Pfizer

Vaccination occurred on 1/12 at 13:00. A few hours after the vaccination, I experienced muscle pain in the vaccinated arm. 1/13: I had trouble sleeping; left arm was in immense pain. 07:00: experiencing arm soreness, muscle pain, nausea, hot flashes; temperature = 99.5 08:20: experiencing arm soreness, muscle pain, hot flashes, chills, sensitivity to light; temperature = 100.6. Took 650mg acetaminophen. 09:00: experiencing arm soreness, muscle pain, sensitivity to light; temperature = 100.8 10:30: experiencing arm soreness, muscle pain; temperature = 99.2 11:15: experiencing arm soreness, muscle pain; temperature = 99.0 12:20: experiencing arm soreness, muscle pain; temperature = 98.0 Extremely fatigued; took nap (13:00-17:00) 17:00: experiencing arm soreness, muscle pain, headache; temperature = 99.3 18:00: experiencing arm soreness, muscle pain, headache; temperature = 99.2. Took 650mg acetaminophen. 19:00: experiencing arm soreness, muscle pain, headache; temperature = 100.8 20:00: experiencing arm soreness, muscle pain; temperature = 98.3 21:00: experiencing arm soreness, muscle pain; temperature = 100.6 21:30: experiencing arm soreness, muscle pain; temperature = 99.2 22:20: experiencing arm soreness, muscle pain; temperature = 100.1. Took 400mg Ibuprofen. 1/14: 07:00: woke up experiencing pain at the injection site, neck pain, headache. These events continued throughout the day. No temperature over 99.5. 18:30: Took 650mg acetaminophen for headache.

0930 red, puffy, tingling hands 0945 cough 0948 benadryl 50 mg administered by medic. pt hx of anaphylaxic reactions to nuts. mom stated she did not have pt's epi pen with her. pt stated these same symptoms happen with anaphylaxis prior. mom/pt wanted transport via ambulance vs POV for peace of mind in case any symptoms worsened. to ED.

Flushing, macular rash/warm. BP 127/74 (pulse 91), O2 sat 95%. Erythematous rash on chest, lungs clear. Given Benadryl 25 mg PO.

A small red, painful rash developed in the anticubital area on Day #14. By day #15, the rash spread down towards the wrist. Continues to be painful but no itch present.

new onset of erythematous pruritic rash that started on scalp and spread throughout body that started 3/31/21. Symptom of Erythema multiforme that started 2 weeks after vaccine, no other etiology found.

The bandaid fell off the next evening and he has a rectangular bruise at the injection site the shape of the bandaid. He only noticed it Saturday evening, so we don't know when the bruise formed.

Eight minutes after receiving his vaccination, he developed lightheadedness and had a brief episode of syncope. He had a small laceration on his right for head.

EMS providers approached by 17 y/o pt complaining of rash local to injection site. Pt stated that he received the first dose of the Pfizer COVID vaccine at 17:21hrs today. Pt denied feeling any itching or pain at the site, and only noticed the rash upon visual inspection of the site. Pt denied chest pain, shortness of breath, nausea, womiting or diarrhea. Upon inspection, (R) upper arm found to have slight, non-raised rash, warm to the touch. Full assessment performed and vital signs obtained. GCS 15, P 76 regular, RR 18 non-labored, B/P 146/P, PERRL, SpO2 99% RA. No other associated symptoms found. Pt administered Diphenhydramine 25mg IM in RA. Pt monitored and denied any worsening of condition. (See Attached)

Urticaria of trunk and extremities developed ~48 hours after vaccination. Relatively mild with only intermittent pruritis. Pain and swelling of feet. Still present as of visit on 4/12/21. No other symptoms.

EMS providers approached by 17 y/o M pt complaining of rash local to injection site. Pt stated that he received the first dose of the Pfizer COVID vaccine at 17:21hrs today. Pt denied feeling any itching or pain at the site, and only noticed the rash upon visual inspection of the site. Pt denied chest pain, shortness of breath, nausea, womiting or diarrhea. Upon inspection, (R) upper arm found to have slight, non-raised rash, warm to the touch. Full assessment performed and vital signs obtained. GCS 15, P 76 regular, RR 18 non-labored, B/P 146/P, PERRL, SpO2 99% RA. No other associated symptoms found. Pt administered Diphenhydramine 25mg IM in RA. Pt monitored and denied any worsening of condition. (See Attached)

Patient had two events that our pediatrician encouraged us to notify about. First, on 4/15/2021 around 13:30, Patient stretched in class and fainted. He was unconscious about 30 seconds. Second, beginning 4/15/2021 around 2100 he noticed a rash across his chest and down both arms. The rash is spreading to his abdomen and back today (4/16/2021). We saw a physician at his pediatric clinic this afternoon for evaluation.

Recipient experienced brief loss of consciousness (few seconds per report) / vasovagal syncope from a standing position. He fell and hit his right frontal bone of skull upon fainting. Patient awoke after a few moments per report and was AAOx4 within moments of this reporting clinician's arrival to scene. Vital signs stable. Patient's frontal bone with minor red abrasion / erythema and scant swelling. He did not complain of changes in vision/ nausea / emesis. Neurological and Musculoskeletal exam intact without issues.

Fever, chills, headache and swallen axillary lymphnodes. Pain and redness in left axillary area limited left arm and shoulder range of motion. Tylenol and warm compress was used to provide comfort. Today a call is going out to the Dr. to provide any further instruction as today is day 3 and there is still quite a bit of axillary discomfort.

first a luttle fever, then rash in the body on Saturday with itch. On Sunday, the rash was there but mild Ob Monday, around 12:00 start to itch again and the rash was medium. Need to provide a Benadryl to calm the itch.

Day 1 (4/16/21): non-emergency allergic reaction = itching all over Day 2 (4/17/21): still itching all over, scratchy throat, hurt to swallow, (normal side effects = elevated temp 100.3, steady headache, dizziness, slight achiness) Day 3 (4/18/21): itching all over, small number of hives on right arm, scratchy throat, inside ears itchy; (normal side effects = nauseous - worse after eating, dizzy, headache, elevated temp 99.6 Day 4: itchy all over, hives now up & down both arms, scratchy painful throat (normal side effects: above but less. Day 5: all improving

The day after receiving the Pfizer COVID vaccine, my son broke out in a rash all over his body. The rash was worse on the arm where he got the shot and on his hands and feet than on the rest of his body, but it was pretty much all over. He hadn't seen the new doctor listed on his insurance yet, and she refused to see him because she does not see new patients online and refused to see a patient with a rash in person because she said it could be a COVID symptom. There is no way he had COVID as he hadn't gone anywhere in months due to the pandemic and going to school online. The rest of our household had been previously vaccinated for COVID. We called the nurse helpline and a friend who is a physician's assistant. Both told us to give him Benadryl, which we did. It took 3 days before the rash disappeared. He had about another 3 days with no rash before it came back just on his hands, including the palms of his hands. We gave Benadryl again and the rash went away 2 days later and hasn't come back so far.

Rash on right lower back going down to right buttock. Small rash patch on right hip and right groin area. Red and raised and pimpley. Constant burning pain. Relief with Tylenol and ice pack. More relief with ice pack. Went to the doctor on April 22nd. Pain and rash not going away. On April 25th pain is subsiding. Rash is still present. Dark red and starting to scab.

Covid vaccine site: Per chart pt received covid vaccine at 1413 accompanied by his Grandma. About a minute later, pt had a syncopal episode while walking to observation area. Per grandma, pt hit L-side of face on plastic chair. Medical staff responded to incident, RN and Dr, pt supine on ground - awake and alert. Dr examined pt. VSS taken: BP: 130/60 HR: 74 O2sat: 99% RA. 1420: With permission from Dr, pt stood up to sit on the wheelchair. Pt wheeled to observation/triage area. Intervention: Ice and gauze dressing. Pt is awake and alert, mild swelling to L side of-face, under eye - small break in skin noted, bleeding controlled. Pt had some juice, water and crackers, no difficulty swallowing. Pain 2/10, tolerable. Cold compression on and helping. Grandma remains with pt - per grandma, pt has history of passing out with blood draws. 1440: Pt remains awake and alert, NAD, no new or worsening complaints. Grandma remains at bedside. 1505: Orthostatic BP done per Dr. Results given to MD. No new orders. 1510: Dr OK'd pt to go home with grandma. Grandma and pt stated they are comfortable to go home. Instructed pt and grandma to monitor for symptoms and to call PCP or 24 hour advice line for new or worsening symptoms. Call 911 or go to emergency if has emergent symptoms. Grandma and pt verbalized understanding and agreed. Pt and grandma exited triage area, ambulatory with steady gait and in no apparent distress. Grandma will drive pt home.

Extensive hives, joint swelling; swelling over left eye. I saw him on 4/26/21. He had some minor hives. I prescribed an epiPen, prednisone (40 mg daily), and benadryl (25 mg tid prn rash, hives). He came back on 4/27/21. He had more hives, swollen left upper eyelid, joint pain, difficulty walking because of hives on soles of feet. He had no respiratory distress. His chest was clear. I admitted him on 4/27/21 to the Hospital.

One week post vaccine, little blisters lower eyelid, itchy and swollen. Prescribed Erythromycin and Cephalexin. Next day, red eye, blisters worse, swollen and itchy. Second opinion, prescribed valtrex and doxycycline. Following day starting to improve. Day 4 just blisters now.

My son since started with pains at the vaccination site, headache, chills, muscle pain, fatigue, little of nausea, thirst, body temperature of 99.1 degrees Fahrenheit at 10:00 pm. Tomorrow medications acetaminophen

Numbness and tingling in right arm and right leg with mild tingle in right cheek. Headache responding to Tylenol, mild soreness at injection site. No weakness or gait changes. Symptoms almost completely resolved at 20 hours.

Itching, hives and pain around injection site. Pain in injected muscle. Pain in shoulder joint. Heat and redness around injection area. Finally, nausea and arm pain. Nausea may be unrelated to vaccination.

Patient experienced a rash around neck and chest within 30 minutes of first vaccine that persisted for several days.

Patient got dizzy, vision was blurry, body felt tingly and hot. Patient felt like he was going to faint. His face/lips turned a gray color. We called emergency number. Patient did not have anaphylaxis. Symptoms started within a few minutes of the dose.

Patient being observed post covid vaccination for hx of anaphylaxis with nuts and many foods. At 30 minute mark, he was observed to have faint hives at left side of face and under chin. Trunk clear. No s/sx of distress. Evaluated by EMS - mouth, throat, lungs clear to auscultation . Patient and his mom decline Benadryl IM - discharged to home. Intends to take PO Benadryl.

Too trashed to train for his sport/described as too weak to train; Swelling; Loss of taste and smell to some extent; Brain fog; Swollen glands; Loss of taste and smell to some extent; Leg pain; Joint pain; passed out/hit the floor, put a big bump on his head; passed out/hit the floor, put a big bump on his head; Redness; Chills; Fever; Too sick to get out of bed; Shortness of breath; Headache; Muscle pain; Tiredness/Fatigue; Pain in the arm; 2 inch diameter raised circle at injection site; could not barely remember his name; tried to study but just wasn't there, head on desk. Still has difficulty focusing; This is a spontaneous report from a contactable consumer (patient's father). A 16-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER2613 and expiry: Jul2021), via an unspecified route of administration in right arm on 31Mar2021 14:30 (at the age of 16-year-old) as single dose for covid-19 immunisation. Vaccination was taken because he was going back to school. The vaccine was not administered at a military facility. No additional vaccines administered on same date of BNT162B2 and no prior vaccinations (within 4 weeks). The patient received first dose of bnt162b2 (Lot: EN6199, Expiry: Jun2021) on 10Mar2021 at 13:30 in right arm (at the age of 16-years-old) as single dose for covid-19 immunisation and experienced loss of taste and smell and joint pain, all events started in Mar2021. Medical history included mild allergy to Birch pollen (which everybody has, but nothing else/patient tested for allergies, and had no significant allergies, they thought he might be because he spilled a sugared soda behind his bookcase in his room and there was mold growing so they thought he might be allergic to mold, so they tested for allergies and he has no allergy to mold) and ongoing vitamin supplementation. Family Medical History included Sarcoidosis with mother. Concomitant medications included vitamin d3 for vitamin supplementation from 2020 (about a year ago) and ongoing; ascorbic acid, rosa canina fruit (VITAMIN C) for vitamin supplementation from an unspecified date (several years ago) and ongoing and an unspecified ongoing multivitamin from an unspecified date (several years ago) at 1 taken daily for vitamin supplementation. On 31Mar2021, the patient experienced pain in the arm at 17:30, tiredness at 20:30, shortness of breath, headache at 22:30 and muscle pain at 22:30. On 01Apr2021, the patient experienced fever at 00:30, chills at 01:30, redness at 02:30, leg pain at 08:30, fatigue (ongoing) at 02:30, joint pain at 08:30, too sick to get out of bed and passed out and hit the floor, put a big bump on his head at 05:30 (about 15 hours after second dose, patient was at the kitchen table with his head between his knees trying to breathe, passed out, hit the floor and put a big bump on his head). On 02Apr2021, the patient experienced brain fog at 14:30, swelling at 14:30, swollen glands at 02:30, loss of taste and smell to some extent at 14:30 and too sick to get out of bed. On day 2 (02Apr2021) and was still about pushing 100 degrees Fahrenheit and on 21Apr2021 (after 21 days) sometimes over sometimes less. On the following Monday (05Apr2021), he struggled back to school after 5 days, but came home early. He has just been trashed, too trashed to train for his sport, further described as too weak to train, he hadn't trained for 3 weeks. He still has a fever. His local doctor did not have any suggestions other than he should take acetaminophen and ibuprofen alternately to get rid of the headache and fever. In 2021, the patient experienced 2-inch diameter raised circle at injection site and disappeared after 10 days and there was a time he could not barely remember his name, tried to study but just wasn't there, head on desk. Still has difficulty focusing and doing his calculus. It was reported that the time to recover from any exertion seems to be longer by a lot. On 01Apr2021, body temperature reached 103 degrees Fahrenheit. The patient tried to do a few things like a week ago just because he couldn't stand to be in the house anymore he took a bike out for about 15 minutes and was just trashed from that experience and took 3 days to recover. The events did not require emergency room visit nor physician's office neither hospitalized. The outcome was recovered from loss of consciousness, head injury on 01Apr2021; from illness on 02Apr2021; from headache on 04Apr2021; from chills on 06Apr2021; from pain in arm and fatigue on 07Apr2021; from erythema on 11Apr2021; from ageusia and anosmia on 14Apr2021; from lymphadenopathy on 16Apr2021; from arthralgia on 17Apr2021; from myalgia on 18Apr2021; from leg pain on 21Apr2021; from vaccination site swelling in 2021; then recovered with sequel from dyspnoea on 05Apr2021 and from swelling on 07Apr2021; then recovering from pyrexia, feeling abnormal; then not recovered from asthenia and unknown for the remaining events.

