Pfizer

COVID vaccine Tuesday. Some soreness at the site that resolved over 2 days. Over the past 24 hours, developed some mild parasthesias [nonspecific]. Aren't painful, but tingling is annoying, contributed to restless night last night. Response 12/26: Acetaminophen, Start B-complex with Fe, report if not already done Chart 12/26: Reported. A bit better this am but will start vitamins Chart 12/29 [excerpt] Still having same symptoms of parasthesias. Started multivitamin as well as acetaminophen. I've noticed it affects only the right side of my body, and that it's purely sensory, no motor changes. Still mild, but not been sleeping well Responded, scheduled appt.   Vaccinated in L deltoid. Describes R side of body feels 'Cold' [dysesthesia] on R side of body and extremities. No weakness, no change in ROM. No joint swelling. No rash. Sensation feels less on R but still sense of touch. Thinks this is about the same- notices more when lies down in bed than in daytime. Symptoms persist 1/5/2021: Referred to Neurology at his request

rash; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ek5730), intramuscular in left arm on 16Dec2020 10:00 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included none. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included influenza vaccine (FLU) on 01Dec2020 at single dose for immunization. The patient experienced rash (non-serious) on 16Dec2020 16:00. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of rash (Benadryl). The outcome of event was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.

Employee returned to vaccination area at 13:45, reported mild intermittent tingling in hands and feet bilat; primarily feet and primarily when he sat down. Also reported mild brief blotchiness to bilat lower forearms. Narrative: Mildly anxious, mild reactions to which he was unsure if he should return to vaccination site or not. Denied dizziness, light-headedness, palpitations. Reported mild feeling of a 'rush' "kind of feeling, like, stimulated". VS: at 13:46: BP 14977. O2 99%, P 79, T 36.3. Reported he had been continuing doing his duties without difficulty but didn't know if he should be concerned. Noted blotchiness on forearms under different lighting when he went to restroom. Blotchiness mild to moderate and mostly resolved before he left. VS at 14:02: BP 136/69, O2 99%, P 80, T 36.7. Reported tingling mostly resolved if he stretches his legs out some. Reported anxiety over "the whole thing. It's just weird and I've been excited about the vaccine". Reviewed S/S to be aware of, when to seek medical attention and that he was feeling completely stable and comfortable before he left. Positively reactive to increased information and seeing improvement in blotchiness. Left at 14:08.

Injection Site Soreness/Pain; This is a spontaneous report from a Non-contactable other HCP. This other HCP reported for a 40-year-old male patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK5730), intramuscular on 04Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 40-year-old. Vaccine location was Left arm. The patient's medical history and concomitant medications were not reported. The patient experienced Injection Site Soreness/Pain. The event was reported as non serious. 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 event was unknown. No follow-up attempts are possible. No further information is expected.

Fevers, rigors, skin sensitivity, muscle aches. Fever's to 102.5 up to 36 hours after injection. Symptoms of rigors, fever and muscle aches began 12 hours after injection. Rigor subsided at 18 hours after injection. All symptoms resolved at 48 hours after injection

Severe nausea x 2 days, body aches x 1 day, fatigue, tiredness, moderate soreness at injection site. All symptoms started the day after the vaccination. Was administered

Frontal headache lasting about twenty minutes. Later that night, about 4 hours after receiving the vaccine, I experienced mild wheezing for less than 5 minutes, but believe this was likely due to allergies and associated postnasal drip rather than the vaccine. The following day I had mild muscle soreness and injection site pain without swelling or redness.

Back pain; Headache; Would be sleeping and would wake up in middle of night; Felt like a sinus headache on one side of the head; Neck pain; Could not lift his arm; his neck he could not turn it; Bruised under the arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 21Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history human immunodeficiency virus (HIV), COVID-19 in 2020 (Jun2020 or Jul2020; tested positive for COVID-19 at that time and has 3 tests after that which were all negative) and since then lost weight (2020), and root canal. The patient had no issues with vaccines in the past. There were issues with the tuberculosis (TB) vaccine, because he would be positive to TB, but this is because of his culture, he is from a specific country, and so they cannot take that vaccine. The patient clarified that he did not take the TB vaccine, what he meant was he is aware he can't take it. On 21Dec2020, the patient works in healthcare and had a patient that came in that tested positive for COVID-19 and so because of that, everyone including him that came in contact with the COVID-19 positive patient had to check and get tested. This happened the same day as his first dose of COVID-19 vaccine, the test (Dec2020) came out negative. There were no concomitant medications. The patient had not had any antibody test for COVID-19. The patient asked the doctor, but she never scheduled him for that, until after last month, she talked to him about it, but by that time he told her that he doesn't need it now - it's been almost a year. The patient had the first dose on 21Dec2020 and at that time he did experience symptoms the next day (22Dec2020). At that time after the first dose administration (21Dec2020), he could not lift his arm and it was bruised under the arm. The next day (22Dec2020), he had back pain, with his neck he could not turn it (neck pain), he could not be on his left side where he got the shot on left arm, it was like that for 3 days. Then on Thursday (24Dec2020), he had headache every time he bended his head down, he would be sleeping and would wake up in middle of night because of the headache, it felt like a sinus headache on one side of the head, and when he bend his head down, he would feel it, it stayed this way till 29Dec2020 (Tuesday). The patient has a question trying to find out with his employer. They told them they need to take the vaccine, they pushed them to take the vaccine, he works in healthcare. If they get sick at the job, he asked if they (employer) would pay for it, how would he get paid. The job told him he gets paid sick days and asked how they would do that. The patient asked how long the vaccine was alive in the body and how does it work. The outcome of the events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Drowsy; Weak; Pain in the knees/pain in his joints/joint pain from his Legs, Arms, and fingers; Both of his eyes feel tired; could not lift arm; bruised under the arm; back pain; neck pain; could not turn neck; headache; Pain with bending head down; This is a spontaneous report from a contactable consumer. A 41-year-old male consumer received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on 11Jan2021 at 07:45 at single dose for COVID-19 immunisation at the age of 40-year-old. Medical history included HIV infection, root canal in Dec2020, COVID-19 in Jun2020 or Jul2020. Concomitant medications were unknown. Vaccination history included first dose of BNT162B2 on 21Dec2020 for COVID-19 immunisation (could not lift arm, bruised under the arm, back pain with his neck he could not turn it, he could not be on his left side where he got the shot on left arm, headache). The patient experienced drowsy, weakness, knee pain, joint pain, could not lift arm, bruised under the arm, back pain, neck pain and could not turn neck, Headache, pain with bending head down, both eyes feel tired. In Jun2020/ Jul2020, the patient resulted positive to SARS-CoV-2 test; then, the patient had 3 negative SARS-CoV-2 test; weight: lost. The outcome of the events was unknown. Information on the lot/batch number has been requested.

I have a reaction to the flu shot so my MD recommended that I premedicate with Zyrtec. I did one hour prior to injection. Around 5 minutes after my injection I could feel my throat swelling. I alerted the nurse and took a Benadryl tablet. The swelling stayed consistent and I was able to breathe so I waited for an hour and then went home. When I arrived home I felt and increase in the swelling so I took another Benadryl. The swelling slightly decreased but was still present for 5 hours post shot and then disappeared. The only other reaction I had was metallic taste in my mouth and extremely sore arm where injection was given for 2 days.

30th January 2021-Am-rash-size od baseball, chills, HA-is this his from his tooth or COVID-19-he wonders, PM-freezing & hot body. 31st January 2021-more of the same-chills, HA, hot body- freezing, rash still present on his left deltoid area 1 February 2021-less chills, moving slowly, Left deltoid less hot, not as freezing Taking Tylenol, motrin. Reminded IF he gets worse-go to the ER. Reminded him-does he need to contact his PCM-do so.

Mild headache; injection site swollen and sore. Swollen lymph node on left side of neck with mild tenderness.

40 y.o. male with PMHx including asthma and HLD presenting to the ED today with c/f allergic reaction. Pt is coming in after about 35 minutes ago he had some extreme flushing he describes it as "feeling like he put his head in an oven and some skin itchiness on his arms. He notes he started taking niacin today. He also got his second dose of his Covid vaccine last night. He has no throat swelling or difficult breathing. He has not had any nausea or vomiting. He denies any recent fevers or chills. He did switch his asthma medications to Trelegy last week. He otherwise has no other allergies. The patient had just started taking Niacin which is more likely the etiology of the case in question and symptoms rather than the vaccine-pfizer. Most likely this was related to the niacin and not the pfizer vaccine.

Within 5 minutes of getting the shot on 2/6 I felt pain in the upper arm that moved down to forearm into left pinky. At approximately 3 pm arm started to hurt at the injection site. Iced for the next 36 hours until the swelling went down. On 2/7/21 at 10 pm started feeling like sickness was starting. On 2/8/21 was lethargic with body aches, headache, dry cough, and temperature up to 101.5 degrees F. Took 325 mg of Tylenol every 6 hrs. 2/9/21 up dose of Tylenol to 500 mg every 6 hrs as fever increased. Experienced night sweating and severe joint pain in hips, lower back, and along the upper spine. Fever broke at approximately 7 pm 2/9/21. Joint pain continues through 2/10/21

tiredness; headache; muscle pain; chills; injection site swelling; feeling unwell; swollen lymph nodes - Moderate-severe (Left axillary lymphadenopathy); injection site pain; This is a spontaneous report from a contactable physician (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection. lot number: EL3249), via an unspecified route of administration on 21Jan2021 at a single dose on left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. No vaccines received 4 weeks prior to vaccination. The patient experienced injection site pain on 21Jan2021. On 22Jan2021 (24 hours after vaccination), patient experienced tiredness, headache, muscle pain, chills, injection site swelling, feeling unwell and swollen lymph nodes - moderate-severe (left axillary lymphadenopathy). All occurred for a duration of 24 hours, except for event swollen lymph nodes - Moderate-severe (Left axillary lymphadenopathy) in which reported duration was 48 + hours. The patient was treated with ibuprofen for the events. The patient was not tested for COVID-19 post vaccination. The patient has not recovered from the events.

I had practically no side effects from shot #1....shot #2 was different. Starting about 6-8hrs after injection I started to feel lethargic. By 10hrs, I started with varying chills/sweats that lasted all night, injection site soreness, and soreness in left breast area. The next day I was extremely exhausted and had trouble staying awake. Muscle aches in both shoulders and neck. Also had varying fever from 100 up to 104.1 throughout the day. At 36hrs after injection. I took 2 Advil to help with the muscle aches...nothing taken to this point. 48hrs After injection some energy returned, but still lethargic throughout the day, and occasion fever between 100-101. During shower, I noticed swelling under my left armpit, not present on the right side. At 60hrs after injection, fever gone, energy returned...lingering soreness of left shoulder and breast area and swelling under left armpit remains. At no point did I have any breathing or lung issues...but otherwise it felt like I had a bad flu (minus the coughing/wheezing) for 2 days.

very sore arm, could not lift it, fatigue hit almost 24 hours exactly after injection, rash the following day over chest and neck

Soreness around the injection site for approximately 30 hours.; This is a spontaneous report from a non-contactable consumer. A 40-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN5318), via an unspecified route of administration in right arm on 26Jan2021 09:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness around the injection site for approximately 30 hours on 26Jan2021 10:15 with outcome of recovered. There was no treatment for the event. No follow-up attempts are possible. No further information is expected.

under my lymph nodes are very painful; right arm was sore for first 2 days/under my right arm are very painful; This is a spontaneous report from a contactable consumer (patient himself). A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 12Feb2021 13:45 at single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unspecified date in Nov2020 (diagnosed with COVID 19 at the end of November 2020 but tested negative since from Dec onwards 2020). Concomitant medication included finasteride at 1 mg (within 2 weeks 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. The patient has not been tested for COVID-19 since the vaccination. It was reported that, my right arm was sore for first 2 days on an unspecified date in Feb2021, however since Monday (15Feb2021 06:00 AM) under my lymph nodes, under my right arm are very painful. The events were considered as non-serious by the consumer. The patient did not receive treatment for the adverse events. The outcome of the events was not recovered.

Feverish, nausea, body aches, pain/swelling and bruising at injection site, hurts from left side of face and ears down to wrist and back to shoulder blade on left side, hurts under left arm pit, tired, soreness in whole body

Itchy skin (hives?) that come and go. I took a Xyzal (antihistamine) and that worked but the hives come back again as I write this (3-6-20). Triggers like metal or holding things tight may be a trigger. I've never had hives in my life. It's not debilitating but rather annoying and concerning.

I have a history of neuropathy that has been dormant most of the last year. I went in with no nueropathy occuring to get my vaccines. After the 1st Pfizer shot I had neuropathy starting the day after that went away in about a week. After the 2nd about 3 days later it started with itching all over my body (neuropathic itch), and burning mostly in my feet, but random electrical shocks throughout my body 24/7 (while awake). It has not subsided and has actually gotten worse. There are at least a dozen people on the clinic message board saying the same thing happened to them, that the vaccine awakened or made worse their neuropathy exponentially. Here is the link to similar complaints.

Rash in the back that looks like erythema marginatum, no itch.; Rash in the back that looks like erythema marginatum, no itch.; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL9262; expiration date: unknown) at vaccination age of 40-year-old via an unspecified route of administration in the left arm on 04Feb2021 13:30 at a single dose for covid-19 immunization. Medical history included mouse allergy, asthma, OSA (obstructive sleep apnea syndrome) and allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included fluticasone propionate (FLOVENT) and menthol, methyl salicylate (SALONPAS). The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL3247) at vaccination age of 40-year-old via an unspecified route of administration in the left arm on 14Jan2021 14:00 at a single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. The patient had rash in the back that looks like erythema marginatum with no itch on 04Feb2021. The events were considered as non-serious. The patient did not receive treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.

Flare up of atopic dermatitis. Became very painful and red the day after receiving the vaccine. Occurrence of severe joint pain in left foot big toe (perhaps gouty arthritis).

Severe fatigue (two days), injection site soreness (two days), dizziness (for several hours after vaccination).

Two days after receiving the COVID vaccine, patient developed a rash to his bilateral arms and legs. The rash has caused moderate itching.

The day after vaccination I had chills, body aches and fatigue The next day I started running a fever as well. The symptoms lasted a week. I was tested for Covid-19 but the test was negative. The fever came and went. I had a two day period with no fever. The fever returned and I started to have signs of Jaundice. My Bilirubin was up to 14. I was hospitalized for five days as a result of the bilirubin level. The physician thought that the vaccine caused an inflammatory response because of medical history. Discharge from hospital was two weeks after vaccine and drain in place for three weeks after.

I'VE BROKEN OUT IN HIVES ALL OTHER LEGS, UPPER ARMS, STOMACH AND CHEST. I'VE BEEN USING ANTIHISTAMINE CREAM AND TAKING BENADRYL. THERE'S BEEN NO RELIEF.

Within a day and a half swelling of the face, especially around eyes. Rashes on face at brow and cheeks with flaking skin, in addition to hive on forearms. The following morning, today, it has become much more severe.

hand and forearm rash day after Pfizer first dose oddly the rash is on opposite side of the injection

Rash over bilateral AC, bilateral lower legs, and bulla over bilateral forearms, with erythematous papular rash over neck and chin and abdomen.

I was surprised that I am having any side effects due to the fact that I am so very lucky in that department, in most cases. The first day, following the shot, I had a bit of soreness at the injection site but it was gone by the following day, Friday, 3/26/21. I had a general feeling of weakness the afternoon and into the night on the day of the shot as well. However, it was about midday or a bit after the following day that I began feeling obvious side effects. These include, primarily, a general feeling of being ill. Headache (but that's not that abnormal & body aches and stiffness similar to a mild version of influenza. It appeared late in the day on Saturday, 3/27/21 and has continued since. (See next page)

awakened with sensation of numbness/tingling in all fingers of both hands on 3/28/2021 after having COVID vaccine in left arm on 3/26/2021. Sensation has been continuously present until 3/30/2021 at 5 pm when he is seen by me for a family medicine clinic visit. He had mild tenderness at injection site but otherwise no other effects. He has no weakness in his hands. No paresthesias in his feet. No clumsiness or motor problem of any time. No fever.

Severe rash affecting both injected arm AND traveling to face - side of cheeks. Rash has raised skin, itches, and can be painful when dry.

They diagnosed the hives as shingles (which I've never had before) and provided anti-viral prescription.; They diagnosed the hives as shingles (which I've never had before) and provided anti-viral prescription.; Headache; Sore neck; Chills; slight fever; This is a spontaneous report from a contactable consumer (reporting for himself). A 40-year-old male patient received first dose of bnt162b2 (COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 17Mar2021 at 13:00 (Batch/Lot Number: EN6206) as single dose for COVID-19 immunization. The patient's medical history included Known allergies: Penicillin. The patient's concomitant medications were not reported. On 19Mar2021 at 03:00, the patient experienced headache, sore neck, chills, slight fever. Friday evening, the patient noticed hives. The patient went to the emergency room (ER) Saturday morning at 3 AM, to be sure hives were not concerning. They diagnosed the hives as shingles (which the patient never had before) and provided anti-viral prescription, Valtrex 1000 mg 3 times per day for 7 days. The outcome of the events was recovering. The patient did not had COVID-19 prior to vaccination and was not tested post vaccination.

Spoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored forSpoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored for 2 hours and sent home with coworkers with resolution of all symptoms. 1/15/2021 f/u: advised doing well, no further issues. review as of 4/01/2021 shows he received flu vaccine on 1/22/21 w/o issues.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Additional Details: PHARMACIST GAVE HIM INJECTION ,HE WAS DIZZI,NOT FEELING WELL ,CALLED 911 ,THEY CAME AND CHECKED HIM OUT ,BP WAS NORMAL, THEN HE WALK OUT FROM THE PHCY

Employee had a reaction approximately 30 minutes post vaccination. Employee had itching and reported having hives. Took 50mg of Benadryl PO. Employee reports having chills and low grade fever the following day.

Mild aches, mild sore throat, fatigue, sore arm at site of injection. Symptoms were first noticed the morning following the injection and persisted until the evening (~08:00 pm).

Patient was witnessed on the ground following his vaccination. He has a loss of consciousness for about 30 seconds. we arrived to find the patient pale diaphoretic with abrasions on his left side of his face and his eye glasses broken. he was placed on the back board and taken to observation area two. He is currently alert and oriented and by 3. BP 133/90, HR 85, Resp 20, oxygen sat 100 on room air. once in the observation area patient removed from the backboard. he is sitting up on the bed and calling his significant other. He was given apple juice and crackers. he states he his feeling better. The medical team at this time is encouraging the patient to be seen in the emergency department due to the the unwitnessed fall from seating position and the fact that he had a positive loss of consciousness. Pt is not wanting to go to the ED due to the fact that he has bad insurance and currently unemployed. 12:50 Bp 138/86 HR 87 Resp18 Oxygen sat 100: on room air patient is feeling better however we are concerned about his LOC and wanting him to be evaluated. His partner arrived BP 133/87 pulse oxygen 100 HR 76. Once he was here he convinced pt to go to the ED. EMS was called and arrived to take patient to the ED at 1343

Thrombocytopenia (109,000); elevated D dimer (3960); fatigue; subjective fever; headache; sweats; injection site pain; paresthesias of hand on side of injection; This is a spontaneous report from a contactable physician (reporting for a patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), intramuscularly, administered in arm left on 15Mar2021 (at the age of 40-years-old) as single dose for COVID-19 immunization. Medical history included hypertension and COVID-19 prior to vaccination; patient had no known allergies. Concomitant medication included lisinopril. Patient had no other vaccine in four weeks and the COVID vaccine was received at a Public Health Clinic/Veterans Administration facility. On 15Mar2021, the patient experienced thrombocytopenia (109,000), elevated D dimer (3960), fatigue, subjective fever, headache, sweats, injection site pain and paresthesias of hand on side of injection. The adverse events resulted in emergency room/department or urgent care. The patient was tested for COVID post-vaccination through a nasal swab and Biofire PCR on 22Mar2021 which were both negative. Therapeutic measure taken as a result of the events included IV hydration. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Patient states the day of vaccine he developed a headache shortly after the vaccine. He has had hives reaction/itching all over body, sparing face. Patient with rash on palms of hands and feet as well.

Moderate pain at injection site and throughout upper left arm developing into joint pain, muscle pain, 101 F fever, chills, body pain, and fatigue, which dissipated 2nd morning after with a lingering low-grade (99-100 F) fever and light fatigue

Itchy red bumps of varying size started on left arm and over the course of a week continue to other areas including right arm, neck, head. Almost like blisters, any itching causes them to break open and bleed. The seem to be subsiding finally (after 2 weeks) but some new small ones still seem to be popping up. I can't seem to match up with anything else by viewing photos online, looks most similar to scavies, but nothing else fits (hasn't spread to family members, location on my body etc...) I was working in a wooded area the weekend prior to vaccination but the bumps don't match anything I can find for plant based rash. Tried to seek medical help, but appointments are all booked and cannot get an expedient visit. I haven't considered it concerning enough for an ER visit.

Pain at injection site 6 hours after injection. Woke up at approximately 3 am (roughly 12 hours after injection) with feverish symptoms such as dramatic body temperature changes and general malaise. At this same time the entire left side of my body was in pain, which lasted the entire next day. Side effects lasted through the next night and had noticeably subsided by the following morning.

Oval shaped red rash on injection arm that starts below the injection site. The size of the oval is 2.25 inch tall, 1.5 inch wide. Appeared about 1.5 days after injection

Bruising on upper back and left arm. Blurred Vision. Gastrointestinal issues. Shortness of Breath. Dizziness. Eyes being extremely sore. Fatigue. Difficulty concentrating.

ER Nursing Intervention/Reassessment [Charted Location: EMR-Emergency Rm Service] [Authored: 04/16/2021 15:18]- for Visit: 004092726008, Complete, Revised, Signed in Full, General IV: IV Intervention: ? IV IV INTERVENTION/REASSESSMENT ? IV 1 Date 04/16/2021 ? IV 1 Time 14:25 ? IV IV 1 ? IV 1 Size 20G ? IV 1 Type peripheral iv ? IV 1 Inserted By inserted per RN ? IV 1 Side right ? IV 1 Right antecubital ? IV 1 Actions flushes easily labs obtained ? IV 1 Dressing needleless valve placed, catheter secured, transparent dressing applied with date/time/initials transparent semi-permeable dressing applied ? IV 1 Response pt. tolerated well pt instructed to call RN for problems ? IV 1 Total Attempts 1 COVID Screening Questions: COVID Screening Questions: ? Have you had a COVID-19 vaccine in the last 7 days? Yes (1) ? Was this COVID-19 vaccine your: First dose (1) Assessment Date / Time: ? Date/Time 04/16/2021 14:25 History of Present Illness: Chief Complaint: ? History of Present Illness allergic reaction ? Onset Time/Last Seen Normal 04/16/2021 13:15 Skin Assessment: Skin Assessment: ? Skin cool diaphoretic ? Mucous Membranes moist intact COVID Screening Questions: COVID Screening Questions: ? Have you had a COVID-19 vaccine in the last 7 days? Yes ? Was this COVID-19 vaccine your: First dose ER Triage Note: ? Triage Date/Time 04/16/2021 14:21 ? Triage Chief Complaint medical, Allergic Reaction to Covid Vaccine ? Additional Triage Comments Pt states he went home after receiving his Covid Vaccine (Phizer) when he noticed he was itching on his back. Pt arrived to ED with generalized erythema, skin cool and clammy, and wheezing. Pt denies contact with chemicals or anything else. ? Have you been sexually assaulted? no ? Stroke Screening no ? Pregnant/Could be pregnant not applicable ? LMP not applicable ? Tetanus <5 years ago ? Immunization up to date yes ? CDC Early Warning Symptoms None Identified ? CDC Precautions standard precautions mask applied Infectious Disease: Infectious Disease: ? Have you traveled recently? No ? Do you have any of the following symptoms? none Mode of Arrival: ? Mode of Arrival private auto Height/Length - Weight for Calculation: Weight for Med Calculation: ? Height (ft) 6 Feet ? Height (remainder in inches) 0 Inch ? Height (cm) 182.8 cm ? Body Measurements stated ? Weight for Calculation (kg) 108 Kg ? Weight Method stated ? BSA (m2) 2.29 M2 ? BMI (kg/m2) 32.3 kg/m2 Triage Vital Signs: ? Temp (degrees F) 97.1 degrees F ? Temp (degrees C) 36.1 degrees C ? Method skin/temporal ? Heart Rate (beats/min) 118 bpm ? Respiration (breaths/min) 18 ? BP Systolic (mm Hg) 156 mm Hg ? BP Diastolic (mm Hg) 103 mm Hg ? Sitting BP right upper arm ? SpO2 Patient On room air ? SpO2 (%) 98 % Treatment Prior to Arrival: ? Treatment Prior to Arrival none Allergies: Allergies/Intolerances: Allergies: ?? Pfizer-BioNTech COVID-19 Vaccine: Anaphylaxis ?? tramadol: Hives Home Medications - OMR: Home Medications - OMR: * Patient Currently Takes Medications as of 04/16/2021 15:11 documented in Structured Notes ?? losartan 50 mg oral tablet: None, 1 tab(s) orally once a day, Hx, Status: Active, Quantity: 0, Refills: None, Last Dose Taken: ?? Albuterol (Eqv-ProAir HFA) 90 mcg/inh inhalation aerosol: None, 2 puff(s) inhaled every 6 hours, Hx, Status: Active, Quantity: 0, Refills: None, Last Dose Taken: Patient Seen Time: ? Patient Seen Time 04/16/2021 14:21 ? LMP not applicable ? Tetanus <5 years ago ? Immunization up to date yes Triage Vital Signs: ? Temp (degrees F) 97.1 degrees F ? Temp (degrees C) 36.1 degrees C ? Method skin/temporal ? Heart Rate (beats/min) 118 bpm ? Respiration (breaths/min) 18 ? BP Systolic (mm Hg) 156 mm Hg ? BP Diastolic (mm Hg) 103 mm Hg ? Sitting BP right upper arm ? SpO2 Patient On Pulseox: 98 % on RA @ bedside monitor -- normal ? SpO2 (%) 98 % ? Acuity Level 3 Preferred Pain Scale: Preferred Pain Scale Numeric Pain Scale© Numeric Pain Score - Rest© 0 - No Pain Numeric Pain Score - Activity© 0 - No Pain Treatment Prior to Arrival: ? Treatment Prior to Arrival none Nursing Documentation Review: ? Triage Review I have reviewed the above Vital Signs, Nursing Documentation and Triage Assessment. Arrived From: ? Arrived From home home after leaving vaccination clinic HPI: ? HPI CC: rash/itching HPI: history from patient He describes Covid just after receiving the Pfizer vaccine, his initial dose. By the time that he returned home he had opened up a soft drink was having some slight cough, trouble swallowing and had sensation of itching on his back. He asked his mother to check his back and it was discovered that he was starting to have rash over his body. This seemed to be persistent and he returned to ER for further evaluation/treatment. He has not had reaction to vaccination in the past. He does have allergy to tramadol. He denies having any allergy to soap, detergent, or other chemicals. He denies having exposure to any chemical, fume, dust, plant material after receiving the vaccination. He denies having any new foods or drinks recently. He is not having any nausea or vomiting. He has felt somewhat sweaty. Allergy: tramadol H/O LE muscle weakness/atrophy , COPD ROS Const: No fever, chills, sweats. No unusual weakness (he does note "my leg is atrophying" when he is speaking about his LLE) HEENT: No runny nose, congestion, ear ache. Perhaps some odd sensation in the throat due to swollen uvula. CV: No chest pain, palpitations. No unusual shortness of breath. No edema to the ankles / legs. No pain with breathing. Abdom: No nausea, vomiting, diarrhea, or constipation. No abdominal pain. Lymph: No swelling to glands. Physical Exam: ? Physcial Exam A&O, nontoxic. Pleasant. No pain distress. Mild physiologic distress. Appears to be overwt adult with component of chronic illness and with acute allergic reaction/process_. Eyes: EOMI, nonicteric, conjunctiva clear. Throat: Moist mucous membranes. Symmetric rise of palate. No pharynx erythema. Tonsils normal size and without erythema or exudate. His uvula is moderately edematous and elongated. He is managing his secretions well. There is no angioedema of the tongue, soft palate, lips. No stridor. No blood in the oropharynx. No rhinitis/runny nose. Neck: supple, normal ROM, nontender. trachea midline. No cervical or supraclavicular lymphadopathy. Thyroid nontender and normal size. Back: No pain on percussion. No muscle spasm. Nontender palpation. No kyphosis. Lungs: fair to good air movement with quiet, fine primarily inspiratory wheezes in the mid to lower lung fields. nl effort, no rales, crackles, rhonchi. Normal resonance on percussion. Cough clear. Cardiac: borderline tachy RRR S1, S2, without murmur or rub. Posterior tibial, Pedal pulses 2/4 bilaterally. No ankle or pretibial edema. Skin: cool & dry extermities. cool & moist (not diaphoretic) back skin. Normal turgor. He does have confluent macular rash to the neck, (somewhat on face), arms, back/chest/abdomen. Some mild hyperemia to the legs/ankles. No urticaria. The right deltoid injection site is involved with the hyperemia/macular rash but no urticaria at this location right now Abdom: Bowel sounds present x 4 Quadrants. Normal tympany to percussion. Soft. Non-distended. Nontender. Nonsurgical. Good muscle tone and moves all extremities. He notes he has his chronic weakness in his left lower extremity. Medical Decision Making: ? Discussed with another healthcare provider Discussed case with another healthcare provider ? Consultation Consultation 1, Consultation 2 ? Consultation 1 04/16/2021 15:54 ? Consultation 1 Comments discussed with RPh. He will come to ER to obtain additional information from patient. This is the hospital's first presumptive Pfizer vaccine reaction. ? Consultation 2 04/16/2021 15:41 ? Consultation 2 Comments discussed with Dr. we discuss presentation. he agrees pt will need monitoring with the persisting symptom/findings and the H/O COPD. 1617 Dr has been to ER and completed eval. pt to be placed on 2nd floor med/tele for additional monitoring and treatment. pt did have labs yesterday. ? Decision to Admit Based On 1446 Based on his symptoms and presentation presumptive acute anaphylaxis to component of the Pfizer Covid vaccine. We will begin treatment with 0.3 mg epinephrine IM once as well as dexamethasone, famotidine, diphenhydramine IV. We will continue to monitor with cardiac telemetry and pulse oximetry. He does have slight wheezing but this may be related to his chronic COPD. No respiratory distress at this time, but his symptoms seem to have been mildly progressive over the past hour (per his report). I believe inclusion of the epi to be prudent based on his presentation. Additionally, I will inform the vaccination clinic of this reaction. he agrees pt will benefit from continued monitoring and repeated IV antihistamine and IV steroid treatment. Pt will need IVFluid for hydration as well. Recheck: ? Recheck Recheck 1, Recheck 2, Recheck 3 ? Time 14:55 ? Recheck patient stable patient improving with treatment ? Comments He is improving. His skin is now warm and moist (not sweatty , not diaphoretic). The rash is receeding from the arms. Good coloration to the legs/ankles. Back & torso rash starting to recede. no nausea/vomiting. no difficulty breathing. still with fading macular rash on the torso and upper back. Lungs: improved air movement compared to the initial exam, nl effort, no rales, crackles, rhonchi. He has lower field (only) quiet fine inspiratory wheezes. Normal resonance on percussion. Cough mildly wheeze @ bases, with improved airflow. Cardiac: borderline tachy RRR S1, S2, without murmur or rub. Posterior tibial, pedal pulses 2/4 bilaterally. No ankle or pretibial edema. ? Time #2 15:05 ? Recheck #2 patient stable patient improving with treatment ? Comments #2 man from pharmacy is here and recognizes patient from the vaccination clinic. Patient rash has faded from his extremities fully and appears to have faded from his abdomen still somewhat at the malar area of the cheeks as well as the neck and torso portion of the chest. His pulse is 98?99 continues to have elevated blood pressure. Pulse oximetry 98-100% on room air, normal. Pharmacist will enter the reaction into the CDC/FDA/Pfizer database. Overall pt notes he feels tired (probably related to hydration & benadryl). He notes he has returned to home about 2 weeks ago after spending some time on the road in mountains playing guitar / touring with a small band , playing music. ? Time #3 15:37 ? Recheck #3 patient stable ? Comments #3 He has been resting. No respiratory distress. His blood pressure and pulse and pulse oximetry are reviewed at bedside and they are nonfocal at this time. Overall he is improving. He notes he still has malaise and feels about the same with itching in his back and the sensation in his throat. When I evaluate his back there is hyperemia/some macular rash that is in approximately the distribution of the trapezius muscle of the back this is where he notes he has the itching. Additionally when I evaluate his throat there is still some presence of uvula edema. There is no other angioedema. Perhaps he does have some mild hyperemia to the uvula and soft palate at this time. He is clinically improving but his symptoms have not resolved fully. Skin warm and dry normal turgor. No diaphoresis Lungs initially some coarseness/mucousy breath sounds to the mid lower fields but this clears after he coughs. Good air exchange at this time. No rales rhonchi wheezes or crackles. Cough initially mucousy then clear. managing secretions well. no stridor. no respiratory distress. Critical Care Times: ? Critical Care Time of minutes excluding, separately billable procedures 35 Disposition Summary: Arrival 04/16/2021 14:21 Disposition to be admitted Disposition Decision Date/Time 04/16/2021 15:54 Does an Emergency Medical Condition Exist at the time of D/C? yes Condition at Disposition Stable Alert and Oriented Guarded Emergency Diagnosis: ?? History of COPD (Z87.09): Entered Date: 04/16/2021 15:59, ICD-10: Z87.09 ?? Anaphylaxis due to immunization (T80.52XA): Entered Date: 04/16/2021 15:59, ICD-10: T80.52XA ?? Drug reaction, initial encounter (T50.905A): Entered Date: 04/16/2021 15:59, ICD-10: T50.905A PCP Summary: ? PCP , ? Select Follow-up Physician Follow Up Physician #1 Follow Up Physician #2 ? Follow-Up MD ? Group Name Primary Care ? Specialty ? Follow-Up MD ? Fax Number ? Follow Up In 04 days Instructions: ? Other Instructions Return to ER for worsening symptoms or other concerns ? Additional Instructions Patient has had clinical improvement and stabilization although he is not fully resolved of his symptoms. He is placed into the hospital for further evaluation and management under Dr. Note Complete: Note Complete This document is complete. Affix my electronic signature. Last Updated: 04/16/2021 16:19 by (MD) References: 1. Data Referenced From "ER MD Exam and Disposition" 04/04/2021 17:40 2. Data Referenced From "1. Vital Signs - Adult" 04/16/2021 14:30

My lips became extremely red and swollen a couple of hours after the shot. I think there was some other minor face swelling around the nose, but the lips were the main issue. I took Benadryl for a few days and the lips were back to normal in about a week.

Shingles developed on back and arms. Painful, raised rash causing stinging and discomfort, Anti viral meds prescribed as well as pain medication

Persistent pain in shoulder at the injection site especially with extremes of flexion or extension. Pain made holding a barbell in the back squat position unbearable.

Client report receiving first COVID vaccine on 03/22/21. Received second COVID vaccine on 04/16/21, exact time not known but was in the afternoon. Adverse reaction started to be slightly noticeable after first vaccine of a rash or acne on lower back around waist line. Reaction more noticed after second vaccine on 04/17, rash noticed to be steadily growing. Rash noted to be slightly itchy, warm to touch, and painful. Client seen by PCP on 04/21/21, given diagnosis of Shingles and prescribed Valtrex. Client will continue to monitor rash and take medication as ordered.

2nd dose of the vaccine was given on Thursday April 15 , Three days after the Injection. On Sun the 18 , I started have painful rash and deep nerve pain on my upper forehead and left ear. After a visit to the doctors On Tuesday the 20 It was announced I had Shingles. It has been slowly spreading over my scalp and on my face.

I came down with Shingles approximately 2 weeks after my 2nd dose. I initially had back pain around my spine and left side of my lower back. About 2 or 3 days later I developed a blistery rash on my left side starting at my spine, down my leg and ending on my pelvis. I was diagnosed and treated for shingles by my doctor.

Body Rash. Began on back of neck and spread upward to ears. Later spread across body trunk (stomach and back). Some rash around scalp hairline and around esges of eyes. The rash was small red bumps, itchy, and took over five days to resolve. Minor joint pain in major joints. Overall similar to a systemic allergy.

Pain around injection site on the left arm one week after covid vaccine, with shingles developing at the same time on the left side of my neck chest and neck.

After 5-6 days I broke out into sever shingles in the buttocks area, several other symptons as well like difficulty urinating, chills, migraine

I began itching mainly in my arms, looked like mosquito bites, then I took off my shirt and realized I had a rash on my entire body. It looks like I am sunburn, but I have not had exposure to sun. It is very red and hot around my neck/upper chest area.

Hives beginning on arms, spreading to entire body beginning 3 days following administration of second dose. Progression occurred within 24 hours. No respiratory symptoms at the time of office visit.

Irritable; was fatigued; Patient has tenderness at the injection site; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received BNT162B2 first dose on 30Mar2021 17:15 (Age at vaccination was 40 Years old) on left arm at single dose for COVID-19 immunization. Medical history included Pencillin Allergy. Concomitant medications in two weeks included SSRI. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has tenderness at the injection site, and was fatigued and irritable beginning approximately 24 hours after vaccination (31Mar202105:00 PM). Symptoms lasted for approximately 12 hours. At the end of that 12 hour period all symptoms ceased. The outcome of the events was recovered in 2021. No treatment for the events. No covid tested post vaccination. No follow up attempts are possible. Information on lot/batch number cannot be obtained.

Night of injection pt developed a low grade fever of 101.0. By monday 4/19/21 patient had a rash on his arms and torso. it then spread to his legs. Rash began as pink and very itch. It has since become a darker pink and continues to itch.

Woke up fine around 6am. As I was moving around, I noticed at about 6:45am that my neck was getting stiff. Within 15-30 minutes my neck could barely move without pain. My head also noticeable was leaning to my right side. My upper back, should blade area became tight and I couldn't really use my arms without having pain in the area. I went home and laid down on a heating pad. I couldn't even flinch without pain in the area. As the afternoon went on, it got a little better. I took Ibuprofen which helped a little. The next day it was slightly better. Today is 4/29, almost a week later and it's still not 100%. My neck is stiff. The right side where my shoulder blade ends is in a lot of pain. I can't really lift anything.

Swollen lymph nodes under injection arm, injection site swelling and redness, fatigue, dizziness, lightheadedness, nausea, joint pains

All body rash in the form of small red dots with small blister in the center. Not itchy or any feeling. Probably 300+ of them on body. Have remained steady for 10 days.

small amount of blood in the bandage a little smaller than a dime/there's blood on his arm/with his second dose, there was blood at the injection site; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 40 years of age), dose 2 via an unspecified route of administration, administered in arm left on 14Apr2021 10:20 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. Historical vaccine included BNT162B2 (at 40 years of age), dose 1 in the left arm on 23Mar2021 for COVID-19 immunisation, wherein he experienced sore arm after first vaccine. He had no other vaccines within four weeks before covid vaccine. It was reported that the patient got the second dose of the vaccine today (14Apr2021) and there was blood on his arm, the first time he got the shot for the first dose there was no bleeding. He added that with his first dose he had no blood at the injection site, he only had a sore arm the next day and that was it. He stated that today, with his second dose, there was blood at the injection site. He asked if this was something he had to concerned about. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Headache; tiredness; Arm pain at injection site; Some left ear pain (4-5 quick pulsing feelings) approximately 30 mins after dose.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via unspecified route of administration at arm left on 16Feb2021 02:45 PM at single dose for COVID-19 immunization. The patient's medical history included asthma. There was no COVID prior vaccination. The patient was not tested for COVID post vaccination. There were no known allergies. There were no other vaccines in four weeks. The patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via unspecified route of administration at arm left on 29Jan2021 09:00 AM at single dose for COVID-19 immunization. Concomitant medication included within two weeks was flecainide one time 2 weeks prior to second dose. On 16Feb2021 at 03:15 PM, the patient had some left ear pain (4-5 quick pulsing feelings) approximately 30 mins after dose. On 16Feb2021 at 08:45 PM, the patient had arm pain at injection site approximately 6 hours after dose that subsided by 24 hours after dose. On 17Feb2021 at 08:45, the patient had headache which started about 18 hours after dose and lasted for a few hours and on the same day the patient had general tiredness the day following dose. The patient did not receive any treatment for the events. The outcome of the events was recovered in 2021.

