal response, VS continued to be stable, O2 98%. Patient was transported to the local ED. She was started to respond when the ambulance arrived and was able to walk to the gurney.

Patient became dizzy, cold and clammy, Starring and not responsive for 1 minute. Jaw was clamped down but upon asking the patient then spoke 2 minutes into episode. Vitals were stable. Rapid response was called. Patient was observed, given fluids and sent home.

Very high heart rate over 120 for 8 hours; Fever.; Chills; Sore muscles; Headache; Dizzy; Very high heart rate over 120 for 8 hours. Fever, chills, sore muscles, headache, dizzy, and tired.; This is a spontaneous report from a contactable consumer (patient). A 16-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left (at the age of 16 years old) on 12May2021 at 18:30 (Batch/Lot Number: EW0186) as DOSE 2, SINGLE for covid-19 immunization. Also reported 'Device Date:19May2021' no additional details provided. Facility where the most recent COVID-19 vaccine was administered was health facility. No other vaccines were given within 4 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Medical history included attention deficit hyperactivity disorder. Concomitant medication(s) included methylphenidate hydrochloride (CONCERTA) 54mg. Historical Vaccine includes BNT162B2 Dose 1 (at the age of 16 years old) on 21Apr2021 at 18:30 Batch/lot number ER8736, Left arm Covid-19 immunization and not events were reported. The patient previously took amoxicillin and experienced drug hypersensitivity. On 13May2021 at 02:00 The patient experienced Very high heart rate over 120 for 8 hours, Fever, chills, sore muscles, headache, dizzy, and tired. The event Very high heart rate over 120 for 8 hours was considered medically significant. The patient underwent lab tests and procedures which included heart rate: high on 13May2021 (Very high heart rate over 120 for 8 hours). No Treatment was given and No hospitalization was involved. The clinical outcome of the events was recovered May2021. Follow-up attempts completed. No further information expected.

had arm pain at injection site; her arm is numb to her hand on injection site side which is the left side.; From the injection site up to her neck is hurting; feels weak and tired; feels weak and tired; she can't feel her hand up to her fingers; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0198, Expiration Date: not reported) via an unspecified route of administration on 12Jul2021 as dose 1, single for COVID-19 immunization (at the age 16-year-old). The patient's medical history and concomitant medications were not reported. The patient experienced had arm pain at injection site, her arm was numb to her hand on injection site side which was the left side, from the injection site up to her neck was hurting, not horrible pain just aching, feels weak and tired, feels weak and tired, she can't feel her hand up to her fingers on an unspecified date in Jul2021. It was reported that, it was patient's first vaccine and getting the second dose on 02Aug2021. The outcome of the events was unknown. Information about lot/batch number is requested.

Patient is a 16 year old female here with mother, complaining of right deltoid pain since MCV4 and Men B vaccination on 07/20. Injection pain up to her neck, later radiating down to wrist. No medication yet.

Per witness, patient was sitting in the waiting room post vaccination w/ Pfizer vaccine. Patient's mother got up and walked to counter to make 2nd dose appt. Patient started leaning over in chair and fell to the floor (witness reports patient bumped head). Per witness, mother ran to patient's side. This writer heard someone call for help. This writer was in the back assisting with immunization clinic. Patient was observed lying on the floor w/ mother at her side. Patient appeared confused and was actively trying to sit upright. This writer and patient's mother explained that she had experienced a vasovagal reaction after her COVID-19 vaccine. Patient was instructed to stay in lying position while vital signs were obtained. Patient was able to verbalize name, DOB, and place. Vital signs at 1040 (BP 98/55, HR 61, O2 98% on room air). Patient was diaphoretic and pale. Patient reported eating breakfast this morning. Patient was observed crying stating "I feel like I can't breathe." This writer continued to monitor vital signs (BP 120/72, HR 77, O2 99% on room air). Staff placed several ice packs on patient. She complained of headache and told staff that her head hurt. Mother of patient requested EMS to be called. Staff called EMS. Vital signs at 1050 (BP 101/64, HR 92, O2 98% on room air). Patient reported feeling better and was able to move to sitting upright position on the floor. Patient appeared less diaphoretic and color was returning to normal. Patient was moved to wheelchair w/ assistance from staff. Patient was provided with water and crackers. EMS arrived to the facility at 1050. EMS evaluated patient, but patient declined to be transported. V/S stable. Patient reports history of passing out unrelated to vaccine administration. Staff explained that mother/patient need to inform staff w/ the 2nd dose of vasovagal hx, so patient can receive vaccine lying down. Staff provided mother w/ concussion education and explained what S/S would indicate a need to go to the ER. Patient was also encouraged to f/u with pediatrician. Patient was taken out to car via wheelchair by staff at 1100.

Body aches, feelings of hot cold, dizziness, temp 101, chills, mild joint pain, resulting in loss of sleep. She drank fluids(some electrolytes), and took two Advil.

Patient had a reaction to the Pfizer Covid-19 vaccine. While waiting for 15 minutes after the shot, patient had a 'seizure' according to patient's mom. She was flapping her hands, staring, and sliding down the chair. 911 was called. Patient was pale and calm but responding to the immunizer (technician) and pharmacist. Patient said she was fine. EMS came and checked the patient and said patient is fine. Patient said she was fine again. EMS left without the patient since she was fine.

Patient and Father were at desk to schedule follow-up vaccination when patient fell to the ground. Writer and additional clinic manager responded to event. Patient was rigid, eyes rolled back and not responding. Writer and manager attempted to arouse patient, with no response. Per father, patient has passed out in the past with blood draws. Feet were elevated and ice pack applied behind neck. Patient's fists were clenched, teeth clenched, back arched and appeared to have urinary incontinence. Episode lasted approximately 1-2 minutes. ED responded. Patient regained consciousness and was able to interact with writer appropriately. Bp 124/78, pulse 80 bpm, oxygen saturation 100%. Patient assisted to stretcher and transported to ED

Heavy sleeping, sore and stiffness in arm that was injected, chest pains and tightness of chest, nose bleeds and severe headaches

Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted in waiting are 5 minutes after shot. Patient's muscles stiffened up and she hit back of head on shelf. Pharmacists lowered patient to recovery position on floor, where pt recovered consciousness and relaxed. Patient's mother said that patient has vaso-vagal responses to shots and that she was having one of those. Patient was well and was able to leave without further assistance.

Patient developed muscle pain and swelling in anterior shoulder area anterior to neck between clavicle and anterior neck , No mass but there was generalized swelling no redness

The rash first started on her hands on 4/2 and was originally attributed to powdered gloves she used during her job at a restaurant. She had her wisdom teeth out on 3/24 and started amoxicillin and steroids for the wisdom teeth on 3/25. She had her first COVID vaccine on 3/30 with arm pain only on 3/31. She was seen in the urgent care on 4/4 . Rash felt to be due to amoxicillin or contact dermatitis (gloves). She stopped amoxicillin. The rash has continued to evolve. Originally maculopapular and only on hands, nby 4/13 there was both a maculopapular rash in addition to urticarial lesions primarily on her lower extremities, but also present on her trunk and in her groin. It is intensely pruritic. It seems to change over time, though the family is not entirely sure about that. Certainly, they describe confluent erythema and swelling over her right ankle the morning of 4/13 which was not present by the time she saw me that afternoon. She has had ankle arthralgias as well. as of 4/16, rash is gone other than feet.

Woke up around 2AM the morning after the vaccine was administered and noticed pain in hands when washing hands. Woke up officially around 9AM. Entire body hurt, most notably headache, backache, and neckache. Pain was intense, took Ibuprofen and muscle relaxer. Stayed in bed in the dark for most of the day because of pain. When standing, dizziness and weakness, fell over once. The pain finally subsided enough to function close to 7PM, disappeared completely by the following morning.

One hour after returning home.Heaviness in limbs, unable to walk, shortness of breath, nausea, heaviness in chest. PCP provided oxygen, steroid shot, shot for nausea in office. Observed until symptoms subsided. Released with Rx for steroids and anti nausea medications

Bad pain with injection-needle went too deep for teen female. Instant pain afterwards increasing. Next day can't move arm-pain spreading to shoulder and neck

Left arm ache, sore with slight bruising. Headache and mild fever. Pain ful menstrual cycle with abdominal cramping and heavy bleeding with the cycle lasting for 6 days ( more than normal ).

ON 4/21/21, SHE BEGAN TO EXPERIENCE SHORTNESS OF BREATH, COUGHING, CONGESTION, SEVERE BACK ACHE, WEAKNESS, FATIGUE, FEVER, CHILLS, VOMITING, DIARRHEA. I TOOK HER TO THE HOSPITAL WHERE WE WERE TOLD THAT IT WAS DUE TO VACCINE AND SHE WAS SENT HOME WITHOUT MEDS. SHE BECAME WORSE AND WORSE AND DEVELOPED HEART ATTACK SYMPTOMS: CHEST PAIN, WHEEZING, TIGHTNESS AND HEAVINESS IN CHEST, INTENSE BACK PAIN. WE RETURNED TO THE ER AND SHE WAS DIAGNOSED WITH PERICARDITIS. WE WERE ALSO TOLD THAT HER HEART WAS SLIGHTLY ENLARGED.

At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was asleep. She had severe muscle aches, hurt to move, hurt to breathe and felt like she was having a heart attack. She felt like she might pass out and had some blurred vision. At 630am, I saw her texts and immediately brought her 2 tylenol and a large glass of water. She went back to bed. She woke up around 10:45 and was feeling decent except for a headache but no fever or anything so we went to try on some Prom dresses. At the dress shop, she collapsed and had a seizure lasting around a minute. She lost her bladder and was completely confused and incoherent. She's never had a seizure before. I scooped her up, brought her to the ER where they ran every test and scan imagineable. Full blood work up and cultures, a chest xray, a CT scan of her brain and lungs. Her temp was high 103-104 and she had full body chills and a pounding headache. Her BP kept dropping and got as low as 81/36. They threw 2 bags of IV fluids into her and admitted her to the hospital. She had also developed a heart murmur. Over the course of the night, her BP stabilized but her temp continued to spike and come back down with Tylenol/Ibuprofen. She also had IV Tordahl for the headache. Her inflammatory markers were high at 15.3 which we were told should be less than 1. They reran labs in the morning but everything can back really low which they felt was a dilution effect from all the fluids so wanted us to follow up with her primary care on Monday. On Saturday night, he lymph nodes were swollen to the size of ping pong balls but have since slowly reduced in size although still there. Her labs were better from discharge and her white blood cell count was within range and her inflammatory marker was down to 1.7. Her blood sugar was a little low. She did pass out and have seizure like response to giving blood in the doctors office, lost bladder control again, shot pupils, etc. She is still stuttering over words, has some short term memory retention and has some motor function issues which they think is a result of the initial seizure and should resolve itself over time. Her liver function tests were totally normal in the hospital but are a high now so they will be checking her out again next week.

patient became very diaphoretic in the observation area, her head went back, eyes closed, extremities became very rigid and patient appeared to have lost consciousness for a brief moment. RN was present at side of patient, patient was hypotensive, vitals checked BP 71/48 and pulse 54. Patient states she felt like she went to sleep, started to feel better several minutes later. EMS was contacted to evaluate and transport patient to ED.

Aches and sight nausea/fatigue the day of vaccine, on day of vaccine I was 142 pounds. Two days later I was 145. Today, 5 days post vaccine, I was 147 pounds. My weight has never fluctuated this much in such a short period of time ever. There has been no change to my diet, activity level, medications or any other factors since vaccination. My weight was steady prior to vaccination. The vaccine in question was my second dose. I had no adverse reactions after my first vaccine.

Fever, headache, light headed, sore body, pain in shoulder where I got the shot all of which lasted for about 24 hours except the sore body which is still continuing on currently.

Passed out right after vaccine; muscle aches; tired; chills; migraine; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 14Apr2021 at 14:15 (Batch/Lot number was not reported) as single dose for covid-19 immunization, administered at the Pharmacy or Drug store. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 at 14:15 in the left arm for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient was not pregnant at the time of report and vaccination. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient passed out right after vaccine, also experienced muscle aches, tired, chills, and migraine; all on 14Apr2021 with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.

By the following morning, my daughter had a large and painful lump(s) in her armpit. We called the doctor and were told it was an adverse reaction. We were to start ibuprofen and ice, avoid any touching of the area, and monitor it for a few days. That was Monday, and it is now Friday. The lump is still there but it is slightly less painful. If it isn't better by Monday, we will see the pediatrician.

After receiving the vaccine on 4/26, she developed headache and temperature to max 99-100 as well as muscle pain in the arm where she received the vaccine. Progressed to diffuse myalgias on 4/27 and 4/28. Was having a slight cough that is typical for her during this time of year due to allergies, no other respiratory symptoms. Then acutely developed severe jaw pain that radiated to the throat and into her chest when she woke up on 4/29 in the morning. She had 10 out of 10 crushing chest pain.

fever 100.9; nausea; back pain; sleepiness; chills; fast heartbeat; This is a spontaneous report from a contactable consumer (parent) reporting for his daughter. A 17-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose and had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization and stated was fine after the first dose. Patient was 17-years-old at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced fever 100.9, nausea, back pain, sleepiness, chills, fast heartbeat on an unspecified date. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

nausea; headache; began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face; pinching in her left shoulder; began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face; patient could not open her eye or control her face; her left leg had goosebumps and chills; her left leg had goosebumps and chills; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8731) via an unspecified route of administration on 07Apr2021 at 15:15 (at the age of 17-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included asthma from an unspecified date and unspecified if ongoing. Family medical history relevant to the adverse event was reported as none. Concomitant mediations included ethinylestradiol/levonorgestrel (JOLESSA) taken "to decrease her periods" from 2019 ("about two years ago") and ongoing and at an unspecified dose, cyclic, for three months straight with no placebo. Then takes a placebo pill for one week straight and biotin taken "for hair and nail growth" from an unspecified date ("she began taking within the last 6 months") and ongoing. There was no history of previous immunization with the Pfizer vaccine, there were no additional vaccines administered on the same date as the COVID-19 vaccine and there were no prior vaccinations within 4 weeks. It was not provided whether there were adverse events following prior vaccinations. On 07Apr2021 the patient experienced began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face, patient could not open her eye or control her face, her left leg had goosebumps and chills, pinching in her left shoulder, nausea and headache. The reporter called to report that her daughter had a severe reaction to the first dose of the COVID-19 vaccine. The clinical course was reported as follows: The patient received the first dose of the COVID-19 vaccine in her left arm. Less than an hour after receiving the COVID-19 vaccine, the patient developed goosebumps and chills in her left leg. The reporter was not very concerned about it at the time. About 9:00PM that same night, the patient started complaining of pinching in her left shoulder. The reporter was not too terribly concerned. By 9:30PM, that same night, the patient started to have left eye twitches. Then they increased to eye spasms, then the patient could not open her eye or control her face. Then, it progressed to patients nose and left side of her face. At that point, the reporter tried to contact a nurse with the health insurance advice line. She waited for 30 minutes. The patient's symptoms continued to get worse, so the reporter took the patient to the emergency room. While the patient was in the emergency room triage, while hospital staff were getting her blood pressure and temperature, her symptoms also started to involve the right side of her face. Around 10:15PM, that same night, the patient started to get nauseous and a headache kicked in. The emergency department took patient straight back to a room. The patient was not admitted to the hospital. The emergency department started an IV on the patient, and they administered Reglan, Benadryl, and Toradol to treat her symptoms. The emergency department ran blood tests, preformed a urinalysis and a CT scan. The reporter did not know what all blood testing that was done revealed; however, the reporter did know that they told her that none of the testing revealed anything and were all normal. The patient was eventually discharged from the emergency department at about 1:50AM. She was sent home with Butalbital, for headache and was advised to take ibuprofen. She was still having the twitching but not as bad when discharged. On 08Apr2021, the patient's symptoms had not completely subsided, but were significantly better. On 08Apr2021, the patient woke up with nausea, chills and a headache. The reporter expected the patient to have these side effects. The side effects continued until very late in the day on 10Apr2021. The patient never vomited, was only very nauseous. The reporter also stated that when the woman was administering the first dose of the COVID-19 vaccine, the woman said "oops" and it was not explained what "oops" meant. The reporter asked if it was possible that the patient received the dose subcutaneously and that was why she had these side effects. The reporter also stated that the second dose was scheduled for 28Apr2021 and she asked if the patient should receive the second dose. The clinical outcomes of the events began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face, patient could not open her eye or control her face, her left leg had goosebumps and chills, pinching in her left shoulder, nausea and headache all recovered/resolved on 10Apr2021. No follow-up attempts are needed; No further information is expected.

After a few minutes of receiving vaccine, patient reported dizziness, light headedness, and blurry/dots in vision. She then became more upset leading to hyperventilation and crying. She then said she had tingling in her fingers, which progressed to difficulty moving her fingers/stiff fingers, and coldness and redness in tips of fingers. She then reported she was loosing sensations in her feet and legs. 911 was called. We tried to have the patient take slow deep breaths. We offered an ice pack and water up front and a heat pack for her fingers. Paramedics arrived. Her blood pressure, heart rate, oxygen saturation, glucose were within normal limits. She was given oxygen and the paramedic was able to help her slow her breathing. Her fingers went back to normal and she felt fine before leaving. She did not feel the need to go with the paramedics.

fatigue; Fever; chills; aches in muscles; This is a spontaneous report from a contactable consumer (Parent). This is the 2nd of 2 reports, for the 2nd dose. A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, at age of 17 years old, administered in Arm Left on 09Apr2021 09:00 (Lot Number: EP6955) at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included depression. Concomitant medication(s) in two weeks included escitalopram, fexofenadine hydrochloride (ALLEGRA), bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10), all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EP6955) at age of 17 years old in Arm Left on 19Mar2021 09:00 for covid-19 immunisation and experienced Fatigue, chills and achy, zofran [ondansetron] and experienced hypersensitivity. The patient experienced Fever, chills, aches in muscles, fatigue on 09Apr2021 10:00. Tylenol received for events. And outcome of event was recovered on unknown date. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335679 same patient and vaccine, different AE and dose

White blister rash that started at injection site then spread quickly over back, chest, other arm, legs. Light headedness, and tingling and numbness in lips and face. Was given Benadryl 25mg and 2 Tylenol. The rash and numb feeling persisted for 3-4 hours. Several hours later symptoms were followed with a fever and nausea. These symptoms remedied within 24 hours and she was just tired and sore.

Pre-syncope while at restraint approximately 45 minutes after vaccine. She slumped to the ground and lost muscle tone before being caught by her grandparents.

Red bullet Mark on arm lasted three weeks. Has pins and needles off and on in feet. Losing muscle function in hands that is not going away. Having hard time holding onto objects or writing. Primary doctor referred to neurologist.. waiting for appointment

The day after vaccine patient developed fever, myalgias, sore throat. Fever persisted 4-5 days. She developed rash on 4/30. Labs done showed low platelets (64k), low WBC with neutropenia. Fever resolved by 4/30 and rash resolved by 5/1/21. Platelets and WBC are recovering.

When I first got the shot I had some soreness and some pain from mid upper are down to elbow. The next day I could be rly wake up, my arm was incredibly sore and I felt sick to my stomach in waves. (rolling nausea) During the day I had off and on headaches that became a full on migraine my dinner. My arm stayed sore and hard to use all day and at night about 7:30 - 8:00 a sharp pain started lancing through my thigh to my knee, after a half hour or so it moved to include down to my ankle, then spaced out between the three randomly till about nine wen it moved to my side for about twenty minutes or so before becoming a dull throb in my leg till I fell asleep. The next day I felt a slight ickyness that last off and on all day as well as a light headache that got worse in the evening. The soreness in my arm dulled down and was just about gone by night, as well as rolling nausea all day though light. Today I woke up a little icky, very tired, and with a headache that has lasted all day and worened during the night, the soreness in my arm is gone.

Evening of 5/6 hives started. Father gave no medications, just watched and waited. Pt went to school on 5/7, came home around 1400, hives noted on neck, arms, legs, groin, back, stomach, all over per father. Father gave benedryl Friday around 10 am, then took to emergency room Saturday morning due to eyes being swollen shut, left arm was swollen hand and wrist. ER gave 2 injections - immediate reacting and long acting, along with 2 benedryl, pepcid. Pt was discharged from ER after about 1 hour. Hives persist today, May 10th. Pt is now on 40 mg 5/9 and 5/10. Hives remain persist on feet and hands today.

Patient received Pfizer Covid vaccine dose #1 at 4:07pm, 10 minutes later patient said that she was not feeling well. She felt her left arm was going numb, light headed, dizziness and chills. at 4:10 BP was 127/81 pulse 70. At 4:25 bp was 136/82 pulse 83. She was still feeling light headed, cold, and shaking. Pt given orange juice. At this point patient stated she has a hx of losing hearing and then a feeling of passing out. This has occurred more than one time. Pt also stated having lost feeling in both legs with no explanation as to why. 4:35pm bp 133/82 pulse 85, she was feeling cold and shaky. 4:42 pm patient stated she was getting colder and was still light headed. 4:56pm very cold, chills and dizziness. Pt was given another blanket. Both pt and father were asked if emergency services should be called. 5pm per parent;'s request were ok to give 480mg of tylenol, she was very dizzy and cold bp 132/85 pulse 89. Father approved of us calling for emergency services. Pt symptoms not improving. Emergency services arrived pt was able to get onto her feet and walk to the stretcher. Pt stated she is still very dizzy.

one week after covid #2 vaccine developed fevers, neck pain, headaches and vomiting, treated for lymphadenitis with oral antibiotics with continued fevers now x 9 days

pt had headache, fatigue, and severe neck pain one day after receiving 2nd covid vaccine. Was seen in ER on 05/06/21 . was seen in peds office 05/10/21 for follow up.

immediately felt tingling in her arm. About 3 hours later, she started having side effects. As of this report, it has been 28 hours since she received the 2nd dose. Her side effects are at their worse right now. They include: injection site pain, severe lymph node pain in her armpit, feeling unwell, nausea, low grade fever under 101 degrees, muscle pain in arms and legs, chills and sweats, some joint pain. dizziness and weakness and labored breathing.

back pain; Left leg it keeps shaking alone; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 09:30 at 17-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter (caller) calling about her daughter. Asked if these were normal symptoms and should be worried. Caller reported that her daughter took her first vaccine dose at 0930 this morning. She reports that her daughter has never had a flu shot or vaccine of this kind. She reports that they waited the recommended 15 minutes after getting the vaccine. They got home and about 30 minutes after the vaccine (15Apr2021 10:00) her daughter started having back pain, slight back pain and her left leg it keeps shaking alone. She reports that when she stands up it shakes, and it comes and goes. She asks if this is normal or should she be concerned. Caller reports that she already spoke with safety, no reference number for that encounter. Caller reported that she wanted to end the call so she could call her doctor, she did not provide any additional information at this time. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

back started hurting; Left leg started shaking/When stands up, left leg keeps shaking; This is a spontaneous report from a contactable consumer or other non hcp(patient's Mother). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration, administered in arm left on 15Apr2021 09:30 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced about 25 minutes after the vaccine, back started hurting and her left leg started shaking. When she stand up her left legs kept shaking, both on 15Apr2021 09:55 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Pt rec'd Pfizer vaccine, completed 15 minute observation period without complaint, then returned to clinic around 10:30am reporting numbness in entire left arm. Pt states she was not able to move fingers in left arm. Upon initial evaluation by nurse left arm was pale and cold to the touch. Paleness and coldness resolved within a few minutes. There was slight weakness in left hand when patient was asked to squeeze nurses hands. Right Arm- b/p: 112/82, O2: 99%, heart rate: 91 BPM. Left Arm- b/p: 98/77, O2: 98%, BPM: 87. Pt was asked again to squeeze nurses hands, pt was able to squeeze slightly harder, however slight weakness compared to right arm was still noted. Pt verbalized improvement in feeling and movement, however states still did not have full feeling or movement back. Advised to stay with school nurse for 1 hour and re-evaluate weakness. If weakness persisted, advised to call physician. Upon f/up from school RN, pt remained in clinic until 11:40am when student stated she felt "much better" and strength of left hand was almost that of the right. School nurse states "vitals remained good".

Approximately 5 minutes after receiving vaccine client became quiet, clenching fists, and started crying. RN asked if she was okay, stated she was scared and that her arms felt weird and her chest was tight. RN asked some questions about her health history, she then offered a granola bar and water. Client drank some water, declined snack. Clients hand began to shake, RN offered to lay client on a cot but client declined. Her dad came to check on her, she broke down saying that her arms were numb and chest was tight. The 15 vaccine minute timer went off, client stood but legs were week. She sat down and then slid herself onto the floor. She at first went into a fetal position then laid out flat on the floor. Client began acting more panicked and frantic with short quick breaths and her hands appeared to be contracting some. Clinic team made the decision to call 911 and administer 0.50 mg epinephrine. Ambulance arrived quickly and client was taken to the Medical Center via ambulance.

faint; Fever; chills; body ache; diahhrhea; nausea; light headed ness; unable to move cause in so much pain- arms felt like lead weights; unable to move cause in so much pain- arms felt like lead weights; ring in ears; lethargic; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 29Apr2021 13:00 (at the age of 17-year-old) (Batch/Lot Number: EW0172) as 2ND DOSE, SINGLE for COVID-19 immunisation. 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 and has not been tested for COVID-19 since the vaccination. Medical history included seasonal allergies and known allergies to non-steroidal inflammatory drugs (NSAIDs), tree nuts, and pitted fruit. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and mometasone furoate (ASMANEX). Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number: EW0150), administered in left arm on 08Apr2021 at 01:00 PM for COVID-19 immunization and experienced foggy head and sore arm which was treated with Tylenol. On 29Apr2021 at 23:30, the patient experienced fever, chills, body ache, diarrhea, nausea, light headedness/faint, unable to move cause in so much pain- arms felt like lead weights, ring in ears, and lethargic. Therapeutic measures were taken as a result of all events. On an unspecified date, the patient recovered from all events.

Approx 2 minutes after receiving dose, patient became dizzy. Per pt's father, patient became stiff and tremored some. He lowered patient to the floor at which time there was LOC. Reaction clinician used smelling salts which brought patient to (pt was out for approx 1 min per staff) No loss of bowel/bladder. Pt was brought to med obs 1 via stretcher. Vitals taken, water and crackers given Pt feeling well and discharged to home with father and sister Vitals: 11:46 HR 82, Resp 16, BP 109/70, O2 100 12:02 HR 86, Rep 16 BP 102/70, O2 100

Diffuse hives and erythematous rash on arms, neck and chest. She had expected fever and muscle aches for 24 hours after vaccine administration but this resolved.

Patient received first COVID19 Pfizer vaccine on 4/18. At that time, had about 3 days of cough and chest tightness. Subsequently began having neck pain on 5/8 and received second Pfizer vaccine on 5/9. Then began having fevers (Tmax 103F), cough. Admitted to Hospital on 5/15 with respiratory failure and shock. Unclear etiology of pneumonia vs multisystem inflammatory syndrome in children (MIS-C). Did not initially respond to antibiotics so treatment for MIS-C was initiated. Now slowly improving but still hospitalized.

17 year old patient with no known allergies who was given 1st dose of Pfizer vaccine at 1655. At 1700 during observation patient mentioned to the mother that she was not feeling well, was slumped over. The RN on observation noticed that she was apneic, whole body was rigid. Vital signs at 1701: BP 153/88, HR: 64. Oxygen saturation 99%. After 5 minutes a recheck of the vital signs: BP 115/74, HR: 64. Oxygen 97%. Patient did state that she gets anxious when she gets shots.The paramedics were called. Vital signs on arrival: 117/83, HR: 58, Oxygen saturation 100%. Blood sugar 70. After a few minutes patient stated that she was feeling a little better. Patient was able to walk to the ambulance for them to perform an EKG: Results were normal sinus bradycardia.(Patient is an athlete). Patient's mother declined further treated and signed AMA form.

Shot given 11:58am. Within 2 minutes symptoms began with feeling symptoms: nauseous, hot forehead. I asked CVS for the nurse to help. By 12:01 patient was feeling extreme pain in her stomach, was sweating profusely, felt tingling sensation from head down to her stomach (including her arms and hands). Patient began screaming in pain. Her hands became rigid and paralyzed. She was completely unable to move both hands. Patient was able to feel if someone was touching her hands. Her face began tingling and feeling numb. Patient was lying down and almost passed our. I asked CVS to call 911 and if they should administer an epi pen. The epi pen was not administered. I (mother) went w/ child in the ambulance to Hospital. EMT monitored her vitals, which were normal. Patient was still unable to move her hands until after she was admitted to Hospital. Patient did not receive any IV r medication at Hospital. The sensation in her hands slowly came back with the numbness subsiding after about 1.5 hours in the ER. Patient was discharged at about 2:00pm on 5/16/2021.

Chest pains, difficulty breathing, outcome: diagnosed with myopericarditis and costochondritis as well as inflammation in joints. Was in the hospital for 7 days and was on IV, morphine and then switched to hydro-morph for severe pain. Was given ketorlax via Iv for inflammation as well and steroids. Has been put on steroids for 1 month, Colchicine for 3 months, naproxen for inflammation.

Patient was extremely nervous prior to vaccine. Got shot, walked out of room to waiting area. about 2-3 minutes post vaccine, realized did not feel well. Passed out. Mom said patient felt a touch rigid and twitched a couple times, then came too. Did hit head when patient fell to floor, although was not a major hit. Patient was worked up after coming to.

She had been bleeding since May 2. We took her to Hospital Pediatric ER on Thursday, the ambulance took her in because she had a seizure on Wednesday (the Ambulance - they stabilized her that day and took her vitals and was sure she was okay - they knew we had an appt to go in the next day at 10:00 am for tests (previously scheduled); Thursday morning she had another seizure - we gave her seizure meds and she came out that - she ate breakfast after and then took her regular meds and the next thing we know ,50 minutes later, her head drop forward and her arms go completely limp and there was no response. She was breathing but she was out. I called the ambulance. And they took her in to ER. What they put in the paperwork was that she had a seizure and they wrote that she had had syncope episode - it took 20 minutes to come out of it. Which she has never had anything like that. We were in the ER for 7 hours. Was admitted to Hospital -from 24th -28th.

Chest Pains Shortness of Breath Costochondritis - Per the Doctor These conditions were present after the first vaccine shot on April 6th and then again after the second shot on April 27th. Doctor initially thought it could be a simple case of Acid Reflux and gave her Nexium. Once that didn't work, she had her Chest X Ray done that came back all clear. She then had her blood tests done and that too came all clear except for Vitamin D3 that came in at 15 so doctor gave her a 50,000 unit Vitamin D3 dose. That also didn't do much to relieve the chest pains and shortness of breath so he had her EKG and Echo done and those were all clear as well. Finally, he gave her a day steroid course of Prednisone at 40 mg/day which is where she is currently. It is helping her a bit but she is still complaining of original two issues - chest pain and shortness of breath. She is also doing cold and warm compressions throughout the day that helps her temporarily.

Patient was very anxious and breathing heavy. About 5 minutes after the vaccination they started to hyperventilate and ended up throwing up. After letting them sit and relax for 5 minutes, the patient then had to throw up again and told their mother they felt like they were going to faint. Mother and myself stood by, while patient did end up fainting. We slowly lowered them to the ground, and on the way down their body got stiff and patient had uncontrollable movements and was hardly responsive. Mother and myself finally got her safely to the floor as they came to and was responding to verbal ques and stimulation from mother. Mother went to get water and i stayed with the patient to ensure no other things happen. Patient ended up doing alright after relaxing for a few and then i walked them and mother to their car and ensured they were feeling good enough to go home. I then advised the mother to seek medical attention.

2 hrs after vaccine started having chills and fever by Thursday April 22 her legs starting hurting pain moved from toes and all the way up to back then it stated moving to her hands and fingers. got admitted to hospital because they wanted to make sure she wasn't having syptoms of MS they did blood work, MRI, covid test, xrays, lupus test, physical therapy, nerves test, lime disease test and everything came back fine by sunday they sent her home and she started having stomach pains and had to go back to Dr. she has experience hair loss and it started her menstrual cycle early. was having alot of fatigue and its's been a month and she is now finally started to feel a little better but Dr dont know how long it will be before she is fully herself

Patient reports muscle aches and significant fatigue for 3 weeks following the second vaccination. Initially just with sore arm, then a few day later developed the fatigue

Fever; Joint pain; facial and tongue swelling/broken out in a rash broken out in a rash that moved to her face and lips/anaphylaxis/daughter's eye started to swell; Serum sickness; elevated CRP; Hives/an allergic reaction/lip and face swelling; This is a spontaneous report from a contactable consumer (the mother) reported for her daughter. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in left arm on 02Apr2021 10:00 (Batch/Lot Number: EN6207) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Colitis ulcerative from 2014 and ongoing, Genetic immune deficiency, additional Information for other conditions: Caller describes it as "22q". patient was born with this but wasn't actually diagnosed until patient was 11 years old. They checked with patient's Immunologist before getting the vaccine especially with her daughter's history. Thyroid disease from 2015 to an unknown date, additional Information for other conditions: patient didn't have a thyroid- her thyroid was removed. Concomitant medications included cetirizine; famotidine; montelukast sodium (SINGULAIR); and epinephrine (EPIPEN) all taken for an unspecified indication, start and stop date were not reported; aloe vera, pramocaine hydrochloride (ATARAX ANTI ITCH LOTION) taken for itching, swelling and hives, start and stop date were not reported. The patient took first dose of Pfizer COVID vaccine on 12Mar2021 10:00 (Lot: EN6207) for COVID-19 immunization and patient had no side effects after the first dose. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient just saw her Immunologist and her Immunologist instructed her to report what is going on with patient. Caller clarifies patient's immunologist plans to call and report as well but also instructed her to call and report the side effects her daughter is experiencing. Her daughter was cleared to have the COVID vaccine. The caller explains they always check with her immunologist because of her daughter's immune issues. Her daughter received the second dose of the COVID vaccine on 02Apr2021. On the evening of 04Apr2021, her daughter broke out in hives. They didn't think it was a big deal, they thought it was just an allergic reaction. She tried Benadryl and several other things. They went and saw her daughters regular general practitioner and the doctor believed it was just a delayed skin reaction, which seems to be common with the Pfizer COVID vaccine. The doctor told her he's seen one other person with this delayed reaction. He gave her daughter a steroid injection, a Steroid Dose Pack and Pepcid. She was also placed on Benadryl as needed. About 2 weeks after this, her daughter and lip and face swelling and ended up in the Emergency Room (ER). At this ER visit, they initiated the allergic reaction protocol and it was not an anaphylactic reaction at that point. Her daughter received IV Benadryl and IV steroids, the caller is not sure what else. She confirms she has no NDC, Lot number and expiry dates for the medication her daughter received in the ER. The ER doctor contacted the Immunologist on call and the Immunologist had seen a few cases with a delayed reaction. Caller clarifies the ER doctor discussed her daughter's delayed skin reaction with the on-call Immunologist. The oncologist put her daughter on generic Zyrtec, 20mg in the morning and 20mg at night. The following week, her daughter woke her up with facial and tongue swelling. She clarifies further her daughter had fever, joint pain, and had broken out in a rash that moved to her face and lips. She immediately took her to the ER. The ER followed the whole anaphylaxis protocol and was given an EpiPen. She explains her daughter was diagnosed serum/covid sickness. This has been going on for over 6 weeks. The reaction will come and go. She was told as her daughter's body develops immunity, she is basically allergic to it. She clarifies at her ER visits, they checked her daughters liver and kidneys. It was noted her daughter had and elevated CRP, which is an inflammatory marker. The caller was told they thought her daughter had serum sickness from the vaccine which may last 4-6 weeks or it may be prolonged, so they just went with it. They told her as long as it didn't move to her lips or affect her daughters breathings, eventually it would wax and wane and go away. Her daughter started breaking out on her arms and legs and last Saturday, she woke up and her face was swelling. She clarifies her daughter's eye started to swell and her tongue. She took her straight to the ER and the ER followed the anaphylaxis protocol and injected her with an EpiPen. They contacted her Immunologist to check and make sure it wasn't anything else and consulted with the Covid Vaccine Clinic and it was found 3 other patients had this happen. No further details were provided regarding the 3 other patients. Right now, her daughter is on 4 different medications and an EpiPen. They contacted her insurance about her being placed on a biologic because not even the current medications her daughter is on is making everything going away. Caller verifies her daughter was never admitted into the hospital. When she was last seen in the ER Monday, she her daughter was monitored for 4 hours after the EpiPen was administered. The events require a visit to Emergency Room (total of three ER visits) and Physician Office. She known the last/third ER visit was Monday, 17May2021. The second ER visit was 04May2021. She believes the initial/first ER visit was probably a week or so before the second one. She clarifies she broke out in hives on 04 Apr2021 and went to the doctor on 07Apr2021 or 08Apr2021 so the ER visit was around the next week. Since her daughter had such a good response from the EpiPen the ER doctor took pictures before and after. She clarifies the name of the biologic they want to put her daughter on is Xolair, it is a monthly injection. She explains the current cocktail they have her daughter on is not working. She provides the following product information for these 4 medications and EpiPen. Relevant Tests included she knows they are testing for any other thing that it could be to rule it out. She knows they ran a CIS-tray, a complete CIQ , a Histamine release something and Tryptase. She knows they checked her CRP (inflammatory marker) because it was elevated. Every time her daughter went to the ER, they did a CBC and all of that was normal except for the CRP inflammatory marker, however her CRP was normal at the last ER visit. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Patient presented for second vocid-19 vaccine. after receiving vaccine, mother reported that patient had chest pain and grabbed chest and was experiencing leg numbness. Patient's parent reports that prior to receiving vaccine, aptietn has had history of one sided flank pain and tardive dsykinesia induced by medication. After vaccine mother reports patient is experiencing flank pain on opposite side. Mother wanting patient to be seen by provider so patient taken to hospital ED

Fever ranging from 99.8 to 102 for 54 hours. Fatigue (slept for 15 hours on first day); lower back ache, headache, muscle ache

Parent had the patient give the description: The next morning, I had sore left side/left side of neck. Later on that day, I was feeling my neck and I felt a giant lump on the left side of my neck. I thought that I had slept on it wrong. Later on, it wouldn't go away - even with massage. It was painful. It caused disturbance, I wasn't comfortable when I was sleeping. It had gotten bigger the next morning. Our doctor said that it was lymph nodes and it was a response of immune system to injection. To make sure, I'm getting an ultrasound. It has gone done but I still notice another smaller lump there still as well. (The two lumps are side by side.) For the pain and swelling, the doctor prescribed me ibuprofen. This has calmed it down. It was still a little swollen - about two weeks after. But it's going down little by little. I still feel it, but it's now very small.

The day after the second dose of the vaccine she started to have pains in all of her joints. Her chest felt painful and even her finger joints. It was a constant pain that got worse with movement. The pain scale without the medication was an 8 but with the medication a 5 on the scale of 1-10. Ibuprofen and Hydrocodone helped control the pain but it did not make it totally go away. The joint pain lasted for three weeks to date but the chest pain has improved. Heat pads also help. She has never experienced these symptoms before. There were similar symptoms after the first vaccine but it is much more intense after the second dose. It has been consistent since the second dose of the vaccine but the medication and heat application does seem to help. Hospital after the first dose for chest pain.

went to urgent care c/o bilateral arm "muscle twitching and neck. Urgent care transferred her to ER. ARNP reports 17 YOF who comes to ER after 4 hours of receiving her second vaccine shot for covid-19 , presenting upper extremity fasciculation. TOE: 1800 TOA; 2200 To PE bilateral fasciculation in arms and neck. NO SOB , no difficulty to swallow or talk. |BP=122/74, HR=120.0 bpm, Temp=96.62 F Oral, Resp Rate=20.0 bpm, Pulse Ox=99.0 on Room Air Patient discharged at 0325

Woke up in morning around 8:00 with nausea and vomiting. Nausea most of the day. Headache, severe lower back pain

Day after vaccination, patient reports intermittent fevers (Tmax 104F), neck pain that radiates down her back, and is interacting a lot less than usual, The following day, she was unable to walk at all and required being carried to use the bathroom. Patient denies and fevers, cough, gi distress. She does states that she is not feeling short of breath at this time, but is having weakness in her hands as well as her legs. Additionally patient states that she has been having chest pain today that comes and goes. On neuro exam Mental status: Appears to be distressed due to photophobia. Lethargy, however easily arousable, able to have a conversation, attention intact to spelling "globe" backwards, intact to high and low frequency words. Able to name and repeat. Speech: Mild dysphonia Cranial Nerves: II: Pupils equal, round reactive III/IV/VI: EOMI. Pupils move in all four cardinal directions VII: Face symmetric when talking, however limited effort to excursion on command VIII: Responds to voice IX/X: Voice normal XI: Turns head side-to-side XII: Tongue midline Motor: Normal bulk and tone. Resistance met to passive motion of BLE RUE/LUE: shoulder abduction 4/5, elbow flexion/extension 5/5, wrist flexion/extension with give-way weakness up to 4+/5, finger flexor 4/4 RLE/LLE: On command, 0/5 -however able to support her legs in a flexed position bilaterally, with encouragement 5/5 on dorsiflexion. Able to support her weight on her legs, however does not walk slowly sits back on the bed. Sensory: Intact to light touch, proprioception intact Coordination: No obvious dysmetria on FNF testing DTR: 2+ brachioradialis, bicep, patellar, ankle b/l. Plantars mute. Absent pathological reflexes: Hoffman, cross adductor

17 y/o F with a hx of asthma and GBS presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F). Pt has been taking Motrin and Tylenol; last dose was at 07:00 today. Note, pt only had a fever after the first COVID-19 vaccination. Mother reports pt's baseline includes normal range of motion. However, in 2016 pt was diagnosed with GBS and was hospitalized for temporary paralysis for 1 month. Pt was also diagnosed with mononucleosis in 2017. Mother reports pt has also had neck pain that radiates down her back, and is interacting a lot less than usual. Pt denies any confusion, but admits to a mild headache. Differential Diagnosis: Guillain-Barre Syndrome, status post vaccine, tick paralysis, thyrotoxicosis, consider meningitis and other infectious causes like UTI, URI. Patient admitted to hospital.

Patient became dizzy, had heaviness in her limbs, was pale,had blurred vision - none of these symptoms improved, so 911 was called.