HPI: Patient is a 16-year-old male who was upgraded to our emergency department after blood work showed a significant thrombocytopenia. Please see walk-in clinic provider NP for presenting history and physical exam. Patient reports to me development of sore throat as well as blood from the throat last Thursday. Patient also began to notice development of bruising to his legs without any injury approximately a week ago. Denies any pain. Denies any blood in the urine or stool. No other medical complaints at this time. Chief Complaint Patient presents with ? Sore Throat was seen a few weeks ago for ear infection, also had sore throat at that time that never went away. School nurse wanted him swabbed for strep and covid PCR ? Bleeding/Bruising has large bruising to right leg for about a week, no injury. also states bruise to upper left thigh and right shoulder and scattered small bruises. School nurse wants his platelets checked. Denies pain. States mild bleeding in gums and states notices blood in back of throat ROS: See HPI above. All other 12 review systems negative otherwise specified in HPI above. ROS PMH: Past Medical History Past Medical History: Diagnosis Date ? Asthma ? GI symptoms 10/2018 with pharyngitis ? Headache ? Strep throat ? Tonsillar and adenoid hypertrophy nasal scope Past Surgical History Past Surgical History: Procedure Laterality Date ? COLONOSCOPY 12/07/2018 with biopsies ? ESOPHAGOGASTRODUODENOSCOPY 12/07/2018 with biopsies ? TONSILLECTOMY & ADENOIDECTOMY 2011 Family History Family History Problem Relation Age of Onset ? Hypertension Father ? Diabetes Mellitus Father Social History Tobacco Use ? Smoking status: Never Smoker ? Smokeless tobacco: Never Used ? Tobacco comment: no second hand smoke exposure Substance Use Topics ? Alcohol use: No Allergies: No Known Allergies Meds: No current facility-administered medications on file prior to encounter. Current Outpatient Medications on File Prior to Encounter Medication Sig Dispense Refill ? albuterol HFA 108 (90 Base) MCG/ACT inhaler Inhale 2 puffs every 4 hours as needed. 1 inhaler 1 ? Aspirin-Acetaminophen-Caffeine (EXCEDRIN PO) ? acetaminophen (TYLENOL) 325 MG tablet Take 975 mg by mouth every 6 hours as needed for Pain. ? naproxen (NAPROSYN) 220 MG tablet Take 440 mg by mouth twice daily - with breakfast and supper. Physical Exam: Blood pressure (!) 148/93, pulse 107, temperature 98.6 °F (37 °C), resp. rate 20, height 6' 5" (1.956 m), weight (!) 348 lb 8 oz (158.1 kg), SpO2 96 %. O2 flow: Physical Exam Constitutional: He is well-developed, well-nourished, and in no distress. No distress. HENT: Head: Normocephalic. Right Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Oropharynx is clear and moist. No oropharyngeal exudate. Mild erythema in the posterior pharynx with some bleeding. No posterior pharynx edema. Eyes: Conjunctivae are normal. Right eye exhibits no discharge. Left eye exhibits no discharge. No scleral icterus. Cardiovascular: Exam reveals no gallop and no friction rub. No murmur heard. Pulmonary/Chest: Effort normal. No stridor. No respiratory distress. He has no wheezes. He has no rales. Abdominal: Soft. Left upper quadrant tenderness. Musculoskeletal: General: No tenderness, deformity or edema. Cervical back: Normal range of motion. Neurological: He is alert. Gait normal. GCS score is 15. Skin: Skin is warm. He is not diaphoretic. Multiple baseball to softball size bruises to the bilateral lower extremities worse on the right than left. Mild petechiae. Psychiatric: Mood, memory, affect and judgment normal. Diagnostics: Results for orders placed or performed during the hospital encounter of 05/10/21 CBC WITH DIFFERENTIAL Result Value Ref Range White Blood Cells 7.72 4.0 - 13.0 K/uL Red Blood Cells 3.48 (L) 4.15 - 5.30 M/uL Hemoglobin 10.8 (L) 11.8 - 15.4 g/dL Hematocrit 30.5 (L) 35.5 - 46.5 % MCV 87.7 77 - 94 fL MCH 31.0 25.0 - 32.3 pg MCHC 35.4 31.9 - 35.9 g/dL RDW 16.2 (H) 11.5 - 14.8 % Platelet Count 9 (LL) 160 - 424 K/uL MPV 11.4 (H) 6.8 - 10.5 fL Neutrophil % Pending % Lymphocyte % Pending % Monocyte % Pending % Eosinophil % Pending % Basophil % Pending % Absolute Neutrophils Pending 1.6 - 7.5 K/uL Absolute Lymphocytes Pending 1.2 - 4.9 K/uL Absolute Monocytes Pending 0.1 - 0.9 K/uL Absolute Eosinophils Pending 0.0 - 0.6 K/uL Absolute Basophils Pending 0.0 - 0.2 K/uL COMPREHENSIVE METABOLIC PANEL Result Value Ref Range Sodium 138 133 - 144 mEq/L Potassium 4.4 3.5 - 5.0 mEq/L Chloride 101 95 - 107 mEq/L Carbon Dioxide 22 22 - 32 mEq/L Anion Gap 15 6 - 15 mEq/L BUN 14 8 - 24 mg/dL Creatinine 0.81 0.69 - 1.20 mg/dL Glomerular Filt Rate NOT CALCULATED due to age less than 18 years. mL/min Glucose 110 (H) 70 - 100 mg/dL Albumin 4.9 3.5 - 5.2 g/dL Calcium 10.0 8.6 - 10.4 mg/dL AST 23 11 - 41 IU/L ALT 28 (H) 0 - 19 IU/L Alkaline Phosphatase 142 90 - 366 IU/L Bilirubin, Total 0.4 <1.5 mg/dL Total Protein 7.7 5.9 - 7.8 g/dL Globulin 2.8 1.8 - 3.7 g/dL A:G Ratio 1.8 1.2 - 2.7 PROTHROMBIN TIME Result Value Ref Range Prothrombin Time 18.4 (H) 12.0 - 14.6 sec INR 1.5 (H) 0.9 - 1.1 PTT, PARTIAL THROMBOPLASTIN Result Value Ref Range PTT 32 23 - 36 sec CRITICAL VALUE HEME Result Value Ref Range Critical Value ED Course: Patient was upgraded to the emergency department after he was noted to have significant thrombocytopenia. Patient is pleasant he has no active complaints other than some throat irritation bleeding in the throat and bruising that was nontraumatic to the legs. My physical examination reveals multiple rather large bruises to the bilateral lower extremities up to softball size worse on the right than left. Patient had some mild left upper quadrant discomfort. Very minimal bleeding in the posterior pharynx. I personally reviewed the labs and CBC revealed an anemia at 10.830.5 hemoglobin hematocrit respectively. Most notably a 9000 thrombocytopenia. CMP essentially unremarkable. INR 1.5 PTT normal. I added on Lyme disease and tick-borne illness as well as a Monospot type and screen. Patient did receive his 1st visor vaccine for COVID-19 on April 29, 2021. IV was established in the emergency department in consultation made to Pediatric Oncology. I spoke with pediatric oncology in regards to patient's history and present illness. He does agree that the patient should in fact be transferred under the pediatric care but recommended under the general hospitalist service. He did not advise to proceed with any active treatment in our emergency department such as gamma globulin, platelets or steroids. Awaited call back from pediatric hospitalist and spoke with Dr. She has agreed to accept the patient in transfer. Patient and family are comfortable disposition plan no further questions at this time. Impression: 1. ITP Disposition: Transfer ED on 5/10/2021 Revision History Detailed Report Note shared with patient Note filed date Mon May 10, 2021 12:24 PM

Initial complaint: feeling lightheaded, couldn't see, diaphoretic, pale 12:10 BP 60 systolic HR 64 Patient diaphoretic, "can't see". Ice pack, granola bar and water provided. 12:15 BP 56 systolic Second ice pack provided. Reports "feel better" Noted having ringing in right ear 12:20 BP 98/42 HR 60 only complaint is the ringing in his right ear. Still Pale 12:25 Color improved. Skin warm and dry. Alert, continues to have ringing in ear. 2nd granola bar offered and encouraged to drink the water 12:30 BP 100/52 HR 64 Right ear "barely ringing" 12:35 BP 104/62 HR 68. Reports ear ringing "gone" 12:40 Discharged with parent. Instructed to inform vaccinator of incident when he comes in for his second vaccine 5/11 Unable to reach for follow up

Mother stated patient skin color changed within seconds after vaccination was given. This nurse observed patient laying in mother's lap face pale with jerky head movement.

On 5/6/2021 Presented to urgent care. Clinically Dx with Herpes Zoster. PCR testing for Varicella pending.

Patient reported pruritus at the injection site on left arm. Denies generalized pruritus. No shortness of breath or difficulty in breathing. No swelling at the injection site., and no other cutaneous symptoms. Patient instructed to notify medical of worsening symptoms or difficulty in breathing. Patient reported feeling better after 5-10 minutes and left vaccine site.

pt received the shot and immediately felt according to him, intense pain in arm and began to loose sight. Patient then seized and went limp. We put the patient flat on the ground to protect from a fall injury and his seizing stopped. His color was very ashy and he was not responding properly to questions we asked. In about 2 minutes, he became more coherent and began talking and responding to our questions. Paramedics were immediately called and they arrived 30 minutes later after 3 phone calls to follow up. Father was with patient.

This is a spontaneous report from a contactable reporter reporting for her son, via Pfizer sponsored program. A 16-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as single dose at the age of 16-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After 24 hours from vaccination, on 25Apr2021, he felt pain on the injection site. For that, the mother gave her son Tylenol to treat the symptoms. Then after 24 hours, on 26Apr2021 he felt fine. However, 2 days after, on 28Apr2021, he felt pain underneath the left side of his armpit, had a fever with a temperature of 102.8 F, and the right side of his neck was swollen. In addition to this, he was experiencing a lot of body aches, headache, and pain on his neck. They already contacted their HCP and prescribed him with antibiotics in Apr2021. He was tired and almost lethargic in Apr2021. Reporter wanted to know if her son should still receive the 2nd dose. The reporter was invited to consult her HCP. The outcome of pain on the injection site was recovering, of all other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; 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 serious events Neck swelling, Armpit pain, and Fever 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.

Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild

Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Medium, Additional Details: Pt is a 16 yo male who came in for second dose pfizer vaccine on 05/18/21. His mother reported that the pt experienced redness and swelling of the left eye at 2am on 05/19/21. At 3am, the patient mother gave her son benadryl and ibuprofen. I called the patient at 11am on 05/19/21 to check up and he is currently sleeping with some swelling and redness present. He has made a doctor appointment later today.

My son developed a rash sometime on Sunday, May 16 after receiving his first dose of the Pfizer shot on Saturday, May 15. The rash is located near the injection site, the chest, stomach, legs, and opposite arm of vaccination site. Unfortunately, I do not know the exact time of the onset of the rash. The rash is very itchy and looks like hives. I took pictures and messaged the pediatrician. They were not sure if it was a reaction or contact dermatitis. My son has not changed soaps, laundry detergents, etc. the only new thing he encountered was the vaccine. The rash is still itchy and is improving a little bit every day. I expect him to be perfectly fine, but the rash is still present.

(Vasovagal Response and Mild Urticaria) ? Felt faint, had very mild rash on both arms. Pt said he saw a flash of ?blue light?. Possible to d/t laying out in the sun. Mom noted possible allergic reaction to cats at home. (Initial BP 100/62 ? 10 mins 118/68). Treatment: Diphenhydramine 50mg/ml injection on right arm.

Child's skin on forearm started peeling and is continuing to peel with a slight spread to upper arm. The top layer is the only layer that is peeling right now.

Patient received above noted COVID19 Vaccine on Friday morning and reported symptoms starting Saturday morning. Symptoms include lip swelling, lip rash, and erythema only affected the lip area of the face. Symptoms have persisted for 3 days and that is when the pharmacy was contacted. Mother has given Benadryl to patient to help with itching/swelling. Pharmacist recommended close monitoring for worsening symptoms and to follow-up with primary care provider for further guidance.

PT REPORTED REDNESS AND ITCHINESS TO LEFT AREM AND RIGHT CHEEK AND CHEST. PT STATED HAS ALLERGIES TO MIGRAINE MEDICATIONS AND GIVEN 25 MG OF BENEDRYL PO @3PM AND PT EDUCATED THAT IT TAKES FOR MEDICATION TO KICKIN PT GIVEN AN EXTRA 20 MIN ON THE TOP OF 30 MIN OBSERVATION TO BE CLOSLEY MONITORED, PT INSTRUCTED TO STAY HYDRATED AND TO NOTIFY THE OBSERVATION TEAM IF SYMPTOMES WORSEN.

