Pfizer

Starting 2-3 days after the day I got the Pfizer vaccine, I had itchiness on my upper chest as well as my neck and upper back. On December, 26th, I looked in a mirror and realized I had red dots on my upper chest, upper back, and neck. Over the next two days (the 27th and 28th) the red dots extended to my stomach, lower back, and shoulders. Up until today, the dots have extended to my upper arms, forearms, hands, and legs. I went to employee health to speak to two nurses who agreed I should report this as a potential allergy to Pfizer's vaccine. I am nervous about taking the second dose but am planning on doing so. I have taken Benadryl and applied hydrocortisone cream on the affected areas. I have a medrol dose pack prescription that I will fill if my symptoms get worse. I do not have trouble breathing, but I am constantly itchy each day.

8 days after vaccination, i began to have hives over most of my body, starting 8:00am on 1/2/2021. On 1/3/2021, i went to a walk in and was prescribed prednisone which seemed to make it go away pretty quickly.

Lips swelled and went numb. Hands swelled and went numb. Rash/redness covering upper body. Hives on arms. Nasal passages clogged

Fever; chills; headache; fatigue; injection site pain; This is a spontaneous report from a contactable physician (patient). A 26-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not available), intramuscularly on 23Dec2020 at 12:15 PM on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included asthma and previously COVID+, prior to vaccination, patient was diagnosed with COVID-19. No known allergy, no allergies to medications, food, or other products. Concomitant medications included salbutamol (ALBUTEROL), montelukast and loratadine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, headache, fatigue, injection site pain; lasted approximately 24 hours on 24Dec2020 at 12:00 AM. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included Ibuprofen. The outcome of the events was recovered in Dec2020. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.

2 days after receiving vaccine patient developed hives and itching. Treated with OTC diphenhydramine.

Injection site muscle soreness/pain; This is a spontaneous report from a contactable pharmacist (patient himself). This 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142), via an unknown route, on 05Jan2021 at 17:30 at single dose for COVID-19 immunisation. Age at vaccination was 26-year-old. Vaccine location was left arm. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 06Jan2021 at 08:00, the patient developed injection site muscle soreness/pain. The patient was not treated for the event. The patient was recovering from the event. No follow-up attempts are possible. No further information is expected.

Fever-like symptoms for 24 hours - beginning 24 hours after vaccination. Temperature 99.3 24 hours after vaccination, body aches, fatigue. Soreness at vaccination route for 72 hours.

Fever; Injection site pain; tiredness; chills; feeling unwell; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899), via Intramuscular on 06Jan2021 08:00 at single dose in the left arm for COVID-19 immunisation. Medical history included Asthma. Concomitant medications were not reported. On 06Jan2021, the patient experienced fever, injection site pain, tiredness, chills, feeling unwell. The patient did not receive any treatment. Outcome of events was recovered on Jan2021. No follow up attempts are possible. No further information is expected.

Pt. states he received vaccine at 1450 and started feeling symptoms at 1505. States itchy sensation, no hives on back, neck, left arm, left leg, down to foot. No rash/hives. At apprx. 1515 144/73, afebrile, 76, 99% on room air. At 1525 bp 134/80, HR 70, 98% room air. Presents only 1 raised red area behind right ear. Employee Health RN assessed skin and no rash, irritation, hives, or redness present. Pt. was ok to return to work after receiving 125 mg of oral diphenhydramine.

Slight chills and some body aches, mild headache, all starting at night. Sore arm at injection site reaction. Vaccine was administered around 10am. Went to sleep and woke up with more severe headache, took Naprosyn, headache resolved. Chills and body aches were gone after sleeping. Some fatigue also present after waking up.

Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; This is a spontaneous report from a contactable other health professional (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) at the age of 26 years old, via intramuscular route in the left arm, on 10Jan2021 at 13:00, at a single dose, for COVID-19 immunization. Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient has no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 12Jan2021, at 07:30 A.M., the patient experienced allergic reaction resulting in full body hives, swollen hands, eyelids and lips. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination. Information on the lot/batch number has been requested.

Sore arm at injection site; cold sore; Sore throat; This is a spontaneous report from a non-contactable Pharmacist(patient). The 26-year-old male patient received first dose BNT162B2(Covid 19, lot EK5730), via an unspecified route of administration at left arm on 28Dec2020 17:15 at single dose for COVID-19 immunization in hospital. Medical history included last cold sore was over 2 years ago. There was no other vaccine in four weeks. There was no known allergies, no other medical history. There were no concomitant medications. The patient experienced sore throat occurred 2 days after vaccination(30Dec2020), sore arm at injection site, cold sore appearance 8 days after vaccination, both on 05Jan2021. There was no treatment. There was no covid prior vaccination, covid tested post vaccination was Nasal Swab with PCR on 08Jan2021 with negative result. Outcome of events was recovered in Jan2021 . No follow-up attempts are possible. No further information is expected.

Patient experienced flu like symptoms the morning after receiving his vaccine (1/29). Symptoms improved by 1/31). On 2/1, patient woke up with a rash all over his body that was pruritic. Patient took Benadryl which helped improve his symptoms. Today (2/2), patient woke up with angioedema. He took another Benadryl--symptoms improved. Denies SOB, tongue swelling, itchy throat, or wheezing. Swelling is localized to lips only.

Bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes - Onset: 12 hours post-vaccination Duration: >40 hours; Bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes - Onset: 12 hours post-vaccination Duration: >40 hours; Fever - Onset: 6 hours post-vaccination Duration: >40 hours; Generalized muscle soreness - Onset: 6 hours post-vaccination Duration - 30 hours; Headache - Onset: 6 hours post-vaccination Duration: >40 hours; Tiredness - Onset: 4 hours post-vaccination Duration: >40 hours; Injection site soreness - Onset: 2 hours post-vaccination; Start Date/Time:17Jan2021 03:00 PM; Start Date/Time: 31Dec2020 01:00 PM; This is a spontaneous report from a non-contactable healthcare professional (patient). A 26-year-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 on left arm on 17Jan2021 15:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. The patient previously took first dose of BNT162B2 (lot number: EL0142) on 31Dec2020 13:00 on left arm for COVID-19 immunization. On 17Jan2021, 2 hours post-vaccination (17:00) patient had injection site soreness; 4 hours post vaccination patient had tiredness for more than 40 hours; and 6 hours post vaccination (21:00) patient had fever for more than more than 40 hours, generalized muscle soreness for 30 hours, and headache for 40 hours. On 18Jan2021, 12 hours post vaccination (03:00), patient had bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes for more than 40 hours. There was no treatment for the events. Patient was not COVID tested post vaccination. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Fever; Chills; Headache; Muscle aches; Injection site burning and soreness for 36 hours; This is a spontaneous report from a contactable healthcare professional (the patient). A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL9262), intramuscular in the left arm on 20Jan2021 10:30 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, and the patient was diagnosed with COVID-19 prior to vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not have any concomitant medications. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced fever, chills, headache, muscle aches, injection site burning and soreness for 36 hours (as reported). The patient did not receive treatment for these events. The clinical outcome of fever, chills, headache, muscle aches, injection site burning and soreness was recovering (as reported). 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

Having fatigue, chills, alopecia, arthralgias, N/V, diarrhea, intermittent rhinorrhea and nasal congestion, lower back pain, neck pain for the last 2 weeks

fatigue; arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247, expiry date was unknown), via an unspecified route of administration on right arm on 03Feb2021 11:30 AM at single dose for COVID-19 immunization, at workplace clinic. The patient's medical history and 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. Since the vaccination, the patient has not been tested for COVID-19. On 03Feb2021, 18:00, the patient experienced fatigue, arm soreness. Patient was not given treatment for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering. No follow-up attempts are possible. No further information is expected.

Rash (red spots, not raised, not itchy) all over abdomen, stomach, a bit on arms, and some on thighs. This rash appeared within a week or so of getting the first dose of the Pfizer COVID vaccine. Over the next few weeks the rash slowly faded (not completely, though). When I woke up the morning after receiving the second dose of the vaccine, the rash doubled in coverage in the same areas of my body. Around the time the rash showed up, I also began experiencing lower to mid-back pain, which grew more severe over time. The back pain is worst in the morning after sleeping, or after sitting/resting for longer periods of time. I've been taking Ibuprofen and Aleve, which helps, as does being active. The back pain did not noticeably worsen after the second dose, but it is just as severe. Currently, the rash has faded (not completely), and my back pain is still quite bothersome.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient fainted, unfortunately did fall, however despite some bruises was ok. Waited for family to come to get him and was able to leave under his own power. Ambulance was called and he was checked, no issues found and did not leave with ambulance.

Two days after second shot Patient experienced: tingling/numbness in both hands; A rash to his face,chin and to both arms; Itching with bumps, swollen fingers and toes; Rash and swelling moves around body with elevated joint/bone pain; fevers on/off. 2/13/21- Went to Urgent Care, given Keflex with no change.2/15/21- Urgent Care second visit, Keflex stopped.2/17/21- Clinic, Benadryl & Tylenol PRN and labs done with no change in rash, Covid test negative. 2/18/21- Dermatology Appointment- Doxycycline 100mg BID, Hydroxyzine PRN, Zyrtec OT, Punchbx left ankle. 3/11/21 - No diagnosis made in Hospital or from follow-up visit with Dermatologist. Continue to have occasional area of transient redness and some numbness and tingling in hands.

Symptoms showed up as swollen lymph nodes on left side of neck and head (around ear) with swollen bumps running up the back of the scalp. These large bumps eventually split into a painful rash and scabbed over.

Significant soreness at injection site; Headache; tiredness; feeling as if in a bubble day of vaccine; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the right arm on 21Feb2021 at 13:45 (at the age of 26-years-old) as a single dose, for COVID-19 immunization. Medical history included asthma, weakened immune system, and allergy to loratadine (CLARITIN). Prior to vaccination the patient was not 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. Concomitant medications included salbutamol (ALBUTEROL) as needed and fluticasone propionate/ salmeterol xinafoate (ADVAIR 500/50). On 21Feb2021 at 14:15, the patient experienced headache, tiredness and was feeling as if in a bubble the day of vaccine. The next day, on 22Feb2021, the patient experienced significant soreness at injection site. The patient was not treated for headache, tiredness, feeling as if in a bubble the day of vaccine, and significant soreness at injection site. The clinical outcome of headache, tiredness, feeling as if in a bubble the day of vaccine, and significant soreness at injection site was recovering.

?Covid arm? Red bumps appeared around spot where vaccine was injected approx 48 hours after dose 1. Itchy. Also had tough time sleeping which is rare for me. Maybe related.

About 24 hours after the first dose, I began developing rashes on various points of my body. Right leg ankle, right forearm, and chest area. It is not painful, just very itchy.

Approximately one day after receiving the vaccine, I started to develop small red, itchy bumps, similar to bug bites, on my left forearm. It has now been almost one week since my vaccine and I now have over 20 bumps 2-5cm in diameter from my wrist to my elbow on the arm that got the shot.

Patient had a few pinpoint papillae red in color, on arms. Vital signs stable. The doctor on site gave 10 mg of Zyrtec. No wheezing, no dyspnea. Has a history of hives and throat closing up but does not have his own epi pen.

Mild pain at injection site & mild fatigue occurred within the 15 minute monitoring period following administration of dose (second dose)

Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Additional Details: Patient experience Syncope

Patient was sitting for his 15 minutes. At about 5 minutes after his vaccine he passed out and fell off his chair to the floor. The Pharmacy intern noticed that the color of his skin was like a purple and he was passed out. When she started to approach him he started slowly moving his head and adjusting his eyes. He said he felt really dizzy and we had him lay down. He was very sweaty and was shaking a little bit. I took his blood pressure at 11:53 and it was approximately 124/93. He was responsive but feeling dizzy and warm and I stayed with him until the paramedics arrived at about 11:54

Thrombocytopenia with Platelet count of 2 with development of petechial rash and spontaneous bleeding from gums noted 3 days after immunization. Patient was evaluated in the Emergency Room and admitted to the hospital requiring IVIG infusion and IV steroids with slow up-trend in platelet count over 4 days of hospitalization prior to discharge with Platelet count of 49.

NEAR SYNCOPE, DIZZY, ABNORMAL FEELING IN THROAT Primary/secondary assessment / observation Vital signs stable, lung sounds clear through out, warm dry skin w/ regular bi lateral radial pulses Patient denied any CX pain, SOB, dyspnea, headaches, visual disturbances, N/V while in observation, patient informed provider he began to feel better & was able to leave. Patients vital signs presented with out any abnormal findings Patient was advised to seek emergency medical treatment if any adverse reactions presented

Patient experienced local site reaction. After administering vaccine, the area immediately began to swell and cause hard bump/knot at the site of injection. I gave the patient Benadryl and monitored for 30 minutes. The reaction became less severe (swelling went down and knot soften).

Long term muscle fatigue/pain. Primarily noticed when doing chest exercises in the gym (I.e. barbell flat bench). Largely only a problem during flat bench, no issues with incline dumbbell press. Pain/soreness is isolated to the medial deltoid where the injection occurred, and only in the left arm where the injection occurred. Only began after dose 2. Noticed the week following the dose, pain persists. No treatment action taken.

Pt called , experiencing symptoms after 2nd dose Pfizer vaccine on Saturday 4/24/21. Rec'd 2nd dose outside of facility sites at a school site . Pt stated experienced minor body aches and headache. Took Tylenol Saturday and symptoms were relieved. Today 4/27 pt began experiencing itchiness on chest, back and arms. Pt works at a vaccination site and was advised by pharmacist he should call for an MD appt for an rx stronger than benadryl. Pt denied experiencing emergency symptoms at time of call. Pt stated only symptoms are itchiness. No swelling or itchiness of face, lip, or throat, and denied difficulty breathing. Advised to go to nearest ED or call 911 if symptoms worsen or trouble breathing or any signs of severe allergic reaction. Pt verbalized understanding. Scheduled telephone provider visit 4/28 confirmed phone number on file. Pt aware of appt.

A few days after my vaccine i was sitting in a chair and touched my calf and noticed that it was numb. It wasnt pins and needles as if it had fallen asleep. It just had significantly decreased sensitivity. I stood up and walked around to try to fix this but the symptoms persisted for at least 36 hours before subsiding to a much lesser but still present degree of numbness. I went to my doctor and they told me that it was not an emergency aince there was no pain and it caused no weakness. This is localized to the skin on my outer left calf. He said this can be caused by crossing your legs too much but i dont ever do that. 3 weeks later and i still have muted sensations in my left calf. It mostly goes unnoticed until i go to scrub my leg in the shower or something and notice that the scrubber feels significantly different on each leg. The left side feels like "static".

Slight chest tightness and very slight difficulty breathing as if he was experiencing allergies; Slight chest tightness and very slight difficulty breathing as if he was experiencing allergies; Slight chest tightness and very slight difficulty breathing as if he was experiencing allergies; fatigue; muscle soreness; injection site soreness; mild nausea; slight nasal congestion; headache; This is a spontaneous report received from a contactable consumer (patient). This 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 01:15 PM in left arm at single dose (lot number=EN6204) for COVID-19 immunization. Medical history included Attention Deficit Hyperactivity Disorder, Obesity, Temporomandibular Joint Dysfunction, Ocular Migraines. No allergies to medications, food, or other products. Concomitant medications included cannabis sativa. The patient previously received first dose of BNT162B2 (Lot number=ER8730) on 22Mar2021 01:00 PM in left arm for COVID-19 immunization. On 13Apr2021 07:00, the patient experienced fatigue, muscle soreness, injection site soreness, mild nausea, slight nasal congestion, headache. Slight chest tightness and very slight difficulty breathing as if he was experiencing allergies which started 14Apr2021 at around 07:30 am while he was setting up for work and had come and gone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No treatment received for the adverse events. The outcome of events was recovering. No follow-up attempts needed. No further information expected.

Shakes Fever Fatigue Flu-like Symptoms Muscle Aches Mental Fog Soreness at Injection Site All Symptoms Lasted about 8 Hours

Initial event was hives that didn't itch appearing on elbows, they continued to spread for about a day. The doctor said to start Zyrtec, pepcid and ibuprofen. Hours later vomiting, diarrhea, and a blackout followed along with a fever of 102. This time ER gave IV fluids, acetaminophen, ketorolac, ondansetron, and sodium chloride .9%. At this time no mention or notice was made of the hives previously looked at. After this Zyrtec, Pepcid and acetaminophen were being taken regularly. Throughout the rest of that day the hives got worse along with pretty severe angioedema. Also, a feeling of swollowing around a lump in my throat. No change through the night into next day (Friday) for the hives,swelling and lump feeling in throat. Went to walk in clinic where I was prescribed prednisone tapered for 16 days. After the first day of steroids not much change. After 2 there was some improvement. As of today one week after receiving the 2nd dose of the vaccine approximately 90% of the hives are gone, only mild swelling and some muscle fatigue and pain left.

Patient reported lightheadedness, blurry vision, and a burning sensation at the injection site an hour after administration.

Patient reported feeling lightheaded, having blurry vision, and a burning sensation in the location of the injection.

Patient is a 26 year old male in the observation area presents with itching and rash on his right lower back post vaccination. Hysical exam with singular hives with 1cm x 1 cm but otherwise physical exam unremarkable. Vital signs stable. Possible allergic reaction from pfizer vaccine. Improved pruritus and hives post cetirizine. Will refer to Allergist for clearance before next COVID 19 vaccine. Sent home stable.

Pt in MOB2 Vaccine Clinic for Pfizer dose#2 Following initial vaccination developed rash with absence of other symptoms Was evaluated by allergy specialist with approval for second dose with 30min observation period. 20 mins after receiving dose complained of subjective itching on forearms. No visible rash, erythema, complaints oral swelling, globus, diff breathing, swallowing. Given zyrtec 10mg SL Observed for 30 additional minutes with no progression of symptoms and resolution of pruritis.

within fraction of seconds I fell down (lost conscious); After sometime i woke up I barely could see; On the same night, my left arm (where shot is injected) started paining; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 20Apr2021 17:45, at the age of 26 years old, (Batch/Lot Number: EW0170) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took Tetanus shot and after 5-10 mins of it he lost conscious for a while. The patient experienced lost conscious on 22Apr2021 07:45 with outcome of recovered, vaccination site pain on 20Apr2021 with outcome of recovered, vision blurred on 22Apr2021 with outcome of recovered. The clinical course was as follows on the same night of vaccination the left arm (where shot is injected) started pain and became pain relief after a day i.e., 21Apr2021. The next day on 22Apr2021 he woke up and went to bathroom for his daily routines. He stepped in shower and stood under water for sometime then he removed the band-aid from the left arm (where the shot is given) within fraction of seconds he fell down (lost conscious) on the left hand side from the bath tub (him legs still in the bath tub) after sometime he woke up and now fell in the bath tub. After sometime he woke up, and he barely could see, tied him towel and came out to him room and laid down for a while. Then everything went back to normal. The patient didn't receive treatment for the events.

developed lump on the same side where the vaccine was administered; This is a spontaneous report received from a contactable consumer (patient's mother) via medical information team. A 26-year-old male patient (reporter's son) received first and second doses BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient got his first dose and developed a lump after the administration initially which did not disappear (just got smaller) not until his 2nd dose where he developed the same lump on the same side where the vaccine was administered on an unspecified date. Reporter would like to know how long do they need to wait until they seek further medical treatment or medical advice from their doctor. Also, if the lump will resolve on its own. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

his arm is sore and tight; his arm is sore and tight; specifically soreness where the shot was.; This is a spontaneous report from a contactable consumer reported for himself. This 26-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer covid 19 vaccine on 20Apr2021 and his arm was sore and tight, specifically soreness where the shot was. Event outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient received second vaccine dose at 12:52pm, then walked into the observation area and sat down in a chair. At 12:58pm while still sitting in his chair, patient was noted to fall out of his chair hitting his right shoulder, right knee and head on the floor. EMT in observation area immediately went to the patient who was laying on the floor. Charge nurse and EMS staff also at patients side. Patient was noted to be pale, and stated he was dizzy. VS stable, Pt stated he usually "passes out" with bloodwork but not with vaccines. EMT's recommended patient be transfered to the hospital due to a potential head injury. Patient consented to transfer to via ambulance. This RN observed a small nickle sized abrasion to patients right knee from fall. Patient was transfered to at 1:06pm.

Swollen neck muscles, enlarged lymph nodes under armpits for about a week and a half (may 1-may 14) lump in neck currently- think it?s a lymph node- swallowing a lot w/lots of saliva , headaches, dizziness, tired a lot, weird flashes over my body, legs feeling warm sometimes then goes, ran a small fever in the beggin. Of may - 99.4, nausea, popping behind ears when I swallow currently, anxious

PATIENT IS REPORTING PROLONGED YELLOW/GREEN BRUISING IN THE AREA OF THE VACCINE. HAS EXPERIENCED SYMPTOMS FOR AROUND A WEEK. NO PAIN OR SORENESS TO THE TOUCH. MOVEMENT IS NORMAL.

Rash, consistent with acute urticaria. Started on antihistamine. Plan for prednisone if no improvement after 24-48 hours.

Patient presented to the ED with swollen uvula, swollen face, hives on neck and waist, and severe headache approximately two days after the first dose in the COVID 19 vaccine series. The patient was treated with diphenhydramine, methylprednisolone, epinephrine, and famotidine.

Was afflicted with Severe poison Ivy on back of left leg from below glute down to mid calf. I had numerous smaller and less severe patches. Before getting the covid shot, I had had poision ivy for about 10 days. On the second day after receiving second shot of pfizer, I had a secondary rash occur that surrounded the poison ivy rash. There was a noticeable difference in that the covid rash appeared to come from within the body rather than the poison ivy rash that looked and felt as a more external rash. The symptoms aside from additional rash was when I would move around and generated any type of body heat the "covid rash" would begin to severely itch and irritate. Additionally, If I would go for walks, the area on my leg that still had the poison ivy rash along with the covid rash would not only itch but burn. It created the sensation that a lighter was being held to my skin. It was quite painful. The other small areas that had the mix of poison ivy and covid rash were not as painful when I was moving around/ walking like the bigger afflicted area.

A few hours after getting the 2nd dose, I had the following reactions (I didn't go to the doctor, I'm just reporting what I experienced): *Slight rash consisting of pen-dot sized raised blisters which only appeared on top of a long-healed tattoo I have *Pain all throughout my right jugular (neck) *Sharp pain behind my right ear *Sleepiness *Dizziness *Muscle aches and muscle cramps Most of these lasted less than 24 hours, but the tattoo rash was progressively becoming worse, I managed to get it under control on day 4 by applying hydrocortisone directly over the immidiate area. I still see a few bumps, but it seems to be healing. I didn't do anything differently in my daily routine; nothing changed (ie: same soap, same detergent, no contact with dust or etcetera). The tattoo also contains phosphorus, which might be related to the reaction. The muscle aches and cramps are still ongoing; which is weird considering how I never get either and my daily activities haven't changed.

Soreness, redness and slight swelling of left nipple; Soreness, redness and slight swelling of left nipple; Soreness, redness and slight swelling of left nipple; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EW0183, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 14May2021 09:00 (at the age of 26-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient has no concomitant medications. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: ER8736, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 21Apr2021 (at the age of 25-years-old) for COVID-19 immunisation. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 15May2021, the patient experienced soreness, redness, and slight swelling of left nipple. The events were assessed as non-serious. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.

Mild soreness in my left arm where the shot was administered; This is a spontaneous report from a contactable consumer (patient). A 26-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247) via an unspecified route of administration in the left arm on 03Feb2021 at 14:45 (at the age of 26-years-old) as single dose for COVID-19 immunization. Vaccination facility was a Workplace clinic. The patient had no medical history. The patient was not allergic to medications, food or other products. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. On 03Feb2021 at 08:00 PM (same day of vaccination), patient experienced mild soreness in left arm where the shot was administered. No treatment was received for the event. Since the vaccination, the patient not tested for COVID-19. The outcome of the event was recovering. Follow-up attempts are completed. No further information is expected.

Cold sores, hives, bumps, rashes, severe itching over arms, legs, chest, and back of neck. Numbness and tingling in cranial nerves. Back of neck hot, pins and needles. Severe head fog, fatigue.

A 26-year-old man with no PMH presented to our hospital with a meningitis-like illness (4/18/2021) about 4-6 weeks after receiving both doses of the Pfizer COVID vaccine. Chief complaints on admission included excessive fatigue, nuchal rigidty, fevers, and, headache, and some confusion. He also had a rash on his L forehead 2 weeks prior to admission that resolved after taking ibuprofen, however this is unlikely to have treated this rash. With the working diagnosis of meningitis/enecephalitis, the patient received Acyclovir (4/18?4/21), ampicillin (4/19), ceftriaxone (4/18?4/22), and vancomycin (4/18?4/19) initiated. All labs (will document below) and patient was discharged on a 14 days course of doxycycline 100mg PO BID to cover empirically for possible Lyme meningitis vs. Leptospirosis. On outpatient follow-up visits, patient reported appropriate adherence to doxycycline, no sick contacts, no further rashes, no fevers, chills, headaches, photophobia/phonophobia, etc. Does not seem to have any lasting sequelae from "meningitis-like illness."

body aches; Swelling and pain at injection site; Swelling and pain at injection site; fever; chills; intense headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number and expiration date were not reported), dose 2 via an unspecified route of administration, administered in arm right on 02Feb2021 at 16:00 (26-years age at the time of vaccination) as 2nd dose, single for COVID-19 immunisation. Medical history included known penicillin allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in right arm on 12Jan2021 at 16:00 for COVID-19 immunisation and experienced body aches, swelling of upper arm, muscle pain, headache, chills and slight fever. The patient had not received any other vaccines within 4 weeks. 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 experienced vaccination site swelling and pain, fever, chills, body aches, intense headache, and nausea on 02Feb2021 at 23:30. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovered on an unspecified date. Information on Lot /Batch Number has been requested. Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

bilateral rash on armpits; Threw-up after 2 hours of vaccine; This is a spontaneous report received from a contactable consumer, the patient. A 26-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) in the left arm via an unspecified route on 13Mar2021 at 11:30 as a single dose (at the age of 26-years-old) for COVID-19 immunisation. The patient had no known allergies. Medical history, past drug history and concomitant medications were not reported. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medication within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 02:00, the patient had threw-up 2 hours after vaccine (vomiting) and bilateral rash on armpits. The patient did not receive any treatment for this event. The clinical outcome of the event bilateral rash on armpits and vomiting was recovering at the time of report. Information about lot number cannot be obtained. No further information is expected.

Sore / achy; Feverish; Chills; red and tender swollen injection site; red and tender swollen injection site; red and tender swollen injection site; Lightheaded; swollen and tender armpit glands,; Elevated heart rate; swollen and tender armpit glands; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: er8735) via an unspecified route of administration on 26Apr2021(at the age of 26 years old) as a single dose, for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications were not reported. The patient reported that his past drug history included dairy (unspecified). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced sore / achy, feverish, chills, red and tender swollen injection site, lightheaded, swollen and tender armpit glands and elevated heart rate on 26Apr2021. The patient did not receive any treatment for the events. The clinical outcome of the events sore / achy, feverish, chills, red and tender swollen injection site, lightheaded, swollen and tender armpit glands, elevated heart rate were resolving 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: Patient email address added, medical history added (known allergies: dairy), treatment received was ticked as No and updated narrative.

Pain in right arm; mild itching all over; neck pain opposite of injection site; joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7533) via unspecified route of administration in the right arm on 27Mar2021 at 17:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included overweight. Concomitant medications were not reported. It was unknown if the patient had any 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. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021 at 10:00, the patient experienced pain in right arm, mild itching all over, neck pain opposite of injection site and mild joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events pain in extremity, pruritus, neck pain and arthralgia were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

he has these spots on his body/showed her a red spot; circular spots on the other arm and there is a deep one the one arm and in the other leg and all over the body; This is a spontaneous report from a contactable pharmacist. A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose unknown via an unspecified route of administration on 09Jul2021 (at the age of 26 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 13Jul2021 14:00, the patient has these spots on his body. The patient came in and it looks like he has these spots on his body. He got the vaccine 09Jul2021. He showed her a red spot near where it would have been given, that looks like it is likely from it. But then there are bullet spots on the other arm and down on his foot. They almost look like targets and are pretty circular. The patient is there now. The reporter clarified the spot that she thought was where it was given was actually on his other arm. It looks like circular spots on the other arm and there is a deep one the one arm and in the other leg and all over the body. The spots first occurred not shortly after lunch time, yesterday, around 2:00PM. He had gotten the vaccine last Thursday and a few days had passed since then. Patient clarifies they were all on the arm, in both arms. The reporter considered the events as non-serious. The outcome of the events was unknown. Information regarding the lot/batch number has been requested.

experienced Flu; Joint Paint; Fever; Muscle Pain; Headache; Tiredness; Nausea; Arm Pain; Injection Site Pain; He is feeling sick after second dose; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program . A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 20May2021 (at the age of 26-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date (at the age of 26-years-old) for COVID-19 immunisation. The patient reported that he experienced Flu, Joint Paint, Fever, Muscle Pain, Headache, Tiredness, Nausea, Arm Pain and Injection Site Pain. He had his first shot of the Pfizer BioNTech Covid-19 Vaccine last day 20May2021 (as reported). Caller wanted to know if he would be allowed to take Dayquil to relieve the current side effects he was experiencing. The patient received his second dose last day (20May2021) but cannot recall exact date of 1st. He was feeling sick after second dose. His symptoms were not much different than what was on the fact sheet. He did not wish to report them at all. He just had a question. His symptoms were very typical of the flu with the usual joint pain, fever, muscle pain, headache and tiredness. He took the day off of work. He just wanted to know if he should take Dayquil tomorrow so he could function and go to work. The patient was referred to HCP. Outcome of the events was unknown. Follow-up needed. Information about batch/lot number has been requested.

Fever as high as 101.6, body aches, severe pain at injection site, convulsions/chills, nausea, cough, migraine

Nausea and drowsiness began 2.5 hours post injection, resolved 9 hours post injection. Sore and tender injection site (left arm), began 30 minutes post injection. Has improved, but still slightly tender 49 hours post injection.

8 hours after vaccination - injection site tenderness 12 hours after vaccination - fatigue, malaise 15 hours after vaccination - headache, fever, chills, tachycardia improvement in symptoms began at 36 hour mark and had resolved at 48 hour mark

Approximately 57 hours after receiving 2nd dose of Pfizer vaccine, I developed hive patches throughout my body. I took 50 mg Benadryl and went to bed. Work up the next morning to observe some res spots, but minimal itching. I reported to work, where I am an EMT for an ambulance service. During shift, at approximately 1500 hours, I had a patient who was cold, so I cranked up the heat in the back of the ambulance. I started to sweat. My hive then came back with a vengeance all over my body. I immediately took 50 mg Benadryl and went to the urgent care center. The doctor told me to continue with the Benadryl and to pick up a prescription of Prednisone if symptoms worsen. Symptoms where mostly cleared up at that point. I got off shift at 1900. Hive worsened at approximately 2000. I picked up the prednisone and intend to begin taking it in the morning if symptoms are not much improved.

3 hours after vaccine: beginning of body aches, arm soreness at injection site 10 hours after vaccine: severe body aches especially in lower back and buttocks, pounding headache, skin sensitivity and chills Over night: inability to sleep, tossing and turning, unknown fever but skin felt very hot with all past symptoms 0430 next day (1/11): nausea, dizziness, pounding headache, severe body aches and sensitivity but no chills 36 hours after vaccine: uncomfortable body aches are still present, most of symptoms have resolved 48 hours after vaccine: body aches are slightly noticeable but resolve during the day

Received vaccine on Sun, 1/10, felt fine initially. On Tues, 2 days later, first noticed rash and hives to chest and back. He took Benadryl on Tues and Weds with some relief. He reported no SOB, no diff breathing, no throat itching, no chest tightness. He is a Cook on the tray line, very hot environment, may be related to the heat/sweating from the location where he works. He went to urgent care on 1/13, was given allergy medication and told to use Benzoyl Peroxide soap wash. He states the hives look better as of Thurs, 1/14. He was not seen by Occupational health, but did review case with employee via phone. He gave consent to have the reaction discussed with Allergy and he has completead a WSIRS with supervisor already.

Patient developed full body, pruritic rash 4 days after vaccine given; no new soaps, detergents, food, medications

injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; This is a spontaneous report from a contactable Other Health Professional(patient). A 27 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via Intramuscular on 06Jan2021 18:00 at single dose in the arm left for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. On 07Jan2021 04:00 PM, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain and fever. The patient did not receive any treatment. Outcome of events was recovering.

About 8 hours after vaccine administration on 1/15/21 - woke up in the middle of the night with chills, headache, pain in joints and injection site, nausea. Sat up on the side of the bed - passed out and woke up on the floor. Tried to readjust slowly, passed out again. Place ice pack on stomach and behind neck to treatment with legs up. 1/16/21 continued to experience chills, headache despite cool compress and Tylenol 1000mg TID and Motrin 600mg x 1 dose at 1900. Fatigue and body aches throughout the day - very limited on any daily activities. Sweats and joint pain and pain around L arm injection site.

Symptoms began at 06:00 on 1/19/21 and included fever, chills, weakness, aches, injection site pain. Tylenol taken. Notified employee health at the facility.

Mild arm soreness at injection site Began approximately 3 hours after administration and persisted for 24 hours. Patient (self) took 400 mg ibuprofen by mouth approximately 24 hours later (1:00pm 1/9/21), which relieved symptoms.

Headache; Injections site pain; Myalgia; Malaise; This is a spontaneous report from a non-contactable physician (patient). A 27-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 09Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was reported as none and no known allergies. The patient's concomitant medications were not reported. The historical vaccine included first dose of BNT162B2 intramuscular at left arm on 19Dec2020 16:00 for COVID-19 immunization. The patient experienced headache, injections site pain, myalgia, malaise on 10Jan2021 09:00 with outcome of recovering. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.

About 12 hours post-injection I began noticing hot/cold flashes and running a fever. Between 10:30pm and noon on January 22nd, 2021 I've experienced continued hot/cold flashes, fever, nausea, muscle aches, injection site pain, congestion, headache, and minor swelling and pain of the lymph nodes in my left axilla area. So far the fever seems to have broken with Tylenol, water, and rest. Still experiencing significant muscle aches, left axilla pain, headaches, congestion, and general fatigue.

Jaundice, abdominal pain, body aches. headache,nausea - started 1/24/21. HGB 6.8, low haptoglobin Pt has a had a history of hereditary stomatocytosis. When the patient had the shingles vaccine 5/2019,he had a similar reaction. Pt is requiring IV pain medications.

1-2 hours following vaccine administration, I experienced moderate injection site pain that limited my mobility with that arm (i.e. pain on shoulder abduction). 18 hours following vaccine administration, I experienced a fever and chills (beginning at 0530 the morning after the vaccine). For the rest of the day, I had mild myalgia, a mild to moderate headache and general malaise that resolved by the following morning (within 48 hours of vaccine administration)

Dose 1 on 26Jan2021: Sore left arm at injection site; persisted for approx. 40 hours. Slight brain fog - difficulty completing basic mental math (addition/subtraction with values less than 50); persisted for approx. 12 hours. Dose 2 on 16Feb2021: Sore left arm at injection site; persisted for approx. 30 hours. Low-level headache focused behind my eyes; effectively treated twice with Tylenol and later with Ibuprofen; onset within 1.5 hours of injection; persisted for approx. 12 hours.

Steadily rising fever began the day after vaccination, eventually exceeding 105F and with associated severe headache, room-spinning vertigo, nausea, fatigue, tachycardia, rigors, occasional cough and stuffiness. Also experienced moderate arm pain at injection site. Symptoms continued to worsen throughout the day and only began to improve after taking 1000mg acetaminophen. Symptoms greatly improved by the next day (post-vaccination day #2) and eventually resolved.

Patient developed a rash to arms and chest after receiving vaccination. Patient declined Benadryl and any other medical treatment. He stated that he spoke with his father who is a doctor and that he will take Benadryl when he gets home. No other distress noted by observer.

After vaccine pt went to observation area .He felt hot and asked staff for H2O. When staff returned c H2O he stated he felt light headed. Staff concerned he was going to pass out so they assisted him from chair to ground with legs e levated . Emergency number and onsite MDcalled . Pt was unresponsive c aBormal breathing and seizure like activity . Epi 0.3mg administered in right thigh. Pt became responsive and breathing 15 RR a minute. Pt diaphoretic c rash on upper extremities. VSS. EMS arrived and transported pt to local ED for evaluation.

After vaccine, pt went to observation area. He felt hot and asked staff for water. Staff returned with water and he stated he felt light headed. Staff concerned pt might pass out so they assisted him to floor with feet elevated. 911 and onsite MD and EOA called. Pt was unresponsive with agonal breathing and seizure like activity. Epi 0.3 mg administered IM into right thigh. Pt became responsive and breathing 15 RR a minute. Pt remained diaphoretic with rash noted on upper extremities. VSS. EMS arrived and transported pt to local ED for further evaluation.

Patient got worked up and anxious during shot. After shot given patient had hives/welps on stomach. Patient looked at by EMS and improved without intervention.

Pt. was vaccinated by another pharmacist at our remote clinic at an elementary school at 11:35am 3/11/21. Within less than 3 minutes the patient informed a student that he did not feel well. He reported: itching, feeling hot, shortness of breath, dizziness, loss of vision, and thirst. The student alerted me and I assessed the pt. He was responsive, but felt "tired". He was sitting on the floor. I told the student to call 911. I continued talking with the pt. as I was preparing the epinephrine and placing a blood pressure cuff on his arm. He became less responsive and asked me for the epinephrine. I injected him with an EpiPen 0.3mg in his outer left thigh through his pants (at 11:43am). Within approximately 30s-1min the pt. became more responsive. I then took his pulse and BP shortly before EMS arrived (11:52am) . They performed the second blood pressure reading and the pt. was transferred to their care at that point.

Nausea, dizziness, headache, extremely red face, swollen bottom lip, pressure and tightness in chest, oxygen levels dropped, difficult breathing, and heart rate was elevated. Treatment at clinic: Oxygen mask was put on to 4 litters, breathing treatment done, Benadryl, Pepcid, Tylenol, and then eppy shot was given. Ambulance then came to clinic and took my son to the ER. Most of the same thing was done in the ER. Patient still felt bad after 4 or 5 hrs in ER room. So he was admitted to stay in the hospital. He stayed 3 days and 2 nights in the hospital. He had breathing issues, nausea, headaches, and Elevated heart rate for the first 2 days. Wasn?t till the 3 day that he felt well enough to go home.

Having muscle aches, chills, pain at injection site, NO fever. Sx coming on in waves. This is day 3 of symptoms, thinks getting better No redness or swelling around injection site.

28 yo M reported feeling unwell (lightheaded, hot, need to sit down) within 5 minutes of receiving first dose of Pfizer COVID vaccine. Subsequently had a syncopal event, while sitting reclined between bleacher seats. His head was supported. Patient was laid down with feet elevated and he regained consciousness within 15 seconds. Vitals: 132/79, O2 98%, P 79, RR 16. No facial edema, rash. Patient was given water and a snack, was observed for 30 minutes, after which he reported feeling much better.

Hives all over torso and face/head. Started 48 hours after administration of first dose and still present two weeks later.

Fatigue several hours later and continuing for 3 days. Body aches for 3 days following. Nausea continuing currently. Arm pain at injection site continuing.

Starting around 9PM on 04/03/2021 I noticed itching and bright red hives on my neck, shoulder, arms, and torso, which soon spread to my waist/upper thigh area. The largest patch was on my right shoulder. I took a dose of Cetirizne, and went to the Emergency Room, as the hives were still spreading. I was examined and given 25 mg Benadryl and 60 mg Prednisone. I was told to take 25mg Benadryl every 8 hours, and 40 mg Prednisone every morning for the next three days. By midnight the hives were less itchy and a more dull red color. On 4/4/2021 the hives were reduced, and significantly less itchy. On 4/5/2021 at 10:00 AM the Hives had spread to bright red patches on the lower legs/tops of feet. Still have on more day of Prednisone to take.

Rashes all over the body causing itching comes up every 2 days and goes away with Allegra. It has been almost 3 weeks now and they keep on coming.

Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pateint \"swooned\" when the observer was getting the timer. He was responsive after 2 minutes. sat upright after 5 minutes.