Hit quickly and strongly. Dizziness, nausea, waves of hot and cold, with profuse sweating. This was followed a couple of hours later by body aches, alternate hot and cold spells and headache. Injection site was sore, which started the previous day. Massive headaches from 4/9 to 4/11. NSAIDs somewhat helped symptoms. Began feeling human on 4/12. Was like a bad influenza, but no one else in household had any symptoms subsequently, so assume it was the vaccination.

Herpetic rash outbreak on chest appearing approximately 4-weeks after receiving 2nd dose of Pfizer COVID-19 vaccine.

Shingles along scalp. Sensitivity started a couple days after second vaccine shot. Rash and blistering a couple days after that. Painful throughout - as shingles tend to be.

The morning after the vaccine, I began experiencing chills, injection site pain, and pain in both calves. The chills and injection site pain went away within a couple of days, but the pain in both calves did not go away and continues to the present. It has not affected by ability to walk, but I continue to experience pain, as well as some throbbing and tingling in both calves. There has also been occasionally tingling I my feet. After extensive consultation with several doctors, and a variety of tests, it is suspected that this is a small fiber neuropathy that was caused by the vaccine.

Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: vivid dreams-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: general feeling of increased inflammation of joint pain

I developed sudden-onset, severe, crushing pain in my left shoulder, radiating down my left arm. This is the location where I received my vaccine one month prior. The pain was 8/10 and lasted approximately 7 hours. It woke me from sleep. I also experienced nausea. I tried Tylenol 1000mg, ice, and heat. Nothing helped. I went to the Urgent Care. They did multiple EKGs and lab tests. They ruled out a heart attack and pulmonary embolism. There was no injury. They were unable to find any cause for the pain. They administered aspirin, protonix, and nitroglycerin. The pain resolved after the third dose of nitroglycerin. (I was told by the cardiology PA that this was probably a coincidence.)

I was vaccinated on Friday 5/7/2021. I got a low fever on the same night and the day after. On Sunday morning 5/9/2021, I feel my inner lap parts are itchy. During the day, I found some rashes here and there over my body. Some rashes are swelling bumps. They are itches. I found my head skin under my hairs are itchy too. It was getting worse throughout the whole day.

Hair loss noticeable from head, eyebrows and body! It is not excessive but definitely noticeable and has never happened before.

He got his vaccine, he had a burning sensation and tingling sensation and broke out really bad on his arms, and the back of his neck and his back. He went to the doctor who send him to the drug store and was given OTC topicals to help with the rash. These medications are helping but it is still not clearing up. He is being sent to the dermatologist for this rash.

Patient complained of right deltoid pain starting about 24 hours after 2nd dose. Difficulty moving the arm. Pain was still present on 5/7/21 when he presented to clinic (similar to an urgent care setting). Recommend ice, Tylenol and follow up with PCP if any worsening conditions.

Long lasting, hives on both arms, both hands, both legs, and groin. At this point, I am 2 weeks and 3 days after my second shot and I have had the hives since 5 days after my first shot.

Site: Pain at Injection Site-Mild, Additional Details: Patient stated they have had random bouts of pain/achiness where they received the shot (received 3 weeks ago). They said it hurt a lot the next day, but now randomly throughout the day it will be painful for a couple minutes at a time.

Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Nausea-Severe, Systemic: Unable to Sleep-Severe, Additional Details: He was covered in red spots, terrible itching. Couldn't sleep or eat for 3-4 weeks. He has taken mostly steroids to treat. Finally cleared on about May 14th. He said the itching was intense, could not eat or sleep. Ready to jump out of his skin. Just wanted to call someone to let them know and document.

on the 7 of may Allergic reaction (Rash) began on the left arm with just two dots similar to mosquito bites and the following days the rash spread to the forearm, it has been almost two weeks since it began.

Severe nausea and vomiting for an entire day. Could not keep any fluids down. Severe burning pain in muscles all throughout the body for 3 days. Severe muscle spasms and cramps all throughout the body. Could not stand or walk for 12 hours. Severe burning sensation on the skin all over the body, felt like a sunburn. Severe headache for 3 days. Minor muscle spasms for an additional 5 days after the severe ones diminished. Moderate fatigue for 10 days. Had tested positive for COVID 4 months prior to being vaccinated, but only had minor symptoms for 2 days.

Allergic reaction; Allergic reaction that developed into a bacterial infection of the lower leg (Cellulitis); itching; Heavy fatigue; vomiting; diarrhea; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03May2021 at 08:45 AM (Batch/Lot Number: EW0173) at the age of 40-years-old as 2nd dose, single for COVID-19 immunization at a pharmacy or drug store. The patient had no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included complex regional pain syndrome (CRPS) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lamotrigine (LAMICTAL); both taken for unspecified indications, start and stop dates were not reported (received within 2 weeks of vaccination). The patient previously received the first dose of BNT162B2 (Lot number: ER8729) on 15Apr2021 at 02:15 PM in the left arm for COVID-19 immunization. On 03May2021 at 11:00 AM, the patient experienced allergic reaction that developed into a bacterial infection of the lower leg (Cellulitis). There was extreme pain and burning in addition to itching, and the patient also experienced heavy fatigue, vomiting, diarrhea, and headache. The events resulted in doctor or other healthcare professional office/clinic visit and also emergency room/department or urgent care. The patient was treated with antibiotics for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.

Shortly after I received the shot, I had minor soreness in the spot of the injection. This was the only symptom for about 12 hours. At the twelve hour mark, about, I almost immediately started shivering uncontrollably. I was very cold ad sweating. I wasnt able to think clearly. My wife said I had a fever. Also, I had a headache. This occurred for about 6 hours. I was still cold and sweating, with a headache, for about another 4 hours, but it wasn't as extreme. I was still unable to think well. I had a desire to drink gatorade, not water, at this time. This was unusual. I drank about 2L of gatorade. I began to not feel cold, and only had a minor fever. Not sure how correlated these are. Over the next 10hrs or so, I slowly improved and was able to carryon daily activities.

Severe rash all over body and joint pain in injection site. Went to pharmacy and they recommended what to do. The rash lasted about 6 days.

Hives covered both lower arms; Extreme malaise; headaches; chills; body aches; Vomiting; diarrhea; Klein-Levin Syndrome episode was triggered; Klein-Levin Syndrome episode was triggered; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 24Feb2021 at 16:00 (at the age of 40-year-old) at a single dose for covid-19 immunisation in workplace clinic. Medical history included common variable immune deficiency, mannose binding lection deficiency, ongoing klein-levin syndrome, peptic ulcer, arthritis and was allergic to Keflex, Reglan and Prilosec. The patient did not receive any other vaccines within 4 weeks. Concomitant medications included pharmacy brand 50+ year old multivitamin (within two weeks). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: PAA156051) via an unspecified route of administration, administered in right arm on 27Jan2021 at 15:00 at a single dose 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. On 24Feb2021 at 22:00, the patient experienced hives covered both lower arms and on an unspecified date in Feb2021, the patient experienced extreme malaise, headaches, chills, and body aches began within 12 hours, vomiting and diarrhea occurred within 36 hours and persisted for approx 18 hours and A Klein- Levin Syndrome episode was triggered 72 hours later and persisted for 17 days. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

extreme skin sensitivity in a few areas: pants waistband on the right side chafed, resulting in rash and blisters

Per Client received COVID 19 in right arm on 5/24/2021, soreness at injection site on same day of vaccine. On 5/25/2021 around 4 am, started having chills and headache. On 5/26-5/27/2021 headache worsened and by Friday on 5/28/2021, along with headache, left sided pain in chest and arm. Per patient was taken to ER by wife and admitted to hospital on 5/28/2021. Per Client, was told first by hospital that he was having a heart attack. Client reported having labs collected, EKG, Catheterization and Ultra Sound. Per Client, later diagnosed with "myocarditis" and is now taking multiple mediations. Per Client was discharged from hospital on 5/29/2021, that evening. Will be following up with PCP in one week.

Hives on face; This is a spontaneous report from a contactable consumer, the patient. A 40-years-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA VACCINE Lot number: unknown) via unspecified route of administration in the left arm on 18Mar2021 at 14:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did 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. The patient was not tested positive for COVID-19 since the vaccination. The patient was allergic to Ibuprofen, Tylenol and Aspirin. The patient was experienced hives on face on 18Mar2021 at 18:30. It was unknown if patient received treatment for the event. The clinical outcome of the event hives was unknown. Information about lot number cannot be obtained. No further information is expected.

Injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6205 and Expiry date: Unknown), via an unspecified route of administration, administered in left arm on 07Mar2021 08:30 AM as 2nd dose, single for covid-19 immunisation. Patient's age at vaccination was 40 years. The patient medical history and concomitant medications were not reported. The patient not had prior vaccinations within 4 weeks and no other medications in two weeks. No known allergies. The patient was not had Covid prior vaccination and not Covid tested post vaccination. Historical vaccine information included first dose of BNT162B2 (Lot number: EL9266) administered in left arm on 14Feb2021 08:30 AM for covid-19 immunisation. The patient experienced injection site soreness on 07Mar2021 12:00 PM. The report was received as my arm started feeling sore about 12 hours after injection so evening of 07Mar2021. No treatment received for adverse event. Patient became aware about reaction when it happened to him. Outcome for the event was recovering. No follow up attempts are possible. No further information is expected.

Vision loss, hearing loss, muscle control loss and fell over. Thought I was dying. Feel better now after breathing and trying to call myself down as it panicked me. Cuts and scrapes on hand and knee and elbow from falling. Scary as luckily I made it home driving ok.

I immediately had numbness in my mouth and face as well as a metallic taste in my mouth. Since receiving the first shot I have had allergic reactions to various foods at an alarmingly increased rate. I have not been able to isolate which foods/ingredients. Symptoms include swollen lips and tongue, splotchy red face and the slight constricting of my esophagus.

Chills, severe headache, muscle pain, injection location pain, tight chest, fever, rash/bumps on the arm of the injection site, tiredness, drowsiness, dizziness and difficulty breathing. Symptoms lasted approximately 24-36 hours

Under the arm I got the injection in it has swelling the size of a grapefruit; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 20May2021 at 17:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in four weeks. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number unknown) on 27Apr2021 at 13:00 (at the age of 40-years-old) in the left arm for COVID-19 immunisation. On 22May2021 at 05:00 the patient experienced under the arm he got the injection in, it had a swelling the size of a grapefruit. No treatment was received for the events. The clinical outcome of under the arm he got the injection in, it had swelling the size of a grapefruit was not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.

Chest pain that was much more severe when sitting or sleeping. Sleep was disrupted nightly and I was not able to sleep on my left side. The chest pain lasted about 6 weeks and occurred most severely 3-4 times per day. I visited my PCP and he said that he heard a loud murmur or wooshing sound. He checked for a fib but heart ECG was normal. We scheduled an echo but the echo was not performed until 2 months post onset of the symptoms. Symptoms seem to point to subacute pericarditis. Increase of Petechiae on the torso. One spontaneously bled. Seems to be fading after three months.

Muscle soreness at injection site; Chills; This is a spontaneous report from a non-contactable consumer (patient himself). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EL3247) via an unspecified route of administration in left arm on an unspecified date in Feb2021, as single dose for COVID-19 immunization. The patient medical history and concomitant drugs were not reported. No known allergies to medications and food. On an unspecified date in Feb2021 patient experienced with Muscle soreness at injection site and chills lasting roughly 6-8 hours starting about 6-8 hours after injection. Treatment received for the events was reported as no. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Date of start of drug 23May2021 06Jun2021; Dolor en el brazo donde fue aplicada la vacuna (Pain in the arm where the vaccine was given).; Dolor en el brazo donde fue aplicada la vacuna (Pain in the arm where the vaccine was given).; This is a spontaneous report from a contactable consumer, the patient. A 40-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot Number: EW0187), via unspecified route, in left arm on 23May2021 at 12:00 (at 40-years age) as 1st dose, single for covid-19 immunization at pharmacy or drug store. The patient medical history was 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 had not received any other vaccines within 4 weeks prior to the COVID vaccine. The concomitant drugs were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot Number: EW0196), via unspecified route, in left arm on 06Jun2021 at 01:45 PM as 2nd dose, single for covid-19 immunization. On 23May2021 at 19:00 the patient had experienced Dolor en el brazo donde fue aplicada la vacuna (Pain in the arm where the vaccine was given). The device date was reported as 16Jun2021. The patient had not received the treatment. No other medications were taken by the patient within 2 weeks of vaccination. The patient was not hospitalized. The outcome of the events was recovered in 2021.

At 6:00, hives appeared on my body, left covid arm broke out first in hives. Left hand became very swollen, and got worse through the night. The next day hand was still swollen.

I got the vaccine shot on a Thursday, and woke up the next Friday morning feeling strong tingles on my face, weird sensations, & some swelling of lymph nodes had started. i thought i might be having a minor reaction, or it felt like i might. Saturday morning i woke up w' some bumps & inflammation w' a painful red sore on my nose bridge next to my right eye. i almost went to urgent care Saturday night but talked myself out of it, then Sunday woke up & had more inflammation & swelling, tenderness, & pain & discomfort. i went to my doctor on Monday as it felt intolerable & was getting worse, i told him about getting the vaccine, reporting it felt like my immune system was confused or something, he said there were some vaccine reactions, that it was possible for it to affect people differently, that it was rare, that he didn't know, but he said it looked like shingles was attacking me & referred me to the Eye Institute to see Dr, who tested me even as my eye was swelling shut. There was a danger it could get in the eye. Prescribed Acyclovir antiviral. My condition kept worsening but i kept taking the antivirals & eventually responded well to them. It hurt everywhere, & the pain was indescribable, at almost every level. It was excruciating. i was fighting off the attack by the 3rd week & could open my eye, but was still in a lot of pain, had to rest almost all the time, could barely eat & speak for weeks, or go outside in the sun for more than a couple minutes, because of the brightness etc. & was overall incapacitated for about 5 weeks. It was completely disabling. The doctors were very impressed w' how intense the condition was, & showed me to all the students at the Eye Institute. They were pleased w' how well i have been healing up. My immune system feels strong too. It was just brutal but i am recovering now, thankfully. i still feel prolonged effects though, w' even some pain at times during the day, or if i am active then i feel like i have to rest. i am just really thankful it doesn't hurt like that now. There is probably gonna be some permanent scarring because of the damage to my face from the nervous system inflammation, as my face is heavily scarred now because of the attack, i could maybeget plastic surgery for the scarring on the right side of my face.

Client received 2nd COVID vaccine on 05/10/2021 at 3pm, 3 days later adverse reaction began of swollen lymph nodes. Two weeks later the swelling went away. The injection site took a month to heal from having swelling. At this time client report he is having weird reactions to bug bites that is causing him to take up to one week to heal from the bites. Client lymph nodes have again began to swell under both armpits, they feel tender to touch. Client has not seen a medical provider for adverse reaction.

PT states that immediately upon receiving vaccine that he experience extreme pain of the right arm, and "immediate pain, pressure at the cartiledge of the injection site. Has had pain of the right shoulder since this time and also says that he has had limited rom of the arm. Has taken motrin, used ice and Tylenol with no relief of symptoms. Has normal grip strength, reports intermittent numbness of forearm to his PCP, who he followed up with on 6/14/21

Pain in the arm where the vaccine was administered; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0187), at the age of 40 years old, in left arm on 23May2021 at 12:00 at single dose for COVID-19 immunisation. The patient's medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines in four weeks of vaccination and any other medications in two weeks of vaccination. The patient experienced pain in the arm where the vaccine was administered on 23May2021 at 18:00. The patient had not been tested for COVID-19 since the vaccination. No treatment received. The outcome of event was recovered. No follow-up attempts are needed. No further information is expected.

WHEN HE CAME BACK FOR HIS 2ND DOSE ON 6/20/21, HE MENTIONED THAT THE 1ST VACCINE GAVE HIM A RASH. IT STARTED APPROXIMATELY ON 6/20/21 ON HIS UPPER BACK. HE DID STATE THAT HE WAS DOING YARD WORK THE DAY BEFORE THE RASH STARTED, AND HE SAID IT DID LOOK LIKE A HEAT RASH. HE NEVER SAW A DOCTOR FOR IT, IT RESOLVED ON ITS OWN. HE DID RECEIVED THE 2ND DOSE ON 7/8/2021. HE WILL REACH OUT TO ME IF IT HAPPENS AGAIN, SO I WON'T UPLOAD THIS UNTIL NEXT WEEK.

Patient came into pharmacy on 7/ 14/21 and described the following: Severe body pain in areas where he has "recent" injuries (vasectomy, back issues). No control over bowel movements. Disoriented/ motor skills severely lacking; couldn't walk down steps or down the hallway. had to call for help to family to do normal tasks. mild hallucinations. mental anguish; things were true in his head but not true in reality; mental dysphoria. Thinking this was the end; was able to recognize it but also very concerning. 3:30 am saturday this started; not all gone yet (7/14). Tension headaches (not prior). Extremely cold, clammy, sweaty; had to change clothes based on the amount of sweat. Not drug user, not alcohol, active military, not 48 hrs prior till recent. no pre workout. no medications. ibuprofen later saturday morning. First vaccine he just had local pain at shot site, some pain to the older issue sites and tiredness but nothing more than 24 hours. No mental illness dx at this time; possible ptsd but never diagnosed, not something he suffers from on a daily basis.

rash developed with a raised, red appearance and filled with fluid; Rash developed around neck, shoulders, butt, arms, chest, and legs; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EW0176) via an unspecified route of administration on 09May2021 at 11:30 (at the age of 40-years-old) in right arm as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history was reported as none and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (Lot number: EW0169) on 18Apr2021 at 10:30 in right arm as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccine in four weeks. Patient not had any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 28May2021 at 12:00, about 3 weeks after the second dose, patient had a rash developed with raised, red appearance and filled with fluid. Rash developed around neck, shoulders, butt, arms, chest, and legs. The event was assessed as serious (medically significant). It was reported patient consulted with four clinicians (two internal medicine and two dermatologists) and none of them could diagnose conclusively the cause of the rash, though all four commented that the reaction could be caused by the covid vaccine. The patient was treated with creams and medications (steroids) and they did not help to improve the symptoms or severity. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Device date was reported as 04Jul2021. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.

sore arm at inject site; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 5318), via an unspecified route of administration on 30Mar2021 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications 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. On 31Mar2021, starting about 10 hours after the vaccination, the patient experienced sore arm at the injected site which lasted until evening the following day. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event sore arm at inject site was recovered on 01Apr2021. No follow-up attempts are needed. No further information is expected.

golf ball sized lump at injection site; golf ball sized lump at the injection site. it is warm and tender to the touch.; golf ball sized lump at the injection site. it is warm and tender to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: unknown) via an unspecified route of administration on 17Mar2021 at 13:00 (at the age of 40-year-old), as a single dose for COVID-19 immunization. Medical history included diabetes, liver disorder and covid-19. Concomitant medications were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. It's unknown whether the patient had any allergies. On 17Mar2021, the patient experienced golf ball sized lump at the injection site, warm and tender to the touch. 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 received treatment for the reported events. The patient underwent lab test and procedure which included BMI with unknown result. The clinical outcome of the events vaccination site lump, vaccination site warmth and vaccination site tenderness were not resolved at the time of this report. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Dr walked into employee health requesting steroids. States has already taken Benadryl. Reddened rash with hives noted arms and neck. States he doesn't want to go to the ER just needs RX for steroids. Noted to his coworkers, RX number given. Rec'd Covid vaccine on 12/20/2020

injection site pain, triedness, headache, muscles pain, chills, fever, joints pain feeling unwell, weakness.

Approx 30 hours after the injection, I began to see a patchy rash appear on my left, lower leg. Over the next several days, the patches spread down my leg and to my foot and blisters appeared.

Sweating, Chills, Extreme Body Aches, Wheezing(never in life before), Dryness of Mouth, 99.8 Fever but fealth much worse, Heart burn, felt like my inside of body was swelled up, slight Gas, Hallusinations, Nightmare, Extreme Back pain not able to stay still, but I had slight back pain before this was 1000 times worse. I thought its coming to an end. This is exactly what happened to me when I had peak of COVID except the wheezing, I though I had COVID all over again. I took Vitamin C, Vitamin D, Zinx, Tums, Ibuprofen and fell asleep around 2 AM. I woke up at 7 AM in a pool of sweat had to remove the blankets to washer. I had no fever and nothing else it seemed like a switch is turned off and everything went away. Injection site was hurting allot during this time, but when I woke up nothing even injection site was not hurting either. It was a horrible night but seemed that nothing happened in AM.

Had slight injection site soreness and slight fatigue the day of treatment. The following 12 to 24 hours I presented with sever fatigue and severe body and joint aches. I was negative for a fever the entire time. 24 to 36 hours after vaccination symptoms went away.

Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fall off; Couldn't sleep; joint pain; had to miss work; fever reaching 104 degrees; chills; muscle ache; headache; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). This 41-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on at arm left 05Jan2021 at single dose (lot number: EK9231) for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received flu vaccine and felt a little tired and sore with Flu vaccine. The patient got his first dose and then worked all day on 05Jan2021. Around 18:00-19:00 on 05Jan2021, he had fever, chills, muscle aches, headaches, joint pain, tiredness, and weakness. Fever was up to 104. The patient was referring to the Pfizer COVID-19 Vaccine first felt short of breath on 05Jan2021. He was wearing a mask and felt like he couldn't breathe. He did not feel really ok on 05Jan2021 like with a flu shot. He was working and felt a little itchy. He came home around 18:00-19:00 and had chills, headache, muscle soreness like arms would fall off. He couldn't sleep. He had fever and chills through the night. He had fever up to 104 on 05Jan2021 and had to miss work. The patient stated his nose was stuffy on an unspecified date. No additional vaccines administered on same date of pfizer suspect. No prior vaccinations within 4 weeks. Outcome of all events was unknown.

Pimple like bumps all over torso, left and right arms, and in both armpits. Some are painful to touch, and some itch.

Mildly sore injection site for 24 hrs post. Pressure headache with sore neck for up to 24 hrs post inj.

Fever 103.8 Perspiration Generalized fatigue and weakness Mild dyspnea without cough- now resolved. Soreness at injection site right arm.

The day after had myalgias and fatigue and arm pain. But on 1/10/21 began developing mild 2/10 headaches. On 1/11/21 the headache worsened to 4/10 and was associated with myalgias and neck stiffness. After a jog, I was in the shower and noticed a rash all over my body that had been pruritic. I went to the ER that night where I tested negative for flu A/B and also tested negative for covid (Antigen then PCR). Got a CMP, CBC, and coags to rule out ITP. everything was normal. The symptoms were so bad I stayed home from work on 1/12/21. Over the next few days the rash improved and the headache slowly went away

After vaccine administration, about 30 minutes after,described itching in various area not localized to injection site and not systemic Benadryl was given and symptoms resolved shortly after. Advised to follow up with PCP. Follow up phone call was made to client and denied any other symptoms and stated that no further itching .

Moderate injection site pain began the day of the injection and lasted for 2 more days, Chills occurred multiple times with first occurrence roughly 13 hours after the injection and last occurrence roughly 60 hours after injection. Mild body aches/pains occurred 1 day after injection and lasted for the entire day. Fever (greater than 100 degrees F with a max of 101.0) was measured 1 day after injection and lasted into the second day after injection. Tiredness began 1 day after injection and lasted till 3 days after the injection. Headaches occurred on the second, third, and fourth days after injection.

Approximately 13 hours after receiving vaccine #2 patient developed hives over his face and neck, then felt tongue swelling & itching. He took benadryl and zyrtec and due to tongue swelling called 911. He was evaluated in the emergency room and given IV steroids and benadryl, then released after being observed for 1 hour.

Approximately 13 hours after receiving COVID vaccine #2 (no events occurred after dose #1) patient developed hives over his face and neck, followed by tongue itching and swelling. He took oral antihistamines but due to ongoing tongue swelling he contacted 911. He was taken to the ER and given IV steroids and Benadryl, then discharged after being monitored for 1 hour.

As I woke the following day- I experienced a sore arm at shot site. I had a headache which I took Tylenol for. I also had body aches. Later in the day I felt more tired than usual and feel asleep on and off.

Myalgias; Neck stiffness; Diffuse pruritic rash over my whole body; Mild headaches/Headaches worsened to about 4/10; This is a spontaneous report from a contactable physician (patient himself). A 41-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer/BioNTech, lot EH9899), via an unspecified route of administration in the right arm on 28Dec2020 11:45 at SINGLE DOSE for Covid-19 immunisation. Medical history included OSA (obstructive sleep apnea) and PFO (patent foramen ovale). He had no known drug allergy. No other vaccine in four weeks. Concomitant medication included aspirin [acetylsalicylic acid]. On 10Jan2021, he began having mild headaches. On 11Jan2021 the headaches worsened to about 4/10 associated with myalgias, neck stiffness and a diffuse pruritic rash over his whole body. To return to work he had to go get tested so he went to the ER, got Flu A/B test, Covid antigen, then PCR test, a CBC, CMP, and coags (to rule out ITP). All tests were normal, Nasal Swab was negative. Treatment given was Normal saline bolus and ketorolac 30mg IV. The outcome of events was recovered.; Sender's Comments: ~~~

Patient received 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA at 2:04pm , <5 minutes after vaccine administration he developed hypotension with loss of consciousness for few seconds. He was sitting in a designated chair for the protocol 15 min observation and fell from the chair to the ground, hitting the right side of his temporal - redness noted around area with skin intact. Clinic staff immediately moved patient to be lying down on the ground with cervical spine precaution and lifted his legs up on a chair. Vitals: HR 78 and BP 118/72 taken in supine position on ground with legs elevated. Patient was transported by EMS to the ED at 2:45pm. ED note: Patient has Hx of vasovagal syncope in the past with similar symptoms after blood draws..Exam and workup shows well-appearing young man, nonfocal neuro exam, normal gait, cardiopulmonary exam unremarkable, no signs of trauma other than a small hematoma to the right forehead. After evaluation, their Canadian Syncope Risk Score is -3 indicating very low risk for 30 day serious adverse events (<1%). Telemetry monitoring during their ED stay has not captured any events. Discussed next steps with patient: given their low risk for 30 day serious adverse events (including death, serious arrhythmia, MI, PE, ICH), they would prefer to be discharged to continue their workup as an outpatient, rather than admission for observation. Patient was deemed stable to discharged from the ED at 5:57pm with counseling to follow up with PCP in the next 2 days and to return to the ED with any persistent or worsening symptoms.

Pain in the injection site 15 after the shot was given. At 1pm fever of 101 started with chill. Around 3pm muscle weakness and tiredness started.

Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was very hot similar to being in a sauna. Removing for changing the blanket to a thinner one resulted in extreme chills within one minute. Covering with blanket resulted in extreme hot within 10 minutes. Repeated this cycle for several hours until fall asleep. High discomfort throughout body. Woke up at 10:00 a.m. with mild grade fever of 99.5° (average resting temperature is 96.5). Felt extreme cold and chills shivering body aches headache until 6:00 p.m. felt hungry and okay enough to eat. Main concern is the extreme hot to extreme cold cycle in early morning. It felt as though the body was not in sync. During fever throughout day/afternoon body's reaction was normal - fever meant chills and shivering, putting on a blanket meant comfortable warmth (after long periods of time). But in early morning no no fever yet body burning hot almost suffocating sauna heat insider body, and removing the blanket a immediate and severe chills with uncontrollable shaking, instead of relief from heat... Concerned if vaccine affects body's heart regulation system (hypothalamus, thyroid, etc). General malaise during this period is an understatement... It was not a single spot or feeling pain it was the whole body wanting to twist itself and feeling 'deprssed' and very 'ill' all over all at once.

Trouble breathing with chest pressure; Trouble breathing with chest pressure; Rash on face with swollen fingers; Rash on face with swollen fingers; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose of BNT162B2 (Lot number: 9264), via an unspecified route of administration on 31Jan2021 10:15 at single dose in the left arm for covid-19 immunisation. Medical history included hypertension and penicillin allergy. The patient's concomitant medications were not reported. On 03Feb2021 09:30, the patient experienced rash on face with swollen fingers and trouble breathing with chest pressure. The events result in Emergency room/department or urgent care. The patient did not receive any treatment for the events. 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. The patient underwent lab tests and procedures which included Nasal Swab: negative on 03Feb2021. The outcome of the events was recovering. The following information on the lot/batch number has been requested.

Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiety and hypertension. Initial BP 161/102 (pulse 102); final BP 132/88 (pulse 95).

Rash started in left armpit and around left armpit. Two reddish/purple spots below waistline. As the days after onset the rash continued to spread and the reddish/purple spots enlarged. Eventually after 2 weeks there is one large red spot between bellybutton and privates stretching between the hips. Rash has spread to mouth, neck, both upper arms, both armpits, front and back of upper torso, and is on the upper legs. Used benadryl pills and cream, hydrocortisone cream 1% and 2.5%, permethrin cream, Zyrtec, hydroxyzine HCL 25mg, prednisone, and montelukast 10mg

Feb 17, 2021 woke up with slight case of covid arm. Feb 18, 2021 covid arm symptoms increased slightly and red patch on shoulder grew in size. Feb 19, 2021 soreness decreased, itchiness increased and the red patch at injection site had doubled in size. Feb 20, 2021 unknowingly slept through alarm, slept 16 hours straight and woke up feeling groggy. Covid arm symptoms started to dissipate, redness and swelling started to dissipate. Feb 21, 2021 no symptoms.

Patient received first dose of Covid-19 vaccine (Pfizer) on 02/08/2021. Rash started on 02/16/2021, first rash started behind left ear. Rash has progressed in cranial to caudal fashion. Maculopapular rash that has been blistering and covers neck, chest then has progressed to extremities.

Burning pain immediately after injection. Pain and redness has persisted. Pain in the left arm radiating down the arm in the elbow, forearm, and wrist. Tingling sensation in the pinky and ring finger. Burning pain and ache in the left arm. Feeling of burning and cold felt in the arm.

shingles on face and near eye; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old male patient received second dose of BNT162B2, lot no. EL3249, via an unspecified route of administration (left arm) on 27Jan2021 05:00 PM at a single dose for Covid-19 immunization at a hospital. Medical history included HTN (hypertension). No allergies to medications, food, or other products. Concomitant medications included losartan, colecalciferol (VIT D3), cyanocobalamin (B 12), ubidecarenone (COQ 10), and fish oil. Historical vaccine included first dose BNT162B2 for Covid-19 immunization on 06Jan2021 05:00 PM (left arm, lot no. EK9231). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient experienced shingles on face and near eye on 30Jan2021 that required doctor or other healthcare professional office/clinic visit. It was treated with Valtrex. The event was 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 event was not recovered.

I have shingle like skin rash on my neck for more than 13 days. it is itching all over my body and tingling kind of pain on my neck and back. I have been using 10% benzoyl peroxide but not getting improvements. I am planning to go to dermatologist next week.

I woke up with a skin irritation all over my body. Patches on my arms, legs, chest, back, and scalp where it was itchy and the skin became instantly red after I scratched it. I took an anti-histamine once a day (Zyrtec) but it didn't have any real affect. The irritation seems to have mostly gone away on its own. This has never happened to me before. I visited my doctor and she recommended that I document this reaction.

Severe pain in the left eustacean tube from the ear to the throat, including jaw. Feels like intense pressure/blockage, but still able to voluntarily open the tube (pop your ears) and no increase in mucus discharge or congestion. No swollen lymph nodes in the neck. Pain got up to a level 6/10. Took Extra Strength Tylenol and went to bed early. Following day it still aches some, about the same as the arm area of the shot. Not sharp pain any longer but sore.

diffused rash with initial derm bx suggesting bullous em; diffused rash with initial derm bx suggesting bullous em; This is a spontaneous report from a contactable physician. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 41 years of age), via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines four weeks prior to Covid vaccine. The patient experienced diffused rash with initial derm bx suggesting bullous em but repeat biopsy is pending. Multiple infection work up (w/u) negative, more esoteric immune work up (w/u) pending. The events occurred on 19Feb2021 with outcome of recovering. The patient was hospitalized for seven days due to the events. Information on the lot/batch number has been requested.

Narrative: Patient C/O mild itching 10 minutes after Pfizer covid vaccine administration. No berthing issue or other symptoms. VS: BP 137/79, 96, PO2 100%. PE: Mild erythema on upper arms, no hives. Symptoms decreased significantly after 10 minutes if observation. Patient released with instructions to take Benadryl if itching recurs or repot to ED if worse symptoms develop.

Swelling at injection site and swelling of hands. Next day migraine, vertigo and rash on right leg. The vertigo has consisted and the rash has spread throughout my whole right leg and now on my left leg.

Pt's wife reports "he had a fever and swollen lymph nodes in his jaw and elbow. the injection site arm was tender to touch"

Numbness and tingling in feet and hands. Burning sensation all over body and muscle twitching all over body. Roof of mouth burning. Tingling on lips and tongue. Bruising and gum bleeding.

suicidal thoughts; Site pain; chills; body aches; tinnitus; depression; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old (reported as 42-years-old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the right arm, on 05Mar2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included pericarditis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included emtricitabine, tenofovir disoproxil fumarate (TRUVADA), omeprazole (PRILOSEC), cetirizine hydrochloride (ZYRTEC), and fluticasone propionate (FLONASE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced suicidal thoughts, site pain, chills, body aches, tinnitus, and depression on 06Mar2021 at 04:00. The patient underwent lab tests and procedures which included nasal swab: negative on 01Jul2020. The clinical outcome of suicidal thoughts, site pain, chills, body aches, tinnitus, and depression was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Patient c/o tightness in face, itching in back of throat, and rash on face and back of neck was noted.

Patient received vaccine on Thursday. Did not start experiencing adverse reactions until Sunday morning. Patient had swollen lymph nodes from neck to ear canal with fever and pain. He also had hives above the left eye on the eyelid and eye was red and itchy. He also experienced a headache and low grade fever. These reactions have not resolved (as of Monday), however, they are slightly improving.

low grade fever; tiredness; pain around injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified dates, the patient experienced low grade fever, tiredness, and pain around injection site. The events were reported as non-serious and did not require hospitalization. The events were treated with ibuprofen. The clinical outcomes of low-grade fever, tiredness, and pain around injection site were recovering. It was also reported that since vaccination, the patient had not been tested for COVID-19.

Day of injection (29th), I had injection site soreness by the evening. Took a dose of Tylenol 500 mg x 2 tablets. Following day (30th), I had the following: Overall muscle soreness; Joint pain in neck, lower back, hips, and knees; Chills; Low grade fever to 101F; Injection site pain. Continued Tylenol throughout the day. added 1 dose ibuprofen 200mg x 2 tablets in the evening. Following day (31st), I only had headache, lasted all day. Took only 1 dose of ibuprofen 200mg x 2 tablets in the evening. Following day (Apr 1st), No more issues.

A small rash approximately 2 cm in diameter appeared on my right anterior thigh about 4 inches above the knee. It started off red and mildly itchy with significant warmth compared to the surrounding area. A day or two later a similar rash appeared on my left wrist and posterior forearm that presented as raised bumps but was similarly itchy. Another day later a similar rash appeared on my right posterior forearm. I then decided to contact a telehealth provider who reviewed via video and decided to prescribe over-the-counter anti-histamine (zyrtec) and a topical ointment of mupirocin. I continued to take the zyrtec and applied the ointment but over the last several days the rash on my leg has increased in size to 20cm x 15 cm with noticeable swelling, itchiness and mild aching pain. Another noteworthy symptom is the area of the original rash on my thigh deepened in color and is now scaly and less itchy.

Patient is 41 years old, male. Alert, oriented X3, clear speech, able to answer to the questions. Underlying medical conditions include Down Syndrome, high cholesterol, and asthma. History of allergic reaction to bethanechol ? swelling, no anaphylactic shock. Denied having allergies to food, other vaccines, or components of COVID-19 vaccine. Patient was tested positive for COVID- 19 in December 2020, was hospitalized for 11 days but was not admitted to ICU or intubated. At 11:50 am, patient received first dose of Pfizer, lot number EW0150, expired on 07/2021 on right deltoid, given by RN. At 12:08, while waiting in observation area, patient reported of tingling and swelling in right hand. EMTs and RN responded. Vial signs were taken every 5 minutes. At 12:08, BP 121/82, Sp02 at 95% room air, HR 110bpm; skin was warm to touch, normal skin color on face and lower extremities. At 12:13 pm, BP 123/82 sitting, HR 107 bpm, 2+, RR 22 res/minute, unlabored, patient was moved to anti-gravity chair. Per sister, patient hasn?t eaten anything this morning. Water and cookies were offered, patient ingested 250 ml and 100% of cookies, patient stated ?I?m feeling a lot better, no more tingling?. Upon assessment, noted significant decreased swelling on right hand, normal skin color, capillary refill <3s bilaterally. At 12:24 pm, BP 121/80, SpO2 92%, RR 20 res/min, unlabored, no acute distress noted. At 12: 28, BP 121/79, HR 104, strong, RR 20 res/min, unlabored, SpO2 95%. At 12:34 pm, BP 121/78, SpO2 95%, HR 102 bpm, RR 20 res/min, unlabored, patient ingested 250 ml of water, denied any discomfort. Patient?s education was provided to patient and his sister, they verbalized understanding. At 12:45 pm, patient left facility, he was accompanied by family members and EMT to their car. Patient was able to walk without assistance, gait was balance.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient experienced numbness in arm a few minutes following COVID vaccine. He was instructed by the pharmacist to sit for 30 minutes for monitoring instead of the usual 15 minutes. After about 30 minutes, he said he was experiencing difficulty breathing (he was alert and orientated and was able to talk but he said he was laboring to breathe). EMS was called. No treatment was given on site by EMS and the patient elected to be brought to the hosptial.

Headache - 4 days and still comes and goes sometimes being very extreme. Fatigue - Started feeling tired around 5:00pm the day of the vaccine and I have continued to feel tired after 4 days. Muscle/Joint pain - Started getting sore arm first a couple hours after shot then progressively getting worse on my entire body for 3 days. On day two is was almost unbearable with my lower back being the most painful. I could not sleep because of the pain with no position that would relief it. Chills - Started getting chills on the evening of the vaccine. They came and went for 3 days. On the second day it was uncontrollable shakes no matter how many blankets I used. Fever - Started the night of my vaccine increasing to 102.4 and reaching the highest on the second day at 103.5. I took ibuprofen every 6 hours for two days straight with it staying steady at above 100. Nausea - Started the evening of the vaccine and got very severe. It has continued for 4 days. Fast Heartbeat - It has stayed consistently above 110 and sometime getting up to 130 while laying in bed shivering.

Received Pfizer COVID-19 Vaccine (1st shot) at 10:20am. Dizziness for 5 minutes after receiving injection then it disappeared. When I arrived at home an hour and a half later I was dizzy again and experienced rapid heart beats. Symptoms lasted for 30 minutes and then the symptoms stopped. While I didn?t experience any more side effects today, I did notice that the are around the injection site is significantly swollen and sore. I?m using an ice pack to help bring the swelling down.

Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of feeling in tips of fingers / thumb Tinnitus Lower back pain Lack of focus / irritable Overall random shots of pain through body Diarrhea legs and feet turned purple Constant frontal headache Lack of appetite/ nausea Some foods taste metallic

It started as just a sore arm at injection spot. Its been 2 weeks. for the last week my arm and shoulder hurts every time i lift my arm. it comes and goes but is painful

Shingles. The day after the second dose of my Pfizer vaccine I felt numbness and tingling on the left side of my body. Specifically on the left side of my left arm and down through the left pinky finger. I also had the same sensation/numbness down the left side of my left leg and into my left pinky toe. The sensation is intermittent and typically on the left side (the same side of the body as the injection). Two weeks later I began to feel more tingling on the left side including up through my left jaw and on the left side of the top of my head. The following day I realized I had two blisters under my left arm pit which made it clear I had shingles. Today is 3 weeks since my second shot and I still continue to feel numbness and tingling.