Two minutes after receiving Pfizer vaccine, member complained of lightheadedness and nausea. Member was given juice and graham crackers and V/S were taken: 1004: 104/60, 77, 98% (room air), 1006: 114/71, 79, 100%, 1009: 127/46, 78, 99%, 1012: 93/52, 85, 99%, 1014: 105/37, 83, 99%. Member stated symptoms resolved after drinking juice and crackers. He stated he did not eat anything today prior to receiving vaccine. Member's mother was at his side. Clinic manager was also called to member's side. Member was transferred to observation via wheelchair for further observation in stable condition, alert and oriented x4, no signs of respiratory distress, denied all complaints. In observation room nurse noted: After episode of nausea and lightheadedness, pt continued to improve in observation area. He remained 30 minutes as VS continued to improved (final check was BP=111/71, HR=60, O2=99%, RR=20). He stated feeling better and facial color much improved. He left the clinic via wheelchair with his mother and brothers.

Patient had vaccine and had no reaction in 30m observation period. Three days later he developed rash on thighs. Likely unrelated but timing suspicious with history of anaphylaxis.

Pt. with parent for second pfizer vaccine. Pt. had no reaction with first vaccine. After 20 minutes, pt noted hives on his legs and chest. EMS alerted. No SOB, no difficulty breathing. No hx of anaphylaxis from vaccines. Pt. given 25mg benadryl at 1657. After rest of allotted wait time pt. states hives are decreasing and pt. has no worsening symptoms. Pt. exited facility with parent.

acute hives secondary to unknown cause. Generalized allergic reaction with skin rash. Prednisone 20 mg: every day for 4 days. 20mg Pepcid daily.

rash on stomach, hand, face and neck; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: Ew0171), via an unspecified route of administration, administered in the left arm on 12May2021 at 17:15 as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 21May2021, the patient developed rash on stomach, hand, face and neck. The patient received Benadryl and cortizone-10 as treatment for the event. The outcome of the event was not recovered. The event was reported as non-serious.

After receiving vaccine, patient stood up from chair and started to feel "dizzy." Patient was assisted back to chair by staff. Upon assessment, patient was pale to face and warm to touch. BP 102/58, P88. SpO2 99% on room air. Given gatorade water to drink and cool compresses applied to neck. Extended monitoring done in recovery. Patient ambulated from facility with mother. No s/sx of distress noted.

Per patient report upon presentation to hospital: Received vaccine 6/9 during the day, in the evening developed typical symptoms (headache, vomiting, warm to the touch) and has chest pain that seemed to resolve with ibuprofen. On 6/12 at 0400 patient woke up with severe chest pain (localized to the middle of the chest), no tachycardia or shortness of breath. Pain does not change when moving arms/neck. No recent fevers, URI symptoms, known sick contacts. On presentation 6/12 troponin was elevated to 9.69, repeat on 6/13 decreased 6.03. Diagnosed with myocarditis, initial ECG was abnormal, repeat ECG has not shown any ischemic changes. Patient will have repeat EKG, ECHO, troponin, and likely discharge from hospital

Focal seizure observed by school staff during lunch. (duration: less than 1 minute) Patient dropped his spoon and the staff noticed his eyes were "fluttering" and he "was changing colors and didn't look right". As soon as it ended, Patient wanted to lay down. We brought him home from school. It has been just shy of 2 years seizure-free.

No immediate reaction. Starting around 48 hours after vaccination (Saturday 6/5), client noted swelling, redness and pain at site of injection that spread to left axillary and breast area. Swelling was significant enough that mother described it as "he looked like he had a breast". They sought medical attention on Monday 6/7 at pediatrician's office. Swelling had decreased but was still present. Pediatrician advised ibuprofen. Symptoms resolved within 5 days post vaccination.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild

Following with reaction like seizure; And after that faint; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; This is a spontaneous report received from a contactable consumer (patient). A 16-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19May2021 at 15:45 at single dose in left arm for COVID-19 immunisation at the age of 16-year-old. Lot number was Er8735. Medical history included Environmental allergies. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000). On 19May2021 at 04:45, the patient experienced chest, neck and head pain with a burning sensation. Following with reaction like seizure. Then, patient started to change the face skin color, cold skin, and memory loss. And after that he faint. The patient was not treated for the events. The patient recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.

Patient has developed shingles. He had chickenpox as a child, where they didn't vaccinate against it. He has a bad rash on his scalp, at the back of his head, slight ringing ears and aching neck. Doctor said outbreak will probably increase around neck before scabbing over and healing.

When asked, patient states he did not eat or drink anything today. He noticed a tiny spot of blood at injection site, while his band-aid was being applied, he asked "Is this bad?". Shortly after after her complained of not feeling well. He complained of having blurry vision and the chills while his skin was warm and moist. Patient was laid down on the chaise lounge, and instructed to do isometrics with legs. Ice bags applied to back of neck and forehead. Vitals at 1152 were B/P - 108/58, SPO2: 99%, pulse: 66 bpm. Vitals at 1157 were B/P - 102/60, SPO2: 98%, pulse: 82 bpm. Patient was given water to drink and encouraged to drink lots of fluids today. Color was pink, skin was warm and dry when stood up to leave with mom and brother. Encouraged to eat and drink before second vaccination three weeks from now.

Large, crusted "psoriatic" appearing lesions to arms. The first one started around June 3rd as a small 1 cm x 1 cm lesion that opened and spread, It is now 5 cm x 5.5 cm in size. It is not plaque appearing, but crusted, he has had several smaller areas develop over his bilateral arms.

Received the first COVID vaccine Pfizer on 06/14/21. The client presented for his 2nd COVID vaccine Pfizer today with his brother. The client alerted RN that he developed a "rash" following receiving the 1st COVID vaccine Pfizer. RN responded to the client. The client reported developing a "rash while walking to the observation area" following his 1st COVID vaccine Pfizer. The client stated the rash was a "red around where I got the vaccine." The client stated the rash was intermittently itchy. The client stated his mom put a "cream" over the rash, but did not know what kind of cream it was. The client stated his symptoms lasted for several hours. The client denied any s/s of anaphylaxis following the 1st COVID Vaccine Pfizer. The client did not seek any medical care following the initial rash. RN submitted a medical consult via text message. Approval to proceed with the 2nd COVID vaccine Pfizer was received from Vaccine Operations. RN educated the client regarding approval to receive the 2nd COVID vaccine Pfizer, s/s of anaphylaxis, when to seek EMS, to follow up with PCP regarding initial reaction symptoms, V-safe. The client was instructed to complete a 30 minute observation period. The client and his brother voiced understanding of this. The client received the 2nd COVID vaccine Pfizer on 07/06/21 Lot#EW0191 exp 09/21 at 3:01 PM. The client tolerated the vaccination well. The client did not alert the EMTs of any adverse reactions during the observation period.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: pt became very white, started to look like he was going to faint, got wet towels and applied to face, neck, arms. kept him conscious be talking to him, called ems but by the time they arrived, he had color and was ok

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

Day after vaccine: headache, nausea, low grade fever, "pinching feeling in chest", decreased appetite. Felt better for a few days, then 4 days after vaccine, low grade fever returned, pt developed rash/swelling on 75% of body, itching, little nausea, elevated diastolic blood pressure when measured at urgent care. pt was given steroids for swelling/rash.

Developed generalized hives on 7/15/21 at 18:00 (78h post second COVID vaccine dose). No respiratory distress, no uvula or lip swelling. Given dose of benadryl 7/16/21 at 09:00 when seen in primary care office with significant improvement in itching. Discharged home with scheduled benadryl until hives resolve. Most likely cause in general is viral/idiopathic but reporting due to timeframe in relation to second COVID vaccine.

Swelling on injection site 1 day after vaccine. Major pain when moving arm, almost unable to move in some directions due to pain.

red rash on lower legs; This is a spontaneous report from a contactable consumer, the parent. A 16-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Er8732) via unspecified route of administration in the right arm on 27Mar2021 at 11:30 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergy to pet dander. 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. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) for unknown indication taken within two weeks of vaccination. On 28Mar2021 at 15:00, the patient experienced red rash on his lower legs. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of red rash was unknown. No follow-up attempts are needed. No further information expected.

First dose: Henoch-Schonlein Purpura; First dose: red blotches under his skin/blotches on his legs; on legs it looked like vasculitis/vasculitis on his bowel; First dose: severe stomach pain; This is a spontaneous report from a contactable consumer (father of the patient). A 16-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0176) via an unspecified route of administration, administered in left arm on 30Apr2021 as dose 1, single (age at vaccination: 16 years) for COVID-19 immunization. Medical history included ongoing crohn's disease. As far as family medical history, it was reported as none and father stated that his son is the only one in the family with Crohn's disease. Concomitant medication included ongoing infliximab (REMICADE) taken for crohn's disease and somatropin (NUTROPIN) taken as growth hormone, both started on unknown dates. The father stated that, after receiving the first dose of COVID vaccine, his son started developing symptoms Henoch-Schonlein Purpura (HSP) which consists of the inflammation of small blood vessels. The symptoms began on or around 07May2021. On his son's legs it looked like a vasculitis. His son had these red blotches under his skin. It did not hurt and he also got vasculitis on his bowel. The symptoms first showed up as blotches on his legs and severe stomach pain. The pain is what alerted him. He was seen at the doctor on 04Jun2021, with a colonoscopy on 09Jun2021. He had a colonoscopy to diagnose the vasculitis on his bowel. It was stated that, the patient also had blood work that showed no abnormalities and a urine sample that did show blood which also indicates HSP. His son was being treated with steroids (treated right now with Prednisone 20mg daily). HSP is a chronic condition and his son has been dealing with it for the last month. The symptoms subsided and the doctor gave the ok to receive the second Covid 19 vaccine. Father reported that his son never had a positive Covid 19 virus test, the PCR test or the Rapid test. Also the patient did not receive any other vaccinations within four weeks prior to the first administration date. About one week after the second Covid 19 vaccine the symptoms flared up again. Now he still had symptoms. He did have photographs of his son's legs he could share. He really did believe the HSP came from the Covid 19 vaccine, but that could be one in a million. The outcome of the events: First dose: Henoch-Schonlein Purpura and red blotches under his skin/blotches on his legs was not recovered and the outcome was unknown for rest of the events. Follow-up attempts are completed. No further information is expected.

Itching on torso and back; Pins and needles on torso and back; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 11:30 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 03Apr2021 at 01:00, the patient experienced itching on torso and back and pins and needles on torso and back. 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 itching on torso and back and pins and needles on torso and back was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient developed a full body rash from the neck down. Rash included redness, severe whelps, and itching. Patient woke up with rash 2 days after vaccine. He is being treated with diphenhydramine orally and this treatment has been effective so far. But as the medicine wears off the rash and its symptoms return.

The shot was to the right arm. After approximately 5-10 minutes after the shot, my son noticed on the underside of his lower left arm there was a streak of dark reddish clotting or bruising underneath the skin. He felt okay, with no adverse symptoms/reactions. I notified the pharmacist and believed it was a mild rash reaction and to wait for any adverse reaction. We went home afterward and the clotting/bruising went away after a few days. I am concerned about whether he should go ahead with a 2nd shot or be evaluated due to the immediate non-adverse reaction. My son took a picture of his left arm after we got home. So if you need to look at it, we have it.

redness and swelling at site of injection immediately after injecting, approx. 4 cm area of redness, 1 cm area of swelling centerally

Pt c/o lightheadness and nausea. vs 98.4, BP 102/74, HR 82, Bld sugar 115 evaluated by Physician and Nurse Practitioner; sent to the Clinic for further evaluation; given fluids. Pt emphasized some change in mental status and sent to the Hospital for evaluation; evaluated treated with fluids and released back to the clinic. 7/15 vital signs stable, c/o slight pain at injection site; no other c/o any issues Later on 7/15 pt c/o sl chest pain and discomfort-examined. vital signs stables dx with controchondritis-treated. No further c/o any problems after COVID injection 7/8 left the clinic and reunified with family

Developed shortness of breath with chest tightness 2 days after vaccination, accompanied by injection site pain, loose stools, and malaise. Chest tightness progressed over 1 day to become chest pain with diaphoresis, dizziness, and continued dyspnea. Patient evaluated twice at Pediatric ED; 1st time (2 days after vaccination): EKG and troponin were normal, discharged home on ibuprofen. 2nd time (3 days after vaccination): elevated troponin and ST-elevation on EKG; admitted to Pediatric ICU.

Patient's mother reports experiencing rash on legs and arms. Patient contacts doctor office and recommended to take 2 pills of Benadryl. The next day, patient's mother reports the rash is gone and he is fine.

Reaction to second vaccine (7/10/2021) -Vomiting -Fever for 24 hours -Pain; on vaccine site, entire right arm and right side of back Took 4 doses of Tylenol (every 6 hours)

Red rash appeared in both arms from shoulders to almost the elbows. No itching. Nurse gave Benadryl & Pepcid to slow symptoms. Rash went away within half an hour. No other symptoms.

Pt developed a bilateral rashes on the arms 10 min s/p COVID vaccine administration. No other symptoms were experienced. Pt received 20 mg of Famotidine and 25 mg of Diphenhydramine. Rash improved. Pt was monitored for 30 minutes, and was able to return home with no issues

Red round bump under his left armpit that is painful to the touch Currently using Ibuprofen and ice packs to help

Approximately 2 hours post injection, hives appeared on the left wrist of patient and remained for approximately 30 minutes.