Headache (lasting 3 days after), Body aches (lasted 2 days after), Neck Stiffness (lasting 3 days after), Chills (lasted 2 days after), Sweating (lasted 2 days after), Dehydration (lasting 3 days after), Nausea (lasted one day on second day after), Pain at Site of Injection (lasted 2 days after), Difficult Taking Full Breaths Nausea (lasted one day on second day after), Fatigue (lasting 3 days after)

Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: WHITE BUMPS ON HANDS-Mild, Systemic: Hypertension-Mild

Rash. Started on left side of chest/stomach area. I took Benadryl and put Cortisone cream on rash at 11:00am. The rash on chest and stomach has gone down but area is still red. Other rashes forming on both arms and center of my chest have appeared.

Patient has the vaccine and then got dizzy and started to put self on floor, passed out and hit face on the floor. Patient has a red bruise on his forehead and nose. Patient was advise that he should go to ER to get checked out because he passed out and hit his head. Patient refused and went home with girlfriend. They were advised as to what signs to look out for and then if the patient gets these symptoms to take him to the ER to get evaluated

Approximately 6 days after my second dose, I began getting red splotchy bumps on my left forearm. 7 days after the 2nd dose these spots had spread up my arm and were appearing on my left Tricep area and shoulder. The lesions are tender to the touch with a mild burning sensation, they are mildly itchy.

After receiving second dose of injection Pfizer vaccine. I begin to experience side effect including headache, redness, swelling, and tiredness. 1 days later, the condition of those got better but the redness does not go away. My under arm begin to form small red area, very similar to chicken pox. these red area return daily and appear more frequence.

Symptoms were arm soreness at vaccination location, tiredness, headache, chills. Took tylenol which improved headache. Slept several hours which improved chills and tiredness.

Patient had itching arm of injection site and left hand. Patient given water and 15 min later recovered. Patient said felt dehydrated. After drinking full bottle of water the itch went away. It could be anxiety induced.

On day 3 following, 2nd dose of Pfizer vaccine, he had right sided calf pain. Initially thought to be recurence of strain injury, although no history of trauma or obvious trigger. Pain conitnued to worsen and had different characteristics than original strain symptoms. Continued to worsen to point wher eunable to weight bear and swollen, hot and red. Saw orthopedist who refered to vascular surgeon, and on day 13 was officially diagnosed with large DVT extending form tibeal & peroneal, popliteal up to the femoral veins. Has no known clotting defects. Currently under evaluation with hematologist who recommended anticoagulants for remainder of his life.

Severe rash on arm opposite of injection site. Spread across entire arm and hand, then to face and arm of injection site.

Patient experienced syncope resulting in a laceration to the chin in the 15 minutes following vaccination. Patient was tended to by the NP on duty, instructed to lie down and drink water while she tended to his cut. Patient mentioned it "tasted like he threw up" and still felt lightheaded after 15 minutes after the event. Patient was insistent that we should not call the squad as he does not have insurance. Patient in the meantime was trying to get ahold of a friend or family member to pick him up as we advised him that he could not leave in this state. We elected to call the squad as he had not recovered yet. Before the squad could come, the patients brother showed up and quickly whisked him away. Squad did show up but there was nothing to attend to so left without intervention.

Patient experienced syncope shortly after receiving first dose of Pfizer COVID vaccine in the lobby during his 15 minute waiting period. Patient hit chin and did lacerate it; this was attended to by NP who was administering shots at the time. Patient mentioned that he "tasted like he threw up," was instructed to drink water. NP took vitals and patient showed no sign of concussion. In the mean time patient was trying to get ahold of a friend or family member to come pick him up. Still felt lightheaded 15 minutes after being attended to, at this time we called the squad. Before the squad could show up patients brother came to pick him up... was whisked away too quickly for us to stop him. Patient was adamant about us not calling squad because he does not have insurance.

About 2 hours after I received my 1st vaccine I developed hives on my forehead,face, neck at my hairline, arms and trunk

Day of shot (4/9), experienced a potential vasovagal reaction and bleeding in the arm. 10 days after shot, on 4/19, began to feel very weak and faint, and movement became effortful, along with chills and muscle aches and soreness. This continued into 4/20. Vitals were checked and found to be normal, and by 4/21 symptoms mostly subsided, except for remaining occasional chills and muscle-aches.

Symptoms started with a light headache a few hours after the injection and slight arm pain at the site of the injection. Nothing serious until I fell asleep, which is when I developed a fever, uncontrollable chills, and aches all over my body, so much that I could not sleep until I took some ibuprofen. In the morning, the chills were gone, but a slight fever and body aches remained all day. They were gone by the next day.

10mins into his observation Client reported feeling itchiness on collarbone and numbness on his right side arm where he had received his vaccine. Client then proceeded to taking his own allergy med that he carries in his bag. Claritin 1 tab 10-15mg. Vitals signs at 3:15pm BP 109/60 HR 60 Respirations 18. He states he is allergic to sulfa, cucumber, avocado, banana which causes him to have an anaphylaxis response. Pt stated he hadn't had anything to eat and a granola bar was provided for him, as well as water. Vital signs BP 130/70 HR 70 RR 18, 3:27pm BP 125/75 HR 71 RR 18. After third set of vitals were taken client reported feeling much better. 3:34pm BP 130/70 HR 70 RR 18 02 97%. Client reported itchiness had gone away. Client was in no respiratory distress and denied having any closing of throat. Client was informed to follow up with his Primary care provider, and emergency precautions were given. He left site in no apparent distress.

Fever; Chills; Mild injection site soreness; Sinus headache; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EL3247 via an unspecified route of administration in left arm on 17Feb2021 at 14:00 (at the age of 27-year-old) as a single dose for COVID-19 immunization. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: Unknown) as a single dose on an unspecified date. On 18Feb2021 at 03:00, the patient experienced fever, chills, mild injection site soreness and sinus headache. The patient did not receive any treatment for the events. The outcome for the events was recovering.

fever and body aches starting @ 1 am the next day, including pain in spine and minor headache, felt like shingles lite (without the itching) Then, 11:50 pm next day: itchy bumps began appearing over body, hands and feet itched profusely for 24 hours until benadryl administered, symptoms diminished consecutively each day,

After eating lunch approx. 24 hours after receiving the 1st dose of the vaccine, I began to cough suddenly. I then got itchy eyes, had some wheezing, and sneezed/got a runny nose. About a half hour after getting these symptoms, I took 10mg of children?s Benadryl (Diphenhydramine). I then found two hives/itchy bumps. One on my right arm near my elbow and one on the left side of my abdomen. About 20 minutes after taking the Benadryl, the symptoms mostly went away and I felt very tired. I still have some wheezing.

got a rash on the other forearm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 27-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: Unknown), via unspecified route of administration on 13Apr2021, (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Apr2021, at night (as reported) the patient experienced rash on the other forearm, the patient also wanted to know if rash and COVID-19 Immunization are related to each other. Also, patient asks if it was okay to get the second dose after this symptom. The outcome of the event was reported as unknown. No follow-up attempts are needed, information about lot/batch number cannot be obtained.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild

Pruritic scaling erythematous patches on trunk predominantly, minimally on arms/upper legs with mild fatigue and chills

right arm, red to dark brown imprint where injection was done; red to dark brown imprint where injection was done; induration as where the band aide was; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported, NDC number: Unknown), via an unspecified route of administration, administered in Right Arm on 30Mar2021 (at the age of 27-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that on 06Apr2021, dark brown induration as where the band aide was. 3 days before on 06Apr2021 at 9:30, patient noticed a red mark at the injection site of his right arm. The area was now changing to dark brown with an imprint where the band aid was. It was not sticky from the residue, it was an imprint in the shape of the band aid. It was not going away. Patient noticed this marking on 06Apr2021 on his right arm. Patient was concerned, would it go away or be a permanent mark his arm. No history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. Events were not required a visit to Emergency Room nor Physician Office. No prior vaccinations (within 4 weeks). No other products. No Investigation Assessment and Relevant Tests. Therapeutic measures were taken as a result of the events included band aid. The outcome of the events 'red to dark brown imprint where injection was done' was not recovered, outcome of the other event was unknown. Seriousness for events 'right arm, red to dark brown imprint where injection was done' was reported as unspecified by reporter. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Loss of consciousness approximately 9:10pm, fall, multiple head and face lacerations. Entered ER ~11:00pm and received multiple tests, EKG, TDAP injection, and sutures.

Woke up the morning after receiving vaccine and had swollen right shoulder/armpit with some edema in armpit. Tender to touch but not painful

27 y/o male was sitting in a chair when he started feeling lightheaded 10 minutes s/p 2nd COVID vaccine. He experienced LOC, which lasted less than 1 minute, and fell on his left side onto the floor. Patient came to immediately and was alert when medical response team arrived. Patient was mildly pale and diaphoretic, which improved as he laid down supine on bed. He endorsed some nervousness but lightheadedness seemed to be getting better. Patient had only had a banana and some water prior to his appointment. He denied chest pain, palpitations, and shortness of breath at the time of syncope. Due to the abrasions on his left maxillary area and ear, patient thought to have hit head on the floor. EKGs done by paramedics showed sinus rhythm with ST elevation in leads V3-V6, repeated twice with same finding. Patient then mentioned that he has been having sharp chest pain intermittently over the past few months that would go away on its own. He had not seen a medical professional for those symptoms. IV line started in left antecubital area. Patient was given baby aspirin by paramedics. Patient?s first COVID vaccination was uneventful. He denied any medical conditions, allergies, or medications. Family history includes diabetes, hypertension, and thyroid disease.

He received the 1st dose of the Pfizer COVID vaccine on 4/22/21 and within 5 minutes, developed coughing, sneezing, and rhinorrhea. Within 2-3 hours, symptoms progressed into pt having swollen and red cheeks and red eyes. Denies any sob, tongue or lip swelling, hives, abd pain, dizziness. His BP was his normal, O2 was normal and he was sent home. He did not take any Benadryl or use epinephrine. That night he had subjective fever and night sweats. The symptoms lasted for 2 days and pt used Tylenol for symptomatic relief. Sx resolved by the 3rd day

Severe muscle pain throughout body (8/10 on pain scale) lasting a whole day tenderness of injection site (still present at time of report) mental haze tiredness fever (no thermometer in house, so unsure of exact temp) Result: fell asleep at 7PM, and slept for twelve hours, not remembering much of the two hours prior to the sleep or the hour I woke up at around midnight. Dayquill reduced the symptoms somewhat, and I woke up the next day feeling significantly better. (If I hadn't I would have gone to the ER) Fever seems to have subsided muscle pain has dropped significantly (down to a 3-4/10 on the pain scale) Mental haze has cleared up Awake and alert

Thought that I was in the clear of any side effects. First vaccine only resulted in a minor sore arm. Got second Phizer vaccine at 10:40 a.m. on 5/6 and went all day with nothing. Woke up at 2 a.m. the next morning (15.5 hours after vaccine) with sore arm at point of injection, chills, fever, aches, and a headache. Symptoms lasted all day. Woke up the next morning (46 hours after vaccine, 30 hours after symptoms started) with no lasting effects.

Hives appeared and covered the whole body overnight 3 days after the vaccine but no anaphylaxis. Took Benadryl in the morning and the hives slowly went away during the course of the day. The following night, woke up at 4am covered head-to-toe in hives, swollen face, lips, difficulty swallowing. Called 911 and was treated with an epinephrine pen, symptoms slowly subsided over the next few hours after being monitored at the ER. No previous experience with allergic reactions or anaphylaxis.

Shortly after receiving the vaccination, the patient began to complain about pain lateral to his vaccination site towards his armpit. I applied a cold pack to the site and the pain resolved itself within 10 minutes.

Body aches, headaches, chills, body very hot, lots of soreness in arm of injected site, arm ache on other arm after a day as well

Severe fever and chills overnight, unmeasured but body noticeably hot to touch. Fever still 99.8 during next day after several hours when thermometer was acquired, but had significantly broken by that point

a few minutes after receiving the vaccine the patient passed out and fell from his chair to the floor. in falling he hit his face on the floor breaking his glasses at the bridge of his nose and cutting that area. he also had an abrasion on his forehead from the carpeting and also chipped a lower tooth. we gave him water, he refused crackers, he did not want us to call an ambulance. he was unconscious for less than 60 seconds and came too quickly and was out of sorts for a few minutes. his mom came to pick him up and said she would take him to an urgent care.

fainted; lost consciousness for a couple of seconds; burning pain that felt like needles on his shoulder, left arm and a little on the right side/extremely, burning pains across his back/He had burning pain on his shoulders, very sensitive, felt like a 3rd degree burn; felt like he could not stand and had to go to the floor, struggled to get up; arms were numb; thought he was having a heart attack; left arm weak; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; left side of face is swollen; left side of face is swollen was reported as worsened.; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; left arm pain; This is a spontaneous report from contactable consumers (patient reported for himself, patient's mother). A 27-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 01May2021 12:00 noon (Batch/Lot Number: EW0170; Expiration Date: 31Aug2021) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunization, at the age at vaccination of 27 years old. The patient's medical history and concomitant medications were not reported. The patient experienced thought he was having a heart attack(medically significant) on 03May2021 01:00 with outcome of unknown, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (medically significant) on 03May2021 with outcome of not recovered, fainted (medically significant) on an unspecified date with outcome of unknown, lost consciousness for a couple of seconds (medically significant) on 03May2021 01:00 with outcome of recovered with sequelae on 03May2021, burning pain that felt like needles on his shoulder, left arm and a little on the right side/extremely, burning pains across his back/he had burning pain on his shoulders, very sensitive, felt like a 3rd degree burn (non-serious) on 03May2021 01:00 with outcome of unknown, felt like he could not stand and had to go to the floor, struggled to get up (non-serious) on 03May2021 01:00 with outcome of recovered with sequelae on 03May2021, arms were numb (non-serious) on 03May2021 01:00 with outcome of recovering, left arm pain (non-serious) on 03May2021 with outcome of not recovered, left arm weak (non-serious) on 03May2021 01:00 with outcome of unknown, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (non-serious) on 03May2021 01:00 with outcome of not recovered, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (non-serious) on 03May2021 with outcome of not recovered, left side of face is swollen (non-serious) on 03May2021 01:00 with outcome of not recovered , left side of face is swollen was reported as worsened (non-serious) on 03May2021 with outcome of not recovered. The patient underwent lab tests which included computerised tomogram (brain CT): no results, electrocardiogram (EKG): no results, both on unknown date. Reported patient was in pain and his mom and dad didn't know what to do. He had sharp pains. No bruises. He remember lowering myself to fall. He didn't fall. It was a strange thing. When he went to the ER they didn't fine anything. He was still in the same amount of pain. Caller stated her son took the vaccine on Saturday. Thirty six hours later around 1:00am he started getting extremely, burning pains across his back.The patient stated he was coming out of the bathroom and felt like he couldn't stand and he had to go to the floor. He lost consciousness for a couple of seconds. Both arms were numb. He struggled to get up. He sat on the couch and then went upstairs after being in the basement. He had a burning pain that felt like needles on his shoulder, left arm and a little on right side. His skin was sensitive. The back of his neck feels like he has a third degree burn. This morning he went to the hospital. Initially said he fainted but clarified that he was speaking about losing consciousness. He had left arm pain. He thought he was having a hard attack. While at the emergency room today he had labs, a brain CT scan and an EKG. He does not have results to provide. Caller added that his skin was hypersensitive. It was like if he moves the hair on his arm it hurts. His parents noticed he has swelling on the left side of his face. The events require a visit to Emergency Room. No Prior Vaccinations (within 4 weeks). Information on Lot/Batch number was available. Additional information has been requested.

Roughly 5 minutes after vaccine patient lost awareness, became red in the face, eyes rolled to back, seizure like activity for about 1 to 2 minutes. 911 was called and the patient was assessed and released.

Shingles (herpes zoster) developed 18 days after first injection. Visible rash on lower right abdomen area with itching and burning. Took antiviral medication for 1 week and rash gradually cleared.

Swollen lips; Swollen tongue; Swollen face; Itchy throat; Lightheaded; weak; feeling Sore on right arm; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: EN 6204) via an unspecified route of administration in right arm on 12Mar2021 at 08:45 AM (at the age of 27-years) as a single dose for COVID-19 immunization. Medical history included allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. On 12Mar2021, post the vaccination, the patient felt soreness on the right arm. On 13Mar2021 at 12.00 PM, he started to become very weak, and light headed. On 14Mar2021, he woke up and his entire face was swollen including his tongue and his throat was itchy and on 17Mar2021, his lips and tongue were still swollen. Therapeutic measures included treatment with methylprednisolone acetate (DEPO-MEDROL) 40 mg/ml injection. The clinical outcome of the events vaccination site pain, weakness, light headedness, swollen face, swollen tongue, swollen lips, and itchy throat was reported as not resolved. No follow-up attempts are needed. No further information is expected.

Started breaking out in hives all over my body a week after 2nd dose. Has continued through today. Dermatologist has me taking 2 Zyrtec every morning to manage symptoms

Day after shot, noticed injection site was inflamed only under bandaid cotton. Same day removed bandaid to shower, hot water on injection site hurt alot. The follow week the skin at injection site followed sunburn like effects. Small amount of boiling, less them 1cm in size, hurt to touch, then lesseded. Skin then peeled/flaked at injection site. 3 weeks after, site still dark in color. no peeling, or pain.

could no longer get an erection (after he received his 1st COVID-19 Vaccine); eczema flared; This is a spontaneous report from a contactable consumer (patient's mother). A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 11May2021 16:00 (Lot Number: EW0176) as DOSE 1, SINGLE for Covid-19 Immunisation. Medical history included eczema for about 7-8 years and sensitive to pharmaceuticals. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12May2021, the patient's mother reported that her son could no longer get an erection (after he received his 1st COVID-19 Vaccine) and his eczema flared like nothing he had ever experienced before. Her son was just covered with eczema the day after his COVID-19 Vaccine, and applied the manuka honey everywhere he had eczema since it had kept the eczema under control. She said her son was very sensitive to pharmaceuticals and would not take pharmaceuticals because of the past side effects he had from them. They also believed that the vaccine had caused him not having erection. After three weeks, it started to come back a little bit but not as normal erection that he had before. The patient's mother was asking how long will the patient experience not having erection. They spoke to their doctor and told them that there is no relation between the vaccine and erection issues. At the time of report, the outcome of the events was recovering. The patient did not proceed on the scheduled second dose appointment because of the side effect.

Headache; injection site is at hurts a little bit.; he is feeling warm, is not sure if it's due to the vaccine and he thought he might want us to know; arm hurts; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 27-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 22Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced headache, injection site is at hurts a little bit, he is feeling warm, is not sure if it's due to the vaccine and he thought he might want us to know and arm hurts on an unspecified date in 2021. Patient asked if it's alright to take Aspirin or place an ice pack on the injection site. Outcome of all the events was unknown. Information about Lot/batch number is requested.

tiredness; headache; muscle pain; chills; fever; nausea; feeling unwell; All the flu symptoms tiredness, headache, musclepain, chills, fever, nausea, feelingunwell; injection site pain; This is a spontaneous report received from a non-contactable consumer, the patient. A 27-years-old male patient of received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 at 08:00 AM (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications was not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 24Mar2021, at 02:00 AM, It was reported that the patient experienced all the flu symptoms, injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received ibuprofen (MANUFACTURER UNKNOWN) and icepack/heated pack as a treatment measure for the reported events. The clinical outcome of flu symptoms and vaccination site pain, tiredness, headache, muscle pain, chills, fever, nausea and feeling unwell was recovering at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Splotchy rash and bumps on stomach, feet, legs.; Very itchy feet and itching around body; Head feels a little foggy.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204), via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not take any concomitant medications. The patient previously received azithromycin (ZITHROMAX) and amoxicillin (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 18:30, the patient experienced splotchy rash and bumps on stomach, feet, legs, very itchy feet and itching around body and head felt a little foggy. It was unknown if any therapeutic measures were taken as a result of the events. The clinical outcome of the events rash, itching and foggy feeling in head was unknown at this time of report. No follow-up attempts are needed. No further information is expected.

Heart inflammation, fever, headache, arm ache, chest pain, shortness of breath, pulsing pain throughout body, extreme pain at injection site, injection site was very hot to the touch, redness at injection site, swelling at injection site

Heavy sweating; Muscle aches; Chills; Fatigue; Rash; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the right arm on 30Mar2021 at 18:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications within two weeks prior to COVID-19 vaccine was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 21:30, the patient experienced heavy sweating, chills, fatigue, muscle aches, rash and headaches. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events heavy sweating, chills, fatigue, muscle aches, rash and headaches were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Within two days of receiving COVID vaccine, I began to have a very heavy period. I have been on birth control on and off for many years due to irregular and heavy periods. As such, I have not had a period in years. There was significant clotting and heavy flow associated with the period which lasted about 4 days before subsiding. No other adverse effects aside from muscle pain at injection site.

Pt. states that he received covid Pzifzer vaccine at 11:17 am on 01/05/2021 to left deltoid IM. Around six to seven minutes at 11:23 am post vaccination patient started having burning sensation at site, felt flushed, diaphoretic, light-headed, nauseated, and now he is experiencing tingling to bilateral feet. Pt. states that earlier post vaccination he was feeling anxious, but he is no longer feeling anxious. Pt. denies feeling this way post vaccination with other vaccines. Pt. states that he is still having bilateral feet tingling up to both calves right greater than left.

sinus like symptoms/ bad runny nose; sinus like symptoms/ congestion/ sinus congestion; Itchiness; chills; body ache; head ache; This is a spontaneous report from a contactable other health professional (patient). A 28-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), intramuscularly on 23Dec2020 at single dose for COVID-19 immunization because he work in a hospital. Medical history was reported as none. There were no concomitant medications. The patient reported to have been vaccinated last Wednesday and developed symptoms on Thursday (24Dec2020) with a pretty bad chills, body ache, headache, itchiness, then got sort of better and that was on Thursday. He felt better on Friday (25Dec2020) but reported a really bad runny nose and congestion, he started to develop sinus like symptoms like runny nose, like sinus congestion and that's so something that he was experiencing like 26Dec2020 to Saturday. The patient was asking if these were the typical symptoms/ normal reaction to the vaccine and if he had that reaction were normal and how long would they usually last. The outcome of chills, headache, itchiness was recovering, of the other events was unknown.

Muscle aches, followed by swollen lymph nodes noted in armpit of arm injected with the vaccine. Noted 2 swollen lymph nodes. Low grade fever prior to going to bed. By the morning symptoms had resolved other than swollen lymph node which remained swollen over next few days.

On the day of the vaccine, 1/7 no reaction. The typical slight sore arm on injection site but nothing odd. On the morning of 1/8 I woke up with noted chills and headache. I checked my temp and noticed 100.4* oral temp. I also had back pain, muscle pain, headaches, continued fever (improved with motrin) and chills. My left arm from my shoulder to my wrist was with noted pain/aches, improved with motrin. On the morning of 1/9 I felt much better, did not take any motrin/tylenol and without any fever/chills. Noted improvement of muscle aches in general and arm felt the same as 1/7 (much better!). Noted lymph swelling of my axillary lymph nodes with aching pain. This has not gone away at current but improved with x1 dose of motrin.

Fever, peaking at 99.8 but averaging 99.5, for 36 hours. General malaise, fatigue, and soreness for 36 hours. Pain at injection site, moreso than 1st injection.

Within an hr after vaccination I had pain at injection site, fever, chills, headache for 2 days and tested positive for covid-19.

Fever/chills/night sweats for 1 day, body aches, injection site pain, nausea for 3 days, headache for 3 days, all resolved. Two doses of 1000 mg acetaminophen needed to resolve fever.

01/11/2021 Pt. reported to facility with c/o hives from his waist down, swollen lips and diarrhea. Instructed to take PO OTC Benadryl and report to ED if symptoms worsen Dx: Acute Urticaria

Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Minor Rash/Itching/Shakiness on left side, followed by trouble breathing; symptoms lasted 1 day

Injection site: soreness, rash/warmth/itchiness; Injection site: soreness, rash/warmth/itchiness; Injection site: soreness, rash/warmth/itchiness; Injection site: soreness, rash/warmth/itchiness; Tiredness; This is a spontaneous report from a contactable healthcare professional, the patient. This 28 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284 ), dose 1 , single dose via an unspecified route of administration in the left arm on 06Jan2021 at 12:00 PM (at the age of 28 years-old) for COVID-19 vaccination. There was no relevant medical history reported. The patient had allergies to non-steroidal anti-inflammatories (NSAIDS). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included alprazolam, lacosamide (VIMPAT) and pantoprazole. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Jan2021 at 12:00 PM, the patient experienced injection site soreness, rash/warmth/itchiness and tiredness all improving over 3 days. The report was reported as non-serious. The patient was treated for injection site soreness, rash/warmth and itchiness with acetaminophen. The clinical outcome of injection site soreness, rash/warmth/itchiness and tiredness was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Pain at injection site; high persistent fever; Chills; Nausea; Severe headache; Diffuse aches; This is a spontaneous report from a contactable physician (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1284), intramuscularly in the left arm, on 08Jan2021 at 16:45 (at the age of 28-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 22Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced pain at injection site, high persistent fever, chills, nausea, severe headache, and diffuse aches on 09Jan2021 at 06:00. The events were reported as non-serious. The events were reported to have started 12 hours after vaccination. The patient did not receive any treatment for the events. The clinical outcome of pain at injection site, high persistent fever, chills, nausea, severe headache, and diffuse aches was recovered in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Developed Rash on bilat arms, small red scattered bumps. No difficulty breathing, or other symptoms. VSS BP 126/88 HR93 (states he always has an elevated HR) O2 sat 100% at 15:05pm. rapid response team called - assess pt - pt declined to go to ER, waited additional 20 minutes. VS at 1530 122/77 HR 91 O2 sat 100%

Tenderness at injection site lasting ~36 hours Noted weakness and loss in dexterity in hand Feeling of swelling in hand Pins and needles sensation in full arm and extending through fingers

Fatigue, following by chills, fever, sweating, shivering, headache. Felt like vomiting, but didn't. Slight pain at injection site. Fatigue and headache lasted about 3 days. Fever lasted about 24-36 hours. Missed 2 days of work.

1st shot of Pfizer-BioNTech: 12/29/2020, left shoulder: marginal shoulder pain from 12/29 to 12/31, no further swellings (ek9231) 2nd shot of Pfizer-BioNTech: 01/22/2020, also left shoulder (el3247): less shoulder pain throughout; feeling that it "spreads" from injection side to left side of the neck in the following hour; on the 01/24 in the morning, palpable swollen lymph node with accompanying calor and dolor right on top of the left clavicular bone; 01/25 swelling reduced, calor and dolor mostly gone but lymph node still palpable No additional drugs taken and on a scale of 0 to 10 maybe a 2/10 causing discomfort

developed itchy papule rash back of R hand 12/27/20, on 12/30/20 migrating muscle aches, weakness, fatigue, 1/1/21 itch/pink rash back R elbow and ant. knees; no resp/thrt, no GI ,improved 1/5/21 , now 75% better, tested 31st and 4th negative covid,

Patient complained of itchiness around the injection site. Observation nurse pulled aside patient and conducted vitals and performed is back, assessment of patients skin. Assessment found some redness around the patients upper arm and on his back. Patient recieved 25mg IM of benedryl will good effects. Patient was monitored for 45 minutes, rash did not spread and benedryl relieved itchiing.

Hives from neck down to elbow on left side. Wet cough, chest pain over sternum and on left side llq on coughing. Fatigue, arm pain, localized swelling/inflammation.

a rash all over my body with yellowish raised skin/bumps; a rash all over my body with yellowish raised skin/bumps; Severe shivering and chills; 5 different fevers; Body aches; Headache; Loss of appetite; Fatigue; This is a spontaneous report from a contactable other HCP reporting for himself. A 28-years-old male patient received the second dose of bnt162b2 (BNT162B2; Lot # EK9231) vaccine , via an unspecified route of administration in the left arm on 05Jan2021 at single dose for covid-19 immunisation . Medical history included , type 2 diabetes mellitus , sinus arrhythmia, gout. Concomitant medication included atenolol (ATENOLOL). The patient previously took lisinopril and experienced drug hypersensitivity, on 15Dec2020 the patient received the first dose of bnt162b2 for covid-19 immunisation and complained from headache, and hyperhidrosis. The patient experienced severe shivering and chills on 05Jan2021 23:30 with outcome of recovering , fevers on 05Jan2021 23:30 with outcome of recovering , body aches on 05Jan2021 23:30 with outcome of recovering , headache on 05Jan2021 23:30 with outcome of recovering , loss of appetite on 05Jan2021 23:30 with outcome of recovering , fatigue on 05Jan2021 23:30 with outcome of recovering , a rash all over my body with yellowish raised skin/bumps on 21Jan2021 with outcome of recovering. The patient received Prednisone and Benadryl as treatment. No follow-up attempts are possible. No further information is expected.

Sore arm near injection site and throughout arm; minor numbness in elbow and fingers; Sore arm near injection site and throughout arm; This is a spontaneous report from a contactable consumer reported for himself. A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration in left arm on 25Jan2021 14:15 at first single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. No other medical history. No other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm near injection site and throughout arm including minor numbness in elbow and fingers. Adverse event start date: 25Jan2021 04:30 PM. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.

Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Patient developed a redness on face and neck which was described as a rash.-Mild, Additional Details: Two hours after the administration of the vaccine, the patient developed redness on his face and upper body. Within 20 minutes, the redness was subsiding without any treatment or intervention. The facility was continuing to monitor the patient.

Soreness, not pain, at injection site on upper left arm for approximately 24 hours, tiredness beginning one hour following injection, but resolved after approximately 3 hours of sleep.

Soreness at injection site; Following morning experienced headache and fatigue throughout day; Following morning experienced headache and fatigue throughout day; queasiness; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248, Expiry date: unknown) at 28 years of age via an unspecified route of administration on the right arm on 01Feb2021 at 09:15 am at a single dose for COVID-19 immunisation. Medical history and some surgeries were none. The patient has no allergies to medications, food, or other products. Concomitant medications included fluticasone propionate (50mcg) nasal spray and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took the first dose of BNT162B2 (lot number: EL3248, expiry date: unknown) on 12Jan2021 at 08:30 am on left arm for COVID-19 immunisation. The patient experienced soreness at injection site. Following morning experienced headache and fatigue throughout day. Some queasiness possibly related to vaccine. Following day, it was reported that the only remaining symptom is a slight headache. The events were assessed as non-serious by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events. The patient was recovering from the events.

Soreness at the injection site/tenderness of arm; Soreness at the injection site/tenderness of arm; This is a spontaneous report from a contactable consumer (patient). This 28 -year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration, on 11Feb2021 (at 15:45) at a single dose on right arm for COVID-19 immunisation, administered at Workplace clinic. No relevant medical history and concomitant medications were provided. No known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 before vaccine. On 11Feb2021 (at 22:00), the patient had soreness at the injection site/tenderness of arm. The events were reported as non-serious. Post vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.

pt experiencing rash to trunk, neck, back, swelling to lower lip and left toes. pt received 50 mg po benadryl, 50 mg iv benadryl, epi 0.3 mg IM left thigh, iv, ns 1 liter IV

COVID-19 Vaccine Reaction Vaccine administered: Pfizer dose 2/2 Patient reaction, action taken, & outcome: 1206 - 2nd Pfizer dose given 1212 - Syncopal w/ fall forward w/ abrasion/contusion injury to left orbital area while walking from vaccination area to observation area. Diaphoretic. Pale. Lightheaded. 1215 - placed on stretcher and brought to triage area. BP 92/55, RR 28, HR 86, SpO2 96. Gave OJ and water. 1220 - BP 94/64, RR 26, HR 90, SpO2 96 1223 - BP 115/73, RR 26, HR 96, SpO2 97 1226 - BP 121/71, RR 20, HR 96, SpO2 96. Sitting EOB. 1335 - BP 98/59, RR 22, HR 85, SpO2 95. Lightheaded again. Gave OJ and laid back down. No longer pale or diaphoretic now, but neck becoming sore. 1240 - BP 114/67, RR 20, HR 80, SpO2 97 1246 - BP 117/67, HR 77 Sitting EOB MD lead at bedside directing care throughout and d/ced patient at 1300 w/ info about concussions and after ambulation.

Fine macular rash over torso, arms, and neck. Not itchy or painful. Treated with IM benadryl. Pt monitored for 2 hours without improvement or worsening of rash. No other symptoms.

Headache; Low grade fever; Nausea; Diarrhea; Sore injection site; Dose 1 administration date:21Jan2021/ Dose 2 administration date:04Feb2021.; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL3248), via an unspecified route of administration on right arm on 04Feb2021 at 14:00 (at the age of 28years) at single dose for covid-19 immunization. Medical history included asthma. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and an unspecified multivitamin which were received within 2 weeks. Historical vaccine included first dose of bnt162b2 (lot: EL3248) on left arm on 21Jan2021 at 16:30 (at the age of 28years) for COVID-19 immunization. On 05Feb2021 at 12:00, the patient experienced headache, low grade fever, nausea, diarrhea, and sore injection site. No treatment was received for the adverse event. The events were considered by the patient as non-serious as did not results in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no Congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered at the workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events headache, pyrexia, nausea, diarrhoea and vaccination site pain was recovered in Feb2021.

I had dermatitis reaction. My body was full of itchy and painful rash followed by weakness and body aches. Treatment: Benadryl 1 tablet single dose.

Full body rash, itchy, pins and needle feeling all over the body. Some joint pain. Noticed the day after the second shot. Got progressively worse over the next day. I Saw PCP Doctor Friday and Dermatologist On Monday. The treatment has been bed rest, 4mg MethlPREDNISolone and Clobetasol 0.05%. Some of the rash is clearing up.

Sore arm at injection site; Joint pain in my knees; Tiredness and fatigue.; This is a spontaneous report from a non-contactable consumer, the patient. A 28-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3247) via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 11:30 (at the age of 28-years-old) as SINGLE DOSE for covid-19 immunization. Facility in which vaccine was administered was a Workplace clinic Medical history included Known allergies: Penicillin. Concomitant medication included paracetamol (TYLENOL). Historical Data includes BNT162B2 Dose 1, Lot number: EL3247, Administered on 22Jan2021 at 12:00, in the Left arm for covid-19 immunization. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 12Feb2021 at 16:00 The patient experienced sore arm at injection site, joint pain in my knees, tiredness and fatigue. The events were considered non serious. No treatment was given for the events. The clinical outcome of the events sore arm at injection site, joint pain in my knees, tiredness and fatigue were recovering. No follow up attempts are possible. No further information is expected.

migraine; Fever; mild chills/uncontrollable heavy shivering; cold sweats; Mild muscle pain at injection site; This is a spontaneous report from a contactable healthcare professional (the patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration in the left arm on 14Feb2021 07:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: ADHD (attention deficit hyperactivity disorder), severe migraine, unknown vestibular event in June-Jul2020 attributed to vestibular migraines based on normal CT, MRI, and EEG. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), amitriptyline, caffeine/ paracetamol (EXCEDRIN), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL4262), via an unspecified route of administration in the left arm on 26Jan2021 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Feb2021, the patient experienced mild muscle pain at injection site onset 1 hour after injection (at 08:30) lasted about 24 hours. At 01:20 on 15Feb2021, also reported as 17 hours 10 minutes post-injection, the patient woke up with mild chills, temperature (oral thermometer) was 97.6°F. Chills and cold sweats progressed rapidly, with severe chills and uncontrollable heavy shivering and sweating present within 10-15 minutes (on 15Feb2021). Temperature at 02:00 15Feb2021 was 103.0°F. Fever slowly waned without medication. By 04:30, fever at 101.2°F, chills mild, sweating persisted. At 07:00 15Feb2021, the patient started to develop early stages of migraine (preexisting condition), took EXCEDRIN 565 mg tablet x 2. At 08:00 15Feb2021, the temperature was 98.2°F. By 10:00 15Feb2021, the fever resolved, temperature 97.6 (individual baseline) and chills had resolved. Sweating has improved to be more mild, but persistent now at 16:30 15Feb2021. Treatment was received for migraine. No treatment was received for the other events. The clinical outcome of mild muscle pain at injection site was recovered on 15Feb2021 08:30, chills and fever both recovered on 15Feb2021 10:00. The clinical outcome of cold sweats and migraine was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: shaking-Mild, Systemic: Shakiness-Mild

Mother called to report information for son. All information documented was information obtained. Luanne counseled to have son contact PCP for further recommendation. 04/02/2021, symptom of nausea, headache and feeling flushed instantly after receiving the vaccine. Client did not report symptoms or wait 15 minutes prior to leaving mass clinic. Symptoms on 04/02/2021 were resolved by morning of 04/03/2021. On 04/04/2021, client woke with swollen eyes and red blotches to face. Client took 50mg of Benadryl, 3 times on 04/04/2021. Symptoms improved over the day, but did not resolve.

Patient had vaso vagal episode 1-2 minutes after receiving the vaccine in the left arm. He was operating his vehicle and crashed into another parked car. When I arrived to the patient he was alert and oriented, not in any acute distress, he did suffer a minor abrasion on the left arm. Patients vitals were stable during his stay in observation.

RNs x 2 responded to pt's vehicle c/o nausea, left arm tingling. RN reported pt was visibly "panicked " and self-reports he "passed out twice:" after seeing blood after getting vaccine. RN reported pt had small of blood on bandaid. Reports history of anxiety, especially r/l blood needles

. Pfizer dose 1 on 3/30. Just had sore arm. Symptoms dizziness began on 4/3. Otherwise feeling well. Labs drawn 4/5 which revealed pancytopenia, rechecked today and numbers are worsening. Working to get him into hematology now. 28 yo male s/p Covid-19 Vaccine (Pfizer) on 3/30 with lightheadedness only when bending down and coming up returns for follow up today for pancytopenia found on labs obtained 4/5. He denies any recent viral symptoms. He did not have any episodes in past that made him question that he may have had Covid-19 viral illness. He is able to tolerate his normal daily exercise and bike without any symptoms. He has no dietary restrictions, eats dairy, meat, lots of vegetables/fruits, pastas and some breads/cereals. He drinks alcohol once per week. He abstains from ETOH every April. He has used edible THC in past, only once per month at most. He has not been tested for HIV in past. His girlfriend, in last semester of school advised him to ask about HIV testing. He denies any chest pain, SOB, HA. Upon review of his lab results yesterday, I called the hematology fellow, Dr. through program at hospital and he recommended the labs to be obtained and rechecking labs in one week. He felt the student was not exhibiting any emergent symptoms requiring emergent evaluation. Patient and I spoke on phone after this call with fell at 1557 4/6 and I advised him to seek emergent medical eval in ED for any CP, SOB, HA or any neurologic symptoms. Patient has not had any of those symptoms. He exercised this morning without difficulty. He notes raised papules on legs which he has had in past. They have currently been present for a few days. He believes it to be related to biking in sweatpants. He has been in a hot tub recently, but after the bumps were present. They do not itch. He has had them in past, more in winter months with heavier clothing. He also notices slight left arm pain today. This was site of his vaccine. He denies any swollen lymph nodes. He is notices only with arm movement. He denies any FH of blood disorder/ blood cancers/MDS. He denies bruising, bleeding or dark stools. He states he likely has not had a blood draw in past, unless one visit to ER, for HA/concussion in high school (9+yrs ago) resulted in any blood test.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Fainted due to fear of needles-Medium, Additional Details: Patient has fear of needles and passed out after administration- EMS called to assess him and he was cleared to go home. No pain at injection site, no adverse effects from vaccine

Almost immediately after receiving the vaccine, I started having really bad blepharospasms which I had not had for about a month and started having general shaking throughout, but especially in my legs. Much of these side-effects began to subside upon the self-administration of clonezepam, but not completely There is a still a lot of pain at the injection site as well as fatigue

Headache started next morning. Very severe headache. The next day fever and chills developed along with severe fatigue and swelling in left arm (vaccination site)

Soreness at the place of injection beginning around 12:10 pm, stomach ache beginning around 7:00 pm, followed almost immediately by tingly feeling in arms and legs. Lost movement below the elbow for 3-5 minutes around 7:15 pm. By loss of movement, I mean my fingers tensed up, fully extended, and I was unable to relax or move them at all.

Dry skin rashes on the opposite side of the palm of my hand (knuckles area) . Tired , mild fever, headache

Diffuse pruritic rash on face, upper back, chest, and arms. Patient woke up with the rash, which seemed to get better as the day went by, but then the next night woke up with significant itchiness due to flare-up of rash again. At time of appointment (within 48 hours of initial rash), diffuse patchy erythematous blanching noted.