Site: Pain at Injection Site-Medium, Additional Details: needle detached from barrel and stayed in pt arm. nurse removed needle tip from pt arm

Anaphylaxis treated with EpiPen, Steroids & Benadryl It began as a hives on 04/16 around 8 PM, the morning of 04/17 I had swelling in my eyes, lips and tongue, Along with difficulty swallowing. I was treated with epinephrine on 04/17 around 1 pm and then again on 0/18 around 11 am.

About a week after my 1st dose I developed a rash that looked like shingles on the top of my right wrist. It was very itchy for 5 days and it has subsided. I have photos as needed

Patient states he was sitting when he got very hot and nauseated before fainting. Staff saw patient fall to carpeted floor face first and ran to his side. Patient briefly non-responsive but almost immediately regained consciousness and turned over onto his back. Legs elevated to chair and patient instructed to remain supine. Vitals at 1:35pm 120/80, HR 91%, O2 level 97%. Patient states he tends to get very hot and nauseated with shots. 1:37 pm: c/o tingling in both hands and requested an ice pack. Obtained his wife's phone number and contacted her using his phone. Attempted to cleanse abrasions to (L) forehead and bridge of nose but he was not able to tolerate the smell. Drinking bottled water provided by staff. EMS enroute. 1:40 EMS arrived; BP 112/72, HR 89, O2 98%. Patient remains alert and oriented. Kept supine. Using his ice packs to hands. 1:57pm: Still has tingling and slightly nauseated. EMS requested privacy with patient.

10-12 hours after receiving 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA, acute body aches were experienced. Discomfort was experienced in the lower back and joints with mild headache. At about 18-24 hours after injection, a fever of 101 degrees Fahrenheit was experienced. Body aches and fever subsided at about 48 hours after injection. After acute discomforts and fever subsided, injection site discomfort persisted to about 7 days after injection. Treatment included generic ibuprofen (400 mg) at 12 hours after injection. 400 mg of ibuprofen was ingested at 24 hours after injection. 220mg of naproxin was ingested at 36 hours after injection. Most of 24-48 hours was also resting (little activity).

After 6 hours that I had been vaccinated, I had welts like an allergy appear on both hands and they itched.

Patient reports he started with "red dots" on both feet the same morning he received the covid shot. As the day progressed the red dots moved to his thighs, then his stomach, his right arm, a little on the left arm and his right neck. He referred to the rash as "hives." States he was very itchy. He took Zyrtec daily. Had the rash for about 5 days. Did not seek any medical attention for this rash/reaction.

Morphea; A lump developed/ lump on his abdomen; Eczema; itch all over his body; large bruise on his abdomen; This is a spontaneous report from a contactable nurse (patient). A 41-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248), via an unspecified route of administration, administered in the right arm on 22Dec2020 at 16:15 as a single dose in the hospital for COVID-19 immunization. Medical history included hypertension and hyperlipidemia both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks prior to the vaccine and received other medications in two weeks prior to the vaccine. The patient was not tested for COVID post vaccination. On 22Dec2021, shortly after the first dose vaccine, the patient started to get eczema and started to itch all over his body. On an unknown date in Dec2020, about 4-5 days after the vaccine, he noticed a large bruise on his abdomen. The bruise went away, however a lump developed on 28Dec2020. He saw his primary care physician (PCP) and he did an ultrasound on an unknown date in Dec2020 that was inconclusive. It wasn't until he went to the dermatologist about the itching and eczema and mentioned the lump on his abdomen that they did a biopsy on 28Dec2020 and diagnosed the patient with with Morphea. The patient received steriods and UVA 1 treatments for the events. The events were reported to have resulted to a disability or permanent damage. The outcome of the event large bruise on his abdomen was recovered on Dec2020 with the outcome of the other events was not recovered. The patient received the second dose of bnt162b2 (lot number: EL0140) on 15Jan2021.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the event Morphea and the symptoms reported with it together with the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information. 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.

vaccine administered 2pm Friday 5/7/21. Onset maculopapular pruritic rash bilateral forearms at 5pm Saturday 5/8/21. +Penile pruritis 11pm Saturday. On morning of Sunday 5/9/21 rash had spread to pelvis/abdomen

Nausea: 1hr Palpitations: 24hr Restlessness: 8hr Insomnia: 8hr Fatigue: 36hr Pain at injection site: 5hr Headache: 12hr

Itchy rash that started on one arm, did not respond to topical rash cream, and continued to spread across both arms. Treatment: Methylprednisolone 4mg dose pack

Ache and today he was feeling "more achy"; Burning sensation, discomfort, and aching in his arm "right where he got the shot"; Burning sensation, discomfort, and aching in his arm "right where he got the shot"; Did not sleep well/ did not sleep good; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm on 14Apr2021 (at the age of 41-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He reports that on Monday 19Apr2021 he experienced a burning sensation, discomfort, and aching in his arm "right where he got the shot" and reports that it feels like he just received the vaccine. He tells me that right after he got the vaccine he worked out and that night (Wednesday night on 14Apr2021) he did not sleep well. He states on Thursday night he slept okay, Friday and Saturday night did not sleep good, Sunday "so so", and then states yesterday (22Apr2021) he started to ache and today he was feeling "more achy." Caller would like to know if it was normal to have a reaction this late to the vaccine. He was concerned about whether he should take the second dose of the vaccine because of this, and states his next dose was due 5May2021. Response: Spoke from the prescribing information PFIZER-BIONTECH COVID-19 VACCINE to let caller know that side effects were reported over a 7-day period following each dose of the vaccine and also let caller know that "the mean duration of pain at the injection site after dose 2 was 2.5 days (range 1 to 36 days)." Spoke from the attached documents regarding contraindications to receiving a dose of the vaccine and what signs of a severe allergic reaction could include. Referred caller to healthcare professional (HCP) for further guidance. Caller would like to know if it was okay to take a medication such as Advil to treat his symptoms that he was experiencing after receiving the Pfizer BioNTech COVID-19 vaccine. Response: Spoke from the attached document regarding the use of medications such as Tylenol and Ibuprofen after vaccination to treat symptoms. Referred caller to HCP for any further guidance on medication recommendations. The outcome of the events was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Eye irritation which progressed to severe swelling, such that patient could not fully open his eyes. The swelling occurred on the eyelid and below the eye to about the jawline. Went to urgent care on 5/4 and was prescribed steroid. Swelling persisted until roughly 5/10 before returning to normal. At the same time, patient broke out ink a series of rashes on his arms, legs, ears, and torso. The rash continues to evolve, spread to new locations, and change appearance.

PT CALLED STATING LUMP ,BRUISING ON LEFT INNER THIGH. PT NOTICED BRUISING HAS BEEN INCREASING. WE RECOMMENDED TO GO TO ER OR CONVENIENT CARE TO EVALUATE .

Patient stated that he developed a rash shortly after getting his first dose of the Pfizer COVID-19 vaccine. He said that his arm turned red and itchy, but it was nothing similar to hives.

Patient arrived for second dose of vaccine and verified name and DOB, patient responded negative to using immunisuppressants, having COVID in the past 90 days and any other vaccinations in the past 14 days. Pt also responded negative when asked if she had ever had a severe allergic reaction to anything ever. Per nurse, in observation, pt notified staff that she started to get hives and had some shortness of breath and carries an epi-pen on her. Per nurse patient wasn't observed to be short of breath at all and was talking just fine. Regardless, patient did not want EM S attention and confirmed she felt ok before leaving facility. Patient's husband was driving her. Pharmacist notified after pt had left.

burning sensation up to the back of the neck and scalp and part of the feet and leg area on the left side; burning sensation at the injection site in the left arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number; ER8734), via an unspecified route of administration, Left arm on 02Apr2021 at 14:00 (at the age of 41-years-old), as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included ongoing heart problem (all of his life). The patient was not receiving concomitant medications. The vaccine was administered at pharmacy. No other vaccine was administered on the same day as COVID-19 vaccine. On an unspecified date in Apr2021, 2 or 3 days after the vaccine, the patient had a burning sensation. Has started in more places, so has gotten worse. It first started at the injection site in the left arm, then up to the back of the neck and scalp and part of the feet and leg area on the left side. Therapeutic measures taken as a result of the events included Advil, but it hasn't been working. The events resulted in physician's office visit, the patient went to the doctor on 29Apr2021. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Recurrent tinnitus, ringing in the ears, which worsened about 2-3 days after second shot and made me question whether to get the second dose; Severe headache 30 hours after first dose, then sporadically especially if fatigued, need to rule out whether they are migraines which I have never been diagnosed with before, continued and worsened after second dose. Malaise; Night sweat about 36 hours after first dose; Chills all night one night after the second dose. Soreness at injection site for first 30 hours after first dose, not as much after second dose. Fatigue, depression and irritability in the weeks after the first dose. After the second dose it is too soon to tell.

Patient complains of itching and tingling. Benadryl was given patient stated feeling better and left.

Significant Allergic Reaction, Itching all over entire body, raised rash/hives began Thursday Afternoon 1 week after injection lasted until end of day following Saturday. Took OTC Benadryl to minimize symptoms until they passes

Pain in left shoulder blade; Tightness in left shoulder blade; Burning sensation on skin; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) on 12Mar2021 at 12:45 PM (at the age of 42-year-old) on left arm as a first dose for COVID-19 Immunisation. Medical history includes body mass index high from an unknown date. The patient was allergic to latex and penicillin from an unknown date. Concomitant drugs include Cyclobenzaprine (MANUFACTURER UNKNOWN) and Pepcid (MANUFACTURER UNKNOWN) for unknown indication. Patient was not diagnosed with COVID-19 prior to the vaccination. The patient was not receive any vaccination 4 weeks prior to COVID-19 vaccination. The patient experienced pain and tightness in left shoulder blade and burning sensation on skin on 12Mar2021 at 5:00PM. The clinical outcome of the pain, burning sensation on skin and tightness in left shoulder blade were not recovered/not resolved. No follow-up attempts are needed. No further information is expected.

IT'S BEEN THIRTEEN DAYS SINCE MY SECOND VACCINE SHOT AND MY LEFT ARM IS STILL SORE AT THE INJECTION SITE AND SURROUNDING MUSCLES.

nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his chest was on fire and his abdomen and his hip and foot; arm at the injection site was sore; Neck stiff; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262; Expiration Date: 31May2021), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 (at the age of 41-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications was not reported. The reporter said the first day he didn't feel anything. The caller states that on the second day after getting the vaccine, arm at the injection site was sore and neck stiff on 08Feb2021. Caller states that the Tuesday after his vaccine, he was fine most of the day but in the afternoon the patient experienced nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his chest was on fire and his abdomen and his hip and foot on 09Feb2021. Caller woke up the next day with no pain, but his left arm was weak. Caller states that the day after that, everything seemed fine except whenever he uses his left arm, the triceps and armpit still hurt. Caller was scheduled for his second dose this coming Sunday, and he was wondering what the recommendations are for getting the second dose with having had symptoms like this following the first dose. Caller reported that the pain to the injection site on his left arm has resolved but he is still having nerve pain in his left arm. It was stated that nerve pain that right now it did not hurt, but if he were to use his arm, and do labor, that was when the nerve pain flare ups. Caller states that when he was resting it was good, but when he uses his arm, it flares up. Caller states the nerve pain was persisting, because it was not worse, but it was not going away. The patient underwent lab tests and procedures which included blood test: everything was good on Nov2020 everything was good. Outcome of the event (nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his chest was on fire and his abdomen and his hip and foot) was not recovered, arm at the injection site was sore was recovered on an unspecified date and neck stiff was recovered on 10Feb2021. Follow-up attempts completed. No further information expected.

2 days after shot, itchy rash is starting to appear all over body.; Itchy hives all over body; Lip swelling; Itchy hives all over body; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8732, expiration date not reported), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 09:15 (age at vaccination 41-years-old) as 2nd DOSE, SINGLE for covid-19 immunisation at workplace clinic. Medical history included Allergies to medications, food: penicillin and shrimp. Patient took concomitant medications within 2 weeks of vaccination included trazodone (TRAZODONE), loratadine (LORATADINE), vitamin d (VITAMIN D NOS) and naproxen sodium (ALEVE) 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, solution for injection, Batch/Lot Number EN6199 and expiration date not reported) via unspecified route of administration on left on 05Mar2021 09:15 for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with covid-19. On 04Apr2021 at 06:00 (2 days after shot), the patient experienced itchy rash is starting to appear all over body, Itchy hives all over body and lip swelling. Patient received treatment oral steroids, Benadryl and zyrtec. The events were assessed as non-serious by reporter with no seriousness criteria (Results in death/ life threatening/ Caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect). The patient underwent lab tests and procedures which included nasal swab negative on 16Apr2021. It was unknown if the patient received treatment for events. Outcome of the events was unknown for rash and not recovered for all other events. Follow-up attempts are completed. No further information is expected

Rare Diagnosis of Ramsay Hunt Syndrome (Shingles in the inner & outer of the left ear & throat) aka Herpes Zoster Oticus. Bedridden, Extreme fatigue, weight loss, weakness, body aches, pain in throat & ear, lymphodema, severe virtigo, tonsillitis, and permanent hearing lose.

I felt completely fine for the first 5 minutes. I left the store. After 5 more minutes I started feeling bad (I was seated). My whole body was sweating and my vision was affected (everything was bright). I was able to return to the store but was close to passing out. I sat down for about 10-15 minutes while the symptoms persisted and I was not able to see well. After that time the sweating stopped and my sight was no longer affected. This was not anxiety and I have no history of fainting with shots. This was a reaction to the shot. After about an hour I felt fine except for muscle soreness at the injection sight. If the reaction was any worse I would have passed out or asked for help. I am hesitant to get a second dose out of concern that the reaction could be worse.

I woke up at approximately 2 am 137 hours after the first injection with hives on my arms, legs, backs and chest and stomach. told me to use a steroid cream and antihistamines, zyrtec, or benadryl. None of it worked, but after about a week the itching went away on it's own. I received the second dose at about 9:30 am, on March 27th, 2021, and by 11:30 am my entire body was itching from head to toe. Multiple times since I have had outbreaks of itching, without an apparent presentation of hives. Specifically when the temperature was higher and I was active outdoors in direct sunlight, though the itching occurs in every location on my body, eyes, ears lobes and canals, nose, face, arms, legs, hands, feet, chest, back, butt, scrotum, and pretty much everywhere else. Continued treatment included prednisone and Banophen after other things failed to Work. Prednisone caused the pain to intensify. Banophen failed to ease the itching.

I received the first vaccine without a single side effect. However, the evening after receiving my second dose, I began to get chills, a fever of 101.7, and night sweats. The next morning I woke up to two rashes on my chest. I continued to experience chills, a fever of 102, and the rash now covers my entire body, including my face. The rash is painful, itchy, and bumpy. This is day two. I have swollen lymph nodes in my neck. The urgent care I saw today told me to watch my throat to make sure it doesn't close up.

side effects in my arm around the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 41-years-old male patient received BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 08May2021 as second dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced still having side effects in his arm around the injection site. The outcome of the event was not recovered.

Patient just reported that he had experienced moderate to severe arm soreness after 1st dose which he felt affected normal range of motion. He nonetheless requested to be given the 2nd dose 3 weeks later in the same arm, and stated that the soreness got worse so he decided to go to Dr. for evaluation. Dr. told him he had shoulder/joint injury due to the COVID-19 vaccine, and patient states was administered two injections to relieve pain and setup for physical therapy. Patient says he is now okay and getting better and back to normal.

Shingles - herpes zoster, Day -1 itching. Day 1 rash in right lumbar region. Day 2 rash spread further, urgent care, start of treatment with acyclovir. Day 3 spread slowed down, blistering. Day 4 blisters start to dry off. Currently Day 7, further improvement, hypersensitive skin in the right lumbar region.

Patient walked out the vaccination room for about a minute or so after 1st dose of Pfizer then suddenly blacked out, fell chin down to floor, got a cut on the chin and bleeding; patient sit up after the fall, was responsive, pain level 3-4 due to the cut on the chin, chilling and shaking. Paramedic arrived after 5 minutes and transferred patient to hospital

vaccine was administered and patient lost consciousness. he began to turn red and did not breathe for several seconds at which we were about to administer an EpiPen. He then took a breath and started to convulse. he regained consciousness and was not coherent at first. He was sweaty and pale. Pt became alert and oriented and stayed in the room while we waited for the emt to arrive. He declined to be taken to the hospital. He moved to the waiting room and was monitored for 30 minutes before leaving

Pt reports lymph node swelling to left side of neck began 5 days after initial dose of Pfizer vaccine (3/25/2021); reports node was firm and "Pistachio size, swelling to a Pecan size." Pt reports muscle pain, and bilateral lower extremities "extremely hot and sweaty." "extreme fatigue and weakness." Pt was seen by his primary provider at local HCF and was prescribed "2 rounds of antibiotics, Zithromycin and steroid." Dr. also had an ultrasound at another HCF which he reports showed lymph note "reactive and inflamed." Pt continued to follow up with medical provider and waited 3 months to received Pfizer booster vaccine (6/23/2021), which he did receive and subsequently reports reaction is "worse." He reports left side of neck lymph node swelled to "Pecan size" and this time left under arm lymph node palpable "pea size" and he became "loopy;" "not fully present" described it as driving as in a fog "dissociated." Extreme fatigue and weakness continue. Pt reports he then again saw his primary medical provider and was prescribed more antibiotics (Rocefin I.M.) and steroids. He is being referred to an ENT MD and infectious disease MD for follow up. Pt reports he tested multiple times in the past for COVID-19 via rapid testing (No PCR confirmatory test done), he reports he never tested positive for COVID-19 but reports he had all the symptoms including loss of taste and smell back in July 2020.

Fatigue, ache, Extreme swelling of the lips. 4 occurrences so far covering all 4 quadrants randomly. Numbness, tingling, itchy sensation. Last episode involved swelling of the cheek and eye on same side as lip. Chest and back tightness

I have a rash on the back of my both of my calves.; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) as a single dose via an unspecified route of administration in her right arm on 10Mar2021 at 17:30(at the age of 41-years-old), for COVID-19 immunisation. The patients medical history included diabetes, clotting disorder and history of pulmonary embolism. Concomitant medications included several unspecified medications within two weeks of vaccination. The patient was known allergic to Benadryl. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not tested positive for COVID-19 since having the vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. On 17Mar2021at 00:00 hours, the patient reported as he had a rash on the back of his both of his calves. It appeared 7 days after he was vaccinated. It does not itch much but it does get warm, and he had no other environmental changes or new medications. The patient did not receive treatment for the reported events. The clinical outcome for the event rash was not recovered at the time of this report. Information about lot number cannot be obtained. No further information is expected

Dx: Angioedema, pruritus Tx: Prednizone, Clairitin, ice Results: Swelling not going down with treatment, itching is now gone.

After shot there was a soreness in the left arm that slowly radiated out to the rest of the body. Morning of 4/4/2021 body was covered with an itchy rash, Dr. tried OTC antihistamines. 4/7/2021 Dr. prescribed steroids and stronger antihistamines. 4/20/2021 ER visit had more steroids and antihistamines prescribed. 4/292021 Dr. prescribed steroids and stronger antihistamines. 5/10/2021 Dr. stopped steroids and tried new cocktail of antihistamines. 6/1/2021 Dr. prescribed visiting allergy clinic and had blood test run. 6/9/2021 Allergy clinic Dr. could not run test as i am on a coattail of antihistamines, have to wait until i can go 5 days without antihistamine and hives before testing can start.

Dizziness; Metallic taste; Metallic smell in mouth and nose; Eyes feels warm; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration on left arm, on 23Mar2021 at 09:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. 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, patient has not tested for COVID-19. On an unknown date, the patient had experienced dizziness, weird metallic taste, metallic smell in mouth and nose, warmness in eyes and injection site pain. No therapeutic measures were taken as a result of adverse events. 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. The clinical outcome of the events dizziness, metallic taste, metallic smell in mouth and nose, warmness in eyes and injection site pain was unknown. No follow-up attempts are needed. No further information is expected.

The night of July 3rd, I started getting severe chest pain, that was worse than before. As well as full body nerve pain, obsessive sweating, shaking, my back was twitching, which led to uncontrollable shaking that went into my legs like they were vibrating. It went all over my body, hands, feet, legs, arms, all over. When I tried to stand up I could barely walk, I went to the ER. They took at CT Scan, blood tests, and just sent me home to get checked by a Neurologist. Since then I continue to have these symptoms. Such as trimmers, in my hands and feet. Heat on my skin all over my body at random times of the day. As well as the sensation that I have water or sweat on random parts of my body. I go to the Neurologist, July 15th to do further testing.

Pt called 5/13/2021 regarding of rescheduling of 2nd covid vaccine. Pt stated pt got 1st covid vaccine Pfizer at 12:05 4/23/2021 and next day pt felt soreness on left arm injection site and chest muscle soreness. pt stated it's not chest pain but felt subtle chest muscle soreness. Pt visited MD and done blood work, chest x-ray, ECG;normal. Pt stated pt feels slightly better chest muscle soreness than last week but still carry chest muscle soreness. Pt has scheduled allergy specialist at outside facility 5/19/2021. Noted pt is not taking any medication, no known allergies. Pt requested to reschedule 2nd covid vaccine d/t pt has scheduled allergy specialist.

Headache; Sore around injection area; Hard around injection site; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 09:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, obesity and bicuspid aortic valve. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient had no known allergies to medications, food, 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. On 24Mar2021 at 16:00, the patient experienced headache, sore around injection area and hard around injection site. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache, vaccination site pain, vaccination site reaction was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Small rash, first on palm of right hand, then on back of left hand on an old scar; This is a spontaneous report from a contactable consumer, the patient. A 41-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 12Mar2021 at 16:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history, and did not have any known allergies. The patients concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date (at an unknown age) 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. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 06:00, the patient experienced small rash, first on palm of right hand, then on back of left hand on an old scar. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event small rash was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Rash below injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 18Mar2021 (13 days after shot), the patient experienced rash below injection site. 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 event rash below injection site. The clinical outcome of rash below injection site was resolved in Mar2021. No follow-up attempts are needed. No further information is expected.

10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196), second dose via an unspecified route of administration, administered in left arm on an unspecified date in Jun2021 at 09:30 (at the age of 41-year-old), as a single for COVID-19 immunisation at pharmacy or drug store. No relevant medical history and concurrent conditions. No known allergies were reported. The patient's concomitant medications were not reported. Historical vaccine given to patient was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), first dose via an unspecified route of administration, administered in left arm on an unspecified date in May2021 at 09:30 (at the age of 41-year-old), as a single for COVID-19 immunisation at pharmacy or drug store. No relevant past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Reported Event: 10 days after the second dose on 27Jun2021 at 02:00 the patient experienced high fever, hives, and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night. No treatment was received for the event. The events had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. The reporter reported events as non-serious. Adverse events result in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jun2021 (Nasal Swab). The outcome of events was reported as resolving and outcome of the event high fever was reported as not resolved. No follow-up attempts are possible. No further information is expected.

both forearms broke out in hives; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 30Mar2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included losartan (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C). The patient had no known allergies to medications, food or other products. 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 30Mar2021 at 20:00, approximately seven hours after the injection, the patient's forearms broke out in hives which were still present a full day later. The right arm was far worse than the left. Later, the patient also noticed them on the lower sides of his abdomen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the event both forearms broke out in hives. The clinical outcome of the event forearms broke out in hives was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.

Chronic hives. Sought treatment in May after it did not go away and became worse. Dr. prescribed 180mg Allegra and 10mg singulair. This seems to keep it under control. After 1 mo. hives came back after only stopping treatment for 1 day. Restarted treatment.

Immediately after administration the patient started bleeding and swelling/small bump appeared at the injection site. The patient's arm was elevated and the bleeding stopped. An ice pack was applied to the swelling for about 20 minutes. The patient was observed for a total of 40 minutes by pharmacy team. No further bleeding occurred and swelling/bump was going down when patient left pharmacy and he was advised to continue applying ice pack and go to ER if any further swelling, redness, itch or trouble breathing occurred. Pharmacy followed up with patient the morning after vaccine administration and he reported no further bleeding or swelling had occurred.

rash became more and in a few more places on my right leg; Shingles; blistered after 2 days.; Nerve pain; muscle soreness; pain in my Hip Flexor tendon and in my quardiceps tendon; few spots on my thigh; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 26Apr2021 15:45 as 1st dose, single for covid-19 immunisation. Medical history included hypothyroidism ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); thyroid (ARMOUR THYROID). The patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, Received first dose of Pfizer on 26Apr2021. On 13May, she started developing nerve pain, muscle soreness, pain in my Hip Flexor tendon and in my quadriceps tendon. I also had a few spots on my thigh. As the next 4 days progressed, the rash became more and in a few more places on my right leg. Became blistered after 2 days. Went to the doctor on 17May and was diagnosed with Shingles. The nerve pain on, muscle soreness, pain in my hip flexor tendon and in my quadriceps tendon, few spots on my thigh on 13May2021 08:00 with outcome of recovering, rash became more and in a few more places on my right leg on 17May2021 with outcome of recovering, blistered after 2 days, on 15May2021 with outcome of recovering , shingles on 17May2021 with outcome of recovering. Therapeutic measures were taken Antiviral meds as a result of nerve pain (neuralgia), muscle soreness (myalgia), pain in my hip flexor tendon and in my quadriceps tendon (tendon pain), few spots on my thigh (rash macular), rash became more and in a few more places on my right leg (rash) , blistered after 2 days. (rash vesicular), shingles (herpes zoster).

Allergic edema; Hearing loss; swelling at injection site after covid vaccination; vertigo; swelling of hand; high blood pressure; rash on legs; This is a solicited report FACILITATED COLLECT based on the information received by Pfizer from biopharmaceutical company (MFR Control No. # 21K-163-3802407-00) from a non-contactable consumer (patient) A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 single intramuscular on 04Mar2021 (Batch/Lot number was not reported) at age of 41 years for covid-19 immunisation; adalimumab (HUMIRA), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg (40 mg,1 in 7 D) for ankylosing spondylitis . Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included omalizumab (XOLAIR) taken for an unspecified indication, start and stop date were not reported. The patient experienced hearing loss (medically significant) on Mar2021 with outcome of not recovered , swelling at injection site after covid vaccination (non-serious) on Mar2021 with outcome of recovering , vertigo (non-serious) on Mar2021 with outcome of not recovered , swelling of hand (non-serious) on Mar2021 with outcome of recovering , high blood pressure (non-serious) on Mar2021 with outcome of recovering , rash on legs (non-serious) on Mar2021 with outcome of unknown , allergy caused eye to swell (coded as allergic oedema) (non-serious) on an unspecified date with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: blood pressure measurement: high on 2021 . The clinical course was reported as follows: The patient had a relevant medical history of asthma.On an unknown date, the patient experienced allergy caused eye to swell. In March 2021, the patient experienced hearing loss, swelling at injection site after Covid vaccination, vertigo, swelling of hand, high blood pressure and rash on legs. Pfizer BioNTech Covid-19 vaccine was also considered suspect.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 04Mar2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer. On 04Mar2021, after taking Covid vaccine patient had swelling at the injection site, high blood pressure, hand swelling, rash on legs, hearing loss and vertigo. He had an allergy that caused eye to swell.The action taken with Humira was unknown The reporter stated that there is no reasonable possibility that the events are related to HUMIRA .While for Pfizer Biontech Covid-19 Vaccine reporter's causality was reported as probable for Hearing loss and vertigo and unknown for the other events. AbbVie's causality for all events vs Humira was reported as follows: No reasonable possibility The reporter's assessment of the causal relationship of all the events except for hearing loss and vertigo with the Pfizer 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; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events deafness, vaccination site swelling, vertigo, peripheral swelling, hypertension, rash, and allergic edema and the suspect drugs. 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.

Empoyee received his 1st dose of Covid-19 vaccine around 1535 on 12/17 at our vaccination clinic. Around 1545, while being monitored by a registered nurse, he leaned over and grabbed his head. The nurse asked if he was okay and he reported, "no". He stated that he felt nauseated. V/S obtained: B/P 158/80; pulse 99; resp 24; O2 sat 99% on RA; FSBS 267. Pupils were slow to react. Skin was flushed and red. Dr. was notified and assessed the employee. At 1558, the Dr. ordered Benadryl 50mg IM. This was given to employee in Left Deltoid IM at 1558 by RN. At 1559, patient complained of heache, chest tightness, being cold. At 1606, O2 sat was 99% on RA; B/P was 126/90. He reported that his headache was going away at that time and that the chest tightness was going away as well. Headache at that time was a 4/5 on pain scale. Recommended that he be checked at the ER. Between 1620-1625, first responders on site. At 1630, employee was transported to ER for evaluation. Status at time of transfer: Alert and Oriented; headache better, nausea getting better.

Red rash at injection site (left shoulder) and red rash on left, middle and right neck 9 hours after administration, also weakness, flushed, hot and cold chills without fever 26 hours later. Red rash disappeared within 1.5 hours after taking ibuprofen.

Muscle ache; Chills; Headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work; Left arm is too sore way it was administered; This is a spontaneous report from a contactable consumer who reported for himself. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as none. Concomitant medications were reported as none. On an unspecified date ("roughly" 6 hours after the vaccine was administered) the patient experienced "muscle ache", "chills", "headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work" and "left arm is too sore way it was administered". The patient reported that he called "because he took the COVID-19 vaccine last night and he had been having reactions from last time till this time" (as reported). The patient stated that there was no doctor that prescribed the medication, it was administered to him because he was a healthcare worker (certified nursing assistant). He stated that he had been having "muscle ache, chills and severe headache, the headache is so severe, the most disturbing one." He reported that one of the Tylenol doses was administered to him by the nurse that administered the vaccine. He reported that he took some Tylenol and ibuprofen but this time it was not helping. He stated that he received the vaccine about 24 hours ago and started to experience muscle ache, chills and severe headache roughly about 6 hours after the administration. He reported that "I could hang in, but it was getting too bad, my head wanted to fall off, so I am driving home now so I could not work." When the patient was asked about the vaccine dose and route he stated "I believe normal dose I believe, I cannot remember I cannot recap anything, but I know it was administered in my left arm, my left arm is too sore the way it was administered." He stated that he received the vaccination for prevention and to be on the safe side. The patient stated that he did lab work with his doctor a few months ago, probably around 6 or 7 months ago. The clinical outcome of the events "muscle ache", "chills", "headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work" were all not recovered/not resolved, while the clinical outcome of the event "left arm is too sore way it was administered" was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Scaled 0-10 Pain at the injection site (6): Can not raise left arm higher than shoulder level Fatigue (8) New or worsened muscle pain (8) New or worsened joint pain (8) Nausea (9): took zofran Vomiting (8) Fever (7): 101F: took tylenol 650 mg Q3 hours since 23:00 on 1/6/2021, 3:00, 6:00, 8:00, 11:00 Chills (8) Other: Burning on urination, eyes burning, left side face tingling,

UrticariaPruritus Narrative: COVID vaccine dose #1 12/28/2020. No c/o adverse reactions couple days following receiving dose #1. Pt states noticed rash on arm today 1/6/2021. 5.5cm wheal noted to LUE administration site. pt does c/o mild pruritis, bot no other complaints noted. No drainage, streaking, or other s/s of infection to LUE. dose#2 scheduled 1/17/2021-1/18/2021. No CDC contraindication to complete series at this time. pt given nurse contact info if status changes. Pt states will take OTC Zyrtec to help relieve mild itching.

Itching; Rash/all over the body, face, neck and back; Fever; This is a spontaneous report from a contactable consumer reported for himself. A 42-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08Jan2021 10:30 at single dose for covid-19 immunisation. Medical history included diabetes. Concomitant medication included varicella zoster vaccine (VARICELLA VACCINE). He noticed a rash on Saturday 09Jan2021 all over the body, face, neck and back; and he had fever. Did not take his temperature. Now today the rash is itching and getting worse. He is planning to get the next injection in 21 days. Mentions he showed the rash to the nurse who gave him this number to call. Information on the Lot/Batch number has been requested. Outcome of event fever was recovered, of others was not recovered.

Developed multiple vesicular rash on entire body from head to toe, redness of ears 2 weeks post vaccine staring on January 18, 2021. Vesicular rashes are itchy and becomes dark and patchy with small discharge. Seen by urgent care and was prescribed Deltasone PO and Triamcinolone 0.1% topical cream

Soreness at the injection site for about a day or so and then might have been exposed during the holidays 12/25 or 12/26. Started symptoms on 12/29 - extreme cough, was tested on 12/30 - positive and then after that symptoms worsened, cough, myalgia, no fever.

Two days after having vaccine, I developed a rash in the left arm wrist area then spreading to in between fingers. Now 3 weeks later, I have itchy bumps on my stomach and thighs and behind my knees. I?ve used hydrocortisone as advised by my healthcare provider.

mild to moderate neuropathic pain starting at injection site, shooting distally towards the dorsum of arm and hand, has progressively worsen over the past day and starting today towards neck (L) and left side of face.

maculopapular rash appearing on arms/ same rash but now involving arm, forearm, thighs, chest, abdomen and was very itchy; maculopapular rash appearing on arms/ same rash but now involving arm, forearm, thighs, chest, abdomen; This is a spontaneous report from a contactable physician (patient himself). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EIC4176, expiry date unknown), via an unspecified route of administration (left arm), on 11Jan2021 17:00, at single dose, for covid-19 immunization. Medical history included diabetes, hypertension and, migraine. Concomitant medication included metformin for diabetes; metoprolol for hypertension; and galcanezumab (EMGALITY) for migraine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899, expiry date unknown), via an unspecified route of administration (left arm), on 21Dec2020 16:30, at single dose, for covid-19 immunization at the age of 42-years-old. The patient experienced maculopapular rash appearing on arms on 15Jan2021 14:00 which resolved/recovered on Jan2021 with Benadryl. On 16Jan2021, same rash but now involving arm, forearm, thighs, chest, abdomen and was very itchy - also resolved/recovered on Jan2021 with Benadryl. The patient had no other vaccine in four weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination.

Fever of 101 after fever reducing meds, chills, aches and extreme lethargy for 8 hrs. Low grade fever, chills, aches and fatigue for subsequent 24 hrs. Intense pain and bruising at vaccination site.

Soreness at injection site within 5 hours; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 22Jan2021 12:00 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 42 years. The vaccine was administered at workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medication included doxycycline. On 22Jan2021 at 05:00 PM, the patient experienced soreness at injection site within 5 hours, reported as non serious. Soreness was reducing within 24 hours. No treatment was received for the adverse event. The event had resolved on an unspecified date in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

I didn't have any symptoms all day, then I woke up at 1:30AM with my left arm (injection site) hurting and swollen and I was violently shaking. Hypothermia. Couldn't get warm. It's like my body forgot how to regulate temperature. I've only ever experienced similar coming out of anesthesia after surgery. Took wearing multiple layers of clothes AND multiple blankets just to stabilize my body temp. It lasted for around 2-3 hours. This wasn't normal "chills". This was whole-body shaking hypothermia. Entire body sore afterwards from the involuntary shaking. Unfortunately, I didn't get an actual reading as anything to measure body temp was downstairs and I didn't want to risk falling.

Patient received his first dose of the Pfizer-BioNTech COVID-19 vaccine on 12/28/2020 without and adverse events reported after this dose. However, after receiving his second dose of the vaccine on 1/15/2021 in his left deltoid, he noted a rash on his bilateral antecubital fossae on the morning of 1/21/2021. He reported that the rash was erythematous in nature, raised, and pruritic describing the presence of small papules over an erythematous patch of skin that was approximately 1 inch in diameter on both sides. He noted the rash on both antecubital fossae at the same time on the morning of 1/21/2021. Since onset, he has been using topical hydrocortisone cream for symptomatic management. Although these lesions have improved, they have not yet completely resolved. He denied any other symptoms associated with the rash and also denied any other exposures or changes in skin products that might have precipitated this rash.

Increased soreness at injection site. Followed by nausea. For next two days: nausea, chills, night sweats, fever, Diarrhea

My shoulder started having a light burn and after the next six days it got worse and worse - my left shoulder. I got x-rays and started doing physical therapy. I took Tylenol for pain. Started improving - I'm probably about 40% better. I received the second dose on January 20th - just had a slightly sore arm.

I felt burning sensation at the injection site. Experienced tachycardia 200 lasted about an hour and 160 HR 200 lasted about 10 minutes.

Area where injection happened was sore the next day; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the left arm on 25Jan2021, at 10:30 as single dose for covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. No allergies to medications, food, or other products were noted. The patient experienced area where injection happened was sore the next day on 26Jan2021, which was non-serious. No other vaccines were received within 4 weeks prior to the COVID vaccine. The outcome of event was recovering without treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of area where injection happened was sore the next day was recovering. No follow-up attempts are possible; information about batch/lot number cannot be obtained.

received COVID #2 on Thursday 2/4/21 in the morning. The next morning, developed a rash to my neck, ears, back and abdomen, with a little on my arms and legs. Its pruritic, lesions come and go, are erythematous, raised. No blisters, pustules or tenderness. No oral/face/throat/tongue swelling, watery eyes, SOB, wheeze, cough, CP, n/v/d. Photos sent and reviewed which demonstrate remarkable coalescing urticaria to trunk. improved with Zyrtec 10 q12

About 3 hours after the shot, my face and upper body broke out in hives. They lasted for about 90 minutes. I used some hydrocortisone cream and took an allergy pill which probably helped.

Day 1-headache-no treatment Day 2-fever, headache, nausea, body aches, chills-no treatment Day 7-rash, left arm, topical ointment on continued through today Day 7-carbonated drinks taste flat continued through today

I have a history of auto immune anemia and ITP. I checked with my hematologist when scheduled if I should take the shot. They stated to take it as not enough data was present to prevent me to take. On 02/11, I spoke with doctors onsite and discussed my medical history. They advised to take the shot as not enough data was present to prevent me to take. On 02/14, I noticed bleeding in gums and petechiae at the injection site. I went to hematologist on 02/15, and platelets were at 2,000. I started 60 mg of prednisone immediately on 02/15. By 02/19, took blood sample and eceived one 70g dose of IVIG. Blood results came back on 02/20, and platelets were at 22,000 but did not cover results from after IVIG treatment. Hematologist decided to stop follow up IVIG treatment and stick to 60mg of prednisone daily as in the past my body has reacted well to it. On 02/24, platelet count went to 300,000. I've started to taper prednisone to 50mg and will continue with weekly blood tests to verify that platelets remain strong. Hemoglobin and all over blood levels in the CBC remained normal during this time. Hematologist has advised not to take second Pfizer COVID-19 shot due to risk.