20 min after the injection, patient started to develop itchness on his arms and back. for the next 48 hours the itchness came and went. small rash (raised red pimps) around the injection spot. I have treated the itch with allergy meds and the rash with hydrocodone cream 4 days later, he still complains of sore arm, periodic metalic taste when he eats, sore joints and arm muscles. Saturday evening he had brief chills, and sunday reported sore throat.

1st Dose: only mild pain and swelling at injection site for a few days. 2nd night had heat flash and chills temporarily with constant brain fog for a week coming and going. 2nd Dose: after 4 hours, extreme fatigue throughout body, brain fog, confusion, and lethargic. Extreme brain fog 11 hours after vaccination. The next day strong fever and stronger symptoms from the day before. The 3rd day felt back to normal. 4th day had a mild brain fog moment.

Patient seen in ED. Patient received 1st dose of Pfizer vaccine at 12:00 p.m. then experienced periorbital swelling and rash to face and bilateral upper extremities starting at 2:00 p.m. Benadryl (17 mL) administered at approximately 3:00 p.m. Symptoms improving. No difficulty breathing/wheezing, drooling/hoarseness, oral swelling, or vomiting observed. No previous reactions to vaccinations. No known drug allergies No recent illnesses. No previous COVID infection. Discharged to home from ED

Pfizer-BioNTech COVID-19 Vaccine EUA Second dose of Pfizer vaccine received Friday afternoon (4/2/2021). Went to bed Friday evening with "normal" side effects of mild fever and sore arm at injection site. Woke up Saturday morning with no sense of smell or taste. Called primary care provider who conducted a video visit and expressed concern that he may have had an asymptomatic case of COVID-19 prior to injection (no symptoms displayed at all in weeks prior). Order a COVID test for Sunday morning. Woke up Sunday morning with sense of taste and smell back. Proceeded with PCR test, which came back as "negative" on Sunday evening. No other symptoms observed, and other side effects noted above (sore arm, fever) resolved by Sunday morning as well. Seems to suggest loss of sense of taste and smell likely due to vaccine since there was a clear temporal relationship which resolved in approximately 24 hours.

Had facial swelling/warmth/redness within 15 months of getting the vaccine. Then had hives on and off over the next 4-5 days.

Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: FAINTED AND SCAR ON FACE-Mild, Additional Details: PATIENT SEATED AT SEAT 5 FELL AFTER FAINTING AND INJURED ON HIS FACE WITH BRUICE ON RIGHT SIDE AFTER HITTING GROUND WITH HIS GLASSES. PATIENT GOT CONSCIOUSNESS IMMEDIATELY AFTER. OFFERED MEDICAL HELP AND ATTENTION. GAVE WATER TO DRINK. HE WAS MONITORED FOR 30 MINUTES AND LEFT PHARMACY HIMSELF.

Hives(gone later that day), Throat Swelling, Pain, Itching Nose Blockage, Itching(better than before as of 4/12/21)

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: epipen was not given by pharmacy, but given by paramedics after getting to the pharmacy

At 10:16 patient's mother brought him to our attention regarding how he was feeling. She states that patient was feeling hot and took off his sweatshirt and complained that he was starting to feel "dizzy" - then he started looking "grey" and not responding to any of her questions. States that he was progressively getting worse over time. Patient was flushed and hypotensive (80's/40's) initially followed by bp of 90/50 then before he left 102/60 at 10:45am. Initially his heart rate was 74 bpm and before he left it was 82 bpm. His temperature was around 97.5. Patient had not had anything to eat or drink prior to appointment. Patient was given a snack and water before leaving.

Bruise like rash broke out on back and arms with spots with several dozen spots up to 1 inch in diameter.

Rash on chest, back, wrist - itchy; Took a dose of benadryl around 10:40AM, no other action taken. Recommendation: Can continue use of OTC anti-histamines (in this case benadryl) if rash continues to itch. Hydrocortisone cream may also be applied to rashes. These rashes can start a few days to more than a week after the first shot and are sometimes quite large. These rashes are also known as "COVID arm." If you experience "COVID arm" after getting the first shot, you should still get the second shot at the recommended interval if the vaccine you got needs a second shot. Tell your vaccination provider that you experienced a rash or "COVID arm" after the first shot. Your vaccination provider may recommend that you get the second shot in the opposite arm.

Two days following vaccine, patient experienced N/V and right lymphadenopathy (on same side as injection) which continued for two additional days. On Day 5, patient experienced neck and facial swelling, rash, itchy mouth, throat tightening, and difficulty breathing following lunch (chicken with cashews, no prior food nor medication allergies nor prior symptoms with any tree nuts nor peanuts nor soy). Symptoms improved with 50 mg diphenhydramine, but swelling continued, administered corticosteroids at urgent care facility and continued Medrol dose pack. Food allergy testing scheduled for mid-May.

Body aches, chills, sweating within 12 hours of shot, lasting for about 36 hours. 72 hours post injection a full body rash appeared, with hands especially affected (red & itchy), and swollen sore lymph nodes in armpits

pt with chronic idiopathic urticaria noted onset urticaria, flushing and itching 18 min after first covid no angioedema no stridor no globus no wheezing no shortness of breath no chest pain no palpitation . vital sign stable exam remarkable urticaria and flushing,o/w wnl pt given oral benadryl 50mg with resolution of sx

Patient has developed what I would describe a large hives on his neck area and small ones on his face. Large red, raised, and dry patches.

Patient received vaccine, was observed for 15 minutes, and left. Patient came back a few minutes later with red swollen fingers. Patient brought to observation room and given 25mg of benedryl. Redness improved by 1843, and was cleared to leave by RN.

Systemic rash with hives and itching, chest pain and shortness of breath, neck and facial edema, edema to extremities, nausea and vomiting Benadryl 50mg PO every 4-6 hours for 4 days and then PRN for itching/rash. Medrol Dose pack as directed, Daily Pepcid PO, Zofran PO PRN

Patient was in his usual state of health. On Wed, 4/7/21, at 10:20am, he received the first dose of Pfizer COVID-19 vaccine. No immediate vaccine reactions. He went home, complained of pain at the vaccination site and took a nap because he stayed up late the night before. On Thursday morning, he woke up with chills and feeling like having a fever. He took Tylenol and then took a nap. On Thursday night, he began to have chest pain but he did not tell his parents. On Friday, he continued to have chest pain so he told his parents about it. His father told him that if chest pain got worse, they would go to an ER. On that night (Friday) at 1am, he told his parents that he was not feeling well, his chest pain had gotten worse and he wanted to be taken to an ER. He also had abdominal pain, dizziness, disorientation, and he vomited. He was taken to ER where he was found to have elevated troponin of 10. The ER recommended transferring for further work up and the father drove him to the hospital. At the hospital, he was found to have elevated troponins and NT-proBNP concerning for myocarditis of unclear etiology. He was monitored on telemetry and had no concerning ectopy. He had an echo on admission that demonstrated no structural abnormalities, trivial mitral valve regurge, and normal biventricular systolic function. EKG was unremarkable. Troponins were trended q6h and decreased from 32 -- > 23 -- > 17. NT-pro-BNP decreased from 439 to 322 at discharge.

This patient was given the 2nd dose 6 days early. The 1st dose was given on 04/14/2021. The symptoms reported by this patient's mom today were tiredness and soreness in his arm or the injection site but no fever noted. I gave a courtesy call today just to check to see how patient is doing. No serious side effects reported.

Within days of 2nd vaccine: Pain at the site, fever, chills, soreness, exhaustion, mental fatigue, swollen lymph nodes. Within weeks of vaccination: depressive symptoms including lack of motivation .

Petechial rash noted to dorsal aspect of b/l feet, not including legs/calves or soles of feet. nontender, nonswollen

1st dose of Pfizer administered. A little over 1 hour elapsed before patient developed hives and itching beginning at injection site (deltoid), spreading first to elbow of the same arm, then to knuckles, chest, neck, torso, and face. Some wheezing was heard by family members, but the patient displayed no other significant signs of respiratory distress. The patient lives where only accessible via boat or plane. Family called a triage line and spoke with a nurse who encouraged immediate Medivac due to location time and extensive transit times to the nearest medical facility; however, family opted to keep child at home. A physician instructed the parents to administer 50 mg of Benadryl every 6 hours, which the family did. Rash and discomfort lasted approximately 4-7 days before total resolution.

Shortly after receiving his first COVID shot, he became faint. Nurse alerted by another parent who had accompanied her son that the patient was dropping his cookie. 0935, as nurse came up behind patient, accompanied by principal, patient slumped to the left and was holding him in place to prevent him from falling to the floor. Color was pale and dusky as moved hair out of his face. Stimulated patient and assisted to cot to get blood flow to brain. BP 120/84, pulse 52 and 97% pulse ox reading. At 9:43: sitting up in chair and drinking water, 99% pulse oximeter and pulse 61. Patient recovered after 30 minutes and went back to class. Principal notified his mother and wanted him to return to class.

Site: Pain at Injection Site-Mild, Additional Details: Patient was waiting after the his first covid shot and he was talking with his parents, they had a conversation for 5 minutes and then the patient fainted, fell down, had seizure for few seconds and then woke up in few seconds. Patient was sweating, feeling hot. He was breathing normal. Face was red. .911 was called. Patient had no issues with needles. HR was 104. Patient felt better after 10-15 mins and left with his parents. No hospitalization needed.

Pt reported itching shortly after receiving the vaccine. Elevated anxiety noted. Pt's mother was present at the time. Advised pt to be observed for 30 min before receiving 20 ml liquid benadryl. MD on call Dr. contacted and notified of the situation. Pt stayed an additional 30 minutes until itching resolved. Pt was stable, A&O x4 , and was driven by mother to home.

The day after the vaccination started hives. But it was slow so thought could be food allergic reaction. Over a period of 2 weeks it developed never went off. Noticing the hives getting worse and the epsode starting day after vaccination suspected it the cause and so went to primary care physician. She diagnosed the hives related to medical side effects and only medical related item he had within the last 1 year was this vaccine. She put him on Methylprednisolone for 6 days along with Cetirizine HCL 10mg. The hives appeared to be suppressed for the first 3 days where the dose was higher, however, when the dosage was getting lower after day 3 it came back with high intensity. Lips, fingers, tongue...swollen and with fever running at upto 101.6. Again went to the doctor, she put him on Prednisone with 40 mg for 3 days, 20 mg for 3 days, 10mg for 3 days and 10mg alternate days. It literally took more than 1 and half month still not recovered. Hives are still on and also severe cold with mucus and cough started since (05/09/21). Fever show up on and off even now. We're referred to allergy specialists. She asked to not take 2nd dose. Increased dosage of Antihistamines, asked to continue Prednisone 10mg for 6 more day daily 10mg and if cold and cough does go in the next 2 days may put on antibiotics.

Pfizer vaccination administered into left deltoid at 0849. Reporter, RN arrived to patient at 0855 after being notified patient had fallen off his chair. Patient found to be laying facedown and unconscious near the chair he was sitting in. No initial response by patient to verbal and physical cues. Patient was pale in color and diaphoretic. Patient was placed into right side laying position. After about a minute of being in side laying position and continued verbal/physical cueing, patient awakened. Assisted patient to supine position, cool packs placed to armpit area, Excess sweat on face wiped. Two small abrasions noted to left side of face; nose and near top of mouth. Upper and lower extremities also had small abrasions. Patient reported he started to feel dizzy and tired shortly after receiving the Pfizer vaccination. Patient does not recall falling. Mother confirmed patient had eaten breakfast, no history of low blood glucose levels. Denied experiencing shortness of breath prior to fall and while nursing staff was present, No neurological deficits noted during assessment. No rash noted. Patient continued to be diaphoretic. Reported stomach was upset. Vitals taken at 0902; blood pressure 116/74, pulse 74, respirations 18, oxygen saturation 98% on room air. Permission by parent given to treat patient with epinephrine. Patient received 0.5 mg of epinephrine at 0900 and again at 0905. EMS arrived at 0912. Patient more alert at this time and diaphoresis subsided at this point. After EMS obtained further information, patient was assisted into a sitting position on the floor. Patient complained of stomach upset again and vomited two times. Ambulance arrived at 0935 and patient placed onto gurney. Ambulance departed at 0935 to transfer patient to Medical Center for further observation.