Blurred vision; Face and skin are red; Lips tingling; feeling slightly itchy at the injection site after the vaccine/Itching all over his head, scalp, arms and hands, everything; Hives; Tongue and lip swelling/Tongue was starting to swell; Tongue and lip swelling; Shortness of breath; Tachycardia; Anaphylactic shock/anaphylactic reaction; Still has a rash and is itchy/break out rash and get itchy again; Not really wanting to eat dinner; I got home my arm had swollen/Whole arm and hand were swollen; I started feeling slightly itchy at the injection site after the vaccine; Nausea; This is a spontaneous report received from a contactable consumers and other Health Professional. This is a report combining information from duplicate reports 2021372891 and 2021368246. The current and all subsequent information will be reported under manufacturer report number 2021368246. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; lot number : EP7533), dose 1 intramuscular, administered in Arm Left on 02Apr2021 11:30 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation. Medical history included Sleep Apnea ongoing; idiopathic hypersomnia ongoing; High blood pressure (They want to treat her husband for high blood pressure but they don't want to do that until after these reactions. She clarifies he was having issues with high blood pressure prior to getting the vaccine); Little overweight. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from 2020 and ongoing 20 mg, 1x/day; modafinil from 2019 ongoing 200 mg, 1x/day for Idiopathic hyposomnia for Sleep apnea. patient got the first dose of the vaccine on Friday and within 30 minutes, went into anaphylactic shock and was taken to the local emergency room after being administered Benadryl and an EpiPen without any kind of changes. He was discharged and then on Sunday night, he went into anaphylactic shock again and was taken back to the ER after once again being administered Benadryl and an EpiPen. Now, he was kind of starting to break out in a rash again. This has thrown them for a loop because most of the time they had heard that more severe reactions come with the second dose. She confirms this was her husband first dose. Her husband had sat at Pharmacy for the required 15 minutes and he was feeling a little itchy around the vaccine site. It was just around the site, so they left. In the 10 minutes to get home, he started itching all over his head, scalp, arms and hands, everything (02Apr2021). they looked at his site and his entire arm was starting to swell and there was a rash that had gone all the way down his arm. her husband whole arm and hand were swollen and his tongue was starting to swell. He was administered liquid Benadryl and the Epi shot, He was brought to the emergency room at the hospital. He went home after going to the ER. Her husband had another anaphylactic reaction last night. He hasn't had any new foods or exposure to anything. states that they did say it was possible to have a relapse but that it was rare. He had presented slightly differently but kind of similar. It started with him feeling nauseated and not really wanting to eat dinner. He went upstairs to shower and he started to get itchy again. So, she administered 50ml of liquid Benadryl to just get it into his system and then about 10 minutes later, it was not really having any effect and his tongue and stuff started tingling. She looked at his tongue and his tongue was starting to swell again. So, that's when she administered the EpiPen and 911 was called. Her husband was brought to the Emergency room again and was discharged a few hours later. They didn't keep him overnight for observation or anything. states he is still experiencing blurred vision, red skin, and chest is still red a little bit at the top, and his face is red. His lips are started to tingle but was not interfering with his breathing yet, shortness of breath, tachycardia 02Apr2021. Caller states that about 1 hour ago, patient took one tablet of Benadryl and was given 20ml liquid Benadryl 15 minutes ago. Tests: X-ray was clear (Negative), blood work came back normal. She just feels like its getting to the point where everything is just being prolonged. When they went to the ER, he was been on Benadryl, EpiPens, they provided him steroids, Oxygen, Prednisone, Pepcid to try and prolong the effects of the Benadryl and it doesn't seem like anything is working. patient started feeling slightly itchy at the injection site after the vaccine. I waited the 15 minutes after the injection without having any serious side effects. By the time I got home, my arm had swollen and developed hives 02Apr2021. received Benadryl and an Epi pen. By that time, the rash and hives had spread throughout my body, and my arm, hand, and tongue had swollen. was having trouble breathing and was taken to the ER. On Sunday evening, had a relapse and it started with nausea. Within 30 minutes, was itchy and my tongue started swelling. Patient had Blurred vision; Face and skin are red; Lips tingling; Not really wanting to eat dinner on 05Apr2021; the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; List of any other medications the patient received within 2 weeks of vaccination: Adderall; Prior to vaccination, the patient diagnosed with COVID-19 was Unknown; Since the vaccination, the patient not tested for COVID19, The patient received treatment for all events except events blurred vision; face and skin are red; tingling lips; appetite lost. The outcome of the events blurred vision; face and skin are red; tingling lips; appetite lost was unknown; rest of the events was not recovered.

seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; blood pressure spiked to higher than normal levels; nauseous; weakness on my left side; pain at the injection site; pain at the injection site, my back, and neck; pain at the injection site, my back, and neck; feel super tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 06Apr2021 11:15 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included axenfeld reigers, bilateral congenital iris coloboma, bilateral glaucoma, hearing loss. Known allergies: peanut, albuterol, amoxicillin-pot clavulante, doxycycline, fentanyl, levosalbutamol (LEVALBUTEROL), oxycodone-acetaminophin, sedation. Concomitant medications in two weeks: cryofood (unspecific), folic acid, cyanocobalamin (B12), timolol and dorzolamide hydrochloride/timolol, all from unknown date for unknown indication. First, patient had a weird metal or acidic taste in mouth. Following that, patient felt heavy. Next, began to feel shaky having back spasms. His blood pressure spiked to higher than normal levels and started feeling shakey dropped. Patient was laid down by nursing staff and blood pressure dropped. After being laid down, patient started having seizures/convulsions, paramedics were called and patient was given midazolam hydrochloride (VERSED, anti-seizure meds) and was taken to the ER (emergency room). Once patient arrived at the ER, he felt nauseous and was given anti-nausea medication, after about 4 hours patient was released. But he was experiencing weakness on left side and pain at the injection site, back, and neck, and felt super tired. AEs onset at 11:30 of 06Apr2021. Outcome of the events was resolving. Patient had no COVID prior vaccination and had no COVID tested post vaccination.

Client received vaccine, no issue. While in observation room, felt light headed, fell off chair and hit his head on contact with floor. Bump on Left forehead and small laceration left ear. vss. Transferred to hospital by EMS

Onset of arm heaviness 45 min after injection Mild fatigue 4 hours after injection Arm swelled x2 in size, retained small amount of fluid 24 hrs after injection Arm swelling down by half, bruising of underside of arm/armpit 48 hrs after injection Eyelids slightly blue in hue/appearing almost bruised 72 hrs after injection Days 4-6 mild to moderate fatigue, difficulty sleeping Day 7 moderate sore throat

~5 minutes after administration of vaccine, patient returned to vaccinator to report firm area around vaccine site. RN noticed patient began to waiver and witnessed patient syncope (no trauma/fall) - patient helped to ground. full LOC and decorticate posturing and tonic clonic activity <5 seconds; immediate return to consciousness; RN provided pillow/legs raised; patient talking and laughing with nurse shortly after return to consciousness. monitored for an additional 30 minutes, water and cookie provided. patient stable to leave home with family member. No medications or other treatment provided to patient. all vitals WNL.

afraid to take second dose of Pfizer COVID-19 vaccine due to the events; brain fog every single day; kind of off and uneasy; body aches; slight dizziness not like he was going to fall over, but cant stand still without lean a little/felt immediate rush to the head and feeling of fainting; very weird like an out of body experience this was almost like an anxiety attack/anxiety attacks for every 30 minutes or so; tension headaches; Chills; tunnel vision/tunneled, it was like tunnel vision and a very very weird like an out of body experience this was almost like an anxiety attack; it was extremely intense; pain at the injection; insane rush from the bottom of his feet to the top of head, felt like he was going to pass out; weakness; This is a spontaneous report from a contactable consumer (Patient). A 28-year-old male patient received first dose of BNT162B2 (Pfizer COVID Vaccine, solution for injection, Lot Number: ER8733; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 28Mar2021 at 17:00 (at the age of 28 years-old) as single dose for COVID-19 immunization. Medical history included ongoing asthma, anxiety experienced years and years ago when he was about 19-20 years old and it has been under control, he hasn't had this happen in years. The patient mother suffers from slight anxiety at times; dad currently has high blood pressure. Concomitant medication included albuterol sulfate taken for asthma (in inhalation (90mcg per actuation 200 metered inhalations: 2 puffs as needed) and liquid form (0.083% 2.5 mg out of 3ml as needed) for nebulizer since he was born). Patient did not have COVID prior vaccination. Patient did not want to contract COVID-19 because he has asthma. On 28Mar2021 at 17:00 (within 5 minutes of vaccination), patient experienced Tunnel Vision, chills, weakness, insane rush from the bottom of his feet to the top of head, felt like he was going to pass out (which was recovered same day with lasting effects), weakness, hasn't felt the same; feels like something is off every day; not himself, very weird like an out of body experience this was almost like an anxiety attack/anxiety attacks for every 30 minutes or so, tension headaches, dizziness and felt immediate rush to the head and feeling of fainting, at 8PM or 9PM, he felt pain at the injection and body aches. The patient visited physician room as a result of Insane tension headaches, and anxiety. On 29Mar2021, he didn't really feel too anxious, but he felt out of place, kind of off and uneasy. The chills and body aches, kind of off and uneasy were disappeared on 30Mar2021. On 31Mar2021, brain fog and slight dizziness does not like he was going to fall over but cant stand still without lean a little/felt immediate rush to the head and feeling of fainting. On 02Apr2021, injection site pain was gradually faded away. The patient states that these events started after the Pfizer COVID 19 vaccine. Therapeutic measures were taken as a result of events included Tylenol. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal swab): Pending on 06Apr2021. The patient did not take any other vaccinations four weeks prior to vaccination. The patient was afraid to take second dose of Pfizer COVID-19 vaccine due to the events. Patient felt very hard to work with these symptoms and to get through everyday life, it is very tough. Patient knows plenty of people that died from COVID-19 and he does not want to have to make changes and fix things in his life that he did not cause and worries this will stick around for the rest of his life all because he took a vaccine. The patient had physician office and Emergency room visit. The outcome of the events insane rush from the bottom of his feet to the top of head, felt like he was going to pass out, pain at the injection, chills and body aches were recovered, while for tension headaches, anxiety attacks, dizziness, weakness, brain fog, hasn't felt the same; feels like something is off every day; not himself was not recovered, and for tunnel vision it was unknown. Information on the lot/batch number has been requested.

Blood clots in stool, weird bloody stringy thing, rash on left arm that appeared days earlier and hasn't gone away.

patient called the observation nurse 1323, explained that he felt a rash on his back. Patient disclosed he has had anaphylaxis shock on previous vaccines and disclosed his allergies (benedryl included). Patient stated that tylenol has helped on previous symptoms. 1325 tylenol was adminsitered, symptoms subsided. Patient stated he was still feeling like the rash was moving up to his neck. My recommendation was to administered an EPi-pen. Patient declined treatment and stated EPI=pen gave more adverse effects. At this time I recommended calling EMS for further evualtion, patient declined and signed an AMA form.

Patient developed redness/hives all over body and face. States this usually occurs when he eats certain foods and/or is stressed. States his breathing/airways are fine. Checked lips and tongue, which were normal and not swollen.

Hives began to show up on my face and scalp and progressed to entire body in 2 weeks post vaccination

Two lumps above clavicle suspected to be swollen lymph nodes on the left side (same side of vaccine injection). One lump is soft and moveable, and one is pea sized and it is firm and also moveable. Both lumps are painless. Discomfort and tension on the side of the neck where the swollen lymph nodes are. I noticed the lumps about two weeks after the first vaccine dose. The day after the second dose, the lumps swelled a bit more and neck tension increased.

Patient got second dose of Pfizer of left upper arm. He immediately started to swelling at injection site about 2cm round fluctuant lump. No SOB, dizziness, CP, itchiness,no TTP, AAOx4. VS obtained 1730: BP=106/70 HR:70 O2Sat=97% on RA. Discussed with pt to get PO benadryl/famotadine. Pt declined all medications. Place ice pack on injection site. Repeat VS: 1745 118/74 HR 77 O2 Sat 97% on RA AAOx4. Reassess site: site lump decreased to 1/2 cm, no TTP, redness, itchiness, SOB , CP, dizziness. Notified pt's boss: himself. Pt stating, "I feel fine."

I started with significant pain in my left arm at the site of injection the day after injection. The day after I had significant swelling and pain in the lymph nodes in my axilla. This pain last for 3 days. After the pain in axilla resolved I started with significant post nasal drainage. So, 4 days after my shot I developed cold/flu like symptoms. These were very similar to the symptoms I had after actually contracting covid 19. These symptoms have now been present for 4 days. I have no chills or fever. I have had aches, severe sore throat, sinus pressure, nasal congestion.

Sparse and itchy hives developed around both forearm, both knees, and both ankles. Injection site has a not-so-itchy small red bump.

Patient received vaccination and was sitting in pharmacy for the 15 minutes to be monitored. After sitting in chair for 5 minutes patient became faint and fell out of chair and hit side of head on ground. Patient sustained cut to his right eye as well as swelling. Patient was given Ice pack to control swelling and stayed in pharmacy for an additional 20 minutes where he was closely monitored. Patient did make decision to get up and leave and was able to walk out on his own.

woke up 3 AM Friday was sore, ache, chills, the small blister noted that Friday evening injection site bump small blemish- scratched and it "popped" similar to a sunburn, it's flat now but a little itchy. Sore arm, body ache, chills - this is resolved 5/4-Placed follow-up call, pt reports that on the left arm the bump went down and not as raised as before, and it is not spreading and not painful. Pt reports took Tylenol ES and drank a lot of powerade and that helped. Pfizer 1st dose 4/8/2021 @ 1630 LOT#: EW0153. Recommend that if it gets itchy or red an apply topical otc anti-itch cream as needed.

I woke up the day after my first shot with severe eczema covering both hands, with particular intensity on the fingers. The eczema appeared to get worse over the next day or so, but receded around day 3 or 4, leaving completely about a week after the shot. A few days after the shot, I also began developing a light full body rash, particularly on the sides of my torso. Eventually, after everything faded, I began getting some peeling skin on my fingers, which I assume were caused by the eczema. I went to urgent care when this rash appeared. Here were her notes: With patient having a recent diagnosis of strep, opted to order a group A strep test that was negative. Patient did not have any exudate noted in the OP. Patient's rash did start after having the COVID-19 vaccine. We will have patient continue to monitor for any increasing symptoms. If symptoms fail to improve or worsen over the next week, will have patient return to the urgent care or follow-up with his primary care provider for further evaluation and treatment. Patient may apply lubricating lotion over the areas. He stated that it was not itchy except for on the hands. He may apply calamine ointment or Benadryl cream to the areas of irritation.

Within 15 minutes, light headed and slight nausea, deeveloping small rash on right arm Within 60 minutes, migraine, nausea, slight chest pain, HBP, fever Within 8 hours, migraines, nausea, body aches, fatigue, fever With 24 hours, migraines, nausea, body aches, fatigue,on/off fever

Pt fainted & fell on L/side of forehead on floor. Regained consciousnes after 1 minute & taken to Obervation area per w/c to lie down. BP116/68 P 60 R 16. Hx of hypertension & seasonal allergies. Abrasion on L/side of forehead cleaned & iced. Pt talked about having a concussion in high school resulting in memory loss & out of school for 3 months. 1:50 pm Continued to be "sweaty" after 10 minutes while lying down. BP 114/75 P 54 2:40 Left walking w/o assistance. Head injury instructions given.

sore upper right arm which is where the injection took place; This is a spontaneous report from a contactable consumer (patient). A 28-year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number and expiry dates were UNKNOWN), via an unspecified route of administration in the right arm on 28Jan2021 at 13:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. On 28Jan2021 at 18:15, the patient experienced sore upper right arm which was where the injection took place. The patient did not receive any treatment for the event. The outcome of event the sore upper right arm which is where the injection took place was unknown. Follow-up attempts have been completed and no further information is expected.

On May 13 (3 Weeks after first covid vaccine shot), I started to feel skin pain on the area above right kneecap. Then I felt nerve pain on the same side of leg. May 14 I couldn't sit down as I felt occasional lumbar pain. I even went to orthopedics and they said no trouble found. Skin pain spread through the whole body. May 15 I had second shot of pfizer, still back pain and thigh pain. Skin pain spread through whole body. May 16 I saw red spots begin to surface on the thigh. Skin pain spread through whole body. May 17 red spot became bigger I thought it was rash, pain persists. May 18 the red spots looks out of control, I scheduled the next available appointment for primary care (2days later!) May 19 Just bigger red spots every time I take off my pants. May 20 black bubbles appeared in the morning, and I got to finally go to appointment at noon, diagnosed as shingles.

Patient presented to hospital 5/22 for acute psychiatric emergency. At the time of admission basic labs where obtained and were significant for platelet count of 4,000 (rest of complete blood count unremarkable). Medications and infectious history reviewed and were unremarkable. He has significant ecchymoses and petechiae on initial physical exam. He was started on treatment for Immune Thrombocytopenic Purpura with dexamethasone and Intravenous IgG with significant improvement in platelet count to over 100K.

Bruising at injection site - starting day of lasting 2+days Headache/body aches- starting day of lasting 36 hours Fatigue- staring day of lasting 24 hours

This is a spontaneous report from a contactable consumer. A 28-years-old male patient received second dose of BNT162B2 (COVID-19 VACCINE, Batch/Lot Number: EW0183, Expiration Date: 31Aug2021) via an unspecified route of administration, administered in Arm Left on 15May2021 16:00) as 2nd dose single dose for COVID-19 immunization. The patient medical history included seasonal allergies (From Unspecified to Ongoing) around 10 or 11 years old and allergic tree pollen mainly, cedar trees and animal fur. The patient concomitant medications included 0.4mg oral tamsulosin HCL taken for kidney stone from 03May2021 to 13May2021, hydrocodone and acetaminophen taken for renal pain from 03May2021 to 13May2021 (patient only took when he was in drastic pain (pain for kidney stone). Not as a daily medication), 10mg oral cetirizine hydrochloride (ZYRTEC ALLERGY) for seasonal allergies so that he can breathe normally, oxymetazoline hydrochloride (CLARITIN ALLERGIC) taken for seasonal allergy, allergy to animal (start and stop date were not reported), paracetamol (TYLENOL). Patient previously received first dose of BNT162B2 (COVID-19 VACCINE, Batch/Lot Number: EW0172, Expiration Date: 31Aug2021) via an unspecified route of administration, administered in left upper arm on 24Apr2021 as 1st dose single dose for COVID-19 immunization. Patient diagnosed with kidney stone (from 24Apr2021 to 13May2021) same day evening when he got the first Covid-19 vaccine. Trying to stay hydrated, noticed a bit of pinkish red when he went to the bathroom, he thought it was just a side effect. Woke up with a lot of pain and after some testing, they told him he had a kidney stone. He was fighting a kidney stone and taking medication for span of time between first covid-19 vaccination and second vaccination. He doesn't think it is related. The doctor gave a couple medications just for monitoring things, the next day after 13May2021, he went for a CT and haven't felt anything since from the kidney stone. Prior to vaccination, patient was not diagnosed with COVID-19. On 15May2021, the patient had little bit of bleeding at injection site and he had treated with band aid. A couple days later when he took off the band-aid he noticed a yellow-green spot around the injection site and it's been there for about 9 days now. Caller wants to know if this discoloration is normal. Patient was generally healthy. He does not know if he has been asymptomatic or not. Willing to help others by getting the vaccine just in case. Patient stated he got covid-19 vaccine two Saturdays ago to be exact and he was feeling alright. There was only one thing that did concern him, and he was not sure if it was a minor side of effect or not. He noticed a yellow/green discoloration around injection site of where he got the vaccine. He was wondering if it was a normal side or something of an outlier. Patient was wondering if they can help him with this or should he go back to website with this. Event occurred with the second shot of vaccine. Around the area around where it was injected there was very light yellow/green and he was just wondering if it was normal for most vaccines because it has been a couple of days and he hasn't really noticed it change back to skin color and all that. Patient tried using google for side effects but he didn't see anything about his problem and searched the vaccine, green skin, yellow skin. It was pulling up information on skin rashes which he doesn't think that is the case because it is skin discoloration. Patient describes this as a small circle-ish blot on upper left arm. Since the vaccination, the patient not been tested for COVID-19. At the time of this report event vaccination site bleeding was recovered on 15May2021 and other events were not recovered. Follow up attempts are needed. Further information has been requested.

Patient reports twitching in left arm throughout day at vaccine site in tricep each day since first covid Pfizer vaccine. Patient reports twitching is getting better.

Slight soreness of injection site, Fever, Chills, Nausea, Headache, Fatigue Within 6 hours of Injection

Injection site sore; Intense headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 11Mar2021 15:30 (Lot Number: EN6204) (at the age of 28-years-old) as 1st dose, single dose for Covid-19 immunisation. Medical history included allergies: latex, tree nuts, shellfish, environmental allergens. The patient did not receive other vaccines in four weeks. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); diphenhydramine hydrochloride (BENADRYL); colecalciferol (D3); lamotrigine (LAMICTAL); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and zinc, all taken for an unspecified indication, start and stop date were not reported. The patient experienced injection site sore and intense headache on 12Mar2021. No treatment was received for the adverse events. The patient was not tested for COVID post vaccination. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Pain at the injection site from as soon as the needle went in to now, almost 2 months later. I can't lift items outside of a certain range. Sometimes the pain stops me from being able to close my car door with that arm.

Rash around the injection site; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), administered in left arm, on 07Mar2021 at 09:30 AM (at the age of 28-years-old) at 1st dose, single dose for COVID-19 immunisation. Medical history was not reported. The patient had not COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medication included triamcinolone injection (reported as other medications in two weeks). No other vaccine received in four weeks. The patient experienced rash around the injection site six days after the first dose of vaccine, on 13Mar2021 at 07:00 AM. No treatment was administered for the event. The patient was recovering from the event. No follow-up attempts are possible. No further information is expected.

Lightheaded(mild); Fatigue(mild); muscle pain at injection site(moderate); tingling in fingertips(mild); This is a spontaneous report from a contactable consumer or other non HCP (Patient, reported for self) A 28-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:15 as single dose for covid-19 immunization. (vaccination Facility: Other). Medical history was not reported. The patient concomitant medications were not reported. patient did not took any other vaccine in four weeks. Patient did not experience COVID prior to vaccination. No known allergies. Patient had no known allergies. Other medical history: None. On 05Feb2021 at 10:45 AM patient experienced Lightheaded(mild), Fatigue(mild) muscle pain at injection site(moderate) and tingling in fingertips(mild). Patient did not receive any treatment for the adverse events. Patient was not tested for COVID post vaccination. Outcome for the events was reported as Recovering. Follow-up attempts are completed. No further information is expected.

felt warm in forehead; forehead was red; rash in forehead/elbow and chest; little bumps in forehead; itch in forehead/elbows and chest; This is a spontaneous report received from a contactable consumer, the patient. A 28 years-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route administration in left arm on 19Mar2021 at 11:00, (at the age of 28-years-old) as a single dose, for COVID-19 immunisation. There was no medical history and no known allergies. The concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) that started on an unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. On 19Mar2021 at 11:30 (30-45 minutes after getting the vaccine), the patient started to get a rash in his forehead; At first, it felt warm and he did not notice it, until his wife pointed out that his forehead was red. After an hour, his forehead started to itch and after scratching it, little bumps started to emerged on his forehead. Later that night, the patient began to feel itchy in his elbows and chest. It was also reported, that the rash on the elbow and chest was smaller compared to the one in patients forehead. On 20Mar2021, (today, was the day after) the patient still had the rash in his forehead, elbow and chest. No treatment was received for the events. The clinical outcome of events rash in forehead/elbow and chest, felt warm in forehead, forehead was red, little bumps in forehead, itch in forehead/elbows and chest were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

on 7/8/21 , patient noticed soreness in his right arm when he moved his arm in a certain direction or position. he stated after vaccine administration on 6/18/21 his arm was sore for 2 days (he stated he experienced average soreness like with any vaccine). Soreness went away completely and had no complaints, but noticed soreness again on 7/8/21 ,around area of injection site on and also sometimes when lifting or rotating arm. He stated he did lift some boxes/totes recently at home and it's possible the soreness could be from that; however, the soreness seems to be in similar area where he received the vaccine 3 weeks ago.

Shingles; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8730), dose 2 via an unspecified route of administration, administered in right arm on 01Apr2021 16:00 (at the age of 28-year-old) as single dose for covid-19 immunisation at doctors office/urgent care. The patient medical history included ongoing selective IgA deficient and ongoing IBS (irritable bowel syndrome). The was not patient diagnosed with COVID-19, prior to vaccination. The patient concomitant medication included amoxicillin, received within 2 weeks of vaccination. The patient previously took codeine phosphate (CODINEX) and experienced allergies. Historical vaccine included dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6204) via an unspecified route of administration, administered in right arm on 11Mar2021 at 16:00 as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shingles on 24May2021. Adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event with antiviral medications. The had not patient been tested for COVID-19 since the vaccination. The outcome of the event was recovering. Follow-up attempts are completed. No further information is expected.

PATIENT GOT HIS VACCINE AND THEN WATCHED HIS GIRLFRIEND GET HER SHOT, PATIENT STATED HE SAW ME WITH THE NEEDLE AND GIVE IT TO HER AND THEN HE GOT SICK FEELING. PATIENT SAT ON FLOOR AND GOT HOT AND TURNED A GREENISH COLOR BEFORE PASSING OUT, PATIENT WAS IN AND OUT FOR ABOUT 2 MINUTES. PATIENT CAME TO AND JOKED ABOUT IT AND SAID THIS HAS HAPPENED BEFORE. PATIENT WANTED TO WALK OFF AND LEAVE, WE HAD HIM SET DOWN AND HIS GIRLFRIEND WENT TO GET WATER AND A SNACK FOR HIM. BEFORE SHE RETURNED HE FAINTED AGAIN AND I HELD HIM UP IN THE CHAIR. HE CAME TO AND STARTED FEELING BETTER. EMS ARRIVED AND CHECKED HIM OUT, PATIENT WAS TAKEN TO AMBULANCE TO BE CHECKED OUT MORE. GIRLFRIEND SAID THEY WOULD RELEASE HIM AFTER WATCHING HIM FOR 30 MINUTES.

Itching.; Random red rash appears on numerous parts of the body; feel headcrawling; This is a spontaneous report from contactable healthcare professional. A 28-year-old male patient received the second dose BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3249) via an unspecified route of administration in the left arm on 12Jan2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE: Lot number: EL0140) via an unspecified route of administration in the left arm on 23Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 12Jan2021 the patient experienced itching, red rash and crawling sensation. The patient had itching, a random red rash appeared on numerous parts of the body one month after receiving the second dose of the vaccine. The patient also felt head crawling. The event resulted in a doctor or other healthcare professional office/clinic visit. On an unknown date, post-vaccination, the patient underwent a COVID-19 virus test (nasal swab test) and resulted negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itching, red rash and crawling sensation were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

On June 25th, 2021 at around 4 A.M. I started feeling itchiness and warmth on my face, neck and arms. Shortly after I noticed red spots on my face, neck, elbows, and hands. Some of the red spots on my face and elbows were raised bumps that were itchy and other red spots were not raised or itchy. On the same day around 10 A.M., the spots on my face faded but others appeared around my knees that were warm to the touch and were raised and itchy. I took allergy medicine (Zyrtec) and applied anti-itch cream (Gold Bond) to the spots which helped with the itchiness and raised bumps but the red spots remained. The following day some of the spots faded on my neck and elbows but some had appeared on my legs, feet and chest. I continued taking the allergy medicine and cream until they completely faded away on like the 4th day, June 28th, 2021.

after the second dose of the vaccine, urticaria started to appear in a very strong way. I was too close to get in shock, I had to visit an emergency clinck. everything started after the second dose and since then it didn't go well. each day I had more symptoms

Soreness at the injection site as well as a light pink color; Soreness at the injection site as well as a light pink color; This is a spontaneous report received from a contactable consumer, the patient. A 28-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 08Mar2021 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to food, medications, or other products. The patient did not receive any 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 had not been tested for COVID-19. On 31Mar2021 at 15:00 (three weeks after first shot), the patient began to feel soreness at the injection site as well as a light pink color. There was no other side effects or reactions. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received treatment for the reported events. The clinical outcome of the event soreness at the injection site as well as a light pink color was unknown at the time of this report. No follow-up attempts are needed; information about lot number cannot be obtained.

After receiving his 1 dose of the shot, patient did not wait as requested for 15 minutes. He went to the gas station next to the pharmacy , and while he was about to pump for gas he had a seizure attack. Patient came to the pharmacy to inform me of the incident. Patient sustained minor cuts and bruises on his chin, leg and hands. I was able to dress his cut by applying band aid after wiping with alcohol wipes. I did follow up with patient today and he's doing well.

PATIENT STATES HE HAD FEVER, FELT TIRED & A HEADACHE FOR THE FORST 48 HOURS. STARTING ON 7/28/2021 HE DEVELOPED HIVES ON HIS HANDS, FEET & BACK. AS OF TODAY 7/29/2021 THE RASH IS NOT SPREADING BUT IS BECOMING MORE DENSE.

Pain and soreness at injection site beginning 5 hours post injection. At 3am on Jan 5th intense chills/sensitivity to temperature, coughing, waves of nausea, headache, and significant joint paint in arms, hands, and knees. Symptoms persisted until roughly 3pm that same day.

Nausea; Chills; Injection site pain; Tingling in his arm; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), via intramuscular, on 28Dec2020 at 13:15, at single dose for COVID-19 immunisation. Vaccine location was left arm. No relevant medical history and concomitant medications were provided. The patient was vaccinated at workplace clinic, age at vaccination was 29-year-old. No other vaccine was received in four weeks. On 29Dec2020, the patient reported normal side effects of nausea, chills, injection site pain. Patient also reported that he was experiencing tingling in his arm. No therapeutic measures were taken as result of the events. Pre-vaccination and post-vaccination COVID tests were not performed. The patient had not recovered from the events. No follow-up attempts are possible. No further information is expected.

Immediate induration without erythema or pain with needle retraction after vaccine given. Area marked with sharpe. Approximately the size of a nickel. A picture of the reaction site was taken with patient phone. He was encouraged to continue to document his reaction with more photos and report the reaction to vsafe patient was instructed to consult with his PCP if needed. He was instructed to seek immediate medical attention at urgent care or the emergency department if needed.

Chills started around 4AM while sleeping. Joint pain, malaise, headache, and localize pain at site of injection upon palpation upon awakening and still continues at the time of this writing (27 hours post-inoculation). No fever noted (99.3 F at 8AM). ONE Acetaminophen ER 650 mg TABLET was taken at 1PM.

Red flushing over the arms and face (upper). No treatment administered. Duration of event: (1 hr approx.)

At around 1:30 in the morning, i became really weak, achey, had the chills, some nausea, a minor headache, a slight sore throat, and minor eye pain like they were dry. Though i I felt terrible, the most concerning side effect was that my skin felt like it was extremely raw in patches all over my body where if my sheets lightly touched one of those ?patches?, it would be very painful. However, there was no rash or discoloration from what I could tell. I also had strange painful sensations at the ends of my toes but were different in quality relative to the hypersensitive/raw painful sensations on my skin. The adverse events kept me awake for hours but when I finally got to sleep and woke up the next morning. I only had chills, weakness, and acheyness which were much less in severity than those early morning hours. It is now 4:45 pm and the only adverse effect I am still feeling is the fatigue. Also, I forgot to mention it on the medication portion but I had taken 400 mg of ibuprofen about 15 minutes before receiving that second dose.

I lost all the hair at the top of my head. I was already slowly balding/ thinning. Two weeks after the injection my scalp felt like it was on fire and the hair started falling out in clumps easily.; I lost all the hair at the top of my head. I was already slowly balding/ thinning. Two weeks after the injection my scalp felt like it was on fire and the hair started falling out in clumps easily.; This is a spontaneous report from a contactable Other-HCP (patient). A 29-year-old male patient received BNT162B2 (Lot/Batch number and expiry date unknown), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included High blood pressure and depression, both from unknown date. Concomitant medication included venlafaxine and lamotrigine. On 30Dec2020, the patient lost all the hair at the top of her head. He was already slowly balding/thinning. Two weeks after the injection, his scalp felt like it was on fire and the hair started falling out in clumps easily. The hair has not grown back. The patient did not receive any treatment for the event. 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 outcome of the events was not recovered. Information on the lot/batch number has been requested.

Generalized Hives started 2 days after the vaccine. I never had any allergic reactions before. The rash did not respond to anti histamine medications. I started to take methylprednisolone tablets by today which seems to help a bit.

1500 pt received vaccine. 1502 pt reports facial and chest itching. Dr called and orders received for 50 mg Benadryl and 10 mg Zyrtec po. Pt took with water, no difficulty swallowing. 1505 BP 132/95, HR 86, O2 sat 97% on room air. Pt itching face, chest and upper arm. 1510 HR 87, O2 sat 97%, BP 130/89, reports facial itching. 1515 HR 92, BP 134/94, O2 sat 96%, reports itching is decreasing, swallowing without difficulty. 1519 pt reports right arm itching. 1525 HR 83, BP 124/91, O2 sat 97%. face itching continues, chest itching stopped. 1545 HR 77, BP 122/93, O2 sat 97%, reports less itching. Patient released at 1600 per physician orders. Pt educated on s/s reactions, reports he has Benadryl at home, spouse called and aware of itching reaction, pt verbalizes understanding when to seek medical care if needed.

Hives; itching; swelling of feet, hands; swelling of axilla, buttocks; redness on hips, worsening after 1 week after second dose; administration date: 17Dec2020 / administration date: 05Jan2021; fever; chills; fatigue; malaise; body aches; headache; tinnitus; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. Relevant medical history included known allergies to poison ivy/ poison oak. Concomitant medications included finasteride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021, at 20:00, after second dose, the patient experienced hives with itching and swelling of feet, hands, axilla, buttocks, redness on hips, worsening after 1 week after second dose. On an unspecified date in Jan2021, for a 3-day period after second dose, patient had fever, chills, fatigue, malaise, body aches, headache, tinnitus, all since resolved except hives worsening. The patient did not receive therapy for the events. Outcome of the event hives was not recovered, for event "administration date: 17Dec2020 / administration date: 05Jan2021" was unknown, while for the other events was recovered. The patient has not been tested for COVID-19 since vaccination.

Thursday evening, patient started having itchiness/redness to bilateral hands. No pain noted. Friday night he had rashes on/off. On 25 Jan, patient hasn't gotten better and decided to contact the medical group. Patient's rash has spread from hands to forearms. Bilateral feet with redness as well.

a mass grew within the muscle at the forearm region; minor pain; swelling; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 22Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included shellfish allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had first shot of BNT162B2 on 22Dec2020 09:00 then two weeks later a mass grew within the muscle at the forearm region, no ecchymosis with minor pain on 04Jan2021 11:45. The patient had heat pad applied to lower the swelling 04Jan2021 11:45. The outcome of the events was recovering. No treatment was given to the patient for the events minor pain and mass in forearm. 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. Information about lot/batch number and expiry date for the suspect product will be requested in follow-up attempts.

That same type of swelling happened the following day directly at the injection site with minor muscle and joint pain and fatigue. Heat pad applied to lower the swelling./Left forearm swelling; joint pain; minor muscle and joint pain; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm on 12Jan2021 at 15:45 at single dose for COVID-19 immunization. Medical history included shellfish allergy. There were no concomitant medications. The patient previously received his first dose of BNT162B2 intramuscularly on left arm on 22Dec2020 at 09:00 AM for COVID-19 immunization, two weeks later a mass grew within the muscle at the forearm region. No ecchymosis with minor pain. Heat pad applied to lower the swelling. After the second shot on unknown date in Jan2021, same type of swelling happened the following day directly at the injection site with minor muscle and joint pain and fatigue. Heat pad applied to lower the swelling. There has been significant relief with just rest and applications of heat to both locations. Left forearm swelling is almost completely gone. The outcome of event vaccination site swelling was recovered on unknown date in Jan2021. The outcome of rest events was unknown. Information on the Lot/Batch number has been requested.

12hr after second dose: increased pain at injection site, but no swelling or redness; headache; Discomfort is a 6/10; gradual onset of soreness raidiating from lymphnodes in neck; gradual onset of soreness in chest/ soreness in bronchi; gradual onset of soreness in back; gradual onset of soreness in hips; gradual onset of soreness in legs; gradual onset of soreness in glutes; soreness in upper lungs; soreness in upper respiratory system; This is a spontaneous report from a non-contactable consumer. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration on the left arm from 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included major depression, anxiety; increased airway sensitivity due to being former smoker from an unknown date and unknown if ongoing. Concomitant medication included vilazodone hydrochloride (VIIBRYD), loratadine (LORATADINE), theanine (THEANINE). The patient previously received the first dose on 28Dec2020 (Lot number=EK3730). There were no noticable effects after the first dose but 12hrs after second dose (19Jan2021), the patient experienced increased pain at injection site, but no swelling or redness. There was gradual onset of soreness raidiating from lymphnodes in neck, chest, back, hips/glutes, and legs; headache; soreness in upper lungs/bronchii (they are hypersensitive and usually sometimes get sore in reaction to irritants in the air), as well as upper respiratory system, but no difficulty breathing. Discomfort was at 6/10 on 19Jan2021. The outcome of the events was not recovered.

Pain on arm of injection; fatigue; chills; fever; muscle aches; This is a spontaneous report from a contactable other health professional (patient). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (left arm) on 19Jan2021 17:30 at 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 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 pain on arm of injection, fatigue, chills, fever, and muscle aches on 20Jan2021 (07:00 AM). There was no treatment received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

On 1/22/21 ,(7 days after receiving #1 COVID 19 vaccine) developed burning, tingling of upper inner aspect of left arm and later that same day developed faint, pink rash over the painful area. Over the next 24 hrs rash became more distinct; pink papules on an erythematous base in region of T1 and C5 dermatones, no vesicles.

Within 5 minutes following administration: - Paresthesia and pain in left upper extremity extending from shoulder to hand Within 48 hours following administration: - Progressive pain in left upper extremity - Greatly reduced range of motion in left upper extremity - Inability to bear any weight in left upper extremity - Large ecchymotic lesion at head of left humerus After 48 hours to current presentation: - Pain in the left proximal arm, left shoulder, left upper back, and left neck extending to the occiput - Painful spasticity in the left proximal arm, left shoulder, left upper back, and left neck extending to the occiput - Pain-restricted impaired range of motion of the neck including flexion, extension, lateral rotation, medial rotation, and lateral bending - Pain restricted impaired range of motion of the left upper arm including flexion, extension, lateral rotation, medial rotation, and abduction - Painful left-sided dysphagia at the level of the cricoid cartilage - Use of left arm impaired versus baseline with no signs of improvement

chills; fever initially 100.6F/Fever returned at 101.1F by about 5pm; aches (injection site); aches (spine); aches (occiput); aches ( hips, knees); This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old male patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 13Feb2021 14:30 at single dose for COVID-19 immunisation . The patient medical history was not reported. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 in left arm on 23Jan2021 at 12:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Beginning approx 11 hours post (14Feb2021 01:00) was chills, aches (spine, occiput, hips, knees, injection site), and fever initially 100.6F. Fever reduced acetaminophen over time. Aches continued. Fever returned at 101.1F by about 5pm day after shot. The patient underwent lab tests and procedures which included body temperature: 100.6 fahrenheit (fever initially) on 14Feb2021, body temperature: 101.1 fahrenheit by about 5pm day after shot on 14Feb2021. Treatment received for the adverse event included acetaminophen, water, rest The outcome of events aches (spine, occiput, hips, knees, injection site) was not recovered, the outcome of other events was recovered on an unspecified date of Feb2021. This case 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. No follow-up attempts are possible. No further information is expected.

Severe itching, welps, lips and eye swelled slighty. Most of my body was red. Looked like I was subnurnt.

Received vaccination on 03/12/2021 at 4:04PM. Symptom onset 03/13/2021 around 10:00AM: soreness at injection site (left deltoid muscle), soreness in leg muscles, fatigue, nausea, chills, dizziness, runny nose, cough, and worry. Axillary temperature: 98.6F.