Within seconds of receiving the 2nd PFizer covid vaccine, the patient slumped over sideways in her chair, losing consciousness. Next, her arms went straight and locked, both her hands locked in a curled position. I looked up at her face and her eyes had rolled back into her head and her body started jerking. Shortly after, she sat upright in chair with her eyes open and didn't realize what had happened. She said a tingling sensation had gone up her arm. She was extremely pale. My tech called 911. I took her blood pressure which was 88/46 with a pulse of 45. As we were waiting for paramedics, she said she was sweaty and started getting abdominal cramps. Paramedics arrived and took over her care.

Received Pfizer vaccines on 3/18/21, 4/8/21 Tested positive for COVID 19 by PCR on 6/11/21. Hospitalized 6/11-6/14/21. symptoms of fatigue, myalgias, diarrhea, dysgeusia, cough Received four doses of Remdesivir.

She woke up this morning complaining of a severe headache, left sided neck pain. She reported she could not see out of both eyes and then vomited. This episodes lasted~10 min and then resolved with residual neck pain.

seizure like event; Dizzy; Her head, neck, back and legs stiffened up/her entire body stiffened; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27May2021 (at 17-year-old) (Batch/Lot number was not reported) at 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Thursday 27May2021, a few minutes after the shot she started having a very small episode of seizure that lasted for maybe 1 or 2 seconds then after that she felt a little dizzy after that and then she was fine. It's described as a very brief seizure like event. Her head, neck, back and legs stiffened up and if she would have been sitting on a stool she probably would have fallen out of her seat. She was sitting in a chair that had a back to it, though, so she did not fall out of the chair. She did not every lose consciousness and he stated that this was not a syncopal event. He reported that it happened very quickly and multiple people did not even notice that it happened. Her entire body stiffened, however, "she stayed with us throughout the entire event and it only lasted a couple of seconds before her body went back to normal position, The reporter offered to call an ambulance the day of the event but the mother of the patient declined. The mother was advised to have her daughter seen by a medical provider for follow up care given the event. The mother also told the pharmacist that the patient would not be receiving the second dose and the pharmacist encouraged her to have this conversation and make that decision with the pediatrician or medical provider. Caller stated that he personally gave about 100 doses of the Pfizer BioNTech COVID-19 vaccine on that day and this was the only serious reaction that he witness. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based from timing of occurrence, the event that occurred with the patient post vaccination which Is seizure like phenomenon cannot be totally ruled out to be not related suspected drug 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

Diarrhea; Pain in the lower right side of my back; This is a spontaneous report from a contactable consumer (patient, self-reported). A 17-year-old female patient (age at vaccination: 17 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0179 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 13May2021 at 12:30 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included allergy to Biotin (big amounts of Biotin). Concomitant medications were not reported. 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 was not tested for COVID. The patient reported that on 13May2021 at 16:00, she had diarrhea and pain in the lower right side of her back, the first few days after the first dose. There was no prolonged hospitalization. The patient did not receive any treatment for the events. Outcome of the events was resolved on an unknown date in May2021. Follow-up attempts are needed. Further information is expected.

Large (3 cm) painful supraclavicular lymph node x 1 on the same side as vaccine sight. The patient also has headache and neck discomfort. Temp to 100.5.

Bilateral knee swelling and pain (severely limiting mobility to the point of being unable to walk due to pain/swelling), rash (c/f erythema nodosum) for 2-3 weeks (presented on 6/18/21). Concerning for flare of JIA vs other autoimmune etiology (infectious studies mostly negative, though some studies pending). Diagnostics ongoing.

Systemic: Body Aches Generalized-Medium, Systemic: Hyperventilation-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt began to display symptoms related to anxiety that progressed to hyperventilation/nausea/full on body aches/ pt states she was then unable to move her arms/legs/hands due to body aches. Pt reported that her body was aching and that she was feeling nauseated. Pt's fingers were turning blue due to intense clenching. Paramedics/Ambulance called for so pt can be further evaluated.

Rash & Fever - went to ED. + burning & itching on back. Joint pain in fingers, joint pain rt elbow and wrist. Pain soles of feet. Started one week prior to 5/31/21. Dx'd with macular rash. Elevated C-reactive protein. Elevated sed. rate. Arthraligia of both hands. (Date of visit 5/31/21)

Severe abdominal and back pain starting at 7:20 May 25, 2021. No otc med worked to relieve pain. Could not get out of bed. Called pediatrician.

Severe neck and upper back pain, headache, dizziness, and vision disturbances began 5/22/21. She was seen at urgent care about 5/27/21 and at her doctor the following week- misdiagnosed twice with myofascial pain. Symptoms mostly persisted. On 6/22/21 she saw an optometrist for the visual disturbances and was diagnosed with bilateral papilledma. Optometrist called us 6/23/21 and advised us to take her to the emergency room immediately. After many tests (below) she was diagnosed with Idiopathic Intracranial Hypertension.

Fever to 101.3 and malaise night of vaccine, "bad cough" on the following day with chest pain which resolved over a few days, then she developed bilateral ankle swelling and pain 80 hours later with a rash and swelling spreading up to her thighs and down through her feet. hands also swelled and turned white (sounds like Raynaud's). knee pain resulting in difficulty sleeping at night. tachycardic on exam. evaluated in clinic on 6/11 and follow up on 6/15. noted loss of appetite for a week and fatigue. Myalgias made ambulation painful. instructed to use NSAIDs and elevation and she improved over the next few days

Pain in sternum, spreading across rib cage; Pain in sternum, spreading across rib cage; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old female patient received unknown dose number of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP7534), via an unspecified route of administration on an unspecified date (at the age of 17-year-old) at single dose for COVID-19 immunisation. The patient's 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 not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. The patient experienced pain in sternum, spreading across rib cage on an unknown date. The clinical outcome of the events was unknown. This report was reported as non-serious by reporter. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: event was recoded to Skeletal pain and Rib pain.

For the 4 weeks following the first COVID vaccine dose the patient had significant loss of taste and smell, mild nausea, mild aches and pains and increased anxiety. This resulted in an approximate 8 lbs weight loss, an acute drop in school performance & psychiatrist increased her SSRI medication dosage. She went to the doctor for blood work and a celiac disease panel, all of which were grossly normal. Unsure if she was tested for epstein-barr virus. Her escitalopram dose was increased. After the second dose of the vaccine the patient became lethargic, lost interest in things she used to enjoy, had poor tolerance for conflict and activity. She began having panic attacks, severe abdominal pains with worse nausea and intermittent vomiting. Her menstrual periods were lasting twice as long (10 days) and she was fatigued to the point of exhaustion. As the symptoms progressed the patient started having thoughts about hurting herself, definitively not suicidal, but so overwhelmed she felt the need to hurt herself.

Patient stated she was nervous and received the vaccine without incidence. After receiving the vaccine while sitting the patient had what appeared to be a vasovagal response. She became pail and her eyes rolled back in her head. Patient appeared to have a seizure stuck both arms straight out and was incontinent. Patients was moved to the floor where her color returned and her pulse improved. Patient was taken to hospital via ambulance.

After we left pharmacy and was in the car at a stoplight, my daughter starting feeling very uncomfortable. She complained that she did not feel well, she could not see and that her ears were "foggy". When I looked over at her, her face was pale as can be and her lips had bluish tinge to them and she looked limp laying in the passenger seat of the car. It came on very quickly and lasted about a minute or so and was extremely scary. It took close to 30 minutes for her to regain her color. We sat in a parking lot for thirty minutes to make sure she was stable and gave her water. Went home and gave her benadryl. She slept through the night fine and this morning so far is ok.

Knee is so swollen that he cannot stand up/walk; knee is so swollen that he cannot stand up/walk; This is a spontaneous report from a contactable consumer, the patient. A 17-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 25Mar2021 at 12:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 19:30, the patient experienced swollen knee that she cannot stand up/walk. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the knee swelling and walking difficulty was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Fever; Headache; Chills; Muscle ache; This is spontaneous report from contactable consumer, the patient. A 17-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in right arm on 24Mar2021, (at the age of 17-years -old), as a single dose for COVID-19 immunisation. The patients medical history was reported as reported as not applicable and she had no known allergies. The concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in right arm, on 02Mar2021 at 17:30, (at the age of 17-years-old), as a single dose for COVID-19 immunisation. the patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 17:15, the patient experienced fever, headache, chills and muscle ache. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the events. The clinical outcome of fever, headache, chills and muscle ache was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Client reported chest pressure from her neck to her chest to the EMT's at 4:47 PM. The client was alert and oriented to person, place, time, and event. The client stated her current symptoms were less intense than her initial reaction. Vitals obtained at 4:49 PM were as follows: BP 126/78, HR 64, and O2 98%. The client denied any other s/s of anaphylaxis. At 4:52 PM the client stated the chest pressure was still present but mild. The client reported less chest pressure at 4:54PM. At 4:58 PM the client reported mild neck pain and chest pressure. At 4:59PM activated EMS. The client denied feeling cold or clammy. Vitals obtained at 5:03PM were as follows: BP 130/70, HR 64, and O2 96%. Felt similar chest pressure after she received the four doses of vaccines at her medical provider in the beginning of July but did not report the chest pressure to her mother. Fire Dept assumed care at 5:09PM. Client and mother refused medical transport at 5:16PM. At 5:20PM the client denied any chest tightness or pain in her neck. The client ambulated unassisted with a steady gait out of the observation area at 5:23PM.

Fatigue, enlarged left breast and lymph nodes. Dizziness, had the feeling of blacking out, headache, muscle weakness, BP was stable 58-60 when patient sitting, spikes to 100 when she stands.

Immediately after receiving the vaccine, she was seated in the pharmacy, where myself and another person witnessed her eyes roll back, body slump forward, then legs at the knee flew up into the air twice. Then upper body stiffened at shoulders, entire upper body made several flailing movememts to the right. Upon standing over her calling her name she then began to respond. She was then brought an ice pack, a granola or protien bar, a chocolate bar and some water. She was asked questions by the Pharmacist and was a little confused with some of the questions but began to improve. She was followed up at the Emergency Room.

Achy joints, soreness throughout the body, a splitting headache that started this morning when the joint pain lessened. Feverish but unsure if I actually have a fever at this time.

APPROXIMATELY 12 MINUTES AFTER VACCINATION, DEVELOPED LIPS TINGLING, FLUSHING, SLIGHT WEAKNESS IN LEGS AND REPORTED FEELING 'OFF'. RECEIVED 50MG DIPEHNHYDRAMINE IM AT 1:43PM. STAFF MEMBER REPORTED SHE FELT GOOD ENOUGH TO DRIVER HERSELF HOME AT 3PM. WAS INSTRUCTED TO CALL PCP OR GO TO URGENT CARE/ER IF SYMPTOMS PERSISTED/WORSENED.

Fever; chills; headache; joint pain; This is a spontaneous report from a contactable nurse(patient). A 18-year-old female patient received first dose BNT162B2, intramuscular at Arm Left on 11Jan2021 14:00 at the 18 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. On 11Jan2021 17:00 the patient experienced Fever, chills, headache and joint pain.There was no treatment received for the adverse events. The patient had no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was Not recovered. Information about Lot/Batch has been requested.

a headache started; I felt sick with fatigue, chills and muscle aches.; muscle aches began; cold chills began; my temperature was slightly elevated for me but still not a fever at 99.1°/99.7°/went up to 100°/100.5°/ 100.2°/99.8° but still elevated; I was really fatigued; my energy levels weren't 100%; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient (not pregnant) received the first dose of bnt162b2 Lot Number: EL8982, via an unspecified route of administration on 16Jan2021 12:15 at single dose at Left Arm for COVID-19 immunisation. Facility type vaccine was other. Medical history included Congenital Partial Aortic Bicuspid Valve, Aortic Dialation, Postural Orthostatic Tachycardia Syndrome, no known allergies. The patient didn't have covid prior vaccination. The patient's concomitant medications were not reported. There were no other vaccines in four weeks and no other medications in two weeks. Patient stated when she woke up, her temperature was slightly elevated for her but still not a fever at 99.1°. At 1:00 pm, she was really fatigued with her temp still at 99.1°, at 2:30 pm, cold chills began and her temp was 99.7°, at 2:45 pm, her temp went up to 100° & muscle aches began, at 4:00 pm, her temperature was 100.5° and she felt sick with fatigue, chills and muscle aches. At 5:45 pm, a headache started and at 7:30 pm, it got horrible and her temp was 100.2°. At 10:15 pm, her temp went down to 99.8° but still elevated and she was very fatigued. The next day, Jan18, the fever was gone and she woke up with a 98.2° temp which was consistent throughout the day but she had a persistent headache most of the day and her energy levels weren't 100%. She didn't take any medications any of these days. Adverse events started from 17Jan2021, 01:00 PM. No treatment was received for the events. The patient had recovered from the events. COVID was not tested post vaccination.

Rash at injection site and muscle aches. Was achy on the morning of 1/28/2021 with 'bumps' on the chest area. Achiness resolved on 1/29/2021 but rash continued affecting her abdomen as well.

Pt presented by EMS for acute epigastric pain radiating to the back. While waiting for lab results, she was found down in her room and in post-ictal state. She was moved from an urgent care room to an ER bed and returned to near baseline when she had witnessed seizure activity and subsequently required multiple medications to break her status that lasted around 30 minutes

Asthma; Syncope; Dizziness; Nausea; Vomiting; Severe headache; Fever; Muscle weakness; Muscle twitching; Fatigue; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: Em9810), on right arm via an unspecified route of administration on 23Feb2021 10:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no known allergy. Concomitant medication included sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 04:45PM on Arm Left for covid-19 immunisation. On 23Feb2021 10:30 patient experienced syncope (medically significant), dizziness, nausea, vomiting, severe headache, fever, muscle weakness, muscle twitching, fatigue, chest tightness, asthma. No treatment was received for the event. Patient not having COVID prior vaccination. Patient not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: Based on the strong temporal association, the association between the event syncope and the vaccine BNT162b2 administration cannot be completely ruled. 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.

Began with heavy feeling in limbs, progressed to painful joints and muscle weakness. Extreme fatigue, headache, and fever and chills throughout the day 3/7. Woke up feeling better on 3/8.

Patient received the 1st dose of the Pfizer Covid Vaccine (Lot: ER8732, EXP: 7/21) on 3/27/21. Shortly after the injection the patient's arm started itching and a rash developed. Patient was dizzy, hot, and had an elevated blood pressure. Patient was transported to Emergency Department by EMS.

migraine at rhe base of my Head; My heart rate rose to around 133 just laying down; extremely nauseous; inability to control temperature regulation; stomach began to have a really intense stabbing pains; Not the worst pain I have experienced but definitely not pleasent; lethargic; getting extremely cold and then hot within a matter of minutes; Her ribs and lungs hurt; Her ribs and lungs hurt; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received second dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 24Feb2021 10:15 (Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included known allergies to Red dye, postural orthostatic tachycardia syndrome (POTS), heart murmur, Wilkies syndrome. The patient was not pregnant. There were no concomitant medications. The patient did not take other medications in two weeks. The patient previously took Excedrin and experienced allergies. The patient previously received first dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 03Feb2021 09:45 AM (Lot Number: EL9269) for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. On 24Feb2021 at around 7:00pm she started getting a migraine at the base of her head. She then was lethargic, and became extremely nauseous. She started getting extremely cold and then hot within a matter of minutes (inability to control temperature regulation). Her heart rate rose to around 133 just laying down. Her ribs and lungs hurt. And her stomach began to have a really intense stabbing pains. At one point it felt as if she could feel every cell in her body if that makes sense. Not the worst pain she had experienced but definitely not pleasant. On a scale of 1 to 10 (10 being run over by a car and 1 being a paper cut) she would say it was a 5-6. The patient did not receive treatment for the events. Facility type vaccine was facility. The patient did not have COVID prior vaccination and did not have COVID test post vaccination. The outcome of the events was recovered on an unspecified date.

Acute DVT in left LE. Patient presented to ED on 3/22/21. She had 2 day h/o leg discomfort and leg was taught and painful on the day she went to the ED. Study was limited due to pt lack of cooperation. Lovenox started.

after vaccination while waiting 15 minutes, patient felt dizzy. mom noted eyes rolled up , head tweisted to left side, body stiffened. mom put her to floor and called for help. episode lasted 20 seconds with also shaking of her upper body not sure if lower. taken to er . in er continued to be dizzy. given ivf 1 liter

The day after the vaccine was received, the patient noticed arm and face swelling. She also experienced shooting pains and tingling in the same arm she received the vaccination. At work, it hurts when she carries things and has dropped items, which is unusual. Pain is mainly in the shoulder, but sometimes in the forearm. She has tried Tylenol, ice and naproxen with no relief. She received methylprednisolone on 4/12, and now feels that she is having an allergic reaction. Complaints of increased wheezing, shortness of breath and swelling of her skin, she has used her albuterol inhaler at home which has provided no relief. On 4/13 she received albuterol by nebulizer and an IV dose of methylprednisolone at the emergency department. She is going to start albuterol nebulizer at home, continue OTC antihistamine, discontinue the methyprednisolone and start prednisone tomorrow.

Two hrs after 2nd dose of pfizer on April 9, 2021, patient experienced the following for the next 48 hours: pain at injection site and redness; fever or 102; nausea; tiredness; chills (lasted 24 hours); headache; and muscle aches all over. All of this was handled through Sudafed Severe Cold tablets as if she had the flu.

Heavier than usual menstruation, lower back and stomach cramps radiating down the legs (from thighs to feet)

[April 10; Evening]: Headache with small pounding feeling, a slight fever. [April 11, Morning]: Slight pressure on injection sight, weak limbs, vomiting, fatigue. [April 11, Evening]: Unconsciousness, nausea, delirious, fever. [April12-14]: Extreme Migraines, dizziness, loss of balance while walking, unconsciousness, loss of appetite. Took Pedialyte and liquid pain reliever everyday.

Chills: 13 - 37 hours after injection Sweating: 20 - 37 hours after injection Leg muscle pain: 23 - 26 hours after injection Hard itchy red lump appeared below injection site

Severe soreness and stiffness within one hour of shot. Fatigue after two hours, still prevalent 8 hours later

symptom started 4/21, with pain and tightness in the left arm, progressively spreading up the arm over the following 48 hours, and then to the distal right arm, and legs. The leg symptom were present when seen 5 days ago, though were not discussed as Patient wasnt sure if thats what was really starting. This is associated with a feeling of "not being able to feel muc" and "doesn't feel right", as if it "feels foreign... body says this is weird," and feels heavy. Also notes that different extremities feel different - left is worse than right. Seen 5 days ago, and noted to have been advised by hematology to stop eliquis approximately 2 weeks prior to onset of symptom after PE/Renal artery embolism 1/2021. At that visit was referred to ER, where workup for repeat clot was normal (CTA, b/l upper extremities dopplers, head/neck CT, CXR). EKG was notable for Sinus tach and nonspecific T wave abnormalities. Discharged home with close follow up. Since then the intensity of the symptom as worsened and the leg symptoms have gotten more pronounced and consistent with the upper extremities symptom. Today notes new difficulty getting dressedon because clothes were getting stuck/he couldnt pull them down. Also notes when his left arm is touched it causes burning pain that shoots up the arm. Reports headache. 2-4/day, last 30 minutes, 5/10 in severity. Worse with movement of head. Frequent nausea, no emesis. but not specifically associated with headache. No waking from sleep. Since PE, has complains of intermittent left sided squeezing chest pain, which he wonders may be due to his anxiety. Lasts a few minutes Received Pfizer COVID vaccine 3/29, hasnt received 2nd dose yet ROS: general: no fevers or weight loss. CHRONICALLY C/O FATIGUE AND TROUBLE FOCUSING. has had evaluation for executive function difficulty in the past (interdynamics), now purusing evaluation at Neurology and awaiting EEG with this. HEENT: no sore throat. + VISION CHANGES - TROUBLE FOCUSING, but not specifically blurry vision. CV: LEFT SIDED CP, NONSPECIFIC T WAVE CHANGES ON LAST EKG W/SINUS TACH. Pulm: SOB, with walking up and down stairs, since PE. not worsening. No Cough. GI: +NAUSEA, no vomitting, no abdominal pain. No current diarrhea. Neuro: + HEADACHES. + SENSORY CHANGES. + family h/o MS

Headache, Fever, Chills, Muscle pain and hard time breathing. Fatigue. Currently treating with Tylenol and Ibuprofen and rest.

Low grade fever 100.4 approximately 8.5 hours after vaccine administered. Severe body aches - complained that bones hurt, especially ribs and legs. Rapid heart beat on. and off for 24 hours. Injection site pain for 30+ hours.

After the Covid-19 vaccine, Patient said that she had back, ears and neck pain. She also felt dizziness and shortness of breath. A few minutes later, these symptoms was improved. After about 10 minutes, the patient was back to normal.

Patient received the 2nd dose of the Pfizer COVID-19 Vaccine in her left arm on 4/28 at 12pm. At 9pm that even she developed symptoms of heaviness, weakness, numbness, tingling and intermittent pain from her left upper arm to her left hand and fingers. She had fever for 2 days. The symptoms resolved after 48 hours. She started having the same symptoms in her left upper arm to her fingers yesterday. She started to have right lower leg pain, numbness and tingling yesterday. She has had no chest, pain, cough, SOB, headaches, blurred vision, dizziness or fever. She has no neck or back pain. She has no rash or bruising. She received the first Pfizer Vaccine on 4/7/21.

5/5/21 Wednesday - got 2nd Pfizer Shot. 5/6/21 Thursday - 2am awoke with shakes/chills and throughout the day had body aches, temperature increased from 98.6 to 101.2, stiffness, nausea, headache, chills and sweats. 5/7/21 Friday symptoms continued from previous day but had strong abdominal pain. I went to my doctor and they suspected I could have appendicitis and also symptoms from the vaccine. They suggested going to the ER after 3 days if systems persisted. I went home after the doctor visit and was nauseous. I had sprite, ate white rice and chicken broth. My abdomen felt a bit better but I had a bad headache. 5/8/21 - Saturday I awoke at 6am with stabbing/burning chest pain that increased as time progressed. The chest pain was increasing and getting worse after 1 hour and 30 minutes. The pain was in the middle of my chest. My mom took me to the Emergency Room.

immediately after the dose she developed chest pain that radiates to the upper back, lower back and hips

Woke up fatigued the next day with a headache and soreness extending to the left side of my chest and back. My head feels like it's stuffed with cotton and it takes a second to process what people are saying to me.

About 10 mins after receiving the vaccine, patient dropped phone and was slumped in chair. Nurse approached patient and patient could not hear or see her. Hands were trembling and body was distorted. Arm felt heavy and she could not hold anything.

slight chills; cold; Extreme nausea/slightly nauseous; Extremely fatigued; Dizzy; Shakiness; Fever/ 101.6 fever/temperature was 100.3; Dehydration; Headache; Muscle ache; Arm pain; Pain; This is a spontaneous report from a contactable consumer. A 18-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in arm left on 06Feb2021 12:45 (at the time of 18-years-old) as second dose, single for covid-19 immunisation. Medical history included partial aortic bicuspid valve, aortic dialation, sulfa wellbutrin allergies (known allergies) and postural orthostatic tachycardia syndrome. No other vaccine administered in four weeks. The patient had not covid prior vaccination. The patient had not tested positive for covid post vaccination. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE) for an unspecified indication, from an unspecified date and unknown if ongoing. The patient previously took bnt162b2 (Pfizer, Lot no EL8982,Administration time=12:15 PM,Vaccine location Left arm, Dose no 1) on 16Jan2021 for COVID-19 immunisation. She received the vaccine at 12:50 PM and my temperature was 98.6 with no symptoms. At 1 am, her temperature went up to 99.6° and a headache, muscle aches and slight chills started. At 4:20 AM, woke up with a 101.6 fever, extreme nausea, dehydration and shakiness. In the morning at 9:00 AM temperature was 100.3 and when I got up around 12:00 PM, was extremely fatigued, dizzy when standing, and slightly nauseous which made it hard to eat normal foods. At 1:20 PM, temperature was 100.7. At 7:00 PM, nausea subsided slightly and was able to eat normal foods. At 10:00 PM, cold chills began in and at 11:00 PM, temperature was 100.4. The next day (08Feb2021), my temperature was at 97.8 upon awakening and felt dizzy, tired and winded with regular activities throughout the days but no fever. By the next day (09Feb), patient was completely syptom free. Arm pain was very minimal, pain level 1, on the day of vaccination and the day after and gone after that. The patient underwent lab tests and procedures which included body temperature: 101.6 (at 4:20 patient temperature was 101.6), 100.3 (at 9 temperature of patient was 100.3), 100.7 (at 13:20 patient temperature was 100.7), 100.4 (at 23:00 patient temperature was 100.4), 99.6 (at 13:00 patient temperature was 99.6F) on 07Feb2021, and 97.8 (patient temperature was 97.8) on 08Feb2021. The patient not received treatment for events. The outcome of events recovered on Feb2021.

Fatigue and mild severe pain in the right armpit. A little pain at the injection site. Been feeling the armpit pain since the morning after the vaccine.

Redness at injection site (Wednesday-Thursday), swelling at injection site (Wednesday-Thursday), muscle pain (Wednesday-today), hives on left arm (Wednesday-Thursday), headache (Thursday-today), nausea (Thursday-today), vomiting (today) , diarrhea (today)

Headache; soreness at injection site; extreme muscle and joint pain; extreme muscle and joint pain; mild fatigue; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 18-year-old female patient received the second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number EW0153) via an unspecified route of administration in the right arm on 15Apr2021 at 08:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included sulfamethoxazole, methylphenidate hydrochloride, and sertraline, all from unknown dates for unknown indications. The patient previously received the first dose of COVID-19 vaccine (lot number EP6955) on 25Mar2021 at 08:15 (at the age of 18-years-old) for COVID-19 immunisation. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. On 15Apr2021 at 16:00 the patient experienced headache, soreness at injection site, extreme muscle and joint pain, and mild fatigue. No treatment was received for the events. The clinical outcomes of headache, soreness at injection site, extreme muscle and joint pain, and mild fatigue were unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Back pain requiring Naproxen, canker sore outbreak in mouth followed by same type of sores in genital area, headaches, spiked temperatures, chills, sweats, body acne, fatigue. Back pain, headaches & fatigue continue today; genital sores and acne improved after several weeks; mouth sores lasted over a month but better now.

18 y/o F with PMHx of anxiety and panic attacks began to have upper extremity stiffening, wrist extension and absent stare x 20 seconds. She became incontinent and lost postural tone shortly after. She states that she was very anxious about getting the vaccine; states that came into the parking lot of the facility yesterday and "psyched [herself] out" so much that she could not come in to get vaccinated. She was evaluated by EMS and clinical leads. Mother states that she tends to have a lot of panic attacks but has never had a reaction like this. Patient's mother also states that she is seeing a therapist for her anxiety and panic attacks but is not currently on any medications.

Polyarthralgia significant enough to require ED evaluation for pain management (received Toradol and discharged)

The first dose of the vaccine went fairly well aside from fever, muscle aches, and pain in the left arm at the injection site. The second dose was reportedly worse. The fever ranged from 104.8 degrees Fahrenheit as a high and 102 degrees Fahrenheit being low, which receded after 3 days of care. In addition, chest pains and heart pain started at 8:00pm the day of the vaccination which was completed at 11:15am. Pain at the injection site and overall body muscle aches lasted for 3 days. The heart/chest pains have yet to recede. Instead it is occurring more frequently in ?bursts? of pain with a constant aching sensation.

One day after receiving the first dose of the SARS-CoV-2 vaccine the patient developed headache, neck pain, and fever. Her symptoms persisted for 2 more days and she then presented to the hospital where she was diagnosed with meningitis with a CSF WBC of 8. Her infectious work up of the meningitis has not revealed the cause to date.

Tachycardia; Lost 14 pounds; Ulcerative colitis flare up; Throat and glands swollen; Throat and glands swollen; vomiting a lot and couldnt hold food and water down; Diarrhea; This is a spontaneous report received from a contactable consumer (reporting on herself). A 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration in Arm Left on 07Apr2021 13:30, as 1st dose, single dose and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171; Expiration Date: was not reported ) via an unspecified route of administration in Arm Left on 28Apr2021 12:30, as 2nd dose, single dose for COVID-19 immunization. Medical history included colitis ulcerative from 2015 and ongoing. Additional Information for Other Conditions: states was in remission for 6 years prior to her second dose of the vaccine. The patient's concomitant medications were not reported. It was reported that she had a pretty severe reaction to her second dose of BNT162B2. States she has been in the hospital for 5 days last week and has now been in the hospital for 4 days this week because of side effects from vaccine that she received on 28Apr2021 which was her second dose. She thought the side effects would go away after the first hospitalization but was readmitted. First admitted to the hospital on 01May2021 for severe reaction to the shot for 5 days then was sent home because they thought the side effects would go away but the side effects have still been heavy. She was admitted again on Friday (14May2021) to the hospital from the side effects that are continuing. States she had lost 14 pounds from the time she was home from her first visit to the hospital. Patient vomiting a lot and couldnt hold food and water down: States that right after she got the second shot a couple of hours later she vomited a lot and couldn't hold food or water down which started 28Apr2021 and that she hasn't thrown up since Friday 14May2021, but has improved. She was starting to recover from it, it was just starting to get better. The really bad diarrhea started on the 28Apr2021 and was ongoing. The doctor thinks the second dose of the vaccine caused an ulcerative colitis flare up. She noticed the tachycardia on 29Apr2021. States her resting heart rate before the vaccine was 55 on average and now her resting rate was 105-115, and when she gets up to walk around it was 140-160. States that this was what was preventing her to be able to leave the hospital now. Tachycardia was the reason for admission for the first hospitalization. she was at urgent care she was tachycardic and her throat and glands were all swollen and they thought she needed to be admitted to the hospital. Swollen glands recovered last week, either 12 or 13May2021 and was completely recovered from that. Clarifies throat and swollen glands recovered 13May2021. Her dates of admission were 01May2021- 04May2021 for tachycardia. States she was currently at hospital and was admitted 14May2021 and was still there today for tachycardia and weight loss. States the tachycardia warranted both hospital admissions but the weight loss also contributed to the second admission as well. States her current weight was 116 after losing 14 pounds. She was weighed on the 4th when discharged from her first hospital admission and she weighed 130 pounds or 59 kilograms then had a follow up appointment with her cardiologist on the 14th for tachycardia and was weighed then and was 116 pounds at that time. They then sent her to the emergency room right after that follow up appointment to be admitted. States she hasn't been weighed again during this hospital admission so she thinks her weight was the same. She coughed and said sorry something got stuck in her throat, then continued her conversation. Ulcerative Colitis flare up- states she was unsure of when it transitioned from diarrhea to this flare up of ulcerative colitis. States she has just starting getting steroids and they increased her normal medications for her condition and was starting to improve. States she has a picture of her vaccine card and the events started after her 2nd dose. They did a procedure to confirm it was flare up at around 15:00 on 17May2021, performed a sigmoidoscopy and just found her left colon and rectum were inflamed as results which was similar to the ulcerative colitis flare up. The patient underwent lab tests and procedures which included heart rate: 55, heart rate: 105-115, heart rate: 140-160 on an unspecified date, sigmoidoscopy: found her left colon and rectum were inflamed as r on 17May2021. The outcome of the ulcerative colitis flare up was recovering, for event tachycardia, diarrhea and on 29Apr2021 with outcome of not recovered , lost 14 pounds was not recovered, and for vomiting a lot and couldnt hold food and water down was unknown and for events throat and glands swollen was recovered on 13May2021.

The night following injection, the patient experience increased anxiety, chills, possible fever, headache, backache, generalized muscle aches, and abnormally vivid dreams throughout the night. Monitoring of symptoms is continually being addressed by the patient's mother.

Pfizer-BioNTech COVID-19 Vaccine . Tiredness, headache, muscle pain, chills, fever. The symptoms lasted for 24 hours.

she fell on the floor and become unconscious; she fell on the floor and become unconscious; She got sick; she lost all energy; She hurt her throat its like she can read but she has very heavy under her neck; She hurt her throat its like she can read but she has very heavy under her neck; This is a spontaneous report from a contactable consumer (Father). An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 16:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient Medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. It was reported that, On 28May2021 caller stated that we took our daughter to get vaccinated on 28th and she loss of conscious and she got sick, and it took almost 24 hours to recover so we need to get the forms, so she does not get her second shot and we do not want to have a second shot for her because of the lot reaction on her body. In the 22nd day later she fell on the floor and become unconscious, and she lost energy and you know it takes time to come up and it take 2-3 minute to come up and she lost all energy and she hurt her throat it's like she can read but she has very heavy under her neck. The event loss of consciousness, fall and illness was recovered on unspecified date in 2021.The event musculoskeletal discomfort oropharyngeal pain and asthenia was unknown. Therapeutic measures were taken Tylenol and green juice as a result of she fell on the floor and become unconscious (loss of consciousness), she fell on the floor and become unconscious, she got sick, she lost all energy, she hurt her throat it's like she can read but she has very heavy under her neck, she hurt her throat it's like she can read but she has very heavy under her neck (oropharyngeal pain). No follow-up attempts are possible. No further information is expected.

The evening after receiving the vaccine, pt began having headache, lightheadedness, shortness of breath, nausea, loss of appetite. Th next day (6/10) she notedmyalgias in lower back and hips with shooting pains in her knees and vomiting. She also noted mild fever and chills, nasal congestion and discharge with mild sore throat, and substernal chest discomfort. She described it as tightness with radiation to her throat and jaw, and right arm, witout radiation to her back, not associated with nausea, but is associated with shortness of breath and diaphoresis. Chest discomfort worse with lying down. Rapid COVID test negative. Upon arrival to ED on 6/11, her troponin was mildly elevated (0.039ug/L), D-dimer elevated at 348ng/mL, CRP also elevated at 5.96 mg/dL. ED physician diagnoses acute myopericarditis and patient was admitted to Critical Care Unit. On 6/13/2021 patient was discharged stable (limited bedside echo showed small pericardial effusion). Pt denies pleuritic chest pain on day of discharge.

Patient came in for first dose and told pharmacist of her existing conditions. The pharmacist had the patient stay for 30 minutes after the vaccine. about 20 minutes later the patient began to faint. Her mother, who was next to her, caught her in her chair and told us that this happens often when she is anxious. We immediately called 911. She was in and out for a few moments so we placed out a mat for her. When she came back to conciseness, she reported pain in her joints and acid reflux. We were able to give her fimotidine for the acid reflux.

4 days after receiving the initial vaccination she began to have nausea and vomiting. She had no signs of an infectious process. Weight prior to this was 123 lb. Current weight is 108 lb. She has persistent nausea, difficulty swallowing, constipation and urinary retention. Recent hospitalization with extensive work up could not identify and infectious, metabolic or anatomic cause.

A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctor's office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; no facilitated urination; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 18-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/Lot Number: EW0158) via an unspecified route of administration in arm right on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included none history. Concomitant medications include levocetirizine (LEVOCETIRIZINE Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date, at 5 mg for an unspecified indication. Historical vaccine includes bnt162b2 (Dose 1 lot number=EP7534 vaccine location=Right arm) on 26Mar2021 for COVID-19 immunization. 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 23Apr2021, the patient experienced a doctors office visit on 28Apr. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots). Started to take 20mg furosemide for 7 days from 28Apr and 20mg prednisone for 10 days and 20mg furosemide on 04May. Even after finishing medication, there were no changes in symptoms. Continued leg swelling and no facilitated urination. There was severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose. After finishing both, the swelling in legs subsided and weight returned to normal. About 10 days later, moderate swelling in legs returned and body weight increased by about 5 lbs. The patient visited nephrologist visit on 02Jun and was prescribed 20mg prednisone, 3 tablets every other am for 20 days. Currently, patient have been taking the medicine since 03Jun. As of now 12Jun2021, the leg swelling partially decreased and the body weight decreased by 1-1.5 lbs. The clinical outcome of all the events was not resolved.

Very tired and whole body aches the next day after 2nd vaccine, and over the following few days I was very very tired and could fall asleep anywhere and almost instantly if I closed my eyes long enough, my jaw was extremely sore after and the preexisting issues got very bad after (muscle tension and knotting). Had bad poops for about a week after and even pooped myself so that was awesome

Patient was administered higher than recommended dose. c/o Left arm discomfort x 2 days. Denies any pain, swelling, redness today (3 days after vaccine). Pt had no other complaints.

Injection site pain.; Tiredness; Chills; Joint pain; Feeling unwell; Muscle pain; This is a spontaneous report received from a consumer, the patient. A 18-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the right arm on 15Mar2021 at 1230 (at the age of 18-years) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient was allergic to bactrim. The patient concomitant medications was not reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, at 1600 the patient experienced injection site pain (vaccination site pain), tiredness, muscle pain, chills, joint pain and myalgia. The patient did not receive any treatment for the events and 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 vaccination site pain, tiredness, muscle pain, chills, joint pain and myalgia was recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.

left arm numbness; tingly; muscle aches; This is a spontaneous report from a non-contactable other healthcare professional. An 18-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6207) via an unspecified route of administration on 18Mar2021 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Mar2021, during 15-minute waiting period after the vaccination, the patient experienced left arm numbness and tingly. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient also complained of muscle aches. The patient was treated with water and she had an excellent response to the treatment. The patient was stable to go home and follow up with primary care physician. The clinical outcome of the events arm numbness, tingly and muscle ache were unknown at the time of report. No follow-up attempts are possible. No further information is expected.

Neck, left arm and chest pain; Neck, left arm and chest pain; Neck, left arm and chest pain; Unable to work; discomfort; Pain; This is a spontaneous report from a contactable consumer or other non-Health care professional (patient). A 19-year-old female (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 19May2021 13:00 (age at vaccination 18-years-old) as dose 2, single for covid-19 immunisation. The patient medical history reported as none and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 28Apr2021 13:00 as dose 1, single for covid-19 immunisation with no reaction on previous exposure to vaccine. Prior vaccination, the patient had no Covid. It was unknown if patient tested covid, post vaccination. On 24May2021 12:00, the patient experienced neck, left arm and chest pain. Patient was unable to work because of the pain and discomfort. The events resulted in doctor or other healthcare professional office/clinic visit. Events considered as serious with disability or permanent damage. The patient received treatment and doctors are still working this up for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

I dropped a considerable amount of weight; headaches; weakness; diarrhea; experience stomach pains; This is a spontaneous report from a contactable consumer (patient). An 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25May2021 10:00 AM (Lot Number: ER8735) as dose 2, single (at age of 18-years-old) for covid-19 immunisation. No pregnancy at time of vaccination. Medical history included covid-19 prior to vaccination. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0179) on 04May2021 11:00 (at age of 17-years-old) in Arm Right for COVID-19 immunisation. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced Drug allergy. On 27May2021 07:00, the second day after receiving the shot, she began to experience stomach pains. On 28May2021 (the third day after the shot) the that symptom increased in strength and transitioned into severe diarrhea. In addition, she also began to suffer from headaches and weakness. She dropped a considerable amount of weight, approximately 10 pounds well experiencing the diarrhea. The events were not received treatment. Since the vaccination, the patient had been tested for COVID-19 included rapid test: negative (nasal Swab) on 28May2021. No Hospitalization Prolonged. Outcome of the events was not recovered/not resolved. Follow-up attempts are completed. No further information is expected.

July 9th - chills, bad muscle pain throughout body July 10th at 12pm - vomiting, 5 times until 6:30 where it finally stopped

My first three days after my shot, I had typical side effects of headache, fatigue, chills, sore arm at injection site and stiff/achy legs. All the side effects subsided after three days except my legs ached along with my arms and shoulders too. The shoulder and arm pain occurs occasionally now...every two or three days for several hours. My leg pain has not stopped. I describe the leg pain as an ache that does not have sharp pain or tingling. It is less intense if I have a sedentary day. On a normal day on a pain scale of 0-10, I rate my leg pain as a 6. Ibuprofen diminishes the pain by a small amount.

Injection site pain, swelling. On Saturday noticed swelling in underarm and hardening of breast tissues. Went to PCP on Monday 7/19 and was diagnosed with costochondritis and myalgia of the neck, chest and back. Patient given meloxicam and sent home.

Nausea; Headache; Arm pain; Muscle aches; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via unspecified route, in right arm on 09Jul2021 as dose 1, single for COVID-19 immunization. Patient medical history included COVID-19. Concomitant medications included meningococcal vaccine for Meningitis. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab: results unknown on an unknown date. The patient experienced nausea, headache, arm pain and muscle aches in Jul2021. No seriousness criteria reported. No treatment was taken for the events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Four days after receiving her vaccine, pt. began experiencing a progression of symptoms. Starting with Nausea, then vomiting and constipation, extreme pressure in her chest, pain in her abdomen and difficulty swallowing / eating causing significant weight loss (123 lbs to 108 lbs). She has no or intermittent sensation to urinate and has had multiple catheters and is currently on a Foley catheter due to retetion. She has Gastroparesis and has not had a bowel movement since this all started. She began to experience Edema at the end of June and is currently experiencing tingling in her arms and legs since mid July.

Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient claims to have had dizziness, stiff neck, nausea, and stomach irritability the following day after administration as well as up through today (7/26/21). Patient has not confirmed symptoms have not ceased as of yet (note: 3 days after administration).

Day 1: pain/swelling at injection site with redness, muscle aches, joint pain Day 2: pain/swelling at injection site with redness, muscle aches, joint pain, headache; worked but with considerable discomfort/strain Day 3: pain at injection site, muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia; unable to work Day 4: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work; attempted to see doctor but was refused care due to "CoVid-like symptoms" Day 5: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work Day 6: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, nausea; unable to work; attempted to see care at Urgent Care but was turned away for having "CoVid-like symptoms;" went to hospital per the recommendation of MD and urgent care Day 7: mild muscle aches, fatigue, feeling unwell, insomnia, sweating, sore throat; unable to work Day 8: sore throat, mild fatigue, sweating; unable to work

patient c/o sore throat, feeling tired and muscle aches after vaccination. Has been taking tylenol and feeling better.

I woke up this morning (approx 18 hrs post injection of my 2nd dose) feeling some myalgia, joint pain (perhaps 7/10 on a pain scale) and fatigue. I was able to work out (exercise bike 30 mins) and shower despite the pain. Then, around noon today (nearly 24 hrs post injection) I began feeling increasingly dizzy and warm. I stood to go to my bed and lost consciousness and collapsed. I was only unconscious for perhaps 15 seconds. I woke up feeling very shaky and cold and breathing rapidly. I was able to slow my respirations. My skin on my face and hands was very pale (lips were whitish blue). My housemate had called 911 for me: FD showed up and took a couple sets of orthostatic vitals. My BP when seated on the floor was around 110/80, pulse 80, and my BP when standing was around 90/70, pulse 100. I was able to walk to the bed without help so I decided to stay home and just hydrate, sleep, and keep a close eye on things. Now (1620, around 4 hrs after passing out). I still feel lots of soreness, but only very minor dizziness.