On Monday I had the COVID vaccination. I noticed no side effects on Tuesday other than tenderness at the injection site. On Wednesday, I noticed light bruising up and down my arms. Thursday morning around 10 AM, I started to have side effect - some so severe they must be documented. At 10 AM, I felt lightheaded and had brain fog. By noon my head was pounding with a headache followed by an upset stomach. At 2 PM things started getting bad and continued to worse. It was not the headache or stomach that need to be noted but a sudden and severe onset of depression and anxiety. - Depression like I have not felt in years when I was at my worst. Throughout the day the depression worsened and by 7 PM, I was unable to stop crying and was overwhelmed with anxiety and PTSD panic attacks. While I have the training to understand this is temporary, - I am very worried about what I?m feeling , because there was no warning or mention of this side effect. I have the resources needed for this but people that are more fragile need to prepare for the sudden o set of critical/ debilitating depression.

soreness at the point of administration of his left arm; Muscle soreness/muscle soreness at the point of injection spread to his whole body; it was like aches all over his body; Fatigue; Frequent urination; Cognitive fuzziness; This is a spontaneous report from a contactable consumer (patient) reported that a 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date 31May2021), intramuscular on the left arm on 28Jan2021 16:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), mentioned he was a patient facing drug addiction counselor in training, smoke cigarettes but he has cut down to a half a pack a day, at most. The patient previously received flu vaccine on an unspecified date for flu vaccination and experienced soreness at the point of administration of his left arm. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken from an unspecified date for ADHD. The patient received his first COVID-19 vaccine this past Thursday, 28Jan2021. The next morning (29Jan2021), he woke up with real soreness at the point of administration of his left arm, well beyond what he remembered for a flu vaccine. The second night (30Jan2021), the soreness progressed. It was hard to sleep on his left arm. It was like he had been punched. He had to sleep on his right side versus his left side. On 29Jan2021, the muscle soreness at the point of injection spread to his whole body, it was like aches all over his body. The soreness has gotten a little bit better day by day. He confirmed he got a rapid nasal molecular COVID swab test because he was just covering his bases and he tested negative for COVID-19 on 02Feb2021. He also experienced fatigue. The fatigue really started to set in on Friday evening (29Jan2021), it was like he got hit by a truck. He was typically a high energy person and its very out of the ordinary for him to feel this way. He normally has class on Saturday from 9-noon but he had to cancel going with the amount of fatigue he was experiencing. He also had some cognitive fuzziness on Jan2021. His fatigue was still there, but it has gotten a little better. He was normally very high energy, but he missed two classes and skipped his internship today. He doesn't feel like himself. He also has had frequent urination which he noticed probably Friday night (29Jan2021), all the way up until now. However, he has been drinking a lot of water. The patient received a test/report showing he has no chromosomal issues and no likelihood of issues on an unspecified date. The outcome of soreness at the point of administration of his left arm and Frequent urination was not recovered; Muscle soreness/muscle soreness at the point of injection spread to his whole body and fatigue was recovering; it was like aches all over his body and cognitive fuzziness was unknown.

After the first vaccination I had a scratchy and sore throat. 42 hours after the second vaccination, I developed hives all over my chest, neck, and back and my tongue swole and became numb. I went to urgent care and the symptoms began to diminish, but the doctor prescribed prednisone and antihistamine.

shingles; rash; shoulder pain; little nerve pain thing; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: from vaccine card: EL then either 0 or O 142), via an unspecified route of administration by injection once to left arm on 13Jan2021 at single dose for prevention (covid-19 immunisation). Medical history was none. There were no concomitant medications. Patient was diagnosed with shingles about 3 weeks after receiving his first injection of the Pfizer covid-19 vaccine. This male consumer received his first injection of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021. He reported being diagnosed with shingles last Thursday (04Feb2021) and stated his symptoms started that same week (Feb2021), which were described as rash and shoulder pain. He reported his shingles are improved and are scabbing over. The consumer was prescribed and was taking valacyclovir for treatment of the shingles. Shingles was now (base on 09Feb2021) healing. Shingles occurred after the first dose, he was not blaming the vaccine, he did fine, he had no reaction, his first dose was on 13Jan2021, and shingles came up last week (on 04Feb2021). The consumer's second dose of the covid-19 vaccine was supposed to be last week (base on 09Feb2021) but this physician recommended he delay due to the shingles. Currently on an antiviral, getting better, feels great, wondering if he can proceed with second dosage. The consumer was wanting to get his second dose this week (base on 09Feb2021). No investigation Assessment. Outcome: he scabbed up, he never had fever, just a rash and the little nerve pain thing (Feb2021), that's it. Stated he had no reaction to the vaccine whatsoever. The outcome of shingles was recovering, of other events was unknown. Information on the lot/ batch number has been requested.

post vaccine nodule, no redness, no pain or tenderness, hard bump size of quarter at injection site immediately after receiving injection

swelling; red spots; tenderness on my right big toe and the toe next to it; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot #: EL3247) via an unspecified route of administration on 19Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient did not receive any other medications within two weeks prior to the vaccination and did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021 the patient experienced swelling, red spots and tenderness on my right big toe and the toe next to it. The clinical course was reported as follows: "two weeks after my COVID-19 vaccination I noticed swelling, red spots, and tenderness on my right big toe and the toe next to it. I visited my podiatrist who recommended NSAIDs for a week. Today, my sister in law who is a nurse said it looked like COVID toes. When I googled an image of COVID toes, the spots looked identical to my own." The adverse events required a physician office visit. The patient received treatment for the events which included NSAIDs. The clinical outcomes of the events swelling, red spots and tenderness on my right big toe and the toe next to it were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Severe muscle/joint pain/swelling in the middle of my left foot. Unable to walk in the morning. Slowly relieved over the next 36 hours. Soreness at injection site. Relieved within 24 hrs of injection.

Stomach tightness upon waking at 6am. At 12pm felt cold and like was about to get sick. By 1pm in bed with multiple layers of clothes, under multiple blankets with heat cranking. Uncontrollable chills, shivering and teeth chattering. Hands white and lost sensation in fingers. 105 fever. Chills lasted a couple of hours, fever lasted 3 full days. Day 1: 105; Day 2: 102; Day 3: 100; Day 4: No fever. Stomach tightness remains.

Excessive swelling at injection site (golf ball sized knot) with tenderness to the touch 103.8 temp started 12hrs after injection and lasted for 48hrs Blurred vision during onset of Temp. Muscle pain/ fatigue during onset of Temp. Full body aches during onset of Temp. Chills with moderate spells of hands shaking during onset of Temp Loss of appetite during onset of Temp.

Severe joint pain in left shoulder with burning/ electrical pain radiating down tricep to my elbow. I?ve used ibuprofen, heat, ice, rest and it still hurts a week later. I?ve missed three days of work now.

2 days after 2nd dose of pfizer vaccine, had systemic itching, and rash, and then blistering eruption of feet 2 months into this illness now the platelets are now lower- began from 160 not at 120, but he is not having any bleeding issues, rest of cbc is normal

Deep itching; dry cough in lungs; chest tightness, heaviness; shortness of breath for 4 days after; This is a spontaneous report from a contactable consumer reported for himself that a 42-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm on 25Jan2021 12:00 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history included Seasonal allergies, various surgeries. Concomitant medication included levocetirizine dihydrochloride (LEVOCETIRIZIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Deep itching dry cough in lungs and chest tightness, heaviness, shortness of breath for 4 days after, events start date provided as 07Feb2021 04:00 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. The patient received the second dose of BNT162 on 13Feb2021 11:30 AM via an unspecified route of administration at Right arm for covid-19 immunization. Information on the lot/batch number has been requested.

PATIENT WAS AT AT COVID-19 VACCINATION OFFSITE EVENT ON 3/18/2021 TO RECEIVE SECOND DOSE OF COVID VACCINE. PATIENT WAS SCREENED BY PHARMACIST VIA VACCINE AGENCY AND INFORMED CONSENT FORM FOR ACCURACY. PATIENT RECEIVED FIRST DOSE OF VACCINE WITH NO ISSUES, BUT HAD AN OUTBREAK OF HIVES 20 MINUTES AFTER THE SECOND DOSE ADMINISTRATION. PATIENT WAS ATTENDED TO BY PROVIDERS WHO WERE ONSITE AND ADMINISTERED 50MG OF DIPHENHYDRAMINE LIQUID, AND WITHIN 20-25 MINUTES OF ADMINISTRATION OF DIPHENHYDRAMINE THE HIVES WENT DOWN. FOLLOW UP CALL WAS MADE BY PPROVIDER 810PM ON 3/18/2021, TO MAKE SURE PATIENT WAS DOING WELL, WHICH HE STATED EVERYTHING WAS FINE AND REACTION STOPPED COMPLETELY.

Patient was normal upon administration. Was given instruction to wait 15 minutes in the pharmacy to monitor for adverse reaction, per protocol. Pharmacy staff was alerted by customer that patient was "not looking good". As we walked to patient, we slipped out of his chair and appeared to loose consciousness and/or have seizure-like symptoms. Patient looked very pale, perhaps had some minor foam at the mouth and was extremely hot. We stayed by patient, protected his head, allowed him to come to, took coat off and applied ice packs, took BP/pulse (normal) and patient was oriented x3. EMS arrived and took over.

Localized sore on the vaccine site , then turned into big localized rash 7 days after getting the 2nd dose with itchiness, bumps, and clear discharges. Currently still have marks on the injection site.

Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes. Upset stomach with vomiting and diarrhea. Body was shaking and didn?t have a fever. Skin felt like it was burning whole body felt swollen. Started around 2:30am with the cramping. It woke me up. Once I got up everything came so fast. Was rushed to hospital where I was admitted very quickly. I was blacking out on the drive there and blacked out while in their care. This was from one dose of Pfizer vaccine for Covid. I was put on a GI, Allergy, and steroid medications. I was hooked up to an IV and 3 drugs were injected. I passed out numerous times but was discharged at 5am.

Itchy/burning rash formed on both wrists and back of hands. Symptoms started easing on their own about an hour after they started. Diphenhydramine 25mg was taken a couple hours after the event started and seemed to help reduce the symptoms further and cleared them up. No re-emerging of symptoms have occurred since.

I developed Shingles shortly after being vaccinated.; The first lesion appeared over my spine/Now have several spanning torso; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 02Mar2021 14:30 as single dose for COVID-19 immunisation. Medical history included allergies to penicillin. Concomitant medications were not reported. On 05Mar2021, the patient developed shingles shortly after being vaccinated. The first lesion appeared over his spine roughly 3 days after my vaccination. Now the patient has several spanning torso and he was being treated accordingly with antiviral pills and medicated creams. The patient stated that he has never had shingles before this. The outcome of the events was recovering. Information on the Lot/batch number has been requested.

The injection was given very high in the left arm. All the way at the top just below should bone. Higher than the recommended injection sites. Subsequently the muscle in my arm at injection feels as if the muscle has been torn. For the first several days I could not move my arm without excruciating muscular pain. By the end of the first week it seemed to be getting better. However, in the following two weeks, the arm has gotten progressively worse. It?s not as painful as the first few days, but I have limited mobility in my left arm. I have since received the second injection in my right arm in the appropriate spot. As of the 24 hours following, I have mild soreness. I am worried that me left arm deltoid muscle has been torn. I have yet to see a specialist or get an mri.

100.5° F fever, body aches, joint pain, tenderness at injection site.. Took two Tylenol Cold+Flu Severe OTC the next morning Monday. Recovered Tuesday morning. no further symptoms except for injection site tenderness,

Erythema multiforme; This is a spontaneous report from a contactable physician. A 42-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The physician reported that a patient had severe erythema multiforme on 12Mar2021, severe rash after getting the vaccine and firmly believe it's a reaction to the vaccine. There is no other reason for him to have it. And one of the patient's questions is should he get the second vaccine. And physician's inclination was - no. But that's the situation physician wanted to report it and find out what the recommendation is for the second dose. When paraphrased the concern, reporter stated, specific rash called erythema multiforme. It's a very specific rash and the phrase that physician used, Erythema multiforme, it should always be recorded as that because it is a very specific kind of rash. It's not just erythema. Event improving. The physician gave patient prednisone, 50 mg per day and he got an additional dose, another kind of a steroid which is Decadron, 10 mg. The patient was not hospitalized for the event. Relatedness of drug to reaction: related. Information about Batch/Lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Flu like symptoms next day. Vomiting and diarrhea. Body aches. Hot and cold sweats and chills. Night cold sweats during brief sleeping periods. Third day was the same. Loss of appetite and dehydrated. Severe itching on my back. Today is the fourth day and I broke out with a rash on my back. Cortisone has relieved it thus far. My appetite is back. I did not vomit but still experiencing diarrhea.

Pfizer-BioNTech COVID-19 Vaccine EUA Tiredness, soreness at injection site, body aches, tingling, fever up to 101 degrees

Patient began to fill itchy at injection site, on lower back, and left wrist. His throat also felt itchy. His shot was at 10:55AM. Patient alerted us to symptoms at 11:15AM. Patient given 50mg diphenhyramine IM at 11:20AM in left deltoid. His blood pressure at 11:30AM was 144/92, which patient said wasn't abnormal for him. His symptoms did not progress and he was feeling fine other than mild itchiness when he left pharmacy at 11:45AM.

After receiving the vaccine he stayed in the pharmacy for 15 minutes and said he was fine. He came back after 30 minutes complaining of rash, itchiness and difficulty breathing. He stated he had a swollen throat. Patient was administered an Epipen and was fine shortly after.

I got my 2nd shot on March 26th. On Monday March 29th 6:00pm, my elbows started to itch and develop hives/rashes. Then my knees and then foot and hands by the night. It was burning and itching and it swelled up a little. Oddly the itchiness and redness goes away and then comes. Taking Allegra does help but its not making the symptoms go away.

Has urticarial swelling of upper face, periorbital areas and upper back; no wheezing or throat swelling

Lymph node in neck became swollen and painful. Mild fever for at least 2 days. Injection site became a red knot that hurt to touch. Injection site was swollen and turned to a large bruise. Lymph node under left arm swollen. Fatigue.

Although I had symptoms of Erythromelalgia prior to the vaccine, flares have increased over last few weeks. Symptoms include daily: 1) Erythromelalgia flares (numbness, redness, searing heat from hands and feet, particularly in PM) 2) peripheral neuropathy (wrist, hands, knuckles, feet). 3)Joint pain, numbness, and swelling (knees, wrists, knuckles)

Vaccine 1st dose in right arm. 2 hours after soreness in arm at site, aching throughout body. 8 hours after injection ... itchy all over body. Wheezing accompanied the inching. I took Benadryl just to be safe. Itching and wheezing went away within 1 and a half hours. Following day aching, lethargic all day and diarrhea for 2 days now.

Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, joint pain, fever (mild), nausea

Patient was in clinic parking lot post observation after first dose of covid vaccine when he decided to return to the clinic for what felt to him as "burning sensation" to back of neck and head. Patient was observed to have raised reddened spots behind neck and on scalp(patient is bald). Patient was also observed to have reddened spots on his back--but patient was unsure if those were there prior to vaccine.

Twenty minutes after injection patient reported tingling to left arm and back. Faint pale pink macular rash to left forearm. VSS. No reported distress. Within 20 min patient reported decreased tingling. Faint rash remained. D/C'd home.

I had a strange feeling in the left side of my face that I wasn't sure if it was a reaction or not. It happened within the first 15 minutes but did not last more than 30 minutes. I did not experience anything else until the first evening when my arm was very sore. The next day my arm was more sore and I had a mild circular red mark around the injection site and the arm was much harder on that side. I also felt a little in my back and neck. By the second day in the evening the only thing I felt was pain in the arm which eventually traveled into my armpit by day 3. It wasn't until day 5 that all the pain was completely gone. I may have experienced fatigue the first two days also.

Mild urticaria & itching developed about 12 hours after receiving the vaccine. Fever of 102, chills, and body aches are also present.

Diffuse rash on abdominal region and chest wall. Pruritic in nature, plaque like, non vesicular, without pain. Not associated with fever, body aches. denies: bites, new food or product exposure, or contact with grass/plants..

Within 1 day of administration of vaccine, I (patient) developed join pain and limited range of motion in in the shoulder of the arm where the vaccine was injected. Shooting/acute joint pain not constant, but is dependent on arm position and use. After five weeks, condition has not improved or changed.

felt tiredness on 3/28; sore arm showed up on 3/29 and disappeared in about 2 days. However, the vaccine arm pain comes back on 4/11, 2 weeks after the vaccine. it is occasional sharp pain around the injection area. still have ongoing pain.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Shakiness-Mild.

7:30 PM- headache, took Tylenol 325 mg x 2 + Benadryl 50mg + 1 packet of Emergen-C next day, 5AM: felt tired, headache persisting throughout the day, when got home at 8PM, took Tylenol 325 mg x 2 + Benadryl 50mg 5AM, woke up and noticed rash on chest while in the shower. Took Benadryl 50mg. 11AM: noticed lump on L arm on the injection site. Took Tylenol 325 mg x2 + Benadryl 50mg and it resolved the next day. As of today, 4/15/21: headache still persisting but nowhere near as bad, "not enough to take a Tylenol"

Experienced pain in lower back, lower spine area one day after shot #1. That went away after about a week. After second dose (3 weeks after 1st one), I had no side effects until a few days after when I got the same lower back / spine aching and pain. About a week and a half after second dose, the lower back pain moved to my left hip area and red spots appeared shortly after (a day or two after the hip pain). The spots on my left hip and butt area started to burn and feel irritated... I had mild aching in my pelvis area and lower back (spine) a few days after the shot and still today. I went to the doctor 2 days ago and am currently being treated for shingles. I am a runner, and ever since I got the 1st covid vaccine shot, my running performance has been worse... my pace per mile is about 20% worse (consistently) since the 1st shot. I feel like it did something to my immune system and am still getting over it.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: AFTER 5 MINUTES OF BEING VACCINATED, PATIENT WAS SEATED WAINTING FOR THE 15 MINUTES AND FAINT LOSSING CONSCIOUSNESS FOR 5 MINUTES, THEN AFTER RECOVERED HE WAS PALE, SWEATING, COLDNESS OF THE HANDS AND DIZZY. WHEN 911 ARRIVED, HE SAID THAT HAD NOT EATEN ANYTHING SINCE 5:00 AM, 10 HOURS BEFORE THE EVENT HAD PLACE, SO MAYBE HE EXPERIENCED A HYPOGLYCEMIC EVENT.

- Sore arm around the injection area for approximately 4 days after shot. - Very mild body warming and aches app. 12 hours after shot that lasted for 2-3 hours.

Patient started noticing dark stools the day after vaccination (4/15) and began vomiting blood on 4/16. One episode of vomiting resulted in a syncopal episode in which the patient hit their head, causing a laceration which required staples. The patient does report intermittent abdominal pain over the course of the past few weeks, but today is more severe and the first time he has experienced bloody emesis. Upon presentation patient was tachycardic, hypotensive, and pale. Patient reports he does not frequently consume alcohol. Patient received a pantoprazole bolus and drip, an octreotide drip, and PRBC. Patient also received several doses of ondansetron. Patient is being admitted for care.

Chills, fever, body aches, headache, pain at site of injection. Symptoms managed by using NSAID (Advil)

severe rash in trunk area, lower back, thighs; This is a spontaneous report received from a contactable other HCP (patient). A 42-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 10Mar2021 17:30 (Batch/Lot Number: EN6204) as SINGLE DOSE for covid-19 immunization. Medical history included obesity, gout, kidney stones and gastric sleeve bariatric surgery. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe rash in trunk area, lower back, thighs on 14Mar2021. The adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot ER2613) on 31Mar2021 at Arm Left as single dose for covid-19 immunisation. Since the vaccination, the patient has not been tested for COVID-19. The outcome was not recovered. No follow-up attempts are needed. No further information is expected.

I developed Shingles approximately 1 week after vaccine was administered. My PCP placed me on 7-day antiviral course. Still having itching and discomfort even after rashes cleared up.

Patient started 2 days after vaccine with shortness of breath and fever/chills. He says he was unable to get out of bed for 24 hours. He said the rest of the week he didn't feel quite right. A week after the vaccine he started with red capillary veins popping up all over his legs. By Saturday his legs were purple and swollen. He has multiple tests run at the hospital. They doctor believes it is vasculitis that has resulted from patient getting the covid vaccine.

Flu-like symptoms. Weakness of muscles, soreness, tired. Missed work. Mental confusion. Sore left arm where shot was received.

Patient had a reaction to the first dose (previously reported), but mainly involved itching and some throat swelling/tightness. Due to the previous reaction, we had him pre-medicated with 50mg diphenhydramine about 1 hour prior to vaccine (per patient took dose around 4PM). He received vaccine at 501PM in the left deltoid. About 10 minutes later his left foot started itching. At about 20 minutes post-dose had several other itchy spots around his body (left ankle, below injection site, left wrist, top of head, left knee and right chin/jawline). He had no swelling/itching or other throat symptoms and no noticeable rash/hives. At 540PM patient was still feeling fine other than mild itching, so he left. He was advised to take another dose of 25-50mg diphenhydramine at bedtime (or sooner if symptoms worsened). If difficulty breathing or any swelling of the face, patient advised to go to hospital immediately.

allergic reaction; itchy, raised hives/rashes all over the body; itchy, raised hives/rashes all over the body; itchy, raised hives/rashes all over the body; This is a spontaneous report from contactable male consumer (patient) reported for himself. A 42 years old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199) via unspecified route of administration in left arm on 01Apr2021 10:45 AM at age of 42 years old at single dose for COVID-19 immunisation. Medical history was not reported. 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 was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. Patient previous received the first dose of BNT162B2 (Pfizer/BioNTech COVID-19 vaccine, Lot number EL3248) on 09Mar2021 02:00 PM at age of 42 years old at single dose in left arm for COVID-19 immunisation. Patient developed itchy, raised hives/rashes all over the body, after 48 hrs (on April 3rd evening) of receiving the 2nd dose of the vaccine. Contacted the Teledoc and got prescription for diphenhydramine hydrochloride (BENADRYL). Patient stated he was the patient who experience the adverse event and he developed the allergic reaction on 3rd April 2021 (48 hrs after receiving 2nd dose). So his aware date was 3rd April 2021 (around 4 pm). The adverse event result in Doctor or other healthcare professional office/clinic visit. After taking 4 doses (36 hrs) all the hives/rashes disappeared. Outcome of events was recovered. No follow up attempt needed. No further information is expected.

headache; Sore arm where the shot was administered; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 42-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unknown route of administration on an unknown date as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications included Colecalciferol, Echinacea. The patient experienced headache and sore arm where the shot was administered. The outcome of the events was unknown. No follow-up attempts were needed. No further information was expected.

Right axillary lymphadenopathy still present. Right arm pain still present. Bilateral hand rash still present.

Had a fever and chills for two days. Less than 72 hours after the vaccine, he started to get a small rash on a few different areas of his body. He took medicine to try to help, but by Sunday morning (the next morning) he had to go to the ER because the rash had spread over 90% of his body. Also, he had some chest pain.

Patient developed diffuse red raised rash Monday 26APR beginning on trunk, spreading to back, chest, neck and arms. No breathing difficulty, dizziness. lightheadedness or wheezing. Completed 10 day course of Bactrim 26APR. Received COVID vaccine # 2 at day 7 of antibiotic.

I had the second shot on April 30th 2021, and then 9 hours later I had mild headache. The day after on May 1st 2021, I started feeling body/muscle aches on around 11:00am. After 6 hours around 5pm the intensity increased. Took 1gr of Tylenol in total each of 500mg which relieved symptoms a little bit. Around 2am on May 2nd 2021, I woke up with severe body ache and feeling of 'electricity' throughout my body with skin sensitivity. Note that the symptoms from the first Pfizer vaccine did not completely disappeared even 3 weeks after administration. The symptoms and reactions were submitted in separate form from this one.

On 25 April I woke up and felt fine and then at 10:30 am I started to feel weak. I had fever and chills and couldn't get out of the bed until 4:00pm that day. I was dizzy and drove to the hospital. They did blood work and did two Covid 19 tests. They released me and the next day I developed Heavy pains. On 27 April I woke up and went back to the hospital. They said I had elevated enzyme levels when they drew blood and they started three iv?s. They said I was having a non emergency heart attack. They had me transferred by ambulance to the another Hospital. They drew more blood and did elf?s and ultra sounds. The next day they said they were going to put a stint in my heart. The next day I was prepped for the procedure and they went in and said my heart didn?t need it. The surgeon said I had Myocarditis and at 7:00 pm that night I was released. My nose broke out with acne bumps and it feels like I have a chest cold and cough.

shingles; This is a spontaneous report from a contactable other hcp (patient himself). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E49899, expiration date not reported), intramuscularly, administered on the left arm on 26Dec2020 09:45 (at the age of 42-years-old) at a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient previously took aspirin and experienced allergy with aspirin. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced fever of 99.4 degrees, fatigue, muscle pain in left hip with radiating burning pain along posterior aspect of leg running from hip to calf , burning pain running across top of foot, blistering on left arch of foot, second, and forth toe; which was later diagnosed as shingles on 27Dec2020 19:30. The patient underwent lab tests and procedures which included body temperature: 99.4 degrees fahrenheit (fever) on 27Dec2020. Patient consulted a physician and treatment was received as a result of the event reported (reported as culture taken to confirm shingles). Events were assessed as non-serious by the reporter. The outcome of the event was recovered with sequalae. Follow-up attempts are completed. No further information is expected.

Swollen/painful lymph node in left groin - started day 3 (4/16), lasted 10 days, still 10% swollen/no pain as of day 22 (5/5). Rash (mild/light pink) around left groin lymph node, creates a semi-circle perimeter 4 inch radius from lymph node - started day 10 (4/23), still persists as of day 22 (5/5)

Patient experience pain and numbing and tingling from the injection site in right arm up through the neck and into the face. Numbness did not affect breathing but did last 12-18 hrs and stayed strictly on the right side of the body (arm, neck, face). There has also been severe joint pain throughout the body that started approx 24 hrs after injection and still lingering 10 days later.

Delayed Inguinal lymph swelling that then had a warm rash covering inguinal area and crease on same side(ipsilateral) as the given upper arm vaccination. Persisting rash still after 3 weeks and 2nd dose NOT GIVEN.

Developed vesicular lesions on back of right calf which tested positive for varicella and was consistent with diagnosis of shingles. Treated with acyclovir with good results.

Syncope. Fell and hit head, woke up within 30 sec - 1 min. Abrasion to elbow and left forehead. EMT applied antiseptic ointment/bandage. Observed an additional 15-20min. Water, crackers given. Stable and released.

Shingles like rash along v cranial nerve on the left side only, extreme pain in left ear, left eye, left upper jaw.

103* F fever, weakness, dizziness, and a severe rash/welts/hives all over the body. I began taking 20mg of Cetrizine HCl daily in the evening of 3/27 for the rash/hives and it cleared up in 2 days. I visited the Emergency Room on 4/1 for the remaining symptoms. I was prescribed a 5 day dose of Azithromycin and I do not know what else I was administered through my IV.

Pain and soreness in my arm around the injection site; Body aches and tiredness; Body aches and tiredness; Pain and stiffness in ankle joint where I had a previous injury.; Pain and stiffness in ankle joint where I had a previous injury; This is a spontaneous report from a contactable Nurse. A 42-year male patient received (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EL3247; Expiry Date: Unknown) dose 1, on an unspecified date on 01Mar2021 at 15:00 (at the age of 42-years-old) into Arm left as a single dose for COVID-19 immunization. Medical history included Amoxicillin for allergy and Pain and stiffness in ankle joint where I had a previous injury. It was reported that the patient had no allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not received list of any other medications the patient received within 2 weeks of vaccination. On 01Mar2021 18:00 patient experienced pain and soreness in his arm around the injection site, body aches and tiredness, pain and stiffness in ankle joint where he had a previous injury. The patient did not receive any treatment for adverse event. The outcome of the events were recovering. No follow-up attempts are needed. No further information is expected.

Mild hives/itchiness on torso/ arms at 30-45 min post injection Severe hives/itchiness on torso, arms and legs at 9 hours post injection Respiration ok, unaffected; face/head unaffected as of 10 hrs post vax

Injection site pain started on 5/14. Woke up on 5/15 with the additional symptoms: Low grade fever Body aches Chills Headache Lasted thru most of the day, subsiding in afternoon. Feeling much better on 5/16.

At first it was a lot of joint and muscle pain all over, and then I got shingles by the weekend. I thought they were bug bites and I wasn't sure where all the pain was coming from and I ended up in the emergency room where I was diagnosed with shingles. After my second shot I started getting shingles by laterally on my right side, but I was already on medication so it didn't get that bad. I also have a lot of joint pain and burning pain in my hands and wrists that shoot up my arms and haven't stopped since the symptoms started. It's much worse at night and keeps me up from sleeping. I have also have been very forgetful and my mind is always cloudy.

Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) several weeks ago. Pt states that after receiving his 2nd dose on 05/06, he noticed his leg stiffness got significantly worse. He tells me that he tried to "push through the pain" and mow his lawn but had to stop d/t severe cramping of the LLE and pelvis. He states he rested his leg and went to bed, and when he woke up he noticed that his left leg was severely swollen. Pt decided to take 3 days off work to continue to rest the leg, but ultimately came in for evaluation at the suggestion of his coworkers. Pt denies fever, chills, chest pain, or SOB. He denies history of smoking, prior clotting, long car travel, air travel, leg injury, or recent surgery. On exam, the left lower extremity is significantly swollen, erythematous, and hot to the touch. Physical exam otherwise unremarkable. Will admit to the hospitalist service for further medical management. ED Course: Hypertensive with BP 170/93. Initial workup significant for WBC 13, K 3.3, glucose 159. CT chest/a/p with findings suggestive of multiple PE's of the left and right lower lobes as well as extensive LLE DVT extending slightly into the IVC. Trop <0.03. BNP 66. ECG shows sinus tachycardia.

Pt got vaccine in R arm and began to feel arm and shoulder pain five minutes after. Pt also began to feel lip and facial numbness. NO sob. No rashes noted vitals assessed and patient released. Last VS: T: 1259, P: 76, BP: 136/99, SpO2: 98%.

On both events, I had stomach cramps that lasted about a week after both shots. The pain went away on its own. In addition, I currently have pain on the arm I received the shot on. This recently started and occurred several weeks after receiving the second dose. The pain is similar to a burn from a sunburn and itches. It varies throughout the day in pain and stretches sometimes from my hand up to the side of my left check. Also on my upper back and back of neck.

Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild nausea. Within an hour started having trouble with focusing his vision. Was given IV fluids at hospital in ER 5 hours after the injection, while leaving the hospital developed a slight limp on right leg Felt feverish when he got home, took Tylenol when he got home. Noted extreme fatigue. The next morning was lethargic, dizzy and right side of face felt heavy, around 11 am. Called for a telemedicine visit around 12:30p. Became weak and unable to use right side of body, upper and lower extremities and right side of face was drooping, visible to wife. Wife had support of right side of body to move around. Went to urgent care around 2p. During urgent care evaluation, his vision became more impaired and speech became unclear, had to really focus to speak. Transferred to ER. Lost ability to write name, couldn't respond when asked for SSN. Admitted as a "stroke 4". Had CT scan, CT angiogram, MRI, blood labs, cognitive tests, neurologic tests. Neurology consult. Had lost sensation to heat and pressure. All imaging and labs were normal. After MRI, had convulsions. Wasn't dx'd as a seizure. Neck felt tight afterwards. Admitted to hospital x 1 week. Had a burning, red, rash on hands, feet. No bumps, hives, but just a "splotchy" red discoloration on surface of skin that would burn and itch, often flaring at night. Rx'd ativan. Checked for autoimmune disease, Bell's palsy, followed by neurologists, repeat MRI normal. Started to improve, discharged after one week with no clear diagnosis. Discharged to rehab facility. Patient preferred to transfer care to outpatient rehab service closer to home with more social support. Repeat hospitalized 3 weeks later, less extreme, went back to ER, stroke eval neg. Developed more aphasia. Called back to ER for further evaluation of C-spine due to mild abnormality on first scan. On further evaluation not thought to be connected to symptoms. EEG report pending. +Right hemiplegia, aphasia persists. +Rash, itching, burning persist.

? Wednesday, May 19, 2021: ? 14:00 EDT - Patient got 2nd Pfizer vaccine. ? 17:00 EDT - arm started to get sore. ? 17:30 EDT - dizzy after sparring class. Blood pressure 107/71. Pulse 59 BPM. Burping. Gassy. A bit nauseous. Watermelon smelled like cut grass (awful). Forcing myself to drink orange juice. Tastes terrible, like Sweet Tarts (My wife says it's just me). ? 20:30 EDT. Found antidote. Antidote is pie. Cherry pie. After kimchi chicken and smokra. Update: Feelin' fine. ? Thursday, May 20, 2021: ? ~ 05:00 - hard relapse. Arm very sore (8/10). Fairly nauseous. Almost regurgitation level. At the same time I do feel hunger so I know it's not real nausea, yet I still can't eat. Bad headache (7/10). Muscle stiffness up the back and up to the neck, getting worse the higher you go; the neck is particularly bad. ? By 9:40, temperature up to 99.6. ? 11:57 temperature 100.7, blood pressure 125/66, pulse 79 ? 2:50 temperature 99.7 ? 3:30 temperature 99.6 ? Friday, May 21, 2021: ? Update about yesterday (Thursday): I ended up spending the entire day in bed. Very nauseous. Couldn't eat. Spiked a high fever (my baseline is around 97.5° F). Blood pressure fluctuated. High pulse (mine is usually around 50 bpm). Sore muscles on entire torso; pain in my lower back (above pelvis) makes it too uncomfortable to sit up. Except for not vomiting or coughing, it felt like the flu. ? Head still hurts (4/10). Weak. Tired. Arm still pretty sore (3/10). Was able to eat kimchi chicken for lunch and shawarma for dinner, but still not completely over the nausea. ? Saturday, May 22, 2021: ? Left arm still sore in a 2" radius from injection site (2/10), but the rest of the arm is fine. Still have the headache (2/10). ? Sunday, May 23, 2021: ? About mid-afternoon, the headache finally receded. Left arm still sore in a 1/2" radius from the injection site (1/10).

hives on my right arm (not same arm as shot)/hives on right leg; This is a spontaneous report from a contactable consumer (patient). This 42-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: 1), as single dose via an unspecified route of administration, administered in left arm on 28Feb2021 16:30 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 01Mar2021 15:00, patient developed hives on right arm (not same arm as shot) one day later. Patient had covid test post vaccination as nasal Swab, on 01Mar2021 and result was negative. The clinical outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected.

pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restlessness; difficulty concentrating; gas; extreme thirst; headache; shakes; This is a spontaneous report from a non-contactable other hcp (health care professional). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262) via intramuscular route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 42-year-old), at a single dose for covid-19 immunization in doctor's office/urgent care. The patient had no allergies and medical history. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246) via intramuscular route of administration, administered in left arm on 11Jan2021 at 11:45, at a single dose for covid-19 immunization and received Influenza vaccine (within 4 weeks of vaccine) on an unknown date for immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 19:00, after receiving the second dose of vaccine the patient experienced fever, chills, joint pain, muscle pain, fatigue, restlessness, difficulty concentrating, gas, extreme thirst, headache, shakes and on 03Feb2021 (24 hours later), the patient experienced pain at injection site. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

1st day - very sore arm of injection, dizziness, and fatigue. 2nd day - very sore arm, dizziness, extreme muscle fatigue, headache, nauseous, shortness of breath, and chest pains radiating to my left shoulder/arm. At one point late in the evening of the 2nd day after the vaccine, I considered calling for medical assistnce. I was unable to sleep well for the first 3 days after the vaccine. 3rd day - sore arm, dizziness, extreme muscle fatigue, neck pain, headache, and nauseous. 4th day - fatigued and somewhat dizzy from time to time.

The day after the vaccine I woke up with tingling in my right hand thumb and forefinger. over the next couple of weeks the tingling would move around the hand and forearm. I also started experiencing my face turning red. I had been building a playground in the backyard with power tools and plenty of sun during the unseasonably warm March, so i assumed the symptoms were related to some sort of physical strain. However, after an appointment in April to review symptoms, and follow-up with my primary doctor in May, i'm not being referred to neurology for review. I don't have a diagnosis, only symptoms at this moment that line up closely to the vacation but also line up closely to an out door home project. The symptoms are intermittent but are moving to more of a daily basis.

Shingles developed on abdomen.; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0179, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 09May2021 15:45 (at the age of 42-year-old) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient had no allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8737, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 18Apr2021 03:45 PM as 1st dose, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17May2021, the patient experienced shingles developed on abdomen. The patient visited emergency room and physician office for the event. The patient received Valacyclovir as treatment for the event. The outcome of the event was reported as not recovered.

lot of pain at the shot location; body aches; headache; Chills; muscle aches; tiredness; nausea; diarrhea; This is a spontaneous report from a contactable consumer. A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0172), dose 2 via an unspecified route of administration, administered in left arm on 22May2021 at 15:45 (at the age of 42-years-old) as 2nd dose, single dose for COVID-19 immunization. Patient's medical history and concomitant medication were not reported. The patient had penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0172), dose 1, administered in left arm on 01May2021 at 15:30 as 1st dose, single dose for COVID-19 immunization. on 23May2021 at 00:00, the patient experienced lot of pain at the shot location, body aches, headache, chills, muscle aches, tiredness, nausea and diarrhea. The patient did not receive treatment for the events. The reporter assessed the events as non-serious. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.

unable to put pressure on left arm where vaccination was administered. Pain rotates from elbow to back shoulder plate.

Skin began to ache and became sensitive about 11 hours after vaccine was received. Began having chills, lethargy, body aches (it felt like both inside of body and outside of skin), nausea, and high fever. Took Tylenol and Advil to attempt to alleviate symptoms. Could not get to sleep until about 12:30 a.m. and woke up at 2:30 a.m. with headache, extreme chilling, and intense body aches. I didn't know if I could walk. I put a sweatshirt and a coat on, and my teeth were chattering uncontrollably. I can't remember the last time that I was that sick. I contemplated going to the ER but didn't think I could drive. The entire day was a headache, nausea and lethargy. When at the clinic, I stated that I had heard that there could be some minor side effects with the 2nd shot and was told, "Nah, people make things up." I'm so glad that I'm vaccinated, but people need to be forewarned of those kinds of side effects. They have to be aware because that was dangerously sick and was totally unprepared to combat it. 103+ degree fever and this kinds of symptoms aren't things that a person should have to try to make it through alone.

60 hours after the second injection hives began to appear on hands starting on the thumbs and pointer fingers of both hands. 6 hours later hives spread to cover the whole hands and started above the beltline on the small of the back. 4 hours later hives had spread up the back reaching around the ribs to the chest in lines. 6 hours later the rash was starting on the head, forearms, feet, shins, neck, chest, shoulders, and hands were swollen and painful to open and close. 88 hours after the injection medical attention was sought, the PA recommended use of Benadryl Over the counter capsules taken 1X per day before bed and Claritin capsules taken 1X per day in the morning. as of 6 days after the second vaccine the hives have stopped spreading and the swelling in the hands and feet has gone down. Hives are still present but not as inflamed.

Secondary cellulitis; Onset tightness left forearm with swelling; Onset tightness left forearm with swelling/Left arm circumference 2.5 inch more than right; Shotty lymph nodes; mild left supraclavicular swelling/Axillary swelling/soft tissues swelling; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), intramuscular, administered in the left arm on 29Mar2021 as a single dose for COVID-19 immunization. Medical history included allergies to latex and pineapple, seasonal allergies, thrombocytopenia and chronic prostatitis (reported as chr prostatitis) from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amitriptyline hydrochloride (ELAVIL); marijuana and meloxicam (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 on 08Mar2021 (lot number and expiry date unknown), intramuscular on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 19May2021, the patient experienced the onset of tightness left forearm with swelling. The left arm circumference was 2.5 inch more than right with mild left supraclavicular swelling. The patient went to the ER and had an ultrasound of left upper extremity including subclavian and cephalic veins which showed no DVT, MRA showed no arterial clots, CT with contrast showed axillary swelling, shotty lymph nodes, soft tissues swelling, no tumor nor clots. The patient was administered with cefadroxil as he may have secondary cellulitis. The patient had not recovered from the events. Information on the lot/batch number has been requested.; Sender's Comments: The causal association between the event secondary cellulitis ad the suspect drug BNT162B2 cannot be totally excluded based on a temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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.

Within 5 minutes very sleepy, 5-10 min nausea and fever with chills sweat. Loss of vision and dissy. Medical staff checked and found skin changed color and very low blood pressure. After 25 minutes symptoms started going away.

Site: Pain at Injection Site-Mild, Systemic: Seizure-Medium, Additional Details: 5-10 minutes after vaccination, patient felt faint. When pharmacist walked over, patient had an absent stare, was unresponsive to questioning, and mild convulsions. Unresponsiveness lasted 30 seconds to a minute. Patient also lost control of urinary tract and relieved himself.