17yo otherwise healthy male presents to clinic for worsening cough, runny nose congestion, and sweats starting 4 days ago. He received the COVID vaccine 5 days ago in the afternoon and initially had what he expected to be normal side effects from the vaccine that evening. Symptoms included body aches, runny nose and general malaise. However, over the last few days he has felt worse and developed more congestion, cough, and sweating. He did improve a little bit 2 days ago but then started to feel worse yesterday and had a worsening cough that is resulting in some chest tightness. Cough is productive sounding. Mom describes it as barking. No appreciable wheezing but he sounds hoarse. He has some SOB after coughing repeatedly. He states it simply feels like it is hard to breathe for 10-20minutes after a coughing attack but then it resolves. He developed sweating yesterday as well. He states he will just start sweating for no reason. No measured fever. No chills. Today he has dried skin and cracked lips from blowing/wiping his nose all the time. No fevers. No vomiting. No diarrhea. No numbness/tingling. No redness/swelling at injection site. No rashes. No HA. EXPOSURE: No one at home is sick, No known exposures prior to vaccine CHRONIC: None, no hx of asthma or allergies, hx of eczema. PCP: None UTD on imms. Vitals: Wt 163.4, HR 60, RR 18, Temp 97.8, O2 sat % 98 Past Results: Examination: GENERAL APPEARANCE: alert, no acute distress, non-toxic, mildly diaphoretic, talking and cooperating throughout exam, sitting comfortably on exam bed, able to talk in complete sentences. HEAD: no visible lesions or abnormalities. EYES: no eye, eyelid, or orbital abnormalities identified. EARS: BILATERAL TMs pearly gray without erythema, effusion, or purulence; EAC with normal amount of cerumen bilaterally, no mastoid erythema or tenderness. NOSE: patent nares, congested, clear rhinorrhea. MOUTH/THROAT: moist mucous membranes, uvula midline, mild pharyngeal erythema without tonsillar exudate, no soft palate lesions, no trismus, no soft palate swelling or erythema, no difficulty swallowing or drooling. NECK: supple, non-tender, FROM. CHEST: normal shape, good expansion, no visible lesions/abnormalities, no tenderness, no retractions, no grunting, no stridor. HEART: no murmur, RRR. LUNGS: clear to auscultation, prior to administration of inhaler, diffuse wheezing and rhonchi throughout, post inhaler, improved air movement with focal rales in RIGHT poseterior middle lung field around T5. ABDOMEN: soft, no tenderness, no masses palpated, normoactive bowel sounds, non-distended. NEURO: alert, non-focal exam. SKIN: warm, dry without rash, petechiae, or purpura. Pneumonia of right middle lobe due to infectious organism Start Albuterol (Eqv-Proventil HFA) aerosol, 90 mcg/inh, 2 puff(s), inhaled, every 6 hours, 30 day(s), 1 Start amoxicillin tablet, 500 mg, 2 tab(s), orally, 3 times a day, 10 day(s), 60 Imaging:XR CHEST 2 VIEWS PA AND LAT Notes: History and exam are consistent with Community Acquired Pneumonia. CXR final read indicates RIGHT middle lobe bronchopneumonia. Suspect that pneumonia is unrelated to COVID vaccine. Pneumonia is an inflammation of the lungs caused by infection. Antibiotics are used to treat bacterial pneumonia. Other medications may help improve breathing and relieve symptoms in bacterial and viral pneumonia. Start and complete entire course of antibiotics. Increase fluids and restas much as possible. Patient informed to return if not improved or go to ER if worsening sympmtoms, SOB, or increased chest pain. Should be rechecked in 2-3 days by PCP. Discussed side effects and risks of medications with the patient. Patient expressed understanding and a willingness to participate in the plan. Patient left the UC in a stable condition with all questions answered at this time. Cough Imaging:XR CHEST 2 VIEWS PA AND LAT Notes: Discussed cough in clinic. Will plan to treat with albuterol PRN cough/wheezing every 4-6hrs and Stiolto Respimat 2 inhalations QD after discussion with Dr. First dose of Stiolto given in clinic with improvement in symptoms and improved aeration. Focal findings now appreciable. Discussed close follow-up and when to return to clinic. Will report symptoms to VAERS. All questions and concerns answered and addressed.

Patient presented 4 days after the start of symptoms, which started 14 days after the second dose of the vaccine. Patient presented with fevers with a Tmax of 102, chills, conjunctivitis, stocking glove rash to the hands and feet and to the extensor surfaces of the extremities, and a geographic tongue.

17-year old M with history of recurrent ear infections requiring PE tube placement who was in his usual state of health until 5/5 when he noticed a new itchy hive-like rash. He was short of breath 5/6, and developed fevers that night along with vomiting. He was seen 5/6 with negative COVID19 PCR and documented fever to 104. Fevers continued, and he was admitted the evening of 5/10 with concern for myocarditis. See below for hospital course. Additional information for Item 18: ...Screening labs were notable for mild lymphopenia, hyperbilirubinemia, hepatitis, and elevated inflammatory markers. Given prior COVID infection, rash, and systemic inflammation, additional studies including troponin, D-dimer, BNP, and EKG were obtained. EKG was reassuringly normal, however the D-dimer (2.48), troponin (1.27), and BNP (469) were elevated. Other work-up included chest x-ray which was unremarkable, and right upper quadrant ultrasound with incidental cavernous hemangioma of the liver. He was started on milrinone (5/11-5/12) after initial TTE was concerning for severely diminished LV function. Follow-up TTE 12 hours later was normal (on milrinone), and remained so after milrinone was discontinued 5/12. Follow-up TTE after discontinuation remained normal. Cardiac MRI was completed 5/14, although read remains pending. He received IVIG on 5/11, and was started on methylpred 50 mg IV BID, Anakinra 100 mg SQ BID 5/14, and transitioned to prednisone 30 mg PO BID with clinical improvement, down-trending troponin and systemic inflammatory labs. Subsequent CBCs have been notable for rising leukocytosis (5/16 WBC 56.3) and thrombocytosis (5/16 plts 690) and 4+ spherocytes (with no known personal or prior history of spherocytosis). He will likely be discharged 5/17. Infectious evaluation was unrevealing including cultures and viral studies. COVID spike and nucleocapsid antibodies were sent, but remain pending. Pt. initial COVID-19 infection was diagnosed October 2020, with positive saliva PCR testing. He was symptomatic for 3-5 days. He received his second dose of the Pfizer COVID19 vaccine 4/27 in his left arm; denies any significant reactions (arm swelling, injection site redness, lymphadenopathy, myalgias, fatigue, or fever). He has had passing contact with school classmates who have recently been diagnosed with COVID19.

Pfizer-BioNTech COVID-19 Vaccine EUA ; On 5/11/21, Patient experienced tingling in left arm minutes after the vaccine was injected (4:07pm). Patient became nauseous. While in the vehicle to go home, patient's breathing quickened. After this, patient's vision became blurry and he was unable to see. Patient also experienced hearing loss with ringing in ears. The father of the patient pulled the car over in case medical attention was needed. Patient eventually passed out for about 30 seconds (about 4:22). Patient recovered, but complained about fogginess (thinking was unclear and unfocused). The next day, on 5/12/21, the patient experienced chills and nausea without a fever. Currently, the patient is doing fine with no further symptoms.

Hives started 27 hours after on neck and spread over the entire body by the next morning. Hives were raised and red plus they itched.

Chest pain (midsagittal), feeling similar to heartburn, pain felt midsagittal throughout chest, but especially immediately below heart. Diaphragm movements when breathing increased severity of pain. Symptoms subsided within 12 hours with use of Kwan Loong Pain Relieving Oil. Unlike heartburn, nothing worked to relieve pain immediately. This was in addition to known side-effects that were present including: fatigue, slight fever, headache, muscle pain, and soreness at injection site.

Significant morbiliform rash noted to bilateral arms, abdomen, back, and proximal legs with erythromelagia to hands and feet, including the palms and soles (accompanied with significant pain which caused inability to ambulate)

After vaccination, the patient fell onto his buttocks, then hit his head. He did have a small abrasion on the back of his head and small abrasion on his elbow. There was no LOC observed. The patient did seem slightly confused. He vomited once. Was alert and fully oriented.

Breaking out in large hives on opposite arm of first vaccination dose, several on leg and a few give spots on the face .

Patient received his first dose of the Pfizer vaccine on 5/7/21. On 5/13/21 he began to feel feverish (unsure Tmax, never took temperature) and was intermittently febrile until hospital admission on 5/20/21. On 5/18/21 he was seen in the ED for fever and tested positive for strep throat and started on amoxicillin. His inflammatory labs were elevated at this time and did not notice improvement on amoxicillin. He returned to the ED on 5/20/21 at which time patient reported headaches on the right side, sharp 7/10 pain which come and go with the fevers as well as fatigue, muscle/body aches, and sweats in addition to persistent fever. He also noticed maculopapular rash on palms and soles and on distal extremities which was not pruritic or painful on day of hospital admission. All infectious workup was negative and patient did not improve on broad spectrum antibiotics. Given his persistent fever, hypotension, and inflammatory labs without other cause, patient was empirically treated for MIS-C and was given IVIG and methylprednisolone as well as being started on prophylactic dose enoxaparin for his elevated D-dimer. Repeat echocardiogram identified a new coronary aneurysm, supporting the diagnosis of MIS-C. Following IVIG and steroids patient remained afebrile and inflammatory markers down trended, however liver enzymes remained elevated at time of discharge. He improved and was discharged to finish steroid course at home with close follow up.

Site: Bruising at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe

Light-headed, dizziness after receiving vaccination Vitals: BP 125/76 HR 84 Resp 16 O2Sat 96 Skin Signs: Warm and dry Circulation: 2 Respiratory: Breath sound clear bilaterally Initial Treatment: Moved patient to triage. Put patient in supine recovery. 6:20 PM Vitals: BP 121/78 HR 80 Resp 16 O2Sat 99 Skin Signs: Warm and dry Circulation: 1 Respiratory: Breath sound clear bilaterally Notes: Patient stated he was feeling better and moved into seated position. Patient advised to seek further medical attention if symptoms returned/worsened.

Patient experienced fatigue, malaise and rash within 24 hours of second COVID vaccine. Then reported feeling short of breath with exertion while at wrestling practice on 5th day following COVID vaccine.

When patient arrived his guardian was not here so he sat and waited. When dad came, we registered patient as normal asking if he feels ill or not and he stated no. When I brought him back to the room we were talking about school and activities he is in and he seemed normal and answering normally just tired. I cleaned his arm and talked him through things that can happen with the second dose of Pfizer. He seemed just fine and once I injected and bandaged him he went stiff and I tried to talk to him and he did not respond. I called for help and they got his dad. he finally started coming too and was extremely warm. I sat with him for 10 to 15 minutes and rubbed his back and we got him water to drink. we started an incident report right away while talking to the dad. nothing further happened and he was told to go straight to the clinic to be checked out.

Patient's mother states her son experienced hives on his right side of his forearm. She states the hives were huge in size also that he also had diarrhea 24 hours after his vaccine. He was taken to the ER to get checked out. At the ER they told her that maybe a bee sting him or it was because of the vaccine. His right hand and forearm were swollen. The hives lasted a few hours then it went away. He was given Benadryl for 5 days straight at the ER which helped to decrease his symptoms. His mother states he is no longer having the hives or diarrhea.

Thursday started with sore throat, fever, chills, stuffy nose and headache. We gave him Acetaminophen. Fever continued into Friday with the same symptoms. Hives began Saturday morning and gradually got worse. We gave him Benadryl at that time and the fever went up to 102.5 F. Wheezing in his chest began. Sunday morning the hives were worse and we decided to go to the doctor. We went to a walk in clinic who after an EKG wanted us to go to the Emergency room due to a "blip" and a concern for myocarditis. At the ER they administered Prednisone and more Benadryl through an IV. They decided to do a CT Scan to look for blood clots. (the ER doctor mentioned he was glad that we brought him into the ER...) No blood clots were found thankfully and they eventually released him, with a prescription for 4 days for Prednisone, more Benadryl and Pepcid. The hives continue today, the day after, and are barely under control by the Benadryl.

Patient passed out at the discharge table 15 minutes after Pfizer COVID-19 vaccine. Medical assistant at discharge table able to catch patient and patient was assisted to ground by clinic staff. Patient skin warm to touch and pale. BP @ 1700 147/77, HR 68, RR 16, O2 saturation 94 % on roomair. Patient complains of dizzyness and numbness tingling sensation to vaccinated left arm. Patient verbalized eating a small meal this am, exercising , and not drinking fluids. Ice pack applied to patients neck. Patient drinks water and sports drink. Doctor present to assess patient. Patient observed in discharge area an additional 30 minutes. Patient ambulated for 5 minutes in the discharge area per physician instructions. Patient stable, denies any dizzyness, or numbness to left arm. BP @1727 was 149/85, HR 76, RR 18, O2 saturation 96% roomair. Patient ambulated independently to exit with family.

PT SAID HE GOT THE SHOT ON 5.30.21, HIS 2ND DOSE, THEN IN 6.4.21,, EARLY IN THE MORING, HE WAS FULL OF HIVES ON HIS ARMS ONLY. BOTH ARMS, THE PT TOOK SOME BENADRYL AND CORTISONE CREAM. IT RELIEF THE ITCHING. HE CAME TO THE PHARMACY ON 6.7.21, TO LET ME KNOW WHAT HAPPEN. HE SHOW ME HIS ARM AND IT WAS AL CLEAR. I TOLD HIM IF HE HAS A BREAK OUT TO FOLLOW WITH HIS DR IF THESE FLAIRS UP AGAIN. HE IS GETTING ALLERGY TESTED, HE SAID HE DINT CHANGED ANYTHING IN HIS DIET, OR NEW MEDICATIONS. ITS SEEMS IT WAS DELAYED HYPERSENSITIVITY REACTIONS TO COVID VACCINE

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: LOSS OF VISION SHORT TERM-Mild, Systemic: Flushed / Sweating-Mild

notified that there was an error in administration of vaccine and my child received 4x the recommended dosage symptoms include fever, chills, soreness at injection site, body aches

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: LOSS OF VISION SHORT TERM-Mild, Systemic: Flushed / Sweating-Mild

6/15/2021 17 y/o with past medical history of cardiac murmur who presents with itching, redness and hives to the left arm post vaccination. Patient states that this is the second dose in the two-dose series. Patient denies previous reaction to first vaccination. Patient states that vaccination was placed to the left arm. Patient denies sore throat, difficulty swallowing, difficulty breathing or chest pain. NP and Paramedics at patient side. Patient left posterior upper arm above the elbow with macular blanching erythema present and three dime sized hive-like rash present, patient with some itching. Patient given 25 mg Benadryl PO x1 and a bottle of water provided. Patient vitals with elevated BP noted (159/81). All other vitals obtained and within normal limits (134-148/72-87 BP, 100% RA, 68-73 HR). Patient observed for 40 minutes with resolution of symptoms. Macular erythema and itch resolved. Mother and patient aware of worsening and concerning symptoms that may present as time passes and advised Benadryl PRN. Patient and mother verbalized understanding and patient discharged in stable condition.