Fever; headache; fatigue; nausea; muscle aches; This is a spontaneous report from a contactable nurse reported for herself. This 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 09Jan2021 15:30 at single dose (vaccine location=left arm) for COVID-19 immunization. Medical history included allergies: Iodine, shellfish. The patient had COVID prior vaccination. Patient was not pregnant, and did not receive other vaccine in four weeks. The patient's concomitant medications were not reported. On 10Jan2021 07:00 AM, the patient experienced fever, headache, fatigue, nausea, muscle aches. No treatment received for events. Patient had not tested COVID post vaccination. The outcome of events was not recovered. Information about lot/batch number has been requested.

Extreme muscle weakness/ache, chills and shaking. Began around 11pm on 1/19/21 and mostly cleared by 3pm on 1/20/21. Was severe enough to prevent working, paid or otherwise.

A few hours after the shot I felt fatigued and my arm was very sore. Later in the day around 3:00pm I got chills and muscle soreness throughout my whole body. I then started to develop pain in my chest while breathing and I was having to gasp for air(this was around 5:30pm). My skin (mostly on my back) felt like it was burning and itchy. That lasted the entire night. 24 hours after the injection and I am still feeling tightness in my chest when I breathe, sore throat, and sore muscles.

headaches; Confusion; Fever; muscle aches all over; This is a spontaneous report from a contactable consumer (patient). A 19-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: EL0140), intramuscular in upper left arm on 11Jan2021 around noon at second single dose for preventative. Medical history included ongoing attention deficit hyperactivity disorder (ADHD, diagnosed when she was 14 or 15 years old), ongoing anxiety (Diagnosed when she was 16 years old), depression. Concomitant medication included ongoing methylphenidate (has been taking for about 4 or 5 years) for ADHD, to help focus and keeps her sane, ongoing primidone (has been taking less than a year) for hand tremors, ongoing fluvoxamine maleate (taking for about 4 years) for anxiety depression. The patient previously took first dose BNT162B2 on 21Dec2020 around noon, intramuscular injection in upper left arm for preventative (Lot: EJ1685). No other prior vaccinations within 4 weeks. No AE following prior vaccinations. The patient got the second dose yesterday (reported on 12Jan2021) around noon and she was experiencing not so great side effects. The biggest thing was headaches that were pretty debilitating. She was experiencing confusion and muscle aches all over. Stated that all the side effects started around the same time around 9 pm last night. The patient reported that her fever was down a bit so she was a little bit more coherent. Fever was slightly improved at 101.5. The patient took a few medicines for ADHD or anxiety and was wondering if they could have interacted with the vaccine. The events did not require a visit to emergency room and physician office. The patient reported her headache with medication was slightly better, but consistently the same. Treatment for headache inclued Ibuprofen. Outcome of event headache and fever was recovering, of event muscle aches all over was not recovered, of event confusion was unknown.

Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies. On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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.

Chills; Body/muscle aches; Body/muscle aches; hot flashes; fatigue; malaise; nasal drainage; arm soreness in injection arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 16Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included Acid Reflux. Concomitant medication included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) and famotidine. On 16Jan2021 19:00, the patient experienced chills, body/muscle aches, hot flashes, fatigue, malaise, nasal drainage and arm soreness in injection arm. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Flu symptoms- 3 days and continuing, began about 5 hours post-2nd vaccine dose: 101-102 degree fever, chills/sweating, severe headache, stiffness in head/neck/shoulders/back, dizziness, extreme fatigue, nausea

Awoke the next morning with severe headache, fatigue, muscle pain (?felt Like being hit by a truck?). Slept 1.5 days, out of breath walking to bathroom from bed. Treated with sleep and sips of water, soup. However, her mild daily migraine became more severe 2 weeks after the 2nd dose, her vision has worsened, and her eyes spontaneously dilated with pounding headache a few days ago along with nausea. It appears this 2nd dose has made her daily (mild) migraines much more severe.

Headache, joint pain, light fever, light-headedness. I almost passed out trying to walk to the dining hall for dinner.

I was tired that night and slept until 11:00 am or 12 pm and muscle aches and body aches were noticed when I woke up. Thursday night, My heart started racing very quickly and it lasted for 30 minutes - my whole chest was hurting really bad and my heart was beating hard. I had a monitor - 207 beats per minutes. Blood pressure was normal. ER - monitored my heart. I think they gave me some medication. They gave me a heart monitor to check my heart for next 14 days. There was not another occurrence.

Got second dose of vaccine the morning of March 10th. Had the "expected" symptoms of fatigue, headache, and chills the evening of March 10th. Woke up on March 11th around 6:50am and felt the same symptoms as the night before but also really hot and nauseous, stood up and began to slowly lose vision. Went to parents for help and they saw me pass out and collapse. Went to Emergency Room and they found I had a really high heart rate and I received an IV to help with rehydration. Was released after that and have continued to have the same symptoms plus muscle soreness but no longer feel as dizzy and haven't had any issues with vision or consciousness since.

3/17/21-3/18/21: Nausea, vomiting, high fever (103F), diarrhea, muscle soreness & weakness, shakes, dehydration, migraine 3/19/21-3/21/21: chest tightness, muscle pain and weakness, low grade fever (100-101F), sore throat

at 1pm EST on 3/19/21 patient reports onset of fatigue. then around 3pm 3/19/21 she developed nasal congestion, sore throat, increased fatigue, muscle aching generalized, backache generalized mid and lower back, chills, headaches, loss of appetite, swollen neck glands. She visited the Health Clinic on 3/20/21 at 3:40pm at which time she was noted to have temp of 100.6 and heart rate of 108. General exam indicated some tender anterior nodes, nasal mucous, and fatigued appearance.

The next morning after I got the second dose of the vaccine, I felt incredibly ill. Stomach was aching to the point I thought I was going to throw up, my joints were aching to the point it hurt to move, my skin hurt so touch, and I had a slight quick fever. These symptoms lasted all day, but went away the day after (Wednesday 24, 2021).

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: difficulty hearing-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: We called 911. EMT came in. All the vital signs were normal. After 30 minutes, the patient recovered.

Sore throat 2 days after vaccine for 2 days, headache after vaccine for 2 days for 1 day, chest pain for a few hours 4 days after vaccine, joint pain for 4 days, body aches for 5 days, blue feet and grey nails for 30 seconds 3 days after vaccine, couldn't walk for 5 days after vaccine, a lot of weakness everyday for 5 days, bruises on both feet 4 days after vaccine for 3 days.

Shaking, chills, fever, severe muscle ache, headache, very painful swollen lymph node in armpit, nausea, apetite loss

Worsening over 6 days: arm injection swelling and sharp pain (severe, 1st day on: ice pack), headache (severe: advil, tylenol, thera flu), muslce aches all over the body (medium: 2nd day on); tiredness (medium-severe: 1st day on), sore throat (severe: 3rd - 5th day: cough drops); congestion/nasal and chest with cough and yellow mucous and sneezing (severe: 4th day on: nyquil); difficulty breathing (medium: 5th day on); runny nose (medium: 4th day on); temperature (5th day on, highest of 102: tylenol); nausea/vomitting/diarrhea (5th day only: bland food, BRAT diet), swollen lymph nodes (medium: 4th day on). Possible loss of smell and taste but could be due to congestion. Doctor prescribed (and was carried out): antibiotic (Cefdinir, just in case) and steroid shot.

PATIENT STATES LEFT ARM WEAKNESS AND TINGLING. PATIENT VITALS ARE BP 134/78, HR 76, RR 18. PATIENT STATES FEELS FINE AFTER MORE OBSERVATION AND DOES NOT WANT ANYMORE INTERVENTIONS.

strange pain on her left collar bone; going to see someone just in case it's a blood clot; lump on her collar bone, left collar bone; does hurt a little bit; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 19-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 intramuscularly administered in Arm Left (like the shoulder area) on 28Mar2021 09:00 (Lot Number: ER8734 and Expiry date: unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No additional Vaccines administered on same date of the Pfizer suspect. On 30Mar2021, the patient experienced going to see someone just in case it's a blood clot, lump on her collar bone, left collar bone, does hurt a little bit and on unspecified date strange pain on her left collar bone. 19-year-old female got the first Pfizer Covid vaccine at 9 am on Sunday, March 28 and this morning, she woke up with a strange pain on her left collar bone and there was a lump there, states when she woke up, she noticed a pain, checked in the mirror, she saw on the left side she saw a bump and checked on the right side and didn't see anything and that's when she got worried. Caller states she was just calling to report it, she's worried that it's a blood clot or something else. Why was the patient taking Pfizer BioNTech COVID Vaccine (Verbatim): she wanted to be vaccinated to protect herself and her community. Caller states she would not like to provide her last name at this time. However, provided her last name initial. She also reports she would not like to provide her address, height, or weight right now. She states she used to volunteer at a hospital. She does not see expiration or NDC number on card she received when she got her vaccine. Caller states she does know that one of her family members has the Factor 5. She is not sure if she has it but would like to be tested for it. The outcome of the event going to see someone just in case it's a blood clot was recovered, lump on her collar bone, left collar bone and does hurt a little bit was not recovered and strange pain on her left collar bone was unknown. Information on batch/Lot number has been requested.

Night of vaccination: sweats, fever, headache, stomach ache, injection site pain Day after vaccination: sweats, fever, headache, injection site pain swelling and tenderness, nausea, diarrhea, muscle pain, chills, fatigue

Nausea; Passed out; Felt a little dizzy; Mumbling, slurred speech; Developed a "static" feeling in her head; Eye shutting; Weakness in her left arm and leg; This is a spontaneous report from a contactable physician. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), intramuscular on 23Mar2021 as single dose for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. 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, it was unknown if the patient has been tested for COVID-19. Concomitant medication included fluoxetine 60 mg taken for an unspecified indication, and an unspecified oral contraceptive. It was reported that on 23Mar2021, the patient received Pfizer Covid vaccine and felt a little dizzy on 11:00. She also started noting mumbling, slurred speech, passed out for about 15 (unspecified) after using the bathroom, developed a "static" feeling in her head and then noted her left eye shutting and then weakness in her left arm and leg. She was taken to the Emergency Room (ER) for evaluation. Symptoms lasted about 5 hours. She fell asleep in the ER. Symptoms seemed to clear by about 8:30 PM. She had lab and head CT at the hospital which were essentially normal. She felt okay the next day, but had some nausea for a couple days starting on the 3rd day on 25Mar2021. She stated she feels fine at the time of report in the Student Health Clinic and asked whether she should receive her second Pfizer dose scheduled on 20Apr2021. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received for the adverse events. The outcome of the event nausea was recovered in Mar2021, and for other events was recovered on 23Mar2021 20:30. Information about lot/batch number was requested.; Sender's Comments: Based on the information currently available and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported event Passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Patient reports 6 hrs. post vaccine developed fever (temp max 102) resolving 36 hrs later with excessive fatigue and joint pain and stiffness. Patient presented in office 4/21/21 with persistent excessive fatigue and joint pain and stiffness.

She has been ill from day of and remains sick with no relief in that time. Developed a 102 degree fever and delirium day of and the following day. Bones hurt, chills, joints swollen. Headache, dizziness, fatigue. The fever remained for 36 hours and she's had mild fevers off and on since. Tylenol would temporarily reduce the 102 fever before it went back up. The other symptoms have remained, predominantly bone and joint pain and stiffness, fatigue, and general feeling if being unwell. Her coloring is very pale, gray-looking. She's missed work and school due to pain and fatigue. She was completely healthy pre-vaccine.

Patient presented with a redness and rash at the injection site and above/around the shoulder. Injection site went numb and shooting pain fired from the elbow, down to the fingers. Diphenhydramine (50mg) was provided and patient was observed every 5 minutes for 15 minutes. Numbness turned to burning sensation, then all symptoms cleared out between 5-10 minutes. All symptoms were gone by 15 minutes other than arm soreness from injection.

Finger, hand and arm trembling, extreme body pain began approximately one hour after injection and continued intermittently for 6 hours the first day. Arm tremors continued for some time the second day, and on and off for the past two weeks. Extreme muscle and body pain for the past 2 weeks, muscle twitching that subsides and returns. Since then, discussing her illness with medical providers brings on the return of the hand and arms shaking/tremors. In addition, warm water, showers lead to the hand and arm shaking/tremors as well. She saw her primary care physician on Friday April 16 who witnessed the shaking/tremors coming on. She was referred to a muscular neurologist at hospital and seen there by Dr. on Tuesday April 20 who also witnessed the shaking/tremors and diagnosed functional movement disorder.

Experienced life-threatening blood clots in both lungs (bilateral pulmonary embolism); chills; flu-like symptoms; difficulty breathing; chest pain; nerve pain in neck; severe rib pain; spitting up blood constantly; severe aches and pains all over my body; This is a spontaneous report from a contactable consumer. A 19-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:45 (Batch/Lot Number: ER8737) (at age of 19-year-old) as single dose for COVID-19 immunisation. Medical history included Polycystic Ovarian Syndrome, and eczema. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) and hydroxyzine, both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient previously took propylene glycol, scopolamine and experienced drug allergy. The patient previously took the first dose of BNT162B2, administered in Arm Left on 16Mar2021 12:00 PM (at age of 19-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was reported on 09Apr2021 12:00, the patient experienced chills and flu-like symptoms that developed into difficulty breathing/chest pain. Nerve pain in neck, severe rib pain, and spitting up blood constantly. The patient started spitting up blood about two days after the vaccine. The patient experienced severe pain and difficulty breathing on12Apr2021. The patient received help from urgent care on 14Apr2021. On 14Apr2021, the patient was directed to receive a CT scan which revealed severe blood clotting in lungs. Rushed to ER where the patient was then admitted to the hospital overnight for observation and to receive blood thinners and pain medication. In the week since leaving the hospital the patient has experienced severe aches and pains all over her body and have continued to spit up blood. The events were reported resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).The patient was hospitalized for the events for 2 days. Events treatment included: O2, Blood Thinners, Oxycodone, and Morphine. No COVID prior vaccination. COVID tested post vaccination on 14Apr2021, Nasal Swab, COVID-19 RNA - SARS Cov-2 test result was Negative . The outcome of events were recovering.

At 7:40 pm on 04/27 I received my second Pfizer COVID19 shot. I felt okay for the rest of the night and went to bed around 2am that night. The next day, I woke up around 10:30am and was sore until about 12pm when I began to feel completely awful. I was tired and no pain reliever helped with the muscle aches in my shoulders and back. I felt like my chest was being weighed down and it felt like a horrible chore to even breathe. About 24 hours after the shot, under my jaws began to hurt terribly and ice didn't do much to help it. I finally fell asleep on 04/28 around 2am and woke up on 04/29 without any pain.

Severe Headache, nausea, fatigue, lightheadedness, muscle weakness in left arm and arm pain in left arm, chills Fatigue started in the morning and other symptoms started to emerge after a few hours. Severe headache started midday. Symptoms made it hard to focus and get work or anything else done. Took ibuprofen which helped headache, but it did not go away completely and lasted in to the next day

I got my vaccine Wednesday afternoon and woke up that night with a fever, muscle aches and spasms, a headache, and dizziness. My fever got up to 101.2 F by 3:00 Thursday morning, when I finally decided to take Tylenol. That eventually brought my fever down and kept it down. I was extremely tired throughout the day Thursday and had full body muscle aches, but I stopped taking Tylenol Thursday evening and my fever did not return. On Friday morning, I woke up extremely dizzy. I had trouble moving around and felt nauseous from the dizziness. It improved throughout the day and was nearly gone by the time I got up Saturday morning. By Sunday morning, my symptoms were pretty much resolved.

Pfizer-BioNTech COVID-19 Vaccine EUA Received Pfizer-BioNTech COVID-19 Vaccine EUA on April 26th in left shoulder. Left shoulder hurt on April 27th - could use it but it hurt a lot to use. Also had a headache and diarrhea. April 28th Left arm still hurt to use about the same as the 27th (didn't use it much). April 29th Left arm felt different than other arm hard to describe it didn't hurt to use it was just weaker than right arm but not too much weaker. Left leg started feeling tingly like ants were crawling up it. April 30th same as the 29th left arm felt different than other arm hard to describe it didn't hurt to use it was just weaker than right arm but not too much weaker. Left leg still felt tingly. May 1st Left arm felt weaker than before but I could still lift things with both arms without noticing a considerable difference. Left leg felt weird not tingly anymore just different than right leg kind of numb. Had a limp when walking slowly. May 2nd felt like left arm and left leg were somewhat numb and weaker than right side. Also noticed I have to concentrate more to move my toes on the left. May 3rd left arm and left leg felt worse left side of face felt kind of numb like when dentists give you Novocain my face felt numb like that ( no difference in my tongue) but I didn't notice anything physically different about it. Left eye achy a little and it got a little blurry May 4th left arm and leg numb and weak, still hard to move my toes, and left side of face feels weird I guess numb is the best way to describe it. Left eye still blurry a little achy but not much. Summary: Left arm hurt at injection site, then whole arm hurt, now it feels weak and numb. Left leg felt tingly now it feels weak and numb. Left side of face feels kind of numb, left eye is blurrier than normal (I wear glasses), and I have had an off and on headache spanning this whole time.

Left arm pit pain Extreme Hypersensitivity all over body, skin burning, blistering and peeling, extreme teeth sensitivity, brain feels swollen hurts.

Night after vaccine (4/30/2021 to 5/1/2021): had trouble sleeping despite being tired (atypical for me), felt overly warm (atypical for me) 5/1/2021, 8am: woke up feeling disoriented, fell back asleep 5/1/2021, 11:30am: woke up and could not fall back asleep, even though I still felt tired. Felt very overheated, had migraine headache, felt sore in hips, knees, and neck. Treated migraine with 2 tablets of 220mg naproxen sodium. Fell back asleep around 12:15pm and slept till 2:30pm. Felt better when I woke up. 5/1/2021, 6:00pm: headache returned, felt drowsy. Napped for approximately 1hr 45min. Woke up and headache was still bothersome. Took 2 more tablets of 220mg naproxen sodium. Headache faded. 5/2/2021: mild headache and soreness persisted on and off until the evening.

I can't be standing for more than a few minutes; My legs begin to cramp up; Muscle aches; Sore throat; Couldn't get out of bed all weekend; White blood and platelets count abnormally low; White blood and platelets count abnormally low; Mononucleosis; Cough; Dizziness; Muscle weakness; Fever; Headache; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in left arm on 15Apr2021 10:00 as single dose for Covid-19 immunization. Medical history included gastritis and sensitive stomach from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. Concomitant medications included drospirenone, ethinylestradiol (NIKKI); pantoprazole sodium sesquihydrate (PROTONIX); and an unspecified vitamin, all taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for Covid-19 immunization. The patient received her second dose on 15Apr2021, Thursday, and on 16Apr2021, Friday night, she got a mild headache. Beginning 17Apr2021 09:00, Saturday, she got severe headache, dizziness, muscle weakness, and a fever. Symptoms worsened throughout the days. On 19Apr2021, Monday, she also got a sore throat. She couldn't get out of bed all weekend. She went to the hospital and they found that her white blood and platelets count were abnormally low, among other low things (white blood at 1.8). She was hospitalized until 20Apr2021, Tuesday, and was found to have mononucleosis. Cough developed and ended Tuesday, 20Apr2021. Beginning 20Apr2021 onward, the muscle aches were the biggest complaint, she can't be standing for more than a few minutes or her legs begin to cramp up. Headaches and dizziness continued. Sore throat stopped, and fever began to subside. On 19Apr2021, the patient underwent lab tests and procedures which included platelet count: abnormally low, Nasal Swab/PCR: negative, and white blood cell count: 1.8. The events resulted in Doctor or healthcare professional office/clinic visit, Emergency room/department or urgent care, and events from 19Apr2021 caused hospitalization until 20Apr2021. Treatment for the events included Tylenol and IV fluids. The outcome of sore throat recovered in Apr2021, cough resolved on 20Apr2021, fever was recovering and for other events was not recovered.

Very swollen arm immediately after vaccine and worsened throughout the day, inflamed and painful joints, tightness in chest

Left arm hurt at injection site; Whole arm hurt; Left arm hurt at injection site, then whole arm hurt, now it feels weak and numb/Left leg felt tingly now it feels weak and numb; Left arm hurt at injection site, then whole arm hurt, now it feels weak and numb/Left leg felt tingly now it feels weak and numb/Left side of face feels kind of numb; Left leg felt tingly now it feels weak and numb; Left eye is blurrier than normal; Left eye is blurrier than normal; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170), via an unspecified route of administration in left arm on 26Apr2021 at 16:30 (at the age of 19-years-old), 1st dose, single for COVID-19 immunization. Medical history included left eye was blurry and wear glasses. Concomitant medications included loratadine (CLARITINE), vitamin B complex (VITAMIN B) and ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A-DAY). Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The vaccine was administered at public health department. On 27Apr2021 at 6:30, the patient's left arm hurt at injection site, then whole arm hurt, and then it felt weak and numb. On the same day of 27Apr2021 at 6:30, the patient's left leg felt tingly, then it felt weak and numb. Her left side of face felt kind of numb and the left eye was blurrier than normal. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Muscle aches in legs and arms, lightheadedness/dizziness, and headache the night following the injection. Fever and runny nose the next morning. Ibuprofen was taken in 6 hour intervals and cleared headache and reduced fever but did not affect muscle aches. These symptoms were all gone 2 days after the injection.

About 10 hours after my second dose, I began to have muscle pain. The muscle pain is different than body aches that I?ve gotten with a cold. My muscles hurt and my skin is sensitive to the touch. It feels like the pain goes from the skin to the bone. I don?t know how else to describe it other than feeling like a bad a sinus infection inside of my muscles. I know that?s a weird way to describe it but the pain is kind of indescribable and unique. The pain is worst in my neck and back. My joints also feel inflamed, it?s hard to close my hands into a fist. I spent most of the night freezing cold and shivering (I live without air conditioning). It has been about 35 hours since I received the vaccine. Cold and shivering has subsided but I have have the sweats for the past 8 or so hours. A bit of nausea and stomach pain started about 15 hours after the vaccine.

COVID shot 4/30. Then the day after getting back pain mid back- constant in pain and headaches. Headaches are in the AM and sometimes at night. She takes Ibuprofen and it doesn't really help. Been nausea after she eats or before she eats. Started 2 weeks ago. With each meal. Not improving and not worsening. Has IUD. No sexual activity.

Patient stated that she was having tingling in her arms, chest was tight and legs were feeling heavy. The feeling started with her arms and then went to legs but didnt notice this until she pulled her phone out and that she was having tightness in her chest. We took the patients vitals at 11:24 am heart rate 92, Blood pressure 132/80, o2 100, and then again at 11:30 am heart rate 69, Blood pressure 112/73, o2 99. I asked the patient how she was doing. Patient stated that legs still feel heavy and that the chest tightness is better. After the second blood pressure the patient stated that her chest tightness was completely gone. Patient also stated that her arms and legs were better. I released the patient home with mom and dad. She was released at 11:40 am.

had the Pfizer vaccine LOT WE0169 clinic she had in less 48 h generalized hives + swollen joints and fingers as well SOB + chest tightness she was prescribed Benadryl but still after 10 days she is still w same symptoms and hives getting more uncontrolled

Patient started having seizure like activity and weakness in her arms and legs; the patient was brought by EMS to the ER and admitted for testing. She had tics that were occurring of her head and neck area. After she was released with no abnormalities noted to be causing her symptoms, she was referred to a Functional Movement Disorder specialist at a clinic, who diagnosed her with Functional Movement Disorder. Her symptoms resolved completely about a week after her hospitalization.

Headache; Episode of stiffness, going pale; Episode of stiffness, going pale; 15 seconds of memory loss; This is a spontaneous report from a non-contactable female other HCP reported for herself. A 19-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via intramuscular route of administration on 19May2021 16:45 (at the age of 19-year-old) as single dose for COVID-19 immunization. Medical history was none, and no allergies were reported. Concomitant medication included sarecycline(SARECYCLINE) contraceptive pill via oral route of administration. On 20May2021 11:00 AM, the patient experienced headache, episode of stiffness, going pale, 15 seconds of memory loss. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment medications for events. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine, diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination. The events were reported as non-serious. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Fever (over 101 degrees), chills, headache (severe), muscle pain, body aches, fatigue, nausea and vomiting starting 2 days after vaccination, lasting over 5 days.

Prolonged severe headache, fatigue, chills, muscle aches, nausea/vomiting for 5 days after injection.

This patient received the Pfizer COVID-19 vaccine on 05/20/21, On 05/28/21 pt brought her child in for catch-up vaccines and reported this "adverse reaction". She stated that upon waking on the morning after she received the vaccine, 05/21/21, the fingers on her right hand, excluding her little finger and thumb, were swollen and "stuck in place". Pt described what sounds like "trigger finger". She took Ibuprofen and Tylenol during the day and was back to normal the next morning. Subsequently, patient stated that on the morning of her child's vaccines, 05/28/21, she experienced this issue again on only one finger. I observed no edema and the patient appeared to move all digits on both hands without difficulty.

1st day of pain: Extreme Pain in Lower Extremities (Right Leg, Right abdomen, right lower back) Swelling of Right Leg 3rd day: Admitted into the hospital after visiting the ER Acute DVT in R Leg, multiple Pulmonary Embolisms 3rd-5th day in hospital: 2 Surgical Procedures to remove blood clot, on Blood thinners for a year to life

Patient has had a 2 day history of left sided chest pain, chest tightness, shortness of breath, dizziness, nausea and tightness in the left shoulder.

Swollen lymph nodes under left arm , Arm of injection is L arm. In addition Rib pain across chest with pain while taking a deep breath

kidney stones; severe left flank pain; extreme thirst; This is a spontaneous report from contactable consumer (patient). A 19-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10May2021 14:00 (Lot Number: EW0168) as single dose (at the age of 19-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no medical history. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), cefalexin monohydrate (LEXIPRON), ethinylestradiol, levonorgestrel (VIENVA), all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Apr2021 02:00 PM (Lot Number: EW0162) as single dose (at the age of 19-years-old) for COVID-19 immunization and experienced Heavy period off schedule from pill pack. The patient experienced extreme thirst since second dose (10May2021). Then, on 27May2021, had severe left flank pain causing an emergency room visit. Preliminary diagnosis is kidney stones. At ER, patient received pain medication, saline hydration drip. The outcome of the events was recovering. The event kidney stones was considered as serious (medically significant). Facility where the most recent COVID-19 vaccine was administered was the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are possible; further information has been requested.

Pfizer COVID vaccine administered 04/27/21. Reports that she started feeling unwell almost immediately after injection. Immediate Reaction (onset <5 min) associated with the following symptoms: ? Visible swelling and pain at the injection site ? Increased nasal secretions and eye tearing ? Chills Around 30 minutes after, she had also developed: ? Swelling of the tongue (felt "heavy") ? Flushing, diaphoresis, and nausea, followed later by vomiting ? Dizziness/lightheadedness/weakness ? Dyspnea, wheezing, and cough ? Hives on arms and chest No throat tightening or tachypnea. She did not attempt speech. No one in the clinic took her blood pressure or pulse ox The patient brought her epi pen with her but elected not to use it. Left after 30 minute observation period. Thinks that the people at the vaccine clinic did not recognize that she had hives because of her dark complexion. The people administering vaccines were not medically trained Patient's mom recognized that she was not feeling well when she picked her up. She took benadryl which helped with allergy symptoms. She then developed fever up to 102.3, chills, headache, nausea, and myalgias x 5 days

patient was given pfizer 1st dose vaccine at 3:35pm and at 4:40pm reported feeling hot/nausea/neck pain (stiffness). BP 102/76 HR 81. Re took at 5:04 BP 96/62 HR 86. patient did report occasional anxiety but not with vaccines. called EMT at her request.

One day after getting 1st covid vaccination vaginal bleeding for 21 days and joint pain. Joint pain has not subsided.

Headache; Nausea; Vomiting; Injection site pain; Stiffness in injection limb; Mild fever (100.2 F); This is a spontaneous report from a contactable consumer, the patient. A 19-years-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 17Mar2021 at 14:15 (at the age of 19-years-old), as a single dose for COVID-19 immunisation. Medical history included Idiopathic intracranial hypertension, Tourettes and fibromyalgia. Concomitant medications included naproxen (MANUFACTURER UNKNOWN), TOPAMAX, CYMBALTA, ATIVAN and trazodone (MANUFACTURER UNKNOWN) taken for unknown indications from unknown dates within 2 weeks of vaccination. 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 the vaccination. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 at 12:00, the patient experienced headache, nausea, vomiting, injection site pain, stiffness in injection limb and mild fever (100.2 F). No therapeutic measures were taken for the adverse events. The clinical outcome of headache, nausea, vomiting, injection site pain, stiffness in injection limb, mild fever (100.2 F) was recovering/ resolving. Information about lot number cannot be obtained. No further information is expected.

Foot drop; pins and needles in her left leg/paresthesias; Nerve pain; Having trouble flexing her foot; weird headache; didn't feel well overall; aches and pains and bad headache with leg pain; This is a spontaneous report from a contactable consumer (patient parent). A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 24May2021 09:30 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. Patient age at vaccination was 19 years old. Medical history included asthma, acne, patient diagnosed with COVID-19 prior to vaccination, she tested positive for COVID antibodies in Dec2019, known allergies to peanuts, some tree nuts, eucalyptus, tea tree oil. Historical vaccine included 1st dose of BNT162B2 on 03May2021 at 02:30 PM in left arm at age of 19 years old for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Multi-Vitamin, cetirizine hydrochloride (ZYRTEC), ascorbic acid (VITAMIN C), VITAMIN D, bifidobacterium lactis (PROBIOTIC), all for unknown indication from unknown date; Topical Skin Creams for acne from unknown date. Reporter's daughter did not begin to experience symptoms until she woke up the next morning. She had a weird headache and didn't feel well overall. She began to experience pins and needles in her left leg. She went to bed around 4:30 pm as she had aches and pains and bad headache with leg pain. On Wed, she called in sick to work and contacted her primary care physician's office who instructed her to go to the emergency room. She had nerve pain and was having trouble flexing her foot. The pain increased the next day and she again contacted her primary care's office and went to the emergency room again. Both times she was referred to a neurologist. She had blood work, ultrasound and x-ray of the leg. She prev (preventively) has surgery to the leg on 14Jun2021- compartment syndrome release & peroneal nerve release (she had exertional compartment syndrome w/ release to all 4 compartments). Yesterday (02Jun2021) the neuro recommended an EMG and the diagnosis on the form was left foot drop and paresthesias. Patient still had headache. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse events was reported as blood work, X-ray and ultrasound, all on 02Jun2021, 3 PT (physical therapy) appointments. Adverse event start date: 25May2021 at 07:00 AM. Patient was not recovered from the events. Information for lot number has been requested.

Patient received first dose of Pfizer covid vaccine. About 1 minute after receiving the vaccine, while Rph was counseling the patient, eyes suddenly rolled back, her body stiffened and patient became unresponsive. She began to slip off of the chair. Rph yelled 911 and patient spoke to them and stated okay and didn't want ambulance sent. She stated this happens when draws blood. Patient had friend with her and left about 20minutes afterwards.

Dizziness; Hungry; Tingling lips; Shakiness/ trembling; Fast heartbeat; Easily irritated; Confusion; Slurred speech; Muscle weakness; Memory issues; Foggy brain; Exhaustion; This is a spontaneous report received from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration in left arm on 20Mar2021 at 12:00 as a single dose for COVID-19 immunisation. The patients medical history included type 1 diabetes, celiac disease, asthma, vasovagal syncope, chiari malformation and major depressive disorder. The patient was allergic with naproxen, nonsteroidal anti-inflammatory drugs (NSAIDs), avocado and almonds. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior vaccination. Concomitant medications included Humalog, Cymbalta and Remeron. On 21Mar2021 at 18:00, the patient experienced dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion. After vaccination on 21Mar2021, the patient underwent lab test for COVID-19 (nasal swab test; RT-PCR for SARS-CoV-2) and the result was pending. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for these events. The clinical outcome of the events dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Inflamed heart and chest wall pain. Went to dr. when breathing and drinking became painful, ekg and chest x-ray were normal. given steroids to reduce inflammation and sent home

Patient in Clinic to for services and review vaccines and request COVID vaccine, Trumenba and Hep A. Gave Pfizer and grandmother requested to wait 15 mins before giving other vaccines. Patient was sitting on table, fainted after about 8-10 mins.Granmother caught her and placed back on table in supine position. Patient very pale, legs stiffened and feet turned inward. Feet were elevated and fan turned on patient. Patient aroused within 1 min. B/P 110/60. Denied difficulty breathing. Dr was present. Patient was cold and clammy. Heart rate 100. Ambulance was called. Ambulance arrived within 10 mins. Patient ambulated to stretcher. Ambulance transported to Hospital.

Patient called on 7/7 and let us know that she had been treated in the ER for HR >100, on and off fever, dizziness, shortness of breath when lying down, fatigue, and neck pain since receiving her second dose of the vaccine. She is following up with a cardiologist and will let us know of the outcome of this appointment.

Pt (adult age 19) was administered her first dose of the Pfizer Covid 19 vaccine at approx 8:30 AM on Friday 7/9/21. Pt did not appear to be in any distress. Upon completion of the vaccine administration, the pt sat in recovery chair with mother. After about 2 min, pt was talking to mother and passed out. Mother revived her by toughing her. She did not fall. the administering pharmacist was notiied and went out to the pt. Pt put head between knees to get blood flow to head and took deep slow breaths. She was given water. CSM, also came over and they both calmed her down and had her move her arms to help with her circulation due to complaint of arms feeling funny. Pt said she had worked the night shift the previous night & had not slept or ate so she got her a bottle of orange juice to sip on. Once pt sat for about 30 mins, she felt better and her mother escorted her out.

muscle soreness around the injection site.; Headache; Low grade fever; muscle pain; Joint soreness/ Pain; Tingling feeling in both legs; This is a spontaneous report from a contactable consumer, the parent. A 19-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 22Mar2021 (at the age of 19_years-old), as a single dose for COVID-19 immunisation. Medical history included environmental allergy (like pollen and dust). Concomitant medication included unspecified immune-tolerance (MANUFACTURER UNKNOWN) therapy for allergy. Prior to vaccination, it was unknown if patient was diagnosed with COVID-19. Since the vaccination, it was unknown if patient had tested for COVID-19. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 (within 24 hours), the patient experienced very common side effects or sequelae like muscle soreness around the injection site, headache, low-grade fever, and more generalized muscle; joint soreness or pain and side effect which was most unusual and disturbing was the tingling feeling the patient had (and was still experiencing without any diminution) in both of her legs. It was also reported that, as per doctor the patient was not experiencing any muscle weakness or numbness, then it was not guillainbarre syndrome (GBS), and she should come back if it worsened, but did not prescribe any course of treatment. Therapeutics measure was taken as a result of events vaccination site pain, headache, low grade fever, muscle pain and joint pain which included the treatment with ADVIL (over the counter nonsteroidal anti-inflammatory drug). The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events vaccination site pain, headache, low grade fever, muscle pain, pain, joint pain and tingling were not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

1. My period, which I got on April 20th (18 days after dose 2), resulted in extreme and debilitating cramps, which are lasting to this day. They're so bad I can't get out of bed for the first two days of my period - then I have infrequent occasional pangs of pain on day 3, and I'm okay days 4 and 5. I have never had cramps during my cycle before April 2021. 2. On April 16th, I was driving my car and I noticed that when I had my foot on the the brake, it was shaking uncontrollably in almost every position I put my leg in. The frequency of this leg tremor during driving became more frequent, and I started noticing heightened anxiety, trouble focusing, weight loss of 7 pounds thus far (my weight has not fluctuated more then 3 pounds in the last 4 years so this was a surprise to me), lightened period, increased heat intolerance, heart palpitations that keep me awake at night and tachychardia, muscle weakness, and fatigue. I had a really stressful semester in school so I chalked these symptoms up to anxiety. Then, in the first week of June, I went to the gynecologist to get the cramps situation checked out. She told me she wanted me to check out my thyroid for the rest of the symptoms. When my blood test came back, my Thyroid Stimulating Hormone (TSH) result came back as 0.03 (lowest acceptable range is 0.4). My primary care provider ran T3 and T4 tests, which came back as 15 and 5, respectively - which are both quite elevated for their range. So, I went to an endocrinologist at my primary care provider's referral, who ran more tests. This time, they found TSH to be 0.006 (got lower), T3 and T4 were elevated, very slightly lower than they were before. My endocrinologist then ran a test for Thyroglobulin antibody, which came back as 53.3, when the highest reference value was 0.9. Thus, my endocrinologist determined hyperthyroidism, but wanted to figure out the what I had so she sent me for a thyroid uptake scan. In the scan, they found my thyroid to be working at 51%, when the highest value after 24 hours of receiving the radioactive iodine was 33%, and my endocrinologist determined that I had Graves' Disease, an autoimmune hyperthyroid disease. I am now on Methimazole and Propranolol for Graves' Disease. I don't know if the vaccine caused my horrendously painful cramps and the onset of the autoimmune disease, but I just wanted the CDC to know! I am curious to know if there is a correlation. Please let me know if you have any questions.

Pronounced weight loss began within two weeks of the first dose. Patient lost 30 pounds in 3 months. She was diagnosed as a Type 1 diabetic July 12, 2021. Her symptoms during those three months included weight loss, dizziness, fatigue, sensitivity to heat, racing heart, easily out of breath, nausea and vomiting.

Site where vaccine was given was super hard, big and bumpy and red and warm; Site where vaccine was given was super hard, big and bumpy and red and warm; Site where vaccine was given was super hard, big and bumpy and red and warm; Site where vaccine was given was super hard, big and bumpy and red and warm; itching; huge bumps all over her arms and legs; left knee was huge and swollen/ ankles were swollen; rash/ rash was all over her arm/ rash was on her feet and legs and ankles; allergic reaction; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 19-year-old female patient (reporter's daughter) that who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0-87) at the age of 19-years, via an unspecified route of administration in left arm on 12Jun2021 at single dose for COVID-19 immunization, in physician office. Medical history was not reported. No other products. The patient historically received flu vaccine and had reactions to it- super sick, a lot of fever, couldn't sleep, talked in her sleep, crying, she would miss school, and right after vaccine she got a bad severe cold and cough, it got super severe and turned into a mild bronchitis and had to take salbutamol (ALBUTEROL), when patient was about 6 or 7 years old. This consumer reported that the patient developed severe reactions which required her to go to the doctor, such as huge bumps all over her arms and legs 12 hours after getting the dose, left knee was huge and swollen, like overexaggerated swelling, the reaction was probably in the joints and really severe; ankles were swollen. Her doctor advised not to receive the 2nd dose as this may be an allergic reaction from the vaccine. Doctor told her not to get the second dose and that the first dose could have been deadly for her. Consumer also reported that on the same day, 12 hours after, around midnight, patient had a rash but her doctor called it something else, and little bumps. The next morning, patient woke up with bigger bumps all over her arms and other parts body. It was on the weekend so the patient did not see a doctor until Monday. The reaction was a little less at that time. The reaction lasted about 7-10 days, patient continued to get little rashes that faded away and then more would come. It was also mentioned that site where vaccine was given was super hard, big and bumpy and red and warm, did not get a rash next to it, but the rash was all over her arm, just not in that area, the mother said the rash was on her feet and legs and ankles. Patient was given allergy mediation to help with reaction but it did not help, she was given cetirizine hydrochloride (ZYRTEC) 1mg/mL oral solution, it did help with the itching but did not help with the rash. Rash result in physician office. The mother wanted to know if these were reported side effects of the vaccine and if her daughter can still get the 2nd dose which is scheduled on 03Jul2021. Lab data included: weight was 138 pounds when she got the vaccine. Outcome of the events was unknown. Follow-up attempts completed. No further information expected.

slight pain/pinching sensation near lymph-nodes on armpit of injection arm; Stiffness/soreness on arm near injection; Stiffness/soreness on arm near injection; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 12:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included norethisterone acetate; ferrous fumarate; ethinylestradiol (JUNEL FE) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Mar2021, the patient experienced stiffness/soreness on arm near injection. On 29Mar2021, two days after injection, the patient experienced slight pain/pinching sensation near lymph-nodes in the armpit of injected arm. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 30Mar2021 which included COVID test and the test result was pending. The patient did not receive any treatment for the events muscle stiffness, vaccination site pain and lymph node pain. The clinical outcomes of the events muscle stiffness, vaccination site pain and lymph node pain were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.

High fever; Chills; Shaking; Extreme muscle pain; Painful swollen lymph node in armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 at 08:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 20:00, the patient experienced shaking, high fever, chills, extreme muscle pain and painful swollen lymph node in armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events shaking, high fever, chills, extreme muscle pain and painful swollen lymph node in armpit was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Experiencing Myocarditis symptoms. sharp pains on back shoulder blade when leaning back, or to side. pain in heart region in chest area. Relief from pain when crouching forward.

Pain in left arm from 1/5 at 8am to 1/6 at 1pm. Ibuprofen did not help and it was hard to be able to move arm or it be touched. Fever, body aches, joint pain, and chills on 1/5 for about 7 hours. Tylenol and Ibuprofen did not break fever or body aches. 1/6 no body aches, fever, chills but very slight pain in left arm.

I woke up with sever stomach pain and nausea. I could not lay down or else it would hurt worse. By the afternoon this turned into chest pain, shortness of breath, headache, sweating, back and muscle pain, and a fever of 101.4.

Side Effects included: headache, body aches (back pain), low-grade fever, chills, soreness in arm after injection and throughout the next 24-48 hours, overall fatigue/tired. Most went away after the 24 hour mark. After the 24 hour mark -- soreness in arm continued and same with the headache.

Muscle aches, headache, and chills for the first 48 hours. After 48 hours, these symptoms ended but rash appeared.

I had pain in my arm when I received the vaccine. I also had nausea, a headache, joint pain, and body aches the day after and everyday since I received the vaccine. Today I vomited twice due to the headache and nausea.

I felt feverish and had joint and body aches the day following my vaccine. I was also nauseous, had a headache, and felt fatigued. Today, 01/18/2021 I had a migraine so bad I vomited twice. I had to go home from work because I was so sick.

side effects started showing up about five hours after time of injection and some are still present currently. These side effects include injection site pain, tiredness, headache, joint pain, muscle pain, and chills. The side effects that are still present are injection site pain and joint pain.