Around 1:00pm received the Pfizer COVID- 19 vaccine at the group home administered by staff. About 10 minutes after getting the vaccine begin to develop an allergic reaction on both arms. The staff observed for about 15 more minutes and advised if condition worsens to seek medical attention. The group home administrator was contacted. As a precaution was taken to . While at the Urgent Care more hives developed on his arms, neck and buttock area. He was evaluated by the doctor and two injections were given. Benadryl 50 mg intramuscular and Solu- Medrol 125mg intramuscular. He was observed by the doctor and nurses for 30 minutes after the injections, the reaction improved. was prescribed Benadryl 25mg 1 capsule every 12 hours for 5 days and Prednisone 20mg 3 tablets daily for 4 days. was discharged and is at home in stable condition with close supervision. will follow up with his Primary Care Physician as scheduled. is doing well. Skin has cleared.

Large erythematous hives / urticaria on limbs and torso. Appeared 3 days following vaccination when I woke up in the morning. Was advised to increase dosage of cetirizine HCL (antihistamine) to 20-40 mg per day (spread out in 10 mg increments) until symptoms subsided. Hives cleared up slowly over span of 3 days. No hives with second injection

Both Arm soreness, both hands soreness/ tingling, Dizziness, Nausea, Tingling of lips, large patches of painful itchy welts covering body including arms, torso, groin area. Took benedryl for two days, welts subsided, soreness remained. Sought out medical attention from physician on 3/16 and was given a steroid injection and prescribed a steroid pack and OTC pepsid as well as continuing the use of benedryl.

Redness and pain at the injection site for a day, which went away, and then a bruise appeared a day later and has remained for another 7 days

PT got vaccine at 10:52am -- came back at 11 complaining of itching on his arm. No hives were seen and he never scratched. At 11:50, 11:20, and 11:25 am he stated that he was fine. Did not want to wait any longer and left. He signed a form saying he was ok to leave.

Patient reported to our clinic on 3/24/21 when he received his second dose, that he had diffuse hives all over his chest/upper body after receiving his first dose of the covid-19 vaccine. He also reported redness and swelling at the site. He reported that the symptoms went away after a few hours and he did not do anything to treat the hives.

left foot toe bruise, petechia in feet and lower legs by the next day. thrombocytopenia diagnosed on CBC collected 3/27/21

Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient had a vasovagal reaction. He states he has had this occur previously. Orthostatic vitals: lying 176/81 HR 81, sitting 129/86 HR 82 standing BP 119/82 HR 83, Pulse OX 99%

Injection site tenderness, pain, and bleeding; headache, sweating, chills, full-body muscle and joint aches, lethargy, malaise, runny/stuffy nose. Started a couple hours after the dose and continued for two days after.

I started noticing chicken pox-like bumps on my back, shoulders, elbows, ear, and nose by Friday night/Saturday morning. They continued to spread and I began to feel flu-like symptoms on Monday the 5th (5 days after the injection) I saw a doctor virtually and sent her pictures and she believes I have contracted chicken pox from the vaccine as I have not been in contact with anyone that has had chicken pox

fatigue, diarrhea, that lasted approximately 4 hours the day after the injection. Resolved on its own. Injection site soreness x 24 hours.

Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient received first dose on 4/1/21. Patient came in on 4/6/21 to report rash/itching throughout his body. Patient first began experiencing symptoms 4/2/21. Symptoms have worsened over time, with rash spreading throughout body. Patient reports no known drug allergies, no new environmental contacts, foods, laundry products, etc. Patient advised to start OTC diphenhydramine and consult with PCP to report potential new allergy and determine risk/benefit of 2nd dose of vaccine.

9 days after the vaccination, the area of my arm where the vaccine was injected became red, swollen and inflamed in a circular area slightly larger than a quarter. There is mild pain and moderate itching. The area feels firmer than the surround areas and is warm to the touch. It is clearly visible from a distance of around 10 ft. I just began experiencing symptoms approximately 2 hours ago, an am monitoring the situation.

Left axillary lymph node inflamed, red, and tender. 4.5 cm x 2.0 cm. Difficulty moving left arm due to pain. Patient has taken Ibuprofen and Tylenol PRN. He also did warm heating pad. No improvement.

Starting the morning after the 2nd shot I began to experience the following... 1. Chills (mild) 2. Muscle Aches (mild) 3. Fatigue (moderate) 4. Arm soreness at injection site (mild-moderate) 5. Dizziness (mild-moderate) 6. Vertigo mild 1-4 had alleviated by the morning of the 12th, however the dizziness has remained, and can be bad enough at times I worry about falling over, turning head rapidly or just standing up or moving quickly can make it happen.

Pfizer COVID-19 vaccine vial was mixed with 1.4 instead of 1.8 ml of diluent. Spoke to patient 04/11/2021. He reported mild soreness of injection site. Provided counseling.

The area where they injected the vaccine has turned into a large bump. The bump is about 2x2 inches, warm, red, and firm, but it doesn't hurt unless I poke it. I haven't done anything to fix it since it doesn't hurt.

Post injection stinging sensation radiating down back from shoulder. Decreased range in motion in arm. Started from approximately 30 minutes post-injection. Has maintained since and worsened. Pain did not decrease with use of Tylenol.

Allergic on skin with red and rash for the whole body. PRO included skin pain (NRS = 3)and itch (NRS = 6). Starting from 1 hour after the vaccine. It lasts for 3 days. I took Benadryl for 3 days, 3 times per day and 50mg each time.

Red dots/ rash across my chest that did not itch or hurt or cause any discomfort but was noticeable and visible. Persisted for 2 days.

Red, nonraised rash appeared on right hand, from thumb to index within 2-3 hours of shot. Rash still present (10 days after). Rash began to get purple, scaley and tender to touch.

pt got first covid shot on 3/20/21 then 2nd shot on 4/10/21. Pt didn't have any side effects after the first shot. For both shots pt got it in the left arm. About 9 days after the 2nd shot of the vaccine pt intially had sore throat, cough and head ache but resolved, pt also had a rash on arm that resolved too. Pt did have one bout of mild diarrhea before admission to hospital on 4/19/20. Pt admitted to hospital on 4/19/20 for tachycardia and on and off fevers since getting the 2nd shot of the vaccine. PCT 0.3 and 0.2 on 4/20, 4/21 respectively. wbc= 23.69 and 16.6 on 4/19 ,4/21 respectively. Working diagnosis at discharge per ID note is prolong side effect to covid vaccine. Pt discharge from hospital on 4/21

Pt experienced several covid like symptoms; fever (TMAX 100.5), cough, body aches, and lastly a raised lace like rash. Unsure if symptoms are from the vaccine or other viral infection. Pt reports negative covid test on 4/22/2021

pt received vaccine, told to wait 15 minutes. went to the restroom here in the store, had fainted in the bathroom. He came back to the pharmacy reported the event to the pharmacy, Upon evaluating him he had a small cut on the back of the head. One of our techs noticed a person from fire rescue in the store shopping she called him over he initially evaluated the patient and called for his emts to come and assess the pt. I know the took the pt out of the store on a gurney. they just wanted to assess him in a more private area (in the ambulance), we were in the middle of a clinicwith lots of people around. Unkown what transpired past that.

Urticaria starting morning of April 22nd, 10 days post 1st Pfizer shot in left arm. Worse in left forearm, but also on right forearm, chest, back, and neck. Suspect new food allergy or possibly recent viral illness.

Soreness at injection site; headache; fatigue; This is a spontaneous report from a contactable consumer. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration, in left arm on 19Feb2021 13:15 (at the age of 29-years-old) as single dose for covid-19 immunisation. Patient historical vaccine was first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), an unspecified route, in left arm on 29Jan2021 13:15 (at the age of 28-years-old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), Centrum multivitamin. The patient had not received any other vaccines prior to the COVID vaccine. The patient experienced soreness at injection site, headache, fatigue on 19Feb2021 16:00. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The outcome of the events was resolved.

"Covid Arm." Swelling and Rash started on April 23rd one week after vaccination. No Pain or itchiness, is going away slowly.

pt received covid shot. waited around the 15 minutes after and girlfriend reported that he fainted in the aisle. He had a gash on his scalp and said he fainted. We put in in a chair with legs raised. took bp and hr. all were normal. pt reported he was still feeling faint and flushed so we called the emt. amubulance and fire truck came. pt reported feeling better and refused medical care.

Dizzy, faint, blurred vision, headache started 5 minutes after shot. I was wheelchaired to fresh air and moved to a cot for 30 minutes of monitoring. I slowly recovered over the 30 minutes. The following day I had a 99.6 fever, headache, chills and weakness. The vaccination site is sore.

Started out feeling out of energy about 12 hours after the 2nd dose along with having aching arms and legs. Around 14 hours after the dose I got a fever, chills, hot flashes. Took Tylenol and went to bed Went to bed and kept waking up feeling hot or cold. Woke up in the middle of the night and experienced a vivid hallucination. This morning as I write this I still have a small fever and headache, running nose. My arm became really sore at the site of injection.

Widespread hives/rash in middle stomach and lower back, with accompanying burning sensation on contact. First noticed late Thursday but spread rapidly overnight, prompting doctor visit. Doctor prescribed Xyzal, famitodine and a topical cream. Hives have not responded to treatment and have continued spreading to neck.

Sprawling rash on the left lower/middle back area noticed on the proceeding morning on 4/21. Taken tylenol three times in the course of past 12 days. Rash has gotten redder and sprawled a bit more to right side of back. I do not have a PCP, planning visit to urgent care this week.

Site: Pain at Injection Site-Mild, Systemic: patient reports changes in taste after his first shot on 4/13/21, presented today 5/4/21 with hesitancy about second shot-Severe, Additional Details: Patient reports that after the first covid vaccine he started experiencing changes in taste. His first shot was 4/13/21, and presented today for his second dose on 5/4/21 with some hesitancy about getting the second shot. Patient says that he had covid before, and had mild changes to taste because of COVID infection. He says that after his first shot, his sense of taste changed and worsened, and was unsure about getting the second shot today.

Full body rash -- mostly located in both shoulders and also included patches on the buttocks, both thighs, lower back, and left hand. Rashes began as patches of dry skin about a week after vaccination, and then progressed into itchy rashes over the course of three weeks. Rashes eventually faded and left areas scared and chronically dry. Appendix also became inflamed approximately three weeks after vaccination and an emergency appendectomy was required to remove the organ after patient went to urgent care for intense stomach pains. Not known if this is related to vaccination.

Experienced racing heart rate (120 bpm resting), mild chest pressure, moderate fever (102 F), chills, nausea, headache, injection site soreness, and left arm lymph node soreness. Rested, and most symptoms subsided over night. Heart rate still slightly elevated (100 bpm resting) with occasional chest pressure.

suspected shingles; painful rash; skin burning; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (23Mar2021), this case now contains all required information to be considered valid. A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 26Jan2021 15:00 (Lot Number: EL8982; Expiration Date: May2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 29 years). The patient's medical history and concomitant medications were not reported. The patient experienced painful rash and skin burning on 29Jan2021 14:00 and he stated that he had suspected shingles on an unspecified date. Outcome of the events was unknown.

While sitting in the recovery area, patient said he felt "nervous" and sat on the floor. Upon assessment, patient was hot to touch. BP 120/82 P59 SpO2 99% room air. Patient said, "I'm dehydrated." Gatorade water given and cool compresses applied to face and neck. Additional monitoring done. Denies EMS evaluation. Patient ambulated from facility with girlfriend. No s/sx of distress noted.

Pityriasis rosea skin reaction throughout the body. Initial large oval bumpy rash in chest and stomach. Smaller itchy bumps in arms, legs and back. Symptoms have been present for about a week or two.

I received the 1st shot of the pfizer covid vaccine on March 11, 2021. Within 2 days I began to feel extremely fatigued. The days following I experienced night sweats, nausea, extreme fatigue, fever. I went to urgent care with a 102 fever, jaundice, and anemia. Urgent care sent me to the ER. At the ER they admitted me to the hospital. I was in the hospital for 3 days with hemolytic anemia. After a lot of testing and ruling out any infections, they discovered I have a rare blood disorder: hereditary elliptocytosis. The pfizer vaccine created an immune response and since I have this blood disorder I was predisposed to this event occurring from the vaccine (hemolytic anemia/juandice) without knowing it. It was a result of the vaccine. I was told to not get the second shot because there is no guidance, but that I am a high risk individual now. I need medical advice from people who are familiar and know.

Similar to covid infection; Similar to covid infection; Shock sensation on different locations of the body; Could not eat or drink; Feeling weird; Heart beat went up; Tensed; Pink warm face; Flushing of the skin for about 20 mins; Pink warm face/feeling warm; Drank water and then it went away somewhat like after drinking alcohol; Butterflies sensations in the throat; This is a spontaneous report from a contactable consumer. A 29-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. It was reported that the patient (male, 29 years old) had COVID and then took vaccine and experienced similar side effects like next morning could not eat or drink, feeling weird, heartbeat went up, tensed, pink warm face, flushing of the skin for about 20 mins, feeling warm, drank water and then it went away somewhat like after drinking alcohol. The patient again felt different sensation, butterflies sensations in the throat, heart rate went up, shock sensation on different locations of the body and taking deep breathing. It lasted for about 3-4 days. The outcome of events was recovered/resolved. Information on the lot/batch number has been requested.

about 5 minutes after receiving the pfizer vaccine patient became sweaty and skin got clammy and he felt like he was going to faint. He lost all color to his face. Blood pressure was taken and it was 92/60. We gave him a cold pack on the back of his neck and had him lay down and elevate his feet and legs. Also got him some cold water to drink. He started to feel better in about 15 minutes after that. We continued to monitor blood pressure about every 5 to 10 minutes and it got to 99/72 and last check was 120/65. He did not want the ambulance or to go to urgent care. We told him to take it easy the rest of day and to have somebody with him til next morning. And then he and his friend left to go to his parents house.

Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: pt's arm muscle sore for the whole month after recieving first dose. got his second dose and that arm was only sore for a few days and is now feeling normal. initially just mild soreness/ache but pt went swimming approx 3 days ago and is not having significan soreness in his arm that he got the first shot in.

Approximately 5-10 minutes after receiving the vaccine patient fainted and slid out of chair onto floor. Patient regained consciousness within a 1 minute of event occurring. After patient was hot, pale, and sweaty. Patient DID NOT complain of nausea, vomiting or visual changes.

patient called later in the day to complain his arm hurt and he thought he had been given the shot too high up in the arm. He stated he felt pain with the shot. Advised him he could take Tylenol or ice the area. I also told him he could return to the pharmacy if he wanted us to look at it and advised him to keep us updated if the pain persisted or got worse.

Pt developed itching at site, 10 minutes post vaccination, no other symptoms. Pt was given 50mg diphenhydramine per Protocol and asked to wait additional 15-30 minutes for observation. Pt's symptoms improved.

This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP6955; Expiration date was not reported), via unspecified route of administration on an unspecified date in Mar 2021 (reported as 10:00 AM) (at the age of 29-years-old) as first dose, single dose for COVID-19 immunization. Medical history included COVID-19 (COVID prior vaccination) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not tested for COVID post vaccination. The patient has no known allergies. On an unspecified date in Mar 2021 (reported as 04:00 PM), the patient experienced heavy fatigue, weakness and pain at injection site. No treatment was taken for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

At the time of injection, he experienced a burning sensation immediately from the injection site to the fingers. The burning lasted a few minutes. He then was standing waiting for his wife to receive her vaccine. He became dizzy and diaphorectic. He passed out for a moment. I kept him in the chair and monitored his breathing and tried to keep him alert and responding to my questions.

Patient's mother called the pharmacy and said that he had developed a rash on his ankle that spread to his knee 4 days after the vaccine was administered. They saw a doctor about the rash and he wanted the pharmacy to be notified to report it.

patient got vaccine. stated doesn't get faint with needles but a few minutes after moved to waiting chair he passed out. his his face off of the floor/wall and broke his tooth and cut his lip. called 911 and patient was taken to hospital by ambulance.

Pt's mother states 06/21/2021 after receiving the 1st dose of Phizer vaccination, hot at the site of the injection then blacked-out, fell face first on face. ER visit, Fractured his jaw, nose and knocked out teeth. 06/22/2021 Surgery/plates required, jaw wired. Currently discharged.

Symptoms began to appear around 1:00 am, 6/16/2021. Symptoms included labored breathing, pounding heartbeat, lightheadedness, headache, chills, injection site soreness, and feeling unwell. Side effects were eased with Tylenol. Symptoms gradually diminished over the course of approximately seven days.

Fatigue; Vaccination site pain; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via an unspecified route of administration in left arm on 22Mar2021 at 15:00 hours (at the age of 29-Year-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient had allergy to goat cheese. Concomitant medication included citalopram (MANUFACTURER UNKNOWN) since an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced fatigue and vaccination site pain on 23Mar2021 at 17:00 hours. The therapeutic measures taken as a result of fatigue and vaccination site pain was none. 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 fatigue and pain at the injection was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.

Petechiae on feet and ankles; bruising on feet and ankles; large blood blister inside mouth cheek; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733); via an unspecified route of administration in left arm on 23Mar2021 at 17:00 (at the age 29-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 at 12:00, the patient experienced petechiae, bruising on feet and ankles and large blood blister inside mouth cheek. The patient underwent COVID-19 virus test (as reported pixel COVID test), via nasal swab on 26Mar2021 post vaccination and the result was negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of petechiae, bruising and blood blister was not resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.

got Mild side effects, had an allergic reaction consisting of hives on body including hands and legs, like 10 places; This is a spontaneous report from a contactable consumer, the patient. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0150, Expiration date: did not have any as such), via an unspecified route of administration, administered in Arm Left on 09Apr2021, as dose 1, single (age at vaccination: 29 years), for covid-19 immunization. Medical history included appendicectomy on an unknown date in Mar2021 (had a surgery a month before first shot vaccination). The patient was not taking any concomitant medication. The patient stated that, within 3-4 hours after taking first shot, he got mild side effects, had an allergic reaction consisting of hives on his body including his hands and legs, stating there were about 10 hives (like 10 places) and they resolved in 2 days and he was fine. After that he was referred to CVC during that time during Apr2021 time, it was mention in CVC that he should not take any second shot even if he had some minimal allergic reaction (hives), so he did not get his second dose of the vaccine because of his allergic reaction. Reportedly, there was no prior vaccination and there was no family medical history related to adverse event. As a treatment for the event, he just went to Emergency and took Benadryl, for which he did not remember the dose. The outcome of the event was recovered on an unknown date in Apr2021.

Soreness at site of injection; headache; This is a spontaneous report from a non-contactable consumer. A 29-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration on 27Mar2021 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unspecified date in Mar2021, the patient experienced soreness at site of injection and headache. The patient did not receive any treatment for the reported events. The clinical outcome of the soreness at site of injection and headache were recovered on an unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.

- Injection site soreness: developed the day after injection and largely resolved after about 24-36 hours. - Headache: minor tension headache developed about 48 hours after injection and lasted a little over a day. - Sore throat: mild; developed about 48 hours after injection and continues to persist about 2 days later.

6 day history of R sided chest rash w/ skin hypersensitivity and pain of R upper body consistent with shingles rash. Received vaccine 1.5 days prior. Went to PMD video telehealth appt and dx with shingles. Had VZV at 5yo. No prior vaccination for VZV.

6 day history R sided chest rash w/ skin hypersensitivity consistent with shingles rash. Received covid vaccine 1.5 days before. Seen by PMD over telehealth appt and dx with shingles. Had VZV at 5 yo. No prior vaccine for VZV.

12/18 VACCINATION 12/19 WOKE UP, HA, FATIGUE, MUSCLE ACHES. 12/20; HA WORSE, SYMPTOMS WORSE 12/21 FELT BETTER 12/22 VERTIGO, FACE IS RED. URGENT CARE. PRESCRIBED NAUSEA MEDS.

Approximately around 1450, 10 minutes after injection, while in monitoring area, employee started c/o nausea and then began to vomit. He then c/o feeling flushed, itching, headache, chest tightness, and SOB. V/S: B/P 126/82; pulse 103; resp 20; O2 sat 99% on RA; lungs clear upon asculatation; pupils equal and reactive; skin pink. Doctor was notified and assessed the employee 1455 - Doctor ordered Benadryl 50mg IM which was administered to the Left arm by nurse. 1505 - FSBS was 87; O2 sat was 98% on RA; pulse 97 1510 - O2 sat was 98% on RA; pulse 90 1520 - O2 sat was 98% on RA; pulse 98; employee was still vomiting; lungs remained clear 1528 - Employee reported that all symptoms were about the same, but waxing and waning; doctor ordered to give Zofran 4mg SL and this was given by nurse. 1530 - O2 sat was 98% on RA; pulse 90; B/P 122/90 1540 - O2 sat was 96% on RA; pulse was 88. Rechecked on Left hand - O2 sat was 98% on RA; pulse was 94 1545 - Employee reported improvement of headache, itching, chest tightness, flushing, and SOB; however, was still vomiting almost continously 1550 - O2 sat was 99% on RA; pulse 83 1600 - B/P - 118/84; pulse 78; resp 20; O2 sat 98% on RA; Employee still vomiting continously 1613 - Doctor recommended that the employee be evaluated in the ER. A family member/friend was called. Employee was taken to a private vehicle via wheelchair and transported to ER for evaluation.

After vaccination, employee went to the monitoring area. Around 1450, he complained of nausea and then began to vomit. He then began to c/o flushing, itching, headache, chest tightness, and SOB. Symptoms began approximately 10 min. after immunization. V/S: 126/82; pulse 103; resp 20; O2 sat 99% on RA; pupils equal and reactive. Dr. was notified and assessed the employee. Dr. ordered Benadryl 50mg IM at 1455. This was administed by RN to Left Arm. At 1505, FSBS was 87; O2 sat 98% on RA, pulse 97. At 1510, O2 sat was 98% on RA; pulse 90. At 1520, O2 sat was 98% on RA and pulse 98. Employee continued to vomit. Lungs were clear upon assessment. Skin was pink. At 1528, employee reported that the symptoms were about the same...maybe waxing and waning. Dr. ordered Zofran 4mg SL which was administered at 1528. At 1530, O2 sat was 98% on RA; pulse was 90; B/P was 122/90. At 1540, O2 sat was 96% on RA; pulse 88 - rechecked on Right hand which gave a reading of O2 sat of 98% on RA; pulse 94. At 1545, employee reported improvement of headache, itching, chest tightness, flushing, and SOB; however, was still vomiting almost coninuously. At 1550, O2 sat was 99% on RA; pulse 83. At 1600, B/P was 118/84; pulse 78; resp 20; O2 sat 98% on RA. He continued to vomit. At 1613, employee was taken via wheelchair to private vehicle of a friend and was taken to ER for evaluation.

1/4 7pm Vaccication 1/4 8pm started feeling itchy mouth and face 1/4 8:30pm took benadryl 50mg 1/4 11:30 symptoms mostly resolved 1/5 830am sysmtoms returned 1/5 845am benadryl 50mg & went to ER 1/5 ER recommended I take Zyrtek & Pepcid instead of bendryl as of 1/6 at 11:30am still have a very mild itchy face and tonge

left sided facial muscle soreness; Arm soreness/by injection in the left arm; This is a spontaneous report from a contactable consumer (patient). The 30-year-old male patient received BNT162B2(COVID Pfizer vaccine, Batch/lot number: EK9231), via an unspecified route of administration on 31Dec2020 at single dose by injection in the left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient stated that he just got the COVID vaccine an hour ago. Within 20 minutes he developed left sided facial muscle soreness, which was the side he got the vaccine on, and arm soreness, on 31Dec2020. There was no treatment. Outcome of events was not recovered.

The patient complained of dizziness, itching, immense sweating within one hour of the vaccine administration. Over the next 12-24 hrs the patient had bloody emesis, diarrhea and noticeable swelling of tongue/lips.

Right after the injection I did not notice any symptoms, I sat for 15 minutes and felt fine. A few days later I noticed some red bumps on my stomach and back area only. The bumps seem to be staying the same, they do not itch and are not in any kind of specific pattern. I do not have any other major symptoms. The rash is not painful, not hot, and i do not believe it was due to anything else.

30 year old healthy male with no preexisting conditions who developed morbiliform rash on the trunk, upper back, and inguinal creases bilaterally, 36 hours after 2nd dose of Pfizer Vaccine. The rash spared the mucosal membranes, face, and extremities. The rash was not itchy or painful. No co current fever or other systemic symptoms. Patient does not have history or drug, vaccine, or food allergies. In particular, no known allergy to polyethylene glycol. Patient does not take any medications daily, though took acetaminophen and Ibuprofen at the time of vaccine and then for the next 24 hours.

20 hours after injection, I started having progressively worsening severe back pain, neck pain, headache, chills (no fever), skin sensitivity, noise sensitivity, fatigue, and brain fog. 2 days after the vaccine, I had abdominal pain, and cough. All of that is now better except for the cough. It is now 4 days after the vaccine, and it seems the vaccine has triggered an asthma attack requiring inhaled albuterol. My asthma attacks typically linger for a couple weeks after upper respiratory infections, and this feels exactly like that, I wouldn?t be surprised if this asthma attack persists for a couple of weeks.

Dose 1 on 12/15- Sore arm for three days after vaccination. Swelling also was present on the deltoid. Upon resolution a large bruise showed up. Dose 2 on 01/05- Sore arm near vaccination site at 12 hours. At 15 hours out woke up in middle of the night with diffuse body aches and chills. These progressively worsened. Fatigue also present in the morning with very mild fever. Developed nausea the next day as well. At 36 hours out body aches were improving but a headache developed at ~ 30 hours out. Next morning 2 days out the only thing thing that persisted was fatigue. This was gone another 12 hours later. No persistent symptoms.

2 days after the vaccination I developed a rash in the lower back and on the left and right shoulder and was really itchy. It came and went for a couple hours and the next day it got worse which made me reach out and have a virtual visit and was advised to take benedry which did help. The rash appeared as a hive.

Three days after second immunizations, spontaneously developed diffuse urticaria on my trunk and face. Associated w/itching, mild abdominal discomfort, and facial swelling. Symptoms somewhat improved w/cetirizine. About 24hr later, had recurrent diffuse urticaria, predominantly in the face. Still having persistent intermittent sweats and significant fatigue.

The evening of 1/10 I spontaneously developed diffuse urticaria of my trunk and face, associated with itching, mild abdominal discomfort, and facial flushing. Symptoms somewhat improved with cetirizine. The evening of 1/11 developed recurrent spontaneous diffuse urticaria, mostly in the face. Having persistent intermittent sweats and significant fatigue. Per Patient, He have had urticaria rarely in the past, associated with shellfish. I have never had anaphylaxis before.

Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Medium, Systemic: Headache-Medium, Systemic: blisters on neck, lathargic,appetite

received vaccine 01/08/21, reported around 02:00PM 01/09/21, onset of chills, muscle aches, fever, did not take temps, flushed feeling, headache, injection site pain, general weakness, fatigue, unable to get up due to weakness. Around 01/09/21 at midnight reported started feeling better. 01/12/21 reports repeat of symptoms like on 01/09/21, however not as bad and did throw up, reported body sweats on this day and only lasted about 4 hours.

Allergic Skin Reaction: Moderate-severe pruritic maculo-papular rash present on bilateral hands including 100% finger and palm involvement and ~20% dorsum of hand. Rash extends on anterior arm up to axilla. Rash also present in inguinal area and 100% of buttocks and extends down posterior leg down to knee. Petechiae present bilaterally on ventral hands hand finger tips (likely related to squeezing hands for itch relief) Rash was present around 60 hours after vaccination starting on buttocks and inguinal area and progressed to hands then armpits over the following day. Rash progressing in severity despite 50 mg oral Benadryl q6h, 40 mg oral prednisone daily, and topical hydrocortisone. Rash still present and progressing and no peak severity has been identified yet.

Starting 6 hours after vaccination and persisting thru present (appx 36 hours later): - extreme fatigue, -fever of 104.0°F (even with taking Excedrin 2 tablets/ 4 hours -injection site pain -chills, body aches

diffuse urticaria on my trunk and face/had recurrent diffuse urticaria, predominantly in the face; Associated with itching; mild abdominal discomfort; facial flushing; Persistent intermittent sweats, and significant fatigue; Persistent intermittent sweats, and significant fatigue; first dose given on 21Dec2020 and second dose on 07Jan2021 (Day 18); This is a spontaneous report from a contactable physician (reported for himself). A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 17:00 at a single dose on left arm for COVID-19 immunization. Medical history included allergies to shellfish. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications were not reported. The patient received first dose of bnt162b2 on 21Dec2020 on left arm for COVID-19 immunization (lot number: EH9899). No any other vaccines within 4 weeks prior to the COVID vaccine. On 10Jan2021 18:00 (three days after second immunization), the patient developed diffuse urticaria on his trunk and face, associated with itching, mild abdominal discomfort, and facial flushing. Symptoms somewhat improved with cetirizine. About 24 hours later, he had recurrent diffuse urticaria, predominantly in the face, persistent intermittent sweats, and significant fatigue. Treatment was given to the patient for the adverse events. The patient underwent lab tests and procedures which included nasal swab (COVID test type post vaccination): negative on 11Jan2021. The patient has not recovered from the events.

First shot was in my right arm on 12/30/2020, I only experienced minor pain in my right arm the next day around the injection site. Second shot was in my right arm on 01/20/2021, the next day I experienced a minor fever, minor body aches, a headache, and tiredness. These symptoms lasted approximately 12 hours. These symptoms matched what co-workers and friends had also experienced.

experienced a rash on torso/Rash on Torso Chest and Neck/red/splotchy and a little itchy; This is a spontaneous report from a contactable consumer. A 30-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 10Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included that patient was tested positive for Covid prior to the vaccine, in early to mid Oct2020. Concomitant medications included bupropion; and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). He took his normal prescription medications in the morning the day of vaccination. Patient stated he received his first dose on Sunday, 10Jan2021 and 36hours, reported as last night 11Jan2021, he experienced a rash on torso, "red/splotchy and a little itchy, but bearable". He noticed that he was breaking out in a blotchy red rash on his torso and chest and it was not going away. It's not too itchy. He was calling to see if this was a normal side effect. He is not a HCP but works at a HCP office. He got his First Dose on 10Jan2021 at 11:30 and the rash started 11Jan2021 about 36 hours later. The Itching and spots showed up at the same time. The rash was only on the torso, chest, and neck. He was noticing that the rash was about the same as when it first started, and it gets worse when heat is applied like if he is in the shower. Patient has not taken any antibody tests and had no issues with vaccines in the past. He did not have to be hospitalized or seek further treatment for this rash. Patient wanted to report his side effects and "make sure it's nothing serious that needs to be addressed" and patient was asking for any information about report of rash and what needs to be done At the time of the report the patient felt fine and looked worse than he this it was. Patient asked if after experiencing side effects from the 1st dose, should he get the 2nd dose of vaccine. The outcome of the event rash on torso/rash on torso, chest and neck/red/splotchy and a little itchy was not recovered. Information on the batch/lot number has been requested.

Developed rash on various locations on my upper body. The largest areas being the right flank, covering about 50% of the area. The rash on the other areas of the upper body were diffuse in small patches, including the left flank and upper back, shoulders, and upper extremity.

Received Pfizer COVID dose #2 on 2/6/21 at 0700. Began to experience general pruritus at 2100 and "scratchiness of throat". This morning he developed urticaria predominantly to right arm, upper chest.

Headaches, site pain, neck pain, numbness in arms and fingers on side if injection site. Extreme fatigue.

Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1100. Patient reported right arm heat sensation, right neck tightness, right facial tightness at 1120 with sensation progressing up arm and across face. Given Benadryl 25mg PO at 11:50 and symptoms resolved after further observation.

Itchy, redness, bad swelling, warm to touch, extremely sensitive, pain with some movements, 2.5 inch circumference of redness, 5.5 inch circumference of hard swelling

Body broke out in extremely itchy rash in armpits, hips, butt, obliques and legs. Hands and fingers also developed small irritated and itchy blisters. Mouth also developed sores on tongue and inside of lips. In addition feelings of achiness and fatigue. Visited dermatologist on 2/16/21 and was prescribed prednisone, prescription cortisol and hydroxyzin. Some improvement seem in 24 hours since then. Dermatologist was unable to determine source of rash and reaction, thought could be related to vaccine. Follow up phone call scheduled for 2/19/21

Pityriasis rosea, herald patch on left upper back with numerous smaller lesions on anterior and posterior trunk extending to proximal lower and and upper extremity with significant pruritus.

Patient stated he developed rash after about an hour of receiving COVID-19 vaccine dose 1. This time when patient received dose 2, he again developed rash to bilateral upper extremity rash. No respiratory distress noted or reported. Patient discharged at 4:10PM.

Fever and chills, debilitating headache, weakness and muscle aches, joint pain, nausea, and fatigue. Local swelling and pain at injection site. Also felt unusually anxious, though unsure if that was directly due to the vaccine or to the inability to sleep for a number of days because of the feverish chills. Acute symptoms lasted for 48 hours, and prohibited me from being able to work from home. I still have what feels like a lingering sinus headache (with no actual sinus symptoms) as well as some fatigue. Lingering headache is not debilitating, but it is irritating. Feels a bit like a sensation of pressure in my forehead.

On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itches.; On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itches.; First dose on 11Jan2021 and second dose on 28Jan2021; First dose on 11Jan2021 and second dose on 28Jan2021; ached all over my body; I felt very weak; I had a temperature of 100.7.; This is a spontaneous report from a contactable consumer. A 30-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on his left arm, via an unspecified route of administration on 28Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included allergies to sulfa medicine. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 07:00AM for COVID-19 immunization (first dose). It was reported that approximately 12 hours after the 2nd shot, the patient felt very weak and ached all over her body. She had a temperature of 100.7. This lasted from late Thursday night until late Friday Morning. On Saturday morning, she woke up with a large rash on her left shoulder and her upper left chest. No treatment was received for the events. The outcome of all event fever was recovered on an unspecified date while recovering for the remaining events.

Headache; Pain at injection site; Swollen injection site; Fatigued; This is a spontaneous report from a contactable consumer (patient). A 30 -year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9626), via an unspecified route of administration (on the left arm) on 30Jan2021 16:15 (at the age of 30-years-old), single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included amlodipine;olmesartan, lorazepam. The patient experienced Headache,Pain at injection site, Swollen injection site, Fatigued, all on 31Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021 Nasal Swab (reported as post vaccination). No treatment received for the adverse events. The outcome of the events was not recovered. Prior to vaccination, it is unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (date of test reported as 06Jan2021). The reporter assessed the events as non-serious.

Body aches; injection site pain; low grade fever; This is a spontaneous report from a contactable consumer(patient). A 30-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at left arm on 16Feb2021 10:00 at the 30 years old at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medications were Lisinopril and sertraline hydrochloride (ZOLOFT). The Historical Vaccine was first dose BNT162B2 on 26Jan2021 12:00 AM at 30 years old at Left arm for COVID-19 immunization. The patient experienced Body aches, injection site pain, and low-grade fever on 16Feb2021 22:00. There was no treatment received for all the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.

PATIENT ARRIVED AT PHARMACY FEELING DIZZY, LIGHTHEADED AND ITCHYNESS ON FACE. NO TROUBLE BREATHING. SLIGHTLY IN PANICKED STATE. HE WAS DRIVING FROM A store ON THE WAY HOME AFTER RECEVING HIS VACCINATION WHEN HE EXPERIENCED THESE SYMPTOMS. STOPPED BY OUR store AFTER FEELING LIKE HE MAY PASS OUT FROM DIZZINESS. IMMEDIATELY HAD PATIENT SIT DOWN AND ADMINISTERED BENADRYL 50MG AFTER CHECKING PATIENT WAS ABLE TO BREATHE, SWALLOW, AND TALK. MONITORED PATIENT FOR THE NEXT 30 MINUTES UNTIL HE CLAIMED HE FELT MUCH BETTER AND WANTED TO DRIVE HOME. OFFERED TO CALL 911 WHEN HE SAT BUT PATIENT REFUSED. COUNSELED PATIENT ON DROWSINESS FROM BENADRYL AND THAT IT MAY WEAR OFF LATER.

Patient received dose of vaccine on right deltoid at 4:09PM at around 4:23PM developed symptoms. Symptoms described as: feeling "warmth, like if feels when you take NAICIN-flushing sensation but only minor". Other symptoms includes light rash in both arms, redness on face and arms. Excluding back, trunk and legs. Patient denies sore throat, swelling or tingling of tongue or mouth, lips. Denies drooling, no difficulty swallowing. Denies chest pain, SOB, palpitations, dizziness or light headed. No near syncope episodes. Patient refused Benadryl due to driving alone and also refused EMS to transport to ER.

headache; body aches; fatigue; pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient, who is also 30-year-old at the time of vaccination, received second dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration on left arm on 02Feb2021 15:30 as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN). The patient received first dose of BNT162B2 on 14Jan2021 at 03:45 PM, lot number not reported; vaccine location=Left arm. On 03Feb2021 07:00, the patient experienced headache, body aches, and fatigue as well as pain at the injection site. The outcome of the events was recovering. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

11pm on day of (Sunday) vaccination felt soreness in left arm at injection site and in entire upper arm when trying to hold it up. Soreness subsided by noon the next day, Monday. No symptoms on Tuesday until late evening when tongue began to feel sore. On Wednesday morning around 6am, woke up with severe body fever, chills, muscle and joint aches, nausea, headache. Hands and fingers very cold to the touch. Severe fatigue and weakness all day. Sore tongue persisted. No respiratory symptoms present. By Thursday (today), body is still feverish, joint and muscle aches persist, light headache at times. Still fatigued and weak. All symptoms today Thursday are much weaker except for the muscle and joint pain which remains high. The reason I am reporting this is that from what I've read and been told, the delayed onset of these symptoms (almost 3 days) is very unusual, especially because I had little/no symptoms in the first 2 days of the vaccine.

Vasovagal syncope approximately 5- 10 minutes post vaccination. Pt reports that he started to feel lightheaded and stood up and passed out. pt then hit his chin on a low setting wall and had a small 1cm laceration on his anterior chin. pt fell prior to my arrival to finding him down. when I arrived pt seemed to be mildly disoriented for about 30 seconds to 1 minute. pt reports that he had + LOC for a few seconds while he fell but was conscious when I arrived. pt was advised to seek out wound closure for chin laceration.

After about 15-20 mins, patient started to experiencing symptoms of mild to moderate itching over several different areas of skin. Patient acknowledged symptoms but felt that he was alright. Symptoms increased to moderate continuous itching most promiment on hands, forearms, lateral sides of neck. Patient had c/o of headache, slight dizziness, increased HR (sustained 110s) and increased BP (approx 184/130). Pulse ox was 99% on RA. No trouble breathing, no angioedema noted. Informed pharmacist and ambulated patient to ER for evaluation. ER continued observation, administered famotidine 20mg (oral), diphenhydramine 50mg (IM), dexamethasone 10mg (IM). Patient remained stable and was discharged within an hour with a steroid pack.

Patient checked in to the observation room. A patient sitting adjacent reported he 'dropped his phone and was out' momentarily. The patient did not fall and MD was alerted. Patient was red, flushed, clammy but alert. BP 73/42mmHg, HR 85, O2sat 97%, and RR 12. He was placed on a stretcher. He had no difficulty breathing or cutaneous symptoms. BP recovered to 120/75mmHg, HR 80, O2sat 96% and RR 12 within 15 minutes. Pt felt well and was able to be discharged home.

Client received first COVID dose 04/01/21 at 1030 am, noticed adverse reaction at 3 or 3:30 pm. Reaction is a rash, possibly hives on chest, was kind of red but is now pink in color. Client report no pain or itching at rash site. Client has taken an antihistamine and will continue to monitor for symptoms.

Headache, chills, aches starting overnight and into the following day (at time of submission). Soreness of injection site started within a couple of hours and persisted to time of this submission as well. None of the symptoms are severe.

Headache; generalized body aches; pain in left arm injection site; severe fatigue; chills; mild fever; dizziness; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3247, Expiration Date: unknown), via an unspecified route of administration in left arm on 17Feb2021 at 03:15 as a single dose for covid-19 immunization. Medical history included ongoing OCD and depression. Concomitant medications included escitalopram (ESCITALOPRAM) 10 mg once daily, Multivitamin. The patient known allergies: Erythromycin and Azithromycin. Historical vaccines included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247) via Left arm for covid-19 immunization on 27Jan2021. The patient experienced headache, generalized body aches, pain in left arm injection site, severe fatigue, chills, mild fever, dizziness on 18Feb2021 at 05:00 AM. Patient has been tested for COVID-19 with test type: nasal swab on 05Jan2020 with result negative. No other vaccine in four weeks. Patient covid tested post vaccination yes. No covid prior vaccination. No treatment received for the event. The outcome of the events was not recovered. No follow up attempts are needed. No further information is expected.