Got the vaccine on 6/13. Developed fatigue, sore throat, runny nose within 24 hours on 6/14. Was stable, but on 6/17 developed high fevers up to 101-102, erythematous rash on his neck, bilateral conjunctivitis and runny nose. Presented to the ED under my care on 6/18 due to ongoing fever, dehydration and neck pain. Currently undergoing full evaluation: COVID19 PCR positive. ESR, CRP, procal elevated. ALT/AST elevated High sensitivity troponin elevated. BNP normal. CBC with neutrophilic predominance, platelets clumped - repeating. RVP pending. Evaluating for MIS, COVID reinfection, post-vaccine reaction, different viral illness, post-covid reaction + development of a cellulitis.

17 yo male with rash beginning approximately 24 hours ago on elbows, rapidly spreading to remainder of body, worse over the last 2 hours, pruritic. Had second Pfizer Covid vaccine 3 days ago ~12 hrs after which had fever to 102, headache, dizziness which all resolved after ~ 24 hours. Took Benadryl this morning ?25 mg, which decreased pruritus. No facial or intraoral swelling, no dysphagia, no wheeze, no shortness of breath, no nausea or vomiting. No known other potential precipitants i.e. no new foods, soaps, lotions, pets, plants, medications. PMH: Neg Allergies: None known Meds: vitamins Immunizations: UTD Surg: Undescended testicle repair Social History: Lives with family. Family History: No conditions relevant to this visit Final Diagnosis 1. Rash R21 2. Allergic reaction T78.40XA Assessment/Plan Rash likely allergic reaction, plan to treat with Benadryl. D/c, instructions given and explained with indications for immediate return to ED.

Patient is currently admitted to the ICU since 7/10/21 with potential post-vaccination myocarditis with associated troponin elevation and EKG changes. Initial symptoms included chest pain (pressure type), shortness of breath, vomiting, and generally not feeling well. Rash was noted by mom on his abdomen that became full body hives and welts (this has now improved). Cardiology is consulted in addition to primary intensivist team. He has been improving from a clinical stability standpoint, is hemodynamically stable now, but is still currently admitted and being monitored.

4-5 days of a tingling sensation, chest tightness (mild, intermittent) post vaccination. Generalized macular rash on chest/back. Denies any shortness of breath or swelling. Vitals stable and within normal limits.

Developed red, raised, itchy splotches, similar to hives on multiple areas of the body, 2 days after receiving the vaccine. Splotches have started to go away on their own, without any medical intervention.

He actually woke up with vomiting/ he threw up; Couldn't walk for a week; The room was spinning and he threw up; Rash over the body and it's on one side of the body right now the inside they're little balls, bubbles with some kind of puss inside, water or puss; Rash over the body and it's on one side of the body right now the inside they're little balls, bubbles with some kind of puss inside, water or puss; Not sure, we look at pictures they look like shingles; He has side effects on his left eye; This is a spontaneous report from a contactable consumer (parent). A 17-year-old male patient (reporter's son) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 03Jul2021 at around 10 at night (at the age of 17-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunization and did not experience any adverse event. Reporter stated, "my son had the Pfizer and he in the states right now and he went to play hockey, he took the second COVID on the next Saturday, he got it around 10 o clock in the night on 03Jul2021 and on 04Jul2021 he actually woke up with vomiting, could not walk for a week, the room was spinning and he threw up, I don't know if I said that and barely made a back to the bedroom, woke up had a rash over the body and it was on one side of the body right now the inside they were little balls, bubbles with some kind of puss inside, water or puss". The reporter also stated "not sure, we look at pictures they look like shingles, I see on the internet that in some rare cases it can be activate shingles in your body and I want to know how rare these side effects are and what to do about it". When confirmed that the vaccine son took was Pfizer COVID-19 Vaccine, reporter stated, yes, he was 17 and he had to take it. When probed anatomical site where vaccine was administered, reporter stated, I don't know that. I know that he has side effects on his left eye (on an unknown date in Jul2021). I don't know what side he got the injection. I would assume you got it in his left hand because he uses his right hand for lot of things". The outcome of the events was unknown. Information regarding the lot/batch number has been requested.

Horrible arm pain ( On a scale of 1-10it was an 11); Redness at injection site; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 17-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 the left arm on 31Mar2021 at 08:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 22:45, the patient experienced horrible arm pain (On a scale of 1-10, it was an 11), redness at injection site and low grade fever (all these reaction had started after 14 hours of injection). The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event painful arm, injection site redness and low grade fever was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: At the time I was administering another COVID vaccination, and heard the patient fall on the floor upon which I noticed he was lying flat on the ground not responsive. I had one of the customers call 911 and assessed his vitals, he was breathing and conscious and speaking. He told me he still had trouble breathing and he felt very cold. By the time the paramedics arrived on the seen and helped the patient sit up on the chair he was feeling better. He was taken to emergency services soon after

Sx. Started with extreme fatigue. At around 16:00. Near 18:00 I had developed a fever, concurrent with aches and chills. Near 22:00 I had developed a headache, one of a dull nature, with Sharp throbs. Between 22:00 and 00:00 01/11/:12 I had developed tinnitus. Near 01:00 01/12/2021 I had developed swelling of the injection sight with contralateral numbness on the left arm and leg. Near 02:00 01/12I had loss sensation In my left arm and developed numbness in the face. From 20:00 01/11 to 22:00 01/12 I had developed episodes of tachycardia with a peak resting heart rate of 143bpm measured via Watch. Between 15:00 01/12 and 22:00 01/12 I had experienced terrible non radiating angina proximal to the sternum. I had developed pain while urinating at around 21:00 01/11 my last urination was at 23:00 01/12, I did not go again until 16:00 01/13. I had experienced lower back concurrent with that. From 22:00 01/11 to 23:00 01/12 I had terrible SOB, and chest pain upon exhalation. Fever and body aches did not subside until through the night of 01/12:13. I had not experienced any symptoms as the night of 01/12. I had developed a rash across my chest near 18:00 01/11 though it has subsided it is still present.

On the third night after receiving the vaccine, I woke up covered with hives all over my torso. The hives are on my torso, back, armpits, underside of arms, pelvic-area, scalp. neck, and chin. They're itchy and were much more inflamed when they first appeared. I have not taken any medications so far to treat this. Presently, the inflammation has gone down and the appearance of the hives have also slowed down. They still continue to be itchy, and have left dried up marks all over my body.

A few hours after the vaccine I had a hive on my chest and my jaw was sore. Next morning it was gone but I had body aches.

PT was in observation period and came up to the consultation window asking if a numb arm was a normal side effect of the vaccines. At further inspection I noticed that he was having a rash . I had a sit for a few more minutes then his mom came up and we noticed that his arm started to swell. We gave him 2 capsules Benadryl 25mg and instructed him to go to urgent care. Called for a follow up later in the evening and found that urgent care send him to the ER. The rash was spread all over and well as the swelling. He swelled all the way to his toes. He also tuned white and became very lightheaded at the ER. They gave him IV Benadryl and dexamethasone and was sent home. It has been recommended by the ER doctors to not get the 2nd dose.

bilateral pruritic highly erythematous papular rash primarily on dorsum of hands with smaller areas on arms and neck. no breathing difficulty or lip swelling. Given topical triamcinolone along with claritin/benadryl.

onset Nausea and vomiting at 3 am the following morning of vaccine. Had about 5 hours of this then fevers, body aches and fatigue. Noted the following day this his eyes looked yellow, more that usual, and came to the clinic on 3/1/21 for evaluation. was feeling better but due to acute jaundice had blood work that indicated markedly elevated bilirubin and low platelets. Further testing for hepatitis was negative. Was sent to the ER the following day as we were unable to get blood drawn and GI consult was desired. There he had a normal abdominal US and bilirubin had dropped and he has since been followed by GI and is currently being evaluated by Hematology for any underlying conditions that may be contributing.

I have a sort of rash that is spread around my entire torso, under both armpits, and is partially on my neck and upper legs. I noticed it about three days after I received the vaccine, and then went to the doctor's office the next day to have it looked at. They addressed it as dermatitis, and I recieved doxycycline and predniSONE to take/use for the following 12 days, which I have been using since the morning of the 6th.

My son received his first vaccine dose in his left arm on Friday April 9 at 8:45 am. By Sunday when he woke up, he noticed a walnut sized lump on his left clavicle. It felt unusual and moved on the bone every time he turned his head or moved his arm. There was no redness or fever and it felt hard. It was still there on Monday morning (April 12) so we called his primary care doctor which is where he received the vaccine. The doctor felt it could be a cyst or swollen lymph node and is sending him to a general surgeon next week for further evaluation. The doctor was uncertain if the lump was directly related to the vaccination. Other than acne, patient has no other preexisting conditions. He did have COVID19 in November with only mild symptoms (positive test on 11-23-20; no fever or cough, just felt tired for a couple days).

My son developed a rash on his bottom, upper legs and forearms. His eyes became puffy. He took OTC allergy medicine and it cleared the symptoms quickly.

Patient received covid vaccine, on the way to observation, turned and fell. Placed in a chair, automatic cuff unable to read bp, hr 40s, sats 94%, pale, diaphoretic, slow verbal responses. Observed patient, another nurse gave candy, applied ice to back of neck. Patient had another brief syncopal episode with quick recovery while seated. Code Medic called. Placed on sim lab stretcher after awake and feeling better while waiting for code team. Abrasion noted to just under chin. Bp improved to 115/74 with HR 67, spo2 100%. Code team arrived and assessed patient. Patient condition improved, attempted standing with observation by code team. Assisted to observation room. Given sprite and more snacks. Mom and patient state both are feeling better.

He developed hives exactly a week later - the hives started appearing on his arms and then spread all over his body - he was very uncomfortable/ itchy all over body It?s still going on now and it?s been 4 days now

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: 18 yo male fell out of chair and hit the left side of his head, ~5 min after receiving vaccine. The patient reported that he remembers becoming dizzy prior to falling out of chair. A nurse and pharmacist immediately placed him onto a sheet and elevated his feet. He was diaphoretic, warm to touch and awake. His initial blood pressure was 89/58. 2nd-4th readings were WNL. He was given water, an icepack for neck and abrasions on his face were treated. He reported that he was feeling much better.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium

Developed hives within 4 hours of vaccination. Has taken benadryl and claritin. Present to me today with hives covering the trunk and neck. Treated with prednisone

Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: patients pulse and heart rate decreased -Severe, Systemic: Hypotension-Severe

Earlobe developed purpura that took approximately 4-5 days to dissipate. No pain. Dark purple in color. No treatment.

Covid arm, swelling and rash around injection site about 3 inched diameter of rash and swelling. Itchy when touched.

Recipient received dose #2 vaccine today, and almost immediately had response with witnessed seizure-like activity, with posturing, tonic-clonic movement of his upper extremities, and eye movement with lateral nystagmus. Loss of consciousness was noted. Symptoms lasted approximately 15-30 seconds, and patient was placed in a reclined position. He regained consciousness quickly and became pale and diaphoretic. He was normally responsive and answered questions appropriately. Initial BP 74/32, HR 38, SpO2 98%. He drank some Gatorade and had improvement of symptoms gradually over 15-20 minutes. Repeat BP 100/58, HR 78. No past history of seizures. One prior syncopal event after pain response with sports injury. No prior difficulty with dose #1. After recovery, patient reported immediate pain with vaccine administration, then vision went blurry and he lost consciousness. Mother was driving the vehicle, and she witness symptoms as well as nursing staff in the vaccine pod. After recovery, options for further medical evaluation were discussed given complicated vasovagal response with seizure-like activity, mother called pediatrician to see if he could be seen, they recommended ER. Mother chose to drive by personal vehicle, rather than EMS transport. Symptoms were fully resolved and patient was transported to ER for further evaluation by personal vehicle.

Sat in recovery for 30 minutes before stating to the monitor that he felt lightheaded, hot. His face was reddened and noted heavy hoody jacket around his neck. He stated that he had not had much to drink today, so started to hydrate with water. At 1:42 pm, VSS: 122/82-112 Hr-97% on room air. His vitals were rechecked at 1:59 pm HR-107, O2 saturation: 97% on room air. States that he works at specific location and needs the evening off to finish a paper that is due. Attempted to call the place of employment as continues to feel lightheaded. Card with contact information given to patient to show work and continued to hydrate until his release at 2:30 pm. He was able to walk out on his own.

I administered first dose of Pfizer covid 19 0.3 ml via intramuscular route to this patient. About 2 minutes after the administration, the patient had syncope for a second. When I arrived to the scene, the patient was conscious. When he passed out, he felt and landed on his head. He had an abrasion. He stated ?he felt hot and dizzy?. He hasn?t had anything to eat all day. Due to the abrasion, he was rushed to the hospital About 3 hours later, I called to check on the patient. At the time of calling, the patient was discharged from the hospital in good condition. He stated he felt perfectly ok and wasn?t sure what had happened.

white tiny bumps on both arms (thousands of bumps) and inflamed (painful) right armpit lymph node, over 28 hours since injection

After receiving Pfizer dose 2 pt. reported hives 12 minutes after injection. Pt reports mild throat itchiness. Negative for orthostasis discharged after completed evaluation, released into care of mother. DC V/S T:1316, HR: 82, R:18, BP: 122/78, Spo2: 100%.

I itch & have rash on random location on my body that last about 20-30 minutes. This happens 5-10 times a day.

Patient called to say she was having a reaction to the COVID vaccine that she received Thursday. She reported that her arm where she received the injection was red, swollen, and itching very bad. It started the same day as the injection. She already takes 3 Benadryl a day and says she cannot apply ice to the area because "ice makes her hurt." I advised her to increase the amount of Benadryl she was taking and that she could use a topical steroid to the area. I also advised that it should go away on its own but to follow up with her doctor if she has any further issues.