Dizziness, feeling weak and feverish, chills, headache, numb hands and fingers, and pain in right shoulder at administration site, especially when lifting my right arm.

generalized pruritus; This is a spontaneous report from a contactable other healthcare professional. A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206), via an unspecified route of administration on his left arm on 08Mar2021 at 02:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient was allergic to latex. Prior to vaccination patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and also within 2 weeks of vaccination. On 15Mar2021 the patient experienced generalized pruritus. The clinical outcome of generalized pruritus was not recovered. No treatment was received for the adverse event. No follow-up attempts are needed. No further information is expected.

I had elevated level. I get feedback term but it appeared that my liver that is been stressed.; Body aches in my legs and more over back; Body aches in my legs and more over back; Body aches in my legs and more over back; Prolonged headache for about 2 weeks; Fatigue of head; Sore arm at the injection site; At my second ER visit they told me I had something called the bell's palsy; after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension; I have history of hypertension but it was under control prior to the taking vaccination."; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, administered in Arm Right on 29May2021 14:00 as (At the age of 42-years) 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. It was reported that patient had history of hypertension, but it was under control prior to the taking vaccination. Concomitant medication included hydrochlorothiazide taken at a dose of 50 mg once per day for hypertension; amlodipine taken at a dose of 5 mg once per day for High blood pressure. Patient did not take any vaccination 4 weeks prior to covid-19 vaccine. It was reported that patient have experienced side effects after taking the first covid vaccination and he visited the ER two times. Reportedly, after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension. He had a prolonged headache for about 2 weeks. Patient experienced fatigue of head, body aches in his legs and more over back. He had sore arm at the injection site and at his second ER visit they said that he had something called the bell's palsy. It was reported that when he went to ER they perform blood tests and COVID test which tested negative. It was reported that he visited his doctor, primary care physician, he ran another lab and he had elevated level. He got feedback term, but it appeared that his liver that was been stressed. It was reported that patient was not treated for liver, he was only treated for the hypertension, for the headache and body ache he was taking ibuprofen over the counter, ibuprofen and the hospital prescribed for the bell's palsy, there are three different medication here valacyclovir, its 1-gram tablet and he take 3 per day. Prednisone, its 20 mg tablet 3 times per day, Erythromycin. The patient underwent lab tests and procedures which included blood test, covid-19: negative, liver function test increased: elevated level on unspecified date. Reporter seriousness for the events was Unspecified. Patient did not got his vaccination card yet as he was not fully vaccinated. The outcome of events was unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested.

The pharmacist carelessly gave me the second shot of my Pfizer.Some dribbled out of the arm.. without asking my permission he gave me a second dose Basically overdosing me. My tongue felt strange my lips sweated. The injection site hurt for 7 days and is still uncomfortable. My lungs have been extra congested with mucus. I missed 3 days of work due to the inability to use my left arm (sore) and general fatigue. Experienced strange twitching of the left arm muscle at injection site on the third day.

Strong muscle pain around the injection site. Slight dizziness. Strong feeling of fatigue, which caused me to rest for at least 6 hours on bed. Feeling a pain around my left armpit around 30 to 40 hours after injection.

My left arm injection site has never stopped hurting. It occasionally itches. It is sore in the muscle.

For 1st vaccine- I experienced first vaccine- one week later I got sick for 15 days, symptoms like I had Covid, body aches, chills. For 2nd vaccine- after one week I experienced had excruciating headaches and shakiness that do not go away. I take Tylenol for pain and as a result have upset stomach. I went to see my PCP who performed exams, lab work, x-rays, CT scan of the head, CT scan of the abdomen and my doctor does not find anything wrong for me. To this day I continue wit the headaches that do not go away. I do not feel well to do my daily living activities and I get anxiety. I feel very tense and frustrated due to my symptoms. I do not have the lot # for my vaccines to provide.

I received the J&J vaccine on March 1st. Based on travel vaccines being recognized by countries and a higher effectiveness rate I also began the Pfizer vaccine on May/June. I receive the second shot as indicated and went into work with no effects. I have had no side effects to any previous vaccines. 4 days later my back and chest began to break out on hives. and my back at spine and sternum began to ache. Extreme pain. 3 days later I had travelled out of town and had full blown shingles across my left torso. As diagnosed at the local clinic. Began receiving anti viral oral medication. Very healthy person, no history of skin disease, no allergies at all, chicken pox at age 8. Never had any type of illness in the manner. Rarely sick, flu, or anything.

Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: patient describes shakiness, anxiety, swelling under and around arm, and pain. Reports taking 600 mg ibuprofen on tues and wed (600 mg po bid on Tues and Wed) "went away a bit and came back a little bit"

Adverse Reaction: Eight hours after receiving the injection I felt a burning sensation in the groin and scrotum. The scrotum turned bright red in color and the testicles swelled. The inflammation and swelling continued overnight until 07/10/21 when it later subsided. The scrotum and testicles remained sensitive but without inflammation until 07/11/21. Additional symptoms: In addition to the adverse reaction I experienced a fever of 101 degrees from 07/09/21 through 07/11/21. I experienced an extreme headache, nausea, dizziness, fatigue, muscle pain, and swelling of the injected arm which started 3 hours after the injection until the end of the day on 07/11/21.

Two weeks after second dose I started experiencing pain in my right hand and muscle twitching. By week 3 the pain began in my left hand and wrist. By June 22nd, I began having severe hand and wrist pain, numbness and tingling in my fingers toes, left pain in my forearm that is sensitive to touch. On June 30th, I had to go to ER due to chest pain and severe night sweats. On July 8th, I developed Shingles. As of today, July 15th, I am experiencing debilitating pain in my hands, wrists and am still recovering from Shingles.

Burning sensation on the right hand; Sudden rash on the right hand; Itching sensations on the right hand; This is a spontaneous report received from a contactable healthcare professional, the nurse. A 42-years-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot number: EP6955) via intramuscular route in left arm on 19Mar2021 at 11:45(at the age of 42 years) as single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. Medical history reported as none. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medication within two weeks prior to the vaccination. The patient experienced burning sensation on the right hand, sudden rash on the right hand, and itching sensations on the right hand on 20Mar2021 at 02:00. The events didn't resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events burning sensation, rash and pruritus was unknown at the time of this report. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Medical history captured as None in patient tab; patient age updated as 42 years old per source; facility name captured.Verbatim updated as "Since the vaccination, the patient had not been tested for COVID-19" in narrative.

Headache, body aches, fever/chills, injection site soreness, muscle aches, joint pain, heart flutters/palpitations .

Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: she had a picture of large red swollen bump on arm. She also had mosquito bites on right leg and 3 large bumps lower left arm that she said her doctor recognized as bug bites. At the injection site though it was a little swollen but not red.

Headache and rash (right wrist, right chest, left hip) began approximately 1 week after first Pfizer vaccine administered. Presented to PCP 2 weeks after symptoms began. Treated with naproxen 500mg BID and Benadryl 25mg BID x7 days. Patient returned to clinic with symptoms unimproved. Patient denied further treatment recommendations and prefers to try CBD and acupuncture.

I experienced minor sneezing, diarrhea , headaches, nostrils discomfort, lower right leg felt weird, back of my ears started itching and general bodily itches. All the symptoms have subsided except mild headaches and mild itches.

Dizziness from 20 minutes after vaccination to 6 hours after vaccination. Headache started 1 hour after vaccination and lasted 3 days. Sore arm for 3 days. Fatigue starting 1 day after vaccination and ended 4 days later Body aches and pains for 6 days after vaccination Rash on head, shoulders, and neck that started on day 3 after vaccination and lasted 5 days.

abrasions to my chest and left leg.; swelling; dramatically decreasedsensitivity to pain.; after receiving the vaccine Ifell; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 12:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as no. The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 08:00, the patient experienced decreased sensitivity to pain, abrasions to chest, fall and left leg swelling. The patient reported that he experienced dramatically decreased sensitivity to pain and while jogging on morning after receiving the vaccine he fell and suffered abrasions on his chest and left leg. Despite clearly visible abrasions and swelling he experienced no pain at all. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event fall, swelling, abrasions to chest and left leg and decreased sensitivity to pain were unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Five days later my body was itching uncontrollably. 6 months later its better but i still have itching issues and take meds for it

Severe muscle pain inability to move arm has continued for 4 days and still going Swelling at injection site Lethargy

Extreme muscle soreness in whole body as well as injection site. Extreme shivering. Dizziness. Nausea. Severe headache. Severe coughing with some sputum.

I have cold and numbness and a dull ache in the arm of the injection; I have cold and numbness and a dull ache in the arm of the injection; I have cold and numbness and a dull ache in the arm of the injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: Eh9899), via intramuscular route of administration, on 19Dec2020 (at the age of 43 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was Hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced cold, numbness and a dull ache in the arm of the injection. No treatment was received for the events cold, numbness and a dull ache in the arm of the injection. The outcome of the events cold, numbness and a dull ache in the arm of the injection was not recovered. Since the vaccination, the patient had not been tested for COVID-19.

Soreness in injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration (arm left) on 31Dec2020 (10:00) to 31Dec2020 10:00 at single dose for Covid-19 immunization. The patient's medical history included GERD (gastroesophageal reflux disease). Concomitant medications were not reported. The patient has no allergy 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 diagnosed with COVID-19 prior to vaccination. The patient experienced soreness in injection site on 31Dec2020 17:00 with outcome of recovering. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.

Pain at injection site; headache; muscle pain; chills; joint pain; tiredness; fever; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via intramuscular route of administration, on 28Dec2020 at 09:15 AM (at the age of 43 years old) as a single dose in the right arm for COVID-19 immunization. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medication were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, at 11:30 PM, the patient experienced pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea. No treatment was received for the events pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea. The outcome of the events pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea was recovered on an unspecified date in Dec2020. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

12/17/2020 Vaccine L shoulder. 12/18 muscle aches, feverish, fatigue. @ night because itchy location on back; reddish and inflamed. 12/19 morning ecstatic 12/20 numbness on penis 12/21 lesions on gland penis; spots pigmented Referred to dermatology; prescribed topical steroid cream. Lesion numbness and itching subsided.

Patient had onset of parasthesia and itching distal to right elbow down to right wrist. No other complaints, denies itchy throat or shortness of breath. No hives or rash noted. Contacted medical director and observed for 1 hour. Will have patient recontact MD for any change in symptoms.

About 12 hours after vaccine #2: - Hives on left back, arm, face. Resolved with Benadryl within 4 hours. - Headache for about 30 hours - body aches for about 30 hours

Vaccine recipient experienced nausea and vomiting after receiving the vaccine. At the end of the observation period of 15 minutes he developed nausea and vomited once. After he vomited, the symptoms resolved. He was sent to the ED for follow-up and observation. Vaccine recipient stated that they drank a lot of juice. He improved and was subsequently discharged. The next day vaccine recipient reported that they felt sluggish and had arm pain around the site of injection. On a follow-up call today 1/11/2021; he reported that his symptoms have resolved. Pfizer-BioNTech COVID- 19 Vaccine EUA.

Right Fifth Cranial Nerve, second branch distribution, burning and tingling , no rash. Presumed to be mild herpes zoster (shingles). Treated with Valacyclovir 1000mg TID for 7 days with resolution.

headache (approximately 13 hours later) , shoulder pain (8 hours later) , slight blistering from band aid adhesive (~10 hours)

Around 8pm I began having chills, body aches and SOB that lasted throughout the night. The next day I felt a little better earlier but got very fatigued, had a headache, chills and a large swollen lymph node developed under my left arm and its still there today. And my arm is sore at the injection site.

Fatigue; Vertigo; Arm pain; This is a spontaneous report from a contactable other HCP (patient). A 43-year-old male patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), intramuscular at left arm on 22Dec2020 13:00 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient experienced fatigue and vertigo, arm pain on 22Dec2020 20:00. It was unknown if treatment received for the adverse event. The outcome of the events was recovered on unspecified date. Information on the lot/batch number has been requested.

Injection site pain & swelling on first & second day. Swollen & painful left axillary lymph nodes on 3rd day.

2 hours post vaccine runny nose, next day myalsia, back pain injection site discomfort, fatigue through Friday and Saturday I felt better and Sunday I lost sense of smell Monday I tested positive for covid, the rest of that week I felt sick and slowly symptoms resolved , I took one tylenol on 22nd

Sore throat, chills, headache, body aches, cough, sneezing, runny nose, fatigue, mental fogginess, and soreness at the injection site.

FEVER OF 102 (1/12-1/14), BODY ACHES, PAIN AT INJECTION SITE, JOINT PAIN (LOCKED UP), HEADACHE, NECK PAIN

12/20/2020 12/21/2020 Notices lymneos above left clavicle swollen and hard, bruising at the sight location of left arm. Several weeks and present at the second shot .

Patient could not open and close hand after the first day of vaccination. On the third day his arm turned purple and could not be moved and was numb. A week and a half after vaccine, arm hurt and was numb. Patient was hospitalized.

Rash on abdomen; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO-140), via an unspecified route of administration on left arm at 10:15 on 03Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. The patient experienced rash on abdomen on 05Jan2021 at 08:00. The patient did not receive any treatment for event. The outcome of event was not recovered. The patient was not diagnosed COVID prior vaccination; The patient had not COVID tested post vaccination.

After the required wait period of 15 minutes I started to drive back home which is 77 miles from the hospital that administered the vaccination. Around 15 minutes down the road I started feeling like something was caught in my throat and was coughing a little. At that time I decided to turn around and go back to the hospital. I took an oral Benadryl 25mg and decided to wait in my car and see if it was something else. After 30-45 minutes I took a drink of water and realized I was having trouble swallowing. I then preceded into the ER and was admitted immediately. In the ER, they started an IV, administered Benadryl, methylprednisolone and a bag of saline. The physician discussed with me and we agreed to hold the Epinephrine to see how I reacted to the previous medications. I was then monitored for a couple hours then released with a prescription of Prednisone 60mg for 5 days and an EpiPen. One day out, no new symptoms besides injection site pain.

Continued left arm injection site pain, left sided neck neuropathy, and feeling of very mild ache to the anterior throat (feeling of swelling) but not having short of breath or trouble talking.

Patient received vaccine on 1/2 (Sat) and today went to the ED 1/5. On Sunday am began vomiting and diarrhea with no blood in stool or emesis. Denies fever. States he only coughs post vomiting and it is un productive. Pt has been urinating and has been able to keep food and fluids down. Noted with skin warm and dry/resps, NAD and color WNL. Pt denies any abdo pain except post vomiting. SARs CoV2 RNA test negative.

Metallic taste in mouth and unusual sensation in posterior pharynx (1st and 2nd vaccination courses)within 15 minutes post IM injection. Approximately 4.5 hours post IM injection (2nd vaccination) again unusual taste in mouth with swelling of posterior pharynx. Swelling not relieved by 20 mg prednisone X , Benadryl 50 mg and Pepcid 40 mg. Second dose of prednison 20 mg alleviated throat symptoms. Approximately 24 hour post IM injection (2nd vaccination), subject felt itchy, especially the eyes. Subsequant dose of Zyrtec and Pepcid alleviated symptoms within one hour.

On 1/18/2021 in the evening, he noticed some inflammation of the left lower lip, then he noticed some hives on his left wrist, then across the beltline. He reports taking Benadryl without improvement. He denies any other skin manifestation, shortness of breath, chest pain, or any other symptoms associated with an allergic reaction. He was following closely with his PCP and had an appointment to see an allergy specialist on 1/19/2021. The allergy specialist diagnosed him with and adverse effect of a vaccine and in the note documented delayed urticaria and angioedema secondary to COVID vaccine #2. .

Patient reported approximately 3 hours post vaccination that they experienced itching on top of their head. Approximately 6 hours post vaccination they reported the appearance of red bumps/hives on chest, upper arms, back, and ankle along with itching in these areas. Patient reported taking a Benadryl and noticed symptoms improved within 30 -45 minutes. The following morning patient reports itching occurred again but subsided after dose of Benadryl. Patient has spoken to two separate physicians about decision to receive second doses.

I got shingles approximately two weeks after the vaccination date. The doctor didn't think it was related to the vaccine, but I wanted to report it since it is rare in people under 50.

multiple bullae present on right ankle/foot 2 days after vaccine administration. Patient had similar event after second dose as well, with multiple bullae present on bilateral lower extremities.

Inflammation and skin welts noted in areas of clothing and watch contact with skin; Inflammation and skin welts noted in areas of clothing and watch contact with skin; acute swelling of lip without trauma; This is a spontaneous report from a contactable physician, the patient. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 12Jan2021 at 09:30 (at the age of 43-years-old) as a single dose for Covid-19 immunization. Medical history was reported as none. Prior to the vaccination, that patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously received dose 1 of BNT162B2 on 29Dec2020 at 09:30, intramuscular in the right buttocks. On 15Jan2021 at 12:00, the patient experienced inflammation and skin welts in the areas of clothing and watch contact with skin; and developed acute swelling of the lip without trauma. Therapeutic measures were not taken and the events resulted in a physician or other healthcare professional office visit. The clinical outcome of the event skin inflammation, skin welts and lip swelling was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Erythema to upper chest, diffuse bibasilar diminished breast sounds with subjective chest tightness requiring diphenhydramine IM once and albuterol nebulized treatment once with complete resolution of symptoms.

Patient felt warm, off balance, disoriented, and was sweating profusely after his vaccination. This reaction started less than 5 minutes after administration of the Pfizer vaccine. EMS took the patient's blood pressure. The first reading was 80/50 mmHg and the second reading was 104/66 mmHg. After having water and sitting for 30 minutes the patient felt fine.

Very slight, small area of tenderness yesterday morning at injection site; This is a spontaneous report from a contactable consumer (patient) A 43-years-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at left arm from lot# EL 3247, on 27Jan2021 (at 43 years old) 12:30 at SINGLE DOSE for covid-19 immunisation . Facility where the most recent COVID-19 vaccine was administered:Workplace clinic. Medical history included asthma, severe Osteoarthritis (OA) in right hip. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR) 100/50, fluticasone (FLUTICASONE) OTC, montelukast sodium (SINGULAIR) 10 mg. The patient previously took theophylline and experienced drug hypersensitivity. The patient experienced very slight, small area of tenderness yesterday morning at injection site on 28Jan2021 07:00 with outcome of recovered. No treatment received. No Prior to vaccination, was the patient diagnosed with COVID 19 .Since the vaccination, the patient hadn't been tested for COVID-19

Entire body rash for 7 days, started at my neck and then to involve my entire body. Fever 101.8-102.9 for 3 days with 1 gram Tylenol and Benadryl. Weakness for a week, unable to work.

7 day post-shot still experiencing pain in arm focused at site of injection. Waves of extreme fatigue requiring me to sit down and overwhelming desire to sleep (unusually) three times day. First dose.

The immediate 48 hours after the second dose was not a problem. It was around 72 hours in which acute muscle soreness occurred at the injection site on my right deltoid. I thought it would resolve like the first dose after three or four days, but this seem to last longer and then it mysteriously begin to travel down my arm. It seems like every one or two days it went more distal down my right upper extremity. It first went from my deltoid to my bicep and tricep. And then a couple days later it was in my elbow and forearm. Now it has been in my elbow for weeks leaving me with weakness and pain that nothing seems to help improve it. It?s like it is in my joint at my right elbow. There is a very specific soreness and pain which has cost me a significant discomfort and weekend my strength and the entire arm.

I received my first dose of Pfizer vaccine (lot # EN6200) around 10 AM. I was perfectly fine after the shot. However, 6 hours later around 4PM my Left outer ear turned bright red and get itchy (no raised or macular rash, no hives, no signs of insect bites or anything) No other redness or rashes in any other parts of my body. I did not develop any other symptoms (no SOB/difficulty breathing, etc) My R ear is fine too. I observed myself to see if the redness/itchiness will spread but after about an hour or so, the redness and itchiness went away. I did not take any antihistamine and did not I apply any hydrocortisone. Just went away on its own. Four days later, it happened again, my L outer ear turned red again, this time it is not itchy but more like throbbing pain. It went away after 1-2 hours without any treatment.

Chills/shivers (first day); Mild fever (first day); Lymph node inflammation in neck (on and off since the vaccine); Headache; Arm pain at injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 13:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included cannabis. The patient experienced chills/shivers (first day), mild fever (first day), lymph node inflammation in neck (on and off since the vaccine), headache, and arm pain at injection on 19Jan2021 16:00. No treatment was received for these events. Outcome of the events was unknown.

SM's reaction (SOB and pruritus) began approximately 15-20 minutes after receipt of vaccine. Patient received 50mg PO Benadryl and had improvement and eventual cessation of sx over his 60 min obs on site. Vitals remained stable (HR 60-72, SPO2 98-100). Patient was written for epi-pen and was retrieved from the site by his spouse. Instructions provided to both in regards to f/u and reasons to report to ED or call EMS.

Bruising at around insertion point and a growth has appeared between my right arm pit and pectorales major.

Fever up to 100.9 F; Sinus pressure; Body aches; Tiredness; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in the left arm on 27Jan2021 at 16:30 at the age of 43 years old at a single dose for COVID-19 Immunization at health clinic/ administration facility. The patient's medical history included mild asthma, CT contrast agent allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) at the age of 43 years old on 07Jan2021 at 12:30 pm in the left arm for COVID-19 Immunization. The patient's concomitant medication included montelukast, albuterol (Salbutamol) and beclomethasone. The patient experienced fever up to 100.9 F, sinus pressure, body aches, tiredness, pain at injection site on 28Jan2021 at 6:00 AM. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: nothing to report

Itchy Rash all over the body hands, legs stomach back it is very Urticaria - cold hives which i usually get in winter on exposure to cold.

Noticed enlarged/swollen lymph node near left side collar bone, same side as injection. Noticed approximately one week after injection. Swelling is visible and can also be felt by touch. No other side effects - no pain, no fever, no headaches.

Body aches, fever (+/- 101°), back ache, chills, severe headache, slightly elevated heart rate, fatigue. Symptoms lasted approximately 24+ hours. Moderate to severe arm soreness at site of vaccination for >36 hours and continuing

Dry mouth, "feels like a knot in my throat" ED Note: 43 y.o. male with a history of hypertension and eosinophilic esophagitis presenting s/p allergic reaction. Patient received his first dose of the Pfizer COVID vaccine around 17:30 today and states that he developed hives down his left arm and was having difficulty swallowing. He does have a known egg allergy and states that he has had prior anaphylaxis reactions to the flu vaccine. Patient was given PO Benadryl with complete relief of his symptoms. He has no complaints at this time and states that he feels "perfectly fine". At bedside for initial evaluation. Discussed plan for continued Benadryl throughout tomorrow and follow-up with his PCP. Patient is agreeable. Plan for discharge. The patient is comfortable with further observation of his symptoms at home. I discussed our workup, answered all questions and made sure there were no other concerns. I provided counseling about standard home and self-care measures and advised on standard return precautions including new, persistent, or worsening / concerning symptoms.

Symptom onset 10 -15 minutes after receipt. Symptoms included pruritis, shortness of breath, perhaps CP. HE does not recall urticaria, oral/facial/throat or tongue swelling, red/watery eyes, wheezing, n/v/d. He was treated with 50 mgs benadryl and observed for one hour. There was no recurrence. Event documentation is very consistent with his report and documents VS R 60-75 SPO2: 98-100 with metal status of A&Ox4.

3/13/21 - 3:00 PM. LEFT EAR ACHE 5:00 PM. ARM HURT WHERE I GOT THE SHOT. TOOK 2 ADVIL 9:00 PM. HEAD AND THROAT ACHE 10:00 PM. CHILLS AND SWEATS 12:00 PM. EYES WATERING 3/14/21 THROUGHOUT THE DAY. SWEATS AND CHILLS, WATERING EYES, HEADACHE, FATIGUE TOOK 2 TYLENOL EVERY 4 HOURS 3/15/21 8:00 AM - SLIGHT WATERY EYES. 9:00 AM - UPPER LIP BEGAN TO SWELL, TOOK TWO ALEVE 10:00 AM. UPPER LIP COMPLETLY SWOLLEN AND ON FIRE. TOOK 2 BENADRYL 11:00 AM. FATIGUE 12:00 PM. CHEST BEGAN TO TIGHTEN AND SHORTNESS OF BREATHE, TOOK 2 BENADRYL 4:00 PM. TIGHTNESS OF CHEST AND BREATHING WORSENED 4:30 PM. WENT TO EMERGENCY ROOM. 3/16/21 - 3/20/21. FATIGUE, SWELLING OF UPPER LIP, TIGHTNESS OF CHEST, SHORTNESS OF BREATHE 3/22/21 - PRESENT. TIGHTNESS OF CHEST, SHORNESS OF BREATHE

Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears. It's sometimes louder than other times. It is piercingly loud when exposed to loud noises. It started the day after the vaccine injection. Other events are: - Frequent headaches (every 2 or 3 days). They started the day of the injection and are current. - Sore throat. It started 2 days after the injection and has decreased in the last few days. - Dry throat and chills. They started a week after the injection and are current. - Soreness in the arm where injected. This has gone away. I visited my healthcare professional about this. No treatment was given. The healthcare professional decided that we'll have to monitor the symptoms for any changes. If the tinnitus gets worse or persists after a month, then it is suggested that I see an ENT (Ear, Nose, & Throat) doctor.

3/31/2021: Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination screening. During the observation period, he experienced an adverse reaction with the following symptoms: Tingling and swelling of face and throat. Tightening sensation to the face including mouth. Sweating, with redness to the face. Mild nonproductive cough. Assessment : Time of assessment 0932am. Alert and oriented. Nurse assessed lung sounds, VS monitored for 30 minutes. Actions taken: assessment of face and mouth, no swelling seen, face is red and he has sweating forehead. Vitals sign taken at 0932 with BP- 185/131, P- 89. R-17 O2- 98% , Benadryl 12.5 mg liquid given po x 1, VS rechecked at 0937, BP - 190/134, P- 84, T- 98.4. R- 18, O2- 98%, Benadryl 12.5 liquid given PO at 0927. EMS on site due to another issue, assessed pts lung sounds and assessed for auditory stridor to neck, patient with slight cough, voices that he is feeling some better, he remains sitting in wheelchair. VS at 0947 , BP- 166/127, P- 82. O2- 98%, VS at 1002- BP_ 154/110, P- 85, O2- 96%. Medications administered: Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 0932 and 0937. Administered by RN. Disposition:Reports swelling to face and mouth has improved, he is advised to follow up with PCP for elevated BP AND SYMPTOMS ASSOCIATED WITH VACCINE/ Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/31/2021 9:08 AM 0.3 mL 12/11/2020 Intramuscular

skin was burning itchy and red; skin was burning itchy and red; sunburn; trouble breathing; tongue swelling and discoloring; tongue swelling and discoloring/ he saw that his tongue was dark chocolate like he had just eaten a black licorice; felt like breaking out in hives/chest was beat red was referring to hives; chest started to get broken out and got beat red; allergic reaction; got beat red; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the first dose of BNT162B2 (BNT162B2, lot number: EP6955), via an unspecified route of administration in the left arm, on 15Mar2021 3:00 PM (received at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included Attention deficit disorder, cholesterol, benign heart palpitations. He also had a previous reaction to insect bites and followed up with an allergist. He went over a decade ago for the insect bite, they gave him epinephrine at the urgent care and said to call or come back if it worsened. The next morning, his symptoms from the insect bite were worse and the urgent care told caller to go to the ED (emergency department). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from an unspecified date and ongoing for Attention deficit disorder; metoprolol from an unspecified date and ongoing for benign heart palpitations; simvastatin from an unspecified date and ongoing for cholesterol; vitamins and minerals; ubiquinol from an unspecified date and ongoing; fish oil from an unspecified date and ongoing. The patient previously had a flu shot in Aug2020. The patient previously took epinephrine and experienced insect bite were worse, and metoprolol and experienced reaction linger. The stated he thought he had an allergic reaction to the Pfizer covid19 vaccine on 15Mar2021. He states that his tongue was swollen (15 min after receiving the vaccine, at 03:15 PM), he broke out into hives. He was in the restroom of the facility where he received the vaccine and that he did not have hives yet after getting the vaccine, but then asked the nurse if he could take Benadryl and was told yes. He states they then let him go because he had no trouble breathing at that time. He drove home and was going to reroute to hospitals if needed. He took 50 mg fast melt Benadryl as soon as walked out of the facility. He drank water, drank two larger bottles of water. His chest started to get broken out and got beat red. He took another 25 mg of Benadryl and then drove home. He then proceeded with Benadryl 50 mg every 6 hours. At 1 AM, the next morning (16Mar2021), he woke up with trouble breathing and tongue swelling and went to ER. They gave him Prednisone 60 mg and then started on 5 days of prednisone. They told him to continue Benadryl, and water and to follow up at hospital if worsens and to follow up with his physician. He stated that he had a previous reaction to insect bites and followed up with an allergist. He went over a decade ago for the insect bite, they gave him epinephrine at the urgent care and said to call or come back if it worsened. The next morning, his symptoms from the insect bite were worse and the urgent care told caller to go to the ED. He added that this experience with the Covid19 vaccine was milder comparatively as they gave him just steroids and not epinephrine this time, and, they told him he was not having trouble breathing this time. Last night, 16Mar2021, at around 10:30 pm, a half hour before next dose of 6 hour Benadryl was due, his skin was burning itchy and red so he took Benadryl a half hour early and set alarm to wake up before next dose. He woke up 4 hours later and waited to see if he would have a reaction and he has not taken it since. He took the morning dose of Prednisone with improvement and is carrying Benadryl in his pocket just in case. He later clarified that he took his 11 o'clock dose last night and then set a 2:30 am alarm to see if it was worse again or about the same. Regarding the allergic reaction, he first noticed around 3 pm Monday 15Mar2021. Within 15 minutes after the vaccine, he was going through his phone and thought he felt strange while waiting at (Name) after the vaccine to see if he had a reaction. This feeling continued until 11 pm last night, 16Mar2021. He took 50 mg of Benadryl when this first happened on 15Mar2021 and then took another 25 mg 15 minutes after the first initial dose. At the time of call, he notices no redness or itchiness or swelling of the tongue. He feels like he is going in the right direction. He noticed tongue swollen within 15 minutes of receiving the vaccine and that it was also discolored (15Mar2021 15:15) and asked a friend who has allergic reactions if this happens and the friend told him that it sometimes happens to other people with allergic reactions. He went to the ER on Tuesday 16Mar2021 at 3 am, exactly 12 hours after he received his shot, because of the swelling of the tongue. This was his first-time experiencing difficulty breathing and gasping for air as well. States that he does not have it now. Prednisone and Benadryl have knocked it out. He was not admitted and was released from the ER about an hour and a half after he got there (discharged at 4:30 am from the ER). He did notice at 3:30 pm that his chest was beat red. He was hanging out and his body would tell him when it was close to 6 hours that he needed to take Benadryl because he would be breaking out in hives. He has to take Benedryl within 6 hours. This is ongoing but he has not had any today. He clarifies that the chest was beat red was referring to hives. He felt yesterday 16Mar2021 that he had a sunburn and that his face was kind of red but he had not been in the sun. He clarified on timeline that he went to check for swelling and hives in bathroom after receiving the vaccine on 15Mar2021. At that time, he saw that his tongue was dark chocolate like he had just eaten a black licorice. There was no redness or anything but he felt like it was going to be occurring so he asked the facility if he could take Benadryl. He is scheduled for his second dose of the vaccine on 05Apr2021 and may be possibly returning but is not sure. He also noticed on Tuesday 16Mar2021 that while sleeping on the couch at 3 am he was going to take the next dose of Benadryl and woke up gasping for air. He got up to drink more water and took a shower and made coffee. Then, he went to the ER. He was really tired. He wanted to be alert to drive. It seemed like the water helped and he drank a lot of water. He did not want to take the next dose of Benadryl. He noticed that it did get better, and he did not want to stay home so he went to the ER. Outcome of the event allergic reaction was recovered with sequel on 16Mar2021. Outcome of swollen tongue, skin was burning itchy and red, got beat red and hives was recovering. Outcome of other events was unknown.

Skin Rash - itching - began 11am on 4/1. Treated with Benadryl OTC medication at noon - symptoms subsided until 9:30 am on 4/2 when the resurfaced again. Treated again with Benadryl OTC Medication at 11:00am

After a few hours of getting the second shot some fever minor headaches and a stuffy nose feel with no mu us present, pain and swollen area of shot and also all my left side from head to toe started to hurt significantly to the point that a walk to the bathtroom was difficult. A few of the symptoms fade away after a few days but the left side swollen area on my leg still an issue not letting me continue my workouts, went to my doctor got a sonogram doppler no clots were found and they sent me home. Told me to rest and elevate my legs been doing that nothing has changed and a few minor headaches have made a comeback.

On March 24 I got the first dose of the Pfizer COVID-19 vaccine and I experienced side effects almost immediately. By the time I got to the resting/observation area I felt that the site of the injection got really warm and I became dizzy/lightheaded and started to feel heavy on the chest and little problem in swallowing and breathing. I was taken to the paramedics on site, they checked my blood pressure (which a little high 150/90), oxygenation, pulse, and EKG (which were normal). It did not became too bad after and was allowed to come back home. However, the heavy chest and swallowing problem lasted for three days. The heaviness in the chested turned into a sensation of feeling like my trachea or the anything under the sternum area was behind strangled. Although I felt like this my breathing and swallowing was almost normal. Every now and then when I swallowed I felt some pain but I could withstand it.

Client became dizzy and lightheaded in the observation area, "he was seeing stars". On exam, no evidence or symptoms of an allergic reaction. BP 70/50, O2 sat= 80%, Pulse=50. Skin= pasty gray. EMS was called due to low O2 sat and hypotension but client was not transported. No chest pain was reported. After 20 minutes, he felt better and BP responded to hydration with water. Skin color returned to normal. Wife drove client home. Client disclosed he recently lost 10lbs and though he was dehydrated. Advised to eat salty foods and drink lost of fluids. Assessment: vasovagal reaction secondary to vaccination, worsened by dehydration prior to clinic.

Three small rashes on left ankle and something that looks like a hive between my fingers on right hand. Currently after a few days the itching in area subsides a little, but the red mark is still there.

Reported onset of frontal headache before leaving vaccination observation area on 5 April; headache later resolved after taking Naproxen and has not returned. Patient also experienced feeling sweaty and clammy evening of vaccine receipt; did not measure temperature; no chills; symptoms did not interfere with sleep and were resolved upon awakening on 6 Apr.. On evening of 5 Apr and on 6 Apr, patient reported generalized achiness diminished after taking Naproxen; aching did not change much between 5 and 6 Apr (no worsening); no joint swelling, warmth, or redness. Also noted "rash" within 2-3 hours of vaccine receipt - not pruritic and only located in antecubital area of left (vaccinated) arm (review of photo showed round/oval, erythematous patch about 3x3, possibly Herald patch); no significant local vaccination site reaction of left upper extremity or axillary tenderness and swelling. Denied symptoms c/w immediate allergic reaction [any hypersensitivity-related signs or symptoms consistent with urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration On 8 Apr, patient reports all symptoms gone except red area on left antecubital, which seems to be getting better

Fever 100.5, chills, shortness of breath, severe muscle and joint aches, weakness. Pain at injection site.Headache.

itch and hives all over both arms and across chest. Treated with additional fexofenadine, resolved after ~36 hours

Felt immediate warmth in injection site. Pain at injection site. Warmth spread rapidly up my shoulder neck and around the left side of my face. Within another few minutes the warm area became slightly numb. I could move my face and feel my skin but it felt like it had gone asleep. Over the next few hours it spread down my body, only me left side, all the way to my foot. Groin area also felt numb, like when you sit on a bike too long and my penis also felt numb. Called a teledoc service on Monday as this lingered. They told me that if it had not dissapated after 2 days to let them know. Symptoms went away on Wednesday March 31st.

Within 5 min of getting the shot my face became flush. That lasted for about 30 seconds. A few minutes later my neck became very itchy. This lasted for maybe a minute or two.. about an hour later my legs became very itchy. This lasted maybe a minute and was immediately followed by my face getting flush again. This also lasted about a minute. Maybe 15 minutes later the same two events repeated in the same order. Both again lasted maybe a minute. During this time there was a little bit of tingling around my lips. This came and went for a few hours. 15 or so minutes after the 2nd round of itchy legs/face flush, my throat became itchy for a couple of minutes. I did go to the urgent care and while was told by that doctor that as all of these had come and gone within a minute or so and that my breathing had not become an issue that I didn't need an epi shot and that I could just go home. I didn't experience any further allergic reactions, just the expected ones.

Face swell and eyes swell shut. Huge bumps all over body and face. I took pics. Throat was also feeling numb

Initial soreness at injection site. Approximately 18 hours after injection, nausea, chills, severe headache. No fever. Chills and nausea decreased in severity throughout the next 12 hours but body aches and severe headache persisted. Nothing taken to treat symptoms (no ibuprofen or acetaminophen) In conclusion: initial reaction began 18 hours after injection and lasted approximately 12 hours.

Injection site pain (lasted for 6 days) Extreme fatigue (lasted for 2 days) Flu-like symptoms/body aches ( lasted 4 days)

Beginning around 4/6, an itchy, painful rash developed on my scalp, spreading and intensifying over the next several days and appearing on my neck on 4/9. Diagnosed as shingles by APN on 4/13. Antiviral medication prescribed on 4/13.

Dermatitis of unknown etiology. Initial distribution is like zoster; however, lesions are not characteristic of that. No adenopathy or adjacent lesions. Treat with Medrick Dosepak and refer to dermatology.

red rashes on left foot, left pan and finger joints; itching; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- ER8727 ), via an unspecified route of administration, in left arm on 20Mar2021 at 12:30 (at the age of 43-years-old) at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food or other products. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced red rashes on left foot, left pan and finger joints and itching from 27Mar2021 at 04:15 PM. It was unknown if treatment was given for the events. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Eustachian tube dysfunction; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Soreness at the injection site; Frequent headaches (every 2 or 3 days); Sore throat started 2 days after injection; Dry throat and chills started a week after injection and current; Dry throat and chills started a week after injection; This is spontaneous report received from a contactable consumer (patient himself). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via an unspecified route of administration in left arm on 20Mar2021 at 16:00 (at the age of 43-year-old) as a single dose for COVID-19 immunization. The patient's medical history was none. Concomitant medications were not reported. The patient did not have allergies to medications, food, or other products and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears on 21Mar2021. It was sometimes louder than other times. It becomes piercingly loud and painful when exposed to other loud noises, started the day after the vaccine injection. Frequent headaches (every 2 or 3 days) started the day of the injection (20Mar2021) and current. Sore throat started 2 days after injection (on an unspecified date in Mar2021) and has decreased in the last few days. Dry throat and chills started a week after injection (on an unspecified date in Mar2021) and current. Soreness at the injection site on 21Mar2021 that went away after a few days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the event soreness at the injection site was recovered on an unspecified date in 2021, recovering for the event sore throat and not recovered for the other events. No follow-up attempts are needed. No further information is expected.

No side effects with the exception of minor irritation at injection site, until 96 hours later, sever flu like symptoms, chills, nausea - which lasted around 1 day. Feeling much better at this point but the delayed response was unexpected. I'm fairly sure there wasn't another event that prompted the symptoms but anything's possible.

PT RECEIVED VACCINATION 2 DAYS PRIOR TO RASH ONSET AT OUTSIDE FACILITY, WAS THE SECOND DOSE OF PFIZER VACICNATION. BROKE OUT IN HIVES THE SECOND DOSE. FIRST DOSE HAD NO REACTION.

Day 1 - diarrhea x 2, Stomach upset, Headache, fatigue, short of breath with ambulation only, rash on left hand - dorsal aspect - pink - pinpoint - non itchy. Did not work (called in sick) Day 7 - Rash is less but present - itchy on day 6 and 7. Fatigue and headache continue. Shortness of breath with ambulation - subsides with sitting. Sleep is normal. Attending work as usual - other than days 1 and 6 - went home after 4 hours of work on day 6. Eating normal - bowels and bladder normal. Denies fever and chills.

extreme fatigue; joint pain; muscle pain; nerve pain; hives; large red skin blotches on arm where vaccinated; Swelling in limbs; Headache; head pressure; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW6208), in left arm on 18Mar2021 04:30 PM (at the age of 43-year-old) at single dose for COVID-19 immunization. The patient's medical history included post-traumatic stress disorder (PTSD) and seborrhea. No allergies to medications, food, or other products were reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported, no other medications were received by the patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Mar2021 06:30 PM the patient experienced extreme fatigue, joint pain, muscle pain, nerve pain, hives, large red skin blotches on arm where vaccinated, swelling in limbs, headache and head pressure. The events were reported as serious since resulted in disability or permanent damage. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event as steroid pills, ibuprofen, aspercreme rubs and ice pack. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.