Rash. It started on my right hand, then appeared on my neck. It next appeared on both arms, the left side of my chest, on my right hip, then on my forehead and eyelid. I went to Dr. and he told me that it looks like Sweet's Syndrome. He took a biopsy to confirm and put me on Prednisone

Patient developed a rash 7 hours after receiving vaccine that resembled hives on his arms, tingling lips, and facial swelling.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium

Recipient became gray, dizzy, light-headed and fainted after receiving the vaccine. Did not hit head or fall on floor. Lost consciousness for less than 10 seconds and stated he did not eat anything that day. 911 was called but he refused to go to the ED and said he was okay.

36 hrs after injection broke out in full body rash over night. Extremely itchy. Areola/nipples were so thin/dry that they became raw from just normal contact with bedsheets over night. Was bleeding from areola area.

Fever, aches, soreness to left arm at injection site, chills, headaches on and off for 36 hours. Treatment acetaminophen/ibuprofen. Within 48 hours complete resolution of all symptoms.

Itch rash all over the body that started with a big one in the back. Dermatologist diagnosed Pityriasis rosea

called to see pt in vaccinator's room; pt sitting on exam table, increased RR, skin color white; pt diaphoretic, warm, responding to some questions; HOB placed flat and legs elevated; sweatshirt removed; mother at bedside telling pt that he is "all right"and states he has anxiety; VS at 1058:141/78; HR 64, regular; RR 22; SaO2 100%. At 1104 pt with slight tremors, continues to respond to questions; ice pak applied to neck; VS 133/84, HR 64, RR 20, SaO2 100%. 1115 pt without tremors, more awake, calm; HOB raised to 45 degrees; VS 122/72, HR 54, RR 18, SaO2 96%; Pt taking sips of Glucola and water, no c/o nausea; pt conversing appropriately. 1130 pt sitting at 90 degrees; states that he feels tired, no other c/o; VS 123/58, HR 55, RR 16, SaO2 97%. Pt ambulating in room, gait steady and strong; ambulated well in hallway. 1145-Pt left clinic stable, no c/o; mother accompanying pt and will drive pt home.

First day after vaccine: chills, fever, whole body aches, expected soreness at site of injection Second day after vaccine: tightness in back of throat (maybe even already in chest, hard to pinpoint) that felt a little like choking Third day after vaccine: moderate headache and general head discomfort, particularly behind eyes No treatments for any of the symptoms, I've just been letting them each run their course and they've each only lasted about 24 hours so far.

Itchy red hives or welts on the face and head, torso arms and legs for greater than 3 weeks. Not improved by oral antihistamines and topical and IM steroids.

Pt complained of numbness at injection site in L arm, radiating down to forearm. BP 151/90, HR89, RR18. No other symptoms or visual changes, self-resolved. Pt discharged in stable condition

Client was vaccinated with the Pfizer Covid vaccine with lot #EW0162 at 11:59am on 04/15/2021. EMT observed client standing at the facility exit speaking to the interpreter. EMT noted upon approach client appeared alert, tracking with his eyes, in no apparent distress. Client had a chief complaint of numbness at his injection site. Client stated that he had completed his 15 minutes and had exited the site but began to experience numbness at his injection site while exiting. This was the client's first dose of the Pfizer vaccine. Client states he has a history of a deep vein thrombosis and hypertension. Client is not on any medications and denies any known allergies. Assessment revealed that client's left arm/injection site was clean, dry and bandage remained intact. Client was negative for hives, swelling, severe sweating, shortness of breath or other signs of anaphylaxis. Client was alert and oriented to person, place, date, and event; and airway, breathing and circulation were intact. Client had full range of motion of his arm and denied any tingling. Client denied any pain upon palpation of the injection site and stated that his numbness was strictly localized to injection site and did not spread to rest of arm. Client's vital signs upon entering EMT station for further evaluation revealed: blood pressure 180/140, respirations 18, pulse 68, 98% on room air; lung sounds clear bilaterally, temp 98 degrees F, eyes remained equal, round, and reactive to light at 5 mm. Client stated that he had his blood pressure taken last week and that his systolic was approximately 160. Client agreed to remain for an additional 30 minutes of monitoring per site lead nurse and was stable throughout observation. Vital signs at 1220: blood pressure of 180/140, respiratory rate of 18, heart rate of 68, and oxygen saturation of 98% on room air. Vital signs at 1235: blood pressure of 160/124, respiratory rate of 18, heart rate of 76, and oxygen saturation of 99% on room air. Vital signs at 1250: blood pressure of 158/118, respiratory rate of 18, heart rate of 76, and oxygen saturation of 99% on room air. At the completion of the client's observation, client stated that numbness was "better" and stated that it was "almost gone." Client's blood pressure improved upon reassessments, and all other vitals were remained within normal limits. Client was provided with vaccine information packets and encouraged to seek follow-up care or emergency care if symptoms become more severe later in the evening. EMS was denied by client, no medication or other interventions were indicated or administered. Client departed facility by ambulation to private care at 1253 in positive disposition. EMT reported to lead nurse about client's status after client left facility already. Lead nurse educated EMT regarding high blood pressure referral to EMS. But EMT stated client denied EMS.

1 hour after shot, throat felt slightly off. 22 hours after shot began to experience headaches and head fog. Following day had extreme body aches (especially on sides), headaches, head fog, and fever. Very lathargic. Throat felt normal again. Following day most body aches were gone, but also received periodic headaches and still had some body aches and soreness. Began to feel itchy. Itchiness location wandered throughout day - began in groin, moved to legs, moved to chest, then to head. Following day still have itchiness but primarily on head and to some extent on feet. In the evening, upper lip also became very swollen. This is current status of side effects felt.

On april 5th i had my first dose. From 1-2 days i had few symptoms like headach, tireness & injection site pain. Since it's been 2 weeks i still have few symptoms like mild headach, tiredness(full body pains), but those are not often (is there anything i need to worried)

Assessment: 1. Suspect acute myopericarditis likely immune related/related to second dose of Covid vaccine. 2. Troponin elevation likely due to acute myopericarditis. This is a 30-year-old male with no previous cardiac history. This past Thursday he got the second dose of Pfizer Covid vaccine. He had the usual muscle aches at the site of the injection. The next day he felt crappy, cold, etc. Nevertheless he went to work. This was Friday. On Saturday he felt better. He visited his grandma. On the way to home he felt a little dizzy. He took a meclizine when he got to the his grandmother's home. He helped her eat, and then went home. On Saturday night he started to feel cold and chilled. His face felt li

Rashes on both of my arms and swollen feet. My left foot is the worse. Have seen a specialist who recommended me to contact.

pt says he had soreness in shoulders, neck and had a headache. next day the soreness was throughout his body. He had sweating, chills, headache and red blisters on his chest going towards his right arm. pt says he has been taking ibuprofen, Tylenol, and Dayquil the symptoms are getting worse and will contact his PCP.

shingles to right top of head, ulcers in mouth, teeth pain, and rash to right side of face. all symptoms are right sided

Moderate arm pain (on arm of injection) through the night (Starting approx. 12 hours post injection). Arm pain less severe compared to first Pfizer Injection (22 days prior). Arm pain lasted approx. 48 hours. 0800 (18 hours post injection) - Elevated temperature of 37.2 C 1000 (20 hours post injection) - Elevated temperature of 37.9 C, severe headache (worst I've ever felt), and general aching - both lasting approx. 6 hours (400mg Ibuprofen was taken at 1500 - approx. 25 hours post injection - and 1 hours prior to relief of headache, fever, and aches)

Diarrhea, Chills, Hives, Itchy Eyes, Runny Nose, Shortness of breath. I took some Benadryl because the reaction felt similar to an allergic reaction. I?m doing lots better now.

Fell asleep around 9:00 pm with slight fever and stuffy nose. then i woke around 1:30 am with a slight headache and patches hives from shoulder to my thigh. I took a benadryl and went back to sleep. Awoke on 4/22/2021 with none of the above symptoms or hives.

Approximately 11:00pm on Tuesday, April 20th, patient experienced red, itchy splotches on abdomen and chest. As of Friday April 24th, rash has started to subside, but still present.

Fatigue, mild fever, chills, body ache on , 4/24, the day after vaccination. Slight pain on the site of injection.

more than likely an allergic reaction to the vaccine; Purple splotches; Dizzy and woozy; Nausea; Headache; Feels awful/slow motion; Tired; Sluggish; This is a spontaneous report from a contactable consumer. A 30-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 22Mar2021 at 12:30 at the age of 30 years-old, (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation . Medical history included dyspepsia from an unknown date and unknown if ongoing Verbatim: Severe Heartburn , blood pressure measurement from an unknown date and unknown if ongoing Verbatim: Blood pressure , migraine from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for blood pressure for 3 years and ongoing; pantoprazole (PANTOPRAZOLE) taken for stomach medication and heartburn for about a year. Patient states he got the first round 3 weeks ago and he is supposed to get the second dose next Monday but was advised by his doctor not to do that. Patient states he got the shot on Monday 22Mar2021 and Tuesday 23Mar2021 he was tired and sluggish. On Wednesday 24Mar2021, mid afternoon, he had purple splotches all over his body, in arms and legs, like discoloration, his head felt like it had been dipped in cement and he couldn't think. States he felt cloudy, dizzy and woozy, nauseous, had a headache and feeling awful. States this occurred like 48 hours after the shot. He contacted a life long friend who is a doctor and works in a covid ward and he told him he was having a reaction and to take some Benadryl and Advil or Tylenol, and the friend told the patient to lay down and rest. He still didn't feel great but splotches went away and head felt a little bit clearer and he didn't feel like he was in slow motion or dizzy anymore by Wednesday evening, so he went to bed. On Thursday, the patient went into work but didn't feel great, not feeling 100%, and about noon on Thursday 25Mar2021, the symptoms started coming back, the purple splotches, his head felt just as bad, he had a headache, slow motion and not himself. The patient called his doctor and his friend and they said he needed to go in and get looked at. The patient tried to go into an urgent care and he states they said nope head to the ER. Patient states he was admitted into the ER and the ER staff said he was having more than likely an allergic reaction to the vaccine. They gave him steroids and an IV but he is not sure what it is and he was given, he thinks, Prednisone over the next couple days to help with side effects, he believes it was Prednisone, he knows it was a steroid. States he is not a fan of it and he doesn't like it at all. Patient states that he thought it was a pretty standard reaction and was not worried about it. Patient states he still gets headaches and maybe it's something else that is unrelated. States he stopped feeling tired and sluggish maybe the 29Mar2021, a week afterwards. Patient states that he has recovered with lasting effects as he's been getting migraines since then, states maybe it's unrelated but didn't happen a whole lot before. He has severe headaches and nothing he takes seems to help, has to turn lights off and works from home and patient reports that he had one yesterday. Patient states the purple splotches went away after he went to the ER and got on the medicine, the steroids. P atient states the nausea was pretty constant when a headache comes on, he doesn't have a headache every day but when he gets a headache he is definitely nauseous. The outcome of the events was for fatigue and sluggish, recovered with sequela, Purple splotches, dizzy and woozy slow motion, recovered, nausea and headache not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

After 2nd dose, client reported feeling hot, dizzy, and light-headed. EMT assisted client into gravity chair. Client was sweating and warm-to-touch. Client drank water from personal water bottle. RN provided education on vaccine side-effects and advised to remain in-place for observation for 30 minutes. Vital signs were within normal limits. Client reported side-effects resolved 15-minutes later. Client was advised to seek emergency medical attention if side-effects return and/or worsen. Client was provided information on VSAFE and walked out of vaccine site unassisted with steady gait after an additional 15 minutes observation.

Patient presents to ER with a complaint of facial swelling, tightness in throat and chest, and shortness of breath. Patient states that his symptoms first began yesterday (4/27) at approximately 1400 shortly after receiving his first dose of the Pfizer Covid vaccine. Patient was seen in the ER for this yesterday, was treated and released. Patient was given prescription for prednisone to take at home, however states that he has not filled or started this prescription yet today. He states this morning he started to have some returning chest and throat tightness, redness around his chest and face, and shortness of breath. He states symptoms of been constant since onset. He states he took a single p.o. Benadryl and used his albuterol inhaler at home, with minimal relief. At this time patient is reporting some mild dyspnea with intermittent nonproductive cough, mild throat tightness, and redness to the skin. IV Solu-Medrol, Pepcid, Benadryl, IV fluids, nebulized breathing treatment. Symptoms improved in the ER, no longer shortness of breath. Pt to continue PO steroid

Arm swelled and redness below the vaccination site. Eye muscles weakened and could not hold eye opened on vaccination site side.

Small cluster of hives appeared on back of neck just around 24 hours after first dose of vaccine. It has been six days since getting the vaccine and still no signs of them disappearing. Followed the guideline of taking 50mg of diphenhydramine as suggested with minimal success in getting the hives to go down completely. They will subside slightly sometimes but not at all entirely and are currently still present. There is occasional itchiness which comes and goes as well as a slight itchy burning sensation in the right hand seemingly random at times. A small hive also developed on the right hand that does not originate from where the itch on the hand comes from.

Adverse event 4/17/2021: severe chills, high fever (max = 102.7 F) that persisted on and off until 4/22/2021. Worst fevers were at night. Required support from spouse to do every day tasks. Stayed in seated or prone positions the majority of the time from 4/17/2021 to 4/19/2021. Treated with Tylenol. I would take 500 mg every 4 hours or 1000 mg every 6 hours and as I got further into the week I tried not to take Tylenol to avoid masking symptoms, but I would take it if temperature spiked which would happen randomly. Adverse event 4/19/2021: Hives developed on scalp and forehead following approximately 30 minutes of exposure to sunlight. These hives began to spread through 4/20/2021 and into 4/21/2021 to eventually cover entire upper torso including stomach, back, chest, neck, face and head. Treated with Singulair and Zyzol starting 04/21/2021 and stopped treatment once hives were gone on 4/23/2021.

Increased tiredness and soreness at injection (relative to first shot) followed by splitting headache and being mildly feverish. Problems fixed with acetaminophen (650 mg, PO, ADMINISTERED ONCE). After the first shot (Lot# ER8732), there was immediate soreness at injection site and hives/itchiness (localized in left shoulder (injection site), left armpit and on right side of rib cage) that started 12 days after injection. Diphenhydramine (50 mg, PO q 4 h for 2 days) resulted in no itchiness.

Itching day after and then 5 days after developed a rash over his entire body. Particularly severe on his right leg

Rash on hands: deep blisters on palms and fingers and smaller dots on the backs of hands. Itchy and painful. Rash on feet: deep blisters on the soles of feet No other symptoms.

Bleeding in the cough; Rashes; Cough; Tiredness; Muscle Pain; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 30-years-old, via an unspecified route of administration in left arm on 07Apr2021 at 08:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient had no COVID prior to vaccination, did not have any other vaccines in four weeks and no other medications in two weeks. The patient experienced rashes, cough, bleeding in cough, tiredness, and muscle pain on 09Apr2021 at 12:00. There was no treatment given in response to the events. The patient was not tested for COVID post vaccination. The outcome of the event was not recovered. Information about the lot/batch number has been requested.

Itchy hives across body. Started on elbow of left arm (same as vaccination arm) and down arm to hand. Overnight, appeared around torso, both legs, and opposite arm.

Got vaccine in my car and parked. Had a little extra bleeding at the time of injection. Once parked, I had immediate and intense nausea. Very dizzy and light-headed. My hearing went away. I closed my eyes for a second and passed out. I awoke about ten minutes later covered in sweat. Felt better at this point and it was my time to leave, so I felt well enough to drive home at that moment. I should have reported the adverse event at the site.

The next day: fatigue Two days later: no symptoms 8 days later: coughing in the morning, shortness of breath, fever 9 days later: no fever, no cough, no shortness of breath, new symptom: hives/rashes and itchiness 9-13 days later: hives/rashes and itchiness Hives/rashes treated with benadryl/antihistamines

Cold sweats overnight, body hot to the touch in the morning but no fever (98.7). Dehydrated, body sore, head ache. Numb finger tips.

Injection on may 6th, on my seventh around 12pm, lymph nodes near ear and below jaw became wnlarged and sore,, noticed red hot itchy spot on left cheek. Progressively expanded through the day, accompanied by fever, body aches. Each day has gotten progressively worse. Rash spreading to scalp following day and migrating left to right across face. May 9th went to emergency room for treatment. Prescribed zyrtec, benadryl and prednisone along with Valtrex. Unable to identify cause of rash. As of May tenth the rash has continued to grow and is now on spread to the top of my scalp, back of my skull and pain as shown up in nerve in jaw on right side

Red, bumpy rash on the insides of my left and right forearms. Similar rash on the left side of my stomach, below my left arm pit.

Patient was given first dose of Pfizer 0.3 mL intramuscular injection on right deltoid. Within 15 minutes, patient states developed itchiness on both arms and felt his heart was racing. Patient's blood pressure was 107/61 mmHg and heart rate 59. Patient was given Benadryl 50 mg IM injection on left deltoid. Monitored patient for an additional 30 minutes.

Within 4 hours developed "hives on the hands and arms, which is still visible 3 weeks later.; "This is a spontaneous report from a contactable pharmacist. A 30-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient reported, within 4 hours developed ""hives on the hands and arms, which is still visible 3 weeks later on an unspecified date. Patient mentioned they declined to give the second dose, and would like to confirm this with Pfizer. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other than soreness in my left arm for the first few days, I did not notice anything else (nor did I look at the injection site). However, today (5 days after the 2nd injection) I noticed my left arm is yellow in color (about 1 inch tall by 2 inches wide), but there is no soreness or any other associated complications.

Needle broke with first injection attempt, had to get stabbed a second time. Injection site pain, Fever (102), chills, headache, fatigue, joint pain. Started mild chills at 6am, fatigue and headache at 9am, joint pain and fever at 11. Took 1000mg Tylenol at 4pm. Symptoms clear by 10am on 5/12/21

Rash with pain and burning sensation located on the arm in a straight line where vaccinated the night of receiving the vaccine. Began to spread along the arm, but nowhere else on the body and develop blisters and redness. Along with rash was constant pain through the whole arm and pain in armpit where lymph node is located. Went to a healthcare clinic one week later who said it was a possible case of shingles. Took a sample to send to lab. Was prescribed valacyclovir.

Swelling and bleeding in gums; lower left portion of mouth; no pain. Took two 220 mg Naproxen Sodium tablets to help with arm pain at injection site; unsure if helped with gum issue. Swelling receded within 12 hours

generalizied non pruritic hives on B/L UE, TRUNK, CHEST, BACK, and LEGS that started the day after the vaccine. He reports he never had any SOB, difficulty breathing, or feeling like his throat was closing. Denied any other s/sx of allergic reaction other than the hives. He also reports the hives are not itchy.

Redness on right side of neck and of right side of back; Blood pressure was measured at 140/70 and in 30 min it went down to 120/70; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received BNT162B2 (COMIRNATY, Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 at 15:15 as 1st dose, SINGLE for covid-19 immunisation at workplace clinic (30 year at time of vaccination). The patient medical history and concomitant medications were not reported. On 08Feb2021, the patient had his blood pressure checked which shows 140/70 and in the next 30 min it went down to 120/70. The patient also experienced redness on right side of neck and of right side of back. The patient reports about receiving shot of intervenors Benadryl as a therapeutic measure. The outcome of the events was reported as recovered at the time of report on 08Feb2021 (as reported). No follow-up attempts are needed. No information about batch/lot number cannot be obtained.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT FELL OFF CHAIR AFTER HE GOT HIS PFIZER COVID VACCINE AND HIT HIS HEAD ON BOARD. HE DEVELOPED A BRUISE ON FOREHEAD. PATIENT LOOKED PALE. PHARMACY TECHNICIAN GAVE HIM SOME WATER AND TARGET STAFF APPLIED ICE PAK ON FOREHEAD AND OFFERED HIM SOMETHING TO EAT

Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day.

Had syncopal episode after vaccine while walking to chair. Fell and hit head, has abrasion above left eye. No head neck or back pain. Is very pale with a heart rate in the 40's and hypotensive. IV established and brought blood pressure up and heart rate up. Was nauseated prior to IV but that resolved. Transported to hospital by ambulance.

Typical flue symptoms: fever, headache, sweat, shiver, a few phlegms, muscular pains (located in particular in the left arm where the vaccine was injected). This lasted for 36 to 48 hours.

I received my second COVID vaccine on 5/13/2021. My arm got intensely sore and it keeps getting bruised around the area randomly and it is still very sore weeks later. I can?t sleep on that side of my arm because it hurts and my arm is constantly ?falling asleep? . It hurts a lot and isn?t normal.

Pain at left arm where first dose vaccine was administered; This is a spontaneous report from a non-contactable consumer(Patient). A 30-years-old male patient received bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 01Mar2021 15:15 as 1st dose, single for covid-19 immunisation. The patient did not receive any other vaccine. The patient medical history and concomitant medications was not reported. It was reported that, Pain at left arm where first dose vaccine was administered. Pain has persisted for greater than 14 hours at time of reporting. No treatment was received. Outcome of the event was resolving. No follow up attempts are possible. No further information is expected.

Developed tenderness and sensitivity under left arm on rib cage / upper torso area approximately 2 weeks after 2nd dose. It was initially suspected to be a rash or allergic reaction, however there was no redness or visible signs of a rash in the area. Approximately 20 days after 2nd vaccine dose, severe migraine headache occurred which lasted for approximately 6 days. After about 3 days of headaches, COVID-19 test was taken and confirmed negative. This was followed by a visit to urgent care facility. Shot of Toradol was given for the headaches and an anti-inflammatory prescription was provided. Also mentioned to the nurse practitioner the sensitivity at left rib cage / upper torso area. It was confirmed by a nurse practitioner to be early signs of shingles. Prednisone and anti-viral were prescribed for the shingles outbreak. Thankfully the shingles were caught early enough to be treated immediately and I only missed 5 days of work (Mar 24- Mar 30) and the shingles did not develop into large blisters or boils.

About 2 days after 2nd covid vaccine I started to get chills, felt like a strong cold, coughed with mucous, skin was very sensitive, had low energy to do anything.

Pfizer vaccine reconstituted with 0.8 ml vs 1.8 m. of diluent. Patient received a more concentrated dose. On 6/12 patient was notified of issue. RN called patient who reported the following, reports feeling well at this time, denies any sxs of anaphylaxis or SE of Pfizer, pt speaking in full sentences.Informed pt we do not expect he will experience any adverse effects but we will still monitor and check in with him, reviewed expected SE of the COVID Pfizer vaccine and how to manage them. Writer reviewed with red flags when needing to seek ED level of care. Patient called again on 6/13 and reports the following: reports feeling well today, no rash at injection site, arm is a little sore but thats it, no other symptoms. Advised wil call tomorrow, pt verbalized understanding. On 6/14 patient contacted and reports, Patient reports he is feeling well.

30 YO M with no PMH who presented on 4/27 with left arm pain after covid vaccine on 4/15. He reports he developed left arm swelling and redness that was progressive following the vaccine. He is now s/p I&D at El Camino on 4/28. Patient with multiple apparent debridement sites 3x around elbow and 1x left deltoid. Continues to have pain and swelling around elbow and in shoulder. No sensation changes, compartments are soft. He was subsequently taken to the OR on 5/4 for debridement with return trips on 5/5, 5/6, and 5/7 with vac placed on 5/7. He tolerated bedside vac change to left deltoid and WTD to 3 sites around elbow. He lives at home alone and is unable to do dressing changes by himself. Wound vacs were placed on all wounds and home health was arranged for MWF visits. In addition, he will follow up in wound care clinic as outpatient. He understands he needs to complete course of oral antibiotics and will have pain meds for vac changes. He was stable upon discharge

2nd Dose: Experienced first symptoms around 6:00pm on June 24, including severe headache and moderate general weakness. Around 9:00pm experienced mild shortness of breath and moderate lymph node swelling under injection arm armpit which carried into June 25. This report is being submitted on June 25 and the mild shortness of breath and armpit lymph node swelling is still present. 1st Dose: Mild to moderate weakness and fatigue day after the first shot (June 3, 2021) with no additional symptoms. Symptoms completely resolved by June 4.

Injection Site Mild discomfort on 0d . Arthritis Flare up on 7d. Arthralgia, right hand joints swollen, numbness, stiffness. Nerve pain on right arm, left hand joint pain at 8d

Pt received first dose of Pfizer at 0856 to left deltoid and felt immediately lightheaded and had syncopal episode. Pt was able to regain consciousness 5-10 seconds after syncopal episodes but still complaint about feeling lightheaded. Pt felt warm to touch and had was pale. An ice pack was applied to back of neck, vital signs were checked immediately. Pt was asked if he has anything to eat prior to vaccine and he stated he did not have anything to eat. Ice water and granola bar was offered. Around 0858 pt stated he started to feel better, 0859 vital signs indicated the following BP 111/45, HR 47, SpO2 97% RA. Pt denied going to treatment room for further observation or laying down on gurney. Pt kept insisting he felt a lot better and "none of that was necessary". Pt's skin color came back to normal state and stopped feeling lightheaded after eating and drinking a cup of water. Vital Signs were taken again as the following: BP 104/57, HR 62, SpO2 98% RA. Pt felt safe to go home with significant other. Pt doing well, speaking in full sentences, laughing, alert and oriented x 4.

patient had hives all over body (neck, arms, legs) several hours after receiving vaccine, not at pharmacy when happened. Reported at second shot appointment.

25 Minutes after receiving vaccine he got numbness and tingling in his face, lip, under his eye and temple. he also had red whelps on his neck, right arm

Hives beginning 2-3 days after 2nd vaccine dose. Has been taking benadryl nightly since. Seen at our office on 7/12/21 and treated w/ prednisone.

My left arm keeps getting bruised and blood clot looking things all over my left arm which is where I got both vaccines. I have had a loss of vision and seeing little black floating dots and have lost over 10 pounds since without working out.

Approximately 30 minutes after the vaccine administration, my face started to turn red and tingle.; Approximately 30 minutes after the vaccine administration, my face started to turn red and tingle.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: unknown) via an unspecified route of administration in left arm on 24Mar2021 at 09:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not applicable. The patient had seasonal allergies to pollen. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not tested positive with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. On 24Mar2021 at 10:15, the patient experienced face red and tingling, approximately 30 minutes after the vaccine administration, the patient's face started to turn red and tingle. The sensation mostly had subsided within 30 minutes after onset. But still, the patient had lingering sensation 2 hours later. The patient had not received any treatment for the adverse events. The clinical outcome of the events faces red and tingling were recovered with sequelae. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

After getting the shot, I was monitored at the hospital clinic for 15 minutes at the facility. I did not have the reaction right away not until I got home. I got the vaccine around 9 am for my pre employment requirement and and I got home at 11 am on July 12,2021. Around 11:30am my left arm where I had the injection is sore, which was expected but the worst was experiencing hives/pruritus for the first time and it was bad. Thankfully we had some benadryl home medication and calamine lotion and I took bed rest and hydrated myself and helped by family members who are nurses. I also experienced body malaise. the symptoms eventually improved after day 3. Currently I feel some heaviness when I take deep breaths and still monitoring.

I also felt like I was struggling to stay conscious./but I had to get up and move around.; I began to start sweating a lot; I felt a warm heat in my body almost like when you get hives. I also felt like I was struggling to stay conscious. I had to get up and use the bathroom and get a drink; I felt a warm heat in my body almost like when you get hives. I also felt like I was struggling to stay conscious. I had to get up and use the bathroom and get a drink; This is a spontaneous report from contactable consumer (Patient). A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection: Lot Number: EW1076) via an unspecified route of administration in left arm on 15Jun202 at 16:00 (at the age of 30-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included the patient had known penicillin allergies. Concomitant medications included methadone, ergocalciferol (VITADONE) both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 15Jun2021 at 16:00, the patient experienced a little nervous because the Agency didn't approve it yet, so I did not know if that what messing with him. After i got the vaccine like 5 minutes after the shot i began to start sweating a lot and i felt a warm heat in my body almost like when you get hives. I also felt like i was struggling to stay conscious. I had to get up and used the bathroom and got a drink but if they would've made him sit in them chairs in the isles, I think I would've passed out. I knew they had them chairs there just in case someone passes out i thought, but i had to get up and move around. The patient did not receive any treatment for the event. The outcome of all events was recovered in 2021.

Fatigue mentally and physically; Sensitive skin similar to when havethe flu but less pronounced.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 15:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the COVID-19 vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 15:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 09:00, the patient experienced fatigue mentally and physically and sensitive skin similar to when had the flu but less pronounced. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fatigue mentally and physically and sensitive skin similar to when have the flu but less pronounced were resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

WIDESPREAD DARK RED, ITCHY RASH OVER ENTIRE RIGHT SIDE INCLUDING THE ARM, TORSO, STOMACH, BACK, NECK, EARS. TREATED WITH ORAL BENADRYL CAPSULES. SYMPTOMS RESOLVED WITHIN 24 HOURS. NO FURTHER MEDICAL TREATMENT SOUGHT.

Chalazion on upper right eyelid starting 5/31/2021 (1.5 months after vaccination). Removed surgically on 7/15/2021 (1.5 months after onset). Sharp, stabbing leg pain and hypersensitivity of skin on right thigh starting 7/19/2021 (3 months after vaccination). No treatment, problem persists to present day (7/28/2021).

Extremely dry skin; Near cracking; Eyes burning; itchy eyes; dry eyes; headache; muscle ache; chills; tired; Sever pain at injection site.; skin warmed; This is a spontaneous report from a non-contactable consumer. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 08:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included LASIK(Laser-assisted in situ keratomileusis) eye surgery on Nov2020. Concomitant medications included lifitegrast (XIIDRA) for lasting headaches from dryness on third and last month of treatment. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 08:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The 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. On 06Apr2021 at 13:00, the patient experienced extremely dry skin, near cracking(chapped skin), eyes burning, itchy, dry (similar feel like seasonal allergies) and other typical symptoms like headache, muscle ache, chills, tired, skin warmed and severe pain at injection site(vaccination site). The patient took advil liquid gel 300 mg as treatment for the reported events. It was reported that all symptoms were muted after receiving Advil. 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 events extremely dry skin, near cracking, eyes burning, eye itchy, headache, muscle ache, chills, tired, skin warmed and severe pain at injection site were recovered on 06Apr2021, while that of the event dry eyes was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Left arm soreness.; Chills and shivering on the night of the vaccine; Severe body aches and back pains; Severe body aches and back pains; Severe headaches; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EK923) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 08:00 for COVID-19 immunization. Medical history included test positive for COVID/ diagnosed with COVID-19 from Apr2020. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not have COVID prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. And the patient did not take any other medications within 2 weeks of vaccination. The patient had COVID test post vaccination in Dec2020(also reported that the patient had not been tested for COVID-19 since the vaccination). The patient had left arm soreness; chills and shivering on the night of the vaccine; severe body aches and back pains; severe headaches; event onset date reported as 30Dec2020 02:00. The patient was tested positive for COVID in Apr2020 and symptoms felt exactly the same. All the events were reported as non-serious. No treatment was received for the events. The outcome of the events was not recovered.

I have start developing a red bruise like the bubbles on my arm; it seems more like under skin there is a bubble and not like inflammatory muscles; I have start developing a red bruise like the bubbles on my arm; it seems more like under skin there is a bubble and not like inflammatory muscles; administered via sub cutaneous with a half inch needle; This is a spontaneous report from a contactable Pharmacist reporting for himself. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730 and expiry date: 31Mar2021), Subcutaneously on 29Dec2020 at 16:40 at single dose at Left Deltoid at Hospital for Prevention. There were no medical history or concomitant medications. There were no prior vaccinations within 4 weeks, no family medical history, and no additional vaccines administered on same date of Pfizer suspect. The patient wanted to know what the recommendations are if the COVID Vaccine was administered subcutaneously. He clarified he received the COVID Vaccine, but he believed it was administered via sub cutaneous with a half inch needle on 29Dec2020 at 16:40. He knew with other vaccines such as the Flu Vaccine, if it is not given intramuscularly, a patient is subject to revaccination. The patient wanted to know if he needs to be revaccinated with the COVID Vaccine since it wasn't an intramuscular injection. Relevant Tests were None. On 01Jan2021, the patient stated that he had started developing a red bruise like the bubbles on his arm; it seemed more like under the skin there was a bubble and not like inflammatory muscles. The patient reported that the shot was given with the half inch of needle because it was only recommended with the one inch or larger; so actually, he was trying to find it on the mail. The question he wanted to ask was if it went to the deep muscle enough or possibly into the tissue. But over the last, like 24 hours, he has started developing a red bruise like the bubbles on his arm. It didn't feel like he ever had any muscle pain or anything and it seemed more like under the skin there was a bubble and not like inflammatory muscles. The patient's weight was reported as 104.33 kg or 230 pounds. The patient did not receive any treatment for the events. Outcome of the events was unknown. Causality between the event "I have start developing a red bruise like the bubbles on my arm; it seems more like under skin there is a bubble and not like inflammatory muscles" and BNT162B2 was reported as related. Follow-up (01Jan2021): New information received from a contactable pharmacist includes additional events (contusion, blister), an additional laboratory data, and the clinical course of the events.

1. Pulsing pain at dose administration site at 11 pm. -No treatment, went to sleep. 2. (12 hrs after administration). Woke up at 1:00 am with severe chills. Lasted 2 hours. -Threw on sweats and another blanket, went back to sleep. 3. Woke up at 6:30 am with intense body and head pain. "was a cant get comfortable in any position type of pulsing pain" Something im accustomed to when i get the Flu. I rolled around in pain for 4 hours while trying to go back to sleep; it even hurt to breathe deeply. - took Tylenol at 11am and the symptoms never came back. *Note. I think i suffered so much pain in the 4 hours that it lasted with me until even now as i write this. Hard to describe, but my entire body has had this tiny ache that has not gone away. Not a big deal to me, but just wanted it documented. I am selecting recovered even with that tiny ache still apparent because physical pain usually takes time to heal. Assuming that's all it is.

Started feeling very fatigued around 6/7 PM on 1/7/21. Ate dinner shortly after and took my normal sleeping pills as previously listed. Around 12:30 AM on 1/8/21 I woke up feeling very cold. I got up, used the restroom and grabbed some acetaminophen (1000mg). I took the medication and started feeling very dizzy and light headed. After that all I remember is sitting on the kitchen floor feeling like my body was buzzing/tingling. My ears were also ringing really badly. I attempted to get up but was unable to get orientated for what I believe was about 15-30 minutes. I called my BF at 1:10 AM after I was able to get up and moving. I elected not to go to the ER because I didn?t want to directly expose myself to COVID. I stayed up for about another hour, drank some water and ate some crackers. I took 25mg of diphenhydramine and went back to sleep. The rest of the day up to writing this I have been very fatigued and achy. Mild dizziness and confused feeling. I didn?t hit my head but I have about a four inch scrape down my back and a small cut on my foot from the broken glass.

I felt fine the rest of yesterday but started to feel really tired and worn down late last night. I took my sleeping pill like normal and went to bed. I woke up feeling really achy and cold so I went to take some Tylenol in case I had a fever. Started feeling dizzy and light headed and I passed out. I cut my foot on the glass I dropped and scraped my back as I fell. I don?t remember being blacked out very long. I just remember sitting on the floor feeling really lethargic. My whole body felt tingly and my ears were ringing really bad. Was able to get up and get back to bed. Decided to go back to sleep and not go to the ER. This morning I?m still a little dizzy but mostly just have a headache and am extremely tired. I plan to get into my doctor today so I will keep you updated. Just wanted to let you know what happened so you could report it.

Approximately five minutes after vaccination the patient developed linear erythema extending into the right distal forearm and ulnar aspect of the hand. This was mildly pruritic. there were no other systemic cardiac, respiratory, or GI symptoms. Vital signs remained stable and WNL. Treatment was started with 25 mg PO Benadryl. Over the next 30 minutes the symptoms significantly lessened. Patient was discharged without further signs.

Body aches, fever, injection site pain and redness, bilateral upper arm erythema, sore throat lasting 8 hrs

pt received vaccine on 1/7/2021. He had soreness at the injection site following the injection. He has been having fatigue, malaise, decreased appetite and low grade fevers that occur at night since the injection. He feels fine most of the day but after leaving work mid to late afternoon, feels very fatigued and no interest in evening meal. Low grade fevers in low 100's in the evening and night sweats. has been self medicating with Tylenol for symptoms. No URI symptoms. Hx of COVID 19 virus in July 2020

I had soreness around my arm of injection site for about 3 days. I also wanted to let you all know that I had a sore throat that started the day after my first dose. Sore throat started off as mild but later got worse by the 2nd day. I also experienced a mild grade fever, headaches, and chills which went away in a couple of days. HOWEVER, today (1-14-2021) I decided to rule out the possibility of me having COVID. So I got tested for covid and I was tested positive via the RT-PCR at a local urgent care facility. So with that being said I am not quite sure if the sore throat, mild grade fever, headaches, and chills were part because of the vaccine dose (first dose) or it could have been from experiencing covid symptoms. Treatment I used were drinking LOTS of water, Tylenolol and Advil, Cephacol lozenges, and sleep.

Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; This is a spontaneous report from a contactable Physician (patient). This 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 15:00 (lot number: EK9231) at single dose in Arm Left for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Migraines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included paracetamol (TYLENOL), ibuprofen (ADVIL) occasionally as needed. The patient previously received first dose of BNT162B2 intramuscularly on 16Dec2020 12:00 at 31-year-old (lot number: EH9899) at single dose in Arm Left for COVID-19 immunisation. The patient experienced Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing on 06Jan2021 03:00 AM. The outcome of Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing was recovering. Tylenol, Advil, Bed Rest was received for the adverse events Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing as treatment. The events were assessed 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.

Within 2-5 minutes of receiving the vaccine, I began to feel dizzy. I signaled for help while in my car and help arrived. Within the next few minutes the severity seemed to go from ?0-100? and I began to feel a deep impending sense of doom and panic/fear. I also felt extremely tense in my muscles and felt itchy in the chest area. That continued for 15 minutes or so before subsiding slowly. Staff surrounded my car and were very supportive and great about the situation. It was one of the most frightening experiences to date I have had. No EpiPen type intervention was done. Once the event was on the downswing I was kept for additional observation and release on my own accord. Everyone there was great. I am reporting for my own records in case further testing reveals I have an allergy to this vaccine for employment purposes should the vaccine become mandated prior to me having alternative means of vaccination or allergy testing competed to determine if it was an true reaction or not so I can get vaccinated safely.

Development of non-tender red spots (enanthem) on soft palate; ~12 hours after the vaccination. Other symptoms included fatigue. No other rash anywhere on the skin. Rash spontaneously fading over the next 36-48 hours.

Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; injection site pain; Mild discomfort (2 of 10), but different than arm/injection site pain; This is a spontaneous report from a contactable other healthcare professional (hcp). A 31-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686; 313,121, expiry date not reported) via an unspecified route of administration on 05Jan2021 15:30 at a single dose in the left arm for COVID-19 immunization. Medical history included patient had known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen (ADVIL) at regular dose, 2 pills, one time in 2 weeks. On 05Jan2021 08:00, the patient experienced left hand tingly/achy/numbness, localized but radiant throughout hand and digits, on-and-off throughout day for past 6 days; mild discomfort (2 of 10), but different than arm/injection site pain, which lasted for 2-3 days. The vaccination was done in a hospital. Patient had a nasal swab test post vaccination (COVID-19 Antigen) on 10Jan2021 and the result was negative. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The events injection site pain and "mild discomfort (2 of 10), but different than arm/injection site pain" were recovered in Jan2021. The outcome of the event "left hand tingly/achy/numbness, localized but radiant throughout hand and digits" was not recovered.

began severe muscle aches, nausea and vomiting and itching. We went to grady clinic today 1/21/21 and was evaluated/treated. He is feeling a little better today - was given several prescriptions.

3 days post vaccination Pt reported red, hot itchy rash developed on left abdomen, still present post vaccination day 5 redness almost gone but itchiness still present.