Caller state that first vaccine 12/22 caused fever 100.0, fatigued, muscle aches, pain in arm pit on the vaccinated arm.. Caller went to doctor diagnosed with swollen lymph nodes lasting 12 days. Second Vaccine 1/12 caused high fever, headache, muscle aches and fatigue. Caller used Tylenol and went to be tested for corvid and results were negative. Caller stated that she still does have some numbness in the hand with the swollen lymph nodes. Caller completed vaers report over phone.

Chills; chest tightness; minor fatigue; joint and muscle pain throughout the body (injection site in upper left arm; shoulder; back; ankles). Injection site soreness began immediately after the vaccine, but is normal for me. Everything else began at time listed on this form (1/25/2021 afternoon) and ended by the following morning. I took one Tylenol to help with the chills and pain about 5 hours after symptoms started and it seemed to help a little.

0300: woke up with widespread body pain/joint pain (7 out of 10), nausea (lasted about 20 hours) Treatment: took Advil and Tylenol according to manufacturers directions as continuously as possible, took 1 dose anti-nausea/motion sickness at 18:30 Symptom-free starting 02/04/2021 at 0915

Symptoms started 15.5 hours after injection, I woke up with extreme joint pain and muscle aches all over my body, particularly my left arm (injection site). Every joint in my body was painful even while resting, I was extremely fatigued and could hardly move. I took Tylenol and Advil around the clock for 24 hours and it made the pain bearable, and when I woke up on 02/04/21 I was completely fine, only a slight ache in the middle of my shoulders.

Muscle aches about 17 hours after injection; injection site pain 3 hours after, fever and headache 20 hours after injection

mental fogginess; headache; body ache; 99.5 temp; swollen lymph nodes; sore jaw (from lymph nodes); swollen lymph nodes; sore jaw (from lymph nodes); swollen injection site; severe tiredness; muscle pain; muscle stiffness (neck and upper extremities); This is a spontaneous report from a contactable consumer (patient herself). A 20-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 13:45 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and glucose intolerance; both from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included metformin and etonogestrel (NEXPLANON) for birth control. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in 4 weeks. The patient had no COVID-19 prior vaccination. On 25Jan2021 at 15:30, the patient experienced mental fogginess, headache, body ache, 99.5 temperature (temp), swollen lymph nodes; sore jaw (from lymph nodes), swollen injection site, severe tiredness, muscle pain, and muscle stiffness. The patient did not receive any treatment for the adverse events (AE). The patient was not tested for COVID-19 post vaccination (pending clarification). The patient was not recovered from all the events.

I have extreme sharp pain in my spine/back and it is burning, Its sort of hard to walk it happened hours after my vaccine I have fever extreme loss of appetite dry mouth headache Pain in arm

ON 2/11/21, DEVELOPED PAIN ALL OVER THAT CAME AND WENT. FELT NAUSEOUS. BODY PAIN, JOINT PAIN, FATIGUE AND HEADACHE.

4 hours post-vaccination: pain and soreness in the arm where the injection was given; soreness got progressively worse for 24 hours and then rapidly improved 12 hours post-vaccination: malaise, nausea, stomach pain, muscle aches, chills (no fever), fatigue, headache, and light-headedness onset; symptoms persisted for 24 hours following onset and improved overnight. 24 hours post-vaccination: axillary lymphadenopathy, currently persistent Overall, adverse effects felt like flu-like symptoms or a severe hangover

barely able to stand; swollen lymph nodes; irregular heartbeat; severe upper back and neck pain; severe upper back and neck pain; She has barely been able to move for several weeks; dizzy; vertigo; headache; This is a spontaneous report from a contactable consumer, the patient's parent. A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 25Jan2021 at 10:30 AM (at the age of 20-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to eggs. Historical vaccination included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 04Jan2021 at 10:30 AM (at the age of 20-years-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered in a hospital. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The reporter explained that the patient's adverse events "started as expected" with a headache side effect (date not specified), however two days after the vaccine, while working as an EMT the patient became very dizzy and had to stop work. She remained dizzy, like vertigo, the next day but attempted to go to work. Her co-worker could see she wasn't right and took her to the hospital. The patient spent two days in the hospital, barely able to stand, getting a head MRI with contrast, evaluated for vertigo, blood tests, and they did not find anything and gave her vertigo medicine and sent her home. She has since had shifting symptoms, swollen lymph nodes, irregular heartbeat, severe upper back and neck pain. She has barely been able to move for several weeks and has seen an ENT doctor, another emergency doctor, and her regular doctor. None have found any other cause and have tried treating her with steroids. The events were treated with Meklazine and unspecified steroids. Lab data included SARS-CoV-2 test COVID 19 testing on 28Jan2021 which was negative. The clinical outcomes of headache, dizziness, vertigo, difficulty standing, swollen glands, irregular heart rate, back pain, neck pain and unable to more for several weeks were reported as not recovered. The patient was tested for COIVD-19 after the vaccination, on 28Jan2021, and was found to be negative.

Dizziness; Headache; Chills; Muscle Aches; Pain in right arm; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via an unspecified route of administration on 02Feb2021 at 12:45 PM (at the age of 20-years-old) at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Public Health Clinic/Administration facility. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. Medical history includes insomnia and migraines. Concomitant medications included eszopiclone (LUNESTA), melatonin, ibuprofen, bismuth subsalicylate (PEPTOBISMOL). On 02Feb2021 at 15:00 the patient experienced dizziness, headache, chills, muscle aches, pain in right arm. No treatment was given for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.

I got Pfizer Lot EN6200 on 02/26/2021 around 3:30 pm in my left deltoid. The 'blister' is on my right hand index finger (measured 9 mm by 7 mm at its widest points, has not changed size or character since appearing) with a fainter in color 'blister' (5 mm by 3 mm at widest) present on my right hand pinkie. No 'trauma' to the site. Nonblanching, two petechiae present within the ring finger's blister, two also present in the one on my pinky. Those petechiae have disappeared in the last two days, but the spots are still present. Red, not warm, sensitive to touch. I had no other symptoms from dose one of the vaccination, outside of a sore arm and some joint pain. Possibly fatigue, but that's likely just me being fatigued as per usual.

Patient reports to clinic with vaccine related illness. Patient received the 2nd Pfizer COVID Vaccine on 3/14/21. She reports having developed symptoms on 3/15/21 including fever, chills, headache, myalgia, chest tightness, runny nose, and productive cough. She reports coughing up purulent sputum. She reports having congestion and ear pain for 2 weeks prior to receiving vaccination, related to seasonal allergies. She denies sick contacts and has not been taking any OTC medications at this point. Vaccine Reaction Patient presents with: body aches, fever and fatigue Presenting symptoms: cough, fatigue, fever, headaches, myalgias, rhinorrhea, shortness of breath and sore throat Severity: Moderate Onset quality: Gradual Duration of current symptoms: 2 days Timing: Gradually worsening Chronicity: New Treatments tried: Rest Worsened by: Activity Response to treatment: Mild improvement Associated symptoms: arthralgias, chills and nasal congestion Associated symptoms: no abdominal pain, no chest pain, no decreased appetite, no dizziness, no ear pain, no neck stiffness and no lethargy Zika exposure risk: None Covid-19 Vaccine #1 Date: 1/21/2021 Covid-19 Vaccine #2 Date: 3/14/2021 Vaccine Manufacturer: Moderna Covid-19 Administration Site: Left Arm Patient prescribed: Bromfed, Ventolin, Flonase,Doxyxyline, and encouraged to take Tylenol and rest. She was educated on when to go to the ER if worse.

Increased pain sensativity, nausea, malaise, fatigue, exasperation of other medical conditions both physical and mental, severe muscle pain, bowl upset, loss of appetite

I had very strenuous muscle and joint pain and soreness. I was very drowsy and had a headache and I was easily physically exhausted. After the first shot, I had a golf ball sized bruise but nothing else. It was the second shot that made me feel very ill.

Sore throat, headache, dizziness, body aches, back pain, fever, fatigue. Used acetaminophen to reduce fever.

Fatigue for over two days, stiff arm for over 48 hours and a lump on neck near shoulder and lymph node swelling.

At 5 PM the day after vaccination, began to experience aches and chills which progressively worsened until around 1 AM, then subsided. Headache began around 8 PM and lasted until 6 AM; took one tablet of ibuprofen at 5 AM. Other symptoms included fast heart rate, minor pain at injection site, and head feeling ?cloudy? or ?stuffy?.

Sharp shooting pain in injection shoulder when I try to move my arm beginning a few hours after injection.

- Fatigue/Tiredness (Saturday Sunday and Monday) - Fever (Sunday) - Nausea (through sleeping into Sunday) - Headache (All day Sunday) - Extreme Muscle and Bone Pain (All day Sunday, very very mild Monday) - Injection site soreness

No reportable adverse event, administration error only. Patient likely given undiluted dose of Pfizer vaccine on 4/3/21. Investigation concluded an undiluted dose of 0.3 ml likely given unintentionally. No adverse effect reported beside expected transient mild fatigue and myalgias. Patient reported full recovery when contacted on 4/8/21.

Within the first 20 minutes her arm was heavy. By 9:30 pm extreme arm soreness, chills, swollen and burning throat. That night intense fatigue but couldn?t sleep because of nausea and vomiting. By morning a cough developed, sneezing and clogged and mucus dripping from nose. By 1:00 pm 4/17/2021 fever of 99.9. By 3:20 pm it is 101 degrees with a headache, body aches and straining eyes.

Full body aches starting the day after i received the vaccine. The next day the body soreness was severe enough to where it was painful to clench my fist or walk even a small distance. I also experienced nausea, loss of appetite, migraines and light sensitivity, and was unable to do normal tasks around the house for about 3-4 days. The full body soreness was the most debilitating symptom and certain aresa like elbows, knees, wrists and hips were painful to the touch. I think my joints were most affected. The soreness and pain can be compared to a flu but it was more intense than anything i have experienced before.

Symptoms are - sore armpits, lightheaded, tingly lips / fingers / tongue but the tingly sensation only happens when I get dizzy from being lightheaded. All happened yesterday and today (within 2 days) of the vaccine

The first and second day I had pain in the arm, muscle aches. This morning, which is the third day I had red urine.

On 04-21-2021, my muscles started to feel fatigued and I had chills. I woke up on 04/22/2021 at 5 am throwing up. I was throwing up all morning, having diarrhea, blurred vision, extreme fatigue, dizziness, shortness of breath, and tachycardia (160.)

Headache behind the eyes, sore arm, sore shoulder, back pain, stomach ache, drowsiness, bloating, nausea These side effects began around 10pm on 04/26/2021, and continued to present day

Iron deficiency; arm soreness; tingling in her toes that gradually kind of was in her legs then her arms too; weakness in her legs; altered sense of touch; Numbness of tongue; trouble moving her lips; This is a spontaneous report from a contactable consumer(patient). A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration, administered in left arm on 09Feb2021 13:00 as SINGLE DOSE for covid-19 immunization. Patient was 20 years old at the time of vaccination. Patient medical history and concomitant medications were not reported. On 12Jan2021 at 07:30PM patient received her first dose of Bnt162b2 and experienced sore arm. On an unspecified date patient stated that her arm was sore again after the second dose, then she started having tingling in her toes that gradually kind of was in her legs then her arms too. She said that she has weakness in her legs , and an altered sense of touch, when she kind of touches her skin it feels not normal, like an altered kind of touch, she says her tongue is numb, and her mouth has trouble moving. She says that when she rubs her lips together like to swish mouthwash, it is difficult. She says she saw someone yesterday, a nurse practitioner, who got labs and her blood work came back, and the nurse practitioner said she had a possible iron deficiency and recommended a supplement. The patient underwent lab tests and procedures which included blood test: unknown. Outcome of the events was unknown. Information about lot/ batch number has been requested.

she felt like she was being stung by wasps at the COVID-19 Vaccine injection site; injection site pain/ bad injection site pain; extremely swollen left axillary lymph nodes; numbness and tingling in her left elbow and left wrist, as well.; numbness and tingling in her left elbow and left wrist, as well.; fatigue; persistent diarrhea; weakness; headache; chills; muscle aches; injection site pain was a burning sensation; it inhibited her left arm movement; left axillary lymph nodes painful; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) via unspecified route of administration in left upper arm on 18jan2021 09:20 at single dose for covid-19 immunization. Medical history includes recurring history of croup since she was young with her last croup diagnosis during Christmas of 2018. Concomitant medication reported as COLECALCIFEROL (NATURE MADE VITAMIN D3 2000iu, UPC Number: 3160403183, Lot Number: 2404901 and Expiration Date: Oct2023) continued taking both the first and second Covid-19 vaccine dose. After second vaccine she only took 2 ibuprofen 200mg tablets on first day. The patient historical vaccines included: flu vaccine in mid-Nov2020 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730, Expiration Date: Unknown) via intramuscular route of administration in left upper arm on 28Dec2020 09:20 at single dose for covid-19 immunization. The patient had Injection site pain, Flu-like symptoms (clarified as flu minus vomiting), Headache, GI symptoms, Weakness, Fever, Muscle fatigue and leg shakiness with the first dose. There were no other vaccines administered within four weeks. On 18Jan2021 she experienced more interesting side effects. She had injection site pain the afternoon of 18Jan2021 by 20:00 that night (18Jan2021), she had laid down in bed, and she felt like she was being stung by wasps at the COVID-19 Vaccine injection site. The injection site pain was not bad but the pain was constant and by the second day the injection site pain had faded. The bad injection site pain clarifying the injection site pain was a burning sensation. She said if she puts her hand on the vaccine injection site now, she can still feel a burning sensation. She said there is not swelling or redness at the vaccine injection site. She said she developed extremely swollen left axillary lymph nodes after her second COVID-19 Vaccine dose. She said the left axillary lymph node swelling was so extreme it inhibited her left arm movement. She said she developed numbness and tingling in her left elbow and left wrist as well. She said the left axillary lymph node swelling has gone down, so the swollen lymph nodes are not impeding her left arm movement now. She said the left axillary lymph node remains swollen enough that her bra hits the swollen lymph node, making the left axillary lymph nodes painful. She said the numbness and tingling in her left elbow and left wrist is less frequent, but not gone. She said her side effects after the second COVID-19 Vaccine didn't improve for probably 4-5 days after they developed. She said the left axillary lymph node swelling has improved marginally, and the vaccine injection site burning sensation is less, but the left elbow and left wrist numbness and tingling is persistent. On 23Jan2021 or 24Jan2021 she developed fatigue, persistent diarrhea, weakness, headache, and very mild chills and muscle aches. She said she had no fever. Her symptoms lasted 2 days and then completely resolved on Jan2021. She said her left elbow and left wrist numbness and tingling is persisting. She said the vaccine injection site still hurts (burning sensation), and her left axillary lymph nodes are still swollen. She said the burning sensation at the vaccine injection site has her concerned. She feels an increase in the burning sensation if she touches the vaccine injection site. The clinical outcome of the event vaccination site pain, swollen lymph node, numbness, tingling, Limb discomfort reported was recovering, outcome of the event burning sensation was not recovered, outcome of event Feeling abnormal and Lymph node pain was unknown and for other events it was recovered on Jan2021. Follow-up attempts are completed. No further information is expected.

Flu-like symptoms; Headache; Weakness; Fever; Muscle fatigue; leg shakiness; GI symptoms; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EK5730 and expiry date unknown), intramuscularly in left upper arm on 28Dec2020 at 09:20 as a single dose for COVID-19 immunisation. Medical history included a recurring history of croup since she was very young, with her last croup diagnosis during christmas of 2018. Concomitant medications included Vitamin D (Nature Made Vitamin D 2000iu, Formulation: soft gel, Lot Number: 2404901, and Expiration Date: Oct2023) 2 doses daily. The patient did not receive any other vaccines within four weeks prior to the vaccination and no vaccines were administered on the same day of vaccination. The patient received flu vaccine in mid-Nov2020. On 28Dec2020, the patient experienced Injection site pain and on 30Dec2020, flu-like symptoms felt like the flu minus vomiting, headache, GI symptoms, weakness, fever, muscle fatigue, leg shakiness. Reported she had an issue after she received her first dose of the COVID-19 Vaccine. She said she had immediate injection site pain. She said the injection site pain was not bad, but the pain was constant, and by the second day the injection site pain had faded. Reported 2 days after receiving her first COVID-19 Vaccine dose she developed flu-like symptoms. She said she had weakness that lasted 3 days. She said she also had a headache, GI symptoms. She clarified her flu-like symptoms felt like the flu minus vomiting. She said she had a fever, muscle fatigue, and leg shakiness, as well, before she moved into the recovery period on 01Jan2021. She said by 02Jan2021 or 03Jan2021, she had recovered completely, and she had no more symptoms, or fatigue, or weakness. The events did not result in emergency room or physician office. No investigations were done. Therapeutic measures were taken with 2 Ibuprofen 200mg tablets, twice a day, for 2 days and had continued as normal taking Vitamin D (Nature Made Vitamin D 2000iu, Lot Number: 2404901, Expiration Date: Oct2023). Outcome of Injection site pain was reported as resolved on 30Dec2020, and all other events were reported as resolved on an unspecified date in Jan2021. Follow-up attempts are completed. No further information is expected. .

Achy feeling like I have a fever started in the middle of the night the night I got the shot, and continued into the next morning. A bit of joint achy-ness.

Headaches for at least 48 hours following, back pain, muscle pain, joint pain, extreme fatigue, nausea

Headache, muscle aches, rise in temperature (not fever) for a little of 12 hours, treated with ibuprofen, cold compresses, and limited mobility through the day.

Sneezing, constant runny nose, achy bones/joints, sore throat, headache, fatigue, insomnia, discomfort/nausea; lasted 24 hours, with only a few lasting effects the next day but nothing severe. Tylenol/general antihistamines, rest, and hydration helped to relieve symptoms

All after second injection: Fever of 100.8. Went down to 99.8 after 4 hours. Took Tylenol to help. Headache 3 hours after second dose, has not gone away. Pain at the injection site, 2 hours after, has not gone away. Chills that started 12 hours after injection. Loss of appetite after 20 hours of injection. Back pain/body aches 8 hours after injection. Some dizziness on and off starting 20 hours after injection. Feeling weak 20 hours after injection.

By 8 pm, I was feeling a headache and my hands were aching. By 9 pm all my joints were aching. At 11:30 pm, I had the chills and a fever. At 3:00 am I had an extreme headache. At 7:30 am, the headache became less intense. I still had body aches and I felt tired throughout the rest of the day.

Fever up to 101.4 for 24 hours, body aches/muscle fatigue, sore throat and loss of voice, headache, chills. 30 hours later still no voice but other symptoms have resolved. Took Tylenol to bring down fever

diarrhea; Vomiting; sore throat; sore shoulder; sore neck; blood in her diarrhea; feeling icky; This is a spontaneous report from a contactable consumer (patient's mother). A 20-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8735), administered in left arm, on 28Apr2021 at 13:00 (at the age of 20-years-old) at 1st dose, single for COVID-19 immunisation. Medical history included bipolar disorder, bipolar depression, anxiety and depression. Family medical history relevant to the adverse events was reported as none. Concomitant medications included ongoing citalopram (provided as CELEXA, clarified that she took the generic citalopram) taken from an unspecified date (has been taking for about 4 years, as reported) at 40mg orally daily for anxiety and depression, ongoing lamotrigine (provided as LAMICTAL, clarified that she took the generic lamotrigine) taken orally from an unspecified date (had been taking for 2-3 years, as reported) at 150mg twice daily for bipolar disorder, ongoing lithium taken orally at 300mg twice daily for bipolar depression. No prior vaccinations (within 4 weeks) were received, no history of all previous immunization with the Pfizer vaccine was considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. The patient experienced blood in diarrhea and sore neck on 30Apr2021, diarrhea, vomiting, sore throat, sore shoulder on 30Apr2021 at 01:00, feeling icky on 29Apr2021 at 18:00. The events did not require emergency room and/or physician office visit. The reporter stated that the patient was fine until 29Apr2021 around 6 pm when she started feeling icky. She woke up at 1 am with diarrhea and vomiting, sore throat and sore shoulder. The patient was having blood in her diarrhea. The last time she threw up was around 7:30. Her daughter developed a sore throat and sore shoulder late last night of the reporting day or early the morning of the reporting day. Reporter added that her daughter also had a sore neck that started late last night of the reporting day or early the morning of the reporting day. No relevant tests were performed. The patient had not recovered from diarrhea, sore throat, sore shoulder and sore neck, had recovered from vomiting on 30Apr2021 at 07:30, the outcome of the other events was unknown.

Patient called having severe muscle pain describing it as feeling like all muscles in body spasming. Said due to spasms it felt difficult to breathe. Patient was advised to get checked out at hospital.

Extreme sharp pain on right side of back when breathing - on 4/14/21 Went to primary care physician on 4/15/21 He had blood work and x-rays done - d-dimer came back 4 Admitted to ER In ER CT done - found pulmonary emboli (severe on the side where the pain was) Admitted to ICU that night (4/15/21) Stayed in ICU for 3 days Moved to floor Discharged from hospital on 4/19/21 Still dealing with extreme fatigue (unknown cause) still on blood thinners - 5/25/21

sharp pain; felt like it was stretched tight or stiff muscle; felt like it was stretched tight or stiff muscle; usual arm pain at injection site; Headache; Chills; Fatigue; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (Patient) reported that a 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/ Lot number and expiration date: Not reported) via intramuscular route of administration in left arm on 23Apr2021 15:25 at single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, chromosomal abnormalities, endocrine abnormalities, genetic / (including diabetes) and obesity. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Solution for injection, Batch/Lot: ED8734) intramuscular (at the age of 20 years) in left arm on 02Apr2021 at 16:30 for covid-19 immunisation and experienced Pain at left arm injection site. The patient experienced the "usual arm pain at injection site which started on 24APR2021 and went away a few days later. On 07MAY2021 having a new pain, that has been persisting since then, it is a sharp pain. On 24Apr2021, the patient experienced headache at 04:00, chills and fatigue at 01:00 or 02:00, Pain in left arm at injection site at 04:00. The patient later stated pain starting at 04:00 pretty similar to normal pain after injection of second dose which was dull and sore and hurt to lift arm. It was the same as the first shot. It cleared up within 3 days. The patient did not notice anything else. Friday, 07May2021, the patient noticed that left arm felt like it was stretched tight or stiff muscle. If patient lifted her arm up in a certain way, very sharp pain near injection site. That has persisted. It did totally go away and restarted as a different type of pain 2 weeks after. After received second vaccine and pain in the injection site. Had sharp sensation near injection site when raising arm. The outcome of usual arm pain at injection site was recovered on 07May2021; sharp pain, headache, chills and fatigue was recovering and felt like it was stretched tight or stiff muscle was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Dizziness, nausea, muscle and joint pain, fever, chills, headache, fatigue Treated at home with Epsom salt bath and rest.

After receiving my first dose of the Pfizer vaccine I got arm pain, headache, armpit pain and fatigue. Eight days later I developed 2 small lymph nodes; one behind my left ear and one on the back of my head.

Was awoken early ~ 16 hours after shot with severe nausea, back pain, hot and and cold chills. Initially also only able to breathe shallowly, (has since resolved). Unusual sensation in bladder/ genital area. Repeated urge to urinate but unable to, also felt painfully swollen/ engorged in genital area, but no actual redness or swelling. Symptoms are still ongoing at about the same level 48 hours after the shot. Still disinterested in food and feels dehydrated despite trying to ingest fluids.

Site: Pain at Injection Site-Severe, Systemic: pain radiating from shoulder-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)

Slight arm pain following vaccine same day but next day I had high fever, chills, fatigue, nausea, muscle pains, and a migraine that debilitated me completely.

Back pain; Fever of 99.2; Aches all over; Fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER1741) via an unspecified route of administration in the left arm on 17Mar2021 at 18:15 hours (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypertension, chronic migraines, depression anxiety disorder and allergy to penicillin and lisinopril. Concomitant medications included norgestimate (MANUFACTURER UNKNOWN) and TRI-SPRINTEC, NORVASC and EFFEEXOR for unknown indication from an unknown date. On 17Mar2021, the patient had blood temperature test results given as 99.2 (units unspecified). On 17Mar2021 at 19:00 hours, the patient experienced back pain, fever of 99.2 (unit and reference range was not provided), aches all over and fatigue. The patient did not receive treatment for the events. The clinical outcome of the events back pain, fever of 99.2, aches all over and fatigue was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Patient states that she started to have shoulder pain the next day and later noticed some weakness. Has had continued pain over her deltoid since especially by the end of the day and with repeated use of arm but has improved to at least 75%. Weakness has resolved.

I was vaccinated on Tuesday, felt normal reaction. Woke up Saturday morning with excruciating pain from my right armpit to the bottom of my rib cage. Pain was worse every time I inhaled. My breast on the right side swelled up and became red splotchy and hot. Had fever symptoms for 2 to 3 days afterwards. The excruciating pain in my chest and rib cage subsided within 6 to 8 hours. However the swelling in my right breast and redness did not subside for about three days.

While patient was waiting in the waiting area after the vaccine, patient started to experience breathing issue, along with neck congestion and tingling in the mouth. Called 911. After 15 min of evaluation still didn't get better, so started IV diphenhydramine and Epi-pen and then take her to ER for further observation.

Vaccine administration error- patient was given an entire vial of Pfizer covid 19 vaccine that was not reconstituted. Patient reports that she had a really sore and stiff arm the day after the shot, but by the next day it felt better.

She read in the Fact sheet that this could be a severe allergic reaction; shivering; temp was up; pale; dizzy; elevated heart rate; weakness; muscle ache pains; Woke up in the middle of the night; This is a spontaneous report from a contactable consumer. This 20-year-old female consumer (patient). A 20-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 08Jun2021 (at the age of 20-yearsr-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date on Jun2021, the patient experienced woke up in the middle of the night with shivering, temp was up, was pale, dizzy, elevated heart rate, weakness, muscle ache pains trying to calm down, but trying to get to relax from shaking/shivering. She read in the Fact sheet that this could be a sever allergic reaction and was wondering if she should received the second dose of the vaccine. As noted in the Fact Sheet for Recipients, should not get the Pfizer-BioNTech COVID-19 Vaccine if the patient had a severe allergic reaction after a previous dose of the vaccine or if had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the events were unknown. Information regarding Lot/Batch number has been requested

Mild soreness on lower back the day after, missed period of 26 days on otherwise regular cycle patient, still no Menstruation at the time of completing this form.

Extremely bad headache, body chills, very painful muscle aches, congested nose, frequent urination. Symptoms lasted for 24 hours.

pt fainted, presented nystagmus of eyes, and muscular rigidity of arms and hands for less than 30 seconds following administration of vaccine.

Sharp pain in left ribs/under armpit; Sharp pain in left ribs/under armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 20-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 17Mar2021 at 13:15 (at the age of 20-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 14:30, the patient experienced sharp pain in left ribs and under armpit, located under same arm where shot was given. The events resulted in emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events rib pain and armpit pain was recovered with sequelae at the time of this report. No follow-up attempts are possible. Information about lot number cannot be obtained.

Patient experienced rigid fingers, nausea, fever, and stuffy ears about 8 minutes after the vaccine was administered. Patient was given a cold water bottle, an ice pack to place on her forehead, and bucket in case she needed to vomit. EMS was called right away. They arrived and checked her out. She was not transported to the hospital. She waited approximately for 30 more minutes and then felt well and left.

8 Days following first Phizer Covid 19 shot, experienced a sharp pain in center of chest lasting about 30 seconds to 1 minute. There after, chest pressure, and chest tightness continued for about 3 weeks. At times felt pain pressure in back region also. Pain level went up and down from 2 to a 4 or 5 on a scale of 10.

The day I got the vaccine, I started getting severe diarrhea and it lasted for 4 days. I then got severe upper abdominal pain for 2 days where I could not stand up straight. My lower abdomen is now swollen and painful and my entire stomach aches every time I eat. I also had 101°F fever for 2 days following vaccination. I have lost 5 pounds since I got the vaccine.

Bodyaches , painfull joints ( more the knees), Fever(102 farenh) and chills the first day followed by swollen lymph nodes on both sides of my neck, super swollen tonsils , which were red with white patches. Then there was a sharp pain on my chest that ran down my left arm but lasted less then a minute.

body/joint pain.; Roughly 24 hours after injection, dark bruising and a line of several yellow blisters grew vertically around injection site. Blisters continued to get bigger, filled with blood, and began to itch.; a line of several yellow blisters grew vertically around injection site. Blisters continued to get bigger, filled with blood, and began to itch; Blisters continued to get bigger, filled with blood,; Blisters continued to get bigger, filled with blood, and began to itch.; Some sites began to drain.; experienced fever; experienced fever, fatigue, and body/joint pain.; experienced fever, fatigue, and body/joint pain.; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0181), second dose via an unspecified route of administration on left arm on 18Jun2021, 16:00 at single dose for covid-19 immunisation. Patient medical history included allergies to Penicillin, Reglan, Iodine, Sulfa, Gastroparesis, PCOS, Insulin resistance. Concomitant medications included medroxyprogesterone acetate (DEPO-PROVERA) on 03Jun2021 on Left arm, levothyroxine sodium (TIROSINT) 150mcg, topiramate (TOPAMAX) 100mg, Metformin 500mg. She received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EW0173) via an unspecified route of administration on left arm on 26May2021, 16:00 at single dose for covid-19 immunisation. She was not pregnant at time of vaccination. Prior to vaccination patient was diagnosed with Covid 19. Since the vaccination patient was not tested for Covid 19. Patient reported roughly 24 hours after injection, dark bruising and a line of several yellow blisters grew vertically around injection site. Blisters continued to get bigger, filled with blood, and began to itch. Some sites began to drain. Also experienced fever, fatigue, and body/joint pain on 19Jun2021. Treatment received for the adverse event was prescribed Pepcid, Allegra & hydrocortisone cream. Averse events resulted in Emergency room/department or urgent care. The outcome of Events was recovering. Information on Lot/Batch number was available. Additional information has been requested.

had a short pain in my armpit in the one that, in the arm that I got the vaccine; mild Headache; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on 29May2021 (at the age of 20-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anaemia (low iron). Concomitant medication(s) included ferrous sulphate taken for an unspecified indication, start and stop date were not reported. The patient that after the 1st dose, I had short pain in my armpit in the arm that I got my shot in, this is the few days after and then I had mild headache after that too on an unspecified date of 2021. Reporter seriousness for both events was unspecified. The patient underwent lab tests and procedures which included blood iron: unknown results, blood test: unknown, lipids: unknown results, metabolic function test: unknown results on an unspecified date. The outcome of the events was unknown. Information about lot/batch number is requested.

Patient received a COVID vaccine. A couple minutes after administration. Patient stated that she was feeling faint and dizzy. Patient mentioned that she was having blurred vision. Pharmacist provided a cool compress to the patient's head, neck, and wrists. Patient was also provided water. Patient's blood pressure was taken several times which read extremely low (90s/ 50s). Patient mentioned that her hands were going numb and stiff. EMS was called for patient for assessment. Patient was observed by EMS in which it was concluded that patient experienced what appeared to be a panic / anxiety attack. Patient believed that the vaccine was giving the patient covid. Once the EMS told her otherwise, patient was able to calm down. After about 25-30 minutes after the vaccine, patient felt better and left with her mother.

had a short pain in my armpit in the one that, in the arm that I got the vaccine; Headache/head would hurt to; my body would get really hot and really cold at the same time and then my whole body aches; my ear would hurt too; Chills; my body would get really hot and really cold at the same time and then my whole body aches; my nose would bleed from my right nostrils for about a week and then head would hurt to and my ear would hurt too; This is a spontaneous report from a contactable female consumer or other non hcp (patient). A 20-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0181), via an unspecified route of administration, administered in arm left on 19Jun2021 (at the age of 20-year-old) as dose 2, single for COVID-19 immunization. Medical history included anaemia (patient stated, I am anemic. You can probably say low iron (later confirmed as anemic). The patient concomitant medication included ferrous sulphate (FERROUS SULFATE) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in arm left on 29May2021 as dose 1, single for COVID-19 immunization and experienced I had short pain in my armpit in the arm, I had mild headache. The patient experienced had a short pain in my armpit in the one that, in the arm that I got the vaccine, headache/head would hurt to, my body would get really hot and really cold at the same time and then my whole body aches, my ear would hurt too, chills, my nose would bleed from my right nostrils for about a week and then head would hurt to and my ear would hurt too, all on an unspecified date in Jun2021. Adverse events: patient stated, Okay, after the 1st dose, I had short pain in my armpit in the arm that I got my shot in, this is the few days after and then I had mild headache after that too. Then after the 2nd dose I had short pain the next day in my armpit again and then I had really bad headache and I have aches and chills like all over my body, my body would get really hot and really cold at the same time and then my whole body aches. Patient stated, Yes, I felt a little bit better after that the 2nd shot but about a week later I started to get a nose bleed for a week. So, every like morning my nose would bleed from my right nostrils for about a week and then head would hurt to and my ear would hurt too. Patient stated, I still have headache and I never had headache or nose bleed before. Date of vaccination: Patient stated, On the first dose it was June on a day like 4, this is actually the 1st dose. I had a short pain in my armpit in the one that, in the arm that I got the vaccine impetrated. When confirmed the date, patient stated, No, the 1st one dose on the 5th of 29th, I mean May, 29th. 2nd dose that was on June 19th. The patient underwent lab tests and procedures which included general blood test showed it was like a iron, lipid, comprehensive metallic, metabolic. Outcome of the event headache/head would hurt to was not recovered and rest of the events was unknown. Follow up attempts are needed. Further information is expected.

Arm soreness; stuffy nose/congestion; tired; knee pain; This is a spontaneous report from a contactable nurse (patient). A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on the left arm on 29Dec2020 12:30 at single dose for covid-19 immunisation. Medical history included tree fruit allergy. Concomitant medication included paracetamol (TYLENOL) and ibuprofen (ADVIL). The patient previously took cefaclor (CECLOR) and experienced drug allergy. The patient experienced arm soreness, stuffy nose/congestion, tired and knee pain on 29Dec2020 17:30. The patient did not receive treatment for the reported events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: pending on 29Dec2020. Outcome of events was recovering. Information on the lot/batch number has been requested.

tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctuating fever; nausea; weakness; weakness/extreme fatigue; loss of taste and smell; loss of taste and smell; muscle pain; cough; sore throat; nasal drip; dizziness; fast heartbeat; injection site pain; anxiety; crying; This is a spontaneous report from a contactable healthcare professional. This 21-year-old female patient reported for herself that she received BNT162B2 1st dose on 31Dec2020 10:00 AM intramuscular at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin and Covid-19. Concomitant therapy included BC as reported. The patient experienced difficulty breathing, chills, fluctuating fever, nausea, dizziness, weakness, fast heartbeat, tiredness, loss of taste and smell, muscle pain, injection site pain, anxiety, cough, sore throat, nasal drip, crying, extreme fatigue, Etc on 31Dec2020 at 06:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency. The patient was hospitalized for 1 day and received treatment included blood thinner rivaroxaban (XARELTO) and had 2 weeks quarantine. The patient had Covid prior to vaccination and tested positive for Covid test post vaccination on 01Jan2021. The outcome of the events was not resolved. Information on Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, SARS-CoV-2 test positive and the other reported events due to temporal relationship. Of note, it is reported that the patient had history of COVID 19 infection prior to the vaccination. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Pfizer BioNTech COVID 19 Vaccine EUA Afternoon 1/6/21 temp was 101.6 mild HA feeling flushed and hot, 1/7/21 temp 99.4 moderate HA, chills and muscle aches

Ran low grade fever reaching only 100.7, muscle aches, bad headache, nausea all after second dose, started around 12?14 hours after injection, lasted for 16 hours before fever broke

5 days after administration- heavy uterine bleeding; constipation; severe knee/shoulder joint pain; light sensitivity; dizziness/ light headedness; thigh numbness; pain when prodded on either sides of thighs; harsh headache; This is a spontaneous report from a contactable Other healthcare professional (patient). A 21-year-old female patient received BNT162B2 first dose on 31Dec2020 03:15 PM intramuscularly on left arm at single dose for COVID-19 immunization. Medical history included Depression, Anxiety, Factor V Leiden, Known allergies to Penicillin and Onion sensitivity. Patient is not pregnant. No other vaccine in four weeks. Concomitant medications in two weeks included unspecified medications. "5 days after administration" (also reported as 01Jan2021)- heavy uterine bleeding (resulting with trip to ER), constipation, severe knee/ shoulder joint pain, light sensitivity, dizziness/ light headedness, thigh numbness, pain when prodded on either sides of thighs, harsh headache. No treatment received for the events. Events resulted in ER and physician office visit. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was not recovered. The seriousness was reported as no. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported uterine bleeding 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.

"I had arm and armpit soreness that evening and still am experiencing some today along with lymph node swelling on the same side where the shot was administered. The night of the 9th I experienced dizziness, chills, and nausea. I woke up with a 102 fever on Sunday which continued into Monday morning. I also had a headache all day Sunday the 10th and was very fatigued."

Soreness at location of injection, during both vaccines on 12/22 and 01/11. Rash located on both arms, chest and back, rash occurred 01/10 and is ongoing as of 1/13/21. Swelling of face, hands, arms and ankles. Ongoing. Doctor advised these may be delayed reactions from the initial dose on 12/22.

Spiked a fever of 101.1, aches, muscle fatigue, general fatigue, nausea, abdominal pain, joint pain, loss of concentration, chills, dizziness. Symptoms came on very suddenly

mouth sores; Nausea; vomiting; stomach cramps; sweats; joint pain; elevated heart rate; This is a spontaneous report from a contactable other HCP (Patient). A 21-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot #EL0140, via an unspecified route of administration on 29Dec2020 12:00 at single dose at Left arm for COVID-19 immunisation. Medical history included Behcets, dysautonomia, Irritable bowel syndrome (IBS), and COVID-19. The patient's concomitant medications included unspecified products within two weeks of vaccination. The patient previously took amoxicillin, MELOXICAM (MOBIC) minocycline and all experienced drug hypersensitivity. On 30Dec2020 12:00 the patient experienced mouth sores, nausea, vomiting, stomach cramps, sweats, joint pain and elevated heart rate. There was no other vaccine in four weeks. The patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The reporter considered all the events are non-serious and stated no treatment was received. The events outcome was not resolved.

Systemic: Chills-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Joint Pain-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Seizure-Mild, Systemic: hand spasms-Mild; symptoms lasted 1 day

Systemic: Chills-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Joint Pain-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Seizure-Mild, Systemic: hand spasms-Mild; symptoms lasted 1 days

Headache Sore arm Sore armpit Chills Body aches Nausea Vomiting Duration 5 hours. Zofran and Advil/tylenol were taken.

Headache; body aches; joint pain; chills; fever; general malaise; dental pain; soreness at injection site; pain; Loose stools; Stomach upset; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 07Jan2021; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 07Jan2021; This is a spontaneous report from a contactable Other healthcare professional (patient). A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0140), via an unspecified route of administration on left arm at 09:45 AM on 07Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) and Women's Daily Multivitamin, Hair Vits. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0140), on right arm at 11:30 AM on 21Dec2020 for COVID-19 immunization and experienced only mild discomfort. The patient experienced headache, body aches, joint pain, chills, fever, general malaise, dental pain, pain and soreness at injection site, loose stools, and stomach upset at 21:30 on 07Jan2021. The events were reported as non-serious. The patient did not receive any treatment for events. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the had not patient been tested for COVID-19.

10 hours after second dose: headache, chills, body aches, and muscle soreness. 20 hours after second dose: all previous symptoms, in addition to low-grade fever, nausea, and vomiting.

On 1/16/21 at approximately 8PM started to experience left axilla discomfort. Initially she thought she may have a muscle strain. On 1/17/21 reports she continued to have left axilla pain and the pain was worse. On 1/18 & 1/19 she continued to experience pain in the left axilla and now in the left arm. The injection site was normal. On 1/20 the pain continued (able to work) and now she had redness and swelling at the injection site. The perimeter of the injection site had plum size redness with some mild to moderate swelling and warm to touch. I instructed to call her PCP that she may be experiencing a localized rxn., to the COVID vaccine. has no other sx. notified her PCP and has a 3pm, scheduled ZOOM call today.

1st covid shot. 12 hours after, developed pain at injection site and muscle pain all over body. 24 hours after, developed severe headache and fatigue

Fever greater than 100°F, extreme chills, cold extremities, muscle aches, hard breathing, and difficulty sleeping. I took 2 tablets of Acetaminophen 650mg when started to fever around 10pm, drank lots of warm uncaffeinated tea, and slept on a heated bed. Slight fever of about 99°F and muscle ache the day after, took another 2 tablets of 650mg acetaminophen at 10am.

Neck pain almost immediately after injection. Headache followed about 4 hours later. Continued to get worse. Very irritable and tired around 3 hours after injection. Advil did not help headache, only sleep did. Feeling much better now (~21 hrs post injection.)

Nausea, insomnia, abdominal pain, fatigue/exhaustion, fever, chills, overheating, dry eyes, muscle aches and joint pain (more/different than usual related to health condition)

After receiving the second dosage of my COVID vaccine at 2 PM on 02/03/21, I only had left arm pain near the site of the injection. However, I went to sleep and at 2 AM on 02/04/20, I started having fever, a severe HA, and myalgia that hindered my sleep. I took 500 mg Tylenol at 6 AM and went back to sleep. When I woke up at 8:30 AM, I went to use the restroom and felt dizzy with hot flashes. Immediately afterwards, I noticed that I had fainted and my mother helped me to my bed. After drinking soup and juice and having a bowel movement, I felt normal and alerted my PCP.

Sore muscles, chills, freezing cold, hard time walking, headache, light headed, nauseous, pins and needles feeling in legs, sore in injection site, bruising in injection site, pain that caused crying

moderate swelling for 36 hours, nausea for 12 hours, fatigue for 12 hours-moderate, muscle and body aches for 12 hours -moderate, fever for 12 hours, chills for 12 hours-mild, headache and diarrhea for 12 hours-moderate

Nausea and body aches 24hours after second vaccine dose. Bruising and mild pain at vaccine site. Very swollen lymph nodes on right clavicle and Supra clavicular fossa beginning at 48 hours. Joint pain in right clavicle, shoulder, and upper hip after 72 hours.