The patient was sitting in a chair on the sidewalk. He received the Pfizer vaccine lot # EW0172 exp 04/25/2021 in the right arm at 10:40am. At 10:41am the patient said ?my arm feels hot,? as he motioned to his right arm where he received the vaccine. RN checked the patients arm. There was no sign of rash or redness. At 10:42am the patient stated, ?Now my whole body feels hot.? The patient denied feeling dizzy or nauseous. Per RN's assessments, patient was not flushed, no rash was present, skin was dry. Skin appeared appropriate color for race. The patient insisted on standing up but reported feeling ?dizzy? and looked unsteady as soon as he stood up. RN assisted the patient to sit back down. The patient was given a mat to lay down on but he refused to lay down or put his head between his legs. He sat up with his hands in his hands covering his face. Vitals were taken at 10:45am by RN. RR 18 and no signs of respiratory distress, BP 130/82, HR 68 with regular rhythm per palpation. Patient was offered Benadryl but he refused and still refused to lay down. At 10:50am the patient said, ?I feel all better now.? The patient was advised to stay for the remainder of his 30 minute observation period but he refused and walked off with a steady gait.

Shingles on left abdominal region. Rash and blisters present. Pain began the day following the vaccination in back and began to wrap around side to midline over time.

Fever overnight following the second injection. Lymph node swelling on left side of head and neck was noticed the first morning along with a burning sensation along the scalp on the left side of head. Lumps formed under hair line on left side of head by second morning after the shot. Lymph nodes still swollen on left side of head and neck. Lumps on left side of head became tender to the touch by third morning after the shot. Sought help at "On Demand Care" on 10th day after Vaccine was given due to pain. The following issue was addressed by CNP: Herpes zoster without complication. Prescribed: acetaminophen, capsaicin and valACYclovir on April 23, 2021.

Injection site pain Extreme fatigue Muscle and joint pain Earache Fever Chills Nausea Weakness Swollen lymph nodes 24 hours of moderate symptoms followed by mild lingering symptoms

At first, my nose hairs were itchy, then I got runny nose. I sprayed Flonase, which didn't seem to help that much except to dry out my nasal passage. Then, I started feeling lightheaded in the same evening and somewhat disconnected from my body. Then, the next morning, and all day, I've been clumsy and uncoordinated.

Forehead began itching after the shot on 4/22/21. On April 23, 2021 noticed patchy rash all over forehead. Rash continuing on to April 24, 2021 all over forehead.

Fever, chills, body aches, fatigue, tiredness, injection site soreness, lump feeling like bruise in armpit.

Patient reported full body rash and facial swelling after the 15 minute waiting period was complete. 5 days later, patient still has full body rash.

Developed a lump a little bit bigger than golf ball size under his left arm in his armpit where he got shot; Uncomfortable and irritable to put his left arm down; Area painful to the touch under his left arm and armpit where he got shot; This is a spontaneous report from a Contactable consumer (reporting himself). This is the second of 2 reports. This 43-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150), via an unspecified route of administration in left arm on 05Apr2021 as a single dose for COVID-19 immunization. The patients medical history (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, genetic/ chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity which included asthma. The patients family medical history was none. The patient had no AEs following prior vaccination. On 05Apr2021, the patient experienced pain at the injection site of left arm and on 06Apr2021, the patient had onset of uncomfortableness under his left arm and armpit, area painful to the touch under his left arm and armpit and it was uncomfortable and irritable to put his left arm down. When the patient woke up on 07Apr2021, that the patient noticed the patient had developed a lump a little bit bigger than golf ball size under his left arm in his armpit which is painful to the touch. The patient thought it may have started to develop that lump on 06Apr2021 but did not notice the lump until morning of 07Apr2021. The patient was wondering what he should do. The patient needs to know if this was serious and the triage nurse couldn't tell him and his doctor hasn't called him back. Event was unusual because the patient has never had a bump like that lump he has at this time-caller stated bump as a descriptor of lump. The agent caller spoke to earlier advised patient that if the patient was uncomfortable or in pain to go to doctors office so patient called primary care provider who said to go in to have it checked. Caller reported the agent tells you about the symptoms and agent said that he had seen swelling of lymph nodes was one of the symptoms in his clinical trials information for the Pfizer-BioNTech COVID-19 Vaccine; and in those reports the swelling of lymph nodes usually goes away in about 10 days. Outcome of that event unable to be clarified as if recovered completely or with lasting effects-when queried caller reported that he did not notice any problems after that, did not have the pain at the injection site of left arm after that day or two. No Follow-up attempts are needed. No further information is expected.

Typical and expected side effects were fatigue for ~24 hours and soreness at the site of injection for ~48 hours. In addition, the morning after the injection I woke up with a bright red face rash and draining on the left nostril, the left eye crusted shut with yellowish drainage, a red blister-like spot on the left lower eyelid, bloodshot eye, and swelling from the eyelid and down into the cheek. The swelling got worse after a couple of days, leading to medical treatment with eye drops and an antibiotic.

Severe skin rash outbreak on right forearm, spreading and worsening, additional spots followed on subsequent days on left forearm, spreading to both biceps. Abdominal spots also appeared.

Pt called to c/o adverse effect to pfizer vaccine received at stadium on 4/22/21. Pt said evening of Thursday 4/22/21, he felt tingling on tongue and back of throat. Friday tingling increased and by evening, per pt, increased tingling, shaking of lips, itchiness all over body. Pt called PCP advise nurse and was advised to take benadryl, Per pt, he took benadryl on Friday evening. On Saturday, there was increased tingling and itchiness, took another benadryl and eventually symptoms subsided on Sunday. Pt advised to f/u with PCP.

Mental and physical fatigue, headache, pain in both jaws and at injection site, sleepless night after shot due to headache and inability to get comfortable

Extreme burning sensation on left arm with burning sensation travelling up to left ear Arm was later swelling and difficult to clinch fist Tight tension turning arm Arm had a small scratch from a rose thorn later and became very itchy No muscle soreness in arm

left pinky toe became very sore, deep purple & red during night following vaccine received in the morning. Symptoms gradually subsided on their own during the next five days.

Rash all over his body; Fever; Didn't feel good; itching; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of bnt162b2 (Pfizer COVID vaccine, Formulation: Solution for injection, Batch/Lot Number: ER8734) via Intramuscular in Arm Left on 08Apr2021 13:00 as single dose for covid-19 immunisation. Patient medical history was not reported. The patient received first dose of historical vaccine, bnt162b2 (Lot: EN6204) in left arm on 18Mar2021 for Covid-19 Immunisation. The patient concomitant medications were not reported. Patient received second dose last Thursday. Next day, on 09Apr2021, got typical fever and did not feel good. Was fine on Saturday. Last night, Sunday evening, he woke up and had a rash all over his body. Feels fine otherwise. No fever now. Just has the rash. Had no fever since 10Apr2021. Rash was began on 11Apr2021 in the evening. He woke up and was wondering why he was itching on an unspecified date in Apr2021. He put some steroid stuff on and took Benadryl so the itching was not too bad after that. Confirmed the Benadryl and steroid stuff helped. Rash was from his neck down and on both sides, but not on his hands or feet. Was on pretty much the rest of his body, but not his feet, hands, neck, or face. The Clinical outcome of the event, itching was unknown, for events, fever, did not feel good was Recovered on 10Apr2021 and event Rash was Not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

strong soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8727) in Mar2021 14:30 in left arm at single dose for COVID-19 immunization. Medical history included high cholesterol, high blood pressure. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the first dose, patient experienced strong soreness at injection site. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.

Pain at injection site; Fever; Body aches; Headache; Weakness/lethargy; Weakness/lethargy; This is a spontaneous report received from a contactable consumer (patient). This 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8729) on 11Apr2021 14:15 in left arm at single dose for COVID-19 immunization. Medical history included high cholesterol, high blood pressure. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8727) in Mar2021 14:30 in left arm at single dose for COVID-19 immunization and after the first dose, experienced strong soreness at injection site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After second dose, starting 12 hours after injection, on 12Apr2021 15:00, patient experienced pain at injection site, fever, body aches, headache, weakness/lethargy. Symptoms fully resolved 48 hours after injection. No treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered on 13Apr2021. No follow-up attempts are needed. No further information is expected.

About 10 minutes after first dose (lot EN 6202, 2/25/21), briefly felt very flush in the face and faint. That passed quickly. Then had extreme burning sensation near injection site for about a minute. Did not report this at the time or before the second vaccine for fear of not being given the second injection. About 10 minutes after second dose, suddenly realized it was difficult to breathe. Removed mask. Started to feel better after a few minutes, replaced bottom, more breathable mask (did not report to observers). Was urged to leave vaccination site due to backlog of patients, so walked back to car. Began to feel pretty out of it (faint again, plus heart racing) on the way back to the car. Considered getting the shuttle back to the injection site, but instead sat in the car until it passed. About 25 minutes after the vaccine, started feeling very hot all over. 30-40 minutes after the vaccine, all reactions seemed to have passed and drove home without incident.

Full Body Hives over 90% of body. Redness, itching. Temp of 102.5. Elevated abnormal heart rate of 132 BPM Treated with antihistamines: cetirizone, famotidine, and hydroxzine. Hive were much less significant after 24 hour with continued use of antihistamines but still present 4 days later at the time of this reporting.

Day of 2nd dose of vaccine received: mild soreness in shoulder, neck and back, around the area where the shot was given. Day after vaccine: lower than normal energy, but otherwise fine. Two days after vaccine: low energy, body aching, occasional cough. Three days after vaccine: similar symptoms of the previous day. Four days after vaccine: lower energy, body aches, coughing, persistent headache, eyes feeling tired and burning, and congestion starting in my chest, all worsened in the evening. Five days after vaccine: congestion in chest, regular cough, sore throat, runny nose, eyes feeling dry and burning, shortness of breath. Was tested for Covid on the fifth day after the vaccine. Six days after vaccine, chest congestion, coughing, sore throat, runny nose, shortness of breath, and still low energy. Covid test result came back as negative.

I have developed a full-body itchy rash. It has spread slowly from my legs 1 day after the vaccine. It has spread from my legs to my arms then my chest and then my face.

reported bumps along below right breast since 4/28 which started spreading on 5/4 to surrounding area. pt later developed large ring rash to right arm pit area.

Rash all over my body started, 5/2/21. Went to urgent care was given prednisone and started to disappear but as of yesterday 5/6/21 it's back and worse this time. Went to urgent care again today 5/7/21. Was given a second prescription of prednisone but stronger dosage this time.

Shingles. I received the second dose of covid vaccine on Wed, April 28. Three days later, Saturday May 1, I woke up with intense abdominal pain, spanning the entirety of my stomach, and wrapping around my right oblique and kidney area. I had thrown out my back one week prior, assumed this was more muscle pain, and treated it as such. The Monday following, May 3, I went to the chiropractor, still in intense pain, but also with a tingling sensation on the affected area, sensitivity to the touch without pain. I assumed that I had burned myself with the heating pad. Wednesday a rash began to form in the affected area. My pain was nearly gone, I no longer felt muscle tightness, and assumed that the condition was resolving itself, and that the rash was heat rash from the heating pad. Friday the rash was redder and my abdomen showed signs of significant swelling. I still thought this was muscular, that perhaps I had pulled the abdomen, treated with ice and decided to visit Orthopedic urgent care Saturday. Saturday the pain had increased. I went to Urgent care, and was told I have shingles. I asked if the covid vaccine could have caused shingles to flare, was told "theoretically", but thar we do not really know enough to say whether the vaccine contributed, or whether it was coincidence. At home, I read a bit on the covid vaccine qnd shingles, saw what appeared to be anti-vaccer propaganda, but also read about this self-reporting system...so, I thought that I might as well submit my info.

No issues day of shot as far as headache, tiredness, etc. and nothing since shot. However, five days after shot began to develop a rash/hives. Started around front of neck and moved to chest, both upper arms, back, stomach. Have some on upper thigh and temples also. Has never itched. Contacted Dr. and sent pictures. Suggested cancel 2nd shot on 5/15. Being still have hives 10 days later and Benadryl did not help take them away went to Urgent Care. Was given Prednisone.

After 2 days of 2nd shot, I started having sensation and rashes in my lower back, left hip and left waistline. In another 4 days it turned into shingles. It is extremely painful. I checked with my PCP and taking medications.

Sore shoulder; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). This consumer reported 2 reports for same patient and different dose, this is the second of 2 reports. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular, administered in right arm (reported as right shoulder) on 26Jan2021 15:30 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation at Workplace clinical. Patient's medical history reported as none. No prior vaccinations. No concomitant drugs. There were no concomitant medications. The patient experienced pain at injection site (seriousness criteria: not serious) on 26Jan2021 15:30 with outcome of recovered on an unspecified date, this event did not require the initiation of new medication/ other treatment/ procedure, sore shoulder on an unspecified date with outcome of unknown. No relevant test. First Dose resulted in a sore shoulder. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021169816 Same patient, same product, different dose, similar events.

received the first dose of Pfizer COVID-19 (Lot#: EN6207) in the left deltoid in the early afternoon of March 24, 2021. He immediately felt left hand tingling/numbness at his left thumb and first finger that has intermittently worsened with flexing his arm. There was no local reaction. The next morning, he experienced severe fatigue, headache, muscle aches/soreness, fever and mild chest congestion that resolved after 5 days. He also developed itching and hives that occurred from his chin downward on his neck, bilateral shoulders, back, chest and abdomen with no hives below his waist. He had photo showing erythematous blotchy rash scattered over this neck, anterior shoulders, chest and upper abdomen. The hives continued daily despite Claritin 10 mg daily and have gradually subsided. There was no nausea, vomiting, diarrhea, abdominal pain, dysphagia, swelling, cough, wheeze or shortness of breath. HIs last hives was 2 days ago and no hives today. Prior to the vaccine he was well without colds or flu-like symptoms in his usual state of health. He had not taken NSAIDs or other medications or supplements.

In between my first and second shots I started having pain in my right side back and right side front. Dull kinda pain, soreness...not super sharp or anything. It was severe enough that I couldn't sleep at night. I still kept my second vaccine appointment which was in a couple days and booked an appt. with my doctor. It was about a week until I could get in to the office. In that time I got a small herpetic rash about the size of two fifty cent pieces on my right side. I went to the office and the doctor identified it as Shingles...which is not something I've had before. He put me on an oral steroid for 6 days, anti-viral medicine(Valacyclovir), and something for nerve pain (Gabapentin). All of which helped and I appear to have recovered so far.

My memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it; Neurological decline; I haven't been able to walk/can't even walk unassisted; My skin feels like it's on fire all the time; Very bad nerve pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8731; Expiration Date: Jul2021), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 (at the age of 43-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included fusion of C-spine, and problems with C spine from an unknown date and unknown if ongoing. Concomitant medication included oxycodone taken for spinal disorder, start and stop dates were not reported. On 11Apr2021, the patient stated, 'I haven't been able to walk, my skin feels like it's on fire all the time, I've got like very bad nerve pain and, my memory, my cognitive skills has declined. I was able to walk and I was functionable before I got the COVID 19 vaccination.' The patient's wife stated, "He was actually admitted in to hospital for 4 days, 2 weeks ago and they did lot of different lab work and medical tests, MRI, CT scans and full blood work as far as the actual individual details of what they ran, it's a long list and I don't have that handy." Further added, "They gave him a lot of new medications to try to treat the burning in the skin and the nerve pain and he is also has now been admitted into an extensive long outpatient recovery program for cognition, we are working with the occupational therapy and his speech therapy." Her husband had only the first Pfizer vaccine and has severe cognitive and neurological decline within a day or so of getting it. He can't even walk unassisted. He's between a walker and a wheelchair right now and cognition is so bad that some days he can't even process how to feed himself. It was reported that the adverse events started on 11Apr2021. The patient was hospitalized for the events from Apr2021 to Apr2021. The patient underwent lab tests and procedures which included blood test, computerised tomogram and magnetic resonance imaging, all with unknown results on Apr2021. Therapeutic measures were taken as a result of my memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it, neurological decline and i haven't been able to walk/can't even walk unassisted. The outcome of the events 'My skin feels like it's on fire all the time' and very bad nerve pain was unknown, while of the rest was not recovered.

arm where injection occurred has had pain since injection. Can be enough to wake him from sleep. Better if avoids using arm, worse if exercises or uses arm in other ways. Also tingling from upper arm to fingers, off/on with no clear pattern

Hives breakout all over body, particularly both forearms, eyelids, groin and waist area. Severe itchiness in both arms started around 3-5 hours after vaccine shot. Proliferation of hives in waist and groin area overnight, extremely itchy eyelids on both eyes, redness around eyes. Smaller effect in legs. After 36 hours, hives have continued. Treated with colloidal oat creams and topical steroids. Topical steroids (clobetasol) did not work, only found some relief with colloidal oat cream (Gladskin).

Increased heart rate a couple of minutes after the shot. Unusual sensation. Had to lower my mask for additional air. Symptoms subsided completely after about 5 minutes following the shot. Remained in the lobby area for a few minutes past my required 15 minutes. After leaving I felt fine. No symptoms hours later or to this point, 5/24/2021 other than pain at the injection site for 2-3 days.

Mild case of shingles. Scalp tenderness, small rash around eye. Nerve pain. Antiviral valocyclovir prescribed 4 days after onset of symptoms. Cleared up after 2 weeks.

The events have been injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swelling, and vomits.

Shingles. Not sure if vaccine related but thought I should report. The shingles occurred on my forehead.

Small rash that started on my chest, then spread all over my chest, arms, neck, head, back and stomach.

Left foot became swollen the day after first dose then continued to swell with numbness in both feet then by the 5th day my right foot became extremely swollen and i went to medical center. A rash formed I also on my ankle area . I took pictures if needed. Spent 2 night in observation at hospital. Still have numbness and raised skin on my right toe.

Pt presented with an itchy throat and forearms approx 15 min post vaccination. Pt was given 25mg iv benadryl. Pt stated that the benadryl helped but did not completely resolve the issue. Pt remained for approx. 30 minutes. Pt complained of chest discomfort. 911 was called. EKG was normal along with vitals. Pt refused transport and treatment. PT was advised to follow up with his PCP before his next shot.

Rash in the genital and waste area. The rash began approximately one week after my first vaccine. It spread from my genital area up to my waste and chest over the next month. The rash was itchy and red with small bumps. I began using over-the-counter medication to treat it, which continued for the entire first month. I went to a doctor on April 23rd and was prescribed tetracycline. I took that for approximately one week, and symptoms subsided, but did not completely go away. Two weeks later I called again and was prescribed a second dose, which I again took until it was completed. Once again, the symptoms subsided, but did not completely disappear. Approximately two weeks later, I again contacted my doctor who prescribed terbinafine hydrochloride. As with the other two prescriptions, the rash seemed to completely go away halfway through the course of treatment, but then returned. I currently have five days of the medication remaining.

With my 1st vaccine I just had soreness around the injection site. After the 2nd vaccine I woke up at 4am on 1/31/2021 with muffled hearing in my left ear and mild numbness in the entire left side of my body from top of my head to bottom of my feet. I experienced vomiting and diarrhea also. I had blood pressure of 150 /105 and pulse rate of 100. My doctor was afraid I had a stroke, so I went to the ER and had a CT scan in brain. I tried to go to work the next day but my head was foggy so I had to leave work. I had a test for carotid arteries and heart test that came back fine. I was sent to a neurologist. He suspected I had possible swelling in the spinal cord, but since I was feeling a little better he thought it was ok to wait to have a spinal tap. He described that the symptoms were MS dialed symptoms but did not feel I had MS. I've gotten better but continue to have a neuropathy pain in my left foot, left hand, and left side of my face. It tends to get worse at night but in the morning it is ok. It continues through the day. None of these symptoms were there before the vaccine.

At 1258. Patient started feeling itch, slightly lightheaded when sitting up, "weird tingle" in throat, dizziness, slight confusion. Vital sings 140-78/HR76 /R16, 93@ O2Sat. Skin warm and dry. Forehead is slightly flushed and war, Cap refill good, breath sounds clean bilaterally. Had patent lay down for vital signs, sat up and given water. Patient became dizzy upon sitting, returned to supine position. 1313 vital signs 122/80/HR76/R20. Skin warm and dry, good cap refill, breath sound clear bilaterally. 1328 had patient sit up, no initial dizziness orthostatic vital signs: Supine 118/80/HR80/R20. Sitting 140/100.. Patient discharged in stable condition in the company of his wife. Pt is alert and oriented times 3. Skin pink, warm and dry. Agrees to follow up with PCP or EMS if any signed of diff breathing, throat tightness were to occur on his arrival home.

Developed mild pain in the chest the day following the first vaccine dose, painful muscle cramps at arm/injection site, muscle cramps in feet, and very painful colon inflammation which made it difficult to move around. Also felt feverish for two nights after the injection but did not take temperature to confirm. All other symptoms and body inflammation appeared to have resolved with the exception of painful inflammation in the knees which appeared after all other inflammation symptoms at various other body sites dimminished.

Patient reported he received a dose of the Pfizer COVID vaccine 1 day before onset of increasing firm nontender swelling of the left costochondral junction at the level of the 2nd rib. On exam, this area was nontender and palpated similar to a skeletal prominence but patient endorsed that this was entirely new to him. He felt discomfort deep to the swelling, but this was not worsened by touching the area.

A rash broke out all over my body; This is a spontaneous report from a contactable consumer (patient). A patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number ER8733), via an unspecified route of administration, in arm left on 08Apr2021 at 14:45 as 1st dose single for COVID-19 immunisation. The patient had no medical history. The concomitant medications of the patient included bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL /HCTZ) and allopurinol both taken for an unspecified indication received within 2 weeks of vaccination. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested with COVID-19. On 08Apr2021 at 17:00, the patient experienced a rash broke out all over body. Therapeutic measures were taken as a result event that included over the counter Benadryl and Pepcid. The outcome of the event was not resolved. Information on Lot/Batch number was available. Follow up letter has been generated for further information.

significant torso hives involving upper arms, trunk, neck, and groin. Occurred 6/26, treated with claritin. Recurred 6/28, treated with zyrtec

rash characterized by fluid filled blisters dispersed approx (1cm apart) in a circular/oval pattern (approx 2"X1" in diameter) on upper interior left arm about 2"X1" with . Talk ied to pharmacist at CVS who indicated that it appeared "shingle-like" based on observation of blisters that had begun to"scab" over. Initially noticed symptoms approx 5-7 days after vaccination which started as a couple blisters eventually spreading to 12 spots in the circle pattern described above. 1 additional blister noted on inner forearm. Area is slightly painful.

Contact dermatitis on my back and forehead. I had a rash, itchiness like an eczema look. I went to a physician who prescribed prednisone and topical creams. I went to a dermatologist who prescribed a stronger topical cream. I went to an allergist who tested for about 80 different chemicals that I might be allergic to. None of them were found in my daily life.

About 6 hours after the first dose, I started experiencing ringing in my ears. Mainly I thought it was the left ear but the fact is both are ringing and the left side is worse. I was panicking and I didn't know what was going on. I went to urgent care three days later and they found nothing that was causing the ringing. They urgent care doctor made a phone call a specialist and she stated that the ringing in the ears is a rare side effect of the COVID vaccine and it should go away. I then went to my primary care doctor and she thought she saw some redness in my left ear and thus prescribed me methylPREDNISolone and an ear drop with the name Ofloxacin. They both did not work. She then prescribed me Azithromycin which also did not work. Since I was not responding to medication, I was diagnosed with tennitus by my primary care doctor. About a week later after the vaccine, I was been experiencing popping in my left ear as well as the noise. But on the right ear, there is only noise. Prior to vaccination, I never had any issue with my ears before. The tennitus is debilitating and life altering in so many ways. I'm still not getting more than four hours of sleep even with melatonin and I'm someone that has never used melatonin or had sleeping issues prior to vaccination.

Hematoma was noted immediately after giving vaccination. Patient was advised to use ice packs or OTC pain relievers if necessary. After 15 minutes of post-vaccination monitoring, patient reported feeling burning sensation up and down the arm and side of neck. Aside from the vaccination site no redness, swelling, or hives were visible. Patient stated no trouble breathing or lightheadedness and was told to monitor for another 15 minutes. After the 15 minutes had passed, patient reported sensation was slowly dissipating but still noticeable. Patient was advised to continue monitoring at home for the next 24 hours and to seek medical attention if symptom worsens or new unusual symptoms develop.

swollen right armpit; redness around injection site which the skin was hot to the touch; headache; body aches; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the right arm on 25Mar2021 at 13:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the right arm on 04Mar2021 at 11:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 18:00, after the second dose, the patient experienced headache and body aches which started by the evening. On 27Mar2021, the patient experienced swollen right armpit and redness around injection site which the skin was hot to the touch. The patient continued to feel body aches. The patient did not receive any treatment 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 headache, body aches, swollen right armpit and redness around injection site were resolved on 28Mar2021. No follow-up attempts are needed. No further information is expected.

Patient called in stating his arm and top of shoulder are swollen and "bruised" from vaccine, no arm/back pain, felt like his blood pressure was raised and slight fever. Just discovered today that his back looks "bruised". Denied emergency symptoms, but states wants to be seen in person. Offered urgent care provider appointment 5/30/21, but declined, wants to go to emergency room to be seen in person.

rashes like small red dots; itching; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male 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 24Mar2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have a history of allergies to medications, food, or other products. 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 27Mar2021 after 72 hours at 18:00, the patient had started noticing rashes like small red dots all over body especially from backside and front side of the body. They are kind of itching but not painful. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event rashes like small red dots and itching was unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

red rashes on my forearms and chest; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 24Mar2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to penicillin. The patient did not receive any other medications within two weeks of COVID-19 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 the vaccination. The patient had not been tested for COVID-19, since the vaccination. On 25Ma2021 at 16:30, the patient had experienced red rashes on his body especially on forearms and chest on the day after vaccination. He did not notice this until the next day of vaccination. Prominently those red rashes occurred multiple times during the day. They remained prominent for 30 to 40 minutes after which they had subsided. He also noticed that they also occurred after he ate something, but he did not change anything as far as his food was concerned. He had the same food that he was had before getting vaccinated. There were no changes in food. The patient did not receive any treatment for the adverse event. 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 event red rash was resolved with lasting effects on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

Mild headache; Mild nausea; Sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248), via an unspecified route of administration in the right arm on 24Mar2021 at 09:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal hay fever. The patient was allergic to tree nuts. Concomitant medication included cetirizine hydrochloride (ZYRTEC) from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the right arm on 02Mar2021 at 11:30 (at the age of 43-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 tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 06:00, approximately 24 hours after second shot, the patient woke up with mild headache, mild nausea and sore arm at injection site. 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 the events headache, nausea and sore arm at injection site was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Site: Pain at Injection Site-Severe, Systemic: fluid pocket under right arm pit-Medium, Systemic: Lymph Node Swelling-Medium

Hive-like rash; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 30Mar2021 at 14:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included finasteride (MANAFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 09Mar2021 at 11:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. 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 had no known allergies. On 02Apr2021 the patient experienced hive-like rash that started on his both biceps and both upper thighs and then spread to underneath both arm pits and lower legs. The patient did not receive any treatment for the event. The clinical outcome of the event urticarial rash was unknown. No follow-up attempts are needed. No further information is expected.

swollen lymph node on left jaw; itchy skin; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the arm left on 02Apr2021 at 16:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included finasteride (MANUFACTURER UNKNOWN) and minoxidil (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6199) via an unspecified route of administration in the arm left on 12Mar2021 at 16:00 (at the age of 43-year-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 23Apr2021 at 16:00 the patient experienced swollen lymph node on left jaw and itchy skin. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events swollen lymph node on left jaw and itchy skin was not recovered. No follow-up attempts are needed. No further information is expected.

Headache-dull/ site pain - at 12 hrs post injection Chills 18 hrs post injection Fever 38C - 30 hrs post Injection Significant fatigue

Posterior headache, nape and upper back pain Low grade fever for about 18 hrs Armpit tenderness on the side of injection

Injection site soreness only first 24hrs.; fatigue; chills; fever of 99.8 F; body aches; headache; vomiting; Diarrhea; This is a spontaneous report from a contactable other health professional (patient). A 44-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 22Dec2020 14:00 at single dose at right arm for COVID-19 immunization. Medical history included Asthma, no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT), omeprazole. 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. It was reported that injection site soreness only first 24hrs. At 30 hrs, fatigue, chills, fever of 99.8 Fahrenheit (F), body aches, headache, vomiting and diarrhea. These lasted for 24hrs. Diarrhea persisted for 48 hrs. To the best of his knowledge he had not ever been exposed to Covid. The events onset date reported as 23Dec2020 23:00 (pending clarification). Treatment received for the adverse event reported as "Called nurse line". 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 unknown.

Achey joints & muscles, fatigue, diarrhea, chills, sweats, headaches, sore left arm (injection side more sore than rest of sore body), pain & edema at injection site limiting shoulder range of motion for two days.

Dizziness-10 min post injection resolved within 60 min, headache-10 min post injection resolved within 60 min Rash, neck and chest area 50 min post injection resolved with 30 mg Claritin reditabs 90 mins post injection Body ache- few hours post injection resolved in 24 hrs Injection site/arm pain 20 min post injection resolved in 3 days Blood pressure increased to 170/100 30 min post injection resolved 60-90 min

extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an "amped" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an "amped" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the BP increased and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Fluid collection and discomfort of left axilla, no erythema, hematoma starting approximately 1.5 days after injection and ongoing. Also had low grade temp and dizziness that was self-limiting.

onset of body aches, fatigue, tachyccardia a few hours after receiving his second vaccine dose on 1/8/21. onset of and L3 dermatome shingles on 1/10/21 pulse was 138 on presentation for evaluation 1/13/21. Hypertensive 170/80

his arm being sore from the vaccination; experienced increased heart rate/Heart rate went up; Mouth dry; He was calling because he is wondering if this is (increased heart rate, mouth dry) considered a severe allergic reaction; This is a spontaneous report from a contactable physician who reported for himself. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) 1st dose via an unspecified route of administration on 17Dec2020 in the evening time (around 6-7 or maybe a little later) at single dose on arm for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. After getting the COVID Vaccine that same day, his heart rate went up and then it came down and he was fine. Later that night while sleeping he got up again because he could feel his heart rate going up. It was not way up, but he could tell it was up. He was trying to catch an actual reading on the monitor of his heart rate, but he was not able to before it came back down. He was calling because he is wondering if this was considered a severe allergic reaction. He got the vaccine and was able to walk to his car. His mouth got dry right after the vaccine within a minute or two and noticed his heart rate went up. Treatment: He took some deep breaths and drunk water and it got better. He drove home, but that at nighttime while sleeping he noticed his heart rate went up a couple of times, but then it came back down. He could not get a reading of heart rate right away. The highest he saw on the monitor that he was able to capture was 101 and then it came back down. He was not sure if this was because he was nervous. He just had a couple of episodes that night and then nothing again. He also experienced his arm being sore from the vaccination. However, he stated that is to be expected. He stated the arm sore started a few days after getting the COVID Vaccine and then it was gone. Stated he was calling because he was concerned because Pfizer said to report any issues. He started to feel better and added this may not even be an issue. He just got concerned. Mentioned he was not sure if real side effects or if he was over thinking things. Outcome of the events was resolved.

right arm became red and swollen and painful. Right arm redness/rash spread to triceps. Denies treatment. Patient states that it resolved on 01/14/21.

aches started 24hrs after 2nd vaccination. Redness and tenderness about the size of a fist occurred @ 36hrs inferior to injection sight. Redness has doubled in size @ 96hrs with itching.

My signs and symptoms begin the next morning I had a rash on my chest neck and face and my throat was a little swollen

Injection site pain, headache, muscle aches, "cottony" taste, congestion, slightly runny first thing in am

Pt reports that from day 7-10 (post vaccine) he had a 'cytokine like response" with redness, swelling and pain extending from left shoulder to under arm and chest area. Did not see PCP. Took OTC analgesic, resoled on day 10 post vaccine the response dissipated.

Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown. Information about lot/batch number has been requested.

Pain in arm below injection site persists over 24 hours later. Strong headache few hours after that lasted hours, which is very uncommon for me

Jan 28. 2nd dose vaccine, sore arm at injection site. Slight fever at night. Jan 29. Still sore arm, temp 99.7F Jan 30. 8pm rashes all over the body and scalp. Fever 100.7F. Tylenol and Benadryl taken. Jan 31 went to urgent care. Possible rashes due to covid vaccine. Methylprednisolone prescribed. HEart rate 115-130s Feb 1 still with rashes temp 99.1 heart rate 100-120s

Fever, chills, body aches, lethargy; strong onset approximately 11 hours after injection. Minor pain/redness at injection. Symptoms lasted 3 days, gradually improving after first day. Highest recorded fever ~101F via forehead scanner, but suspect higher the first night (did not record it) based on very strong chills and shivering. Multiple Fever Blisters/Cold sores after 2 days, treated with Abreva. Note there were no symptoms/side effects after first dose (Lot# EL3302, administered 01/08/2021).

woke up next day with "splotches" right side nipple area. Progressed to right under arm & right back area. Itchy & painful. He went to his PCP's office & saw NP. Diagnosed with shingles & started on medication. In process of recovering now.

diffuse hives entire body x 4 days daily and continuously starting 2 days after vaccine administration. Treated by urgent care with steroids and benadryl but not helping

bell palsy; Headache; rash; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 44-years-old male patient received the first dose of BNT162B2 via an unspecified route of administration on 15Jan2021 15:30 at single dose in deltoid left for COVID-19 immunisation. Medical history included ongoing hypertension, Lactose intolerance, and lipids were a bit elevated on 14Jan2021. Family history included mother has diabetes and hypertension. The patient was allergic to Olives. There was no other vaccine in four weeks. Concomitant medication included ongoing lisinopril daily for blood pressure, ongoing colecalciferol (VITAMIN D) weekly, ongoing duloxetine to help with the blood pressure control, and ongoing Multivitamins daily. On Friday 15Jan2021 night around 11:00 PM he started experiencing headaches and rash. On Sunday night (17Jan2021) he experienced the bell palsy/Facial Paralysis and went to the ER. For bell palsy, the patient first had a shot of steroid, then was given oral Methylprednisonole and oral Famcyclovir. Treatment also received for headache and rash. He is still taking Still taking Methyl-prednisolone and the Famcyclovir and he will end these medications tomorrow. The patient had blood work on 14Jan2021 with normal result, lipids were a bit elevated. Events outcome was not recovered. 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.

Migraine; body aches; a headache; nausea; right ear became clogged, and today he can hardly hear anything out of his right ear.; sluggish; kind of tired/felt fatigued; The injection site was sore; This is a spontaneous report from a contactable consumer. This 44-year-old male consumer (Patient) reported that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176) at single dose for COVID-19 immunisation on 19Jan2021. The vaccination was given at 08:15-08:30. He assumed the anatomical location of administration was the muscle in his left shoulder (left arm). Relevant history included back surgery with nerve impact. He was just a big guy. Family medical history was none. Relevant concomitant drugs included Gabapentin 600 mg due to back surgery with nerve impact for 2 years, and Generic cholesterol medication for High cholesterol for years. The patient received the vaccine on Tuesday morning (19Jan2021). He reported that he was kind of tired and the injection site was sore, but nothing significant. He experienced being tired and fatigued at 20:00 and progressively got worse, by Wednesday (20Jan2021), he was more sluggish. On 20Jan2021, he had a headache, nausea and body aches at 10:00. In the evening, his right ear became clogged/"clouded" or muffled, and on 21Jan2021 he could hardly hear anything out of his right ear at 17:00- 18:00. The tiredness got significantly worse on Wednesday, but it had improved on 21Jan2021. The headache lasted about 12 hours, but it was better. The nausea also started with the headache. It was persisting, but mild. The body aches progressively got worse and were gone at the reporting time. He took Treximet for Migraine around 14:00 on 20Jan2021. NO ER or physician's office required. Depending on what he finds out on 21Jan2021, he will go see someone. The outcome of events Tired and fatigued, Body aches, headache, injection site was sore was Resolving, the outcome of events Nausea, Right ear became clogged and can hardly hear anything out of it was not resolved. The muffled ear maybe even worse on 21Jan2021. The outcome of other events was unknown. There was no additional Vaccines Administered on the Same Date of the Pfizer Suspect. No history of previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) was none. Relevant test was none.

Injection site soreness; tiredness; headache; muscle soreness; chills; joint soreness; This is a spontaneous report from a non contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EL9261), via an unspecified route of administration on 22Jan2021 10:30 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Military Base. Patient age at time of vaccination was 44 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included chronic sinusitis. The patient has no known allergies. Concomitant medications included atorvastatin, ibuprofen (ADVIL), guaifenesin (MUCUS RELIEF), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A DAY). On 23Jan2021 20:00 the patient experienced injection site soreness, tiredness, headache, muscle soreness, chills, joint soreness. No treatment was received 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. No follow-up attempts are possible. No further information is expected.

Patient had sl. reddened area at vaccination site after his first dose ,which lasted only a day. Now a week after his second dose, he has developed a red rash at the injection site, approximately 4 inches in diameter. There is also a hhardened area approximatedly 2 inches in diameter within the reddened area. He complained of itchiness at the site, but no pain. I gave him benedryl 25 mg last night. and the itchiness went away. This morning, he still has the rash, but denies any pain or itchiness. and he feels fine.i did call the doctor's office, but the nurse felt no other treatment was needed.

mild injection site pain - onset at 13:00 on day of injection (90 minutes post dose), lasting several hours.

Rash on bilateral arms, neck and face, at approx 12:30 given 25 mg Benadryl denies SOB, no respiratory stridor, no swelling of mouth, lips or tongue, Per doctor would like lab order of Tryptase

Started itching of mouth face and upper body within 10 minutes of injection. Became dizzy with tunnel vision. Went to urgent care had elevated blood pressure of 178/110. Receive steroid injection and prescription for hydroxyzine.

Patient had recieved vaccine and was walking toward the waiting area in the bleachers. He began to feel dizzy and light headed. He syncopized and struck his head on a concrete stair. He was immediately seen by provider who was at a nearby table. The patient regained consciousness within moments without any evidence of post ictal confusion. He suffered a laceration to the head. Bleeding was controlled, EMS was contacted expiditiously, and the patient ambulated from the building approximatelyh 20 minutes later and was brought by EMS to the nearest emergency department to be evaluated.

small heart attack; myocardial/paracardial issues.; My injection location had redness, hardness; My injection location had redness, hardness; pains in chest; headache; chill; running nose; shortness of breath.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 19Feb2021 17:45 at single dose for COVID-19 immunisation at hospital. Medical history included coronary artery disease. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unknown date for covid-19 immunisation. The patient did not have covid before vaccination. The patient experienced small heart attack and myocardial/paracardial issues on an unspecified date with outcome of unknown. These events were serious as life threatening, disability and requiring hospitalization from 21Feb2021 till 23Feb2021 at 14:00. On 20Feb2021 07:00 the patient experienced headache, chill, running nose, shortness of breath with outcome of recovering. The patient experienced also pains in chest on 21Feb2021 11:00 with outcome of recovering and injection location had redness, hardness on an unspecified date with outcome of recovering. Clinical course was as follows. 19Feb2021-5:45pm the patient went to receive vaccine shot. 20Feb2021 the patient had headache, chill, runny nose, and shortness of breath. 21Feb2021 11am still had shortness of breath and pains in chest. Went to clinic had a rapid Covid test come back negative, pain increased and he went to emergency room. The patient was admitted to the hospital with small heart attack and myocardial/paracardial issues. Inflammatory response seems to possibly triggered possible underlying issue of minor heart disease. Then induced heart attack and myocardial issue. The patient would gladly be admitted to a clinic for observation and testing to assist Pfizer in understanding this unfortunate situation. The injection location had redness, hardness. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment due to the event which included multiple lab tests, Angiogram, CR scan and pain medicine.

injection site soreness; This is a spontaneous report from a contactable consumer (Patient). A 44-year-old (also age at vaccination) male patient receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration at the left arm on 09Jan2021 (reported as 29Jan2021; pending clarification) 08:30 at SINGLE DOSE for covid-19 immunization. Medical history included that prior to vaccination the patient was diagnosed with COVID-19. 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. The patient had no allergies to medications, food, or other products. The patient was vaccinated at a workplace clinic. The patient's concomitant medications were not reported. It was reported that the patient experienced injection site soreness on 30Jan2021 (as reported date: pending clarification). The outcome of the event was recovering. The treatment received is Diclofenac 100mg. Case was not considered serious (for any criteria).

injection site soreness; severe back pain; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration into the left arm on 29Jan2021 10:15 AM at a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date prior to vaccination. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration into the left arm on 09Jan2021 08:30 AM at a single dose for COVID-19 immunization and experienced injection site soreness. On 30Jan2021, patient experienced injection site soreness and severe back pain. The events were reported as non-serious and the patient was treated with diclofenac 100mg. Outcome of events was recovering.