I had some minor bruising but the most particular thing was these small red dots that appeared on my arm at the injection site. Probably a total of eight small red dots size of a little bigger of a pen tip. Appear to be blood pooling. They were in a straight line that seemed to outline the Band-Aid so it really stood out as strange. No pain nothing else going on. Just kind of a weird sight.

Woke up with symptoms 15 hours after 2nd Pfizer dose. Fever of 101.2F sustained for approximately 12 hours after onset. Accompanied by chills, shivering, sweating, pain at injection site, and headache. 1g oral acetaminophen used as treatment every 6 hours from onset (4 doses total). All symptoms alleviated approximately 24 hours after onset.

Large rash around the injection site; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular (left arm) on 28Dec2020 19:00 at single dose for Covid-19 immunization. There was no medical history; no known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced large rash around the injection site which lasted 7 days. There was no treatment received for the adverse event. The outcome of event was recovered on 04Jan2021. The patient has not been tested for COVID-19 since the vaccination.

This is a spontaneous report from a contactable other healthcare professional (patient). A 31-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on the left arm on 12Jan2021 at 13:30 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had no known allergies. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 23Dec2020 at 03:00PM. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced hives on 15Jan2021 at 16:00. Treatment for the event included Corticosteroid, h1 and h2 blocker. The event resulted in Emergency room/department or urgent care. The patient had no COVID prior vaccination and had not tested for COVID post vaccination. The event had not resolved. Information on the lot/batch number has been requested.

Soreness at the injection site; Pain and soreness in armpits and groin; Pain and soreness in armpits and groin; Headache; Fatigue; Muscle aches; This is a spontaneous report from a contactable other health care professional, the patient. A 31-year old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), intramuscular, in the left arm on 09Jan2021 at 08:00AM (at the age of 31-year-old) as a single dose for COVID-19 immunization. Medical history included Penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 592671001), intramuscular, left arm on 19Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jan2021 at 18:00 PM, the patient experienced soreness at the injection site, pain and soreness in armpits and groin, headache, fatigue, muscle aches. The patient did not receive treatment for the events. The clinical outcome of the events soreness at the injection site, pain and soreness in armpits and groin, headache, fatigue, muscle aches was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Moderate pain and swelling in the injection site; Moderate pain and swelling in the injection site; moderate headache; chills; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK4176), via an unspecified route of administration on 20Jan2021 at 14:00 at single dose on left arm for COVID-19 immunisation. Medical history and concomitant medications were none. No COVID prior vaccination. No COVID tested post vaccination. Known allergies: None. The patient experienced moderate pain and swelling in the injection site started abought 5 hours after receiving the vaccine and experienced moderate headache and chills as well, on 20Jan2021 at 21:00. No treatment was received for the events. Outcome of the events was resolving.

Approx. 15 min after receiving vaccine, patient c/o itching along his back and chest which progressed to his arms and head. Small area of urticaria noted along back (likely secondary to scratching). Patient was given 50 mg of Benadryl. Denied any cp/palp/sob./fever/chills/dysphagia. His heart rate was slightly elevated (HR=91-100) but BP remained wnl (123/82). His 02 saturation in room air remained 99%. Patient was monitored with serial vitals for 2 hours and discharged home with instructions regarding contacting 911 or go to nearest ER if symptoms returned/worsen. Next day, patient return to clinic, symptoms resolved, exam was wnl. Patient advised to f/u with immunologist/allergist for evaluation if safe to receive Dose 2 in 21-42 days. In the interim, patient was advised not to receive the second dose unless cleared by Allergist/Immunology provider.

Erythema and pruritus at site, about 8cm in diameter; Erythema and pruritus at site, about 8cm in diameter; This is a spontaneous report from a non-contactable physician (patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1686, on 11Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 19Dec2020. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no Covid tested post vaccination. The patient had no Known Allergies. The patient had Erythema and pruritus at site, about 8cm in diameter on 13Jan2021. No treatment was received for the events. The outcome of the events was resolved. No follow up attempts are possible. No further information is expected.

a red mark the size of a silver dollar in the place I received the shot.; I ran a fever of 103 the day after I got the shot; body aches; chills; injection site pain; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at 17:00 at single dose in left arm for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient previously on 05Jan2021 at 18:00 received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in left arm for covid-19 immunisation. On 27Jan2021 at 07:00, the day after he got the vaccine, patient ran a fever of 103, with body aches ,chills and injection site pain. Three days after the shot, patient still had injection site pain and on 30Jan2021 he had a red mark the size of a silver dollar in the place he received the shot. The final outcome of the events was recovering. NO treatment given.Information on the lot/batch number has been requested.

Symptoms began with fever 102 F, chills, joint aches, and injection site soreness approximately 12 hours after vaccine was received. Symptoms were abated with naproxen and resolved approximately 10 hours after they started.

The day of the vaccine everything was fine sore arm. On the following morning notice rash on the right side of the mouth was flare of shingles on day 7 rash had crusted over. Around 2 more weeks still exp nerve pain right side of the mouth.

headache; Immediate injection location pain; left chest pain/Continuous left chest pain; Symptoms similar to migratory arthritis randomly occur from day two to four, mainly in both knees, left groin, and left wrist; This is a spontaneous report from a contactable Other Health Professional (patient). A 31-Year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL9262 and Expiration Date unknown) via Intramuscular on 03Feb2021 09:45 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included Hypertension. The concomitant medications was reported as Lisinopril. There is no other vaccine in four weeks. Immediate injection location pain and left chest pain on 03Feb2021 10:00. Continuous left chest pain and headache for about 12 hours on day one. Symptoms similar to migratory arthritis randomly occur from day two to four, mainly in both knees, left groin, and left wrist. The outcome of events was recovering without treatment was given. No follow-up attempts are possible. No further information is expected.; 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 Migratory arthritis 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.

Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (left arm) on 26Jan2021 09:00 (at the age of 31years) at single dose for Covid-19 immunization. The patient's medical history included Covid-19 (prior to vaccination the patient diagnosed with COVID-19). Concomitant medications included cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE); both from an unspecified date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 07:00, the patient experienced sore arm at injection site. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering. This case is non-serious. Information on the lot/batch number has been requested.

Sore and stiff arm at injection site only; Sore and stiff arm at injection site only; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EN 5318, expiration date unknown), via an unspecified route of administration on left arm on 27Jan2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history included asthma, moderate to marked outdoor allergies. Allergies to medications, food, or other products was none. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), triamcinolone acetonide (NASACORT) and montelukast. 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 experienced Sore and stiff arm at injection site only on 26Jan2021 at 17:00. 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 patient has not recovered from the events.

small red bumps on crook of right arm. Lasted a couple of days, majority gone now. As they disappeared they turned brown.

7 days after receiving my first shot, I developed rashes/hives under both of my arms in my armpit and down my arm a bit. I waited a few days and then on Feb 24th went to an clinic to receive a steroid cream which mostly resolved that. However, the rash/hives continued to spread across my body and are now on my sides, chest, back, arms and neck. I went to the clinic and received a steroid pack. The consensus from my clinic was that this was likely a reaction to the vaccine -

Patient is a 31yo male ADSM with a hx of eosinic esophagitis, received Pfizer Covid vaccine #1 and had positive PCR to Covid-19 wild type infection day 9 after receipt. He experienced fatigue, malaise, ear pain, head congestion, fever day 1-3, followed by general improvement but development of a diffuse erythematous maculopapular pruritic exanthem, loss of taste and smell day 4, and episodic bloody diarrhea day 6 or 7. The exanthem has had limited (if any) response to steroid (day 5-9) and he has continued to self treat with Benadryl and atarax at home. He has just been released from quarantine. The dermatitis is improved but not resolved. CBC and CMP were normal.

Sore arm at injection site began hours after (nothing terrible). Woke up the next day with mild to severe body aches, muscle soreness, joint pain and pain in my stomach/abdomen. Developed a 101 fever 24 hrs after receiving the vaccine, and continued until this morning (3/16). Vomiting multiple times in the middle of the night on 3/14. The vomiting was only a one night deal, but every other symptom that I experienced has been persistent until this morning. I feel about 80% back at the moment. Symptoms were very similar, maybe even a little more extreme, than the ones I experienced when I contracted Covid months ago, but they didn?t last as long.

Stinging feeling in my left eye lid and face. Progressively got worse. Change in feeling and temperature on the left side of the face between my eyebrows and chin.

Shingles flare up; Shingles flare up; This is a spontaneous report from a contactable nurse (patient). A 31-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL9262; expiration date: unknown) at 31-year-old vaccination age via an unspecified route of administration in the right deltoid on 18Feb2021 9:00 AM as a single dose to protect self (covid-19 immunization). Medical history included chicken pox virus as a kid and shingles. The patient has no family medical history. There were no concomitant medications. Historical vaccination included varicella zoster vaccine (CHICKENPOX VACCINE) for vaccination for chicken pox and received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3246) at unknown vaccination age via an unspecified route of administration in the left deltoid on an unspecified date as a single dose to protect self (covid-19 immunization). The patient received the vaccine in a hospital and did not receive other vaccines administered on same date of Pfizer suspect. The patient did not have prior vaccinations within 4 weeks. The patient reported that he just got a flare up of shingles on 28Feb2021 and doesn't know if it is related or not to the covid vaccination he took. The patient reported that he did nothing unusual in the last 14 days. Doesn't know if that is something to report to see if there was any trending. The patient inquired if a shingles flare-up has happened before after the COVID vaccine. He got the vaccine ten days before (18Feb2021) the shingles flare up started. He added that it is on right side of torso in the thorax area and goes from midline abdomen all the way to midline on his back on the right side. The adverse event required urgent care visit (emergency room visit). The nurse considered the event serious. The patient did not have relevant tests and was only clinically diagnosed with a shingles flare up. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "Shingles flare up" cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

1) Injection site soreness, intensified approximately 3 hours after injection, peak at 24 hours after injection. Resolved approximately 72 hours after injection. 2) Stool consistency was between 5 and 6 on Bristol chart. Bowel movements at 6 times over the course of first day of immunization, approximately once every 1.5 to 2 hours starting close to 3PM (3 hours post-injection). Woke twice from description of bullet point 4 due to bowel movement. Resolved by 24 hours. 3) Muscle pain/tightness in other locations of body, such as upper left thigh, right shoulder, right buttock starting approximately 24 hours after injection. These were not experienced prior to vaccine, although occasional skeletal related pain in right shoulder from prior injury one year prior is reported. 4) Fatigue began approximately 6 hours after injection, drowsiness following where patient was somnolent 12 hours after injection (4 to 5 hours prior to typical sleep time for patient).

Report red raised lesion bumps of the face along the jawline with intermittent purulent discharge. No change in routine. Denies itching, began 2 weeks post vaccination. Treatment: none Outcome: Recommend to see dermatologist or allergist. Does not interfere with ADLs.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Syncope-Medium, Additional Details: Patient was in the waiting area after recieving vaccine where he fainted and fell out of his chair. His female friend asissted him and reached out to us. He regained consiousness and was able to speak to us clearly. There was a small cut above the left eye. He expressed that he has a fear of needles and this has happened before to him as well. He had no symptoms of an allergic reaction, no headache or visual distrubances. We monitored him for 30 minutes and did not feel the need to call 911.

3/24/21 Fever and chills for most of the day. 3/25/21 Hands swollen, itchy started around 5 pm. 3/26/21 Thighs, Knees, Lower back, legs ,basically the whole lower body was swollen, decent size blister developed on the left foot. 3/27/21 Symptoms are still the same as the day before

Approx 15 mins post injection, right arm heaviness and pain. Then extreme fatigue, vagal stimulus when stood up, vasovagal near syncope, diaphoretic. Approx 18-20 mins after injection throat and tongue tingling and swelling. PO liquid diphenhydramine 50mg given at that time. Then taken to ER for further observation. In the ER, right arm did lock up. No further treatment given.

I was recently diagnosed with Shingles. I don't know if this is related to the Pfizer vaccine I received, but I started having symptoms about a week and half after taking the vaccine. I had chicken pox as a kid, and the case has been really mild, but I thought this was important to report, because I have read where other people reported similar things happening.

Nausea, vomiting, dizziness,head ache, diarrhea also arm injection was put it is very painful and swollen

Patient fell out of chair and was unresponsive about 10 minutes after vaccination. When able to talk complained of itching all over. EpiPen was administered. During fall landed directly on face resulting in laceration to nose and subconjunctival hematoma to left eye. Patient continued to be alert and responsive and itching resolved with EpiPen. He was transported by ambulance to Emergency Department.

Tingling - much like the sensation of novocain wearing off - from the injection site on my left shoulder to my left cheek. The sensation is most noticeable on my left shoulder ( injection site), left neck, and left cheek (from jaw to cheekbone)

All over body aches, chills, headache, abdominal pain, diarrhea, rash in the face, hive breakout in armpit underneath injection site, nausea, motion sickness when attempting to drive, unable to wear contact lenses.

Rectal Hemorrhage Pain in the administered area; Pain in the administered area; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 17Mar2021 14:00 as SINGLE DOSE for covid-19 immunisation. Medical history included meniere's disease. Concomitant medications included gabapentin; atorvastatin; pantoprazole; acetazolamide all taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient experienced rectal hemorrhage pain in the administered area on 17Mar2021 17:45 with outcome of unknown. Patient didn't receive treatment for the adverse events. Patient didn't have covid prior vaccination nor tested covid post vaccination.

patient complained of mild itching approximately 15 minutes after administration. patient self administered benadryl and was monitored for 30 minutes. patient stated that he was feeling fine after observation and left on his own accord.

Injection Site pain - 3-31 ~7pm to current (4-2 ~2pm) currently just in left shoulder, lat, left pec and under arm area ribs Tiredness - 3-31 ~8-10pm to 4-1 ~11pm-12am Headache - 4-1 ~7am to ~1pm went away with Advil Muscle pain - 4-1 ~7am to about 4-2 ~1:30am went away over night Joint pain - 4-1 ~7am to about 4-2 ~1:30am went away over night

5 days after vaccination, left arm got progressively more sensitive to the tough. Rash appeared along spinal column, on chest, and on left shoulder blade by day 6 after vaccination. Rash turned more pustular, with increased sensitivity and needling feeling. On day 9, diagnosed with herpes zoster reactivation (shingles).

Pimples on right side of stomach and chest and shoulders, at first no itch now itch on neck and shoulders,

I started getting small red marks on my skin about 3 days after the injection. They are about 8-10 in number now and are on my arms and chest area predominantly. I was also feeling muscle soreness which is a bit better and I still feel very fatigued.

Small itchy red bumps on my arms and legs. Feels like mosquito or spider bites. Lymph node in my neck is swollen and painful.

injection site ache from time of injection that has not subsided, general body ache onset from approximately an hour after injection that has not subsided, general body weakness onset within 12 hours after injection that has not subsided, headache onset from approximately 15 hours after injection that has not subsided, dizziness onset approximately 19 hours after injection that has not subsided, fever onset approximately 24 hours after injection

Pfizer-BioNTech COVID-19 Vaccine EUA About a minute after the shot I experienced dizziness, weakness and a bad headache. I also become very nauseous, had injection site numbness, a tingling feeling in my fingertips, lower back pain/joint pain and felt sick the rest of the day.

When the needle entered my arm, that felt normal. But I felt extreme pressure and immediate pain as soon as the plunger got depressed. After the needle was removed, I continued to feel pain within my shoulder, not at the injection site. On my ride home, the pain started to worsen and was very painful when I got home, throughout my shoulder joint. I took Advil when I got home, and have taken it very 6 hours since, along with lots of water. I have used a heating pad with some immediate relief but no improvement in the pain. I am trying to stretch and move the arm, but am requiring assistance with even that because of how much pain is involved with simple movements. It does not seem nerve related as it does not radiate down my arm. The pain is isolated to my shoulder joint.

Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium

5 MINUTES AFTER RECIVING INJECTION, PT HAD LIGHTEHEADEDNESS AND ITCHING. NEVER HAD SYMPTOMS TO FIRST DOSE OR TO OTHER IMMUNIZATIONS PRIOR. HE WAS WHEELED INTO OBVS BY WHEELCHAIR, NEEDED NO ASSITANCE TO GET ONTO STRETCHER. WAS OFFERED AND GIVEN SNACKS AND WATER. PT REPORTS IMRPOVEMENT UPON ARRIVAL IN OBVS. VS @ 5:10PM: BP: 124/70 HR:70 RP: 20 O2SAT: 98% ON RA. VS @ 5:20 PM: BP: 132/75 HR: 72 RP: 20 O2SAT: 97% ON RA. VSS AT TIME OF DISCHARGE. NO S/S OF DISTRESS NOTED. PT ESCORTED TO EXIT WITH STAFF, PT REQYESTED TO AMBULATE REFUSED WHEELCHAIR.

On 4/11/2021, I noticed a rash like symptom appear on my left lower abdominal area. On 4/12/2021, I went to Patient First to see about the rash like symptom after waking up the next morning and it was red in color and having some discomfort in the area. The doctor stated that I had Shingles and was given Valacyclovir to take.

I developed a rash on my back and in axillary region. It spread to my stomach and thighs. I started treatment of prednisone and hydrocortisone cream. The rash cleared up within 4 days after treatment began.

I started developing another rash on my right low back, I had pain in my lower back on the right side and superficially on my stomach (right side). More rash formed, also on the right side of my low back and right side of my stomach. Swollen inguinal lymph nodes on right side. Treatment is valtrex.

Received the vaccine on Saturday, 4/10/2021 at around 12p. On Sunday, 4/11/2021 woke up around 11am with a fever and feeling extremely run down. In addition had no appetite and somewhat nauseas. On Monday morning around 10am, felt better with no fever yet still less of an appetite. Through out the day kept improving and then at 12:30a Tuesday, 4/12/21 I began to get hives on my inner thighs, arms, feet, buttocks which started to rapidly spread to all over my body. After about an hour my lips swelled up and the hives were puffier and immensely itchy and painful including my arms and feet. On

Patient received dose 1 of the Pfizer COVID vaccine (lot ER8731, exp 7/2021) at 1230. At 1240, patient reported to EMT that he felt lightheaded, dizzy,sweaty, and anxious. EMT assisted the patient in moving to the reclining zero-gravity chair and laid him in reclining position. Vital signs: O2 97%, pulse 92, respirations 20, blood pressure 150/78. Patient reported he had not eaten in 16 hours but had been drinking fluids. Patient was offered water. Patient reported no allergies or medications, medical condition includes psoriasis. At 1247, PHN offered Benadryl, patient declined as he drove himself and did not want to feel drowsy at the wheel. Patient reported improvement in symptoms. At 1250, vital signs: blood pressure 130/78, O2 98%, pulse 98, respirations 22. Patient reported symptoms had resolved. At 1259, patient sat up monitored by EMT and PHN. At 1307, patient stood up monitored by PHN and EMT , continued to report no symptoms. PHN advised patient to call 911 and follow up with provider. Patient reported he did not have a medical provider, PHN encouraged patient to call for assistance with medical insurance and provider.

Body Aches, Headache, soreness at injection site. Took some 500mg Acetaminophen, plenty of water and rest

On 4/19 he received the first dose of Pfizer vaccine oh 4 PM. Administration of vaccine was uneventful. The next day he noticed sore shoulder at 3 PM on 4/20 he noted he had upper wrist pain that progressed to his right thumb as well as redness with a shiny quality that was consistent with previous gout flares so he took 2 doses of colchicine and 2 doses of Advil which did not relieve his symptoms. A couple hours later he noted hand numbness and tingling as well as feet numbness and tingling bilaterally. The numbness progressed to his extremities with the left arm more affected than the right arm (he received vaccine in his left arm). He had accompanied pain of his extremities and wrists that was described as 10 out of 10. He then felt 2 episodes of chest tightness and difficulty breathing prompting him to present to the strong ED. In the ED his exam was notable for hypertension (240/90), tachycardia, wrist flexion in distress and yelling in pain. His exam also showed bilateral hyperflexion of bilateral wrist with mild swelling and diminished sensation and motor function throughout. He was administered IV hydromorphone, and Benadryl with dramatic improvement in his symptoms. His labs are notable for abnormal electrolytes including magnesium, potassium, phosphorus, calcium and he was repleted with magnesium potassium and phosphorus. He is admitted to ED OBS. overall felt his symptoms were most likely due to gout flare and hyperventilation, not likely related to vaccine.

Client reports uneventful night after receiving vaccine. Day two, client noted mild itching before bed. Day three when client awoke, he experienced rash, itching, and pain on the right side of his torso, back, neck, shoulder, and armpit. Day three the client saw his PCP who referred him to a dermatologist, the dermatologist in turn referred him to an immunologist who confirmed the shingles diagnosis. Diagnosis based on assessments of providers - client denies any specific imaging or studies done outside of a bloodwork panel that he reports was all WNL. Client currently reports feeling "about 80% recovered" and still experiences what he described as internal pain, with the outward rash spots drying/scabbing and fall

24-48 hours post injection, pt experienced a sore arm consistent with other immunizations which resolved shortly thereafter. 9 days post immunization, pt experienced pain and inflammation in the area of the injection. Symptoms included radiating pain into the scapular area, mimicking that of a labral tear. Pt continues to experience pain/inflammation at the site of the injection that continues to radiate and feels like a fatigued arm with excessive movement (as of today (Day 14)).

Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Additional Details: Fainted, lost consciousness and fell to floor. Hit head and had redness above eye brow. Patient said he had anxiety surrounding needles. Wife will bring to ER

I am having rashes in my upper torso. Itchy but thankfully not overly painful. I took pictures. They appear to go away, and then flare up. Not sure why

Extremely minor allergic reaction to injection. Within minutes of injection I had a red butterfly shaped fash in my cheeks. The rash was very warm to the touch and my face felt warm in general. I developed no further symptoms of an allergic reaction, and the rash went away within 2 hours untreated.

Itching at site occurred ~36 hours after shot and redness at site the size of a golf ball ~50 hours after shot.

First dose was uneventful. but second dose was followed by fever and chills on Thursday. These resolved. On Saturday he developed the hives that were diffuse and he came to the ER on Sunday and got prednisone single dose and Benadryl. The rash improved for one day then recurred yesterday and today. He now complains of facial swelling but is breathing and swallowing fine. No other complaints. Has a history of allergy to Nickel.

31 year old with onset of arm and leg urticaria 10 days after first Pfizer COVID-19 vaccine. No immediate reaction. No prior history of allergy or urticaria. No other suspected recent food, medication, illness, or environmental trigger identified. Managed with standard antihistamine for urticaria. Advised to get second vaccine as normally recommended.

Fatigue directly after the shot, developing into chills at 11pm that evening. Injection site soreness. Woke up at 7am (8 hours later) with a low-grade fever (~99-100F), dizziness, nausea, and a terrible headache. Took an Aleve to help. Symptoms mostly went away by 11pm that evening (16 hours later, 48 hours from injection time). All symptoms besides minor muscle aches were gone by the follow morning.

Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: After 15 minutes he was walking out and his arm started itching. He said he already had a little bit of a sunburn. We gave him 25mg benadryl and got him to wait another 30 minutes.

April 26 2021 10:00 pm onset of noticeable chills 11:00 pm onset of severe chills, difficulty handling cutlery and other small household items precisely April 27 2021 01:00 am woke up with severe headache and neck pain, dehydration, dry mouth, general soreness body wide. Chills were gone by 01:00 am 01:30 am-03:00 am moderate fever, burning up 03:00 am onset of mild nausea, difficulty drinking water to rehydrate 03:30 am onset of severe nausea, unable to drink water or ginger ale. headache subsides to moderate 05:45 am vomited 06:00 am nausea subsides to mild, again able to drink some water and ginger ale. neck soreness mild, rest of body back to normal 01:00 pm headache has subsided to mild and nausea is mostly gone 03:00 pm headache mostly gone, but recurs when standing up or sitting down quickly 08:00 pm mostly back to normal. mild lingering neck soreness In addition, pain at injection site (left deltoid) prevented me from raising my arm above my shoulder from April 26 ~8:00 pm to April 28 ~8 am. Symptoms other than feeling jet lagged were over by the time I woke up again the next day (8:20 am April 28) Light to mild pain using my left arm persisted until the morning of April 29.

7-8 Days after 2nd dose of COVID Vaccine, the skin on my fingers started to peel like they would after a sunburn. There was no prior rash. I can only remember around 4 days after the vaccine, my fingers felt warm as if they had a sunburn, but I had no exposure to sun, UV, or any heat source that might explain the heat/peeling. This did not occur to my wife, who received the same vaccine at the exact same times from the exact same batch from the exact same CVS. The only side-effect she had was a swollen thumb on the hand belonging to the arm which received the vaccine. This last form day 2 till about day 6 after the 2nd dose. Did not occur during 1st dose, so we don't know if its related to the vaccine. Again, we found no other cause for the potential swollen Thumb.

Painful shingles like rash on right hip/waist area. By 5/3 pain has started to subside and rash redness and soreness appears to be subsiding.

8 minutes after shot got dizziness, really warm all over body, nausea, blurred vision. Went away after 30 minutes.

Swelling in left pectoral (chest area). Became red and squishy. Went to Hospital on 04/19/2021 at 12:30 pm into the Emergency Room. Took 5 hours for a nurse or doctor to look and given an uncertain diagnosis. Was prescribed by the doctor Benadryl and Pepcid AC.

Diarrhea, chills,fever, total body aches, sensitive to light, sinus headache, extreme soreness around injection site

Fever, chills, headache, sore arm, swollen arm, lethargy, sensitive and sore skin. These began within 6 hours of the shot and were debilitating for 48 hours. Severe for 49-72 hours and then fever broke and other symptoms gradually subsided over next 48 hours. At some (unknown) time after the vaccine, I developed viral pericarditis. In addition to the above, this manifested in chest pain (no difficulty breathing) which radiated from what felt like the lungs, through my windpipe, into a sore throat, jaw muscles hurting, inner ear and neck soreness. These symptoms lasted after all had subsided and didn?t disappear until 14 days after the 2nd vaccine.

Extreme Fatigue, Fever, Chills beginning 24 hours after 2nd dose, & lasting for 12-16 hours. Skin rash on arms, back, chest, stomach that developed 3 days after 2nd dose

First dose 12/08/2021 without any side effect, but 2 months after the second dose urticaria developed on my head and neck the. Developed to my extremities. 4 weeks later became more localized on my face and back intermittently. No other signs of allergy.

Covid Arm. Red rash of about 3 inches in diameter a few inches below injection site. Now yellowing is appearing on the edge of one side of the rash.

Initially I didn't have many adverse outcomes of the shot, but after three weeks I have had a serious outbreak of shingles on my body at 31 years of age.

Extreme itching over entire body. No visible rashes, or lumps on skin. Slight redness on skin in some places.

Broke out in rashes all over my chest, belly, and back so far; This is a spontaneous report from a contactable consumer. A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No covid prior vaccination. The patient previously received first dose of bnt162b2 on 28Jan2021 for COVID-19 Immunization. The patient experienced broke out in rashes all over my chest, belly, and back so far on 25Feb2021 17:00. Treatment included Benadryl. Outcome of event was not recovered. No covid tested post vaccination.

Rashes across the whole body started appearing after 48 hours of the second dose. Rashes across both arms, legs, chest and back. Been 24 hours since noticed and hasnt subsided yet at the time of filling this information.

he started feeling pain at injection site at arm, fatigued, really tired, sleepy, body aches but no c/o of fever. He complains that his temperature is fluctuating between hot and cold. No c/o sob but he states he has upper back by shoulder blade pain (states feels like someone is stabbing him but it comes and goes). He also states a slight neck pain and c/o his bones are hurting all over. Patient stated he felt nauseous in the morning after breakfast but no longer has that feeling. Patient took Motrin on Monday @6:30am and around 12pm but didn't do anything. Advised patient to take Tylenol as directed, rest up and hydrate and monitor himself. Also informed him if feels any SOB or chest pain to seek medical attention (ER or urgent care).

On 4/29 pt worked out at 7am and then during the evening saw a rash on the arms, neck and torso. Rash improved some but then flared significantly from neck to knees. Gets severe "needles" or itchy feeling when he heats up.

Patient received vaccine and was standing in waiting area and had witnessed syncopal episode and fall. Hit back of head and had laceration. Patient slow to arose and provider from urgent care called to evaluate. Awakened and able to answer questions. Appeared laceration would need sutures/staples. Ambulance called for and transported.

I got my first shot of Pfizer at pharmacy, I sat for the recommendation of 15 minutes. I then got in my car to drive home when within 3 minutes of driving on the road I lost consciousness and crashed my car into a pole totalling my sedan. I was rushed to the hospital by ambulance and did various test but thankfully I ended up with only bruises and scrapes.

I had fever and achiness the day after. Fever of 101 degrees. This was on top of an injection site reaction with pain. 36 hours after the shot I developed extremely swollen lymphnodes in my chest area, accompanied by soreness and pain. Along with this has been continuous (seemingly non-stop, as the issue has not been resolved) muscle spasms.

Vomiting 24 hours later. The next few days intense heartburn followed by a full body rash (small red hive looking bumps) and extremely swollen feet (May 11). Swelling on lip and leg May 15 too.

burning and itchy rash consisting of big, red bumps on joints - predominantly on elbows, ankles, heels and toes. burning and itchy rash - small red bumps on chest, stomach and back

slight discomfort at injection site; feeling of fatigue, not severe but noticeable; This is a spontaneous report from a non-contactable consumer (patient). A 31-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: WN5318, Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 29Jan2021 at 11:45 (age at vaccination was 31 years) as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history included peanut allergy. Concomitant medications the patient received within 2 weeks of vaccination included cyanocobalamin (VITAMIN B12) (50 ug vitamin B12/day) and colecalciferol (VITAMIN D) (1000 IU vitamin D/day). The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) which caused drug allergy. On 29Jan2021 at 12:00 pm, the patient experienced slight discomfort at injection site, feeling of fatigue, not severe but noticeable. The patient responded "not recovered" but kept in mind that a very short time had elapsed between the adverse event and reporting. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse events. The events were reported as non-serious. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

sleepless night; abdomen pain; rash that started on my left ankle and spread onto both feet, legs, and arms/red dots on my extremities; Joint pain that got progressively worse; inflamed bowels; joint inflammation and pain; currently home in the same pain and red dots on my extremities; Henoch schoenlein purpura vasculitis; Stomach ache that got progressively worse as the day went on; This is a spontaneous report from COVAES. This is a report from a contactable consumer (patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 (Batch/Lot Number: EW0164) as 1st dose, single (at the age of 31 years) for covid-19 immunisation. Medical history included hypersensitivity to Penicillin. The patient did not receive "any other vaccines" within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced stomach ache that got progressively worse as the day went on (hospitalization) on 22Apr2021 08:00 with outcome of not recovered , sleepless night (hospitalization) on an unspecified date with outcome of unknown, abdomen pain (hospitalization) on an unspecified date with outcome of unknown , rash that started on my left ankle and spread onto both feet, legs, and arms/ red dots on my extremities (hospitalization) on an unspecified date with outcome of unknown , joint pain that got progressively worse (arthralgia) (hospitalization) on an unspecified date with outcome of unknown. The patient went to the ER (emergency room) 2 times in 3 days, then was admitted into the hospital for 5 days of tests and observation. The patient was diagnosed with henoch schoenlein purpura vasculitis (hospitalization) on an unspecified date with outcome of unknown , inflamed bowels (hospitalization) on an unspecified date with outcome of unknown , joint inflammation and pain (hospitalization) on an unspecified date with outcome of unknown and currently home in the same pain and red dots on my extremities (hospitalization) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included nasal swab: negative on 26Apr2021, sars-cov-2 test: results not on unspecified date. Since the vaccination, the patient has been tested for COVID-19 however, no results were reported. Therapeutic measures were taken as a result of stomach ache that got progressively worse as the day went on. Treatment included Pain medication, diet change/reduction, and observation.

Measured a 101 Fever; Severely sore arm around injection site upon waking up; Chills; This is a spontaneous report from a contactable consumer (patient). This 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8733) via unspecified route on left arm single dose for COVID-19 immunization on 19Apr2021 01:15 PM, at 31-year-old. Medical history included: Metabolic syndrome/Moderate obesity. Concomitant medication included: lovastatin from 09Apr2021. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8733) on right arm for COVID-19 immunization on 29Mar2021 12:30 PM, at 31-year-old. On 20Apr2021 04:30 AM, the patient had severely sore arm around injection site upon waking up, could not lift arm to put on jacket without significant pain, began taking ibuprofen (ADVIL). Chills set in during the day. Measured a 101 Fever with ibuprofen in system just after 5:00 PM. Outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.

Upon receiving the second dose of the COVID-19 vaccine, I immediately felt tingling or chills in the arm where the shot was administered. This developed into muscle soreness as I sat through the waiting period before leaving the facility. (For this reason, I had taken acetaminophen at about 8:30 that morning.) I experienced both of these symptoms after my first shot of this COVID-19 vaccine, so these did not concern me. After taking a nap back at my house, I woke up about 3:30 p.m. experiencing some partial numbness in my left arm, which received the injection. It was not inhibitive, but I can somewhat relate it to the neuropathy my mother experienced before being diagnosed with diabetes in 2005. It was a bit like the tingling I first experienced after the injection, but throughout the injected arm. As I continued through that afternoon and evening, my arm kept getting stiffer and stiffer. This prompted me to take my temperature at about 8 p.m. and then again at 10 p.m. Both of these tests resulted in a normal temperature of 98.3 or 98.4 degrees. By the time I was about to climb into bed at midnight, the stiffness had spread to my shoulder joint -- such that almost any movement of that arm elicited some mild discomfort, especially if I leaned against the wall with that shoulder or raised my arm above my head. I took a third dose of acetaminophen. My normal prone sleeping position was not comfortable with this stiffness, so I did my best to sleep on my back. Next, I woke up too hot about 3:30 a.m. (Wednesday, May 26) and could not get back to sleep. Full-body chills set in soon after, prompting me to turn off my ceiling fan. I faced some mild nausea as I attempted to get comfortable in bed again. I suspected I was feverish by at least 4 a.m., but I did not get up to check my temperature until 5 a.m. The thermometer gave a reading of 100.3 degrees, so I took another dose of acetaminophen (my fourth in 24 hours) and tried to go back to sleep.

pressure headache; tinnitus; hyperacusis; grainy and double vision; photophobia; facial twitching; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Burning sensations in back and arms; Muscle weakness in legs and arms; Large rash at injection site; Swollen lymph nodes in both arms; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: ER8736, Expiration date: not reported) via an unspecified route of administration in left arm on 23Apr2021 at 10:00 AM (at the age of 31 years) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included diabetes (controlled) and concomitant medications were not reported. The patient had a history of allergies to Demerol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955, Expiration date: not reported) via an unspecified route of administration in left arm on 31Mar2021 at 12:00 PM as 1ST DOSE, SINGLE for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was reported as Vitamin C, D3. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021 at 07:45 AM, the patient stated that he woke up with pressure headache, tinnitus, hyperacusis, grainy and double vision, photophobia, facial twitching, pain in back, shoulders and arms, burning sensations in back and arms, muscle weakness in legs and arms, large rash at injection site, swollen lymph nodes in both arms. The adverse events resulted in the doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received for the adverse events which includes Prednisone. The events were reported as non serious. Outcome of the events were reported as Not recovered.

Lymph node on my collarbone (the left side). skin rash over different parts of my body (right hand +right leg).

Red hives appeared on the back of my legs (hamstrings). They did not itch and they were not painful. Appeared approximately 1 hour after injection and were gone the next morning.

Within a minute or less of receiving the shot, I experienced a rapid and intense onset of blurred vision, lightheadedness, profuse sweating, and extreme numbness all over but especially in my hands and feet. I came close to losing consciousness and was instructed to lay down with my knees bent to increase blood flow. I slowly came to over the course of probably 10 minutes while laying on the ground, but my hands and especially my fingers remained numb for 30-45 minutes while I experienced chills. My left hand and fingers were extremely pale and bluish during this time. I also had minor pains on the left side of my neck and left shoulder blade. Color came back to my left hand and chills subsided around an hour after my shot.

Injection site swollen around my back arm and armpit, small hive left inner elbow, increased heart rate, blood pressure was 183/110. Was hard to breathe, clammy, faint, confused, and panicky. Left arm went numb. I went to hospital twice, and clinic twice due to the symptoms coming and going.

After first shot there was minimal effects, just a sore arm and fatigue. These went away within a day or so. Second shot had immedate fatigue, body aches, and headache within 12 hours. Again these subsided within 48 hours. However within the week I developed a mild red rash across my body from my chest down to my knees, and an ache in my left ankle. I assumed I had twisted the ankle without realizing and the rash had to do with my seasonal allergies. I began taking Benadryl for the rash and rested the ankle, but the rash only slightly faded and while the ankle got slightly better, the ache moved to my right shoulder, then my left elbow, then the left knee, then right knee, then to the joints in fingers on my right hand. Finally mos recently the ache has moved to joints in the left hand. Each time the aches move the previous location feels slightly better but isn't back up to 100 percent. And aches seem to move every 4/5 days. It has now been over a month since the second shot and the joints of my body still feels abnormal and strained. And in the last few days I have developed a terrible headache that doesn't seem to go away.

This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EW0167, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 12May2021 at 08:30 (at the age of 31 years old) as first dose, single for COVID-19 immunisation in a hospital. Medical history included overactive bladder from an unknown date and unknown if ongoing. The patient has known allergies with beeswax. Prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medications included tolterodine, xantofyl (LUTEIN), fish oil and vitamin d, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. When the patient got his shot of BNT162B2, the patient felt no pain when the nurse administered the shot. On 12May2021 at 21:00, the patient started to feel numbness occasionally in the thenar muscle on the radial side of the patient's left hand. The numbness was most obvious during complex hand movements such as hand washing and but it wasn't persistent. It was further described that it felt like the sudden numbness the patient gets when he accidentally hit his elbow against the wall but less intense. The patient woke up the next day with persistent numbness in his entire left hand, affecting the wrist, palm, and all 5 fingers. This persistent numbness the patient had felt was like the numbness he gets when he was sleeping on his side with his hands under his head. It extended to the patient's distal forearm on 15May2021. At the day of the report ,the 5th day after vaccination (as reported), the soreness of the injection site had subsided but both types of numbness in the patient's left hand remained. They're were not as bad as "pins and needles" and there was no tingling sensation but it was concerning the patient. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was not recovered.

Client received the COVID vaccine (Pfizer dose 1, lot # EW0187, expiration date 7/12/2021) in his left deltoid at 1835. The client reported to RN at 1705 that he was experiencing itching. RN informed EMT and RN , who responded at that time. The client stated that the itching had started "5 minutes" after he was vaccinated and he was experiencing itching on his bilateral upper and lower extremities, as well as the back of his head. The client denied any shortness of breath or chest pain. The client didn't have any observable swelling on his head or tongue, and he had no observable rashes on his extremities or head. The client stated he had a history of hypertension but takes no medications, and he stated that he had an allergy to penicillin. The client stated that he last ate at noon. At 1710, the client's vital signs were as follows: blood pressure 158/112, heart rate 76, respiratory rate 18, O2 97%. The client stated he did not know his usual blood pressure range. The client denied any headache and his pulses were normal. The client stated that he was feeling "heat"; the client's skin was pink, warm, and dry. The client continued to denied any difficulty breathing. The client was alert and oriented x4. The client was offered water and oral Benadryl (50 mg) at 1710, which he accepted. At 1720, the client's vital signs were as follows: blood pressure 152/102, heart rate 74, O2 96%. The client stated that the itching had stayed the same. Education provided to the client and his partner regarding emergency management, primary care follow up, and v-safe. At 1730, the client's vital signs were as follows: blood pressure 150/96, heart rate 78, O2 95%. At 1735, the client stated that his symptoms of itching and heat had resolved. The client was sitting in his chair comfortably resting. At 1740, the client was able to stand without dizziness, and ambulated with a steady gait out to his car, where his partner drove him home.

Initially on the first couple of days (Tues & Wed) I was experiencing the usual symptoms that were being reported. Localized Soreness at vaccination site, extreme fatigue, fever, and chills. Then on Thursday morning, I had chest pain that i've never experienced in my life. I went to a clinic where they ran an EKG report. There were off-signs that concluded I need to be sent to the hospital. An ambulance came and took me to hospital. I was met with a team of close to 12 doctors as they all checked for signs of heart attack. I stayed a total of 2 nights and 3 days in which several tests were conducted. EKG, Echogram, Angiogram, and an MRI. I was diagnosed with Myocarditis and Pericarditis. I have no history of smoking and I do not drink alcohol.