The patient developed chicken pox 12 days after receiving his second Covid-19 vaccine. He was vaccinated for varicella twice as a young child. Interestingly, his father developed shingles 15 days after his first Pfizer Covid-19 vaccine. The father developed shingles 20 days before my patient developed varicella. The father had chicken pox as a child. My patient was not systemically ill and all of his lesions crusted over by day 9 of the illness. The rash was atypical in that he only had a few vesicles and none of the classic pustules seen with varicella. (I have been in practice for 40 years and have seen many cases of varicella, but none for a long time.)

Patient's mom called about 40 mins after receiving dose and said that patient's right hand (vaccine was in right deltoid) felt tight and was red. She said that he did NOT have any redness or swelling at injection site. She said that he is on the spectrum, so complicates asking him about symptoms. She confirmed that he was NOT experiencing any lip/tongue swelling or trouble breathing. She said he was running hand under water because it "felt tight". After counseling, I followed up with her 40 mins later and she reported that his symptoms were much improved without any treatment.

Site: Pain at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: Patient lost conciousness a few minutes after dose was given. Patient was unresponsive for approximately 2 minutes. Neck felt tight, difficulty breathing, was not alert/oriented when finally awoken. Patient was given 1 shot of epi 0.3 due to a temporary interuption in breathing that lasted seconds. By the time paramedics arrived, he was becoming more alert. Was taken to the ER and discharged.

The customer , within 5-10 min post vaccination, felt light-headed, dizzy, and fell from the chair while was on a 15 minute waiting , seated on a chair post vaccination. A mild bruise seen on the forehead. As soon as, within few seconds, pharmacist was notified. The customer immediately responded to pharmacist's questions. Did not call 911 due to his response and alertness. Epipen was ready but was not required.

Patient is 18 year old male who received his first dose of Pfizer COVID 19 vaccine. graduate intern, administered the dose and within the first minute, patient tensed up and passed out. He appeared to look like he had a seizure. Patient was passed out for less than a minute. When he came to, he said he fell asleep. He said he felt warm. We checked his Blood pressure and it 94/62 and pulse was 54. We called 911 and laid patient on a mat. He was given gatorade and a warm wash cloth. Paramedics arrived and rechecked BP. It was 110/66 and pulse was 66. They evaluated him and told him to have someone drive him home. Patient has not history of seizures and no history of adverse reaction to vaccine. He did receive a tetanus booster on 5/17/21. Only other medical history is asthma. He uses albuterol prn but has not had to use it for > 4 years.

Patient had the second Pfizer vaccine on Monday 5/17/2021 at 3:30PM. He was fine until Tuesday 5/18 around 3:00PM. He started feeling tired and had a fever. We gave him Tylenol and he was OK that night. On Wednesday 5/19, he had fever again. He took Tylenol again and was fine until the next day. On Thurday 5/20, he started feeling itchy on his legs. He claimed that he had some mosquito bites. On Friday night 5/21, He felt itchy all over his body, except his face. Now the red spots are bigger. Like mosquito bites but bigger. We gave him Benadryl and Cortizone. It helped. On Sartuday 5/22, he had rashes again, we gave him Benadryl and Cortizone twice. It helped. On Sunday 5/23, it completely cleared.

Nurse administered the 2nd dose of Pfizer vaccine to patient and within 5 minutes after administration patient slide from the chair and fell on the floor with a vaso- vagal reaction. Patient loss consciousness for a brief seconds while on the floor, one small bruising noted on R knee, no head strike. VS taken while on the floor BP 127/50, HR 100, O2sat 99% on room air. Rapid response called and patient was taken to the ED for further evaluation.

Fevers; Headaches; Chest pressure; Rash on palms and soles; Myopericarditis; Possible atypical Kawasaki disease; Sore throat; This is a spontaneous report from a contactable physician. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 07May2021 (at the age of 18 years), as first dose, single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On the day of the first dose of vaccine (07May2021), the patient developed sore throat. The next day (08May2021), the patient had fevers and sore throat, developed headaches and chest pressure. Fevers persisted for 5 days so presented to emergency department with rash on palms and soles, diagnosed with myopericarditis, possible atypical Kawasaki disease; all started on 08May2021. The events were considered serious per hospitalization in May2021 for 8 days. Treatment received for the adverse events included vancomycin, ceftriaxone, intravenous immunoglobulins (IVIG), ibuprofen, aspirin, and dobutamine. Since the vaccination, the patient has been tested for COVID-19 (nasal swab) that was negative on 12May2021. The patient was recovering from the events. Information about lot or batch number cannot be obtained. No further information expected.; Sender's Comments: Based on current information available, the event myopericarditis, Kawasaki disease, sore throat, pyrexia, headache, chest pressure and rash mostly represented intercurrent condition in this patient, unrelated to Bnt162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate

Symptoms started out with rigors and a fever. This progressed to a diffuse maculopapular rash that resolved within 24 hours. Following day, he was tachycardic and tachypneic when he presented to the emergency department. Ultimately he was found to be in septic shock with myopericarditis. He required pressors. He is currently still in the hospital

Pt was in usual state of health until 6/2/21 and experienced fevers, chills, sore throat, shortness of breath, chest pain, erythematous rash on trunk and limbs, arthralgia inthe ankle. Presented to ED on 6/4-febrile, tachycardic and mildly tachypneic. Pt is still currently admitted in Unit. left axillary adenopathy

Few hours after vaccine developed fevers for 2 days which resolved. Then 6/2/21 developed fevers, rash, chest pain, admitted to hospital 6/4/21 with fevers, rash, pancytopenia, pericarditis, myocarditis

Approximately 3 minutes after receiving vaccination, patient experience seizure in waiting room. Seizure lasted approximately 45 seconds-1 minute. Regained consciousness. 2 inch laceration to chin and chipped tooth post seizure. EMS called. Patient transported to local ER for further treatment.

COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose 04/13/2021 EW0158 Pfizer COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose 05/04/2021 EW0171 Pfizer AE: Pt received above vaccines; second dose was given on 05/04/21, rash appeared on 05/07/21. Pt presented to Primary Care office on 05/21/21 w/c/o cycling rash x 2 weeks, starts w/eruption of raised hives that enlarge, then flatten and remain pink and blotchy sometimes w/central clearing then fading; as areas clear others appear, the rash has been consistently cycling x 2 weeks, not getting worse, not getting better, and is itchy. Pt is taking Benadryl w/o relief. Denies any new exposures, no new detergents, outside exposures, no new lotions, deodorants, etc. Has no hx of allergies, feels fine other than "weird rash that won't go away" Tx: Advised pt to take daily antihistamine, will add prednisone. Start prednisone 10 mg tablet 2 tablets every day for 14 days Send for allergy referral High level of suspicion for serum sickness type reaction r/t COVID vaccine, it is concerning that this has lasted 2 weeks, will refer to allergist for further eval. Though pt is at a virtually negligible risk for sig effects from COVID, he got the vaccine bc is making us" and natural antibodies are not recognized. Outcome: pt has had refill of prednisone as rash is still erupting to date, awaiting allergist appt 07/07/21 for further eval

As soon as vaccine administered, patient stated he felt like he was going to faint. RN grabbed his shoulders, he fainted in chair and started snoring. RN lifted his head to open airway and pt started convulsing and turned bright red. RN yelled for help. RN leaned the chair back to lay on the floor, holding patents head so it would not hit hard. Pharmacy worker called 911. Pt stopped convulsions and started coming too then turned very pale. He said he was starting to feel better but wanted to remain laying on the floor. When paramedics arrived they assisted him up in a chair, took his vitals, he was stable. Then checked his blood sugar and pt immediately passed out again. RN again assisted to lay him back in the chair to be flat on the floor. He again became very pale. Paramedics placed him on the gurney and took him to ER to be evaluated.

Patient developed a rash on his torso, but no difficulty breathing or swallowing. Mother was told to give the patient Benadryl tablets and if the reaction intensifies or leads to difficulty breathing or swallowing to seek emergency help immediately. Spoke to mother at 6:00pm patient was at work had taken the Benadryl and reaction had not intensified

Otherwise healthy 18 yo male who developed urticaria roughly 33 hrs after receiving 2nd dose. Urticaria involved trunk, upper extremities and neck. No systemic symptoms (no wheezing, angioedema, vomiting, lightheadedness, etc). No other obvious cause of urticaria, but urticaria onset seems rather delayed to be due to Pfizer COVID-19 vaccination

facial urticaria - eyelids and cheeks. lasting 3 weeks. tx with topical steroids and oral antihistamines

red rash spreading down the arm then a dark welt for 24 hrs patient took Benadryl and symptoms lessened after 24hrs leaving dark skin patch wher welt had been

Allergy to red meat became prevalent again. Since becoming allergic to red meat in the summer of 2020, I had gained a tolerance to red meat to the point where I could consume as much as I wanted. This lasted between August 2020 and the date listed in this report. On that date I consumed red meat and had an allergic reaction to it. The reaction was a swelling of the fingers, hives on the arms and knees and wrist. As I didn?t have any reactions to red meat in the previous 10 months I didn?t make the connection that I was allergic to red meat again. The following Monday I consumed more red meat. That night I was very drowsy and went to bed at 1900. At around 0100 Tuesday morning I woke up with a terrible stomach ache and could feel my hands itching. I tried to go back to sleep. At around 0430 I woke up again with completely swollen hands to the point where I couldn?t bend any joint in them, hives on my wrists, knees, elbows, neck, forehead, back, and back of thighs. I went to the hospital for a severe allergic reaction. This is the exact same allergic reaction that I would have when I consumed red meat in June 2020 at the height of my allergy, but I had never had a reaction like it since then. Now I am sensitive to red meat again and I can?t think of any reason except that I received the vaccine. I have not consumed red meat since.

It was afternoon. I was in the field, manning the disc toss station and waiting for participants to come up for the ring toss. I first set up shop within the fenced area, facing northeast. I made several calls looking for people to play, but only one contender arrived. I decided to move northeast, toward the treeline but remained within where the sun could shine upon me. Now I was facing southwest. I often turned and looked for participants, but no one came. I helped out on a nearby station, which faced west. At the end of the day, my school watched a magic show at the front doors, facing northeast. I don?t remember exactly how I was turning, but there was one critical mistake I made... I forgot my sunscreen. A bit later my arms started to rich from the sunburns. It wasn?t really painful to have them, but one thing struck as off: my left arm was slightly itchier and hurt slightly more when hit (not simply touched) than my right arm. It struck me as a little odd since both of my Pfizer shots were to the left arm (the first shot was on April 16 this year), but this could simply be a coincidence. Just thought this could be noteworthy. Both sunburns were left untreated, but subsided by the next day.

Bruising, itching, and small bumps at the injection site; Bruising, itching, and small bumps at the injection site; Bruising, itching, and small bumps at the injection site; This is a spontaneous report from a contactable consumer, the patient. An 18-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 18Mar2021 at 14:30 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced bruising, itching, and small bumps at the injection site. The patient did not receive any treatment for reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site bruising, vaccination site pruritus, and vaccination site lump was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

symptoms began as blurry vision, extreme light sensitivity (couldn't open eyes because of pain), and severe headache. He also had what looked like a red rash or blood bruise on both eyelids. The symptoms got increasingly worse and his vision became completely blurry and he was unable to focus his eyes and his photosensitivity so severe that he had to be in a dark room, even when his eyes were closed. His headache increased. We initially went to an urgent care clinic where they ran bloodwork, and then we were sent to an eye specialist for a thorough exam, which was excruciating for him to sit through on account of having to examine his eyes open and with light. After a few hours at the eye specialist we went home and he went to bed, unable to sleep because of his extreme headache. The symptoms lasted the following day, and the day after with loss of visual focus, extreme headache, and the rash on his eyelids appeared to had gotten a bit worse. I would say that Saturday evening his eyesight began getting gradually better (vaccine on Wednesday evening). His headache and aversion to sound continued. Over the next week his vision began gradually getting better, different eyes at different rates, as well as his headache. He still has the rash on his eyelids.

MOTHER CALLED IN STATING SON HAD HIVES AND WAS VERY ITCHY. HIVES WERE NOT LOCALIZED TO SITE OF ADMINISTRATION AND SPREAD ONTO TORSO. RECOMMENDED BENADRYL, MONITORING AND IF IT PROGRESSED OR NOTICED TROUBLE BREATHING TO PROCEED TO THE EMERGENCY DEPARTMENT.

Chest and back itch incredibly; Does feel hot; now swelling of his face or throat; now swelling of his face or throat; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient's father). An 18-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, batch/lot number: EN0187 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25Jun2021 14:30 (at the time of vaccination 18-years-old), as a single dose for COVID-19 immunization. The patient's medical history include sunburn and reported that he did have a sunburn 3 days ago. No concomitant medications were not reported. The caller provided other relevant medical history including but not limited to these conditions; diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient did not have any other vaccination prior to COVID vaccine (within 4 weeks). No family Medical History Relevant to adverse events. On 25Jun2021, the patient experienced chest and back itch incredibly, does feel hot, and now swelling of his face or throat. It was reported that, today (25Jun2021) the caller 18-year-old son had the Covid-19 vaccination. He had the vaccine about 2 hours ago. Everything was fine up until about 30 minutes ago. He claims his chest and back itch incredibly. He had no other symptoms and no rash. He does feel hot. He had no difficulty breathing and now swelling of his face or throat. The caller wife was a nurse. She did not feel like it was an emergency at that point but being a nurse, she wanted him to check and see if they have any Benadryl. No relevant tests. Patient did not visit to emergency room, physician office and not hospitalized. The outcome for all the events was not resolved. Additional Information has been requested.