Soreness at injection site - started approximately 5 hours post vaccine - no treatments required Generalized fatigue - started approximately 12 hours post vaccine - no treatments required

a tender lump under my left arm in my armpit; Chills; headache; tiredness; This is a spontaneous report from a contactable consumer for himself. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Feb2021 10:30 (Lot number: EL3247) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization at workplace clinic. The patient had no medical history and not had allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 14:30 (Lot number: EL3247) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient has not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient has not taken any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient experienced chills, headache, tiredness the second morning after the second dose administered on 23Feb2021 the patient noticed a tender lump under his left arm in armpit on 25Feb2021 06:45. The reporter assessed the events as non-serious. The patient has not received treatment. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Dizziness, Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: dose 1-day 2-3-soreness inj site; day 2-3 nausea; aches; dizziness; ha Other Relevant History:

Burning sensation in injection side shoulder, Swollen/painful lymph node along collar bone 6 days following vaccine

Headache, Arthralgia, Injection site pain, injection site erythema, Injections site swelling, Fatigue Narrative:

Slight fever; soreness at the site of injection; headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247, second dose) solution for injection intramuscular on 16Feb2021 at 10:00 (at the age of 44-years-old) at single dose for COVID-19 vaccination. There was no medical history. Concomitant medication included lisinopril. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 26Jan2021 with no adverse effect reported. The patient had no 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. On 16Feb2021, after the second vaccination, the patient experienced slight fever, soreness at the site of injection and headache. There was no treatment for the events slight fever, soreness at the site of injection and headache. The outcome of the events slight fever, soreness at the site of injection and headache was recovering. Since the vaccination, the patient has not been tested for COVID-19.

Left arm pain that starts at the injection site from the second shot and then radiates down the length of the arm to the fingers causes the pinky and ring fingers to go numb . This started about 2-3 weeks after the second vaccination right after the bruise at the injection site resolved. It gets worse if I use the arm a lot . It also hurts if I don't use the arm too but not as frequently. I have demonstrably less strength in the pinky and ring fingers when comparing left to right hand. I went to the doctor and have been referred to a neurologist but the earliest appointment available is in April. No treatment for the pain was initiated until evaluation from the neurologist in April. The pain is getting worse and the numbness in the fingers is getting worse as well as time progresses to the point it is interfering with sleep and normal activities.

small rashes inner left arm; burning sensation inner left arm; This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number ENG201) via an unspecified route of administration on 19Feb2021 at 16:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. Prior to the vaccine the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included fexofenadine (ALLEGRA) from an unknown date for an unknown indication. The patient had no allergies to medications, food, or other products. On the first day (also reported as 12Feb2021) at 18:00, the patient experienced burning sensation on the inner left arm. On the second day, the patient experienced small rashes on the inner left arm but different spots from the first day. The events were reported as non-serious. The patient was not hospitalized for the events and did not receive any treatment for the events. The outcome of burning sensation on the inner left arm and small rashes on the inner left arm were recovering. 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.

Random itching throughout body - started on arms and legs and then was all over body, no hives, no rash. Additionally sharp, random pains - feels like pins and needles - started on the next day

3:03PM: Patient received Pfizer Covid vaccine and went to waiting room for 15-minute observation period 3:17 PM: Nurse Called to waiting room; patient states of warmness and dizziness, alert with eyes half open 3:17 PM: Non-responsive to name; head back and nonresponsive; Eased to floor; remains non- responsive for approximately 22 seconds. Opens eyes and responds to name. 3:18 PM: NP present. Neuro assessment completed. Pt remains alert and responsive, skin warm and moist. B/P 132/78 3:24 PM: Remains alert and oriented; states of feeling better; assisted to sitting position 3:25 PM: B/P 110/62 Pulse remains strong at 68, denies dizziness; placed in chair with supervised presence in waiting room 3:35 PM: Offered juice and granola bar; eating without discomfort 3:40: B/P 112/62, 68 and regular, skin warm and dry; encouraged to find ride home or back to work 3:50 PM: B/P 118/72, pulse 72 and regular, continues to state of feeling weak, oriented and alert 4:08 PM: Walked around waiting room without dizziness or dyspnea. Pulse 78 and regular; B/P 112/62 4:18PM: walking around room without discomfort or change in consciousness; B/P 116/72, pulse is 72 and regular. 4:30 PM: Remains alert, skin warm and dry, Pulse 74 and regular.

Soreness in left arm around injection area the following morning (3/30). No treatment. Soreness mostly gone by the next morning (3/31).

Injection site soreness; headache; body aches; This is a spontaneous report from a non-contactable consumer, the patient. This 44 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) , single dose, dose 2 via unknown route of administration in the left arm on 16Feb2021 at 13:30 (at the age of 44 years-old) for COVID-19 vaccination. Medical history was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 26Jan2021 at 2: 15 PM. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient did not receive any concomitant medications. The patient was not on any medications in two weeks. On 16Feb2021 at 16:00, the patient experienced injection site soreness, headache and body aches. No treatment was received for injection site soreness, headache and body aches. The clinical outcome of injection site soreness, headache and body aches was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.

I had shingles. Starting next date I had a poking feeling in my forehead, and head heck for couple days guess 3rd day started seeing pimples in forehead and it started developing on my left forehead and until my left eye.

Shaking chills for over 12 hours then diminished then came back 2 hours later for another 5 hours. Began 9 hours after injection. Rash on both forearms within 4 hours. Headache and body aches same time as chills.

After the shot, which I received on a Saturday, I developed pain and redness in my right leg. Two days later, on Monday morning, I contacted my primary care physician's office, who told me to go to the ER to be evaluated for a blood clot. At the ER, they performed a doppler ultrasound on my right leg and found a superficial clot in the greater saphenous vein of my right leg. There was no evidence of a DVT in the right leg.

Patient had fever after second dose for 1 week associated with right shoulder pain and limited range of motion. He was neutropenic and found to have MSSA Bacteremia. MRI of right shoulder with no drainable collection, no septic arthritis. No procedures, lines, dental work, nothing else that could explain it.

He had his first vaccine March 19th, 2021 at 12:15, same lot as above, and 24 hours later he had difficulty breathing, shortness of breath, fatigue, shakes, chills and feeling of weakness/dizziness. It lasted a few days. Then, April 9, 2021, he received his second Covid19 Pfizer shot, same lot at 12:15 pm and the next morning, Saturday, April 10th around 9 am Ira felt the same symptoms from shot 1, but more intense. He was feeling weak, had chills, shakes, profuse sweating, difficulty breathing, shortness of breath, dizziness and vomiting. He was unable to keep water down and stayed in bed. A little after 12pm, he complained of difficulty breathing and possibly not getting enough oxygen so I grabbed my equipment (since I'm a CNA) and checked his vitals. His B/P was very high ( 166/107), no fever (96.7), pulse was normal 72, and low respiration but oxygen was above 90. He said he needed to use the bathroom, I suggested using his urinal but he said he needed to have a bowel movement. Once he was in the bathroom, I went downstairs for a glass of water and then suddenly I heard a huge thump. I ran upstairs, knocked on the bathroom-no response but I could hear noises, so I opened the door and I saw he was face down on the floor, head under the bathroom sink counter, blood everywhere, and he was convulsing. I grabbed him immediately and moved him to his side (I had my fitbit on, it said it was 12:30pm), and he kept seizing. He looked discolored almost blueish color. I held him on his side, he vomited, making noises, but unable to speak, continuing to have a seizure. Seizure lasted three minutes. At 12:33pm, once he had calmed, I ran downstairs to find my phone. I was back at his side calling 911 at 12:35. Paramedics arrived 9 minutes later and took him to the hospital. My brother picked me up and took me to the hospital. Once outside his door, I noticed he was finishing taking X-Rays when he suddenly had another seizure.

I have what look to be hives on my stomach. I received the shot on a Friday on the Sunday immediately following I started to see what I thought were bug bites on the left side of my stomach. Over the past few days a few more red itchy bumps show up and they are moving from left to right and bottom of my stomach to the top.

Extremely sore back. Soreness is occurring in mid right side of back near ribs. Very minor red rash has occurred in this location as well. It is very tender in this spot and has slight ichyness at times.

As I was administering the vaccine I was discussing with the patient the adverse reactions I wanted to monitor after the injection. The patient winced as the vaccine was being injected and said it was more painful than the last time he go it. He immediately stated he didn't feel well. I applied a little pressure to the injection site which he said made it feel better but he was starting to feel flushed and faint. I kept the patient in the chair and got him some water. He reported that he had experienced this before with vaccines but it had been a long time. He asked to lay on the floor so we got him into a prone position on the floor on his right side. He laid there for a few minutes then drank some more water and laid back down. After a few more minutes he was ready to sit up. He moved to a chair in our waiting area left when he felt well enough. I called patient 2 hours later to check on himand he reports he is doing fine.

This is a 44 year old male, history of high cholesterol, not currently on medications. Patient presented for Pfizer covid-19 vaccine today, approx. 9 minutes post vaccination, patient reported he felt dizzy and light headed with left arm pain at injection site. Patient then began to report seeing flashes of lights, frontal headache, left arm and left leg heaviness and felt sweaty and if he was going to pass out. EMS was activated, patient was transferred to the ED.

Numbing in left arm, within 5 minutes, that traveled halfway up the left side of my face. Once it finished traveling, approximately 10 minutes after shot, the taste of metal appeared on the back of my tongue. The numbness passed within 15 minutes of the shot and then pain began radiating from the shot to my elbow every few minutes. I had a feeling that could be best described as inebriation after about 15 minutes and could smell pizza to be specific. There was no pizza around. This went away within about 10 minutes of onset. I slept for about 4 hours, woke up with a headache, and arm pain for 2 days.

2ND Pfizer covid-19 vaccine administration 1/14/2021. Patient symptom onset 3/16/2021 - headache, 3/21/2021 - rash diagnosed to be herpes zoster V1/V2 distribution, 4/12/2021 - herpes zoster ocular involvement with scratchiness, visual halos and decreased visual acuity of 3 days duration.

Site: Itching at Injection Site-Mild, Systemic: Complained of \" tingling all over \" at 5:25 PM-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Complained of tingling approx 15 minutes after the injection. No rash noted. Stated some brief itching on left forearm, no rash noted. Refused Benadryl, stated he would take some at home. Vital signs at 5:30 PM, T 96.2, P 64 Regular, R 18, BP 128/80. No stridor, Vital signs at 5:53 PM, T 96.6 temporal, P 64 regular, R 20, no stridor, BP 110/80, no rash, went home at 5:55 PM. Stated he would take some Benadryl at home. Advised to pull over and dial 911 if any signs of respiratory distress/shock

Bruise-type pain at injection site starting +5 hours lasting for about a day. Mild Diarrhea starting +8 hours roughly every 1-2 hours for a day or so. Persistent headache starting +12 hours for a few days (somewhat hard to judge causation given being a long time regular migraine sufferer but seemed more than usual / different). Mild vertigo / balance issues starting +2 days lasting for 3-4 days. Can't confirm causation but definitely atypical / no other known cause. Difficulty maintaining balance (like walking while drunk only I don't drink anymore) NO nausea/spinning just balance.

Patient called 2 days after vaccination to report that he had developed a rash on both his arms, arm pits, and bilateral upper legs. The patient was instructed to take benedryl and if signs of troubled breathing were suspected to go to the ER. Patient was asked if they had changed use in laundry detergent as he did describe changing his detergent recently, but did not have issue before.

muscle ache; Chills; soreness at site of injection; headache; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: el3247) via an unspecified route of administration in the left arm on 18Feb2021 at 10:15 (at the age of 44-year-old) as a single dose for COVID-19 immunization. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el3247), via an unspecified route of administration in the left arm on 28Jan2021 at 10:15 as a single dose for COVID-19 immunization. On 18Feb2021 at 21:00 (reported as 12 hrs after injection), the patient experienced chills, soreness at site of injection, muscle ache, headache and fatigue. The patient did not receive any treatment for the events. The outcome for the events was recovered on an unspecified date in Feb2021(reported as symptoms lasted 18 hrs). Follow up attempts are completed. No further information is expected.

Several lumps on right side of head and neck.; Several lumps on right side of head and neck.; Welt on Eye/swollen eyelid right side; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 23Mar2021 12:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included hypercholesterolaemia from an unknown date and unknown if ongoing. Concomitant medication included rosuvastatin, calcium, vitamin, fluticasone propionate (FLONASE) and multivitamins. The patient experienced several lumps on right side of head and neck, welt on eye and swollen eyelid right side on 26Mar2021 07:00 with outcome of not recovered. No treatment was given for the events.

An itchy rash with welts appeared on my thighs and underarms. In addition, my neck and ears turned red. I took a shower and 2 tablets of Benadryl Allergy prior to going to sleep. I also contacted my primary care physician, who instructed me the next morning to continue taking one tablet of Benadryl every 6 hours. The redness around my neck and ears was gone the next morning and the rash on my inner thighs started to disappear. However, when I let more than 6-8 hours laps between doses of Benadryl, I would feel the itch start to return throughout my body. This continued for roughly one week. As of today it appears that the rash is gone and I am no longer taking Benadryl on a regular basis. If necessary, I have pictures of the rash from the initial onset.

One week after getting my first Pfizer shot, I got a rash on my right arm opposite side of elbow. It's around 2 inch by 2 inch and is sometimes itchy.

Patient developed hives from their left arm to their trunk and legs within 24 hours. After speaking with provider it was deemed contraindicated for them to receive their second shot.

pt got vaccine 4/7.. on 4/8 he said his whole body broke out in a rash. he said he has trouble breathing often and has asthma and "wasn't sure if his breathing was worse with the vaccine or not, since he has that trouble often". he reported this adverse rxn on 4/28 when he came for his 2nd dose. we told him we cannot do the vaccine today, he needs to go to the hospital for another dose if they will administer it, he needs to call

Dose 1 (lot no. ER8730) was 03/24/2021 at same pharmacy. Dose 2 (described above) was 04/21/2021. I started feeling very sensitive skin when I woke up the morning of 04/28/2021. On 05/01/2021 red splotches began to appear on my right shoulder, upper chest, and neck. The skin from the top of my scalp (right side) to my right hand is sensitive. The condition has been diagnosed as shingles.

I experienced a large, itchy rash covering my upper left arm near the site of the first vaccine injection. The rash appeared appropriately 3 days after being vaccinated with the first dose. The rash lasted for approximately 2 weeks before subsiding.

10 days after my second shot I developed Shingles. It could be a coincidence, but reporting it here just in case. I'm taking Valacyclovir and advil. Symptoms are moderate.

My left arm broke out in a rash with blisters. Mainly around site, but was present through wrist and on palm of the left hand. Shoulder pain and fatigue.

Systemic: complaints of numbness in injected arm and side of face lasted 5 hours and then subsided-Medium, Additional Details: Contacted patient the following day and he reported feeling fine. Was getting ready to go to work.

ITP - he received the Pfizer COVID vaccine the day prior to admission. He subsequently felt fatigued and awoke this morning with intermittent petechiae. While golfing, he subsequently noticed increased bruising over his left shoulder. He had two episodes of epistaxis for which urgent care and then ED evaluation revealed evidence of thrombocytopenia. Platelets found to be 3,000, normal Hb, normal WBC, no splenomegaly, no lymphadenopathy,. Oncology saw recommended decadron 40mg daily for 4 days

Immediate reaction: fatigue only Approximately 1 week after vaccine, developed rash on back of hands. I have had this twice before but this time it did NOT respond to any topical treatment. Urgent care gave me medrol pack and it cleared 90%. days later moved to my face--everywhere I touched (e.g., around eyes) or had pressure (e.g., forehead where I rest when sleeping). Again no response to topicals--another medrol pack and it cleared 90%. I've had lingering symptoms for the past 4 weeks, but it is getting worse again.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: Patient reported that after shot his left thigh and stomach broke out in a red, itchy rash. He took some oral benadryl and applied hydrocortisone cream twice daily in order to make the rash go away. Rash lasted about 7 days

After the first shot, very tired all day. Slept 3 times, a little headache, minor arm pain at spot of injection. Felt lethargic the next day, by the third day I was fine. After the second shot, a little tired, less than after first shot. No other symptoms. By night time I was fine.

Onset of warmth, dizziness, sweating after the vaccine. No Syncope. Felt better quickly when supine. VSS No orthostasis before dismissal. Self resolving vasovagal reaction.

Full body rash with swelling and hives and pain in his foot hands torso legs. He was given 100 mg of Benadryl by mouth and partial Medrol pack by family. Then later that day he went to the emergency room and was only treated with Decadron 10 mg and Benadryl 50 mg. He was discharged with a Medrol dose pack. Continues to have hives and pain all over his body.

I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection site soreness; redness; skin sensitivity; brain fog; hot flashes; fatigue; swollen lymph nodes (left armpit); This is a spontaneous report from a contactable other hcp. A 44-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9268), via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included migraines. Patient had no known allergies. Patient had not covid prior and post vaccination. Concomitant medication(s) included ibuprofen (ADVIL LIQUI GELS); acetaminophen (ACETAMINOPHEN). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 02:45 (at the age of 44-year-old) as 1st dose, single for COVID-19 immunization. The patient stated that on 13Feb2021 02:00, he had a 102.5 degree fever off and on for two days, severe body aches, chills, headaches, injection site soreness, redness, skin sensitivity, brain fog, hot flashes, fatigue, and swollen lymph nodes (left armpit). Patient did not received any treatment for the events. The outcome of the events was reported as recovering. Follow-up attempts have been completed and no further information is expected.

Vaccine was at 9:50am on 5/18, patient called pharmacy back at 4:30pm on 5/18 to state hives and itching started at 3pm on 5/18. No S/S of anaphylaxis. Informed pt to follow up with MD.

Pfizer-BioNTech COVID-19 Vaccine EUA Extreme stomach distress followed by massive red hives 1' wide surrounding entire torso and back.

Patient had his first dose of Pfizer COVID-19 vaccine on 4/8/2021 and his second dose on 5/13/2021. He developed Shingles on 5/16/2021.

At the six week mark post 2nd vaccine, developed a severe case of Shingles; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 25Feb2021 00:45 (Batch/Lot Number: EN6202) as 2nd dose, single (at the age of 44 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 28Jan2021 07:30 PM (lot number:EL8982), on left arm at the age of 44 years old for COVID-19 immunisation. The patient experienced at the six-week mark post 2nd vaccine, developed a severe case of shingles. The patient had muscular adjustments as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

Developed a rash at approximately the date listed. I did not pursue treatment for another week when I went to my physician and was diagnosed with Shingles.

FIRST DOSE I WAS DIZZY BUT AFTER THE SECOND DOSE I WAS DIZZY AND NOW I HAVE HAD A RASH SINCE THE LAST DOSE AND YES I WENT TO THE ER AND THEY DIDNT DO NOTHING AND THEN I WENT TO MY PRIMARY AND HE GAVE ME SOME MEDICINE TO SEE IF IT WILL WORK TO CLEAR IT UP

1st shot 4/13, no issue with injection site. About a week later had trouble breathing, chest pain, felt like lungs were hurting in my back, weak, tired, couldn't catch my breath when i went upstairs and almost passed out. 2nd shot 5/04, felt pain at injection site (that was expected), that night started to get a bad headache and got worse and worse. Next morning, whole body aching, upper body, lower back, bad headache, Left underarm (lymph) swollen. 2nd day slight headache, neck ache, left underarm swollen. That night had rash on arms, chest, and stomach. 3rd day, nighttime rash arms, chest, stomach. Still red where band aid was over injection site. Over a week later still have redness shape of band aid, Seems I have sensitive skin since the 2nd covid shot. 10 days after 2nd shot I still have redness the shape of the Band Aid on my left arm. Got a red spot on my nose (looks like Rosacea). 4 weeks later, still have a red spot on my nose. I have itchiness between fingers left hand, on my face left side, neck, arms (left wrist, right arm in places) redness on chest, and rashes on back, left buttocks, and itchiness on legs. i noticed that it gets worse at night. As far as i know i did not get the Covid Virus, i did the rapid test and regular test and both were negative. But i was very sick with my stomach and had issues breathing in late 2019 and again early 2020, took medication (antibiotics) both times. I had to write on this form over and over again kept getting frozen with error from the PDF. Even if I hit OK, it keeps popping up and does not let me finish, so I can imagine that lots of people gave up, like I may. Pfizer 4/13/2021 EW0162. After 5pm Pfizer 5/04/2021 EW0170. After 2pm

rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/problems with sleep; felt movements in his chest at times; felt like he had COVID all over again/ if he possibly has COVID-19 again; soreness; heart rate accelerated; some swollen in lymph nodes; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer sponsored program. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 at around 13:00 or 13:30 (at the age of 44 years old) (Lot Number: EP7534, unknown expiration) as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 in Nov2020; sneezing and runny nose both on 21Mar2021. The patient's concomitant medications were not reported. The patient reported that he received his first dose of Pfizer COVID vaccine on 22Mar2021. He felt fine after receiving the vaccine, but there was little bit rash on arms just afterwards and felt maybe a little restless but felt fine and went for a walk on 22Mar2021. As the night went on, he really noticed how sore his arm was/pain in his arm and when he was sleeping, he had trouble sleeping/problems with sleep (Mar2021) and felt movements in his chest at times (Mar2021). It felt like he had COVID all over again and had chills, soreness, and his smell was kind of gone in Mar2021. He was previously feeling pretty good. He had COVID-19 in Nov2020, and his symptoms feel very similar including loss of sense of smell but no coughing. He had a fever but that has gone away in Mar2021 and he did not take aspirin or anything for it. He also had fatigue, some swollen in lymph nodes, and his heart rate accelerated in Mar2021. He had sneezing and runny nose the day prior to receiving the vaccine. The patient would like to know if his symptoms are related to the vaccine or if he possibly has COVID-19 again. His symptoms are the same as COVID as far as what he can see, and his symptoms are really high. He would like to know if he can still receive the second dose of the vaccine if he has a positive COVID test after the first dose of the vaccine. The patient mentioned that there was very pretty high percentage of people having the symptoms after having the vaccine, kind of virus "causing". The patient asked if he needs to be tested to see if he had the virus before he was vaccinated and to know if these are one of the side effects or one of the symptoms of the virus, and to make sure that these are not actually corona virus. The patient recovered from fever in Mar2021, while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.

Client received his first dose of the Pfizer Covid-19 Vaccine on 5/5/21 (Lot #EW0167 Exp. 08/2021) and his second dose of the Pfizer Covid-19 Vaccine on 5/26/21 (Lot #EW0185 Exp. 08/2021). Client came in on 6/9/21 at 10:45 AM asking to speak with a nurse about a possible vaccine reaction. Nurse went outside to talk to client. Interpreter was present. Client reported that approximately 48 hours after his second dose of the Pfizer Covid-19 Vaccine, he began noticing small red marks on both arms. The rash was not on any other body part. The client still had the rash on arms today (6/9/21), 15 days after his second vaccine. The client denied any other symptoms. The client also denied being short of breath or having difficulty breathing. Client denied any abnormal side effects from his first dose of the vaccine. The client has no known allergies, denies any prescription medication, and has no significant medical history. The client did not contact a care provider due to lack of insurance. The client also took Benadryl for the rash but stopped because he ?didn?t like the way it made (him) feel?. We discussed the situation with Nurse. Nurse called to find the nearest health center that takes clients without insurance. Nurse then educated client about the need to see a primary care provider, as we cannot give medical advice since we are a vaccination site. Client was provided with phone number and address of Medical Services. Client departed in positive disposition and stated that he was going to ?call and make an appointment? at the health center.

Client came to vaccination site at 1715 for his 2nd Pfizer dose on 06/13/21. After being seated with RN, he expressed concern about receiving his 2nd dose due to the reactions he experienced after receiving his 1st dose. RN requested Lead RN speak with the client regarding his concerns. At 1720 Lead RN spoke to client. Client stated that 1 ½ days after getting his 1st dose, he experienced soreness & tenderness in the axillary area of the left arm. Client stated that 3 days later his axillary area began swelling. The swelling continued below his axillary down the left side of his abdomen and onto the left side of his back. Client stated the pain level was a 4 on a scale of 0-10. He also stated there was no discoloration or redness in any of the areas where he experienced swelling. On day 10 the left side of the client?s neck began to swell. He also started to experience discomfort at the injection site and arm fatigue. Client stated at no time did he experience any trouble breathing, shortness of breath, or chest pain. Client stated he has been dieting and lost 145 lbs. in the last year. He previously had high blood pressure, but no longer does. He also stated the only other underlying conditions he has is a thyroid problem (hypothyroidism), and he is not medication compliant. Over the last 6 months he has only taken his levothyroxine intermittently. In the last 2 months he has not taken any of his levothyroxine until a few days ago. Client takes no other medication, but is allergic to penicillin-based antibiotics. Client stated he gets dizzy, hallucinates, and swells up in various places on his body. However, he does not experience shortness of breath or trouble breathing. Client did not take any medication for the side effects he experienced after receiving his first Pfizer injection or seek medical treatment. Client stated all the swelling began to subside on day 17. Lead RN performed a medical consult with Clinical Care Coordinator who authorized moving forward with administering client a Pfizer 2nd dose in the opposite arm with a 30-minute observation. Prior to RN administering vaccine, Lead RN educated client on normal vs adverse effects of the vaccine. Lead RN confirmed with client that he has access to a HCP for follow-up, if needed. Lead RN also recommended client follow-up with his HCP regarding his hyperthyroid condition. Lead RN instructed client to seek emergency care if he experienced shortness of breath, trouble breathing, or chest pain at any time after leaving the vaccination facility.

A few days after my first shot I came down with shingles on my buttocks. They were typical shingles blisters that burned and itched unlike any other pain I have ever experienced. It occured on Sunday so I had to do a virtual Doctors visit. I was prescribed 2 different drugs to counter act the shingles. I do not remember what they were but my doctor should have a record of it.

center of left upper arm needle pain (shock feeling), numbness shooting down arm to fingers. loss of squeeze motion. these effects are intermittent. went to chiropractor for adjustment before i found out others were having similar problems.

Sore at injection site; Bloody nose; Diarrhea; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). This 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unknown route, on 02Feb2021 11:30 (at the age of 44-year-old) as single dose for COVID-19 immunisation, administered at hospital. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. The patient did not have a relevant medical history and concomitant medications. On 03Feb2021 at 10:00, the patient developed sore at injection site, bloody nose, diarrhea, and fatigue. The patient was not treated for the events. The patient had recovered from the events on unknown date in 2021. No follow-up attempts are possible. No further information is expected.

4 days following vaccination, I awoke with severe pain, swelling, and immobility in my right ankle. No prior trauma or injury. X-rays and MRI showed no injury. Severe bruising in the ankle developed over the next week with nerve pain attacks at night. Over the next two months, I began having pain in both ankles and neuropathy in both feet and arms. Have since had full exams by an orthopedist and rheumatologist, but neither can find an underlying cause. All rheumatology related blood work returned normal, but for presence of HLA-B27 marker. Neuropathy continues. Recent occurence of episcleritis in left eye. Awaiting neurology consult as next step.

Fever, between 100 and 101 degrees approximately 12 hours after inoculation. Injection site soreness, muscle aches, fatigue, and a lip blister.

Mild body aches; Mild body aches and head ache; Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration in the right arm on 22Mar2021 at 12:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration in the right arm on 01Mar2021 at 12:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The Patient previously took Penicillin for unknown indication and experienced an allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Mar2021 at 12:00, the patient experienced mild body aches, headache and soreness at injection site. 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 mild body aches, headache and vaccination site pain was recovering. No follow-up attempts are needed. No further information is expected.

Pain at the injection site; Tiredness; feeling unwell; This is a spontaneous report from contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration to his left arm on 22Mar2021 at 3:30 PM for COVID-19 immunisation. Medical history and concomitant medications of the patient was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 22Mar2021 at 21:00 PM the patient experienced pain at the injection site which began several hours after injection, leading to intense stabbing pain whenever the upper arm was moved, tiredness and generally feeling unwell. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient did not receive any treatment for the adverse event. The clinical outcome of the event pain at the vaccination site pain, tiredness and feeling unwell was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.

Pt fainted falling on L/side of head in 15 minute waiting area after vaccination. BP112/62 P62 R16 O2 SATS 96%. Red bump noted on L/side of head. Moved to resting are via w/c. 3:45PM Alert & talking. Left w/o assistance.

Large rash on chest, pain through the body, wakes up drenched in sweat, low grade fever and chills, sensations throughout body, feels as though electricity is going throughout body, stabbing pains in veins, heart pains, organ pains, reflux in veins and legs stabbing pains in eyes, double vision, blurred vision, light headed and dizzy, allergic reactions to foods. Doctor's were unable to diagnose him with anything. He stated that he has a history of mental illness,

Site: Pain at Injection Site-Medium, Additional Details: When administering dose the vanishpoint syringe clicked and it appears the needle shot backwards in barrel in the middle of the shot instead of the end resulting in vaccine spurting out. I removed the barrel for destruction. I drew up another dose and was able to administer this successfully. Patient did report pain afterwards to which I gave him an ice pack but he returned a week later saying pain had improved 40%.

Multiple bruises on both arms, not at the injection site. They started to improve after two days but you can still see where they were.

I experienced nothing but arm soreness and some fatigue after the second dose. Four months after the second dose I got a Prodromal Headache which progressed to Herpes Zoster which was isolated to my face. I had to get eye drops for my eye. It has healed with treatment but I have some scarring.

About 15 minutes after vaccine was given, patient started feeling numbness and pain in right upper arm where vaccine was given. Patient has a PMH of stroke on the right side and diabetes. Patient also reported itchiness in right leg and dizziness. Vitals were taken and neuro exam performed. Patient given water and snack but started feeling stiffness in neck. Referred to ED for evaluation of symptoms.

At 2 days after the vaccine patient says he experienced a rash that started on lips, then to the back of his hands, and also to his groin and left leg. Patient took benadryl and used alcohol topically to dry out bumps for 10 to 12 days

21 hours after; hives all over left side chest, waist, ankles, inner thighs. Although after a Benadryl it subsided, it did come back several days again. Otherwise 24 hours after the shot exprienced, slight fever, chills, muscle aches, headache, head sinus pressure, joint pain, diarrhea and nausea. Also several days later arm still hurts. 3 days after had shooting pain in injection arm, leaving me to not use my left arm. 4th day much better.

shingles; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0162), via an unspecified route of administration in arm left on 28Apr2021 at 04:45 AM (at the age of 44-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history included HIV undetectable, peanuts, known allergies to toradol, tramadol, peanuts, spleen removed and immune suppressed. Past drug event included toradol and tramadol for known allergies. The patient's concomitant medications received within 2 weeks of vaccination was reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown, could not enter info on shots), via an unspecified route of administration on an unspecified date in Apr2021 at 04:45 PM (at the age of 44-year-old) as a dose 1, single for COVID-19 immunisation and experienced pain from my navel to my spine on my right side and it was extreme pain, I had hurt my back and shingles. 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, has the patient been tested for COVID-19 was reported as no. It was reported that, after the first shot the patient had pain from his navel to his spine on his right side and it was extreme pain so he went to the emergency room and stated that, he had hurt his back, days passed and he went to another doctor and they said that, he indeed have shingles well nothing appeared until after the second shot and then he was covered and shingles overnight and the patient had been dealing with this since the first vaccine. Stated that, why was this not told to the public and especially the immune suppressed. Stated that, he had his spleen removed if he had knew all this. Stated that, he wouldn't have taken it and they all didn't do clinical trials on these types of people. The patient was very pissed off. Stated that, this wasn't the way they all should have ran things and he will be discussing this with his attorney. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the event included pain medicine and acyclovir. The outcome of the event was not recovered. Follow-up attempts completed. No further information is expected. Follow-Up 28Jul2021: Follow-up attempts are completed. No further information is expected.

received vaccine 12/21 and on 12/29 noted bilateral ear lobe swelling redness and facial flushing. on 12/30/2020 patient reports increased hive like rash on abdomen, trunk arms, and neck redness. Patient seen at her PCP and diagnosed with allergic reaction. Patient has taken benadryl and clariten and symptoms resolving.

I had a rash on the left forearm after I had the Covid-19 vaccine in the same arm 10 mins later. It was getting bigger up to about 0.8x0.8cm size with itching and red color. It lasted for 40min. After I was given two tablets of the anti-allergy medicine, the rash gradually became smaller and disappeared 30min later.

Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swollen lower lip, nauseated, weird sensation of not feeling right almost like out of body

Diaphoresis, petechiae, and tachycardia. onsent post vaccine, Benadryl 25 mg by mouth, 2nd round of sweating onsent: Benadryl 25 mg by mouth. Lower lip swelling, administered Epi-pen, called rapid response. Transferred to ED at 09:11am

Rash Rash on face and facial swelling Narrative: Developed a rash the day of the vaccine and then woke up with eye and facial swelling the following day. States he took Benadryl which helped the rash go away, but some of the swelling remains today. States it was difficult to open his eye lids first thing in the morning.

Patient had vertigo, dizziness, cold sewats, redness near side of neck repoerted agter 15 minutes of observation. HR was nor remarkable, went from 80's to 90's. After addiitonal 10 minutes rapid response was iniciated and patient was given water

Mild hives off and on on both arms and some times on torso, mostly in the mornings and self resolves in 2-3 hours without medicine. Also., partial lip edema twice noticed in the morning once on Dec31 and second time on January 4th. Both times lip edema resolved with in 4-5 hrs. on its own without any medication. Mild hives continue to show on arms and hand sporadically and self resolve with in few hours with any anti-histamine.

Rash/rash on his forearm that went to both forearms; elevated blood pressure/He already has high blood pressure and it was elevated after the vaccine; felt warm inside; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), via an unspecified route of administration in left arm, on 06Jan2021, at single dose, for COVID-19 immunization. Medical history included high blood pressure from Apr2020 and ongoing. Ongoing concomitant medication included lisinopril from Apr2020 for blood pressure/high blood pressure. The patient received the vaccine between 1:30-2:00pm yesterday afternoon (06Jan2021). He waited for 15 minutes after receiving the vaccine and he was ok. Later, on 06Jan2021, he developed a rash on his forearm that went to both forearms. He already has high blood pressure and it was elevated after the vaccine. During the night he felt like he was warm inside. He took a low dose Bayer Aspirin. The outcome of the event rash and hypertension was not recovered, and the outcome of the event feeling hot was recovered on 07Jan2021. Information on the lot/batch number has been requested.

headaches - starting Jan 6th and persisting but less intense joint pain - starting Jan 6th and persisting but less intense Rash on arms, legs, thorax - erythematous, raised, vesicular in places and mildly pruritic - Jan 10 and persisting

PRONOUNCED PAIN @ INJECTIONS SITE TRAVELING DOWN ARM. HEADACH AND BODY ACHES. NAUSEAS. TOOK ADVIL FOR PAIN, PEPTO AT NIGHT (1/12) AND MORNING (1/13)

Approximately 2 days after 2nd injection I started developing itchy hands with associated swelling as well. 4 days after injection I developed a rash to feet, legs, groin and parts of torso with associated swelling. No shortness of breath but do have some slight burning to hands and legs with mild pain.

Received second dose of Pfizer COVID vaccination on January 9, 2021. At the time of the vaccination he experienced discomfort of left deltoid (site of injection) as well as paresthesia at the injection site. He also experienced systemic symptoms of fatigue, myalgias, and arthralgias for 24 to 36 hours. Over the course of the next several days he experienced continued significant numbness and weakness in left upper extremity, specifically in left deltoid muscle. By Sunday 1/17/2021 the significant left deltoid weakness and numbness persisted, specifically not being able to lift his arm greater than 45 degrees using his deltoid. He contacted health on 1/17/2021. On 1/19/2021 he had a consultation with a physician. Based upon his clinical examination, and symptom complex, physician does not believe that this is a cervical spine issue but rather a local nerve injury related to the injection site. He was prescribed a steroid taper. Unclear whether this is temporary or permanent issue.

The arm muscle that received the shot became quite sore overnight, and lasted throughout the next day. The rest of me felt like I had a mild case of the flu. Aches and fatigue all over, with some chills. I have been training for a half marathon, and this through off my training due to knee pain. I also had diarrhea that has lasted through Saturday. The first day after was the worst, and things have improved each day since.

This is a spontaneous report from a contactable consumer. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1686), via an unspecified route of administration in the left arm on 14Jan2021 10:45 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with covid-19 prior vaccination. The patient was not tested for covid-19 post vaccination. The patient had no known allergies. On 14Jan2021 11:00, the patient's face starting itching and developed a rash. No treatment was received for the events. Outcome of the events was recovering.

15-36 hours after: headache, chills, injection site pain 9 days after: Hair follicle and or skin tenderness concentrated to the back left lower quadrant of head.

Low grade fever, chills, Red, hot, swollen rash at injection site that is spreading to half of upper arm

Rash to groin, legs, parts of torso; swelling to hands, feet and legs; This is a spontaneous report received from a contactable nurse (who is also the patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiry date: unknown), intramuscular in the right arm, on 14Jan2021 07:45, at single dose, for COVID-19 immunization, in the hospital. Medical history included hypertension. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination. Concomitant medication included losartan potassium (COZAAR). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the right arm, for COVID-19 immunization. On 16Jan2021 at 06:00, the patient experienced rash to groin, legs, parts of torso and also swelling to hands, feet and legs. No treatment was given for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was unknown.

hives; itching; itchy feeling tongue; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LEK5230), intramuscular at the right arm on 18Dec2020 08:00 at a single dose for COVID-19 immunization at a hospital. Medical history included allergies with latex, sulfa., and penicillin (PCN). Concomitant medications were unspecified. The patient previously took erythromycin (ERY) and experienced allergies. The patient experienced hives, itching and itchy feeling tongue on 18Dec2020 09:30. Patient took 50 mg of diphenhydramine (BENADRYL), 20 mg famotidine (PEPCID) and 10 mg of cetirizine (ZYRTEC). The patient has not been tested prior and post vaccination. The patient was recovering from the events.

achiness in his legs and hands; Chills; Fatigue; injection site swelling and achiness; injection site swelling and achiness; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A 45-years-old male patient received bnt162b2 (BNT162B2; Batch/lot number: EK4176), via an unspecified route of administration at left arm on 13Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient experienced fatigue on 17Jan2021 with outcome of not recovered, achiness in his legs and hands on 18Jan2021 with outcome of not recovered, chills on 18Jan2021 with outcome of not recovered, injection site swelling and achiness on 13Jan2021 with outcome of recovered on 14Jan2021. The patient reported after he got the first COVID vaccine on 13Jan2021 he experienced fatigue, achiness, and injection site swelling. Patient wanted to know if this is normal after the first dose and this was discussed. Patient explained that the fatigue - this didn't start until 17Jan2021 and was ongoing. On 18Jan2021 he starting having achiness in his legs and hands and he also had a few chills today. The injection site swelling and achiness there, was gone after the 14Jan2021. Patient was really looking for an answer to his question on if it was normal or should he get a COVID test. He was on day 5 after getting the vaccine and from what he read most people have side effects within a 24 hours and gone within 48 hours. Some of his side effect didn't start until 4 days later. The Vaccination Facility Type was hospital. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Patient did not go to Emergency Room or Physician Office. There was no Prior Vaccinations (within 4 weeks).