The patient is a 31 year old kidney transplant recipient who had been in his usual state of health and feeling well over the past months. On May 7, he received the first dose of COVID vaccine and experienced intense myalgias at that time. He recovered, but then around May 17 noted the onset of pain in the R thigh and lower R back and subsequently developed a vesicular rash in this area. He saw his primary care physician who prescribed gabapentin. However his pain worsened and the rash extended and he presented for admission. He was diagnosed with disseminated zoster, was hospitalized from 5/24/21 - 5/29/21 and was treated with IV acyclovir followed by oral valacyclovir.

Patient presented with a maculopapular rash that started on his chest 3 weeks ago and has spread to his abdomen, lower legs, and most recently his right forearm. He has been treating with benadryl, over-the-counter hydrocortisone cream, and neosporin. I started him on a 21 day prednisone taper dose pack

Soreness in arm at injection site.; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: EL3302) via unspecified route in the left arm, as dose 1, single on 19Jan2021 at 14:30 and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: EL3302) via unspecified route in the right arm, as dose 2, single on 09Feb2021 at 14:45 for COVID-19 immunization (at the age of 31-years). The most recent COVID-19 vaccine was administered in the hospital. The patient medical history and concomitant medications were not reported. The patient previously took cephalexin (cefalexin) and amoxicillin and experienced drug hypersensitivity. 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 experienced soreness in arm at injection site on 20Jan2021 with outcome of recovered. The events were assessed as non-serious. The clinical outcome for the events was recovered on an unspecified date. Follow-up attempts are completed. No further information is expected.

Directly after vaccination administration, patients states, "Should I feel dizzy and sweaty?" Upon observation, patient was pale and diaphoretic. Nurse asked patient if he needed to lie down. Patient states, "I have multiple panic attacks a day, and i think I will be ok." Patient then stated that he wanted to lie down. Patient was placed in a wheel chair at 12:23 and taken to a private area for observation. Assisted patient to lie down, feet elevated, cool rags applied to forehead and anterior neck. Patient then continued diaphoretic, blood pressure 172/92. HR 78/PO2 / 98%. During this time, patient was accompanied by Uncle. Patient was continued to be observed with frequent vital sign measurements. 12:29 - 155/95, HR 72, PO2 - 99%, diaphoretic, and complaints / shortness of breath. 12:32 - 158/108, HR 76, PO2 98%. 12:35 - 166/111, HR 83, skin-dry, continues SOB. 12:42 - 171/114, HR 105, PO2 -98%. Patient consented to Ambulance for further evaluation in ER. (12:49) Fire-fighters arrived first w/ evaluation of patient w/ manual blood pressure / 162/114, and HR - 99, PO2 - 98%. Ambulance arrived at 12:52, and care was transferred to the hospital.

Increse in sense of smell (mostly disgusting odors) for 2 days. Back pain (the whole spine for 3 weeks predominantly in the morning and relieved with daily activity). Chills (3 days) Pain in the site of the injection with a radius of about 8 inches.

Injection site occasionally has dull pulsating pain. Will go away but returns every few days for about a couple minutes.

I am getting like shingles and now I am getting like some other skin issues; then also like I get almost like all over shingles at 30; I am getting like shingles and now I am getting like some other skin issues; then also like I get almost like all over shingles at 30; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8736), via an unspecified route of administration in upper left arm on 19May2021 (at the age of 31 years old) as single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731), via an unspecified route of administration in upper left arm on 28Apr2021 (at the age of 31 years old) for covid-19 immunisation. The patient medical history was not reported. Family medical history related to adverse event: Reporter stated that not that he know of and they just took the vaccine and never had any of that. Concomitant medications included gabapentin; lisdexamfetamine mesilate (VYVANSE) for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reporter stated that on 28May2021, after application he had little side effect for like all over a month now, he is not sure why they and know they gave him since second dose from the vaccine and he getting like shingles and now getting like some other skin issues and then also like he get almost like all over shingles at 30. He never had shingles before never really had or anything else like elementary school almost 32 now, like last when he had a hearty look like a long time. For treatment consumer stated for like shingles and stuff, they haven't really gave him anything for it. He knew they keep try to give him antibiotic so that it can do any good. No treatment was received for the event. The outcome of events was unknown.

That evening after the vaccine, I notice a pimple-like red bump on my left side of the forehead. The next day, I noticed it started to spread the next 2 days on my face and worked its way to my hairline and down the left side of forehead to my left eye and left cheek. On day 3, I decided to go to the ER. They ran some tests, did an eye exam and gave me a medication named Valtrex and diagnosed me with Shingles. 2 days later, I was still having problems with my left eye and it was completely swollen shut. I went to another ER. They ran some more tests and I was prescribed an ointment for my eye and a pain medication Hydrocodone. Within a few days, my eye was back to normal and my shingles was also resolved.

Back of hands, elbows, thighs, knees have been itchy; Flushed; Regular rash. Knuckles, elbows, knees flushed in red and warm.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm left on 21Apr2021(at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and past drug history were reported as no. Concomitant medications were reported as not applicable. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in Apr2021, a week after receiving the vaccine the patient experienced itchy and flushed on back of hands, elbows, thighs, knees for past 4 days. No visible, regular rash. Knuckles, elbows, knees flushed in red and warm. Therapeutic measures were taken for the reported events and included treatment with oral antihistamine(unspecified). Itching had minimally reduced with oral antihistamine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event Itchy rash, flushed and red rash was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.

Red dots all over lips and nose, face red (same as sunburn); Numb right arm; Left arm only numb at injection site; Very hot head and neck; Dizziness; Anxiety; Nasal congestion; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 08:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included generalized anxiety disorder. The patient was not allergic to food, medications, or other products. Concomitant medications included nicotinic acid (NIACIN), garlic extract and cayenne pepper. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 13:30, the patient experienced red dots all over lips and tip of nose, numb right arm, left arm only numb at injection site, very hot head and neck, red face which was same as sunburn, dizziness, anxiety and nasal congestion. 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 events red dots all over lips and tip of nose, numb right arm, left arm only numb at injection site, very hot head and neck, red face which was same as sunburn, dizziness, anxiety and nasal congestion were resolved on 06Apr2021. No follow-up attempts are needed. No further information is expected.

5 MIN POST ADMINISTRATION: SOB, DIZZINESS, CHANGE IN VISION - GAVE BENADRYL 25 MG AND 1 VIAL ALBUTEROL VIA NEB 1 HOUR POST ADMINISTRATION: SWOLLEN LIPS, RASH ON CHEST AND ARMS - GAVE 1 DOSE OF EPI PEN AND IM SOLU-MEDROL, CALLED EMS, LEFT TO GO TO ER BP, HR, OXYGEN STABLE THROUGHOUT

c/o "itchiness" on arm and back; observed red raised descending rash from nape of neck to lower back and banding clavicle area; elevated B/P 167/111 HR 89/79; became anxious and diaphoretic; declined treatment/transport to ED however agreed to walk over to ED accompanied by RN. Evaluated by ED Triage RN , not checked in ED. Also reported has chest tightness with reaction. Patients reported ED doctor told him to take Benadryl. But he was working and wanted to continue to work so took Zyrtec instead. Still have the rash just above the injection site?comes and goes.

-Swollen left supraclavicular lymph nodes (1 medium and 1 large that are hard like marbles) -Entire left supraclavicular fossa region is swollen around hardened lymph nodes

flu like symptoms; aching pain at injection site scale 8/10; chills; Fever 100.3 F; body aches; This is a spontaneous report from a contactable nurse (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: EK9231) intramuscularly at right arm on 04Jan2021 at 02:00 PM at a single dose (dose number: 1) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin, glucosamine and fish oil. Facility where the most recent COVID-19 vaccine was administered was at workplace clinic. The patient experienced flu like symptoms, aching pain at injection site scale 8/10, chills, body aches. fever 100.3 F; all with start date on 05Jan2021 at 12:00AM. The events were reported as non-serious. No treatment received for events. The outcome of events was recovering. Since the vaccination, the patient had been tested for COVID-19.

Mild to moderate pain at injection site.; Severe tension headache that started approximately 24 hours after injection and lasted approximately 18 hours; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received the first dose of bnt162b2 (COVID 19 vaccine, brand: Pfizer) lot no: EH9899, via an unspecified route of administration in left arm on 27Dec2020 12:30 at a single for COVID-19 immunization in workplace clinic. There were no relevant medical history and concomitant medications. The patient had no COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. No known allergies. The patient did not receive other vaccines in four weeks or other medications in two weeks. On 28Dec2020 at 12:00 pm, the patient experienced mild to moderate pain at injection site. Severe tension headache that started approximately 24 hours after injection and lasted approximately 18 hours. The events were alleviated by single acetaminophen (TYLENOL) and sleep. The events were reported as non-serious. The patient recovered from the events.

Patient developed localized induration and erythema of approximately 5 cm over a period of 3 -5 minutes and mild generalized non pruritic non urticaric rash. He developed mild diaphoresis . There were no other respiratory symptoms or cardiac symptoms. Patient was treated with PO Benadryl 25 mg. Over the course of an additional 30 minutes observations period all symptoms resolved with the exception of a minimal erythema of 1-2 cm peri-insertion site.

Anaphylaxis Please note previous VAERS report of Bell's Palsy 8 days following the first dose and subsequently treated with prednisone and valacyclovir. This neurologic diagnosis was not reported by the patient during the consent process with the COVID19 vaccination center staff. Confirmed following review of the consent form. Documentation from Emergency Department Provider: Patient is serially reassessed following treatment for anaphylaxis. Patient has significant improvement in diffuse erythema and hives within 20 minutes. He has gradual improvement in his sensation of throat swelling. He is observed while in the emergency department serially over 4 hours with no recurrence of symptoms. He does not require any repeat dose of epinephrine and feels at baseline. Discussed my suspicions that patient may have had a reaction to COVID-19 vaccine as he has had no other new medications or exposures that he is aware of. As he will not be receiving another vaccine there is nothing to necessarily stay away from. Make sure he notifies individuals about this for any new vaccine should he receive them. Patient is observed for sufficient time but discussed possibility for biphasic reaction. Recommend he return should he have recurrence of symptoms. Recommend he take EpiPen as prescribed for any throat swelling or progressive shortness of breath. Recommend follow-up with a primary care provider for this visit..

With in 12 hours had muscle soreness in right arm, headache. Got weakness in arm for 2 weeks. Shooting pains in arm. Feels like a pinched nerve when the left arm in moved. Numbness in thumb.

The morning after receiving the vaccine, I began to develop a fever, chills and fatigue, along with soreness at the injection site. I had taken my temperature throughout the day with a Tmax of 101 F, which broke ~36 hours after receiving the vaccine. No additional symptoms were experienced (diarrhea, nausea, vomiting, etc.)

32 yo male received 2nd dose of Pfizer/BioNTech Covid19 vaccine. 3 days later developed itching and urticarial rash all over his torso, arms, and legs. Eyelids slightly swollen. No shortness of breath, tongue or lip swelling, wheezing, nausea, diarrhea, cough, fever. Presented to ED, received diphenhydramine, famotidine, and methylprednisolone IV. Had significant improvement of urticarial rash and eyelid swelling. Patches still present. Discharged home on 5 day course of H1/H2 blocker and prednisone. After first Pfizer Covid19 vaccine dose, patient only had sore arm. In ED, chest xray has no radiographic evidence of an acute cardiopulmonary abnormality, PCR panel (Cepheid GeneXpert System) negative for Covid19, influenza A/B, RSV. No new food or detergents in last couple days. No other vaccines administered in last 30 days. This event is being described a couple hours after ED discharge. Unknown at this time if patches resolved with subsequent discharge home treatment.

Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Medium, Systemic: Confusion, Delrium -Severe

01/11/21: MOnday: Chills, feverish, headache, bodyache 01/12/21:Tuesday: Chills, fever (99.9), bodyache 01/13/21:Wednesday: chills, feverish, bodyache 01/14/21: Thursday: Hives all over body, itchy, Chills, feverish. Went to clinic. abbot now test done. NEgative for corona virus. allegra and benadryl taken. 01/15/21: Friday: Hives

presents with itching and urticarial rash all over his torso arms and legs. He received a second Covid vaccine 3 days ago. He denies any other exposures to new foods or other medications. He did start having some eyelid swelling as well as some shortness of breath while going upstairs and therefore came to the ER for evaluation. Patient denies any tongue or lip swelling. He has no wheezing. He states that the shortness of breath is improved without any intervention or treatment. Patient does have Covid exposures on a regular basis as he is respiratory therapist and takes care of Covid patients. No symptoms of cough or fevers. No vomiting or diarrhea.

woke up with fever to 102F; rigors; body aches; headache; R arm pain and redness at injection site; R arm pain and redness at injection site; R arm pain and redness at injection site; the 1st dose on 22Dec2020, the 2nd dose on 08Jan2021; This is a spontaneous report from a contactable Physician (patient). This 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the 1st dose on 22Dec2020, the 2nd dose (lot number: EL0142) on 08Jan2021; both at right arm via an unspecified route of administration at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. 12 hours after vaccine, the patient woke up with fever to 102F, rigors, body aches, and headache on 09Jan2021. Severe symptoms until around 24 hrs, then continued mild body aches and chills up to 50 hours after shot. Continued R arm pain and redness at injection site currently, at 72 hours after vaccine. No treatment was received for events. The patient had no COVID prior vaccination, no COVID tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of all events was recovered. No follow-up attempts are possible. No further information is expected.

Approximately 5 minutes after receiving vaccination in his right arm, he reported itching of his right lateral thigh. He appeared pale. He denied respiratory complaints, chest pain or difficulty speaking or swallowing. Over the next 2-5 minutes while sitting on gurney, he reported progressive itching of his upper back and neck and then his buttocks. He was administered one dose of adult Epipen at 16:25 in his right lateral thigh. His vital signs were BP=130/84, PR= 80 and RR=18. His itching symptoms improved but he still had thigh and neck/upper back itching. At 16:33 he was administered 25 mg diphenhydramine IM in his left deltoid. Over the next 15 minutes he had continued improvement of his symptoms.

Muscle stiffness through out the body, headach/migraine, sore area at injection site with tenderness. All of this was after the second dose.

Patient was administered Pfizer COVID-19 series one vaccine on 8JAN2021. Upon receiving the vaccine IM in his L arm the patient noticed pain at injection site which is an expected side effect of Pfizer COVID-19 Vaccine. Patient reported to his Primary care facility on 15 Jan 2021 with Limited Range of motion and continued pain in L arm. Patient was unable to lift his left Arm higher than aprox 20-40 degrees without significant pain. Patient returned to primary care clinic on 22 JAN2021 with the same symptoms with no improvements. Patient has been referred to physical therapy and prescribed naproxen in hopes of alleviating the issue.

pain at injection site; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9241, expiration date not reported) via an unspecified route of administration on the left arm on 24Dec2020 12:15 at a single dose for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. On an unspecified date the patient experienced pain at injection site with the first dose. 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. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.

Pain at injection site; Severe headache; Myalgias; Fever; Chills; Night sweats; Weakness; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK4176), via an unspecified route of administration in right arm, on 13Jan2021 at 10:15, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot Number: EK9241) on 24Dec2020 at 12:15 PM for COVID-19 immunization (left arm) and developed pain at injection. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The facility where the vaccine was administered was in a hospital. On 13Jan2021 at 8 PM after the second dose, the patient developed pain at injection site similar to the first dose but also developed severe headache, myalgias, fever, chills, night sweats, and weakness about 8-10 hours after the injection that lasted throughout the night. The patient was currently more than (>) 24 hours after the second injection and while most symptoms have resolved, the patient still had significant weakness and myalgias. Treatment was received for the events including paracetamol (TYLENOL). Post-vaccination, the patient has not been tested for COVID-19. The patient was recovering from "Myalgias" and "Weakness". The patient recovered from the remaining events in Jan2021.

This is a spontaneous report from a contactable consumer. A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the left arm on an unspecified date in Dec2020 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. He had no known allergies. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. He was not tested for Covid post vaccination. The patient's injection arm and entire upper body was sore for roughly 3 days on an unspecified date in Dec2020. The patient did not receive any treatment for the events. The patient recovered from the events on an unspecified date. Information on the lot/batch number has been requested.

Rash arms, abdomen, chest > 72 hours. Rash is slowly going away but still there as of 1/25. No difficulty breathing, SOB or GI upset.

2 HOURS AFTER INJECTION I EXPERIENCED SORENESS AT THE INJECTION SITE. 13.5 HOURS AFTER INJECTION I WOKE UP WITH A FEVER AND CHILLS. I TOOK ONE TYLENOL WHEN THE FEVER AND CHILLS WOKE ME. THE FEVER AND CHILLS LASTED APPROXIMATELY 3 HOURS. THE SORENESS HAD SPREAD TO MY UPPER BODY BY 4AM, 17.5 HOURS AFTER INJECTION. THE SORENESS/BODYACHE PERSISTED FOR THE DAY FOLLOWING INJECTION. I DID NOT SEE A DOCTOR AS THE SYMPTOMS RESOLVED THEMSELVES.

scheduled for the same day as the 2nd Hep B vaccine; scheduled for the same day as the 2nd Hep B vaccine/ realized they were not supposed to give vaccinations like that, the error was caught; Received his first dose of Covid19 vaccine on 18Dec2020/ Received his second Covid vaccine on 11Jan2021; Pain in the left arm; Felt woozy/Small bouts of dizziness; Felt nausea; Not too much pain around the injection site; Rise in temperature of 97.7 to 99.9; This is a spontaneous report from a contactable consumer reporting for himself. A 32-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 08:45 at single dose, left arm (lot number EK5730); and second dose via an unspecified route of administration on 11Jan2021 at single dose, right arm (lot number EJ1685) for COVID 19 prevention; hepatitis b vaccine (manufacturer unknown), via an unspecified route of administration on 14Dec2020 at single dose (arm once) for immunisation (Prerequisites of working in long term care facility). Medical history reported as none. There were no concomitant medications. The patient received the Pfizer-Biontech Covid19 vaccine in within a close interval with a Hepatitis B vaccination. On 14Dec2020, patient received the Hepatitis B vaccination 4 days prior to COVID-19 vaccine which patient reported was not recommended, then received his first dose of Covid19 vaccine on 18Dec2020 (he was 32 years old at that time, he turned 33 years old on 25Dec2020). He received his second COVID vaccine on 11Jan2021. Patient reported he has since learned that a dosing interval of 14 days is usually recommended. Patient stated this was not supposed to be done within 14 days. He stated that CDC mentioned that three vaccines that were possible to do this but unknown safety hazards to doing this. Stated that it did not mention Hepatitis B. Stated it was an error on nurse's judgement. He stated there was a second co-administration to happen on Monday, patient was scheduled for the same day as the 2nd Hep B vaccine (unknown date), but that she was on vacation. He stated that the person could not find Hepatitis B vaccine. He stated that his original paperwork was not filed. He stated that he got a second COVID 19 on Monday, and on Wednesday (13Jan2021) they realized they were not supposed to give vaccinations like that, the error was caught, and he would not get the second Hepatitis B vaccine. Stated that he was unaware of any symptoms that occurred immediately after vaccination. He wanted to know how to proceed from this point. Patient stated that It was the person in charge of vaccinations told him there was no problem giving co-administration of COVID-19 vaccine. He also reported mild adverse events after both COVID vaccines which include not too much pain around the injection site, some nausea 10-12 hours after the injection; felt woozy/small bouts of dizziness, pain in the left arm at 17:00 (to point could not lift or sleep on it), rise in temperature of 97.7 to 99.9 (also reported as for 5-6 days were at 99.9 never breaking 100) on 18Dec2020. Treatment was not given for all events. Patient had blood work done on an unspecified date with unknown results, and rise in temperature of 97.7 to 99.9 on 18Dec2020 and 11Jan2021. Outcome of the events rise in temperature of 97.7 to 99.9, pain in the left arm was recovered on an unspecified date; events felt woozy/small bouts of dizziness and felt nausea was recovered on 18Dec2020, while outcome of not too much pain around the injection site was unknown.

In addition to achiness, I have experienced a numb sensation at the injection site and the entire deltoid muscle that extended towards the elbow. The numbness lasted at least an hour after the injection and a couple of times over the past three days. I have experienced a mild fever (99.8 F) each day since the vaccination, but only in the mornings or late at night. I treated this by taking Tylenol.

Body aches starting around noon on left side, 02/03/21 6:00am left arm sore and swollen at injection site, increasing redness warmth and itching at site, max size to 3cm diameter and firm till 02/05/21, decreasing size and minimal discomfort

Swollen lymph nodes; Developed Shingles on his face; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported for a 32-year-old male patient (her fiance). A 32-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration at the right arm on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 on 08Jan2021 for COVID-19 immunization. The patient developed shingles on his face on 31Jan2021 and swollen lymph nodes on 01Feb2021. The events were reported as serious (medically significant) and worsened. There were no investigation assessment. The patient had not recovered from the events at the time of the report. Information on the batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the Company considers the event swollen lymph nodes is possibly related to suspect vaccine BNT162B2. Other than a temporal association, there is no evidence or argument to suggest a causal relationship between BNT162B2 and the event shingles, which is likely an intercurrent condition. 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.

Hives and rash in the face around the cheeks, forehead and nose area. Felt light heart palpitations with Itchy throat, itchy eyes, lightheaded, and headache. This occurred an hour after the vaccine was administered.

Joint pain in arm, shoulder, hip, and leg on side of injection site; joint pain in arm, shoulder, hip, and leg on side of injection site; Joint pain in arm, shoulder, hip, and leg on side of injection site; fever of 99.8 F; Headache; Constipation; Sweating, so much sweating; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 10Feb2021 (13:00) (at the age of 32years) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration on 20Jan2021 (12:00PM) (at the age of 32years) for COVID-19 immunization. The patient has no medical history; no allergies to medications, food, or other products. Concomitant medication included vitamin B complex (VITAMIN B) also reported as "B vitamin supplement" taken from an unspecified date. 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 10Feb2021, the patient experienced joint pain in arm, shoulder, hip, and leg on side of injection site. The patient woke up with fever of 99.8 F that ended approximately 03:00 PM on 11Feb2021. The patient also experienced headache, constipation and sweating, so much sweating. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event fever was recovered on 11Feb2021; the outcome of other events was recovered on an unspecified date. This case is non-serious.

fever, chills, bodyaches, after first day and resolved in 24 hours. hives started 2 days after vaccine, took 50mg benadryl for this. Prescribed prednisone 40mg daily as well.

shingles rash; pain; This is a spontaneous report from a contactable healthcare professional via a Pfizer-sponsored program. A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date. The patient developed shingles after the second dose of the Pfizer covid 19 vaccine. He received the vaccine on 29Jan2021 and developed a shingles rash on Sunday (31Jan2021). The healthcare professional wanted to know if he can take antivirals, if it is safe for him to get antivirals, and what he could take for pain on an unspecified date in 2021. Information on the lot/batch number has been requested.

4 hours after vaccine, started feeling itchy. Observed rashes and hives spreading around my body centralized around my torso. Symptoms disappeared 3 hours after taking anti histamines. Symptoms have been reoccuring every other day till today 3/12 and disappeared after taking anti histamines.

Patient had expected discomfort at injection site for 1-2 days. Started feeling tired about 3-5 days after injection but continue to function well. However, he has had progressive weakness, tiredness and falling asleep just couple hours after sleeping all night and it is at a point as of today where he cannot do his usual work. He also has headache and very cloudy mental status with inability to concentrate and loses his trend of thought. He is highly accomplished individual. He is a compulsive mask wearer and follows strict isolation guidelines. Please advise as we are becoming increasingly concerned.

Bruising at injection site arm and back aches for a week. Now I have yellow bruising and two lines of blood under my skin at the bruised area.

Patient had just received his injection and just sat down in the observation area when he had a sudden syncopal episode that was witnessed by other bystanders. EMS responded immediately. Patient was difficult to arouse, with some muscle rigidity. Patient returned to consciousness within 30 seconds. Patient was moved to WC, and still felt syncopal. HR was 62. Patient was laid down. Patient did have a small carpet burn on his right wrist, and some tenderness on his right side of his neck, and tenderness behind his left ear from his mask. After 30 minutes, patient was able to stand and walk without assistance. He was transported to home by his wife. Patient denied need for further medical assistance and would have his wife observe him at home.

injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell

Muscle soreness, weakness, and limited mobility in the area of the injection, peaked in intensity 10 hours after the dose was administered. Soreness is still ongoing as of this form submission, but isn't as intense. Insomnia, occurred 12 hours after the dose was administered, it took me about 2.5 hours to fall asleep after going to bed (12:00AM - 2:30 AM)

About two weeks after first shot, I got shingles. It could be unrelated, but since I'm young, perfectly healthy, not abnormally stressed, and haven't ever had singles before, I thought there might be a chance it is related. I've seen online other young people who are saying that they got shingles after the first shot of Moderna or Pfizer. Maybe it was just a coincidence, but I figured it was worth reporting. It is overall a pretty mild case because I got on the antiviral drugs pretty quickly. Wondering if I should still get my second shot on schedule or wait until my shingles is all cleared. I have asked my doctor and am awaiting a response. I first noticed the symptoms on Saturday (3/20) exactly two weeks after my first shot.

Patient returned to clinic 2+ hours post vaccination stating that he had generalized itching and a rash developing on his chest and bilateral arms.

Tiredness and chills next day. Severe headache and night sweats evening of the next day. 2 days later an itchy, raised, red rash appeared on arms and some spots on torso when I went outside. They went away shortly after returning inside. This continued to happen any time I went outside for greater than a 15 minute duration and lasted for 2-3 weeks.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: Pt was sitting for observation, after 8min, pt suddenly fell to lateral side, pt denies head trauma. IM Rx and Technician responded immediately.

Was feeling fine the day I received the shot, albeit some pain at the injection site. I woke up early the next morning and my left jaw was sore, my left knee was swollen and hurt to move/walk, and the bottom of my left foot felt strange. There is also a very, very dull wave-like ache across the bottom of my front teeth.

Fever of 100.1, pain at site of injection, body aches at lower back/upper leg the morning after the shot.

Low grade fever, muscle aches, joint aches, headache, nausea, lethargy. Red bump and swelling at the injection site.

Started with sweeping of hands, feeling hot and flushed, then redness of face. Extremely itchy. Fainted once arrived to ER.

Allergic reaction, rash on all upper body. Especially on both arms, arm pits and both sides of stomach.

Fever, chills, and fatigue starting around 7PM the following day (4/2/2021). Rash was noticed later in the evening along upper chest and lowe neck, also along upper left portion of chest. Rash is relatively minor, but red and irritated and itchy.

About a week and a half after receiving a booster vaccine shot, I started to experience signs of Shingles. I went to the urgent care and was confirmed to have Shingles.

pt says his neck was itching and had swelling and bumps on his neck. His body was itching and it would swell and turned red everywhere he would scratch. he took an antihistamine with helped. He woke up next day and all symptoms were gone with the exception on swelling and redness in the neck which he has a spot the size of a golf ball. Pt is still taking the antihistamine. Pt will contact PCP if symptoms do not subside.

Approximately 9 days after injection in left arm, started experiencing symptoms in right armpit consistent with swollen lymph nodes including: intermittent sharp stinging pain similar to ingrown hair or inflamed hair follicle, as well redness and dull pain upon palpation. Over several days, swelling has increased significantly and pain has increased a little as well. Today, 14 days after injection in left arm, starting to experience onset of lymph node swelling in left armpit as well. Additionally, starting 9 days after injection, concomitant with lymph node swelling, I believe I have felt slightly fatigued and have felt 1 degree warmer than usual, though not actually feverish. I confirmed a temperature of 98.9F today around 5:45PM, whereas my normal temperature is about 97.7F when measured by the same method.

Approx 3 minutes s/p 1st vaccination, pt c/o hotness and Pruritis to R forehead. `1 urticaria noticed (the size of a quarter) redness and itching present at site. Pt denies shortness of breath, chest discomfort, heaviness of the tongue, or swelling of the throat. Upon exam VSS SBP/ 134/90 HR 58 R 18 O2 99% on R T 98.1, Uvula midline, no wheezing heard, no swelling of the tongue or lips noted, pt does not have urticaria present anywhere else on body, PE benign. Secondary, to history of allergies (seasonal and shrimp) for which he is under the care of an allergist, Benadryl 50mg po was adminstered at 10:11, with resolution of urticaria 10:41

-Fever beginning around 12 hours after injection. At 24 hours, fever hovered between 101-102. At around 36 hours, fever hit 103.2. By 48 hours, fever dropped to around 100. -Full body aches that correlated with fever. Extremely achy and discomfort. -Mild nausea -Intense dull headache -Injection site muscle pain -By 48 hours after injection, symptoms heavily subsided. Lethargy and fatigue remained until 72 hours. No symptoms by 96.

2020-04-05 - Fatigue with some diarrhea (also common with Nivolumab/BMS986016 that I'm also taking) 2020-04-07 - Noticeable malaise and back pain near left shoulder blade 2020-04-08 - Mild rash developing on left side of chest above nipple (same height as back pain) 2020-04-09 - Rash progresses - diagnosed with Shingles via text chat with photos with provider

Developed a medium size knot where shot was given that was hard and sore to the touch. Then also developed the same thing up on my collar bone area (may be a lymph node) that is more sensitive to the touch than my arm. Makes me arm feel somewhat numb and harder to grip at times.

4/9/21 Patient called to report symptoms that he believes resulted from his 2nd COVID Vaccination. He received his 2nd Pfizer dose on 4/7/21. He states that by the afternoon of the next day he developed severe headache, nausea, and feeling feverish. He states in the middle of the night he started vomiting red-colored vomit which he felt was from blood. He vomited approximately six times over an hour. The vomiting stopped after that. He also complained of soreness at the injection site which spread to shoulder. He rated his pain at that time as a ?7? on the ?1-10? pain scale. As of 4/9/21, he now feels better with no further symptoms other than muscle soreness. RN encouraged patient to follow up with his PCP to let them know about his symptoms including his complaint of bloody vomiting. Patient agreed to follow up with his PCP.

Felt mild itchiness at various parts of my body, starting a few hours after the shot was given. I'm not positive if the itchy feelings began within the first 4 hours after the shot, but I think so. I took an antihistamine before bed that night. The next day I occasionally felt very minor tingling, which I believe was the itchiness diminishing. By the third day the itchiness/tingling was gone. I never developed a rash, hives, or swelling. I spoke with my primary care physician during an unrelated annual physical exam that took place a couple days after the vaccination, and he said it's possible it was a very mild allergic reaction, but in his determination it was nothing to be concerned about or to prevent me from getting the second dose of the Pfizer vaccine 21 days later.

First day was just soreness at and around the injection site. The next day on the other hand. I woke up from what felt like hitting the exhaustion wall. Along the lines of being so worn out you can't even sleep. Along with heavy lethargy, soreness, a mental fuzziness, and a general feeling of unwell. To the point of forgoing water and food while famished as it meant having to move and stand in front of the stove. By about 1700ish I started to notice chill's/fever (I think, I did not grab a thermometer and check) As of the time of writing this some of the lethargy has subsided. Though the rest has stuck around. Given that the second dose is more known to cause adverse effects. I am not looking forward to it. Which is to no way state that i won't go back and get my second dose. Just that at least for me are pretty rough.

2 days after vaccination the injection site was mildly swollen and hot. Treated with cold compress and ibuprofen. The event lasted one day.

Woke up with soreness in muscle where shot was given, felt like was working out all day yesterday. Feeling feverish, very lightheaded and dizzy with headaches behind the eyes. Felt like a bad cold or flu.

client complained of tingling sensation to left arm after receiving 1st Pizer Covid Vaccine. Client had completed 15 min observation when he informed EMT he was feeling tingling sensation to left arm, upper arm, not radiating. Client asked to stay longer in observation. First vitals at 1336: blood pressure 120/78, pulse 66, oxygen 97%. Alert and oriented, no other complaints. At 1344 PHN arrived, reassessed client. Alert and oriented. Per client only upper arm tingling sensation, left arm is where he received vaccine. Tingling not worsening or radiating anywhere else. Arm motor and sensory intact. Vitals at 1347: blood pressure 132/76, pulse 83, oxygen 98%. Per client tingling improving. Wanted to go home. ER precautions given. Client left facility at 1350 with steady gait

3/26: first dose Pfizer 4/6: insane nausea, chills, migraine, body aches, vivid dreams, insomnia 4/7: severe lower abdominal pain, cough, rash on injection arm

Patient returned from outside at about 40 minutes after injection. Symptoms included rash development on face and trunk, swelling of face and lips and slight shortness of breath. One adult epipen was administered and EMS was called (9:15 am). Fire Dept arrived approximately 10 minutes later and EMS followed. Symptoms were subsiding and pt refused transit with EMS. Patient received ride with parent to ER

On April 6 a.m. developed fewer-like symptoms with muscle pain typical foe fewer with these symptoms steadily worsening by evening. Night shower at appr. 9 p.m. caused a feeling of spinal nerve pinch followed by acute pain during certain movements and breathing. Following day (Wednesday) spent in bed taking Ibuprophene thinking is just a nerve pinch. Called virtual appointment tele doctor who prescribed Katorolac which I took from Wednesday night to Thursday morning per prescription with no effects. On Thursday evening called tele doctor again and got Ibuprophene 800 mg prescription. It helped for 20-30 min only. Same evening coughed some blood. On Friday kept taking Ibuprophene for very temporary relieve. On Saturday April 10 was admitted to hospital and was hospitalized with blood cloth diagnosis for 4 days.

At approximately 4:58 PM on 03/31/2021 patient during 30 minute observation developed dizziness, general itchiness and urticaria to his hands. Pt administered in RA IM 50mg Benadryl at 5:00pm. Pt AA&Ox4, airway patent, breathing normal and non-labored. Pulse strong and regular with adequate perfusion. Pt lung sounds clear upper and lower lobes. Pt stated improvement, and intially refused transport to the ED, when upon sitting patient felt profound dizziness without syncope and patient was consulted again about emergency transport, who consented. Pt transported via emergency services to Hospital. First and last vitals as follows: 4:50pm 160/100bp, 122p, 22r, 98% O2 5:20pm 152/92bp, 110p, 20r, 98% O2

Site: Pain at Injection Site-Mild, Systemic: Fatining/loss of conciousness - otherwise no sysmptoms of anaphylactic reaction - however pt said that he doesn't respond with that severity to the flu vaccine and was concerned about his reaction to this vaccine which usually only happens with blood-draw-Mild, Systemic: Flushed / Sweating-Mild

Fever of 103 the night of. Several days later developed hives all over body and a low fever that lasted 3 days and itchiness another day.

Sore arm, could not lift for 3 days, red raised bump started April 14, small puss bubble April 16 at injection site.

Radiating soreness/numbness (whole left arm/injection arm), neck/spine pain (similar to arm soreness) but 'pricklier', traveling pain/soreness (effected right arm), night sweats, dry throat, 'frog' in throat, sneezing, runny nose, stomach discomfort

Supraclavicular lymphadenopathy noticed; Generalized blanching rash covering thighs abdomen chest and arms,around 24 hours after the second dose resolved within a day; This is a spontaneous report from a contactable Physician (patient) A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: unknown, expiration date: unknown) via an unspecified route of administration anatomical location Left arm on 13-FEB-2021 12:45 at single dose for COVID-19 immunization. Patient historic vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: unknown, expiration date: unknown) via an unspecified route of administration anatomical location Left arm on 23Jan2021,10:30 at single dose for COVID-19 immunization. medical history included Autoimmune urticaria. concomitant medication include Antihistamine. On 14Feb2021 13:00 patient experienced Generalized blanching rash coveringthighs abdomen chest and arms, around 24 hours after the second dose resolved within a day.Supraclavicular lymohadenopathy noticed 72 hours after. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior and post to the vaccination, the patient was not diagnosed with COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior and post to the vaccination, the patient was not diagnosed with COVID-19.The outcome of event was Recovering/Resolving. Information on the lot/batch number has been requested

Diagnosed with shingles on 4/16/21 after waking up with shingles rash. Told by nurse practitioner at the urgent care highly likely related to COVID vaccination. Now seeing studies showing shingles as a possible adverse reaction. Encouraged to fill out VAERS report. Given steroid shot, B12 injection, and started on Valcyclovir at the urgent care.

Patient received the 1st COVID-19 Vaccine (Pfizer, Lot #: EW0162, expiration date: 07/31/2021) at 10:00. At 10:12 patient ambulated to Medic in the observation area, asking to use the restroom due to complaints of nausea. Patient was advised by Hospital that he would not be able to use the restroom due to his physical presentation of pale, warm, moist skin, pupils becoming greater than or equal to 9 mm, and a look of confusion. Medic attempted to assist the client with ambulation to anti- gravity chair, when the patient?s knees buckled and he was assisted to the floor. Nurse and Nurse responded to assist Medic. Patient lost consciousness and was then assisted into anti-gravity chair and sternal rub applied. Per Medic , patient?s loss of consciousness subsided after 3 seconds and became conscious, alert, and oriented to person, place, time, and event (CAOX4). Patient stated he has ?syncopal episodes every time he has a procedure done that involves needles.? Baseline vitals were obtained by Medic at 1015, while patient was sitting: blood pressure: 98/50, heart rate: 60, respiratory rate: 18, pupils equal and reactive to light at 5 mm. Patient claimed that about 2 minutes status post- vaccine, he began to feel ?lightheaded, nauseous, and had a hot flash. Patient stated he has similar reactions every time. Patient denied chest pain, headache, vomiting, abdominal pain, and blurry vision. Patient was given water to sip on. At 1020, second set of vitals were taken by Medic, while patient was sitting: blood pressure: 90/60, respiratory rate: 16, heart rate: 97, and patient was conscious, alert, and oriented to person, place, time, and event (CAOX4). Patient?s skin was normal color, warm, and dry. Pupils were 3 mm and equal and reactive to light. Patient claimed last oral intake was on 04/15/2021 with minimal fluid intake as well. Patient denied any complaints and claimed he was feeling better. ALS interventions offered by Medic for further evaluation and care, but patient refused. Third set of vitals were obtained by Medic, while patient was standing, at 1030: blood pressure: 118/76, heart rate: 82, respiratory rate: 14, and patient was conscious, alert, and oriented to person, place, time, and event (CAOX4). Patient was negative for orthostatic pressures and was released into the care of his spouse, after waiting in the observation area for about 1 hour. Patient drank a full 12 ounce water bottle and was able to walk out on his own, with a steady gait and in no distress.

Fainting; Swelling of arms and hands; Feeling hot; Hives on the face and limbs; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 32 years of age), dose 1 via an unspecified route of administration, administered in arm left on 31Mar2021 14:30 (Batch/Lot Number: EW0150) as a single dose for COVID-19 immunisation. Medical history was None. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. He was not diagnosed with Covid-19 prior to vaccination. He has not been tested for covid since the vaccination. He had no allergies to medications, food, or other products. The patient experienced swelling of arms and hands, feeling hot, hives on the face and limbs. He also had shortness of breath and fainting. The events started on 31Mar2021 18:45 with outcome of recovered with sequelae. Therapeutic measures were taken as a result of the events as the patient was administered with IV saline, steroids and antihistamine. The events resulted to Emergency room/department or urgent care. Information on the lot/batch number has been requested.

I think shingles. I have a small patch of red, raised bumps on my right lower back. They don't hurt but I can constantly feel them. They hurt to touch. My front right torso is also slightly tingly in certain spots to touch. Forget this.

15 hours after vaccine - headache, mild fever, severe body aches 39 hours after vaccine - period of extreme exhaustion 42 hours after vaccine - all prior symptoms subsided 80+ hours after vaccine - body covered in itchy rashes and hives (current symptom)

Sporadic bumps showing up all over my body, one on the bottom of my foot. Most were very itchy. Seemed to flare up when fatigued or during sleep. They would be red and raised, almost like a small mosquito bite. Then they would dissipate, although some would leave a tiny red dot. Almost seemed that there was a bug in my clothing, so I showered, changed my clothes, and searched thoroughly in bed, closet, clothes for, bugs but there were none. My wife also did not get any of these itchy bumps in spite of sharing a bed. It may be worth noting that my wife got shingles 10 days after receiving the 1st Pfizer dose.