My first dose of the vaccine was on 1/14/2021. I had a mild headache and experienced dizziness and nausea the night of receiving the vaccine. My second dose of the vaccine was 2/8/2021. I felt tired the night of receiving the vaccine and went to bed a 8pm. I woke up at 6:10am on the 9th with a severe migraine, severe nausea and dizziness. I ate a small amount and laid back down. I got out of bed at 9am and noticed both of my eyes and face were swollen and my throat was swollen. At this point I called my doctor and spoke to a nurse on the phone, she was short saying I needed to go to ER. Personally, I did not feel it was necessary at the time so I took a Benadryl and Ibuprofen. Throughout the day I continually got worse experiencing the same symptoms as the morning including sharp chest pain, restricted breathing, a low grade fever of 100.4, severe lower back pain and leg numbness. I took more ibuprofen and placed heat on my back. I took ibuprofen PM and woke up the morning of the 10th feeling better. Still have headache, lower back pain and swelling but is better than yesterday. I will notify my doctor today of the event that occurred yesterday (2/9/2021).

Woke up at 5 am to a migraine and a fever of 102.1. I was sweating. I had muscle aches. When I woke up later my fever and migraine was still there. The rest of the day I was fatigued and nauseous.

Muscle aches; joints ache; slight head ache; This is a spontaneous report from a contactable consumer. A 21-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 25Jan2021 at 13:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN), montelukast (MANUFACTURER UNKNOWN), and omeprazole (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) from unknown dates for an unknown indication and experienced drug allergy. On 25Jan2021 at 19:00, the patient experienced muscle aches, joints ache, and slight headache (reported as in the morning). The patient did not receive any treatment for the events. The clinical outcomes of muscle aches, joints ache, and slight headache were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Fever that lasted for about 15 hours, headache, fatigue that lasted for about 24 hours, chills that lasted for about 10 hours, muscle pain that lasted for about 20 hours, pain at injection site.

The morning after my second dose of Pfizer?s Covid-19 vaccine, I woke up feeling freezing (at 9:00 am) and suspected I had a fever. After waking up again later (around 12:30 pm), I took my temperature and found that I have a fever of 101°F. I still have a fever and chills (2:50 pm). I have not taken any medication to treat the fever yet and plan to just take it easy. If I begin to feel worse, I might take an ibuprofen. After getting the vaccine, my left shoulder was sore, and is still sore, but it?s my understanding that this is normal, and just as my arm was sore with the first vaccine, it may be 2 days before my arm feels better. I am not concerned about the soreness of my arm.

Pain at injection site began 1-2 hours after and lasted 1 week, tearing axillary pain on same side as injection began next day and lasted 1 week, chills and body aches began next day and lasted ~12 hours.

Severe headache; Nausea; Myalgia; sore/itchy throat; Sore/itchy throat; Fever and chills within 3-4 post vaccination; Fever and chills within 3-4 post vaccination; This is a spontaneous report from a contactable healthcare professional who reported for herself, a 21-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), intramuscular in the right arm, on 30Jan2021 at 18:30, at the age of 21 years, at a single dose for COVID-19 immunization. Medical history included asthma, and known allergies to azithromycin (ZITHROMAX) and sulfa. The patient was not pregnant, and not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. On 30Jan2021 at 21:30, the patient experienced fever and chills within 3-4 post vaccination. The patient experienced severe headache, nausea, myalgia, and sore/itchy throat the next day, on 31Jan2021. No treatment was received for the events. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

chills, nausea, fatigue, muscle soreness, headache, vomiting; patient reported she is feeling way better and all the symptoms are gone except she still feels a little of muscle sore, and nausea

headache, N/V ongoing, soreness, feeling weak Adv pt to gently try to rehydrate with small sips of fluid or ice chips/pedialyte popsicles. If vomiting is persistent, symptoms of dehydration, or generally feeling unwell enough where home care is insufficient adv ed evaluation.

I got the shot around 5:20. About 4 hours later I started to feel nauseous and ran to the bathroom and vomited. About an hour after that I had diarrhea. I went to bed, couldn?t fall asleep until 3. I woke up at 6 am sweating a lot and having body aches that were very persistent and painful in my legs. This persisted to 3/12/2021 until about 6 or 7 pm and I began to feel a lot better. That entire day I was hot and cold and had body aches. But no longer had vomiting. Then on Saturday, 3/13/2021 I woke up with a sore left armpit and neck but the armpit was way worse. I looked it up ?sore left armpit after covid vaccine? and it said swollen lymph nodes - so I?m guessing that?s what both pains were as my roommate who had the second dosage of Pfizer vaccine the week before had a protruding lymph node on her neck. They both are still in pain until today 3/15/2021.

Immediately, I had increased heart rate - 194 - I fainted to the ground. I became nauseous, sick and had seizure like episode and then I had tingling sensation in my face and limbs. They gave me shot epi-pen - two doses. I was pretty much paralyzed for hands and legs. I was brought to hospital and they treated me there for about a week and I had muscle weakness. I gained feeling back in my hands but not in my feet. I was at Haywood for a week. Outpatient therapy and a visiting nurse for three weeks. B12; Iron; Gabapentin and that was for anxiety through it all. Test results came up as neuropathy on left side of my body. I have pins and needles pain now. I did gain my walking back. I take Gabapentin for neuropathy pain. I went to hospital - went one day and I didn't get anything back from them. I now use handicap parking for disability.

Had really bad neck pain following shot. Was awoken in middle of the night with ?brain on fire? feeling that lasted about 10 minutes and then went away.

I received my shot at 11:47 and started to lose sensation in my hands in the waiting area. After about 25 minutes I felt dizzy and was about to stand up but my muscles started shaking. My heart rate was checked and found to be 140. This lasted for about another 30 minutes. My heart rate went down and I was taken to a private area and checked out by EMS they gave me water and concluded it was some sort of panic attack. However, these are the same symptoms I have whenever I am allergic to a medication, NSAIDS, dicyclomine, etc. It always starts with ascending numbness from my fingers to the rest of my body. Then I start to shake and my heart rate goes way up. Usually I start to cough then vomit and my airway closes. Thankfully this time we were able to slow the process and I never experienced some of the last symptoms.

Nerve pain throughout the entire body lasting approximately 18 hours. Felt like ants crawling through all my muscles. Not exactly painful, but aching and deeply affecting. Almost itchy like all my muscles needed to stretch but they were also exhausted. All nerves in my body were highly activated, including my taste buds. Could not taste because I could taste everything and the food ended up feeling like individual particles rather than a cohesive flavor. Some nasal congestion. Overall, felt like being sick, but worse. Exhaustion Soreness in left arm

Sore arm at injection spot that started at 3:00pm on 3/25/2021 and I took Tylenol. Fatigue started at 4:00pm on 3/25/2021. Developed slight cough at 9:00pm. I took Benadryl to help sleep through the night in case of any other side effects. Cough went away overnight, but my arm remained sore. I took Tylenol again on 3/26/2021 at 6:30am. At 7:00pm the same day, my left armpit began to feel sore which could not have been caused by anything other than vaccine as I haven?t been doing any physical activity. This worsened the next day, but I have not taken any Tylenol to alleviate it at this point.

Our daughter began having bone pain around 9 p.m. She threw up approx 11 p.m. Through the night, she began to develop a fever 101.9. Around 5 p.m she said something was wrong over and over. We got ready to go to ER. She wanted to go to bathroom and throw up. When she did, she had a grand mal seizure. My husband had to begin CPR. Fire Rescue team arrived and transported to ER. She was treated and released. Follow up with cardiologist, primary care, and neurologist.

Patient states she noticed a pain while throwing a rock in her shoulder, the same side as her 1st COVID vaccine, about a week before her 2nd dose. Reports she has full ROM without pain pain now and has not had pain since she threw the rock. She did not seek medical care and denies any other s/s.

Hospitalization with pneumonia and E coli sepsis on 4/2/2021 Symptoms started with sore arm on 3/30/2021. Patient called healthcare provider on 3/31/2021 because patient developed headache, myalgias, fatigue, fever to 100. On 4/2/2021, patient presented to ER and admitted to hospital with fever, chills, shortness of breath, productive cough, labored breathing. CXR showed left upper lobe pneumonia and small pleural effusion. Blood culture subsequently grew E. coli. Work up for source of E. coli is ongoing including CT scan due to patient's history of rectal inflammation and presacral abscess several months back.

Arm soreness and nausea began at 4:00pm on 04/07/2021 and are continuing. Back pain/cramps/spasms; headache; tightness in chest; chills began at 5:00am on 04/08/2021 and are continuing.

Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)

anxious, shaking 5 min after vaccine. BP 118/79, O2: 99%, HR:135. Pt. assessed by MD and EMT, observed for 35 minutes and sent home. No meds required.

I woke up with a slight fever and a sore arm that got progressively worse as the day went on, I am now feeling Nauseous and my joints ache specifically my lower back. I keep having to move my arms because they keep falling asleep/getting tingly.

After the first course of Pfizer's vaccine, in three hours, I had a severe headache, sore arm, and was rather tired. I went to sleep for the rest of the day. 24 hours from the time of the injection, I still had a headache, so I went back to sleep. Eventually, at 48 hours after the injection, the headache, muscle soreness, and fatigue no longer lingered.

Passed out and threw up within 15 minute waiting period. Since then have had a fever, body aches, headache, nausea, chills and joint pain.

Within 25 minutes of getting the vaccine I had a metallic taste in my mouth. Shortly thereafter, I had a headache and body aches. I felt tired, feverish, and pain at the injection site. The next day all of these symptoms became worse and I had joint pain. The third day I had bad headaches and fever all day. The metallic taste remains constant and I can't taste "sweet" accurately. Most sweet things taste tart and extremly sour.

I started to have hives form along essentially my whole body besides my face starting 36 hours after my initial vaccine. My legs are the most concentrated with hives. I awoke up with swelled up hands, eye lids and wrists. Today, I woke up with a swollen upper lip and swollen bottoms of my feet.

The first 2 days she had mild nausea and headaches. The 3rd day she developed chest pain, worse on the left than right, radiates to the back. She states chest pain has continued and has been constant since then. Worse with movement, deep breaths, and lifting a heavy case at work. Rates pain 3-6/10 and describes as sharp and "twinge" with movement. She has taken OTC medication for the pain without relief. There is no where that is tender to touch. She is able to do her usual activities and states she is very active at work. Feels the pain limits her breathing at times and causes some SOB. She is able to speak in full sentences over the phone without difficulty. No audible wheeze. Had asthma as a child but much improved as an adult. Denies left arm, neck or jaw pain, lightheadedness, dizziness, nausea, vomiting, cough, fever, or sore throat. She is eating and drinking normally. She notes she has a family hx of cardiac disease and stroke. No MI before the age of 50 or sudden cardiac death that she knows of. She has a nexplanon implant and is on norethindrone and estradiol.

Day of Pfizer COVID-19 Vaccine, pt experienced fever, soreness under her arm, HA, chest and back aches and hand numbness. She took tylenol for relief--had chest pain(sometimes occurs with pain med usage). Did not reach out for medical advice. Symptoms resolved on their own.

Patient had dizziness, pain (left shoulder, injection site). Felt lightheaded + foggy, alert & oriented. Placed in Trendelenberg position with good effect. Provided orange juice. Patient dizziness/lightheadedness resolved, stable, released from vaccination site.

apr 4,2021- after first dose: only pain and soreness in right arm april 25/26, 2021- (most symptoms on the day after) after second dose: pain/soreness in left arm and whole body, migraine, feverish (dont have a thermometer to check temperature), chills, pain in neck, sharp pain in inner ears (maybe a part of the migraine not sure but it hurts worse than the migraine)

Approximately 10 hours after injection (injection at 5pm on 4/21), the first symptoms came on suddenly and lasted for about 7 hours (3am-10am on 4/22). These symptoms included severe nausea, headache, weak/rapid heart rate, chills, muscle aches, and a fever of 101 degrees F. Lymph nodes in the left armpit were also swollen and painful to the touch. After 10am, the chills and fever subsided, but the headache, general muscle aches, swollen lymph nodes, and bouts of nausea persisted (these lasted the entire day). The following day (4/23), nausea and muscle aches subsided but the headache remained. The headache only came on whenever changing elevation of the head (standing up, sitting down, bending over), at which point it would be painful for a few minutes after moving. An extremely stiff, painful neck also began the same day (4/23) and persisted for approximately 2 days after injection (accompanied by the headache). Lymph nodes under the collar bone on the left side of the body also became swollen (4/23). Lymph nodes in armpit and under collarbone are still swollen 6 days after injection, although not painful.

Fatigue, nausea, dizziness, back pain, chills, faint feeling while working out. Happened very next day, stopped after 24 hours, then resumed.

Extremely heavy (irregular) period with continual bleeding which has with in the last week stopped; Extreme lasting fatigue; Muscle Soreness; Tingling Skin; This is a spontaneous report from a contactable consumer (patient). A 21 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 25Mar2021 14:00 (Lot Number: EN6207) as SINGLE DOSE (at the age of 21 years old) for covid-19 immunisation. Medical history included ventricular septal defect (VSD) from an unknown date and unknown if ongoing, heart murmur from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not have any known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was also reported that since the vaccination, the patient had not been tested for COVID-19. On unknown date, the patient experienced Extremely heavy (irregular) period with continual bleeding which has with in the last week stopped, Extreme lasting fatigue, Muscle Soreness, Tingling Skin. No treatment was received. Outcome of the events was Recovered/Resolved with Sequel.

Symptoms developed about 14 hours after vaccination. Low-grade fever (lasting 24 hrs), shakes/chills (lasting 3 hours), muscle aches (lasting 12 hours), nausea (lasting 7 hours). Vomited twice. Symptoms gradually disappeared, with all starting roughly about the same time.

Experienced the expected headache, high fever, chills, soreness for more than twelve hours starting at 4 am, 12 hours after receiving the vaccine. IN ADDITION I experienced a severe endometriosis flare up. I have been on both the birth control pill and the Mirena IUD to control my endometriosis symptoms and had not experienced a flare up in over a year, which is how I know it was connected to the vaccine. The symptoms of my flare up were severe abdominal pain and pelvic cramps, along with back pain radiating from my shoulders down my legs. The pain could not be controlled by over the counter medication, heat, ice, or any other usual methods. The worst of the flare up lasted exactly as long as the expected side effects, though I did have residual cramping a day or two afterward.

Cough Fatigue Muscle or body aches Headache New loss of taste or smell Congestion or running nose Nausea or vomiting

Headache; fatigue; muscle and extreme joint pain; muscle and extreme joint pain; This is a spontaneous report received from a contactable other health care professional (HCP). A 21-years-old non pregnant female patient received bnt162b2 (BNT162B2, Solution for injection ), via an unspecified route of administration, administered on arm left on 26Jan2021 10:30 (at the age of 21-year-old) as single dose for covid-19 immunization. Medical history included fibromyalgia and postural orthostatic tachycardia syndrome (POTS). The patient had no covid prior to vaccination and no covid tested post vaccination. Concomitant medication included ibuprofen and fluoxetine hydrochloride (PROZAC). On 27Jan2021 03:00, the patient experienced headache, fatigue and muscle and extreme joint pain. The patient did not received any treatment for the event. The outcome of the events were recovering. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

40C fever around 24hours after injection, chills, muscle aches, starting around 12hrs after injection, vomiting and nausea 24hrs after injection, fatigue remained for a week, other symptoms went away after around 60 hours.

Night of: Arm sore, Shakes, Fatigue, Muscle aches Took Tylenol, went to bed early. Had trouble sleeping/bad sleep. Day after: Arm sore, Armpit sore, Fatigue, Muscle aches, Fever, Hot flashes, Headache (back of head-weird to move around too much) Took Tylenol, drank water, rested in bed. Third day: Arm sore, Armpit sore, Headache (back of head-weird to move around too much) Fourth day (Today): Armpit sore, Headache (back of head-weird to move around too much), Some sort of inconsistent sharp nerve pain on upper back, neck, behind/ in front of ear, temples Did some minor neck stretches and massaging of area. Helped a little.

Muscle Aches; Migraine; Nausea; Constipation; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) at the age of 21-year-old, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she had the following symptoms including Muscle Aches, Migrane, Nausea, and constipation starting from 24-72 hours after her injection. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Has intractable epilepsy, she usually has 5-6 seizures per day that are generally brief myoclonic-astatic type of seizures. The day after received her second dose of COVID19 vaccine she had an increase in seizure frequency. By 4/25/2021, she started to develop fevers and new type of seizure with more body twitching and stiffening of her arms. She was admitted to Hospital in on 4/27/2021 with fever, status epilepticus, found to have an aspiration pneumonia. She required antiepileptic medication dose adjustment with addition of Valproic acid to her drug regimen, but this caused excessive sedation. She was discharged from hospital on 5/14/2021. Status epilepticus did resolve and she was more alert by the end of hospitalization.

Sharp knife piercing pain in left ear. Extremely painful tinnitus. Ringing in ear kept me up all night. Fever, muscle pain and chills.

4 days after first shot, she called me complaining of bad back pain. She was going to her family doctor the next day for her 21 yr old well visit and was going to get it checked out then. She had a complete physical and was cleared even her lungs were clear and she was good. Tuesday night April 13th at 10pm, she told me she had "air bubbles" in her chest. I said you mean indigestion, take tums I said. She said not mom, actual air bubbles and they are popping in my chest. I said you just got your physical, you are fine. They Thursday night April 15th she started having difficulty breathing and was out of breath. She went to urgent care on April 16th because she felt awful and they saw in an X-ray that she had a "cyst" in her upper right part of her lung and her lung was about to collapse. Sent her home on bed rest with a stereos and 2 inhalers. We got her Friday night from college because the pain in her back and now her chest was worse. Took her to ER and she had a collared lung and pneuomothroax. She was admitted to the hospital and they tried to see if the lung would heal itself. It did not. They had to do surgery to repair the hole. When they were in there they saw a cobblestone texture where the hole was an they removed that texture and repaired the hole. She has never had a lung issue. Ever. She is also the 3rd person in my family to have had an adverse reaction to the shot. 6 of us vaccinated and 3 with injuries.

Very fatigued; muscle pain; arm pain; This is spontaneous report from a contactable consumer (patient). A 21-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EWO171) via an unspecified route of administration on 22Apr2021 at 14:15 (at the age of 21-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included migraines and anxiety. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was diagnosed with COVID-19 prior to the vaccine. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), propranolol, fexofenadine hydrochloride (ALLEGRA), and birth control from unknown dates for unspecified indications. On 22Apr2021 at 21:00 the patient experienced very fatigued, muscle pain, and arm pain. The patient did not receive any treatment for the events. The outcomes of very fatigued, muscle pain, and arm pain were recovered with lasting effects. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Patient fainted less than five minutes after receiving the vaccine, and was unconscious for less than 60 seconds before waking up and sitting up. Complained of ankle pain and that she was feeling hot. Paramedics were called to assess vital signs. Patient walked out of the store after finishing with paramedics.

Feeling muscle aches; FEBRILE; SORE THROAT; HEADACHE; This is a spontaneous report received from a contactable nurse. A 21-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), intramuscularly in her left arm on 19Jan2021 (age at vaccination 21-year-old), at 07:15 for COVID-19 immunisation. On 09Feb2021, the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9261), via an unspecified route of administration in her right arm. The patients medical history was not reported. Concomitant medication included loratadine (MANUFACTURER UNKNOWN) 10 mg, ESTARYLLA 0.25mg/0.035mg, calcium supplement (MANUFACTURER UNKNOWN) 500mg, multivitamin (MANUFACTURER UNKNOWN), FLONASE for an unknown indication from an unknown start date. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since having the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Jan2021, the patient experienced muscle aches, sore throat and she was febrile for 2-3 weeks until second dose, regular symptoms like headache happened for first 48 hours. The patient did not receive any treatment for the events. The clinical outcome for the events headache (happened for first 48 hours), muscle aches, febrile and sore throat was resolved on an unknown date (2-3 weeks until second dose). No follow-up attempts are needed. No further information is expected.

Patient reports feeling faint immediately following the injection with an elevated heart rate and nausea. The following day she started having episodes of vomiting, nausea, anxiety, tachycardia, pain in the sternum, shoulders and back, dizziness, weight loss, exercise intolerance, insomnia, muscle weakness, fevers, and an overall "depressed feeling".

12 hours after receiving 2nd dose of Pfizer Covid-19 vaccine, urinary tract infection symptoms showed up, in addition to general aches and pains in the legs and lower back. After a 5 day completed course of antibiotics (nitrofurantoin), symptoms of UTI returned

A few hours after the shot, there was a very mild sense of weakness in my right arm. Slowly over the course of several more hours, the mild weakness shifted to mild-moderate pain in my right arm. I went to sleep and I woke up around noon-ish in so much pain, it felt a lot like when I fractured my right tibia and fibula in I think it was 2008. I still had a soft cast from that, so I wore it and did my best to avoid using my right arm at all. Slowly over the course of the week after, the pain went away until it faded completely. I considered going to the ER, but decided against it since it did not seem life-threatening. I did not know I could report adverse effects until now, but if I did, I would have mentioned this weeks ago.

Starting on 06/17/2021 I had chills and very intense body aches, which went away the next morning. However, when I woke up on 06/18/2021 I had decently swollen lymph nodes the size of olives on the left side of where my neck meets my trapezoid muscle. I also had physically noticeable swollen lymph nodes under my left arm. Both swollen areas are painful and tender.

choking on phlegm; phlegm; Coughing; Serious sinus drainage; Fatigue; could not hold food down; This is a spontaneous report from a contactable consumer. This 21-year-old female consumer (patient) reported for herself: Product detail: product=COVID 19, brand=Phizer Start Date/Time: [Phizer] 2Jun2021 03:30 PM Lot number=Bw0182 Lot unknown=False Dose number=1, Vaccine location=Left arm Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No Reported Event: Serious sinus drainage, coughing, fatigue (if I do fall asleep I will wake up choking on flem) can't hold food down Prior to vaccination Since the vaccination, has the patient been tested for COVID-19?:No Device Date : 05Jun2021 If patient recovered: Not recovered If treatment AE: No If covid prior vaccination: Unknown If covid tested post vaccination: No No follow-up attempts are needed. No further information is expected.

Extreme vaginal bleeding; Some difficulty in breathing; Prolonged period; Migraines; Dizziness; Nausea; Lower back pain; Abdominal pain; Weakness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 21-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 10May2021 (age at vaccination was 21 years) as 2nd dose, single for COVID-19 immunization. Medical history included known allergies to Sulfas. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 19Apr2021 (age at vaccination was 21 years) as 1st dose, single for COVID-19 immunization. The patient previously took amoxicillin and experienced known allergies. The facility where the most recent COVID-19 vaccine was administered was Other. 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. The patient underwent lab tests which included Nasal Swab: negative on 21May2021. On 28May2021, patient experienced extreme vaginal bleeding/ prolonged period/ migraines, dizziness, nausea, lower back pain, abdominal pain, some difficulty in breathing and weakness. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The device date was reported as 23Jun2021. The case was reported as non-serious. The outcome of events was not resolved. Information on lot/batch number was available.

pain and soreness in her back and shoulder,; pain and soreness in her back and shoulder,; pain, the regular soreness; she was feeling the armpit pain; swollen arm/whole right arm and hand swollen; armpit is painful and swollen; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (patient) reported that a 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0183), via an unspecified route of administration in right arm on 29Jun2021 at 08:17 (at the age of 21 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not had history of previous immunization with the Pfizer vaccine considered as suspect. No family medical history relevant to adverse events was provided and no relevant tests were performed. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had initial onset of side effects on 30Jun2021 starting with pain, the regular soreness; then she was feeling the armpit pain and then slowly during the day started feeling the back pain; she is having back pain and her whole right arm and hand are swollen. She is not sure about the back pain; she can't sleep on her right arm because of having the vaccine shot and usually she sleeps on that side; so it could be that being tensed up from not sleeping on the right side could have caused the back pain. The armpit pain and swelling of right arm and hand she is not sure about. She is experiencing swollen arm, armpit is painful and swollen, pain and soreness in her back and shoulder, whole right arm and hand swollen. She asked for further information about these side effects. She specified outcome of side effects as persistent. The patient did not visit emergency room or physician office. Treatment received: Tylenol 500mg every 6 hours after the vaccine for the soreness; they told her to take it so she did and it helped the pain come down a little bit. Tylenol: Lot: SMA034, Expiry: Aug2022, UPC: Unknown, but . The outcome of events was not recovered.

Muscular weakness; fatigue, all over body but mainly in lowerextremities; This is a spontaneous report received from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route administration in the right arm on 05Feb2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) from an unknown date for unknown indications. 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 an unknown date as a single dose for COVID-19 immunisation. 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. On 12Feb2021, the patient experienced muscular weakness and fatigue all over the body but mainly in lower extremities. On an unknown date, the patient had undergone the COVID-19 test which included nasal swab and the results were unknown. The patient did not receive any treatment for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of muscular weakness and fatigue was not recovered at the time of report. Information about lot/batch number cannot be obtained. No further information is expected.

Mild fever; Swollen lymph nodes on the left side ofmy body (the side of the injection),especially along my neck, jaw, and underarm.; Tender lymph nodes on the left side ofmy body (the side of the injection),especially along my neck, jaw, and underarm.; Neck soreness; Shoulder soreness; Upper arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 17:45 (at the age of 21-years-old) for COVID-19 immunisation. Medical history included latex allergy. The patient was allergic to macrobid (antibiotic). Concomitant medications included birth control pills (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 31Mar2021 at 08:00, the patient experienced mild fever, very swollen and tender lymph nodes on the left side of the body (the side of the injection) especially along the neck, jaw, and underarm, neck and shoulder soreness along with the upper arm. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic treatment was taken for the reported events. The clinical outcome of the events mild fever, very swollen and tender lymph nodes on the left side of the body (the side of the injection) especially along the neck, jaw, and underarm, neck and shoulder soreness along with the upper arm were resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Upon injecting, patient said, she immediately felt like her arm was warm, radiating down her arm, up to her neck. Patient said she had a sore throat prior to the shot, and she felt her throat was warm, and her face was warm. Patient said, her arm felt numb and heavy but not tingly. Pharmacist called EMS. Her vitals were normal, but her BP was slightly high because patient was experiencing anxiety. Patient said she normally suffers from anxiety. Patient's mom said, she was nervous from the morning. EMS said, it's likely a mixture of anxiety and not feeling well combined.

numbness, tingling, muscle weakness and pain in hands and feet for about 14 hours. Couldn't grip anything and constantly stabbed with needle like sensations in hands and toes. Recipient still struggles with muscle weakness in hands and feet four months after vaccination.

Patient developed chest pain on the left side with inhalation. Left shoulder had a sharp dull pain with activity. Symptoms did not improve with ibuprofen. Patient was evaluated in the ED and her EKG came back normal.

pneumothorax, her right lung collapsed; cyst that was ready to burst on her lung; swelling in her right arm under the arm and in her chest area and breast; swelling in her right arm under the arm and in her chest area and breast; a heart murmur; a high resting heart rate; Back pain; lymph node swelling under her right arm pit into her chest; swelling in her lymph nodes and in her chest that were painful; swelling in her right arm under the arm and in her chest area and breast; This is a spontaneous report from a contactable consumer (patient's mother). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr2021 (lot number EW0153), at the age of 21 years, as the first single dose, for COVID-19 immunisation. Medical history was not reported. Concomitant medication included an unspecfied low estrogen birth control (she just took a birth control pill every day, probably on it since she was 16 or 17 years old). On 12Apr2021 the patient experienced back pain. On an unspecified date in 2021 the patient experienced lymph node swelling under her right arm pit into her chest. She had swelling in her lymph nodes and in her chest that were painful and she could touch them. On 16Apr2021 the patient experienced pneumothorax (on that day she went to the urgent care and they told her that her lung was about to collapse). The reporter finally got her daughter to come home from school and she took her to the emergency room on 17Apr2021. When the lung had collapsed, she felt worse and then she was in the hospital for an entire week. This event required hospitalization from 17Apr2021 to 29Apr2021. On 23Apr2021 she had a tube in her chest that was drawing the air out and they did something where they inflated her lung to see if it would stay and it wouldn't stay so they had to do surgery on 26Apr2021. When they went to do surgery they saw that on the outer part of her lung where the hole was that it wouldn't heal and they saw that it was like a cobble stone texture on the outside of the lung. The patient was in the hospital until 29Apr2021 and she was in the ICU the entire time. She went for check-ups and everything seemed to be good and her lung had healed. The caller was trying to connect dots between her family members and she had asked her daughter how she felt right after the COVID vaccine and her daughter said that she felt like "ehhh" and then on 12Apr2021 she had the back pain, then on 13Apr2021 she had air bubbles in her chest and on 15Apr2021 she was trying to walk to bars and she was out of breath. On 16Apr2021 the urgent care said they saw a cyst that was ready to burst on her lung and she was on bed rest and was given steroids. The caller thought that the swelling and the lymph nodes and having the cobble stone texture were all from irritation and then it had made a blister that popped creating the hole. On 29Jun2021 the patient experienced heart murmur and a high resting heart rate. Around 29Jun2021, the patient was feeling like her heart was moving in her chest and that it was out of synch and not right and that it was racing high and so the reporter called their family doctor who saw the patient the next day. They did an EKG that was irregular and now she had a heart murmur. She wasn't born with that and she had never had that and she didn't leave the hospital with that. She was fine until now with her having the murmur and the high resting heart rate, around 85. The caller didn't know the exact EKG irregularities because it said "normal" but they gave a copy to her and said to bring it to the cardiologist because it was not normal. The reporter didn't know the details and won't until the follow-up appointment on 16Jul2021 which was when they would have a better idea about what they were going to call this. She had the swelling in her right arm under the arm and in her chest area and breast, she was thin breasted, this was on the right side and then her right lung collapsed. The caller says that this was not a coincidence. There was no way that she would have three family members injured if it wasn't for the COVID vaccine. Her daughter should be taking an allergy medication but she won't take it. The patient did not receive the 2nd dose (when she had gotten out of the hospital after her pneumothorax that was when she was supposed to get her 2nd dose but they didn't go get it because they couldn't risk that). Back pain resolved on an unspecified date in 2021. The other events outcome was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021899289 same reporter/product/patient, different dose/event

This is a spontaneous report from a contactable consumer, the patient. A 21-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 02Apr2021 at 13:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 01:00 the patient experienced pins and needles in her fingers and her hands. When she woke up on 03Apr2021 the problem persisted, and she also began to feel weakness and numbness in her hands. It was difficult to grip things, and at night she began to feel pins and needles in her feet, arms, and shoulders. On 04Apr2021 the problem still persisted, although she felt less of a tingling sensation in her shoulders. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event pins and needles in fingers and hands/pins and needles in feet, arms and shoulders/tingling sensation in shoulders, weakness in hands, numbness in hands and difficulty to grip things was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

Patient was monitored 15 minutes after giving 1st COVID vaccine. Once she returned to the worksite approximately 30 minutes after her vaccine was given, she experienced some flushing and severe sweating. Patient was taken to the nearest ED on 12-31-20 @ 5:00pm and per patient stated that ED doctor said it could be a reaction to the COVID vaccine. On 1-1-21, patient started experiencing low grade fever, body aches and a major headache. Patient was told she can take Tylenol OTC to help with this. Patient stated on 1-2-21, she started experiencing sore throat and a metallic taste in her mouth. Patient was told she needed to go see her doctor as soon as she could to follow up with this. On 1-3-21, patient still complained of sore throat and lower back pain. Patient was advised to go to nearest Urgent care if possible. Patient stated that she was going to go to a local urgent care today and she was told to follow up with Public Health after she was seen at the urgent care.

I received the vaccine yesterday at 5 pm. This morning starting at 8 am I had muscle aches, chills, and a headache. I took my temperature around 1 pm today and had a fever of 100.8. Throughout today, my headache has gotten progressively worse. The pain is sharp at the base of my head and radiates down my spine. I cannot put my chin to my chest without excruciating pain. I have had migraines before and this does not feel the same. This headache is more localized in the back of my head and spine. I also have had COVID19 before at the beginning of July 2020 from which the only symptom I had was a loss of smell which returned 2 weeks after my positive COVID test.

pain between her right scapula and spine; pain between her right scapula and spine; This is a spontaneous report from a contactable nurse (patient herself). A 22-year-old female patient started to receive BNT162B2 (lot number: EJ1685; expiry date unknown) intramuscular (right arm), on 28Dec2020, at a single dose, for COVID-19 vaccine injection/ vaccination. The patient's medical history and concomitant medications were not reported. This nurse was administered her first dose of Pfizer COVID-19 Vaccine on 28Dec2020, in the morning. Her first concern was that the nurse put the COVID-19 Vaccine injection really low into her right arm, but believes it did go into the muscle. She was concerned that it did not really go into her muscle but the more she has been lifting her arm and seeing where the shot was administered and where her muscle in her arm ends she believes it did go into the muscle. She contacted her primary care provider today because about 30 minutes to 1 hour after she was administered the COVID-19 vaccine injection on 28Dec2020 she had a pain in between her right scapula and spine, which is the side she got her vaccine on. She also reported that her right arm does not hurt at all, she has no pain at injection site for COVID-19 Vaccine which she finds really weird. She also felt the pain if she hunches her shoulders backwards, sits up really straight, crosses her arms or hunches forward; she does not really feel it if she takes a deep breath. She was wondering if these events are normal or expected or serious. Outcome of the events was not recovered.

low back ache; sore throat; low grade fever; body aches; severe headache; hot flashes; sweating heavily; felt flushed; This is a spontaneous report from a contactable Nurse. This 22-year-old female patient received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 16:30 (at the age of 22-years) as single dose, intramuscular in left arm for COVID-19 immunization. Medical history included the patient had no known allergies. The patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID virus in Oct2020. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was given first dose of the COVID vaccine on 31Dec2020. The patient was monitored 15 minutes after receiving the vaccine. When she went back to work on 31Dec2020 she felt flushed, having hot flashes and she started sweating heavily. The patient was taken to the nearest Emergency room (ER) for evaluation and states that the (ER) doctor told her it could have been a reaction to the vaccine. On 01Jan2021, the patient started having low grade fever, body aches and severe headache. On 02Jan2021, the patient was having a sore throat and low grade fever still, but no body aches or headache. On 03Jan2021, the patient was still having the sore throat and a low back ache, the patient was told to go to an Urgent Care to be evaluated. The patient states that she was given antibiotics and was negative for Strep. The patient was also swabbed for COVID again. The patient was given treatment for sore throat but it was unknown if patient received treatment for other events. Lab data included SARS-CoV-2 test (PCR nasal swab) on 03Jan2021 which is pending. The patient did not received treatment as a result of the event. The outcome of event felt flushed was recovering, hot flashes was recovering, sweating heavily was recovering, low grade fever was not recovered, body aches was recovered Jan2021, severe headache was recovered on Jan2021, sore throat was not recovered and low back ache was not recovered.

Body aches Sore back Fever - temp was 102 Fatigue Took 3 doses of Tylenol which seems to have helped. 24 hours later still feeling pretty sore and tired.

On 12/30/2020 I received my 1st dose of Pfizer vaccine. Felt fine, no symptoms or side effects until 12/31/2020 I did get hives on my arm site where I received the vaccine and those hives then started to spread throughout my body. I started having hives and rashes all over for a total of 6 days . Itching, swelling on my ears, arm, wrist, hands, back etc... took Benadryl for the 6 days and it helped for the 1st 2 days of my adverse event after that the Benadryl did nothing. Me and my PCP has agreed it was a possible delayed allergic reaction to the vaccine.

Developed a very sore arm about 36 hours post injection. About 48 hours post injection developed swelling; redness; itching and pain at injection site. Acetaminophen used but ineffective.

Soreness at injection site roughly 10 minutes after injection, soreness went away a few minutes afterwards. Injection was given in the morning, around 10am, around late afternoon, 4-5pm, area around injection site was very sore, as if there was a bad bruise there, but there was no visible marks. Shoulder was very sore to the point of hardly being able to lift arm to the side away from the body. Day after injection arm was still sore but the pain was less. 2 days after injection, arm was only slightly sore in the morning with no pain by mid afternoon.

Pt. sat for 20 minutes after vaccine. noted some pain in left back (same side as arm vaccine was given in). Left to car and came right back in 5 minutes saying it was hurting even with walking, and thought it was the chair she was sitting in but it wasn't going away. One the vaccination RN's examined her back but there was no evidence of any reaction on her skin. Backpain continued until later that day. Followed up with PCP wanted her to get covid tested 1/5, negative results, due to developing more symptoms days later (fatigue, slight cough, back pain (resolved that same day).

Fever of 101.8, joint pain, chills, nausea beginning at 0300 on 01/12/2021 and continuing currently (1/12/2021 1030). Poorly controlled with Motrin and Tylenol every six hours. Symptoms return 3-4 hours after taking medication.

muscle aches; nausea; joint pain; neck pain; headache; severe abdominal pain; vomiting; diarrhea; second dose on 04Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 16Dec2020 17:00, second dose on 04Jan2021 18:00, both via an unspecified in left arm route at single dose for covid-19 immunization in hospital. Medical history included gluten intolerance. 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 vaccine. Other medications the patient received within 2 weeks of vaccination included birth control. The patient previously took nitrofurantoin and experienced allergies. The patient experienced muscle aches, nausea, joint pain, neck pain, and headache 24 hours post vaccination (as reported). She then experienced severe abdominal pain, nausea, vomiting and diarrhea 36 hours post vaccination (as reported). The adverse reaction was also reported started from 05Jan2021 7:00 AM. The events was reported as non-serious. There was no treatment for the events muscle aches, nausea, joint pain, neck pain, headache, severe abdominal pain, vomiting and diarrhea. The outcome of the events muscle aches, nausea, joint pain, neck pain, headache, severe abdominal pain, vomiting and diarrhea were resolved with lasting effects. Information on the Lot/Batch number has been requested.

Fever from 3:00 am to 6:40 pm (99.7 - 101.4) treated with extra strength acetaminophen. Temperature is now 99.5 Fatigue for 1/11 and 1/12 Intermittent muscle aches on arms and calves

Onset of new joint pain, muscle pain, headache and fatigue at 1600 on 1/8/21,headache and fatigue faded by 1/9/21 with worsened joint and muscle pain continuing through today (1/13/21)

14:16 COVID vaccine given IM in right deltoid 14:34 Patient states she isn't feeling well, nauseated, pain at injection site 4/10 on pain scale, itching to right arm. VSS 98% on RA, 86 pulse, 131/82 BP, 98.8 temp. BAND AID removed. 14:34 50mg BENADRYL given lot 202906 exp 9/20/23. Sitting in chair with fan. Noted that Pt was drinking a Bang energy drink with 300mg caffeine 1/4 gone. 14:45 c/o pain in right upper abdomen/lower right rib pain with breathing, "trouble breathing- hard to take deep breaths d/t this pain, a little throat pain, 14:49 Dr called/updated orders Tylenol 1000mg PO now. 14:56 Tylenol 1000mg given PO with water, c/o dry mouth, throat "tight", Right arm where injection given- c/o pain 8/10 on pain scale. 98.8temp, 126/83 bp, 100% sa O2 on RA, states not feeling well. 15:02 bilateral lower legs beefy red, capillary refill >8 seconds, pulses present states her feet are tingling. 15:00 Pt states she doesn't feel well and asks to go to the ER to be evaluated. 15:05 Ambulance dispatched. 15:15 Ambulance arrived and assessed Pt and at 15:21 Pt left the facility per ambulance stretcher accompanied by EMT's x2

Exactly 12 hours post second dose of covid vaccine I had 103 fever, chills, body aches, muscle and joint pain. Came about very suddenly. Fever lasted about 12-15 hours. Rotated Tylenol and Advil to calm fever. Day 2 post vaccine still suffering headache, fatigue, muscle and joint pain

Day one: extreme malaise, fatigue and muscle soreness onset 4-5hrs from injection and lasted for 2 days. Day three: at midnight started itching and I had just dismissed it. Woke up at 6am itching in sleep on more place. Currently (0900 day 4) moderate hives presenting bilaterally on knees, elbows, sides, back, ear and eyes. Most of the hives present are fairly bilaterally. Applied benadryl tropical cream to spots and fighting the urge to itch.

Dizziness; Palpitation; I had tingling in my face and my legs; Myalgia; Nausea; Headache; Fatigue; This is a spontaneous report from a contactable consumer (emergency department technician like a clinical assistant). A 22-year-old female patient received her first injection of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EK9231) intramuscularly at a single dose on 17Dec2020 for Covid-19 immunization. The patient had a medical history of migraine. Concomitant medications included cyproheptadine for migraine and multivitamins. The patient experienced dizziness and palpitations initially and then little bit later on the day she had tingling in her face and legs and she had myalgia, nausea and headache and fatigue. The symptoms lasted for 2 days. The patient medicated with Benadryl and Famotidine. Outcome of the events was unknown. The patient had her second vaccine injection on 06Jan2021.

started with left sided lower back pain; This is a spontaneous report from a contactable Nurse (patient). A 22-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration at left arm on 16Dec2020 13:45 at single dose for covid-19 immunization. Medical history included allergies for All fish. The patient's concomitant medications were not reported. The patient had the first covid vaccine on 16Dec2020 and on 20Dec2020 started with left sided lower back pain. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days), Life threatening illness (immediate risk of death from the event). The patient received the Heparin drip and xarelto at home for the event. The patient was not pregnant. The patient received the covid test post vaccination on 09Jan2021. Test type was Nasal Swab. The result was negative. The outcome of the event was recovered with sequel on unspecified date.; Sender's Comments: From the information provided it is unclear what is the nature of the reported event and what are the reasons that have put the subject at immediate risk of death. The event is considered possibly related to the suspect product based on the positive temporal association.

I had the flu-like symptoms on 1/9/21 - body aches, headache, and jaw tightness. 1/10 = woke up with facial swelling, took tylenol, had 100.5 fever that night 1/11 = woke up with a HUGE face, lots of swelling - went to urgent care had a 101 fever, they sent me to GW ER (facial swelling looked similar to MUMPS - I have been vaccinated)

fever (101.5º); chills; muscle aches; nausea; This is a spontaneous report from a contactable Nurse (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284), intramuscularly on 07Jan2021 at single dose for covid-19 immunization. Vaccine location was right arm and it was the second dose. The facility type vaccine was hospital. Patient Intramuscularly received the first dose of BNT162B2 on 17Dec2020 (lot number EH9899) at arm left. Patient is not pregnant. The patient medical history and concomitant medications were 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 patient experienced fever (101.5º), chills, muscle aches, nausea on 08Jan2021 with outcome of recovered in Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.

fever; chills; muscle aches; This is a spontaneous report form a contactable other healthcare professional (Other HCP) reporting for herself. A 22-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EK9231, expiry date: not reported) via an unspecified route of administration, on 07Jan2021 on Arm Left at a single dose for COVID-19 immunization. COVID-19 vaccine was administered at a hospital. Medical history was not reported. The patient has no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. She 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. The patient had undergone Nasal Swab tests on 08Nov2020 and 05Dec2020, both with negative results. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: not reported) via an unspecified route of administration, on 17Dec2020 03:30 PM on Arm Right at a single dose for COVID-19 immunization (at the age of 22-year-old). On 08Jan2021 02:45 AM, the patient had a fever, chills and muscle aches in the middle of the night into the morning of the following day. Treatment was not received for the adverse events. Outcome of the events was recovering.