Almost 48 hours after 2nd vaccination; patient awoke with rash on trunk and extremities. Rash was slightly itchy but not painful. No medical treatment was sought and rash cleared in about 48 hours.

On evening of 1/31/21, patient experienced a red rash on his feet, groin, abdomen, axillary, and lower back. Rash was not itchy. Slightly warm to touch. Not painful. Patient took one dose of expired Benadryl on 1/31/21, which did not help. As of today (2/4/21), the rash is mostly resolved. Injection site pain started within a few hours post-vaccination.

large hive at injection site; scattered hives/smaller hives scattered; tightness in throat; thick feeling tongue; bubbled ulcer looking site on his lower left deltoid; left arm soreness; This is a spontaneous report from a contactable nurse (patient). A 45-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176), intramuscular on 08Jan2021 at a single dose on the left arm for COVID-19 immunization in the hospital. Medical history included allergies to penicillin (PCN), sulfa and latex. The patient did not have COVID-19 prior to vaccination. It was unknown if the patient had other vaccines in four weeks. The patient has other medications (unspecified) in two weeks. The patient previously took erythromycin (ERY) on an unspecified date and experienced allergies. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: LEK5230) on 18Dec2020 at 08:00 AM via intramuscular route of administration on the right arm at a single dose for COVID-19 immunization and experienced hives, itching and itchy feeling tongue wherein the patient took Benadryl, 20 mg Pepcid and 10 mg of Zyrtec. After the second vaccine the patient experienced scattered hives, with large hive at injection site and smaller hives scattered on an unspecified date in Jan2021. The patient also had tightness in throat and thick feeling tongue also on unspecified dates in Jan2021. The patient took 50 mg Benadryl, 20 mg Pepcid, 10 mg of Zyrtec and albuterol inhaler with spacer four puffs. The patient also has a bubbled ulcer looking site on his lower left deltoid with left arm soreness eight days later both on an unspecified date in Jan2021. The outcome of the events bubbled ulcer looking site on his lower left deltoid and left arm soreness was unknown while the outcome of the other events was recovering. The patient has not been tested for COVID-19 post vaccination.

Symptoms began 12 hrs after injection and lasted for 24 hrs from onset of symptoms. Sore deltoid/inection site, chills, body aches, fatigue, mild headache, max recorded oral temp = 99.6 degrees (personal norm 96-97 degrees oral). Out of work x1 day due to COVID-19 screening/symptom algorithm.

Local nerve injury/significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work; At the time of vaccination he experienced discomfort in left deltoid which was the injection site; Cannot lift his arm greater than 45 degrees; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; This is a spontaneous report from a contactable pharmacist. A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular n deltoid left on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. At the time of vaccination he experienced discomfort in left deltoid which was the injection site, cannot lift his arm greater than 45 degrees, local nerve injury, systemic fatigue ,myalgia and other arthralgia for 24-36 hours, developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work or task, all in Jan2021 with outcome of unknown. He called the employee health on 17Jan2021 and 19Jan2021 he saw a neurosurgeon. The neurosurgeon didn't think it was a cervical spine injury rather a local nerve injury related to the injection itself and he was prescribed a steroids taper, unclear whether if it was a temporary or permanent issue. Because this was like 10 days after the vaccine and he didn't really describe how much this issue affected his ability to perform usual work or task but he was a surgeon. The outcome of the events were unknown.; Sender's Comments: Based on the compatible time association, the peripheral nerve injury is possibly related to the injection technique, not vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

45-year-old male follow-up from the ER. He received a COVID-19 vaccine on 1/22/2021. This was his first dose. He began having bilateral lower extremity pain the following evening. In addition to the pain, he has been dealing with headaches, dizziness, auditory hallucinations, and large areas of redness and warmth on the left upper extremity and bilateral lower extremities. He went to the ER on 1/27/2021. Upon review of those records, he had microscopic hematuria. The patient states that he passed some kidney stones this week. Other abnormal labs include very elevated liver enzymes which the patient has not had before. He does not drink any alcohol. No new medications. He also had thrombocytopenia. O) Gen: Patient is in a wheelchair during today's exam. This is the first time he ever been in the exam room in a wheelchair. He required assistance to stand up. He says the pain is what makes it so difficult to stand up. Skin: On the left forearm, there is a large area of redness and swelling. The redness is relatively faint. On the lateral aspect of the right thigh, there is a large area of redness and swelling which is more prominent. ASSESSMENT 1. Severe myalgias 2. Elevated liver enzymes 3. Thrombocytopenia PLAN 1. Check sed rate and CRP. 2. Recheck CMP along with viral hepatitis panel and lipase. 3. Recheck CBC with differential. 4. Further recommendations based on these results. ADDENDUM Patient called on 2/1/2021 and reports his pain is getting worse to such an extent that he has been unable to make it to the bathroom fast enough and has been having accidents.

Soreness at injection site initially which progressed to mediate pain, like a knot in the arm that was painful. Also, around 4 hours after the injection, extreme fatigue set in and it felt like I was getting sick, like I normally do with a cold or flu. After 12 hours of sleep from the tiredness, I felt normal the next day, but site where shot was in the left arm was very sore and painful.

1. Moderate Pain Site of the Injection (started 12 hours after injection) lasted (4 days) 2. Painful Lymph-nodes : Location Right cervical , Right side supra clavicular and infra clavicular , lasted for 1 week 3. Light headed lasted 2 days 4.nauseas lasted 3 days 5 diarrhea mild lasted 2 days 6. Chills , lasted for 3 days 7 weakness , lasted 10+ days

Generalized myalgia during the night after vaccination Injection site muscle pain for 36 hrs Generalized pruritus and urticaria/raised red rash after scratching, starting 24 hrs after vaccination

Injection site soreness (mild) and mild muscle soreness during first 24 hours after 2nd dose of vaccination. At about 29-30 hours, noticed mild numb feeling along right jawline from middle of mouth to right ear, and around the right ear. By morning (about 48 hours post vaccination), numb feeling appears gone on right jawline, but seems to have moved to left jawline (still mild). No trouble breathing or eating at all. Consulted primary care doctor out of concern over odd sensation, but not treatments at this time. Considering taking a benadryl tablet just to see if it has any effect.

Headache; pain in left arm; This is a spontaneous report from a contactable consumer (patient himself). A 45-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 3247), via an unspecified route of administration in left arm on 27Jan2021 11:15 AM at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medications included PROBIOTIC and colecalciferol (VITAMIN D). The patient have not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 12:00 PM, the patient experienced headache and pain in left arm. The patient did not receive treatment for the adverse events. The events were considered as non-serious by the consumer. The outcome of the events was recovered on an unspecified date in 2021.

1. Diaphoretic 10 minutes after vaccine administration 2. Tongue swelling 3. Right arm cold and left arm hot 4. Throat tightening Was treated with Bendryl and EpiPen then sent to the ER

Hives and rash covering about 80% of body. Itching and burning sensation. Raised welts on torso, arms, legs, back. No reaction on face or genitals. Occurred when I woke up on Saturday morning with only hives on arms. It spread throughout the day to cover the entire body. On Sunday body was covered in more hives. Took benedryl and Claritin starting day 1 of symptoms but it didn?t help. Continued to take. On Sunday evening took Pepcid AC. Starting to resolve as of Monday morning (now).

Discomfort on left neck / collar bone area perceived a few days after injection and several bumps located on chest and collar bone area approximately 5-6 days after injection. Sought treatment with a general practitioner who has referred me to an oncologist for follow-up. That follow-up appointment is pending.

Mental fogginess, to the point a coworker had to drive him home. In the evening became achy all over severe arm pain at injection site, and temperature. Phoned PCP who told to go to the ER and he did not. went to PCP office 2/1/21.

Severe subacromial bursitis in L shoulder limiting arm movement x three months. Followed 1 week later by R middle finger MCP joint severe stiffness with inability to flex finger. Now after second dose I have torn medial gastrocnemius head. I am avid runner and weightlifter and none of these conditions existed prior to vaccine. I am currently on crutches unable to walk.

Weird rash on that arm on his forearm, on the top of the elbow and then he kind of started on the other arm and then on the legs a little bit, around his belly; His tongue looks like he has swollen taste buds or something; Itchy; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247) intramuscular on the right arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medications included supplements and vitamins. The patient got the COVID Vaccine on the 21st of January the Pfizer one and the following day he felt fine but he has this weird rash on that arm on his forearm, on the top of the elbow and then he kind of started on the other arm and then on the legs a little bit, around his belly and then his tongue looked like he has swollen taste buds or something, but he said he felt fine but the reporter don't if that's a side effect. "Should he be worried, should he go to a doctor?" Reporter stated, "Because we weren't sure what it was, he did take one Benadryl like the ones you find at the drug store and then that was it. And then I put Calamine lotion, so topically couple times just to prevent him from scratching but not regularly just when he feels really, really itchy." Outcome of the events was unknown.

Reported bruising and left upper arm pain which started on 3/3/2021 after receiving 2nd COVID-19 vaccine and persisted until 3/4/2021. Pain improved on 3/4/2021 but not resolved. Left upper arm/shoulder pain w/full ROM. Reported no side effects after 1st COVID-19 vaccine.

Sore left arm - 15 hours after dose administration Body Aches and Chills - 24 hours after administration

150-200 red bumps / hives on my body. Very itchy. Mainly my torso but now spread to my legs & arms. Some of these red bumps are getting larger & becoming more like pimples that I could squeeze/pop.

slight fever; sore joints; sore injection site; a slight sore throat; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular in the left arm on 10Feb2021 at 11:45 (at the age of 45-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 20Jan2021 and experienced headache. 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 11Feb2021 at 05:00 (after second dose), the patient experienced slight fever, sore joints, sore injection site and a slight sore throat. No treatment was provided for the events fever, sore joints, sore injection site and sore throat. The outcome of the events fever, sore joints, sore injection site and sore throat was recovering. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148082 same patient, different vaccine dose/AE

Two and one-half months after getting vaccinated, I developed shingles. [Have no idea if related to vaccine, but reporting just in case.]

Left injection soreness (3/12/21) Right knee pain where replacement is (3/14/21). Right hip pain where replacement is(3/14/21). Right scapular pain (3/14/21). Bilateral hand coldness (3/14/21. Taking Naproxen 220mg 1 tablet daily since 3/14/21.

Injection site pain (severe for 24 hours and mild for next three days), 24 hours of tiredness, chills, feeling unwell, slight fever, dizziness.

This was the first shot of the Covid vaccination, brand Pfizer. The nurse administered the shot in the wrong place entering my rotor cuff tendon of my left arm. The evening of February 19th, the same day as the shot, I could not lift my arm. The pain continued throughout the weekend. My doctor was called on 2/22/21 and the nurse stated that it was SIRVA (shoulder injury related to vaccination). She said to apply ice to the area and call in two weeks if it didn't feel better. Went to a chiropractor on 3-5-21 and he did range of motion and said it looks liked an injury however he would recommend a Physical Therapist to examine it further. He did light shoulder manipulation. 3-8-21, went to Physical Therapist and he confirmed through range of motion that the injury occurred to a tendon located in the rotor cuff area. He diagnosed it as tendonitis (possible tear) with possible bursitis. 3-10 and 3-11 PT appointments. 3-12-21 second COVID shot in the correct deltoid muscle. No issues. 3-16 PT appointment. 3-19 -21. From favoring my right arm, my lower back went into spasms. Dr. appt with Doctor over the phone consolation. Prescription administered. At this time, therapy will continue. Previous to the first 2-19-21 shot, I was in perfect health with an A+ doctor physical, worked out weekly, and took no medication. Since this time, I have been unable to continue to work out, it has effected my lifestyle, and caused continued financial expenses to manage. This is the 3rd event I have heard of throughout State of the same sort. The local PT doctor is treating someone for the same thing and a local teacher experienced the same thing at another site. The training is obviously not in place.

ABDOMINAL PAIN, MORE INTENSE IN THE LOWER LEFT SIDE. RASH ALL OVER THE BODY MORE INTENSE IN HANDS AND HEAD.

Burning Skin (face, feet) alternating with deep chills (but no fever); Extreme fatigue; Brain fog fatigue and brain fog still persistent 6 days after symptom onset (13 days post-vaccination). Burning skin significantly lessened after 5 days (still happens occasionally)

Right ear pain started on the Wednesday afternoon, two days after Vaccine shot. By Friday evening the ear pain was intense and it had moved below the ear to lymphnode area. Saturday, his ear was really swollen and red. He went to the Urgent Care and they prescribed an antibiotic Cephalexin thinking it could be some sort of ear infection or insect bite. Sunday morning he woke up with his face droopy. We tried to get an appt. with Urgent Care, but they sent us to the ER. The ER did a physical assessment and concluded he had an ear infection and Bells Palsy. The prescribed another antibiotic Doxycycline, an antiviral Famciclovir and a steroid of prednisone. By Monday he was extremely nauseas and had started having vertigo. We went to Urgent Care and they prescribed him Ondansetron for nausea and made the assessment that he had Shingles in his ear. We saw PCP on Wednesday and he assessed that this was a zoster ear infection causing facial paralysis and vertigo, also known as a rare condition called Ramsay Hunt Syndrome and that it was most likely attributed to his Covid vaccine shot and not to get the second vaccine shot. The Dr. took him off the antibiotics and put him on a higher dose of prednisone, a different antiviral (valacyclovir) and Meclizine for vertigo symptoms. He sent referrals for Neurology, ENT and Eye Dr. He saw the Neurologist that Friday and he concurred Ramsay Hunt Syndrome, most likley from Covid Vaccine and do not get the second vaccine shot. The neurologist referred him to Physical Therapy to treat his vestibular issues. He ordered an MRI and some blood work. We are still waiting for the results. We saw an ENT an he had him have a hearing test which showed moderate high frequency hearing loss. The ENT prescribed Gabapentin for the ear and face pain. He started to see a physical therapist this week, he had his MRI on Wednesday and we see the ENT again on Monday. He has no improvement yet, other than the nausea has subsided.

sore and achy all over; headache; sore arm at injection site; soreness and achiness progressed; This is a spontaneous report from a contactable consumer. A 45-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247) via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:45 at single dose for covid-19 immunization. The patient medical history was not reported. Historical vaccine included the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247) via an unspecified route of administration, administered in Arm Right on 21Jan2021 09:45 at single dose for covid-19 immunization. Concomitant medications included loratadine (ALAVERT) taken for an unspecified indication and melaleuca multivitamins/minerals. As per adverse event description, on 11Feb2021 18:00, sore and achy all over, headache, sore arm at injection site, but not right away, it took until the evening the same day as the 2nd injection. The soreness and achiness progressed a bit more from the evening into the morning, today. I felt nothing at all after the first injection. The patient did not received treatment. Upon follow up, it was confirmed that he mentioned that he noticed the onset on 11Feb2021 at around 6 pm, the start of it, but then felt the symptoms increase into the night and then more so the next morning on 12Feb2021. The outcome of events not recovered. No follow-up attempts are possible. No further information was provided.

soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 03Mar2021 at 11:40 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced soreness at the injection site and no other symptoms. The outcome of the event was unknown. Information on the batch and lot number has been requested.

Injection was inserted very high in the shoulder. I think the injection may have gone into the bursa. The injection was quite painful. Significant pain within 2 to 3 hours post injection. I could barely move the arm for about 5 days due to overwhelming pain. There were no visual symptoms from this injury. It began resolving after about 5 days and has mostly resolved but I still have some discomfort in the shoulder joint after more than 3 weeks.

Caller stated very minimal soreness approx 2 days after rcvding the vaccine, more of a discomfort around the injection site but otherwise felt okay. Caller stated on Friday morning on 3/26/2021 he felt fatigue, tired, and muscle ache in his arms and legs. He took Ibuprofen on Sunday evening 3/28/2021, felt better the next morning but still felt very fatigue. Caller also stated he tests positive for COVID-19 on 3/31/2021, and as of today his throat feels scratchy and itchy, and still feeling fatigue. 4/5-Patient symptoms have resolved, awaiting to take second vaccine in the upcoming week.

At 1335 in the observation unit, client stated he felt itchy and warm to the touch. Vital signs BP 116/58, Pulse 70, Respirations 20, SaO2 95%, Temp 96 F. No pain. No complaints of shortness of breath. Benadryl 25 mg PO given immediately. Client tolerated passing the medication and water without difficultly. At 1345 itching reduced according to patient. No other signs of rash, hives, present. Patient denies dizziness. Steady gait. Alert and Oriented. 1400 Vitals BO 120/90, Pulse 78, Respirations 16, SaO2, 95%, Temp 97.9. Patient stated that he wanted to leave the premises. Patient educated on S/S of a severe allergic reaction and too seek medical attention if reaction occurs. Patient left site without incident.

throat tightening, wheezing and itchiness, provide patient with o2 via nonrebreather and administered epipen

Dull pain at the injection site; second shot seemed fairly high on my shoulder/ pain at injection site and general shoulder area was severe; I could'nt move my arm at all due to pain; barely sleep due to shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL9266, Expiration Date: Not provided) via unspecified route on 16Feb2021 at 09:45 AM in the left arm as single dose for covid-19 immunisation. Patient's medical history included shoulder injury due to fall (5 years ago). Concomitant medications were none.The patient previously took Ibuprofen and Amoxicillin and experienced allergies, also historical vaccine includes on 26Jan2021 at 10:00 AM, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EN5318, Expiration Date: Not provided) via unspecified route in the left arm as single dose for covid-19 immunisation. The patient did not receive any other vaccines in four weeks. On 16Feb2021 at 15:00, the patient experienced pain at the injection site, "barely sleep due to shoulder pain", shoulder injury. Clinical course of the event as follows: On 16Feb2021, about 5 hours after the shot in the left arm, patient started feeling the typical dull pain at the injection site, about at 11pm (13 hours after injection) the pain at injection site and general shoulder area was severe. About 9 out of 10 he could barely sleep due to shoulder pain. Patient couldn't move his arm at all due to pain. The pain began receding about 24-36 hours later till 8 days after injection, he still had shoulder pain when he moves arm a certain way. It was reported that it felt like a shoulder injury for him. It was further stated that, the same shoulder was injured mildly about 5 years ago due to a fall but made a full recovery a couple months later. The patient informed that pain after first shot was only mild dull pain at injection site. Also, of note is that the injection site for second shot seemed high on shoulder as opposed to the side of the deltoid for the first shot. Events were not treated. Outcome of events was resolving.

Within 4hrs of receiving the 2nd dose of Pfizer COVID-19 vaccine I began to experience ringing in the ears followed by onset of extreme headaches and body aches somewhat dissimilar from the flu. These aches felt like painful internal construction of the head neck back and thigh muscles. Severe pain in the left arm where I received the jab. I was extremely fatigued and could barely make it from bed to the bathroom. I treated the condition with Tylenol 1g every 4hrs followed by 200mg of Motrin. I also ensured adequate fluid hydration and electrolytes 120+ oz per day. The symptoms continued for about 36hrs. I began to feel better but 48hrs later I relapsed with the onset of ringing ears then headache followed by extreme fatigue. I treated the 2nd round with continued bed rest over 3 days with Tylenol (1g) and Motrin (400mg). I eliminated Tylenol day 2. I reduced Motrin to half on Day 3. I felt better for 48hrs and again relapsed but only needed smaller 200mg doses of Motrin for a day along with bed rest. The ringing in the ears have been consistent since the onset of the symptoms 4hrs after receiving the 2nd shot. The ringing is greater when I?m active and late in the day. The ringing in the ears is less after min of 6hrs full sleep during the night. I have yet to be able to exercise since racing that 2nd dose. I?m slowly progressing in reducing the fatigue by consuming 30mL shots of ginger juice daily along with 500mcg of Vitamin B12 as directed by my Dr.

Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely nauseous, weak, excruciating headache and dizzy. Unable to stand, had to crawl to nearby chair and call for wife. Thought might be dehydrated, extremely pale, tried to drink water, but began vomiting. BP was elevated, but no temperature. Tried to eat crackers and drink more water, but continued to violently vomit. Never felt so badly in entire life. No strength to stand or get up the stairs to be taken to ER, so had to call paramedics. When they arrived, BP had come down, but they felt needed to be transported to ER, so they took to healthcare facility at about 1:30 pm.

Chilled and feverish, drowsy, all over body aches, dizziness, nausea in the morning, injection site pain. Symptoms did not require a dr appointment. Symptoms appeared morning after Vaccination and lasted only one day.

Symptoms started in left ear with itchiness around March 24 and by March 26 the itchiness had spread to his arms, legs, hands, and neck with a fine red rash and some areas with red lesions. Warm water made it worse. Worst areas on knuckles and near his elbows along with the back of his neck. Took Benadryl with no resolution. He saw his doctor on Monday, and received a steroid shot and prescriptions for prednisone and hydroxyzine. By April 2, he was almost done with his Medrol dose pack and felt much better. He felt pretty normal by his call to the health dept. On April 7.

Developed pain in elbow, that later became evident as shingles on 4/1/21. Treated with Valtrex, no issues. Caught early. My 3rd shingles event since 2014

I have been experiencing the subjective sensation internally of heat on the top of my ears and scalp. My ears also feel warm to the touch compared to my fingers. Sometimes it makes me feel like the room is hot when I know it is not. This has been happening on and off for 6 weeks since shortly after my first shot.

2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. headache. confusion. 48 hours after 2nd shot random blurred vision and Hives all over but more on the arm I received the shot. Random cough followed by extreme heartburn with a lot of saliva being produced and nasua.

Two days after receiving the second shot, I developed hives across my torso, legs, and arms and have experienced muscle stiffness. I am not prone to hives. Periodic lightheadness has also occurred.

Prior allergy to varicella vaccine; Swelling of the back of the throat, Nausea, Itching, BP 167/88 HR 78 RR 16; Administered Epi 0.3mg to Right Thigh and provided EMS transport to hospital

Blood clots developed in the 3 arteries in my lower right leg, cutting off all blood flow below my ankle. Extreme pain in my calf, my foot immediately lost its color and no pulses could be detected in my ankle or foot. Rushed to ER by ambulance. Vascular surgeon diagnosed it as simultaneous arterial thrombosis in the posterior tibial artery, anterior tibial artery, and fibular artery of the lower right leg. Admitted to the ICU, treatment was heparin drip for 3 days until all 3 clots cleared and all foot pulses were detectable.

Soreness at injection site disappearing after 4 days. Strong shooting pains in left quadriceps lasting 5 days with decreased frequency and intensity on subsequent days.

I had chicken for dinner at about 5:30 in the evening and within fifteen minutes, I start to itch all over and then I broke out into hives on my hands, neck, shoulders, back and sides. I thought at first that I was just having an allergic reaction to the vaccine so I took two benedryl and the hives went down the following day. I had chicken two days later and the same thing happened. I only realized that this was a chicken allergy on April 16th 2021. Each time the allergic reaction was more intense and lasted longer. I am now apprehensive about taking the second dose of the same vaccine as I am not sure whether or not this will intensify the adverse reaction and amplify the food allergy.

Extreme pain at the injection site and upper arm. The injection site has hard knot and is a little swollen.

Developed bumpy rash on LEFT (received injection in RIGHT arm due to being left handed) upper arm/shoulder with smaller rashes on forearm and inner elbow. Does not itch. Minor pain from clothing rubbing it. Taking Advil.

Noticed a quarter sized yellowish green spot on my abdomen and then on Tuesday 4/20/2021 I had a vision incident where I saw images of lines in the fire ground that lasted about 1 minute

Developed shingles under left arm, next to pit, and above left nipple. Approx 20 vesicles at each area, 40 in total. Developed intense, debilitating headache several days later (Apr 18th) which lessened the following day, but continues to the present day (Apr22)

2 days after my second shot I broke out in Hives and welts down my torso, Arms, and legs. I went to urgent care and they gave me a shot of prednisone and gave me a pack of the same steroid to take over the next 6 days they also prescribed some prescription Claritin and Famotidine.. The following day 4/16/21 around 1130pm I woke up to my face being swollen as well as my tongue. I was taken to the ER where the triage unit gave me epinephrine as well as another steroid to stabilize the swelling as I was having trouble breathing. Once stabilized I was released and took 50 mg of Benadryl every 6 hours as well as the Claritin, famotidine, and the prednisone. I had hives for a few days after and followed up with my primary doctor, but as of today I feel like i am back to normal.

Super itchy and inflamed groin, buttcrack and armpits Thursday 5 hours after the vaccine, also a vaccine welt at the site on injection. Saturday afternoon noticed hives on palms of hands spreading up the arms.

No symptoms on day of vaccination. Day 1 following vaccination, tired. Day 2 following vaccination, diffuse rash on face, neck and chest. Day 3 following vaccination, rash worsening and spreading to arms; also cold feet, especially toes. Day 3, met with telehealth physician who prescribed prednisone 40 mg once daily for 5 days and diphenhydramine 50 mg TID.

Hives all over body they were larger and worse on the side of my body where I received vaccine. Received vaccine at 10:20 and hives started at 11:00 . Immediately took 2 Benadryl tablets with some relief repeated every 6 hours. Today 4/27/21 I stopped taking the Benadryl and around 6pm I broke out in hives and extreme itching again.

Dull pain in injection shoulder two weeks after injection. Major discomfort. Unable to sleep comfortably. Advil doesn?t help. Ice has helped some.

After being seated for monitoring period after 2nd dose, patient was witness to loose consciousness. When nurse arrived to assist patient, patient took a deep, snoring breath and regained consciousness. After being placed on monitor, patient noted to be bradycardic with HR as low as 36. Pulse palpable. O2 sats remained stable. BP noted to be 80 palp. Blood glucose level noted to be 91. Patient coloring noted to be very dusky originally and patient noted to be clammy. Patient oriented when regaining consciousness. O2 applied via nasal canula and HR returned to low 70's. Patient given Gatorade and monitored by EMS. Patient declined transport to hospital and left ambulatory without any lasting symptoms.

3 days after second dose: Itchy hives on legs and torso, and arms to a lesser extent. Persisted for 2.5 days. After hives subsided, achy and mild chills. Some post-Guillain-Barre residual sensations in legs recurred as well and still continuing, 9 days after the second dose.

Rash and itch in several parts of the body (including hands, chest, arms, groin and legs). Rash is not severe but started occurring regularly after the second shot.

a raging rash / rash started on his right arm/ rash did spread to his other arm/ rash is super itchy; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 01Apr2021 (Lot Number: ER8737) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first Pfizer COVID vaccine on 01Apr2021 and experienced a raging rash 24 hours later (02Apr2021), still had the rash, he was due for second dose on 23Apr2021. He's had this rash 13 plus days. The rash started on his right arm, not the arm where he received the Covid 19 vaccine. The rash was super itchy, super annoying. The rash did spread to his other arm. He did see his doctor as soon as he could. His doctor told him maybe the rash was related to the Covid 19 vaccine, maybe it's herpes zoster, maybe it's contact dermatitis, it's probably not the Covid 19 vaccine. His primary care doctor prescribed him a topical steroid, Clobetasol and Benadryl for itching. He then saw a dermatologist. The dermatologist took a closer look and decided to prescribe an oral steroid, Prednisone, he's on his second day of taking the Prednisone. The dermatologist told him to get the second Covid 19 vaccine even if his rash isn't resolved by then but the first doctor her saw said he might need to worry about anaphylaxis. That's scary. He wanted to get the second Covid 19 vaccine. He stated maybe his body started making all these T-cells the next thing he knew he had this rash. He stated his PCP and dermatologist advised him to call Pfizer regarding the treatment of his rash, he wanted Pfizer to recommend what to do to get rid of the rash. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

18 hours after the shot, I experienced a rash with itching and clear visible sign of redness and liquid (1 inch wide and 3 inch long). This was at the area between my right leg and stomach (groin). I took a Benadryl and the rash went down after a few hours.

After my first vaccination shot I started getting small, itchy red bumps on top of both of my hands. The bumps subsided a bit between the two shots, but after the second shot, the bumps came back, more severe. I used cortisone, bacitracin, took Claritin and Benadryl. My doctor recommended oatmeal bath. It has been one week since my second shot and the bumps are starting to go away.

Started with break out on scalp, Then lymph Nodes swollen in neck area. then turned into hives break out over entire body.

Was diagnosed today with shingles- rash on chest, back and under arm on one side. Stabbing pains and tingling. Have had chicken pox but this is first time with shingles

Chronic hives that moves around whole body, neck, shoulders, arms, legs, stomach, back, hands, and feet. Itches, red swelling and little raised bumps. Comes and goes. Been a month and hasn't gone away yet.

I didn't have a rash around the injection site (COVID arm), but I'm having skin breakouts/itching on other parts of my body. I initially used OTC hydrocortisone cream, however, my Dr later prescribed triamcinolone acetonide 0.5 % Cream

At approximately 7:30p.m.; pain at injection site 10 minutes later at 7:40p.m. ; severe headache and fatigue At approximately 8:00p.m.; severe fever and chills At 8:30p.m.; dizziness

Upon injection, felt immediate soreness at injection site (left arm, near shoulder). Had also felt soreness after first shot in series, which went away. Ten weeks after the second shot, I still feel considerable soreness at the injection site, which sometimes increases from general soreness to mild pain. A specific example is a general difficulty sleeping on my left side, which will wake me with pain and often cause mild pain for the remainder of the day.

I developed shingles. First sign May 1, first rash May 2, diagnosed May 6; This is a spontaneous report received from a contactable consumer. A 45-year-old male consumer (patient) reported that received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EW0151), into the left arm on 06Apr2021 09:15 (at the age of 45-years-old) at single dose for COVID-19 immunization. The patient had received first dose of vaccine on 9Mar2021 09:15 AM (lot Number: EN6206) in Arm Left. Medical history was none. The patient's concomitant medications were none. The consumer reported that developed shingles. First sign on 01May2021, first rash on 02May2021, and was diagnosed on 06May2021. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment with 'medicine'. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

Started with flu like symptoms, after 3 days my left arm would swell slightly, become red/warm, and itchy at injection site. At 1 week I began feeling extremely worn down, exhausted, short of breath after moving at all, coupled with a slight fever and continuous nausea.

Rash, itching, swelling, pain Diagnosed with Herpes Zoster - Shingles on 05/29/21 at same medical facility Treated with Rx medicine Valacyclovir

Bowel discomfort and stuffed right ear, partial hearing loss, vertigo, nausea, shingle like rash on right side of the body. Treated with antibiotic and beclomethasone , seems to help with vertigo. vertigo came back one week later after finishing the antibiotics round. now on 30 days round of doxycycline, no vertigo , very little dizziness and nausea. 2 weeks back started a high dose of vitamin C that it seems to help with the dizziness and nausea. Right ear still stuffed and feeling weakness from time to time.

I get my first dose of COVID Pfizer vaccine on May 11, 2021, then 5 days later on May 16, about 20 small blisters (herpes) appeared on each inner side of both my arms, which have not gone away so far. Today, I went to the pharmacy to get a second dose of vaccine. After telling the pharmacy staff about my side effects, they asked me to report the side effects to you and wait for the results before getting the second dose.

Following 2nd dose COVID vaccine, the patient complained of itching in torso and arms, diaphoresis also noted. The nurse monitored the patient and administered 50 mg of Benedryl by mouth at 10:34 am. Symptoms resolved around 10:45 am.

On first night, broke out in hives. Now on day 11 of fevers. Fevers have gotten as high as 103.7, but usually around 102

I woke up with petechiae on 5/10. By 5/11 the petechiae developed into thrombocytopenia purpura with a platelet count fo 1000, including mouth lesions and prolonged mucosal bleeding. Admitted Hospital for treatment on 5/11. Treatment included a high dose of oral dexomethasone for four days, IVIG transfusion for two days, and a single platelet transfusion. Fluid developed in the lungs, but that was determined to be a byproduct of treatment, and not part of the adverse reaction. By the time of discharge on 5/14, platelet count had risen to 88000. One week later at outpatient, platelet count had risen to 180000.

muscle pain; joint pain; headache; fever; injection site swelling; nausea; diarrhea; vomiting; arm pain; This is a spontaneous report from a contactable consumer reported for himself. A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19May2021 (at age of 45 years old) 09:00AM (Lot Number: EW0179) as 1st dose, single for covid-19 immunisation. Medical history included covid-19, No known allergies. The patient's concomitant medications received within 2 weeks of vaccination were none. The patient experienced muscle pain, joint pain, headache, fever, injection site swelling, nausea, diarrhea, vomiting and arm pain, all on 19May2021 11:00 PM, no treatment received for events, and patient was not recovered from events. Adverse events result in Congenital anomaly or birth defect and Seriousness criteria reported as Congenital anomaly/birth defect (pending clarification). Prior to vaccination, the patient was diagnosed with COVID-19, 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.

Patient presented at facility for second dose of Pfizer. Patient received his first dose of Pfizer on 4/27/2021 at location in another area. Patient developed a diffuse itchy rash over arms and legs one week after initial vaccine. Patient reports never had similar rash in the past. Continues to have severe itching and irritation now for past four weeks later. Dr recommended patient wait until rash has completely resolved. Patient can return for second Pfizer dose and will be monitored for one hour after. Patient was referred to PCP for referral to allergist. Patient understood and is in agreement.

initially got a rash around the injection site; whole body rash/ I have developed rashes over my entire body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:00 (Batch/Lot Number: EP7534) as 1ST DOSE, SINGLE DOSE and dose 2 via an unspecified route of administration, administered in arm left on 20Apr2021 12:00 (Batch/Lot Number: EW0162), at 2nd dose, single dose for covid-19 immunisation. Medical history included on an unspecified date Panhypopituitarism, secondary hypogonadism, low thyroid, and adult growth hormone deficiency, ventriculo-peritoneal shunt, migraines, seizures, super-cellar arachnoid cyst, lack of energy and exercise capacity, no libido, nonfunctioning pituitary gland, brain surgeries (6 brain surgeries to treat hydrocephalus secondary to a super-cellar arachnoid cyst), VP shunt (Ventriculo-peritoneal shunt), on an unspecified date in 1993 hydrocephalus secondary, on an unspecified date in 1998 low testosterone level. Concomitant medications included botulinum toxin type a (BOTOX) taken for migraine; galcanezumab (EMGALITY [GALCANEZUMAB]) taken for migraine; lamotrigine (LAMICTAL) taken for seizure; levetiracetam (KEPPRA) taken for seizure. The patient previously took, humatrope for adult growth hormone deficiency, synthroid for low thyroid level, allopurinol (ELAVIL) and experienced drug hypersensitivity, metformin and experienced drug hypersensitivity, Cytomel 5 mcg. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date in 2021 the patient had whole body rash. On 22Apr2021 12:00 he initially got a rash around the injection site, which he heard was to be expected (COVID Arm). However, he has developed rashes over my entire body. These rashes developed gradually. First, it was the rash around the injection site, but that went away. Then, a rash developed further down the arm that he received the vaccine in (Left Arm), including on my hand. he has since developed rashes on my abdomen, right arm, thighs, legs and feet. he also has a breakout on my back. he submitted a report on the side effects (whole body rash) that he experiencing as a result of getting both shots of the Pfizer COVID-19 vaccine. he has whole body rashes that have developed since he got the second dose of the Pfizer COVID-19 vaccine. He first COVID-19 vaccine shot (Pfizer) was on 29Mar2021. He second dose of the Pfizer COVID-19 vaccine was administered on 20Apr2021. Adverse event resulted in emergency room visit and physician office visit. Patient received treatment for the events. Physician prescribed Triamcinolone Acetonide Cream USP, 0.5% with a total quantity of 45 grams. Three 15 gram tubes to treat the rashes. This treatment hasn't worked and, in fact, the rashes have spread. Because of this, patient PCP referred patient to a dermatologist, but that appointment isn't until next month. Furthermore, How do patient get compensated for the money patient was out of pocket to treat patient whole body rash. Furthermore, patient also need to know how patient would be compensated for the money patient have paid out of pocket and would pay out of pocket in the future due to the rashes patient have developed. Keep in mind, this isn't just the rash that developed around the injection site, but also rashes that have developed elsewhere on patient body after getting the second dose of the Pfizer COVID vaccine. Also, patient have pre-existing health conditions. These include having had 6 brain surgeries to treat hydrocephalus secondary to a super-cellar arachnoid cyst. As a result of my surgeries, patient now have a non functioning pituitary gland. In 1998 patient was initially diagnosed with a low testosterone level by pediatric Neurosurgeon. Patient was 21 at that time, however, patient had been a patient at Children's since the age of 16 or 17. Patient was referred to for the hydrocephalus in 1993. Anyway, after the diagnosis of the low testosterone level in 1998, patient was referred to the physician. That is where patient saw Endocrinologist. On patient initial visit with physician, he prescribed the testosterone replacement. He then went on to talk about patient other symptoms, which included lack of energy and exercise capacity, no libido, among other symptoms. recommended patient be tested for Adult Growth Hormone Deficiency (AGHD). Patient was enrolled in the HyPOCCS study, which covered the cost of the testing, as well as the treatment of the eventual diagnosis of AGHD. Patient was started on Humatrope later in 1998. Of course, Patient was also taking my testosterone replacement as well. Later on, when patient switched to another Endocrinologist closer to where patient live, he diagnosed patient with a low thyroid level. Patient was started on Synthroid, however, there was low T4 to T3 conversion. As a result, patient was also put on 5 mcg of Cytomel. Of course, this Endocrinologist was also treating my other hormone deficiencies as well. The seriousness of the events was reported as non-serious. Outcome of the events was not resolved. Information on Lot/Batch number was available. Additional information has been requested.

Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: numbness on left side from neck to toes. did not go away for days

Sevrve Rash under right knee started approximately 5 hours after shot. Applied deximethasone ointment to affected area it helped

I have had hives ever since first shot in April and they have not stopped. Flares ups have slowed down, but are very much persistent. Hives cover hands, arms, back, buttocks, chest and feet. I had swollen lymph nodes near base of neck and shoulder blade.

extremely congested; right wrist and forearm swollen; red and swollen; allergic reaction to the vaccine/histamine reaction; left side of his face swollen and puffy in lips, chin and cheek; left side of his face swollen and puffy in lips, chin and cheek; left hand swollen and itchy/forearm swollen; left hand swollen and itchy; allergic reaction to the vaccine/histamine reaction; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 23May2021 12:50 (at age of 45 year old, reported as "was Given: 12:50pm, right before 1:00pm", Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient not had medical history and family medical history. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 02May2021 12:50 (at age 45 years old, reported as "was Given: 12:50pm, right before 1:00pm", Batch/Lot number was not reported) as single dose for covid-19 immunization. Patient had the second dose of the Pfizer COVID-19 vaccine last Sunday (23May2021). Since then, he thinks he had an allergic reaction to the vaccine. On 26May2021 (Wednesday late morning, early afternoon), he woke up and the left side of his face was all swollen and puffy in the lips, chin and cheek. It started out in the lower cheek and then kind of spread through out the day. It eventually went down to the lower lip on the left side and moved up to the upper lip on the left side. His face was still swollen but to a much less degree. He took Benadryl and it kind of went away and was getting better. His left hand was all swollen and itchy now. It started after but was simultaneous with the face swelling. On 27May2021, he woke up this morning and his right wrist and forearm was swollen. Not really a rash but was red and swollen, and looks like a histamine reaction. Right wrist and forearm swollen was reported as worsened. He had been extremely congested the past 2 days. Was extremely congested with 99 percent blockage. He took Afrin which knocked it out. It was better but he was still very congested. No physician office visited. He was at Urgent Care right now. The outcome of the events "left side of his face swollen and puffy in lips, chin and cheek; extremely congested" was recovering. The outcome of other events was unknown. Information on lot/batch number has been requested.