Experienced chills, feverish, headache, body aches less than 24 hours after injection. Around 36 hours later broke out in sever hives rash. Hives keep improving and then getting worse again hours later even after Benadryl, steroid shot and Zyrtec

The patient was administered 2nd dose of Pfizer vaccine in right arm. Within seconds, the patient complained of itching to his neck, head, arms, and shoulders. He denied difficulty breathing; VS were nromal. Affected areas appeared red due to scratching, but no other visible lesions noted. Pt denies history of reactions to medications and past immunizations.

Injection site pain/swelling, body aches, chills, generalized fatigue. Symptoms began roughly 18 hours post vaccination. Subsided 40 hours post vaccination. Now in good health.

Rash about 3 inches wide developed on the mid-back. Also seems to be currently developing on right oblique. Very itchy. Has been being treated by Benadryl.

Patient completed wait after vaccine with no complications. Approximately 1.5 hours after vaccination noted rash to arms and legs while feeling well with no distress or itching. Returned to vaccine site. Vss. Continued to feel completely well. Urticaria noted to forearms and calves. Face and torso clear. Reported 3 episodes of urticaria since first covid vaccine. Oral benadryl given. Urticaria faded. PT has started to use a new body wash. All rashes have occurred since that change. D/c'd home with family. Advised re rest, fluids and additional benadryl prn. Call md/911/ er if increased problems or concerns.

Site: Pain at Injection Site-Medium, Additional Details: patient believes it may have been injected too high on first dose. His shoulder still hurts when he raises his arm. He will monitor and get checked by md if needed and notify the pharmacy.

Immediate and continuous cramping/twitching pain in right shoulder. Shoulder now appears permanently indented. Trouble sleeping and increased pain when exercising.

Severe skin reaction all over body appearing approximately 60 hours after 2nd dose. Started out as hives and quickly became more red in color and more ubiquitous. After appointment with PA-C, she thinks this is a systemic reaction to vaccine and prescribed prednisone and Zyrtec

Within 3 hours, flu-like symptoms of low grade fever, headache, fatigue, aches and chills. Next day a slight cough developed, and persisted through until 2 days after. Injection site remained sore. Just took hot showers, slept, and used alkaseltzer day/night tablets as needed for symptoms.

A 32 male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 14:30 (Lot Number: EW0170) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. The patient medical history was not reported. Concomitant medications included amoxicillin, daily multivitamin, probiotic supplement. The patient previously received the first dose at arm left on 30Mar2021 14:00 as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling, reddened skin, and itchiness at vaccination site, low- grade fever for 36 hours, slight cough, headaches, extreme tiredness, brain fog from 19Apr2021 19:00. No treatment received for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Outcome of the events was reported as recovering. No follow-up attempts are needed. No further information is expected.

Right hand: red rash/bumps from thumb knuckle to base of CMC thumb joint. Spread to webbing between thumb and index finger. Rash restricted to the thumb. Red bumps restricted to below thumb towards wrist. Blisters formed on the rash 8-9 days after injection. Itchy. Left hand: Mirrors right hand except much less pronounced. In addition, dime-sized red patch on first knuckle of index finger. No itching on left hand.

Same day - fever; pain in injection site; mild pain in legs and back; lethargy Next day - extreme fatigue; muscular and joint pain throughout body; headache; worse fever and reddening of face; difficulty moving and walking due to pain; general cloudy feeling; fever delirium 2-3 days after - nausea

After my second dose at 12;45pm on May 13th, 2021, I started to have large areas of itchy rashes on my neck, arms, legs, and body at 8am on May 16th, 2021. I've been applying Itch Relief Cream and taking Allergy Relief since 4pm on May 16th, 2021. There is no sign of relief or deterioration at this point (8am on May 16th, 2021).

Shingles; he couldn't sleep; breaking out in a rash on his scalp, chest and neck/ starting to itch/ it was looking less red/ rash felt like a sunburn or if like he was hit with a cactus/ did sting some; breaking out in a rash on his scalp, chest and neck/ starting to itch/ it was looking less red/ rash felt like a sunburn or if like he was hit with a cactus/ did sting some; felt like he had a scratch on his scalp; felt like he had a scratch on his scalp and his wife told him that it looked a little swollen; This is a spontaneous report from a contactable consumer (patient) and pharmacist. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered on the left arm on 04Mar2021 09:45 (also reported as 12:00) (Batch/Lot Number: EN6199) at the age of 32 years old as 1st dose, single for COVID-19 immunisation. Medical history included seasonal allergies (had it his whole life), sore arm and a family history of shingles (he's had an uncle or something that had shingles before but nothing with his parents). The patient had no allergies to medications, food or other products. Concomitant medication included loratadine (CLARITINE) from Feb2021 for seasonal allergies. The patient wanted to know on what he should expect after receiving the second dose of the vaccine and if he was eligible to receive the vaccine. The patient reported side effects on v-safe. He heard from other doctors that shingles had been reported from the first dose of the vaccine. He wanted to know if shingles would impact the antibodies that he may develop post vaccination. The patient stated that the fact sheet indicated that the second dose should be administered 3 weeks after the first dose, he was scheduled to receive the second dose 4 weeks later and wanted to know if it was safe to receive the vaccine outside the of the recommended time frame. The patient stated that he should be trying to take loratadine everyday (usually takes at night before bed) 1 since he does get kind of bad allergies sometimes. On 12Mar2021 (8 days later after the vaccination), the patient was diagnosed with shingles after breaking out in a rash on his scalp, chest and neck. The patient met his doctor and was recommended to report the adverse event. The patient went through CDC V safe and was provided with an information sheet that from Walgreens that listed the number for Pfizer to call if he needed further information. The patient reported that the noticed the rash (present on his scalp, chin, neck and up around his neck on his right side) on 06Mar2021 or 07Mar2021. The patient stated that the rash onset was "two fold". He noticed it when the back of his head on the right side started to become agitated in Mar2021. He stated that he sleeps with an eye mask on due to block out the lights from the baby monitor for his 6-month-old and originally thought that it was the sleep mask that was bothering him. He mentioned that on 06Mar2021 or 07Mar2021, he felt like he had a scratch on his scalp and his wife told him that it looked a little swollen. He then reported that the rash on his scalp started to get more and more uncomfortable. When the patient came home on 10Mar2021 around 17:00 or 17:30, he removed his shirt and his wife looked at him and asked what it was. He then reported that the rash appeared on his neck and chin and showed up overnight or that morning. He then stated that the rash on his chin and neck was not painful or anything. The patient then stated that the rash on his head was getting pretty agitated as of 10Mar2021. The patient thought that the rash on his chin, neck, and chest was eczema or heat rash, but thought it was odd because heat rash is normally flat. When he woke up on Wednesday (10Mar2021), the rash was looking worse but was still not bothering him except for the rash on his head. He considered going to urgent care on Thursday (11Mar2021) but didn't follow through. On Thursday night to Friday night (11Mar2021 to 12Mar2021), he couldn't sleep. His rash felt like a sunburn or if like he was hit with a cactus, and the rash on his neck started to bother him. The patient went to urgent care on 12Mar2021, and when the nurse practitioner walked in, looked at him and said that it was shingles. The patient saw 3 people at the urgent care, a nurse, nurse practitioner and a resident doctor as a doctor was needed to confirm the diagnosis. All three of the staff members said that the rash was shingles where the rash was following a nerve pattern. The patient used a cream to treat the rash, he mentioned that he tried diphenhydramine HCl 2%, zinc acetate 0.1% (Benadryl Extra Strength Itch Stopping Cream, Topical Analgesic Skin Protectant; Lot 1790LZ/3, Exp: May2022) briefly on the back of his scalp for 1 night as it was starting to itch and feel weird. He mentioned that it did sting some but didn't think anything of it as sometimes the cream will sting when put over a scab. He also used Aquaphor Healing Ointment Baby Advanced Therapy (Exp: Aug2022, UPC: 0 7214063386 8; NART number 63386), taking slabs of it and putting it over the rash. He then stated that neither did anything. After going to the urgent care, he was put on antibiotics (late described as an antiviral that should clear up in 7 to 10 days since he was young and healthy) that day and essentially said there was not much he could do. The staff also recommended that because he had 6-month-old he should call his son's pediatrician but that his infant son should be okay. He followed up with his son's pediatrician and his doctor, who stated that it should be fine, just to minimize contact with his son. The rash was still visible on his chin, neck and chest. On his scalp was harder to see because of his hair. He stated that going on feel, outside of one spot it felt significantly better. He can now wash his hair and lay on that side of his head without pain. The rash on his neck looks like some are starting to scab over. He reported that not one patch has disappeared yet, but his wife said that it was looking less red and inflamed. His doctor scheduled a routine blood draw for 08Mar2021 during his physical and stated that he was willing to go through test results as he was unsure what would be helpful, but there were numerous results for each lab test (CBC with auto differential, Lipid panel with reflex to direct LDL, Comprehensive metabolic panel, PSA, total, Urinalysis, and Vitamin D (25-hydroxy) total). He reported that his doctor had sent him a message in the evening on 08Mar2021 that said "results all normal". The patient didn't require a visit to the emergency room but required a visit to physician office. The patient had no prior vaccinations (within 4 weeks). He stated that there was no history of his parents experiencing an adverse event with vaccines, just the usual sore arm, stuff like that. On 19Mar2021, the pharmacist reported that the events were non-serious. The pharmacist reported that the treatment used for the event was famciclovir. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events pruritic rash and erythematous rash was recovering, for shingles was recovered, while unknown for the other events. Follow-up attempts are completed. No further information is expected.

Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hearing and vision difficulty-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Vitals were normal after 30 minutes

Moderate pain at injection site: Started within 6 hours of injection, lasting 36 hours. Felt like severe bruising. No visual signs. Minor Fatigue: Started within 8 hours of injection. Lasted 36 hours. General tiredness. No visual signs. Minor to Moderate Aching: Started 12 hours after injection. Lasted for 24 hours. Whole body aching pain with minor chills, felt like I was coming down with a cold or flu. No visual signs. All adverse events were most pronounced the morning after injection, and had mostly subsided the morning after that.

Patient received 'steroid' injection from allergist and 3 days later received 1st dose of Pfizer COVID-19 vaccine, then 3 days later received another 'steroid' injection. Patient then developed headache associated with fever and chills for 1 day. The patient travelled at which time his symptoms came back now with nausea, vomiting and diarrhea. Patient also noted to have erythema and itchiness for 3 days prior to coming to the hospital. Patient has a rash on left arm, as well as bilateral lower extremities. Patient was admitted for septic shock with an AKI. Patient received IV fluids, Levophed, vasopressin, IV Fentanyl, IV antibiotics, and IV steroids. Patient is now off of vasopressors and is improving.

Slight soreness in left arm where the shot was administered; This is a spontaneous report from a non-contactable consumer, patient. A 32- year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN6208) via unspecified route of administration in the left arm on 16Mar2021 at 11:45 pm as a first dose for COVID-19 immunisation (Age at vaccination: 32 Years). Medical history and concomitant medications were not provided. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 patient had experienced Slight soreness in his left arm where the shot was administered. The patient did not receive any treatment for the event. The clinical outcome of event was recovering at time of reporting. No follow-up attempts are needed. No further information is expected.

I received the COVID-19 vaccine at 9:30 am from vaccination clinic. I had just recovered from COVID-19 about two and a half weeks prior. I had no immediate reaction. I worked the entire day with no adverse effects other than a sore arm, which I expected. Later in the day at about 7:45 pm I went for a 6 mile run and got home at approximately 8:49 pm. Within half an hour of getting home, I quickly became feverish. The fever continued to rise until I was extremely hot, and hotter than I can ever remember as an adult or child. I did not have access to a thermometer so I cannot reliably report what the temperature was but I am estimating 103. It felt like every part of my body, including my legs, was hot to the touch. By 1 am I had serious chills and was shivering under winter blankets despite an outdoor temperature of 70-80. In addition, I had an extremely elevated heart rate and chest pain. I also had generalized muscle aches all over my body. I did not sleep at all that night. The fever began to slowly dissipate early in the morning but the elevated heart rate continued for approximately 24 hours. The discomfort resulting from my elevated heart rate was substantial and alarming enough that I sought advice from my primary care physician after a nurse at my Occupational Health clinic suggested potentially getting an ECG. Ultimately, by Thursday morning, the symptoms had decreased and I declined any follow up. However, this was the single worst reaction I've ever had to any vaccine and the single worst fever I've ever experienced as an adult or in my memory as a child. Although I am aware that people who have already had COVID-19 tend to have worse reactions to the first COVID vaccine, I am filing this report primarily because of my concern that exercise may trigger an especially severe reaction.

Colorless, itchy hives under the injection site, which I noticed 53 hours after injection.; Colorless, itchy hives under the injection site, which I noticed 53 hours after injection.; This is a spontaneous report from a contactable other hcp. A 32-years-old male patient received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 12Mar2021 15:30 single dose for COVID-19 immunization. Medical history included Known allergies to Penicillin. Concomitant medications (other medications in two weeks) included escitalopram (ESCITALOPRAM) and trazodone (TRAZODONE) from an unspecified date and unknown if ongoing. The patient had no COVID prior vaccination not tested for COVID post vaccination. On 14Mar2021 at 09:30 PM the patient experienced colorless, itchy hives under the injection site, which he noticed 53 hours after injection. No treatment received for the event. The outcome of event was recovering. No follow-up attempts are possible. No further information is expected.

Rash on left foot occurred several weeks after vaccination. approx 2 weeks later more rashes occured on my right foot. All primarily around the knuckle area of toes. They do not itch or burn but are red/pink in color and unsightly. I did have Covid confirmed 1/2/21 (I believe that was the date)

Pt noted mild rash 30 min post vaccine. No resp or OP sx. No other skin involvement. PE blanching erythema UE only Probably sunburn -Advised sunscreen -Warned of sx of anaphylaxis (unlikely)

I have been having nerve pain on the right side of my body. I have NEVER in my life had any nerve pain what so ever. This week the pain got much more noticeable. My right arm by inside bicep has a pain of burning and itching. My right leg has burning nerve pain in multiple spots. I know my body and this is 100% because of the vaccine. The pain itself is not very bad, but it?s very noticeable. Burning sensation in different parts of my right limbs. Will this go away? I fear getting my second shot and this getting worse. Any advice?

Hives; rash; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left at age of 32 years on 17May2021 15:00 (Lot Number: EW0182) as single dose for covid-19 immunisation. The patient medical history was included diagnosed COVID-19 prior to vaccination. No known allergies. Concomitant medications included cefalexin (Cephalexine), sulfamethoxazole, doxycycline. The patient previous took fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at age of 32 years on 26Apr2021 15:00 (Lot Number: ER8736) as single dose for Covid-19 immunization. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent covid-19 vaccine was administered was pharmacy or drug store. Since the vaccination, the patient has not been tested for COVID-19. Hives and a rash started to appear on body roughly 24-26 hours after second shot. The rash started around both arms, mostly above the elbow and slightly on the torso. By the next morning, the rash spread to the rest of body, growing denser in many areas on arms and back and middle of the chest and stomach. The adverse event resulted in Emergency room/department or urgent care. Treatment received for the adverse event included prescribed prednisone, taking Tylenol and Benadryl. Adverse event start date was 18May2021 19:00 PM. Seriousness reported as no. The outcome of the events was recovering. Follow attempts are needed. Further information is expected

Sore at injection spot after 1st shot for about 1 hour. Sore arm from elbow to shoulder from 5 hours after 2nd shot. Continued for about 24 hours. site of injection was red and size of a quarter.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild

Dose 1: Zero side effects Dose 2: Fatigue within four hours, migraine headaches to follow periodically for three days, Pain in left shoulder and swelling and redness, Swollen Lymph Node under the armpit, pain followed in shoulder and arm for one week

PATIENT REPORTED WITHIN 24 HOURS POST VACCINE HE EXPERIENCED FULL BODY RASH, EDEMA, TACHYCARDIA, AND SHORTNESS OF BREATH. HE SAUGHT EVALUATION FROM THE ED AND WAS THEN DISCHARGED WITH RX FOR TYLENOL. PATIENT STATED STILL FEELING OFF ON 6/14/21 AND I ADVISED HIM TO GO BACK TO THE DOCTOR.

Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient passed out 3 minutes after receiving vaccine, came to after about 1 minute. EMS called and evaluated patient, patient refused to go to hospital.

Patient was seen by primary care physician and opthamologist. Patient was diagnosed with shingles (also ocular shingles). Patient reported a rash from top of head to eye, and from nose to ear on the right side of the body. He experienced swollen lymph nodes on the right side and eye swelling. He lost half of his vision in the right eye that has still not returned at this time. In addition to the shingles, he experienced an excrutiating mgiraine (10/10 on pain scale) which he described as the worst he has ever experienced. He also expreinced joint pain and fatigue. At this time, he is being treated with a course of valacyclovir.

After 4 days I started having shortness of breath, itchiness when breathing and chest pain. At the one week mark I started having palpitations and high blood pressure.

Left leg numb from the whole left butt cheek down to his knee/ left arm feels kind of numb and a little heavy; Left arm feels kind of numb and a little heavy; Fatigue; Was sleeping a lot; Pain from the shot at the injection site; This is a spontaneous report from a contactable consumer (patient, self-reported). A 32-year-old male patient (age at vaccination: 32 year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0217 and expiry date was not reported), via an unspecified route of administration, in Deltoid Left (upper arm), on 03Jun2021, as a single dose for COVID-19 immunization at Pharmacy. The patient's medical history included dysautonomia (he was born with it) and herniated disc. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (GOODY'S) (powder for headache or something like that, or back pain powder, in the week or 2 before the vaccine. It was like a pain powder that comes in a little pouch instead of actual pill like Tylenol. No further information provided). There was no family medical history relevant to adverse events. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0182 and expiry date was not reported), via an unspecified route of administration, in Deltoid Left (upper arm), on 14May2021, as a single dose for COVID-19 immunization at Pharmacy and no reaction on previous exposure to vaccine. The patient did not receive any vaccine within 4 weeks prior vaccinations, he had never even had the flus shot before. He had never even had the flu either. Investigation assessment was not done. The patient stated he was calling regarding the Pfizer Covid vaccine. He got the second shot 03Jun2021, about 2 weeks ago. The back side of his left leg was completely numb from the whole left butt cheek down to his knee and it has been since he got the second shot. Also, his left arm felt the same, kind of like he has been holding it over his head for a long time, it felt kind of numb, but not really, but kind of heavy. This probably wasn't a common thing, so he wanted to report it. He had some other side effects, but he wanted to give it a little more time to make sure it didn't go away. The patient's left leg numb from the whole left butt cheek down to his knee which started within the next day or 2 and it hadn't gone away. It felt about the same. It felt like it fell asleep, the whole back side area. It was like holding the arm above the head too long where it loses a little blood. It felt kind of cold and stiff and felt a little heavy. It started around the same time as the numbness in the leg, but it may have taken a little bit to notice because he did have the fatigue and was sleeping a lot the first couple days. That might have been why it took a couple of days to really notice what was going on with his arm. It was after the second dose and lasted a couple of days. It has stayed the same. Numbness was 2 inches higher where he has a herniated disc. The patient's had pain from the shot at the injection site on 03Jun2021, which was normal and went away, the heaviness of the arm was still there and was just right at the injection site. It didn't feel any worse than a tetanus shot. It was kind of a longer needle and all, so he expected that to be normal anyway. The soreness went away the second day. The adverse events did not require a visit to emergency room or physician office. No relevant tests were performed. The patient did not receive any treatment. When asked if he had any other concerns, patient stated, not unless Pfizer was going to help with the copay for going to the doctor and clarified that this was not an actual request, says he was joking. Outcome of the event pain from the shot at the injection site was recovered on 04Jun2021 and for the events fatigue and was sleeping a lot it was reported as unknown and for all other events, it was not recovered. Information on the lot/ batch number has been requested.

After 10 minutes, clammy hands which lasted for 10-15 minutes. After 4-5 hours, sore arm on injection site. Soreness persisted and relieved for 3 days. After 5 days, louder than previously experience in right ear along with pressure inside of right ear. Persisted for a few hours, hard to sleep. Then relieved. After 5 days, scratchy throat, even swallowing caused gag reflex. Persisted for a few hours, hard to sleep. Then relieved. After 6 days, right arm lymph node swollen to a little over a half centimeter. Saw doctor and got blood test for white blood cell count. Has not relieved yet. Please contact me at a later date to understand how long it lasted.

Bad headache; Bad muscle pain; Cramps; Fatigue; Low grade fever (~102 max); Diarrhoea; Feeling dehydrated; sensitive skin; This is a spontaneous report received from a contactable consumer. A 32-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 9:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and ADHD (attention deficit hyperactivity disorder). The patient was allergic to penicillin. Concomitant medications included amfetamine aspartate, amphetamine aspartate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and salbutamol (ALBUTEROL) for unknown indications. The patient did not receive any vaccination 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 18Mar2021, the patient experienced headache, myalgia, muscle spasm, fatigue, low grade fever (102 maximum) (unspecified unit), diarrhea, dehydration and sensitive skin. No treatment was received 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, myalgia, muscle spasm, fatigue, low grade fever, diarrhea, dehydration and sensitive skin was recovered with sequelae. No follow-up attempts are needed. No further information is expected.

PATIENT FELT DIZZY IMMEDIATELY AFTER VACCINATION, STARTED SWEATING PROFUSELY, FELT THIRSTY. HIS BODY WAS WARM AND WANTED TO LIE DOWN. HE LIED DOWN WITH FEET ELEVATED. STARTED FEELING BETTER AFTER 15 MINUTES.

Patient says that he broke out in red bumps on both arms 1 day after receiving his first dose. He says that the effects lasted for 1 week then went away.

12:00 Client received Pfizer #1 12:01 Client felt tingling in his injection arm 12:02 Client felt lightheaded, black flashes in his vision, and then had full syncope 12:02 Client came to in the chair in observation and felt sweaty but improving. 12:03 Client moved to a cot where he recovered fully over the next 20 minutes.

A rash that started on the shoulders and face and then spread to the trunk of my body. Eventually it covered most of my arms and legs as well.

Site: Pain at Injection Site-Medium, Additional Details: Patient came in today 7/19/21, reporting that they are still experiencing pain at the injection site, in which they received the last 2 vaccines. Gave advice to patient in terms of OTC options for pain relief, as well as making recommendation that patient seek medical care from MD if pain is persisting to identify if there are more permanent issues requiring treatment.

I got shingles. I got a Toradol shot for the pain and was given an antiviral medication, Ibuprofen, and Tylenol 3 with Codeine.

Shingles 3 days later.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Mar2021 at 19:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination; the patient was diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient had not been tested for COVID-19. On 27Mar2021 at 20:00, 3 days after receiving the vaccine the patient developed Shingles. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the reported event and included treatment with viral medication. The clinical outcome of the event Shingles was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Soreness in body; Congestion in nose; Congestion in throat; Nausea; Itching in random spots on body; Headache; just overall felt terrible.; Soreness in neck area; Soreness in injection arm; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 10:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included Localized epidermolyisis bullosa simplex from an unspecified date. Concomitant medications included terbinafine (LAMISIL), ascorbic acid; biotin; calcium pantothenate; cyanocobalamin; ergocalciferol; iron; nicotinamide; pyridoxine hydrochloride; retinol; riboflavin; thiamine hydrochloride; tocopheryl acetate (CENTRUM) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 the patient experienced soreness in injection arm, side and neck area. On 02Apr2021 the patient experienced a headache and nausea and just overall felt terrible. Over the next few days, soreness in body, congestion in nose and throat, and itching in random spots on body. 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. Clinical outcome of neck pain, general body pain, nose congestion, throat constriction, nausea, painful arm, itching, headache, feeling miserable was resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.

Employee got the Pfizer lot EL1284 on 01-04-2021 in left arm. There is now a bump about quarter of an inch high. It is not painful or itchy. Will keep an eye on it, use ice and Tylenol as needed.

Pruritos Hives on chest, back, stomach and upper arms; This is a spontaneous report from a contactable physician reporting for himself. This 33-year-old male patient received on 18Dec2020 11:00 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FJ1685) at single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies. Prior to vaccination, the patient was not diagnosed with COVID 19. Post vaccination, the patient had not been tested for Covid-19. Concomitant medications were not reported. On 24Dec2020, the patient had pruritus hives on chest, back, stomach and upper arms. No fevers/chills, difficulty breathing, throat swelling or other symptoms. Outcome was not recovered.

soreness in left arm the following day along with fatigue and body aches; soreness in left arm the following day along with fatigue and body aches; soreness in left arm the following day along with fatigue and body aches; This is a spontaneous report from contactable other healthcare professional. A 33-year-old male patient received first dose of BNT162B2 (lot number: EH9899; expiry date: unknown) intramuscular (left arm), on 23Dec2020 at 14:00, at a single dose, for COVID-19 vaccination. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced soreness in left arm the following day (24Dec2020) at 8:00 a.m. along with fatigue and body aches. The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date in Dec2020.

neck stiffness; left thumb joint pain; right arm pain around injection site; This is a spontaneous report from a contactable unspecified health professional. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, expiry date: unknown, intramuscular at the right arm, from 22Dec2020 12:15 at a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included simvastatin. On 22Dec2020 18:00 (Tuesday night), the patient experienced left thumb joint pain and right arm pain around injection site. On Wednesday, above issues continued. On 24Dec2020 18:00, Thursday, patient had neck stiffness. The joint pain all over was not severe but noticeable. Outcome of events was reported as unknown. There was no treatment or hospitalization involved. This case is non-serious. No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.

Arthralgia, UrticariaPruritus, NauseaVomiting, stomach cramps Narrative: 12/29 approximately 15 min after vaccination, employee reports onset of "foggy brain", stomach cramps, and widespread itching. He was transferred to the ED. Evaluation revealed no rash and the physical exam was normal. He was treated with 50 mg of benadryl PO and observed in the ED for about 90 minutes and discharged back to work. He was given a prescription for hydroxyzine 25 mg po q 6 hours x 5 days. On 12/30 - he reports his arm is sore and he still feels itchy. Now he has some nausea and his joints hurt. He plans to stay home from work to rest today. He had to leave work early yesterday (works night shift). 12/31 - reports he feels better but still has a headache and feels achy. He hasn't taken the hydroxyzine because his itching is not as intense. 1/4 employee reports his symptoms have improved and has mild achiness, fatigue, and itching which he describes as 1-2 on a scale of 1-10.

Symptoms - ? at time of vaccine, pain at injection site, worsening overnight. EE reports arm as feeling heavy. EE reports unable to sleep over night and tossed and turned. EE reports feeling chilled this am and took temperature. Tmax 102.2 taken at 08:45. EE reports + runny nose and congestion. EE denies travel and COVID-19 exposure without proper PPE. Home remedies? - motrin 600 mg at 08:55 Any improvement? ? none at this time Recommendation? After completely algorithm, EE meets criteria to be COVID tested and removed from work at this time. EE provided with EH command center and instructions to notify them need for COVID-19 testing. EE educated to notify his manager. EE verbalized back understanding and denied further questions at this time.

Rapid swelling, redness, itching, and warmth developed in the exact location of the injection. Swelling was egg-shaped, approximately 3 cm x 4.5 cm. Subsided over the course of three days

Pfizer-BioNTech COVID-19 Vaccine EUA. After 10 minutes I started hyperventilating, difficulty breathing, difficulty swallowing, Left arm numbness, lightheaded, and elevated heart rate. After 1 hr symptoms subsided as I was looked after by 3 nurses. Then last night I woke up at 3 am with body aches, chills, difficulty breathing, lightheaded, tremors, sore arm, elevated heart rate, and swollen injection site. By 6:30 I was sitting up but still too weak to stand. By 9 am I am still lightheaded, sore arm, body aches, and fatigue.

Normal, arm soreness in the beginning. This morning. Skin on hands starting to peel. Has not been in the sun. No behavioral changes for the patient.

Intermittent headaches for 48 hours; general malaise; chills without fever; Sore injection site; This is a spontaneous report from a contactable Physician reporting for himself. A 33-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular Right arm on 16Dec2020 10:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included allergy to Shellfish. The patient's concomitant medications were none (None medication the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Intermittent headaches for 48 hours, general malaise and intermittent chills without fever, Sore injection site on 16Dec2020 13:00. 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 event Intermittent headaches was recovered on 18Dec2020 13:00, the outcome of the other events was recovered on an unknown date.

Moderate pain at injection site started about 3 hours after injection and is still present the next day, though it has become mild and appears to be resolving.

The adverse events were injection site pain, nausea, headache. I took Ibuprofen 800 mg before bed and all symptoms have resolved besides the injection site pain.

2 separate complaints: heart rate is in the 90-100 sitting, 120's walking x 72 hours along with fatigue, intermittent chills and pain at injection site

Severe urticaria all over body, for approximately 48 hours, relieved somewhat with claritin but not fully.

flu-like sxs. joint and muscular pain. abdominal cramping. pins and needles/hypersensitive skin. headache. fever. unable to sleep. sxs had rapid onset appx 12 hrs after dose administration, have continued for 12 hrs to current time.

Left arm pain at rest and with movement; headache; full body myalgias; sore throat; This is a spontaneous report from a contactable physician (patient). A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231 expiration date unknown), intramuscular in left arm on 12Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical historywas reported as none. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) on 22Dec2020 at 12:30 PM for COVID-19 immunization. The patient has not had COVID prior to vaccination. The patient had no other vaccines within four weeks. On 13Jan2021 at 14:00, the patient experienced left arm pain at rest and with movement, headache, full body myalgias, and sore throat. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. The patient was not tested for COVID post vaccination. The outcome of the events was recovering.

About an hour after I received my second shot I felt extremely hot and my knees and elbows started to hurt. I felt so hot that I walked outside to my car (about .3 miles away) in freezing cold temperatures with no jacket and didn't feel the cold at all. I developed a brain fog shortly thereafter and made several mistakes while performing my job throughout the day. My supervisor provided me with extra strength tylenol and within an hour or so the joint pains subsided. By 7 PM that night I had very bad chills and was shaking under a blanket on my couch. My temperature got up to 99.8 which is pretty high for me. I went back and forth between feeling like I was freezing cold and on fire. I got very little sleep that night and had disturbing dreams. The following morning all my joints hurt and I felt extreme exhaustion. I laid on my couch all day the day after receiving the shot and felt exhausted and and had no appetite. From 6 PM the day of the shot to 9 PM the following day I ate NOTHING and had no desire to eat. As I'm typing this 60 hours after receiving the second shot the joint pain is gone, the exhaustion is gone and my appetite is back to normal. There's a lingering pain at the injection site but otherwise I feel like I did prior to receiving the second shot.

site was sore; Brain fog; Fatigue; rash on his hand; Extreme anxiety; Headache; This is a spontaneous report from a contactable consumer (patient). An adult male patient with age at vaccination of 33-years-old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EJ1685), via an unspecified route of administration, on 30Dec2020, at single dose for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient stated he got the shot on 30Dec2020. There was no allergic reaction however, the site was sore, sore for a couple of days from an unspecified date. The patient added that from an unspecified date, he did have kind of brain fog, fatigue, and headache for 3 days. Those symptoms subsided after 3 days. Additionally, 2 or 3 days ago in Jan2021, he started getting a rash on his hand and have also now been suffering from extreme anxiety, fatigue and brain fog. He informed that he went to the emergency room yesterday and he was prescribed some Xanax for the anxiety and a steroid for the rash. The patient was currently taking those now. He also did some basic lab testing yesterday, 13Jan2021, and all his labs were pretty much okay. The outcome of the events site was sore, and headache was recovered on an unspecified date; the outcome of event rash on his hand was unknown; while the outcome of the other remaining events was not recovered.

mild dyspepsia; loose stools; Moderate deltoid soreness at injection site; chills; myalgias; hyperalgesia; headache; fatigue; grogginess; This is a spontaneous report from a contactable physician reported for himself. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 07Jan2021 08:45 at single dose in left arm for covid-19 immunization. The patient medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included triamcinolone 1% cream and diphenhydramine 2% cream. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration on 17Dec2020 05:00 PM at single dose in left arm 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 07Jan2021 12:00, the patient experienced moderate deltoid soreness at injection site within 2-3 hours; chills, myalgias, hyperalgesia, headache, fatigue, grogginess from 12-36 hours post injection (on 07Jan2021); mild dyspepsia and loose stools 24-36 hours post-injection (on 08Jan2021). The patient did not received treatment for the events. The outcome of the events was recovered in Jan2021.

After a run I developed a rash that start at my neck, arm pit and inner thighs and spread overnight. The next day it was at my chest whole arms and legs/feet. I took benadryl for the next couple of days and it has gotten better. I have pictures but did not see a doctor

on 1/27 intense headache and fatigue began Overnight chills and high fever developed. On 1/28 upon waking high fever developed with intense headache, loss of apatite, and fatigue. Symptoms persisted (high fever) until 1/31 at which point fever dropped and has not returned. However, I developed a light pink rash on my torso, head, and neck and a little on my arms. Rash was not itchy or painful. Night of 2/1 developed hives on back, arms, torso, and groin area.

Site of injection (Left Upper Arm), there is now an infection where needle was inserted. Puss is noted along with redness and hard to touch. Approximately 1/4" in diameter

second dose of Covid 19 Vaccine on 11Jan2021; little pain around the injection site; some nausea; some bouts of dizziness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration on 11Jan2021 at single dose on right arm, mid bicep for COVID-19 immunization. There were no patient history. Concomitant medications included hepatitis b vaccine on 14Dec2020, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number:EK5730) on 18Dec2020 (left arm) and he experienced little pain around the injection site, some nausea and some bouts of dizziness. The patient received the Covid 19 Vaccine 4 days after receiving the Hepatitis B vaccination, so he identified this as an error in administration. So the Hepatitis B vaccination was given on 14Dec2020 and the first Covid 19 Vaccine was given on 18Dec2020. He received the second dose of Covid 19 Vaccine on 11Jan2021. Patient stated that originally the prescriber who administered it the first two doses had scheduled him to receive the second dose of Covid 19 Vaccine as the same day as his second Hepatitis B Vaccination and he identified this error last Wednesday and stated "I believe or potentially today, I'm not sure which one I'm sorry I had to check with that". So, he was trying to get this all cleared up. He did report symptoms for both Covid Vaccines as little pain around the injection site, some nausea, some bouts of dizziness. So, patient had already discussed the common adverse reactions with him. Patient was told that co-administration has not been studied yet and referred him to his HCP for continued guidance on how and when to space out the additional Hepatitis B vaccination that he will need. Patient was "32" back in December when this happened. He had his birthday and turned 33. Second shot for the Covid was scheduled the same day the Hep B (Hepatitis B Vaccine) but due to inveigle in-charge of the vaccine, he had lost his paper work and he had been on vacation and stated "had been vaccine was not found they just gave me the second Covid Vaccine and told me to come back by Thursday and I should have found it and have everything cleared up by then but then Wednesday they called me and told me that they have realized that they are not supposed to give vaccine co-administered with 14 days window before or after. I haven't got my second Hep B (Hepatitis B Vaccine) just the first one was administered within the 4 days period of the first shot". Patient work at Dietary Providence. The patient had his blood drawn this morning (20Jan2021). Patient does not have product details for hepatitis B vaccine. Patient stated that the nurse on duty had said that the vaccine they had stocks was "Engerix-B hepatitis B recombinant" but that was not verified as far as definitively is just what she had stocked when he was going on his incident report. Patient further stated, "As far as all things are concerned you know I went to a doctor got checked he said breathing was great, heart rate was great, oxygen level 98 percent, he has drawn blood by then is there anything that I should be doing at this point cataloging thing any other test any other people to contact. What should I do going forward specially what can I do to be helpful for you guys to get this situation clear." Outcome of the events was unknown.

On 26DEC ( 5 days after first injection), he started experiencing pain and weakness in the Right deltoid radiating down to the fingertips . Within a week, started feeling similar symptoms in Left extremity. No shoulder/neck pain. Pain starts at the deltoid at the injection site and has caused stiffness, pain, and tightness of the upper extremities alone. Decreased grip b/l. Symptoms have persisted since ( almost a month now) but did seem to resolve while on prednisone, but returned after cessation. No respiratory issues, chest pain, paresthesias, or lower extremity symptoms.

11:25am- Pt found rash @ left arm and return to covid vaccination station after 15 minutes observation (pt had 2nd pfizer covid vaccination). Pt denied SOB and difficulty to breath. VS stable. Continue to monitor pt 30 minutes per Doctor's order. 11:55am- rash noted @right thigh, pt denied SOB, report given to Doctor, Benadryl 25mg po given per Doctor's order

Body Aches and pains, headache, swelling and pain at injection site all which lasted around 20 hours.

right arm which the vaccine was injected into became extremely sore and was unable to move it without feeling pain.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247, expiry date not reported), via an unspecified route of administration on the right arm on 28Jan2021 13:00 at single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported experiencing right arm which the vaccine was injected into became extremely sore and was unable to move it without feeling pain on 29Jan2021 05:00. No treatment was received for the event. The patient recovered from the event on an unspecified date. No follow up attempts are possible. No further information is expected.

got Pfizer vaccine yesterday at the vaccination clinic. Last night developed hives on his back, relief with cold compresses and Benadryl. Saw pcp today and received steroid shot. PCP instructed caller to get a different vaccine, specifically johnson and johnson.

Severe body ache; ache at the injection site; headache; chills; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration in the left arm on 18Feb2021 at 12:00 (at the age of 33-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not aware of allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient previously took first dose of BNT162B2 (Lot number: EL3247 and left arm) on 28Jan2021 at 12:30 (at the age of 33-years-old) for COVID-19 immunization. On 18Feb2021 at 23:00 severe body ache, ache at the injection site, headache and chills. The seriousness criteria were considered as non-serious. The patient did not receive any treatment of the events. The outcome of the events was not recovered.

Patient reported a pounding headache for 1 day followed by local muscle soreness at the injection site following his 1st dose of his Pfizer COVID vaccine.

Injection site soreness; enlarged, painful lymph nodes in left arm pit; enlarged, painful lymph nodes in left arm pit; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EM9810), via an unspecified route of administration at Arm Left on 04Feb2021 17:00 at the 33 years old at single dose for COVID-19 immunization. The medical history was none. The Known allergies was None. The concomitant medication was hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The Historical Vaccine was first dose BNT162B2(lot number EL3249) on 15Jan2021 07:00 at 33-year-old at Left arm for COVID-19 immunization. The patient experienced Injection site soreness and enlarged, painful lymph nodes in left arm pit on 06Feb2021 05:00. The event Injection site soreness was resolving after 36 hours. There was no other vaccine in four weeks. There was not treatment received for all the events. The patient had no Covid prior vaccination. There was no Covid tested post vaccination. The outcome of the event Injection site soreness was recovering, the other events was unknown.

Felt intense itching on face; Developed alopecia barbae approximately 1 week from second dose/subsequent hair loss has remained permanent since; This is a spontaneous report from a contactable physician. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration on 09Jan2021 14:00 at a single dose on left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: K5730), on 19Dec2021 at 02:00 PM, on right arm, for COVID-19 immunization. The patient experienced developed alopecia barbae in Jan2021 approximately 1 week from second dose. After the shot (24h) the patient felt intense itching on face on 10Jan2021; subsequent hair loss has remained permanent since. The event alopecia barbae was reported to have resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No treatment was given for the events. The outcome of the events was not recovered. The patient did not have COVID prior vaccination and was not COVID tested post vaccination.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.

Swollen right eye; Rash under the eye; Fatigue; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A 33-years-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was administered the Pfizer Covid19 vaccine on 01Mar2021 and experienced a swollen right eye with a rash under the eye. He also said he experienced fatigue. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Shingles to the left side of my face and left eye; Impetigo to my jaw line on both sides of my back and back of my neck/hairline area; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-years-old male patient received bnt162b2 (BNT162B2),(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL1284) dose 2 via an unspecified route of administration, administered in Arm Left on 10Jan2021 as SINGLE DOSE for covid-19 immunisation .Medical history included hypertension from an unknown date and unknown if ongoing , nephrolithiasis from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included potassium citrate (POTASSIUM CITRATE) taken for an unspecified indication, start and stop date were not reported; amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; chlorthalidone (CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles to the left side of my face and left eye on 19Jan2021 15:30 and impetigo to my jaw line on both sides of my back and back of my neck/hairline area on 19Jan2021 15:30 and The events were considered as non-serious by the other healthcare professional. The outcome of the events was recovered

Patient developed tingling in fingers, shortness of breath, pruritic rash to forehead and chest, blanched with applied pressure, associated sweating, feeling hot and shaky within 20 minutes of vaccination.