Currently ongoing, starting approx. 12 hours after second dose: Nausea, severe chills, severe arthralgia, severe myalgia, low fever (100.0 F). Currently ongoing, starting approx. 24 hours after second dose: What is listed above, fever (101.1 F), and diarrhea. I can keep water down and some food. Ibuprofen helps mute the symptoms but does not mask them well enough for comfort. Losing sleep and drying to stay hydrated.

Fever, full body muscle aches & joint pain, fatigue, soreness, pain at injection site, nausea, dizziness (each of these started/were most severe the day after vaccine and continued to 2nd day after vaccine)

Fever; chills; muscle aches; This is a spontaneous report from a contactable nurse. A 22-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscularly on 06Jan2021 at 18:30 at a single dose on the left arm for COVID-19 immunization in the hospital. The patient's medical history and concomitant medications were not reported. The patient previously took spironolactone and had allergies. 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. On 07Jan2021 at 05:00, the patient experienced fever, chills, and muscle aches. No treatment was given to the patient. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date in Jan2021. The events were considered non-serious.

Fever, chills, diaphoresis, body aches, head/neck pain, lymph node swelling/tenderness in left armpit (received vaccine in L arm), numbness/tingling/pins/needles sensation throughout entire body.

Patient started feeling left arm joint pain including intermittent ache with and without movement. Pain alleviated with no intervention and came back a few days later. Patient had no other symptoms.

1135 - (L) ear ringing it migrate to (L) neck. V/S BP-116/70, HR-76, O2Sat-97% on RA, R-18 1142 - Diziness and middle back pain start hurting. V/S BP-110/68, HR-75, O2Sat-96%, R-15 1150 - pt. continue to have symptoms, escort to ER.

Beginning the day I got the 2nd shot, I had arm pain./severe arm pain/hand in the arm I got the shot; chills; fever (100.7° F); nausea; muscle aches; loss of appetite; joint pain/elbow, wrist; severe arm pain that radiated to my armpit, back, elbow, wrist, and hand in the arm I got the shot; severe arm pain that radiated to my armpit, back, elbow, wrist, and hand in the arm I got the shot; This is a spontaneous report from a contactable other Health Professional (patient). A 22-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 07Jan2021 09:45 at single dose in left arm for covid-19 immunization. Medical history included OCD (obsessive-compulsive disorder)/anxiety, obesity. The patient had no allergies to medications, food, or other products. Concomitant medications the patient received within 2 weeks of vaccination included fluvoxamine and ethinylestradiol, norgestimate (SPRINTEC). The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and 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 vaccine. On 07Jan2021 22:45, beginning the day the patient got the 2nd shot, the patient had arm pain. That night (on 07Jan2021 22:45), she had chills, fever (100.7 F), nausea, muscle aches, loss of appetite, joint pain, and severe arm pain that radiated to her armpit, back, elbow, wrist, and hand in the arm she got the shot. This all lasted about 24 hours. The arm pan has been present for about 2 days now. No treatment was received. The outcome of the event arm pain was recovered on 09Jan2021; the outcome of the rest events was recovered on 08Jan2021. information on the lot/batch number has been requested.

Stiff joints, fever, body aches, severe fatigue, loss of appetite, headache, increased thirst, muscle weakness

I have a circular redness around the spot of my shot. It looks like a bullseye because it?s almost a yellowy white in the middle. The muscle is also very swollen. It doesn?t hurt though.

This is a spontaneous report from a non-contactable nurse (patient). This 22-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 21Dec2020 10:00 AM at left arm, and 2nd dose on 11Jan2021 07:45 AM at left arm, both at single dose via an unknown route for COVID-19 immunization. Facility type vaccine was hospital. Medical history was not provided. Patient did not have COVID prior vaccination. Concomitant drug in two weeks included polycarbophil calcium (FIBER). Patient did not have other vaccine in four weeks. No COVID tested post vaccination. Patient's left armpit had an aching pain with movement or palpation. It was also swollen. She thought her lymph nodes were swollen. Event onset date was reported as 12Jan2021 05:00 AM. This also happened with first dose and it lasted for two weeks. No treatment received. Outcome of the events was resolving. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Patient received Covid Dose #1 vaccine on 01/25/2021. Patient felt well immediately after receiving vaccine. 30 minutes later, she stood up and started to feel lightheaded, nauseous, and dizzy. She also experienced bilateral leg weakness - legs gave out under when she tried to stand. Feels some subjective shortness of breath. She has experienced similar constellation of symptoms plus palpitations in past related to her tachycardia-induced myopathy. Patient admitted to observation for monitoring same day 1/25/21 at 1618. Patient did well in observation overnight, no acute events. Patient was discharged at 1035am on 1/26/21. Patient instructed to follow up with primary care physician in 1-2 weeks.

fever, muscle aches, headache, chills Had a fever of 100.5 this morning. Still has all other symptoms

Headache; Body ache; Muscle pain/muscle soreness; Feeling down; feels may be like it's a knot in the muscle; Like a lump like at the bottom of my neck; This is a spontaneous report from a contactable consumer reporting for herself (Medical Assistant). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiry date: 30Apr2021), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient stated, "I just wanted to ask about, I just received my second dose of the vaccine and I was having some adverse effects. I had headache yesterday when I got it. And body ache and muscle pain today and then I'm feeling down, and kind of like a lump like at the bottom of my neck, like to the side, on the left side, the arm that I got the (incomplete sentence). It feels may be like it's a knot in the muscle. I don't know if that is normal." The patient asked and stated, "If anybody else has had any of those symptoms? I know that the headache and the muscle pain is normal, I don't know about the like a lump or anything." The patient further stated, "It's been pretty constant headache, second day was body ache and right now just like muscle soreness." The patient stated, "I took some Tylenol, acetaminophen. And I think I had one Ibuprofen last night." The outcome of the event headache was not recovered and the outcome of the remaining events was unknown.

She has abdominal cramping now; Chills; she develops joint pain /They were sore and stiff; she develops joint pain /They were sore and stiff; This is a spontaneous report from a contactable consumer patient via a Pfizer-sponsored program. A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685, Lot Expire Date: unknown), intramuscular injection in left deltoid on 30Dec2020 07:15 AM at single dose for COVID-19 immunization (reported as "Why was the patient taking COVID19 Vaccine (Verbatim): healthcare worker "). Medical history included ongoing allergy to sulfa antibiotics since 1998 (diagnosed within her first year of life) and allergic to the cold from 2011 and ongoing. She has an allergy to the cold and people sometimes confuse it with Raynaud's. It is not Raynaud's. Concomitant medication included etonogestrel (NEXPLANON) from May2019 and ongoing for birth control. The patient received the vaccine on 30Dec2020 and developed symptoms 4 days ago (10Jan2021), she was experiencing joint pain and chills, also reported as "just over the last 2 days she develops joint pain and chills". Patient experienced chills on 13Jan2021. Patient just called about possible side effects and she was wondering if she should get the second dose. Her side effects were minor. They were joint pain and chills. Joint Pain started in the hips and felt like something was wrong. They were sore and stiff. She has abdominal cramping now and she was not sure if that is from the joint pain or regular period. She just finished her menstrual cycle and normally she has cramps afterwards. She does not have a fever. Patient has checked her temperature three times. 30Dec2020 was when she received her first dose. Vaccination Facility Type was health center . The events did not require a visit to emergency room and physician office. No prior vaccination within 4 weeks but patient reported that events following prior vaccinations was "the worst was swelling and tenderness with HPV vaccine. HPV vaccine manufacturer: unknown". Outcome of the event chills was not recovered (ongoing) while for other events was unknown.

small fever on and off and back pain, this personally happens every time I get a flu shot as well, I have the same symptoms. got the shot at around 10 am and started feeling a little sick on the same day but around 7/8 pm

Fever, chills, headache, backache, and fatigue that began 14 hours after injection and lasted 24 hours

Swollen tonsils; Neck stiffness; Congestion; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. There were no medical history or concomitant medications. The patient experienced swollen tonsils, neck stiffness, and congestion on 15Jan2021. Event details: The patient got the shot yesterday and when she woke up this morning her tonsils were swollen. She had neck stiffness, her neck was stiff, forearms, a lot of congestion. The outcome of the events was unknown.

piercing headache at temples; diarrhea; Nausea; severe chills; severe arthralgia; severe myalgia; fever (100.0 F, 101.4 F); This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 15Jan2021 at a single dose on right arm for COVID-19 immunization. Medical history included depression. Concomitant medication included ibuprofen, vortioxetine hydrobromide (TRINTELLIX), buspirone, ondansetron (ZOFRAN MELT), ethinylestradiol, levonorgestrel (LUTERA). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 26Dec2020 at a single dose on left arm for COVID-19 immunization. The patient experienced nausea, severe chills, severe arthralgia, severe myalgia, fever (100.0 F) on 15Jan2021 19:30, approx. 12/hrs post 2nd dose. Then on 16Jan2021, patient experienced all the above, and piercing headache at temples, fever (101.4 F), diarrhea, approx. 24/hrs post 2nd dose. No treatment received for the adverse events. The outcome of the events was not recovered. The patient is not pregnant. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. Not diagnosed with covid prior vaccination. Not covid tested post vaccination.

headache, body aches (shooting pains in ear, lower back, top of head), low grade fever (100.0) for 3-4 hours, fatigue

Chills, fever, muscle pain, joint pain, headache, general malaise, sensitive to touch- lasted for 36 hours starting late night of injection. Swollen lymph nodes starting about 24-36 hours after injection. Increased normal treatment for chronic conditions including extra saline infusion and rest

Hot flashes; Chills; Body aches; Migraine; Neck pain; Fatigue; This is a spontaneous report from a non-contactable Nurse. A non-pregnant 22-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3246), intramuscular in the right arm on 11Jan2021 at 11:30 AM (at the age of 22-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular, right arm on 21Dec2020 for COVID-19 immunization. On 11Jan2021 at 23:30 PM, the patient experienced hot flashes, chills, body aches, migraine, neck pain, and fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events hot flashes, chills, body aches, migraine, neck pain, and fatigue was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Severe headache, extreme fever, intense chills, muscle aches across entire body, extreme fatigue... symptoms starting around 2am on 02/06/2021 and still happening today (02/07/2021) in the evening.

Beginning at 2:15 pm I experienced injection site soreness. At 10 pm I experienced a mild headache and muscle aches. Between the hours of 12-1 am I experienced chills, vomiting, and muscle aches. At 2 am I experienced insomnia, a fever of 102, continued muscle aches, and my oxygen saturation was between 92-95%. At 2:25 am I took 1000 mg of Tylenol to reduce the fever and muscle ache discomfort.

Fever (highest- 102.5 F), dizziness, muscle aches/soreness, chills, fatigue, chest pain, shortness of breath, muscle weakness, night sweats, vomiting, fainting

Vaccine given at 3:30pm Left Arm; At 3:45 she reported that her right arm felt like she had the injection in it. It felt "heavy". She went upstairs to work and felt immediately her LEFT leg felt like it was "falling asleep" pins and needles up calf and back felt heavy.; 3:45 examined, no SOB, lips and mouth okay, right arm non remarkable. 4pm BP 236/80 HR 96 POX 98; 4:15 No change, had her have some water, go for a walk. 4:30 feels the same, pins and needle in leg, but otherwise fine. Working with nurses for next few hours. Told her to report any issues to nurses.

This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration in the left arm on 25Jan2021 (at the age of 22-years-old) as a single dose for COVID-19 immunization. Medical history included sulfa allergy, depression, and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN), and ibuprofen (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 on 08Jan2021 (at the age of 21-years-old; Lot Number: EK9231) for COVID-19 immunization in the left arm. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines (except the first dose) within four weeks prior to the vaccination. On 25Jan2021, hours after the second dose, the patient had severe full body flu like aches, lingering joint pain/some joint, dizziness, exhaustion, and weakness. On 26Jan2021, the patient had soreness at injection sight red and swollen. The patient did not receive any treatment for the events. The clinical outcomes of the full body flu like aches, lingering joint pain/some joint, dizziness, exhaustion, weakness, and soreness injection sight red and swollen were recovering.

Nausea: 2 hours after shot, intense at night and the morning after injection Chills: 2 hours after shot, lasted a day and a half Vomiting: morning after injection Headache: started 2-3 hours after injection until 2 days later Sore Joints, specifically knees: when walking day after injection soreness at injection site: evening after injection to three days out

First 36 hours post vaccine beginning about 7 hours after injection: Freezing cold shakes for several hours straight, fever of 101, vomiting (1x), diarrhea (8-10x, nausea, sweats, dizziness, muscle aches everywhere not just the injection site, incredibly stiff neck, migraine. Took ibuprofen in the middle of the first night and it helped a little. Fatigue and some reasonable arm pain and neck stiffness continued for a while. Migraine has continued since the vaccination; it's been 5 days. I've had to take at least 2 Advil every day to help it. Can't even complete an aerobic workout even with the Advil because my head is shaking so much. I've had mild migraines before surrounding my period, but they always disappear when I sleep and aren't there first thing in the morning like this has been. I feel so bad, I find myself having to keep stop walking during the day when completing a task just to hold my pounding head. Not sure what to do.

Onset: Started 7:30 pm, had vaccine at 4 pm. Occurrence: acute. Symptoms: Dizziness, blurry vision - both eyes, headache, muscle aches, nausea. Patient then went to the Emergency Department - presents to the ED with a chief complaint of a headache that began today. The patient had her COVID-19 vaccine today around 1600 and began experiencing multiple side effects afterward. The worst symptoms for her are the headache and body aches. Her other symptoms include dizziness, blurred vision, nausea, weakness, and muscle soreness in the left arm where the shot. Eyes: Positive for visual disturbance. Gastrointestinal: Positive for nausea. Musculoskeletal: Positive for muscle pain. Neurological: Positive for headaches, dizziness and weakness DIAGNOSIS at time of disposition: 1. Adverse effect of vaccine, initial encounter Acute patient signs symptoms are consistent with an adverse reaction of COVID-19 vaccine. Patient is experiencing the immune response mediated by the vaccine. She is hemodynamically stable, nontoxic, afebrile, well-appearing. She is not taking any medication for symptoms. She is given oral meclizine here in the emergency department for dizziness and nausea. She is given a prescription for this to use at home in addition to Tylenol or Motrin. Patient was instructed to follow up with primary care provider for ongoing evaluation and treatment of current symptoms. Patient was instructed to return to the emergency department for new or worsening symptoms. Patient understood the results, agreed with the plan, and was discharged home in stable condition.

Severe joint pain; chills; muscle weakness, causing minimal ability to walk (bed bound); muscle weakness, causing minimal ability to walk (bed bound); This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on the left arm on 26Jan2021 at a single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus and attention deficit hyperactivity disorder (ADHD). Concomitant medication included dextroamphetamine (dexamfetamine) and ethinylestradiol, norgestimate (TRI ESTARYLLA). The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 07Jan2021 on the right arm On 27Jan2021 10:00, the patient experienced severe joint pain and muscle weakness, causing minimal ability to walk (bed bound) and chills. No treatment was given for the events. The patient was recovering from the events.

After vaccination, client stated that she felt faint . Syncopal episode ensued for 10 seconds with muscle tension in arms per mother's report . MD on site assessed client and ALS / EMS activated at 11:05. Chief informed and patient transferred to hospital at 11:18.

Headache; vomited in the toilet for 15 minutes; Woke up another couple times with soft urgent poop; Woke up another couple times with soft urgent poop; couldn't get comfortable or to sleep because of position and chills/hot flashes; nausea; cold flash; acid reflux; small dose of lower back pain; had arm and shoulder pain; had arm and shoulder pain; uncomfort on side of injection/shoulder joint uncomfort on left side (vaccination side); chills; hot flashes; This is a spontaneous report from a contactable consumer (patient). The 22-year-old female patient received second dose BNT162B2(lot_number: EN 5318?, incomplete number), via an unspecified route of administration in left arm on 15Feb2021 15:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included venlafaxine, ethinylestradiol, norgestimate (TRI-SPRINTEC), loratadine (ALLERCLEAR). The patient previously took z-pak for antibiotic therapy and experienced rash, sertraline hydrochloride(ZOLOFT) and experienced dizziness, first dose bnt162b2(lot: EN5318?) for covid-19 immunization on 26Jan2021 at 03:30 in left arm. The patient experienced started on 15Feb2021 at 10 pm with acid reflux and a small dose of lower back pain, had arm and shoulder pain, uncomfort on side of injection, chills and hot flashes kept waking her up throughout the night, at 2:15 on 16Feb2021 she woke up went to bathroom and had a hot flash/nausea so laid on the floor until cold flash came. At 2:30 She got back up and vomited in the toilet for 15 minutes (total of 10 or so times within the 15 minutes first few were just dry heaving until anything came out.) She took acetaminophen before going back to bed. She woke up another couple times with soft urgent poop. She couldn't get comfortable or to sleep because of position and chills/hot flashes. At 6:30 I was feeling nauseous and still chills. At 11 am she woke up with just a headache and minimal chills. Headache lasted until 5pm or so she had taken meds again for the headache. On 16Feb2021 had acid reflux again. After finally getting to sleep she woke up 17Feb2021 morning with just shoulder joint uncomfort on left side (vaccination side). Therapeutic measures were taken as a result of vomited in the toilet for 15 minutes, headache. There was no treatment for other events. Events were assessed as non-serious. Outcome of events was recovered in Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.

neck pain (base of skull); neck stiffness; nausea; hot flashes; general fatigue; feeling unwell; sick; This is a spontaneous report from a non-contactable consumer (patient). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient was previously vaccinated with first dose of BNT162B2 on unspecified date at single use for COVID-19 immunization. The patient experienced neck pain (base of skull) / neck stiffness, nausea, hot flashes, general fatigue, feeling "unwell" and was sick on an unspecified date. The outcome of the events was recovered on unspecified date. 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. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and were not a congenital anomaly/birth defect. No follow-up attempts are possible. No further information is expected.

On Monday at around 2pm I started having severe pain in my chest near my right breast, and as the day progressed it got worse with a horrible migraine. It began to radiate to the left, and Wednesday I went to Urgent Care because I was scared. My EKG & chest x-ray were clear. Today I feel even worse with migraines, chest pain (that radiates up my neck and around my back), and overall feeling gross and exhausted. My head is what?s bothering me the most along with my joint pain.

face/head was numb on and off for just over 2 hours; Severe arm soreness stiffness for 2 days; Severe arm soreness stiffness for 2 days; fatigue; nausea; This is a spontaneous report from a contactable consumer. A 22-years-old non-pregnant female patient received BNT162b2 (Pfizer-BIONTECH Covid-19 Vaccine) Lot number=EL9262, via an unspecified route of administration in left arm, on 25Jan2021 at 09:00 ( at the age of 22) as a single dose for covid-19 immunisation. There were no other vaccinations within 4 weeks. Medical history included Asthma, rheumatoid arthritis, and insomnia. Concomitant medication included ethinylestradiol, levonorgestrel (DAYSEE). On 25Jan2021, the patient experienced severe arm soreness stiffness for 2 days, fatigue for 2 days, nausea, and on day 4 (29Jan2021) face/head was numb on and off for just over 2 hours. No issues with speech or motor function, but the numbness came and went in various parts of her face, scalp, and outer ears for 2 hours. The outcome of the events was recovered. It was unknown if the patient tested for COVID-19 post-vaccination.

I tested positive for COVID on March 2, 2021 after having all of the symptoms. I had a body rash, no taste or smell, muscle aches, diarrhea, cough, shortness of breath.

I received the vaccine at 4:30 PM and later that night, I had a headache and I felt very out of it. By the end of the day; however, I was feeling better. The next day, I woke up around 5 AM and my muscles were all tensing very strongly and I could not stop shaking. This went on for about 30 minutes, and then I stopped shaking and tensing so much, though my muscles still felt a bit tense. I can't really eat in the morning, so I drank two glasses of water over the course of a few hours and took 2 acetaminophen. I stayed in bed until around 10 AM. Then, I took a shower, but while taking it, I felt very lightheaded and my vision had some black spots, and I had to sit down several times. After I got out, I tried to eat something, but then I felt really nauseous and had acid reflux for at least 30 minutes. Afterwards, I drank a bit of water and went back to bed. My muscles started tensing and shaking again, though not quite as intensely as when I first woke up. I felt very cold, so I turned up the heat and put on warm clothes. I fell asleep for about 20 minutes around 12, and when I woke up I felt a little less nauseous and headache-y. I stayed in bed for an hour, and I ate some pudding over the course of an hour or two, but I thinking about eating much else made me feel nauseous. I fell asleep around 5:30 and woke up again around 7:30. I felt better after waking up, but still had a bit of a headache and my muscles were slightly tense. On Sunday and Monday (today) I felt about the same, physically tired but otherwise mostly ok.

fatigue immediately following then loss of appetite, muscle aches, headache, abdominal pain, lightheadedness, fever, and chills 30min later

Ear pain/pressure, headache, and body aches started on 3/11 around 7pm. Around 11am on 3/11 through the end of the day I was having waves of feeling very hot. No fever. Body aches, ear pressure, and fatigue on 3/12 with radiating left arm pain which stopped. Radiating arm/shoulder pain came back on 3/13 around 12:45PM.

Swollen Lymph Node- Golf ball sized; axillary region, under left arm; Very swollen and painful; lasted for a duration of 7 days

The day after the vaccination I started to feel pain in the armpit area. When I touched the area, I felt a lump about the size of a quarter. The pain nor the size has diminished to this day.

fever; nausea/intense nausea; extreme muscle pain; pain at the injection site; congestion; Couldn't eat much; headache; extreme fatigue; cold sweats; chills; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the left arm on 07Feb2021 at 09:45 (at the age of 22-years-old) as a single dose for COVID-19 immunization. Medical history included depression and anxiety, both from unknown dates and unknown if ongoing. The patient had no allergies to medication, food or other products, and did not have COVID-19 prior to vaccination. Concomitant medications included duloxetine from an unknown date for an unknown indication; ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE) from an unknown date for an unknown indication; ibuprofen from an unknown date for an unknown indication; and acetaminophen from an unknown date for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, it first started as a headache and extreme fatigue about two hours after the vaccine. She took two ibuprofen and felt better for a few hours, but the fatigue kept growing and then she started to get cold sweats and chills. The day after was the worse. She had fever, nausea, extreme muscle pain and fatigue, pain at the injection site, and congestion. She took acetaminophen through-out the day and couldn't eat much. The second day the fever and cold sweats went away but she still had intense nausea. It was the third day (as of 10Feb2021) and she felt better but still had fatigue and minor nausea. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of headache, extreme fatigue, cold sweat, chills, fever, nausea, extreme muscle pain, congestion, couldn't eat much and pain at the injection site were reported as recovering. It was also reported that since vaccination, the patient had not been tested for COVID-19.

Client felt lightheaded when asked how she was feeling. She was immediately advised to put her vehicle in park. Client started seizing and nurse was called over. Her eyes were rolling and her muscles were tightening up. ALS called over. Client regained consciousness but was confused. Fire Dpt. and ambulance was called as well. PT moved to stretcher. While being moved, car seat was noted to be wet. ALS took PT to ambulance, patient transported to local hospital.

Pharmacy gave wrong dosage of vaccine. I was given 0.8 ml of medication instead of 0.3ml. I have not been given the pharmacy report yet to verify dosage or details of why I was overdosed. Between the dates 02/28/2021 - 03/23/2021, I have been feverish, nauseous, tired, headache, chills, diarrhea, pain and swelling at injection site that last 24 days. Ear pain in both ears. Left arm pain from shoulder to elbow for 24 days. Muscle pain. Left leg pain. Treated with prednisone 20mg.

On the evening of my vaccine my left arm became swollen and painful. I then became nauseous, had a high fever of 100 degrees Fahrenheit and suffered from a migraine in the front sinus cavity all night. The next morning of the 27th my symptoms persisted, now accompanied by body aches, specifically my hip flexers were very sore and I was exhausted all day. by the morning of the 28th all symptoms subsided.

Extreme back pain with headache. Hospital visit with multiple medications given including pain medication and Benedryl

Directly after receiving the Pfizer vaccine, my arm went fully numb, was red and hot. I was advised to take allergy medication, which I did. My arm has been heavy and painful since. My throat is sore and I am fatigued. *Not severe reactions, but I'd like to add reporting data for the younger generation. ** Also note that it has only been one day since receiving the first Pfizer vaccine

I first noticed a pain in my left armpit on Sunday 04/04/2021, but I just thought I pulled a muscle or something. Then on Monday, it wasn't any better, and when I looked in the mirror I realized my lymph node was very swollen and tender. This brings me to today where the lymph node in my left armpit is still swollen. I talked to a nurse to be safe, and she told me it should go away within a week-10 days, so I'm not too concerned.

Low grade fever (99.5°), nausea, joint aches, lack of appetite, chills, moderately severe headache, fatigue

Started as a my arm being sore I could not fall asleep then my muscles started to get sore and a fever with chills happened right after and it wouldn?t let me sleep.

Arm pain near injection site that started 3hrs after and increased until pain was almost unbearable in the evening and through the night. I also had headaches the next day, lots of fatigue, strong body aches around neck and upper back, lightheadedness, and chills. I made sure to sleep as much as possible, drink plenty of fluids, eat well, and took vitamins.

Acute nausea onset 4-5hrs after injection. From hours 5-12, experienced continuous vomiting and diarrhea (approx. 5 - 15 minutes between bouts). Between 12-36 hours after injection, symptoms subsided to moderate nausea and extreme fatigue/muscle soreness. Mild nausea and fatigue continued for another 24 hours, then subsided.

Moderate to severe bicep muscle pain on right arm that developed the day after receiving the vaccine. Still currently an issue. Muscle cramping, swelling, redness, bruise formed at injection site.

I looked in the mirror & saw my bottom right eye orbit swelled.; I had fatigue & chills the following day after i got my vaccine.; I had fatigue & chills the following day after i got my vaccine.; I took ibuprofen for the pain in my back & arm; I took ibuprofen for the pain in my back & arm; When I stared to rest, I felt pressure when opening & closing them; This is a spontaneous report from a contactable other hcp (Patient). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8737) via an unspecified route of administration at arm left on 30Mar2021 16:45 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history was not reported. Concomitant medication included vitamin d nos (VITAMIN D NOS). On 31Mar2021 The patient experienced and had fatigue and chills the following day after she got vaccine and took ibuprofen for the pain in my back & arm and when stared to rest she felt pressure when opening & closing them and looked in the mirror & saw her bottom right eye orbit was swollen and was conserved if she was having a reaction to the vaccine and called a nurse & tell a doc. They advised me to do cold compressions & take benadryl. Therapeutic measures were taken. The outcome of the events was recovered.; Sender's Comments: The causal association between the event bottom right eye orbit was swollen and the usage of the vaccine BNT162B2 cannot be excluded based on strong temporal association. As there is limited information in the case provided, the case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Dry heaving, hands and feet went numb while driving (16 hours after). Fever of 102 (while taking max dose Tylenol ATC), myoclonic jerking, hypersensitive skin- it was painful to touch sheets/blankets, muscle aches, DTRs +3: I was concerned I was going to have a seizure. Signs and symptoms resolved at around 0100 on 03/30/2021.

symptoms: sharp shooting/ tingling pains throughout body, emanating from joints, severe chills, and headache. Any slight movement of body was excruciating. pain is still present upon this submission, though significantly less severe than earlier.

Sore muscle throughout bicep, not just at injection site. Occurred about 3 hours after initial injection.

Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; This is a spontaneous report from a contactable consumer via COVID-19 . A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 (at the age of 22 years old) via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included shrimp allergy from an unknown date and unknown if ongoing. The patient did not have any vaccine in four weeks. Other medications in two weeks: ADHD medication and birth control. The patient experienced "left arm, breast, butt cheek, and thigh feel sore/weak - left side only" (as reported) on 10Apr2021 15:00 with outcome of not recovered . No treatment was received. The patient did not have covid prior to vaccination, was not tested post vaccination Information on Lot/Batch number has been requested.

Around 3:30am on Sunday, I woke up due to feeling very cold. My teeth were chattering and regardless of the amount of layers of clothes or blankets added, I could not get warm. Later in the day I checked my temperature and it registered at 100.6 degree Fahrenheit, but I did not feel as cold as I had earlier that morning. I also had what felt like a sinus headache and my whole body felt stiff/achy. There was also some slight nausea that occurred. The nausea and slight fever went away by 11am, but the headache and body aches lasted until about 9PM Sunday night. After my nausea went away I was able to take some Aleve to help with the stiffness. At the site of injection, it is slightly raised red bump (about two inches across horizontally and vertically), and there is some slight pain in the armpit area on this side as well. The swelling of the bump was slightly bigger yesterday, but the swelling has gone down some this morning.

Symptoms started five days after vaccine. Symptoms gradually lessened and I am now on week 4, I was bed ridden through week 3. Symptoms included my body feeling strange, visual disturbances, migraine aura (no previous history of migraines), chest pains, hot breath, temperature changes, faint feeling, fatigue, head pains all around head, pain in spinal chord, pain and numbness on entire body (mostly head), confusion, heat around nape of neck, ringing in ears, nausea, weight loss, strange breathing (not soreness)

Pain in my joints and muscles started later that night after having the vaccine administered. When I woke up the next morning my whole body hurt so bad I could barely move. Over the next few days I felt better in some ways but my joints and muscles still hurt and they never have before. I am still feeling aches . I did not go see anyone as I do not have insurance.

On April 5th, 2021 I went to the E.D. , for shortness of breath and severe right shoulder pain. While there they got a chest x-ray, ran labs, and did a chest CT. The CT revealed that I had one blood clot in my left lung and two blood clots in my right lung, as well as slight pleural effusion in the right lower lobe. They put me on Xarelto for the next 3-6 months and monthly follow up visits with my primary care provider. I was also given Hydrocodone as need. I experienced extreme pain with breathing and sort of movement for a week and half but currently only have occasional shoulder and back pain usually at the end of the day.

Muscle aches, fatigue hours after the injection. 12hours was hard to sleep accompanied by all over body aches. Body aches continued into the day after the injection, accompanied by headaches, fever, and fatigue.

VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/08/21pfizer,Lot#EL3248 2nd dose: 01/29/21Pfizer,Lot# EN5318 Diagnosed covid positive:04/23/21 Exposure:Home Exposure Symptoms:Fever, sore throat,fatigue,chills,muscle aches,runny nose,loss of smell/taste,HA

Full vial of vaccine given. Patient reported arm heaviness in left arm. Patient also reported some minor neurological symptoms. Patient was sent to ER and discharged to home later the same day.

Site: Pain at Injection Site-Medium, Systemic: hotness in the arm 30 mins after numbness in fingers and weak arm-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium

I woke up with a high fever of 102 about 13 hours after my second dose of the Pfizer vaccine. This developed into nausea, headache, dizziness, and muscular weakness/soreness for about 20 hours after. I still have some muscle soreness, and I have recently developed some minor digestive issues.

Onset of headache 7-8 hours after injection Restless light sleep the night following injection (potentially caused by fever) Fever of 100.3 noted upon waking the following morning Inability to sleep and generalized muscle aches over the course day following injection Fever of 100.7 noted 24 hours after injection 650mg Tylenol taken 26 hours after injection--All symptoms (headache, fever, muscle aches, inability to sleep) cleared within one hour of taking Tylenol Intercostal muscle soreness with no apparent cause localized to upper left side 48 hours following injection-- cleared within 24 hours

feeling antsy/cannot relax even though she was tired; can not relax even though she was tired/tiredness; muscle and joint pain; muscle and joint pain; headache was worse/headache very much so; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 21Apr2021 (at the time of 22-year-old) at single dose for COVID-19 immunization. The patient medical history included chronic migraines. Concomitant medications were not reported. The patient previously took acetylsalicylic acid/caffeine/paracetamol (EXCEDRIN) for chronic migraines. On an unspecified date it was reported that patient had the first dose of the Pfizer covid 19 vaccine yesterday, 21Apr2021. She has underlying health issues. She was feeling antsy which only started today. it was not like her heart was racing or beating really hard, just she cannot relax even though she was tired. She has chronic migraines and took Excedrin earlier. It was also reported that maybe the ingredients of the vaccine do not coincide with the caffeine in the Excedrin. She has muscle and joint pain bad today, but her arm was fine. Tiredness and headache very much so. The headache was worse today. She took fiorinal with codeine for the bad headache because the RPh (registered pharmacist) said it was ok. she read side effects and asked the agent if agent was saying that feeling antsy is not a side effect of the vaccine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Muscle aches: 10:00 pm 4/29- 1:00 am 5/1 Fever: 3:00pm 4/30-6:30pm 4/30 Chills: 12:00pm-8:00pm 4/30 Fatigue: 8:00am-6:00pm 4/30

constant pain in my neck. On a scale of 1-10 it's a 6-7; Upon getting shot in my left arm, not only did my arm bleed; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 15:00 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation, at 22 years old. The patient has no medical history. The patient's concomitant medications were not reported. Patient is not pregnant. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient has no known allergies. On 15Apr2021 15:15, upon getting shot in patient's left arm, not only did patient's arm bleed after, but a minute or two (15:16) after she had a constant pain in her neck. On a scale of 1-10 it's a 6-7. Treatment was not given. Outcome of the event was not recovered.

14 days after first shot, Pt had stinging/burning pain in her right big toe at bedtime. She thought she hurt her toe working out. As days went on, pain got so bad she went to urgent care for an x-ray. They found nothing wrong. The foot started to swell. Went to the school to see dr there. They said not broken just irritated the sesamoids under her big toe. 4-6 weeks to heal in a soft boot. The on April 16th she got her second shot. As she sat there waiting her 15 mins, she said her right foot went numb. We then went home. That night we iced her bad right foot and I noticed both feet were purple!! I looked up reactions to shots and it actually said it is a side effect. I called my doctor and he said the fact that the toes turn purple and then back to normal was ok. 9 days after the second shot she said the same pain started in her left foot. She can't walk on either foot!!! It is neuropathy from the shots!!! My doctor is scheduling tests for her.

No adverse effects after does shot. 12 hours after second shot symptoms began: chills, slight nausea, extreme tiredness, slight headache, back ache. Nausea lasted a few hours, chills stopped after 12 hours, extreme tiredwas gone the next morning when I woke up at 10 am. Slight headache in the morning on days 2 and 3

muscle aches, fatigue, headache, low grade fever, joint pain, shakiness. Symptoms started with a headache at 2am on 5/2, grew steadily worse throughout the night/day, but only lasted until about 4pm on 5/2. Tylenol helped alleviate symptoms.

Symptoms began around 12 hours later. Fever in 100s, chills, muscle soreness, aching right arm, pounding headache, and extreme fatigue. Nausea began around 18 hours later but only lasted for 20 minutes. Fever did not break until nearly 24 hours after the vaccine was administered. Extreme fatigue well into the next day.

Pain and tingling immediately and thereafter. Weakness in arm. Doctor thinks a nerve was hit with the vaccination needle.

Fatique; Muscle pain; HA; Tinnitus / Ringing in her ears; This is a follow up spontaneous report from a Pfizer sponsored program. A 22-years-old contactable female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Patient previously took first dose of BNT162B2 for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. Patient received the series for covax a month ago (Pfizer covid vaccine 4 weeks) and still having side effects. Her-side effects started after the 2nd covax with fatigue, muscle pain and HA. Now ringing in her ears, she knew that some of the side effects resolved within a few days, but she is still having tinnitus that has still going. Patient asked how long will side effects last. She wanted to know about the duration of this side effect to know if this is permanent or not. Patient was aware that there were thousands of reports of tinnitus for the covid vaccine. Patient got response that there were no reports of Tinnitus and the duration of each side effect is different between patients. Recommended to consult her physician about treatment recommendations. The side effects reported goes away in some days, but we did not have any report that is permanent. There were unaddressed medical questions referred or forwarded to Medical Information. There was no PQC. Outcome of the events fatigue, muscle pain and headache were recovered on unspecified date. Outcome of the event ringing in her ears was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Symptoms: joint pain and inflammation Diagnosis: Rheumatoid Arthritis (no hereditary history) Progressive course

Headaches, neck and shoulder pain, fatigue, body aches, started 12-14 hours after receiving second dose, used Tylenol as treatment, worked for 4-5 hours

patient had aggravated the sesamoid bones in her right big toe/ Diagnosed with sesamoiditis of right foot; Pain in right big toe after first vaccine/It was stinging and burning and painful.; Pain in right big toe after first vaccine/It was stinging and burning and painful.; This is a spontaneous report from a contactable consumer (patient's mother) who reported for her daughter (patient) that a 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in arm on 26Mar2021 as 1st dose, single for covid-19 immunisation. Medical history included having the COVID virus in Feb2021, her symptoms were mild, she lost her sense of taste and smell; patient started her period before the shots (HPV vaccine) they weren't regulated yet. Family history included cancer (patient's father). No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Concomitant medication included unspecified pill to help regulate periods. Patient previously received first dose of HPV vaccine vlp rl1 4v (yeast) (GARDASIL) in May2011 (Lot Number: 0087Y), second dose in Jul2011 (Lot Number: 0087Z), third dose in Nov2011 (Lot Number: 06918A), all for immunization at the age of 13 years. The mother reported that she believes her daughter had an adverse reaction to the HPV vaccine. Stated that the following year they were going on a family vacation in Jun2012. She took the kids to get their annual blood work and her daughter's (patient) came back abnormal. Patient was retested and was told that she had Hashimoto's Thyroiditis in Jul2012. When patient went to high school she had a lot of problems with her menstrual cycle, her period stopped. They thought maybe it was because she was thin and played a lot of sports. Then patient was diagnosed with premature ovarian failure. Patient had started her period before the shots so they weren't regulated yet; but after the Gardasil vaccines it was worse. Stated that patient does not produce estrogen and has to take a pill; also takes a pill to help regulate her periods. No further information provided about these pills. The mother said they are worried she will have a hard time having children. Patient has periodic ultrasounds of her ovaries and has been told they look normal. The mother stated she did not want patient to get the COVID Vaccine after this experience, they believe was related to the HPV Vaccine. Stated patient was very anxious about COVID-19; worried she would give it to her parents, especially her father who has cancer. Patient had the COVID virus in Feb2021, her symptoms were mild, she lost her sense of taste and smell. The mother consulted with their family doctor who said it didn't make a difference how long patient waited after the Covid Virus to get the Covid Vaccine. Patient became eligible to receive the vaccine in Mar2021. Patient got the vaccine and about 9 days later, the mother thought she had hurt her right big toe. It was stinging and burning and painful. The patient was seen at an urgent care and at an institute. The doctor at the Institute said patient had aggravated the sesamoid bones in her right big toe and was diagnosed with sesamoiditis of right foot on an unspecified date in 2021. The patient was given a walking boot to wear. The events did not require a visit to emergency room (discrepancy noted), but they visited physician office due to pain in right big toe after first vaccine. Outcome of the events was not recovered. No follow up attempts are needed. No further information expected.

Symptoms: 9pm-1am weakness and muscle aches 10pm-12am fever ranging from 100 degrees to 101.7 degrees, shivering, chills

First dose Pfizer administered 1158. Patient immediately stated she was not feeling well. Patient described tongue and jaw "tingling", lightheadedness, difficulty speaking, and difficulty swallowing. Patient was noted to be slurring her words. Both hands were also noted to be stiffening with patient stating her hands were "numb", unable to grasp writer's hand, with shaking of legs. Epinephrine was administered at 1203. EMS called at 1204. Vitals at 1205: blood pressure 115/71, HR 128. Patient was still in distress - verbalizing difficulty speaking and swallowing, rapid breathing, legs shaking. A second dose of epinephrine was administered at 1209. Vitals at 1210: blood pressure 115/63, HR 133. Pulse ox at 1214 was 100% with HR of 105. At 1216, patient stated her tongue and jaw were still "tingly" but the lightheadedness, hand numbness, and leg shaking had subsided. Vitals blood pressure 109/65, HR 100. 1220: Tongue and jaw tingling "calming down" per patient. 1223: Patient states "everything is back to normal" No tongue swelling or jaw tingling. Vitals: blood pressure 104/60, HR, 95, oxygen 100%. EMS arrived 1252 - vitals blood pressure 102/64, HR 104. EMS asked patient if she wanted to go the ER, patient declined stating that she feels back to baseline except lethargic post epi. Patient had no complaints at this time. Patient was advised to have Benadryl on hand and to follow up with her PCP or go to the ER if any symptoms of a reaction return. Her fiancee states he will be home with her today.

Severe muscle soreness/pain at injection site, muscle soreness, headache, sore throat, limbs falling asleep, slight fever

22 year old female pt present today due to a LARGE lump on her left armpit. Patient states has always had pea like pimple under arm pit area but 2 weeks ago noticed growth and its is getting bigger, Warm to touch from scale to 0 to 10 pt states pain is a 7, worried because her breast is also tender. Patient admits took pfizer vaccine and after first dose she develop a "bump under her axilla on left side, pt went to get second vaccine 5-17-2021 and used right arm due to the bump on left and now both axilla are hurting, swollen mildly and pain in both breast. NO fever, no pus , no erythema, mostly pain as per patient.

Woke up the morning after receiving the shot & felt fine, so I went to work. As the day went on, I got muscle aches and pains all through my body (especially in my left arm - the injection site - of course) and fatigue. It continually worsened throughout the afternoon and evening, despite bedrest and proper hydration, and I could barely sleep. However, the next morning I woke up just as I did the day before - no problems, feeling fine.

Full body/muscle aches, headache, nausea, fatigue, generalized weakness, dizziness, tiredness (distinct from fatigue), injection site pain, chills AND overheating, polydipsia, and joint pain.

Within 30 minutes of the injection she developed forceful, involuntary muscle contractions to her abdomen and B. hands. Had less severe muscle contractions to jaw. She has had similar reactions to compazine and to influenza vaccines.

Started experiencing dizziness on the day of the second dose (4/30/21). Dizziness continued for 2 weeks and then stopped for a week and came back and have been experiencing it for almost 2 months now. Have gone to 7 doctor visits including an opthemologist, the emergency room twice and my primary care physician and a walk in clinic. I have been prescribed servers medications which do not alleviate the symptoms including meclazine, hydroxaline, scopolamine, amoxicillin, prednisone, Valium, and reglin (for headache). About 3 weeks after getting the second dose I began experiencing headaches so I went for a CT scan in the ER on 5/24 which came back normal. I returned to the ER on 2/27 with blurry vision and was sent for an MRI on my brain and neck which also came back normal. I have upcoming appointments with a neurologist and an ENT next month. I have also been experiencing muscle aches for the past 3 days specifically in my joints, my arms, and legs. I have also had headaches that feel like my head it being sliced or stabbed on the right side.

Night of vaccine there was mild pain in arm, the following day severe pain and not wanting to lift arm from said pain. Joint pain, aches and headache at the same time. Next day sore arm.

Chills; Shaking; Body joint ache; Sore arm; Slight dizziness; Fatigue; Nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 22-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 20Mar2021 at 11:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not receive any concomitant medication in two weeks prior to the COVID-19 vaccine. The patient was not allergic medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 19:30, the patient experienced chills, shaking, body joint ache, sore arm, slight dizziness, fatigue, and nausea. The treatment received for the adverse events included ibuprofen. The clinical outcome of chills, shaking, body joint ache, sore arm, slight dizziness, fatigue, and nausea was recovered on an unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.

Sore arm; Burning sensation; Muscle stiffness; Infection; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: ER8727), via unspecified route of administration in the right arm on 20Mar2021 at 15:15 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included erathema nodosum and allergy. Concomitant medication included birth control (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown date. The patient has not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient has not tested for COVID-19. On 21Mar2021 at 00:00, the patient had experienced sore arm, muscle stiffness, burning sensation and infection. The patient did not receive any treatment for the 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 sore arm, muscle stiffness, burning sensation and infection was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Systemic: Body Aches Generalized-Medium, Systemic: chief complaint of left neck muscle soreness (opposite of inj site)-Medium, Additional Details: Pharmacist who gave the vaccine was contacted and explained that the immunization encounter "was just a very normal" one. No reports of adverse events were given to the pharmacy personnel.

around 1.5 weeks after 2nd vaccine dosage, I began experiencing severe, debilitating pain in my arm/shoulder. With no prior injury, sickness, history, accident, or physical activity, I had no idea where the pain was coming from. I've never broken a bone, I'm healthy, and I hadn't done any strenuous activity in the past year. The pain continued and worsened to the point I was unable to use my arm, sleep laying down, and act without pain medication. Almost 2 weeks and no pain subsiding, I went into a walk in ortho clinic where they found abnormal x rays of my arm/shoulder. My humorous bone was in the wrong place because the muscles were weighing down & there was no fracture/anything wrong with the bone. After a visit to an orthopedist, I was treated for **parsonage turner syndrome** and put on steroids. Currently scheduled for physical therapy and still only have limited use of my arm.

Chest pain, upper back pain, shortness of breath, O2 at 90% on room air, pain radiating from injection site down arm, headache, pain down left side of neck, nausea, UTI, rash

Symptoms after my second dose of Pfizer is a missed period, armpit pain (like a popping sensation), neck stiffness, muscle aches, headache, vaccination site soreness, and gastrointestinal changes. 2nd shot took place on July 5, 2021 at 3-3:15pm.

Dizziness and lightheadedness, turned into neck pain, nerve pain down right and left arm, back pain, loose hip joints, hip pain, cervical headaches

The first dose I experienced flu symptoms with a body ache/chills/headache that lasted for about 2-3 days. 2nd dose, next day had a fever/chills/headache/body aches, a few days later experienced shortness in my breath, numbness, and pain in both legs, extreme lower back pain and abdominal pain/cramping and the pain is still there, I have 2 swollen lymph nodes located in my groin area. I have seen the Dr a few times and had a CT scan. They discovered I have an enlarged liver/swollen spleen that they found a blood clot, the doctor has me taking aspirin for 3 months, and will need to follow up with another CT scan

Eight hours after receiving the first dose, I experienced flu like symptoms, muscle aches, joint pain, chills, headache, and a fever. Then those symptoms went away. I had pain in the injection site for two days. In April 2021, I spent 4 nights in the hospital. I was diagnosed with Myocarditis. I was also hospitalized for 3 days in May as well. On the 8th of July, I spent 1 day in the hospital. I received blood thinners when I was in the hospital. I am currently taking anti inflammatory medication.

Received Pfizer vaccines on 4/15/21, 5/10/21. Tested positive for COVID19 by PCR on 7/15/21, symptom onset date of 7/13/21; known exposure to COVID-19, symptoms of New headache, New muscle aches, New cough, New sore throat

This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 29Mar2021 at 16:30 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. Concomitant medications included escitalopram 10 mg (MANUFACTURER UNKNOWN) and ethinylestradiol, norgestimate (TRI FEMYNOR); both started on an unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 09Mar2021 at 16:30 (at the age of 22-year-old), as a single dose for COVID-19 immunisation. It was unknown if the patient had any known allergies to food, medications or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 at 12:00, the patient experienced severe muscle aches, hypersensitive skin (washing hands was uncomfortable and anything bumped into was hurt 100 times worse), headaches, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any therapeutic treatment for muscle aches, hypersensitive skin, headaches, chills and fatigue. The clinical outcomes of the events severe muscle aches, hypersensitive skin, headaches, chills and fatigue were not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Sharp pain under the left rib cage (around spleen area) when bending, laughing, etc. It started the night after receiving my second shot of Pfizer vaccination.

Administration of the vaccine was unremarkable beyond a mention of pain/discomfort during administration. Roughly 1 minute post she began experiencing dizziness, complained of nausea then became verbally unresponsive; exhibiting all the signs of a seizure- including an absent gaze and muscle tensing/spasming most noticeably of her legs and hands- which abated after 1 to 2 minutes. She did not sustain any physical injuries . She continuously refused any additional care. Stating "heck no" at the suggestion EMS come even just to check her out. She gradually recovered over the next 20 minutes before requesting to use the restroom. I had a female associate accompany her as she was more comfortable with a female staff member and that staff member could alert me if her condition changed at all. She then remained at the pharmacy for approximately an additional 10 minutes and seemed completely lucid and oriented. While marked as 'no' on her VAR she and her companion then recounted several past seizures matching this one. None of which were associated with a vaccine. She further stated that she has been medically evaluated but no definitive diagnosis was made. At this point she asked to leave. I offered follow-up care/evaluation one last time and she declined. At this point she left under her own power.

right side weakness; tingling/ numbness in limbs; muscle twitches/ spasms; palpitations; dizziness; nerve, muscle & joint pain; nerve, muscle & joint pain; nerve, muscle & joint pain; altered sensations; heat & humidity intolerance; heat & humidity intolerance; difficulty concentrating/ finding words; balance and gait issues; balance and gait issues; fine muscle movement issues- hands; blurring vision; muscle spasms; tingling in limbs; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in right arm on 14May2021 10:45 (Age at vaccination: 22 year) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included hypothyroidism from an unknown date and unknown if ongoing and migraine from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE) taken for an unspecified indication, levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication and topiramate (TOPIRAMATE) taken for an unspecified indication. The allergies include Azithromycin. The patient previously took bnt162b2 dose 1 via an unspecified route of administration, administered in right arm on 23Apr2021, 10:45 AM dose 1, single (lot number: ER8732) for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On an unspecified date in May2021, the patient experienced right side weakness, tingling/ numbness in limbs, muscle twitches/ spasms, palpitations, dizziness, nerve, muscle & joint pain, altered sensations, heat & humidity intolerance, difficulty concentrating/ finding words, balance and gait issues, fine muscle movement issues-hands and blurring vision. AE resulted in: Doctor or other healthcare professional office/clinic visit. The event outcome was not recovered. No further information is expected. Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected

Constant pain in left armpit (arm where shot was received). Intermittently worse at times. A small cyst developed in left shoulder/neck area. Painful with pressure.

Patient calls in reporting new fast breathing, fever, diarrhea, vomiting, chills, muscle aches, shaking/chills

Swelling in the armpit and breast on the same side as the injection; Pain in the breast on the same side as the injection; Pain in the armpit on the same side as the injection; Body aches; Low grade fever; Fatigue; Light, red and non raised rash at the injection site; Non raised rash at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 27Apr2021 at 13:45 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and food allergy. Concomitant medications were not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 06Apr2021 at 14:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 15:30, the patient experienced pain and swelling in the armpit and breast on the same side as the injection, body aches, low grade fever, fatigue, light red non raised rash at the injection site. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with BENADRYL. The clinical outcome of the event swelling in the armpit and breast on the same side as the injection, pain in the armpit and breast on the same side as the injection, body aches, low grade fever, fatigue and light red non raised rash at the injection site were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

When I take deep breath my chest hurts; Chills; Pain in the arm where I got the shot; Feeling cold; This is a spontaneous report from a contactable consumer. A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0185; Expiration Date: 01Aug2021, at the age of 22-year-old), dose 2 via an unspecified route of administration, administered in Arm Right on 19May2021 as dose 2, single for covid-19 immunisation. The patient medical history included pneumonia and covid both on an unspecified date in June2020 (Last year like around June. I did get COVID like the actual COVID and that gave me pneumonia but that was back in June. I was admitted to the hospital and they prescribed some medicines to take but I dont remember those. I am not taking those medication anymore) and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0170; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 28Apr2021 as dose 1, single for covid-19 immunisation. The patient stated, she got second dose of Pfizer vaccine today, during the day she was fine but had some pain in the arm where she got the shot but right now when she took a deep breath her chest hurts. She had lot of chills and wanted to know if that was normal? She stated, she was around 160 pounds, she thought she gained weight, it's around there 160, 161. It's one of that two. Stated, no just a pain reliever for this, Acetaminophen, 500 mg, this is the first time that she took it today. She did take it around 4 pm, so this was her second one. The outcome of event for when I take deep breath my chest hurts was not recovered and for the other events it was unknown. Follow up needed, further information has been requested.

First 30 minutes after vaccination: Hot tingling sensation in forehead Cold tingling sensation on tip of tongue Slightly numb left leg Slightly upset stomach First day after vaccination: Sore throat Fatigue Stiff arm

Arm pain at the injection site that started several hours after the injection. The next day she began having pain in her armpit and under her collar bone on the same side as the injection.

Fatigue; muscle soreness at site; muscle ache; mild joint pain; fever 100.1; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 28Dec2020 12:00 at single dose at left arm for COVID-19 immunization. Medical history included known allergies: Penicillin, erythromycin. Concomitant medication received in two weeks included melatonin. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 15:00 (03:00 PM), the patient experienced fatigue, muscle soreness at site, muscle ache, mild joint pain, fever 100.1. Treatment received for the adverse events included Acetaminophen. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Muscle aches, chills, pain at injection site; Muscle aches, chills, pain at injection site; Muscle aches, chills, pain at injection site; This is a spontaneous report from a contactable nurse, the patient. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Ek9231) solution for injection intramuscular in the left arm on 26Dec2020 at 10:30 (at the age of 23-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020 at 01:00, the patient experienced muscle aches, chills, and pain at injection site. No treatment was provided for the events muscle aches, chills, and pain at injection site. The outcome of the events muscle aches, chills, and pain at injection site was recovering. Since the vaccination, the patient has not been tested for COVID-19.

Injection site soreness; Headache; Nausea; Body aches; stiffness in neck and shoulder area; Muscle soreness; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscularly on 21Dec2020 at 09:00 AM on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included pre-diabetes, previous liver failure from ciprofloxacin (CIPRO) in 2019, 3 septoplasty due to recurrent sinus infections and nasal cysts in 2016 and 2017. Known allergies included Ciprofloxacin. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included Metformin, Spironolactone, Sertraline. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site soreness, Headache, Nausea, body aches, muscle soreness and stiffness in neck and shoulder area on 22Dec2020 at 02:00 AM. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered with sequel in Dec2020 (also reported as Recovered with lasting effects). The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.

Chills, fever, headache, muscle aches, fatigue beginning around 3pm 1/5/21 and ending around noon 1/6/21

Fatigue and overall lethargic feeling/Sore throat; Dark colored urine despite pushing fluids; Frequent urination; Migraine; Swollen joints and could not move arm that received vaccine in; Swollen joints and could not move arm that received vaccine in; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Chills, body aches, spiked fever of 102.; Chills, body aches, spiked fever of 102.; Chills, body aches, spiked fever of 102.; Fatigue and overall lethargic feeling; Fatigue and overall lethargic feeling; Sore throat; The initial case was missing the following minimum criteria: Invalid for no adverse effect. Upon receipt of follow-up information on (31Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EH9899, Expiry Date: Mar2021), intramuscular at Deltoid Left on 29Dec2020 07:20 at single dose for COVID-19 immunization. Medical history included covid-19 from Nov2020 to an unknown date (had covid in the middle of November), surgeries from an unknown date and unknown if ongoing (She also had previous surgeries and has foreign objects in her body. Those areas were super hot. Those antibodies were like rejecting those foreign bodies because they were super hot.) There were no concomitant medications. Received call from RN calling about the Pfizer COVID vaccine. She got the vaccine on Tuesday and had a terrible reaction to it and she called a couple of different hotlines and spoke with the people who administered it. She confirmed that she did not report to Pfizer though. The people at her work that she spoke with told her to go to an Urgent care. They told her she should not get it within 90 days of having COVID. She had COVID in the middle of Nov2020. She went ahead and got it on Tuesday and had this terrible reaction. She would like to know if she should get the second dose or wait until 90 days after she had COVID and start again. There was no prescriber. She received it as part of the (hospital name withheld) front line health worker precaution. She thought that this was a normal reaction, but was told it was not. Fatigue and overall lethargic feeling happened exactly 12 hours after receiving. She works night shift and that is her base line. Pretty much everything hit after that within an hour. She was told low grade fever was normal, but not 102. She never spikes fevers, so it is medically significant. It persisted for 24 hours and is better today. She is on the 48 hour mark now. Stomach pains, nausea, diarrhea, lymph node swelling all over, including swelled armpits and groin area, Migraine, Frequent urination, were also listed as side effects. She was trying to push more fluids but her urine was dark color more than normal, despite pushing fluids. Swollen lymph nodes in her groin and armpits were concerning. Her head is lumpy. Meaning, she can feel swollen lymph nodes in back of neck area. Migraine was consistent through 24 hours and now has improved. Urine color remains dark and she will keep an eye on color. She had swollen joints, but really terrible swollen joints, and she could not move the arm that she got the vaccine in. She could not lift to above shoulder height. AE Details and time of onset: Sore Throat 12:00 on 29 Fatigue and overall lethargic feeling 20:00 Chills, body aches, spiked fever of 102: 21:00 Stomach pains, nausea, diarrhea, swollen lymph nodes- 21:00 Migraine- 21:00 Frequent Urination 23:00 Dark colored urine despite pushing fluids 23:00 Swollen joints and could not move arm that received vaccine in: 21:00. ER or physician's office required: Went to urgent care 36 hours after administration. No treatment given. She just wanted to make sure no additional infection was causing anything weird. All test were negative. Prior Vaccinations (within 4 weeks): none. Events Swollen joints and could not move arm that received vaccine in, Stomach pains, nausea, diarrhea, swollen lymph nodes, Chills, body aches, spiked fever of 102 were serious with criteria of medically significant, while the other events were non-serious. The outcome of the event Fatigue and overall lethargic feeling/Sore throat (Condition worsened) was unknown, the outcome of the events Swollen joints and could not move arm that received vaccine in, Chills, body aches, spiked fever of 102., Migraine, Dark colored urine despite pushing fluids, Frequent urination was recovering, while the outcome of the other events was not resolved.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to 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.

Presented to ED 1/3/2021 Tachycardia, fever, headache and myalgia. Complaints of shortness of breath.

Approximately 1 hour after receiving the vaccine I developed tachycardia that ranged between 130 and 95, this lasted from 01/08/2021 until 01/09 ~10 AM. On 01/08 ~5 PM I began to develop a fever that reached a peak of 102.4 at 4am (01/09), despite taking 1000 mg of acetaminophen every 6 hours. Last fever recorded 01/09 ~9PM of 99.5 (while still taking 1000 mg of acetaminophen every 6 hours). Additional symptoms have been severe nausea, dizziness, lightheadedness, bilateral lower back pain with some mild bruising to the kidney region, difficulty breathing, chest pressure, shortness of breath along with a cough upon exertion (developed ~6 PM 01/08), which is still present today (01/10 1:25 PM), and an erythematous rash that covers the anterior side of the right forearm, from wrist to elbow (first noticed on 01/10 ~11 AM).

The night of the vaccine I became very fatigued, had moderate muscle aches, and a mild headache. In the middle of the night I woke up with severe chills, severe muscle aches, and mild headache. The next morning I had a temperature of 99.3 which climbed throughout the day to a temperature peaking at 100.9 in the evening. I had moderate chills, severe muscle aches, severe body aches, mild headache, and moderate injection site soreness. I also felt generally ill. I took Tylenol and ibuprofen alternating starting the evening of the vaccine. Day 2 after the vaccine my temperature is 98.6, I have mild body aches and mild headache. No other symptoms remain.

Fever, tyneol lowered it. Cant break 99.0°. Cough. Fatigue. Joint pain in legs. Migraine. Tightness in right leg, very painful. Possible blood clot? Testing in process.

After around 12 hours from getting my vaccine, I experienced strong aches, mild fever, and headaches. Treated with ibuprofen. 21 hours post vaccination was the peak of the symptoms, temperature of 101.6 with ibuprofen, strong body aches, weakness, and anorexia. Symptoms became more mild at hour 31 post vaccine. I had a swollen lymph node after the first vaccine above my left collarbone (injected on left side) and still have this, and now I have a swollen armpit that is very painful on my right side (injected on the right side).

Joint pain for 1 day, all over muscle ache and fatigue for one day, and headache for one day; not resolved

woke up in the middle of the night with a fever of 100.2 degrees F and muscle soreness took Tylenol 500mg at 5am then at 8am fever and muscle sorenessbeginning to come back around 5pm

Around 9pm, I started getting the chills and some body aches. Body aches were worse in my hands, neck and lower back. By 10pm I felt extremely exhausted, continuing with body aches and chills. Around 12am I had a fever of 102.6 and extreme 10 out of 10 lower back pain. I have never felt more sick in my life. The back pain was so severe I thought I was having a kidney stone. I was ready to go to the hospital. The fever lasted until about 4am when I took some ibuprofen. I felt tired and had mild body aches until 3pm the following day.

Fever, chills, body and joint aches, headache. Currently taking ibuprofen to decrease symptoms. Symptoms started roughly 12 hours after the vaccination was received.

c/o temp 100.6, chills, sore throat, & muscle aches 12 hours after receiving vaccine. Symptoms resolved in 48 hours

Per email received on 1/18-So I had my first dose of Pfizer?s covid vaccine last Friday (3pm). I experienced several side effects that day: lightheadedness, dizziness, fainting, nausea, throat constriction leading to shortness of breath and difficulty in swallowing, hives, flushed face, and fatigue. The throat constriction honestly frightened me and I almost went to the ER, but it eventually went away. For Saturday and Sunday, I developed fever, muscle ache, and extreme fatigue. Today, I thought it would get better but I still have fever and the extreme fatigue has not gone away. And unfortunately, as I am typing this, I think my tongue is getting quite swollen and is making it uncomfortable to breathe and swallow

Pain to the arm which traveled to my arm pit the next day with swelling to lymph nodes on axillary region causing pain at rest and increased pain with movement. Pain is reduced today but is still present at rest

Injection site soreness/muscle pain - ongoing soreness Tiredness - general tiredness/fatigue Headache - started morning after vaccination Chills - lasted a couple hours before fever started Fever - started after chills subsided Chest pain - lasted a couple hours simultaneously with chills

About 5 hours after receiving the second dose, the arm that had been injected started to feel very sore. I also began to feel a soreness in the back of my throat and my ears. Mild fatigue was also observed. Around 2am, 14 hours following the injection, I woke up with whole body muscle aches and a mild fever. Mild fatigue, muscle soreness and arm soreness continued into the next day.

Pfizer-BioNTech COVID-19 Vaccine EUA Symptom onset was 2 weeks after second vaccine. Initially started with 48 hours of neck pain on the left side which then progressed to left sided facial drooping, inability to taste on front of tongue, decreased tear production in the left eye. Consistent with Bells Palsy. Started course of methylprednisolone today. No improvement yet.

1/8/21 evening: arm swelling (baseball-size circumference surrounding vaccination site), onset of fatigue 1/9/21 morning: onset of dehydration, worsening of arm soreness (limited ROM) 1/9/21 evening: fever--onset near 10PM (unsure of highest temp. Temp after 400 mg ibuprofen: 99.6 F. Fever broke after 3AM.), body aches (mild-moderate in both arms, all fingers, back, and both knee 1/10/21 evening: shortness of breath/coughing fits (required use of inhaler--3 puffs with symptom onset. Mild shortness of breath for remainder of day w/o need for inhaler), mild altered taste (only lasted approx.2-3 hours) 1/11/21: onset of arm itchiness surrounding site of vaccination, frequent urination (at least every hour) 1/12/21: worsening of arm itchiness (itches from shoulder to elbow), ROM improving at this point but still painful to touch 1/13/21 morning: worsening of dehydration (back pain, headaches, muscle cramps), arm itchiness improving at this point 1/13/21 evening: urination frequency returning to normal, back aches (from dehydration, less severe than morning), headaches continuing (less pain with ibuprofin, but on/off pain still present), nausea improving at this point 1/13-1/14: late start to menstrual cycle 1/14/21: most symptoms improving at this point, headaches and nausea still mild 1/19/21: first full day with no nausea 1/21/21: first full day with no headaches 1/22/21: symptom-free

where patient experienced chills; skin sensitivity; joint pain in upper/lower back and fingers; sensitive/painful lymph nodes; and ran a 102.3 fever for several hours/Patient broke fever on 13Jan2021; body aches; headache; This is a spontaneous report from a non-contactable other HCP. A 23 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 12Jan2021 at 07:30 intramuscular at single dose for COVID-19 immunization. Relevant medical history included asthma and allergy to ibuprofen. The patient received first dose of vaccine on 24Dec2020 at 05:00 intramuscular on left arm. Concomitant medications were not reported. On 12Jan2020 at 19:30, the patient experienced chills, skin sensitivity, joint pain in upper/lower back and fingers, sensitive/painful lymph nodes in armpits/groin/neck, and fever (ran a 102.3) for several hours. Patient recovered from fever on 13Jan2021 and was recovering from other reported events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

01/23 sat left arm soreness and left axillary intensified pain/ was so uncomfortable/feel like crying for intensified pain on Sunday and had no pain relief after Tylenol 1000mg and Children's Motrin 15ml

Intense lower/middle back pain; Chest tightness; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 23-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EJ1686, expiry date: not reported), via an unspecified route of administration, on 12Jan2021 12:30 PM, at a single dose on left arm for COVID-19 immunization. The patient received the vaccine at a hospital. The patient was not pregnant. Medical history was not reported. The patient had no known allergies. Concomitant medications included sertraline (other medications in two weeks). The patient previously received another vaccine within 4 weeks, flu vaccine on 06Jan2021. On 12Jan2021 09:30 PM, the patient experienced intense lower/middle back pain and chest tightness. The patient was not diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. The patient received no treatment. Outcome of the events was recovering.

About 1.5 hours following the administration of the second dose of the vaccine, I developed hives, pruritis, and erythema on both arms, torso, and neck. I also experienced headache, nausea, and leg muscle cramping/weakness.

This is a spontaneous report from a contactable other health professional (patient). A 23-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), intramuscular on 21Dec2020 16:30 at single dose in left arm, the second dose intramuscular on 12Jan2021 at single dose in left deltoid for COVID-19 immunization. Medical history was none, no known allergies. Concomitant medications included spironolactone, clindamycin, dapsone 5%, vitamin c [ascorbic acid], Multivitamin. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. The patient experienced fatigue, excessive exhaustion, left arm muscle pain, stomach upset/bowel upset on 22Dec2020 20:30. No treatment received. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Severe flu-like symptoms began 6 hours after the shot and lasted for 2 days with fatigue and weakness continuing for another 2 days, 2 days after the shot (1/13) developed costochondritis which a PA believed could be tied to vaccine, this lasted for 9 days

around 12 hours post vaccine: 105°F fever for 12 hours, neck and back stiffness for 4 days, fatigue- could not move without assistance, uncontrollable shaking, chills, soreness

Fatigue and muscle aches - day of to present Low fever (99°F) - Saturday, Tuesday, and Wednesday Pelvic/intestinal cramping that woke me up in middle of night - Monday/Tuesday Joint pain - Friday, Saturday, Sunday Swollen lymph nodes (axillary) - Sunday, Monday Swollen lymph node (right neck, under mandible) - Saturday to present, getting bigger and more painful Headache - Friday-present

Severe mid and upper back pain, abdominal pain, nausea, vomiting, fever, chills, cold sweats, body aches

Day 1 of vaccine got typical body aches, fever, chills, etc which resolved within 24hrs. Day 2 after vaccine (Wednesday) I got severe nausea with vomiting. Vomiting lasted less than 12hrs. Nausea into friday. Friday had nausea, lightheadedness and Bilateral feet "heaviness". Nausea resolved after ER visit due to inability to function due to nausea and lightheadedness. From Saturday-Current still experiencing bilateral leg weakness, and heaviness and sensation of being "pulled to ground with magnets". Had PCP visit and neurology visit. Needing labs and imaging.

First 2 days after vaccination, I had some injection site pain that was improving. Day 5 after vaccination, I developed lymphadenopathy on my left side with swelling into the chest area developing on day 6. Day 8 after vaccination, my injection site turned red and itchy and I began to have trouble breathing. I went to urgent care. I saw P. A. She said that it was more likely that the difficulty breathing would be due to my asthma, but she could not recommend whether or not I should receive my second dose. She proscribed 20mg of Prednisone and refilled my albuterol prescription. About 20 hours later, my breathing is still difficult and my arm still itches. We also discussed that the respiratory symptoms could be caused or exasperated by COVID-19, so I am waiting on results from a covid test.

The evening after I got the first dose I experienced painful muscle aches starting in my legs and progressing to the rest of my body, around 7pm. My left shoulder was a little achy, but no different than any other shot. About 30 minutes later I felt chills and felt really cold. I went to bed and tried to sleep. I woke up several times in pain. I did not take any pain meds. At 1am I went to the bathroom and felt nauseous and lightheaded. My vision got blurry and it felt like I was going to pass out, so I grabbed the towel rack and closed my eyes. I must have blacked out for a second and lowered myself down to the floor. I came to, and I was sitting on the ground, sweating a lot. I stayed on the floor for at least 10 minutes cooling down. (I had dressed warmly and turned on my heater after the chills started). I heard ringing in my ears while I was sitting on the floor. It went away after 5 minutes. I got up and went back to bed. I woke up at 9am and felt a lot better. Some minimal soreness. No more chills.

Flu like symptoms from midnight following vaccine to midnight the next day. Fever (101 degrees F), chills, fatigue, muscle aches, sore throat

all symptoms began approx. 12 hours post vaccination Duration 2 hours: Full body tremors, sweating, moderate nausea Duration 36 hours: severe headache, moderate-severe joint and generalized muscle pain, severe fatigue 600mg ibuprofen taken at 20 hours post vaccination (8 hours after symptoms began). 400mg ibuprofen taken every 4 hours after for the next 30 hours.

full body muscle aches; patient received first dose on 27Dec2020 and 2nd dose on 13Jan2021; arm muscle sore; Extreme fatigue; vomited 4 times; legs and arms are still store; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302 and Expiration date: May2021), intramuscular at the left arm on 13Jan2021 15:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC) and spironolactone. The patient previously received the 1st dose of bnt162b2 for COVID-19 immunization at the age of 23 years old on 27Dec2020 @ 2PM at the left arm, Lot number: ET1685 and Expiration date: Mar2021. On 13Jan2021, the patient experienced arm muscles sore. The next day on 14Jan2021, full body muscle aches slowly developed. Extreme fatigue two nights later (Jan2021) and vomited 4 times 6 days later (Jan2021). Legs and arms are still store from Jan2021, still fatigued. The patient received first dose on 27Dec2020 and 2nd dose on 13Jan2021. This was assessed as Inappropriate schedule of vaccine administered. Treatment was not received for the adverse events arm muscle sore, full body muscle aches, extreme fatigue, vomited 4 times and legs and arms are still store .The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events arm muscle sore, full body muscle aches, extreme fatigue, vomited 4 times and legs and arms are still store was not recovered.

5-10 minutes post injection, pt reported "I don't feel well" States feels hot/nauseous/weak. Assisted to chair. Had brief (15-20 second) episode of stiffening, apnea, dusky coloring, arched back with stiff extremeties and shaking and loss of consciousness. Spontaneous respirationss returned when stiffness/arching ended, with slow return of pale/pink skin coloring. Able to converse. Remained dizzy, diaphoretic. During event pulse thread and fast. BP 84/42 post return of consciousness. 911 called. Patient transferred via EMS to ER.

Injection Site Pain/Muscle Pain- ongoing soreness; Injection Site Pain/Muscle Pain- ongoing soreness; General Fatigue; Headache; Chills; Chest Pain; Fever; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 23-year-old female patient received second dose of bnt162b2 (manufacturer: Pfizer, lot number and expiration date: unknown), via an unspecified route of administration on her left arm on 21Jan2021 09:45 at single dose for covid-19 immunization. The patient's medical history included anaemia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 on 02Jan2021 for covid-19 immunization. On 22Jan2021 at 00:30, the patient experienced injection site pain/muscle pain-ongoing soreness, general fatigue, headache, chills, chest pain, and fever. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Bell's Palsy; progressed to left facial drooping; loss of taste on anterior part of tongue; decreased tear production in my left eye; started with left neck pain; This is a spontaneous report from a contactable other health care professional (HCP) (patient). A 23-year-old female patient not pregnant received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Left arm on 09Jan2021 at 04:30 PM as a single dose for COVID-19 immunisation, lot number: EL1283. Medical history was reported as none. Concomitant medications in two weeks prior to the vaccination included oral contraceptive pill (OCPs). Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at 04:00 PM at Left arm for COVID-19 immunisation, lot number: EK5730. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 22Jan2021 03:00 PM (Symptom onset was 2 weeks after second vaccine) patient initially started to experience left neck pain, and then progressed to left facial drooping, loss of taste on anterior part of tongue, and decreased tear production in her left eye. Presentation consistent with Bell's Palsy. Patient started a course of methylprednisolone the day of the report with no improvement yet. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. Patient had not recovered from the events, at the time of the report.; Sender's Comments: The events left neck pain, and then progressed to left facial drooping, loss of taste on anterior part of tongue, and decreased tear production in her left eye are considered possibly related to the suspect product based on 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.

The night after I was vaccinated I experienced knee and ankle pain as well as soreness at the vaccination site (left arm/shoulder). I experienced this throughout the night and this made sleeping difficult. The next morning, I took 2 500-mg tablets of acetaminophen. This relieved my pain for several hours. At about 1 pm, I became very fatigued. I slept the whole afternoon, ate dinner, took 2 more 500-mg tablets of acetaminophen, and slept for 11 hours. The next day, I felt good and have not had any symptoms since

I experienced extreme muscle and body ache for 2-3 days after both injections. Low-grade fever, fatigue, and injection site pain radiating throughout my entire arm.

On 2/10/2021, two days after my 2nd dose, I started experiencing mild abdominal pain at around 10am. I knew it was a side effect from the vaccine for I had been experiencing severe chills, fever, muscle and joint pain, fatigue, headache, diarrhea, and nausea the day before (2/9/2021) and those symptoms except for the fever had subsided on the 10th. I had been unable to eat all day on the 10th due to the pain but it was manageable. At 2pm the abdominal pain got worse. At 4:30pm the pain became unmanageable and I could not walk erect without severe pain. I was crying and bend over trying to walk. I had a family member drive me to the ER and arrived at around 4:40pm. Lying down with my knees up seemed to help the pain a bit but was exacerbated when lying flat or ambulating. I was given Pepcid, zofran, and toradol all IV push at 8pm and the pain subsided within 15 minutes. Today I still have mild abdominal pain but I would rate it at a 1/10.

Shot 1: Pain and bruising at injection site Shot 2: Slight fever, shoulder muscle pains (some shooting), wrist aches, fatigue- all starting 20-24 hours post shot -swollen lymph node in armpit of the same arm as injection approximately 36 hours after injection all other symptoms receded overnight -took aleve at about 1500 the day after injection and nyquil around 19:30 the day after injection

C/o dizziness pain forehead and shoulder. P 112 BP 161/97 O2 99 lungs clear. Stayed an extra 10 minutes and called family for ride home.

A few hours after receiving my second dose of the COVID vaccine, I was extremely fatigued. I lay down for a short nap and woke up 4 hours later still feeling groggy. 12 hours after the dose, I began feeling very ill? I can?t describe it better than that it was like being hit by a car. Every muscle and joint in my body hurt. My temperature spiked to 100, and kept going up. In half an hour it went from 101* F to 101.5* F. I was exhausted, but could only sleep intermittently all night because I was in so much pain. I was also very nauseous and very thirsty? the only thing I wanted was Gatorade, which I drank 8 bottles of in 12 hours. It was difficult to walk up and down stairs. The whole-body pain faded after 36 hours. The pain in my left arm and the fatigue lingered longer, lasting for 72 hours after vaccination.

20 hours after the first dose of the Pfizer vaccine I developed right flank pain that felt like a kidney stone. The pain was mild at first but got quite severe within an hour to the point where I was on the floor crying. My boyfriend talked me into going to the ER, and I felt very nauseated in the elevator and the car. At the Hospital?s ER I received pain medication (Toradol and an opiod I can?t remember the name of), and a CT scan to determine if I had a kidney stone. No stone was seen on CT. After discussing the events with Dr., we determined that the Pfizer vaccine was the most likely, yet still quite unlikely, cause of my symptoms. I was sent home with some pain (Norco) and nausea (Zofran) medications and was told to follow up if the lain didn?t resolve over the next few days. My pain slowly faded and was gone by the next morning. Later that day (Jan. 16, 2021) I noticed I felt like I had a sunburn starting just superior to my right iliac crest and descending anteriorly about 20 cm, but my skin had no visible abnormalities. A few days later on Jan. 21 I noticed the area was slightly red. I took a photo and sent it to my mother, who is a PCP, asking what I should do and she instructed me to try applying topical Hydrocortisone. I did so 2-3 times per day as needed and the redness resolved within a few days. The sunburn sensation faded slowly but lasted until about a week ago (Feb. 12). Yesterday (Feb. 17) I noticed that my skin in that area is slightly numb. I can feel pressure and temperature, but I am unable to tell the difference between a touch and a light scratch. Sensation outside the affected area is normal.

Fever, malaise, weakness. Onset approximately 6 hours after the vaccination with LA soreness and muscle aches. Peak signs/symptoms on 02/15/2020 at 5 am when fever, malaise and muscle pain onset. Worsened throughout 02/15 and was slightly improved with tylenol. Slept throughout the day on 2/15 and throughout the night. Woke up on 02/16 feeling well. Some headaches have persisted, but all original adverse events have been resolved.

Soreness in arm, persisted for 2 days Muscle aches all over body, began 2/16/2021 in the evening, 8 hours post-vaccination - persisted for 3 days Fatigue/tiredness, began 2/16/2021 in the evening 8 hours post-vaccination - persisted for 4 days

Night after vaccine: extreme muscle pain 2 days later: supraclavicular and anterior cervical lymphadenopathy

I received the COVID-19 vaccine yesterday, Monday December 21, at 0700. Last evening I was up all night with fairly severe symptoms, including a severe migraine unrelieved by pain medication, nausea and vomiting, muscle and joint pain, and a low grade fever. I felt unsafe to return to work today and called out due to my fever.

Symptoms began immediately after injection. Shoulder pain, limited range of motion lasting about 48 hours, bruising at site of injection, tingling and pain down the right arm and fingers lasting up to time of report

24 y.o. female with no significant past medical history who was diagnosed with COVID-19 (NP PCR on 1/27/2021) with mild symptoms (3-4 days of rhinorrhea and myalgia) and complete recovery with return to work who recently completed COVID-19 vaccine series (Pfizer 1/8/2021, 2/5/2021) now presenting for hospitalization (2/26/2021) with fever, rapidly progressive hypoxia, and hyperinflammatory state including elevated ESR, CRP, ferritin, D-dimer, and troponin (20) in the setting of positive COVID-19 NP PCR (2/26/2021) and positive S.pneumoniae urine ag with clinical diagnosis of MIS-A s/p high dose methylprednisolone and IVIG.

Sore Arm after injection; Nausea; Muscle Aches; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received first dose of BNT162B2, via an unspecified route of administration (vaccine location=left arm) on 01Feb2021 at a single dose for Covid-19 immunization at a workplace clinic. Medical history included unspecified allergies to medications, food, or other products. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She was not pregnant at the time of vaccination. The patient experienced sore arm after injection, nausea, muscle aches, headache, and fatigue on 01Feb2021. No treatment received for the events. The events were reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Chills and body aches that night. Arm that vaccine was injected was sore. Armpit of the arm that was injected was sore. Developed swollen lymph node above clavicle on side of injection.

muscle pain in arm and back; Soreness/Tenderness in arm as expected; Headache; fever; chills; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3248), via an unspecified route of administration on the left arm, on 02Feb2021 08:15 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. 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. On 02Feb2021 20:00, the patient experienced soreness/tenderness in arm as expected. At around 8pm (12 hours after injection), patient started feeling muscle pain in arm and back. About an hour later, patient started to run a fever and had chills. Headache came on after and lasted through the night and into the next morning. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date. Case was reported as non-serious.

patient became lethargic and briefly passed out 1 minute after receiving vaccine. Patient did not have swelling or breathing problems so an epinephrine pen was not needed. Patient became sweaty and had muscle rigidity of her hands and arms. Patient had rapid heart rate and extreme exhaustion. Ambulance was called and patient care was passed off to the EMTs and the hospital.

Patient states she received COVID-19 vaccination on 03/05/2021. States later that night, her arm became"stiff and sore and couldn't move it or touch it". Rated pain at a 9/10 on Friday through Saturday. Reports pain was constant. States she did not lose range of motion, but "didn't move it because it hurt a lot". Reports she took ibuprofen every 4 hours and iced injection site throughout the weekend. Reports she "didn't do much on Saturday related to the pain". Reports "constant pain" improved late Sunday night. Describes injection site located "where the shoulder meets the arm at the top".

Chills and muscle aches that lasted for 5 or 6 hours. I bundled up, rested, and drank lots of fluids.

The first day I got my vaccine, I felt fine, but my arm with the injection sight was very sore and body slightly achy. The second day I woke up and my arm was sore, but other than that I felt normal. Around 4pm on the second day, my back started to hurt where the break break in my spine is. It was just a normal amount of pain at first, but within an hour there was throbbing pain in my lower back, spreading into my legs. This is where I normally feel my chronic pain, but I had a spinal injection a little over 6 months ago and doesn't usually stop working until about a year. It is the normal pain I experience in the normal places, but the pain is worse and out of no where. That is not usually how the pain comes on when the spinal block wears off. It is much more gradual. It could be a coincidence, but the pain is not the way I have ever experienced the pain. My back hurts too much to do things I need to do to function, which only happens to me when I have done something with a lot of physical activity that puts tension on my back like jumping, dancing, roller coasters. Before I started experiencing this pain, it was just a normal day for me where I didn't exert my back any more than normal, which is very little.

Almost 24 hours after my vaccination, I began to experience a moderate headache throughout almost my entire head. It lasted a little over 5 hours until I took ibeuprofen. Since then I have experience body aches and muscle weakness. Muscle weakness experienced especially in my extremities. Lastly, I woke up on 3/23 and had moderately severe pain below my ribs in my stomach. It most commonly occurred on my left side and was occasionally felt on my right.

Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, INJECTION SITE PAIN Narrative: Other Relevant History:

Fatigue and myalgias set in about 6 hours after vaccine was administered Shortly after, tachycardia set in with pulse at 140-150 bpm resting. Fever set in at 8 pm at 103F. One OTC Benadryl brought pulse down to 130s resting. Performed Valsalva Maneuver with pulse improvement to 110s. By morning, fever was still at 103F, with headache, muscle pain, chills, fatigue, pain at injection site, and swollen lymph nodes present. Tachycardia had resolved. Within 48 hours after vaccine was administered, all side effects had resolved except fatigue and swollen lymph nodes and headache. All side effects had completely resolved 9 days after vaccine was administered.

Injection at 8:00am. Woke up around 2am the next morning with strong chills, muscle aches, and mild fever. Took 2 ibuprofens which helped the fever, but still had trouble sleeping. Later in the morning 8am, had same symptoms plus had 3 different sudden episodes of dizziness, nausea, and light headedness. I had to physically sit down as it felt like I might pass out. From 9am-1pm the symptoms steadily decreased until there was just a bit of muscle weakness. I was taking ibuprofen every 6hrs.

Chills 15 hours after, sore arm, sore armpit starting 15 hours after, swollen armpit, menstrual period started early after both shots (2 days after shot administered)

After receiving vaccine at 3 pm I started to have anxiety and my heart rate went up. This was presumably because I also have a needle phobia but I did almost faint and had to have on site EMT asses condition and observe for 30 minutes. At 4 pm one hour after injection face felt itchy and irritated and noticed hives on neck and jawline. Immediately administered benadryl 50 mg which made the hives subside.

Approximately 7 hours after receiving my second dose of the Pfizer/BioNtech COVID-19 vaccine, I developed soreness in my right arm near the injection site. Around two hours later, I noticed mild aching in my back and legs accompanied with a low grade fever of 99.0 degrees, compared to my normal temperature of 97.8 degrees.

Pain under left arm near underarm - so far 12 hours hurts to move and not move dual stabbing pain. NOT THE INJECTION SITE.

sore arm next day for a few days - then stopped then restarted about 5-7 days later with additional sharp pain in arm neck back, wrist and hand ongoing still happening. still hard to use arm. had dr appt at urgent care and will be getting an MRI

Muscle and skin pain are the most tolling. I also have a full headache and some nausea. Tried some ibuprofen which may have slightly helped. But still feeling it.

Vomiting starting at 4:30 Am - 12 pm on Saturday April 5. Followed by bone pain and 103 degree Fahrenheit fever until 9 PM.

Vomiting, severe headache, 2 seizures , muscle aches and weakness in the legs, unable to walk, knee paralysis

Severe back pain and spasms in lower back that were not present before. Treated with electrical stimulation and chiropractic care to reduce the pain until it subsides.

The second the person gave me the shot my index finger went numb, stiff and my range of motion decreased. Within less than 24 hours day my whole hand and lower arm were stiff, numb, painful, and tingling. I also have overall weakness and doing basic tasks like writing essays for school has become painful and difficult. My hand is stiff and looks like a claw. While it has gotten a little better after taking medications that my doctor prescribed my fingers are still weak stiff, numb, tingling, and painful. The vaccine was administered too far up and too far to the left which has most likely caused nerve damage. There is also a small bruise at the injection site and the injection is still visible 5+ days later. This could have been prevented through better training of health officials working at state-run vaccine sites. I hope this hasn't caused lasting damage.

VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose: 12/20/20 ,PfizerLot#EK5730 2nd dose: 01/08/21, Pfizer Lot# EL3248 Diagnosed covid positive:03/31/21 Exposure:unknown Symptoms:Fatigue,Muscle ache,Runny Nose

1.RASH AND ITCHING ON UPPER EYELIDS 12:30 PM 2. ONGOING FRONTAL HEADACHE PAIN RADIATES TO BASE OF NECK AND SKULL AT PAIN LEVEL 10+ /GREATER @ 4PM, ONGOING BODY RASH WITH ITCHING, AND REDNESS UPPER EYELIDS, FACE, CHIN, CHEEKS, LOWER FOREARM, BACK, AND ENTIRE BODY. 3. THROAT FEELING THICK AND ABNORMAL 4.FACIAL SWELLING NECK AREA UNDER CHIN, BACK OF NECK, UPPER ARMS AND LOWER ARMS, UPPER BACK ACROSS SHOULDERS, AND ENTIRE BODY TENDER TOUCH. 5. BILATERAL SWELLING OF THIGHS AND LOWER LEGS CALF AND ANKLES 6. BREATHING FELT LIKE RECOVERING FROM AN ASTHMA ATTACK 7. BLURRED VISION, VISION FELT WEAK 8. FATIGUE TREATMENT OF CARE: WENT TO URGENT CARE FACILITY LOCATED IN ON . RECEIVED IM INJECTIONS OF BENADRYL 50MG IN BUTTOCK AND SOLUMEDROL (STERIOD) INJECTION IN OPPOSITE BUTTOCKS. ON 08APRIL21: PT RECEIVED ZYRTEC PO, BENADRYL 50MG AT BEDTIME FOR ITCHING AND RASH, PREDNISOID 08APRIL202: PATIENT EXPERIENCED NAUSEA AND VOMITING AT 8PM, ON 09APRIL2021 PT C/O ZONING OUT MEMORY FOGGY AND FEELS LIKE SHE IS NOT WITH IT. 10APRIL: RASH CONTINUES TO SPREAD ON FACE, CHIN, UNDER CHIN AND NECK. FRONTAL HEADACHE CONTINUES, NECK SWOLLEN AND SHARP PAIN ON RIGHT SIDE OF NECK AND LOWER JAW. LYMPH GLAND FEELS SWOLLEN ON RIGHT SIDE OF NE``

Intense flu like symptoms and soreness at vaccination site. Fever, muscle aches, congestion, swollen lymph nodes.

Low grade Fever on Saturday and lethargic. Sunday no symptoms. Monday fever of 101° back pain, chills, headache.

Had 103 fever during night following vaccine. Muscle aches and headaches. Frequent diarrhea for 2 days following vaccine. Started menstrual cycle within 24 hours of vaccine. Severe menstrual cramps, bloating.

Patient had complaint of dizziness and fatigue with heaviness and tingling in left arm. Patient insisted on being seen by EMS. EMS assessed patient and determined patient was stable and dehydrated and released to go home.

23 year old female presents with right sided neck pain x 1 day, reports associated symptoms of headache, coughing, sore throat and myalgias s/p first dose of COVID19 Pfizer vaccine yesterday. Pt reports she couldn't sleep because she felt her heart was beating faster. Pt reports she received COVID19 vaccine dose in left deltoid. Pt denies fever, coughing, emesis, diarrhea, chest pain, SOB, lower extremity edema, lower extremity tenderness. No known sick contacts, no recent travel history. She reports she took Tylenol yesterday and today, with moderate relief. Pt offers no other complaints. Vitals at time revealed normaltensive T98.4F, HR of 100bpm Cardiorespiratory exam on auscultation +S1/S2, tachycardic at 100bpm on repeat, lungs CTAB There was a palpable tender anterior right cervical lymph node that was mobile and well circumscribed around 1x1cm. Pt was advised to take Tylenol and/or Motrin for neck pain, headache. She was discharged home with anticipatory guidance and ED precautions should she develop chest pain, shortness of breath, dizziness, jaw pain, and/or chest pressure, slurred speech. Pt was receptive to advice. She was contacted the following day, (today on 4/16/2021) and she reports she feels much better: palpitations and headache has resolved, and neck pain is improving.

Postural orthostatic tachycardia syndrome; Pain in arm; Joint pain; This is a solicited report from a contactable consumer (patient), via a non-Pfizer marketing program. A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on an unspecified date as single dose for COVID-19 immunization and adalimumab (HUMIRA), subcutaneously from an unspecified date at unspecified dose for moderate to severe adult crohn's disease. Medical history included hemorrhage of colon from 2018 and moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. On an unspecified date, patient experienced postural orthostatic tachycardia syndrome, pain in arm and joint pain. The events were reported as serious, medically significant. The action taken in response to the events for adalimumab was unknown. Outcome of event pain in arm was unknown while for all other events was recovered on an unspecified date. Causality assessment for the drug Humira and the events Postural orthostatic tachycardia syndrome and Joint pain was reported as No reasonable possibility by the reporter and manufacturer while for the event Pain in arm was not reported by the reporter and No reasonable possibility by the manufacturer. Causality assessment for the drug BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the events postural orthostatic tachycardia syndrome, pain in arm and joint pain was not reported by the reporter. The reporter's assessment of the causal relationship of the events with the suspect product 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 lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of the vaccine BNT162B2 to reported events cannot be fully excluded based on the presumed temporal relationship and since it is part of the product safety profile. Underlying hemorrhage of colon and moderate to severe adult Crohn's disease may be contributory to the event orthostatic tachycardia syndrome. Case will be reassessed if additional information is received The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

rheumatoid arthritis aggressive symptoms; This is spontaneous report from a contactable consumer or other non hcp. A 23-year-old female patient (cousin, not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 01:00 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient recently got diagnosed with rheumatoid arthritis. This has been something that has been through reporter dad's side of the family. Reporter's aunt has had it since she was a kid. The patient who was just diagnosed started having aggressive symptoms a month after her second dose of the covid vaccine shot. The outcome was unknown. Information on the lot/batch number has been requested.

I (patient) developed swollen and painful lymph nodes in the underarms on both sides of my body. They began on the side of the injection but spread to include both arms. In addition, two similarly swollen and painful lumps have appeared, though I am not sure if they are lymph nodes given their locations. One is along my the line of my waistband in the front of my body, not in the traditional groin area where most charts ascribe lymph nodes to be. One is directly below my areola on my right breast. Along with these lumps, I developed a rash made up of several small, inflamed hives that range from painless, to itchy, to painful. They are concentrated along my bra line, particularly around my breasts, but are spread everywhere from below my neckline to above my ankles. These symptoms began approximately 7 days after my second dose of the Pfizer-BioNTech vaccine and are continuing at the time of this report.

quick onset with severe back pain, high fever that would not go down with ibruprofen, sore throat, fever that would not stay away without tylenol for 48 hours, migraines over left eye, night sweats, body pain so severe that it limited mobility

Day after vaccination, woke up right shoulder shoulder has loss of sensation, over one week the numbness spread lower arms and upper chest right side, 2 weeks numbness now beginning in top of right thigh. Headache for 3 days since vaccination. April 18th light pain and swelling left eye lid, and right ankle.

After patient received the vaccination, within moments she fainted and fell to the floor from a seated position, pharmacists immediately responded and patient regained consciousness almost immediately. Patient reports hitting her head and a sore neck. patient was monitored by pharmacist until patient was back to baseline. Upon leaving patient states feeling fine and refused additional medical treatment at the time of leaving.

Woke up exactly 12 hours after my second dose at 3am with a high fever, vomiting, and visual hallucinations probably due to the fever. It felt like things were moving in slow motion, frame by frame, when I woke up at 3am. Was light headed, couldn't stand, chills and shaking. I vomited from 3-4 am and then again at 8am when I woke up, with my visual disturbances limited to the 3-4am hours. I took Advil and was able to go back to sleep for most of the day, sleeping from around 9am to 1pm. Nausea, fever, and vomiting have all have cleared. Now I just have a headache and muscle aches, especially near the injection site. Almost 24 hrs after my vaccine now and I feel drastically better than I did overnight.

At about the same time the standard soreness at the shot site from the shot began to form (in the left arm), soreness also began to form in the left armpit. Both signs of soreness began around 7pm the evening of the shot. The day after the shot was administered the soreness in the shot site began to lessen but the pain in the armpit persisted. The armpit pain, the day after the shot was administered, felt sore, almost as if I have been holding a golf ball tightly between my arm and torso for hours and a bruise had formed. That night I checked my armpit to see if there was any swelling or bruising. There was some swelling and a small lump within the tissue of the armpit the night of the day after the shot. The morning of the 23rd , two days after the shot was administered, the armpit pain persisted and the lump was bigger than the night before and the swelling remained.

Shortly after receiving the vaccine, complaints headache, and sharp mid back pain, and epigastric burning. Anxious about getting shot. Blood pressure 128/70, HR 90, Sat 89-91%. Complaints of dizziness when standing up. Oxygen 2 liters started and pulse ox at 92%. First response team notified. Transported to ER via wheelchair. First response team given report on patient by this lead.

Muscle aches, chills, fever, dizziness, chest tightness, trouble breathing, fatigue. Started in the middle of the night after the vaccine and lasted the whole next day, although symptoms were worst in the morning and gradually improved as the day went on.

1-2inch solid mass grew in my left arm, near my armpit starting a day after the injection; otherwise only general Muscle soreness.

Dyspnea and pleuritic chest pain onset 4/22-23, prompting presentation to ED. Found in ED on 4/24 to have central R pulmonary embolus extending into interlobar, segmental, subsegmental branches of RUL & RLL, mild R heart enlargement without evidence to suggest RH strain, and mild pneumomediastinum most notable at the thoracic inlet. Tolerating RA. Started on AC with heparin drip, transitioned to xarelto at discharge.

My family has a strong history of arthritis. Mine has never been active, I?ve never been tested for it, I have never been diagnosed. But my grandma, mom, aunt and twin sister all have it. I woke up on Wednesday the 28th with a slightly swollen and stiff knee, not triggered by any activity or environmental factor. There has been no injury or stress on the joint. But it has swollen and appears to be experiencing an RA flare up.

I got really warm (no fever) and extremely tired for about an hour. My arm muscles were very sore around the injection site.

I got warm and felt relaxed, almost tired. My arm muscles hurt at the injection site. Around 5am or a bit earlier on 4/24/2021, my whole body?s muscles began to ache. This only got worse as the day wore on. It was so severe it was hurting just sitting and doing nothing. Tylenol relieved the pain around 4pm. My arm at the injection site was only sore for another day or so.

When the shot was being administered, the person who gave me the shot squeezed my shoulder and put the needle in while still squeezing. When the needle was pulled out, I felt liquid run down my arm and the person who administered the shot wiped it up. I'm not sure if this is normal or if I was not given the complete dose of the shot. I want to know if I should get my second dose administered again just in case. It has been 4 hours since I got the shot and my only symptom so far is a sore shoulder.

muscle aches all over my body; chills; Fatigue; a low grade fever of 99.8; headache; mild nausea; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration on 18Feb2021 14:45 as SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included asthma and anemia. The patient previously took amoxicillin, ibuprofen and Advil and experienced known allergies. Historical vaccine included: the patient received first dose of bnt162b2 (Lot Number: EL3247), via an unspecified route of administration on 28Jan2021 10:15 as SINGLE DOSE in Arm Left for covid-19 immunization. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine in four weeks. Concomitant medications included: unspecified birth control medications. On 19Feb2021 at 5:30, the day after second dose of the COVID-19 vaccine, she experienced muscle aches all over my body, chills, fatigue, a low-grade fever of 99.8, a headache, and mild nausea. The patient did not receive any treatment for adverse events. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was recovering.

Patient developed right foot tingling and posterior right lower leg achiness and fatigue of the leg the day after receiving COVID-19 vaccine (1st dose). No known injury or trauma. She did some sciatica exercises, had minimal improvement. Reports symptoms worsening after 2nd COVID vaccine on 2/25/21. Feels like she has to move the leg all the time, almost like a constant restless leg syndrome.

Extreme fatigue Dizziness Muscle aches Fever Pain at vaccination site Muscle soreness in right arm began within 39 minutes of shot administration. Pain worsened throughout the day, and by evening it was difficult to move it around because of the pain. This level lasted 30hrs and is reduced to initial soreness on day 3. Dizziness began around 10pm, everything seemed disoriented. Extreme exhaustion occured about 11pm and patient slept for 18 hours. With brief episodes of coherence lasting no more than 5 minutes. Dizziness was still present when conscious. Fever occured in the middle of that night at 100.2. Fever was gone by 5pm. Dizziness had subsided also by 5pm. Muscle pain in full body persisted until 1am on may 4.

Site: Pain at Injection Site-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: throat felt dry and scratchy -Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Severe, Systemic: Weakness-Severe, Additional Details: pt received 2nd dose on 5/2/21 at pharmacy (did not get first dose here). pt had severe pain in right arm, numbness and tingling in hand, severe pain from wrist to upper shoulder to neck. pt had weakness as well and couldnt move arm. pt did see her pcp today. he diagnosied her with brachial neuritis which he states is a direct adverse reaction from vaccine. he did confirm not an administration error.

Patient reports, "On April 3rd, 2021 I experienced numbness and tingling of the left and right arm lasting about 2 hours. This occurred at about noon." Beginning on 4/11/21 patient reports experience balance impairment, loss of feeling in her toes, and weakness in her arms. She recently has began experiencing diarrhea and incontinence. These symptoms starting on 4/11/21 have not resolved. Client saw her Chiropractor on 4/13/21 and was recommended that she see a medical professional and report her symptoms to the Health Department. Patient is currently looking to find a provider.

Extreme fever (103) Tuesday morning, horrible aches and chills, migraine. Didn't eat for 24 hours (7 pm Monday to around 7 pm Tuesday). Slept 18+ hours Tuesday (normally 6-7 hours a night). Nausea all morning. Bruising (size of an orange) at injection site), as well as swelling (normally doesn't happen when I get vaccinated). Very sore joints and muscles (hard to stand, rotate, or walk) from late Monday night (11 pm) to Wednesday morning (8 am).

I received the Pfizer second dose on May 5th and started to have an allergic reaction on May 6th at 02:32. I was not able to attend classes due to muscle pain, headache and nausea. I was having some sort of fever where I felt hot but my body was cold. I slept for the majority of the day. Around 16:35, when I woke up, I noticed a rash and that my body was feeling swollen. I took 2 Benadryl gel pills at 18:03. I felt some difficulty breathing, and itching sensation all over my body and still had a lot of tension on the left side of my jaw. I went out to eat with my boyfriend, because we had plans and he had also complained of having some cold chills from the vaccine, and he noticed that I had red marks on my hands. By May 7 10:05 I called off of work to go my doctor, because I had massive splotches of raised itchy hives all over my body. It was confirmed that I was having an allergic reaction and I received a steroid shot in my upper gluteal muscle, as well as Famotidine 20mg twice daily for 5 days and Prednisone 20mg twice daily for 5 days.

Pain in arm that injection was received in (left arm). Upper arm/shoulder had shooting pains, felt like it was in the bones.

Sweeling soreness of right axillary lymph node. Started at around 10 am and lasted all day until bed.

Arrhythmia; headache; hypersexuality; worsened muscle/join pain; fatigue; chills; vomiting; worsened muscle/join pain; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration, administered in left arm on 22Apr2021, at 14:45 (Lot Number: ER8736) as SINGLE DOSE for covid-19 immunization. Medical history included bipolar I disorder from an unknown date, allergy to cilantro, pollen, and lactose from an unknown date. Concomitant medication included citalopram (CITALOPRAM) 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Apr2021 at 16:00, the patient experienced arrhythmia, headache, hypersexuality, worsened muscle/join pain, fatigue, chills and vomiting. No corrective measures were taken by the patient for the reported events. The outcome was reported as not recovered for the reported events at the time of reporting.

Weeks 1 . Extreme dizziness and headaches. Week 2.- Brain fog, disorientation, double vision, headaches, depersonalization, dizziness, heart palpitations. Week 3-Brain fog, painful nerve pain in feet, legs, arms, hands. Hand/eye tremors. Double vision, headaches. Week 4-Brain, persistent nerve pain, leg weakness, hand weakness, disorientation , double vision, headaches , depersonalization, persistent tremors.

Swelling in joints - including ankles ( worst- pitting edema), knees, wrists, hands, hips,. Unable to get up day after vaccine, slowly resolved and then came back stronger and still having symptoms months later.

9 am - vaccine administered .11 am - half dollar sized red bump formed ( mild discomfort). 5pm- shoulders neck and arm begin to stiffen and spasm . 10pm - full body aches and spasms.. excruciating headache behind my right eye. Lymph nodes were sore ( neck and arm pit) . 3-4 days after I kept experiencing 9/10 headaches ( behind my right eye), armpit( lymph node) pain and whole body spasms / tightness.

As soon as shot injected, felt a pinched nerve-like pain go down from injection to index finger. Index finger hurt to bend for 5 minutes, and the entire arm was tingly. Felt slight pain and tingles up towards cheek and neck for 1-2 minutes during the time when my finger was hurting. Light headedness started 15 minutes after shot and has continued for 30 minutes.

After second dose: I was fine for the first day. I got it at 10 am and then around 7pm started feeling chills and started to feel sick. A few hours later I got a fever and then got very sore. The next day around 5 pm I got a horrible pain in my upper back and stretched to my chest. It was unbearable. It did not hurt to breathe but it hurt to sit. It hurt in increments. I do not think it was muscular as it didn?t hurt when I moved or stretched. This lasted into the night. Next day, today, all is well. Just sore arm.

It's been a month today since I received my second dose of Pfizer-BioNTech (Lot #EW0164) on April 18, 2021. My first dose was at the same location, on March 28th, 2021 with lot #ER8732. I experienced extreme muscle soreness the day after, which I took with Tylenol. The feeling subsided. A month later on Sunday, May 16th, I started feeling pain at the injection site again. Though I've felt no other side effects, it's bizarre that this muscle soreness should come back. I took tylenol, but it's noticeable and very uncomfortable.

Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night.; Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night.; Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night.; This is a spontaneous report received from a contactable consumer. A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 08May2021 as single dose in left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included severe ovarian cysts, PTSD, food allergy and past drug event was bactrim. Concomitant medications included benadryl, ibuprofen, naproxen, acetaminophen. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After vaccination the patient experienced extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night on 08May2021. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.

Injection site reaction onset about 3 hours following the vaccination. These symptoms include deltoid muscle pain, deltoid swelling, as well as left scapular and trapezius pain. Exacerbation of asthma 7 hours after vaccination with wheezing, cough with secretions, chest and back pain. Woke up the next morning (5/21) at 8am with 100.7°F fever, body aches, headache, chills, worsened cough with secretions, nausea, chest tightness, chest pain, neck pain, back pain, body aches, and loss of appetite. Injection site symptoms remained the same. After an urgent care visit with a negative covid test, I purchased Severe Cold and Flu medication as well as VapoRub to help relieve my symptoms. I took these as advised per the packaging and my symptoms eased some. On 5/22 I woke up with neck pain, headache and mild cough with no fever and less chest tightness. Injection site and surrounding muscles are still sore but the swelling has gone down.

05/22/2021 9:00pm - muscle aches, fatigue 10:30pm - migraine, chills 11:00pm - fever (100.6) 05/23/2021 1:00am - fever (101.5) 11:00am - sustained fever, migraine, fatigue 8:00pm symptoms begin to subside

Fatigue - onset: 2 pm after 10 am dose, lasting 48 hours Full-body muscle aches - onset: 7 pm after 10 am dose, lasting 15 hours Full-head headache - onset: 5 pm after 10 am dose, lasting 2 hours Hives on toes - onset: 8 am 48 hours after dose, lasting 1 day (still continuing) Itchiness and painful vaccination site - onset: 11 am after 10 am dose, lasting 72 hours

Muscles aches, severe headache, and a fever of 101 f. Fever broke around six hours later. Muscle pain and headache also subsided gradually thereafter. No fever reducers were taken.

?Pfizer-BioNTech Covid 19 Vaccine EUA? The night of getting the first shot I barely slept because I had chills all night long & my entire body was so sore it hurt to lay in any position. In the morning, I still had extreme muscle pain all over. I was extremely light headed & dizzy, I had a throbbing headache so I took 2 aleve pills. I was getting super nauseous and almost passed out while trying to get to my bathroom just in time to throw up only water. Just before throwing up my vision went fuzzy, my ears were ringing, I was dripping sweat, it was getting hard to breathe, & my hands were shaking. After taking a cold shower, laying down, & drinking some water I feel a bit better but not 100% normal.

I woke up 6 days after receiving the vaccine and I had some pain at my collar bone. It felt bruised and I felt something that felt like a ball rolling around. I called advice from clinic and they scheduled me a visit with Dr. for a video visit. At my visit with him, I explained what it was and I mentioned that I heard about lymph node enlargement after the vaccine. He told me that he hadn't heard anything about that, but scheduled an ultrasound for me. I scheduled an appt with my PCP and she told me that she did hear about the lymph node enlargement from the vaccine. I had the ultrasound on 03/30 and the results came back benign. Dr. called with my results and requested a follow up in 3 months.

Severe burning of skin over entire body; Hypersensitive to touch including fabric; Swollen neck and hands; Swollen neck and hands; Pain in pelvic area and anus; Pain in pelvic area and anus; Severe lower back pain accompanied with chills; Severe lower back pain accompanied with chills; Headache; Fever; Nausea; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot number: EW0202), via an unspecified route in the right arm on 04Jun2021 at 11:00, as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included topiramate 50mg and norethrindrone 35mg (medications the patient received within 2 weeks of vaccination). Patient previously received first dose of BNT162B2 (Pfizer covid-19 vaccine, Lot number: EW0202), via on an unspecified route in the right arm on 14May2021 at 11:00, as a single dose for covid-19 immunization. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 04Jun2021 at 22:00, patient experienced severe burning of skin over entire body, hypersensitive to touch including fabric, swollen neck and hands, pain in pelvic area and anus, severe lower back pain accompanied with chills, headache, fever, nausea and fatigue. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

dizziness; Nausea; Not feeling well; Left arm pain; fever; Chills; Facial swelling; pain to neck; Muscle spasm in face (lips); This is a spontaneous report from a contactable consumer, the patient. A 23-years-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6207) via an unspecified route of administration in the left arm on 13Mar2021 at 14:00 (at the age of 23-years-old) as a first dose for COVID-19 immunisation. The patients medical history included diabetic, arthritis, fibromyalgia, High blood pressure, neuropathy and Gastrointestinal (GI) problems. Patient was allergic to Benadryl and certain anaesthesia. Concomitant medication taken within two weeks included ADVIL, HUMALOG, aspirin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), FURMIDE, gaba (MANUFACTURER UNKNOWN) all taken for unknown indications from unknown dates. 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. The patient had not been tested for COVID-19 since the vaccination. On 13Mar2021, at 14:30 the patient developed dizziness, immediately after dizziness patient had nausea, the patient was not feeling well and had left arm pain, fever, chills, facial swelling and pain to neck and muscle spasms in face (lip). The facility where the vaccine was administered was reported to be other. No therapeutic measures were taken for these adverse events. The outcome of the events dizziness, nausea, was not feeling well, left arm pain, fever, chills, facial swelling, pain to neck and muscle spasms in face (lip) was recovering at the time of report. No follow-up attempts are needed. No further information is expected.

Chest pressure, headache, joint pain and tingling sensation that lasted from June 16th until today June 25. Visited urgent care on the 20th and was prescribed a high dosage of ibuprofen. EKG came normal. As of June 25, the side effects are slowly wearing off.

On the day of the vaccine 1st dose Pfizer, about 45 minutes later, I started feeling like I was having a heart attack. I had tingling down my arm, increase heart rate, and chest pains. This lasted for a couple of hours. I did not do anything and it went away with time. I did not seek any medical care. I felt well enough and decide to get the 2nd dose. About 2 days after the 2nd dose, I start to get heart palpitations and it was not going away. I was also having syncope multiple times a day. About a month and 1/2 later, I decided to go to the emergency room. I was hospitalized for 4 days. I was tested for many things and everything came back normal. I was prescribed folic acid and lidocaine pain patches for my lower back pain. I am still having symptoms of accelerated heart rate, syncope and heart palpitations. I am to be followed up with a cardiologist and my appt is next month. Lot number of both vaccine doses unknown (it was not on the vaccine card).

Fatigue; Slight muscle aches in my neck; This is a spontaneous report from a contactable consumer or other non hcp. A 23-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, second dose on 25Jan2021 08:00 (Age at vaccination was 23-year-old) via an unspecified route of administration at arm Right as a 2nd dose, single for covid-19 immunisation. Medical history included asthma and known allergies: sulfa. Patient did not receive any other vaccine prior to four weeks. Concomitant medications included methylphenidate hydrochloride (CONCERTA); buspirone hydrochloride (BUSPAR); ethinylestradiol, etonogestrel (NUVARING); and cyanocobalamin (B12-VITAMIIN). Historical vaccine included BNT162B2 (First Dose on an unknown date and lot number and expiry date was unknown) for COVID-19 immunisation. The patient previously took Lorabid for product used for unknown indication and experienced drug hypersensitivity, keflex [cefalexin] for product used for unknown indication and experienced drug hypersensitivity. 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 25Jan2021 12:00, the patient experienced fatigue and slight muscle aches in her neck. No treatment was received due to events. The outcome of the events was recovered on an unknown date. Follow-up (13May2021): Follow-up attempts completed. No further information expected.

Severe, full-body muscle pain beginning the morning following my second vaccination. This was tempered only a little with 600mg of ibuprofen, but the aches worsened around 3pm, a full 24 hours after my shot. On Saturday morning I was unable to leave the bed due to how painful it was to move. My legs hurt the worst, I couldn't lift, bend, or walk on my legs in the morning. I also had severe pain in my lower back, my hands, wrists, and forearms. I forced myself to walk through tears and agony which eventually helped "loosen" my legs. Throughout the day the mobility in my legs came back and the pain eased slightly. I continued to need to either support myself or rest often. On Sunday the same symptoms as described above came back with a vengeance. I didn't have to even move to be in agony all of the time. Forcing myself to break through the stiffness and pain seemed to help awaken and revive my muscles slightly. Ibuprofen didn't help much, I was taking a maximum of 800mg doses about three times a day. Monday is the first day the pain is not unbearable, though it is extremely painful and difficult to move. I struggle to go up or down stairs, I struggle to get up from a sitting position, I struggle to put my pants on, and I struggle to walk. If I stand for too long of a duration my legs shake and I feel like I might collapse.

Extreme muscle pain. Mostly in right neck/shoulder area that migrates down to mid-arm. Sensitive back muscles, if moved in a certain way, tenses up and causes extreme pain. Nausea and headache.

Minutes right after the vaccination, I had burning in my left eye, like a nerve in my head burning. I was offered Tylenol by the pharmacist, which I denied. When I stood up, I got really light headed. I went back to work anyways and the symptoms lasted for 2 hours. I came home and noticed my left butt cheek started to ache and feel sore. I did not take any medications. I went to bed and woke up with full blown flu like symptoms- extremely weak, fatigued, body aches and soreness, muscle stiffness, headache, intermitten light headedness, and left eye could not focus properly. These symptoms lasted for about 24 hours and most went away, however I was still unable to focus with my left eye. On 6/5/2021 I had a very bad explosive severe headache, I had loss of balance, loss of vision in left eye and could not speak coherently and decided to go to the ER. In the car en route to ER, I felt like I was paralyzed and could not move. I was diagnosed with migraines, given a RX for Compazine, and to follow up with the PCP. I went to the doctor on 6/7/2021 with extreme fatigue, difficulty walking and balance, light headed and left eye focusing issues. I was referred to an opthamologist. On 6/8/2021 I went to the opthamologist and had an eye exam and retinal screening and was referred to a better hospital. On 6/9/2021 I went to a hospital to be seen by an opthamologist and neurologist and I did lots of blood work, an MRI of my head, neck and brain which showed my optic nerve was swelling and causing my brain to swell as well. I was diagnosed with inflammation of the optic nerve. I am being followed up by the neurologist. I have been having intermitten episodes of severe headaches and would have body paralysis for about 30 minutes and it would go away. I am having these episodes about once a week. Every time I have an episode, I would go see my doctor who would run more tests. I have been tested for epilepsy which is negative.

Pain in left armpit; Tender to touch; Body aches; Tiredness; Headache; Muscle pain; This is a spontaneous report from a Non-contactable Other Health Professional (Patient reported for herself). A 23-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration, administered in left arm on 06Feb2021 at 08:30 (at the age of 23-year-old), as a single for COVID-19 immunisation in public health clinic/veteran's administration facility. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient was dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 16Jan2021 at 08:30 (at the age of 23-year-old), as a single for COVID-19 immunisation in public health clinic/veteran's administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 06Feb2021 at 20:00, the patient experienced pain in left armpit, tender to touch, body aches, tiredness, headache, muscle pain. Adverse events resulted in was reported as none. No treatment was received for the events. The outcome of the events was reported as resolving. No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.

Tachycardia; Motion sickness; Numbness of right forearm; Entire body swelling all extremities; itchy red rash: face, neck, upper chest, forearms, thighs, back eyebrows; severe frontal occipital lateral stabbing headache; sore & tender body; sore & tender body; chills; blurry vision; light sensitivity; foggy memory; swollen neck/neck was swelling; nauseated vomiting/Nausea and vomiting; nauseated vomiting/Nausea and vomiting; burning sensation; Right upper shoulder discomfort with swelling that goes into her neck; Light sensitivity; having a rash; rash is itching; scaling, and her skin is peeling; scaling, and her skin is peeling; redness; severe headache; This is a spontaneous report from a contactable Nurse (patient's mother). A 23-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8737 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 07Apr2021 at 11:00 AM (age at vaccination: 23 year) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included anemic, eczema, gastric reflex, known allergies: citrus food, latex gloves, Compazine, Augment, and headaches from concussions. Concomitant medications included Ferrous Sulfate, Diethylpropion HCL, and glucose, sodium chloride (DNS). The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. There was a product complaint to report. On 07Apr2021 12:30, the patient experienced swollen neck/neck was swelling, nauseated vomiting/nausea and vomiting, entire body swelling all extremities, itchy red rash: face, neck, upper chest, forearms, thighs, back eyebrows, severe frontal occipital lateral stabbing headache, sore, tender body and chills. On 07Apr2021, the patient experienced right upper shoulder discomfort with swelling that goes into her neck, light sensitivity, having a rash, rash is itching, her skin is peeling, redness and severe headache. On 09Apr2021, the patient experienced motion sickness and numbness of right forearm. On 12Apr2021, the patient had tachycardia and scaling. When probed to determine when the tachycardia began, the caller mentioned that the tachycardia was noted at the doctor's office. She confirmed the tachycardia began Monday, 12Apr2021. She clarified it was her second doctor's visit so if the caller gave the wrong date, they were able to find it by her records on her second doctor's visit. Caller confirmed with her daughter the tachycardia was still intermittent, it comes and goes. It seems to be that it has improved. She could consider it was medically significant because they didn't know what the root cause was. Her daughter has never experienced tachycardia before being dosed with the Pfizer vaccine. There was not treatment for tachycardia. Her daughter was still having a rash; she was breaking out intermittently. She confirmed she did not report online that her daughter was intermittently breaking out. At that time when she filed the report online, the rash just broke out. At that time, she didn't know if her daughter's rash was going to abate and then re-appear. If so, then she would have had to re-open a new event with a new date and time and rate it. She just looked at her daughter's skin, it's peeling. These were very itchy. Caller then clarified most of these events started the day of the vaccine, 07Apr2021 at 12:30 PM. She confirmed some of these events were reported online on the date of the incident and were still present. The severity of each event was on a grading scale, and right now her daughter's grading scale was 10. Online, the patient couldn't even tell how they really were feeling. The severity of each event needed to be asked. By the lack of getting all the information and the less Pfizer has, the better it looks for Pfizer. When probed for outcome, the caller confirmed the rash was still ongoing and it was medically significant because she was going to have to take her to dermatologist. She has been using hydrocortisone cream as treatment of the rash and it's not working. She did not have the NDC, LOT,EXP for the cream. She explained the skin peeling/scaling has been ongoing. Her skin breaks out in a rash and then becomes really scaly and then it peels. She clarified overall, she had a rash, but the rash was itching, had redness, scaling, and her skin was peeling. On scale of 1 to 10, the caller would rate this event as a 10. She confirmed and that it's continuous/ongoing and had not improved. Stated the rash was not to any localized area on her daughter's body, it's all over. She clarified further the rash can appear on her daughter's eyes, chin, cheeks, forearm, wrist, and leg. The severe headache was reported on the day of the vaccine as well as the rash, too. The severe headache was ongoing; caller gives it a grade 10+. She confirmed the headache was medically significant. It did prevent her daughter from driving a car, reading, or doing activities. Caller added that the headache was also disabling because it disables her daughter from functioning at her normal capacity, she's been hindered. Her normal activities she could not perform if the headache was present. The headache was described as stabbing, excruciating pain and burning sensation. When probed for the outcome of her daughter's severe headache, the caller explains it's in between persistent and worsening. On a good day, it's a grade 8.5. On a bad day, it's a grade 10+. No medical treatment for headache, she was not really allowed to do anything. She was waiting for Pfizer vaccine to wash out of her daughter's system. She explained her daughter was laying low and not introducing any more drugs to enter her body since she had a reaction. Caller again stated they were waiting for Pfizer's vaccine to wash out of her daughter's system because they feel as though something was triggering the rash that keeps appearing and the headaches were still there on a grade level of 10+. Her daughter was afraid to take medications, so they were having to do treatments like hot compresses to her daughter's head and neck, massaging her head/neck/back and turning the lights off. The Nausea and vomiting began on 07Apr2021 and was still ongoing. No treatment for nausea. Her daughter just gets still and goes to sleep. When the headaches were excruciating, it brings on nausea and vomiting. Also, she noticed motion sickness. When her daughter was riding in the car and she was experiencing a headache, she had terrible motion sickness. Caller confirmed the caller never had this motion sickness prior to the vaccine. The motion sickness was still ongoing. Her daughter was not treating the motion sickness in any way. She states maybe her daughter has taken one Zofran because it was so bad. No further details provided. The numbness of the right forearm started on 09Apr2021. She confirms the numbness is still ongoing, it comes and goes, intermittently and did not receive any treatment. On 07Apr2021, her entire neck was swelling, left and right side. The left side was better but the rightnside had intermittent swelling, there was ongoing swelling on the right side of her neck and did not receive any treatment and just rubbing of her daughter's neck. Her daughter also has right upper shoulder discomfort with swelling that goes into her neck that was ongoing. She confirmed this event to be medically significant and it has hindered her daughter's normal activity if her shoulder was swollen too bad and she was hurting. Her daughter just started physical therapy. The light sensitivity was still ongoing. If her daughter was not experiencing a headache, the light sensitivity was pretty good and treatment included dark rooms/ black out. Her daughter was following up with an allergy testing by the allergy doctor. She has to find out if there were any active ingredients in the Pfizer vaccine that triggered her daughter's reaction. Caller stated, "something in the COVID-19 vaccine triggered her daughter's body to react the way that it did". Her daughter also was following up with a dermatologist. Her primary care physician requested her daughter to be followed up with her allergy doctor and to be tested. Caller requested Pfizer's adverse team or someone to call and let the caller know how Pfizer follows up with their patients and how well Pfizer's values each patient. The patient's symptoms have not abated. The events of swelling, nausea, vomiting, tachycardia, motion sickness, hypoaesthesia, musculoskeletal discomfort, photophobia, rash, rash pruritic, skin exfoliation, erythema and headache were considered to be medically significant. The events caused the patient to visit emergency department and physician's office. The patient received IM Benadryl 50mg and IM Solumedrol steroid as treatment for the events. The outcome of tachycardia was recovering and for burning sensation it was unknown, and for all the other events, it was not recovered.; Sender's Comments: There is a reasonable possibility that the events nausea, vomiting, pruritic rash, erythema, and severe headache were related to BNT162b2 based on known drug safety profile and close temporal relationship. The association between the events swelling, tachycardia, motion sickness, hpyoaesthesia, musculoskeletal discomfort, photophobia, skin peeling, and scaly skin with BNT162b2 can not be fully excluded based on temporal relationship. 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.

Sore arm on side of injection Tender armpit on side of injection Woke up with fever day after injection Pain in middle of back similar day after injection

Stiff arm; slightly sore/stiff arm; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 28March2021 at 10:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Mar2021, the patient had only a slightly sore/stiff arm and the patient could still do her workouts without any problems. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The ice helped the patient with the pain and stiffness. The clinical outcomes of the events stiffness and pain in arm were recovering at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Two weeks after the second dose was administered, I started having constant headaches every day. Until being hospitalized from April 16, 2021 to April 30, 2021 with symptoms of headache, stiff neck, loss of mobility in lower and upper extremities with unexplained seizures. I was treated with a diagnosis of aseptic meningitis but with negative results. I was discharged with physical therapy treatment as I lost mobility and muscle function in my legs and arms. Right now today 7/12/2021 I am currently still in physical therapy.

Chronic shoulder pain. Limited movement of arm, constant pain for exactly one month so far. Not getting better but actually getting worse. Injection was too high in the shoulder with possible nerve damage or needle going into the bone.

Back pain; Neck pain; Head pain; Nausea; Fever; Feel warm almost 24 hours out; This is a spontaneous report from a non-contactable consumer, the patient. A 23-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via unspecified route of administration in the right arm on 26Mar2021 at 11:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) for treatment of adverse event. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration in the right arm on 05Mar2021 at 11:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had just sore arm after first dose. The patient was known allergic to sulfa medicines, amoxicillin, eggs, milk, cheese, wheat, gluten and ragweed. 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 vaccine. On 25Mar2021 at 21:00, the patient experienced back pain that made it difficult to stand which spread to head and neck. Within couple of hours, the patient felt nauseous and felt as if she had fever. The patient reported that she never registered a temperature higher than 99.0 F. she experienced this for 12 hours before the pain stopped. The patient still had slight nausea and feel warm almost 24 hours out, but no where near as bad as she did before. Therapeutic measures were taken with ibuprofen for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events, back pain, neck pain, head pain ,nausea, feeling warm and fever was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose :04/12/21pfizer,Lot# EW0150 2nd dose: 05/05/21,Pfizer,Lot# ER8736 Diagnosed covid positive:07/16/2021 Exposure:Travel Symptoms:SOB, cough,fatigue,muscle ache,chills, fever. sore throat.

Pfizer-BioNTech COVID-19 Vaccine EUA on 7/21/21, experienced chills, body aches, fever and fatigue; took two extra-strength Tylenol (500mg ea) around 10pm. Around 1am on 7/22/21 took temperature at it read 100 degrees; chills and aches increased at this time. Took a sleeping pill and sucked on frozen ice treat to help cool off. Around 4am on 7/22/21, woke up feeling less feverish with the onset of stomach cramps. Then had to go to the toilet and diarrhea began. The diarrhea continued every ten minutes on average until around 6am; it lessened, but the stomach cramps continued. Ate some grits and drank water and took Imodium to help with diarrhea around 10am. Then the afternoon of 7/22/21 fever went up to 100.7 degrees and took 1000mg of Tylenol. On 7/23/21, woke up with no fever and still had sore joints. Stomach cramps went away.

Woke up with strong shivers, hard jawquivering; 103 degree fever; extreme muscle fatigue; Slept a full day; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non pregnant female patient received the unknown dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA vaccine, lot no: unknown) via unspecified route of administration on 27Mar2021 at 14:30 (at the age of 23-years-old) as a Dose number Unknown, Single for COVID-19 immunization. The medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and 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 vaccine. On 28Mar2021, at 03:00, the patient had woken up with strong shivers, hard jaw quivering, 103-degree fever, extreme muscle fatigue and had slept a full day. 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. No therapeutic measures were taken as the result of adverse events. The patient underwent lab tests and procedures that included Body temperature of 103 degree. The clinical outcome of the events shivers, hard jaw quivering, fever, muscle fatigue and sleepy were recovered/resolved on an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: 1. Vaccination Facility Country added; 2. 103 degree fever added as lab data.

During dose 2, injection made into acromioclavicular rather than deltoid muscle; Persistent pain; Back pain; Neck pain; Face pain; Shoulder pain; Head pain only on side of injection (left); This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 29Apr2021 at 10:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 10:00, the patient experienced persistent pain which resulted in shoulder pain, back pain, neck pain, face pain and head pain only on side of injection (left). The patient reported, during dose 2, injection made into acromioclavicular rather than deltoid muscle as directed. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events persistent pain, back pain, neck pain, face pain, shoulder pain and head pain only on side of injection (left) was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

On 12/24/2020 started developing severe headaches with dizziness. On 12/27/2020 started getting chills, muscle aches, got covid tested (negative). On 12/29/2020 face and eyes started to swell, another covid test (negative). Continuous chills, sweats. Took tylenol, motrin, and benadryl around the clock. 01/02/2020 scratchy throat, more difficult to swallow, started on prednisone.

A day after the vaccine, the patient experienced joint pain and muscle aches, and both eyes started to swell with redness in both eyes. This continued for 5 days post-vaccination. Eyes were not dry, but just swollen. Pt took Tylenol and put compresses on her eyes at home. Symptoms are now resolving. Patient instructed to follow up with her PCP should symptoms continue or worsen. Patient said she was just reporting so we'd be aware but felt she was getting better.

Woke up at about 3:30am feeling warm. Checked my temperature and it was 101.4. Also experienced joint aches and a headache.

I felt very fatigued starting around 6pm. Severe chills began around 9pm, followed by a fever. The fever went from 100.1 to 102.2 over the course of about an hour (11:30pm-12:30pm), at which time I took 400mg of ibuprofen. The fever was 102.1 thirty minutes after taking the ibuprofen. Along with the fever I experienced tachycardia, body and muscle aches, and moderate to severe deltoid pain at the injection site. I believe the fever broke around 3:00am. The fatigue and body aches lasted about 24 hours since they began, but the majority of the rest of my symptoms were gone after the fever. The arm pain at injection site was noticeable and painful for about 72 hours before subsiding.