Sore at injection site; Fatigue; Flu like symptoms; Twitching in my left arm; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep7534), via an unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and amoxicillin (MANUFACTURER UNKNOWN); experienced drug allergy. Prior to the vaccination, the patient was unknown if 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. The patient did not receive any other medications within 2 weeks of vaccination. On 30Mar2021 the patient experienced sore at the injection sight and felt super fatigued with flu like symptoms and twitching in the left arm. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the events of vaccination site pain, fatigue, flu-like symptoms and twitching. The clinical outcomes of the events vaccination site pain, fatigue, flu-like symptoms and twitching were unknown at the time of the report. No follow-up attempts are needed. No further information is expected.

Pain around injection site; Severe fatigue; mild muscle/ joint pain; mild muscle/ joint pain; Mild nausea; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6995), via an unspecified route of administration in the right arm on 25Mar2021 at 08:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications received within two weeks of vaccination included methylphenidate hydrochloride (RITALIN), Sertraline hydrochloride (ZOLOFT) and testosterone (MANUFACTURER UNKNOWN) for unknown indications from unknown date. On 25Mar2021 at 12:00, the patient experienced pain around injection site, severe fatigue, mild muscle/ joint pain and mild nausea. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vaccination site pain, severe fatigue, muscle pain, joint pain and mild nausea was unknown. No follow-up attempts are possible. No further information is expected.

Sore arm at injection site; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in left arm on 29Mar2021 at 11:30 as a single dose (at the age of 18-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021 at 16:00, the patient had sore arm at injection site (vaccination site pain). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event sore arm at injection site. The clinical outcome of vaccination site pain was unknown at the time of report. No follow-up attempts are needed; No further information is expected.

Rash near the site of the shot; Swollen neck; Swollen neck that led to pain when moving; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204), via an unspecified route of administration in the right arm on 31Mar2021 at 13:30 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to amoxicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 31Mar2021, the patient experienced rash near the site of the shot, swollen neck that led to pain when moving and swallowing, chills and fever for the first night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as the result of rash, swollen neck, neck pain, chills and fever. The clinical outcome of the events rash near the site of the shot, swollen neck, neck pain, chills and fever were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: pt was advised to wait 15 minutes after the vaccine but was in ahurry. He fainted in the front of the sore @115pm. vitals signs were taken and everything was okay. we also called 911 and he was transported to the hospital with mional injuries. Deviation of his nose and nose bleeding were the prmary effecs.

Tremendous headache; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 12:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had drug allergy to amoxicillin. Concomitant medications were reported as not available. 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 03Apr2021 at 12:00, the patient experienced tremendous headache and injection site pain. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of headache and vaccination site pain was recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Attendee received first dose Pfizer vaccine at 13:10 in the left arm. Lot# FA3780. Attendee was directed to observation area. At 13:15 voiced complaints of nausea and feeling hot. Chest discomfort 1/10. Attendee's skin was warm and dry. Attendee assisted to the wheelchair and was taken to the cot to lie down. Icepack applied to face and neck. 13:21 - Attendee still with nausea and feeling hot. No chest discomfort, at this time. HR: 63 BP: 100/60 RR: 20 O2Sat%: 99 Temp: 97.4 13:35 - No voiced complaints- skin warm and dry. HR: 82 BP: 102/60 RR: 18 O2Sat%: 99 13:45 -Denied complaints - skin warm and dry. 13:50 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with his partner. Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.

Within 10 minutes of vaccination, the patient reported feeling numb in the left arm. It was not painful, there was not swelling or redness. I advised patient to contact doctor if the numbness persisted for 3 days, I advised the patient to take Tylenol or ibuprofen. I called the patient back 4 hours later and the patient's mom reported that the numbness was gone, but the arm was now itchy. I advised the patient to seek out his PCP if the feeling was still there after 3 days.

Spoke to patients mother on 07/26/2021. Patient had first dose of the Pfizer vaccine administered on 07/25/2021 at around 11:30am. At approximately 8 pm patient had swelling of the throat and felt pain upon inspiration. Patient had red skin colorization/rash on upper chest and neck. Ambulance was called and patient taken to the emergency department. Patient was administered oral Benadryl and epinephrine. Patient was discharged with paper prescriptions for a steroid dose pack and an Epipen. Mother said after an hour in the hospital (after administering Benadryl and epinephrine) patient felt well and had some lingering throat pain. Per mother, hospital was not sure if the reaction was due to the COVID-19 vaccine or to some other form of exposure.

At time of vaccination ~5 minutes after the injection of the pfizer vaccine I developed a tightness in my throat, I was still waiting in line and I did not think much of it, therefore I did not alert the medical personnel about the reaction. Approximately @15mins after the injection I left the site and developed a sense of something wrong and did not feel "right", my chest became tight, hoarseness in my throat and speach, lightheaded, and I remember taking a sip of my coffee thinking it was more difficult to swallow than usual. May I note I was in the passenger seat and not driving the vehicle. I alerted my mother of the reaction, both sceptical because of my hx of no known allergies. We both figured as long as I can breath and I was still conscious, with no signs of cyanosis I would be fine. At around 10:45 I took my BP: which was 106/62 I typically run low. I then took two 25mg Benadryl capsules which did help the throat tightness to an extent, however the tightness in the chest, lightheaded and dizziness still persisted. I was aware of the potential for Bi-phasic anaphylaxis so we had an Epi-pen on stand by just in case. I was stable for the rest of the day. At approximately 10pm I did notice a small erythematous non-pruritic rash across my chest. The symptoms of the reaction did subside within 24hrs. I remained in stable condition and recovered with time.

I had pain at the injection site and headaches for three days then since then from the seventh I had had red dots appear around my neck and left shoulder

Bumps kind of like bug bites, that later make the skin dry and leathery. some are itchy and some just appear over night. the pop up locations are random.

Received vaccination on Jan. 20th 2021. No symptoms till two days later on Jan 22nd 2021. Symptoms include achy muscles, redness, and quarter sized hives all over body. Main location of hives were located on L and R shoulders and back. Symptoms continued for three days then stopped completely. Redness and hives symptoms then reappeared on Feb 4th 2021. Continuing off and on till Feb 9th 2021.

Pain in vaccine shot site; Headaches; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient, who is 19-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number: EL9261, via an unspecified route of administration at Left arm on 28Jan2021 13:30 as SINGLE DOSE for COVID-19 immunization. Medical history included Brain trauma injury. On 28Jan2021 16:00, the patient experienced Pain in vaccine shot site and headaches. The outcome of the events was recovered. Therapeutic measures were taken as a result of the events which includes Tylenol and Motrin. No follow-up attempts are possible. No further information is expected.

Client had a syncopal episode and fell from a sitting position to the floor. Pt was lying with eyes closed and non-verbal for 30 seconds or less. Tactile stimuli and deep sternum rub done to mid chest wall. Pt eyes open. A/O x3. LCTA. Medium size hematoma noted to left side of forehead with small abrasion noted to bridge of nose. Pt denies pain. EMS was notified. Once EMS arrived orthostatic v/s was obtained per EMS with last reading b/p 133/82 HR 72 RR 22 O2 99% RA. Pt refused further tx . Placed in w/c and pushed to lobby with family and RN at side. No acute distress.

Had hives over chest, legs and arm. No shortness of breath. he was given Benadryl. Did not take epi. Hives resolved within 6 hours.

Pt reports pain as soon as injection happened. Reports Numbness in Right shoulder and area around injection site. Denies any redness or swelling. No other symptoms of covid 19. Discussed cold compress for 20 minutes and reaching out to PCP. Advised on s&s to monitor for and when to seek further medical treatment or call 911.

Pruritic round lesions along left leg, left side of torso, and back. First happened the night of vaccination on 21 APR with a few round lesions on the left leg. The following morning the patient noticed more lesions on the left side of his back and torso. Patient seen here in clinic on 23 APR for concerns of these lesions.

11:38 PSO298% pulse 113 reports throat feels tight and pain down his left arm to his elbow. 11:42 pain down left arm to wrist at this time. At vaccine site arm is blotchy red. Throat is feeling better. 11:52 left arm vaccine sight it itching at this time. Throat tightening is almost not noticeable. Ready to leave. PSO2 99% pulse 91. Informed to seek medical attention for further problems and to report the issue for today.

Patient had syncope episode & loss consciousness hitting back of head on concrete floor. BP 80/54. Was taken to observation area to be monitored & ice to hematoma on back of head. He laid flat until dizziness subsided & could resume walking. BP 116/76 Mother came to pick him up. Instructed to watch for signs of brain injury.

Patient reports about four hours after receipt he noted pruritis to his left calf. The next day he noted a raised erythematous papular lesion at the pruritic site. Lesions appeared along his belt line and on day 2 on his hands and continued to develop on his abdomen, back legs, more pronounced on the vaccine side of his body. Palms of hands were not affected, and no lesions to his feet. Lesions take 4-5 days to resolve and new ones develop in the interim. He currently has a new site to his left posterior thigh. HE feels well, denies fever, chills, malaise, headache, CP, diarrhea or vision changes. He denies oral lesions, or to any other mucosal sites, groin, genitals, anus. He treated with topical steroid (Triamcinolone) x1. He took benadryl x1 which made him too somnolent.

Injection arm was really sore until around 4-5PM - a lot worse than the first vaccine I received and I had a 4/10 headache the whole day. Other symptoms started about 12 hours later which included: Whole body was sore and weak Sluggish/exhausted About 13-14 hours after injection: Sudden chills Treatments: I took two ibuprofen and took a warm shower and I was completely fine afterwards.

Patient presented with superficial red bumps that did not previously recall on left inner thigh. Patient encouraged to stay further after drinking 16 fluid ounces of water, Patient stated he was okay to drive.

WITHIN 5 MINUTES OF RECEIVNG FIRST DOSE OF COVID19 PFIZER VACCINE, PATIENT RETURNED TO PHARMACY STATING HE WAS FEELING DIZZY, AND COLLAPSED INTO COUNTER. MANAGER WAS ABLE TO HELP HIM TO A CHAIR SO HE DID NOT FALL, PATIENT CAUGHT HIMSELF WITH THE SHIELD/COUNTER. CALLED 911 AND EMS ARRIVED WITHIN A FEW MINUTES. ASKED PATIENT TO DESCRIBE SYMPTOMS, PATIENT RELAYED FEELING DIZZY, TROUBLE SEEING, VERY WARM, SWEATY. PATIENTS VITALS WERE CHECKED BY EMS, PARENTS AND PATIENT CHOSE NOT TO TRANSPORT AFTER ABOUT 30 MINUTES PATIENT WAS CLEAR OF ALL SYMPTOMS.

5-1-21 Woke up with hives covering 35% of body; took Benedryl throughout day; 5-2-21 Woke up with hives covering 85% of body; Received steroid injection, started steroid dose pack, 2 additional antihistamines. Took 4-5 days for hives to completely go away. Then on 5-10-21 and 5-11-21 Body aches, headache, and 102.3 fever. Unable to get much relief with ibuprofin and acetominaphen.

lump under his armpit on same arm that he got the shot in; lump under his armpit on same arm that he got the shot in; swollen lymph nodes (lymphadenopathy); Chills; Fever; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old male patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EW0157), via an unspecified route of administration, on 21Apr2021 at 10:30, administered in Arm Right as single dose for covid-19 immunisation. Patient's first dose of bnt163b2 (BNT162B2, Batch/lot number: ER8733) was administered on 31Mar2021 at 10:30 in left arm. The patient's concomitant medications were not reported. On 21Apr2021 the patient experienced fever (08:00), chills (thinks around 21:00 or 22:00). She says on 21Apr2021, the same day as his second dose, he took ibuprofen. The dose was 300mg or 400mg and he took a total of 3 doses. She does not know the NDC number, lot number, or expiration date of the ibuprofen he took. On 23Apr2021 lump under his armpit on same arm that he got the shot in. On 23Apr2021 swollen lymph nodes. Prior Vaccinations within 4 weeks were none. The patient was not sick at the time of either vaccination. There was no family history. The outcome for events fever and chills were recovered on 22Apr2021 but for event lump under his armpit on same arm that he got the shot in was unknown. No follow-up attempts are needed. No further information is expected.

Has a lump under the arm that got injected.; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team. A male patient (reporter's oldest son) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in Arm on 21Apr2021 at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced has a lump under the arm that got injected. The reporter stated that her whole family got vaccine on 21Apr2021. They all had a little bit of symptoms here and there but her oldest son has a lump under the arm that got injected. She is wondering if this is common, if it'll go away and if she should consult his doctor. Outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

PATIENT REPORTS DEVELOPING "WIDE SPREAD HIVES ALL OVER BODY" WITHIN 24-48 HOURS FOLLOWING INJECTION. SOUGHT CARE FROM MD AND WAS ADVISED NOT TO RECEIVE SECOND DOSE.

Desquamating rash of hands, feet, groin/legs after covid vaccine. Patient received his first COVID-19 vaccine dose on 5/2/2021. Patient initially had sore throat that started 5/4/2021 followed by rash 5/6/2021. He had TAV with on 5/8/2021 and reported headache, sore throat, swollen glands, tactile temps, chills, nausea, vomiting, loss of appetite. Prescribed amoxicillin for 10 days. TAV on 5/13/2021 complaining of diffuse itchy rash all over body, started on face, but now everywhere including groin. Video appointment on 5/17/2021; sore throat better after antibiotics, rash continues to itch. Advised to stop antibiotics and pending in person clinic visit. Seen in clinic on 5/18/2021; antihistamine and hydrocortisone ointment has not helped the rash. Rash by this time less erythematous than when started and skin starting to dry/peel. Rash on bilateral palms, axilla/neck, groin. Telederm appointment probable atypical viral exanthem and recommended moisturizers, low potency topical steroids. Came to the ER on 5/20/2021 for continued skin peeling. Discussed with dermatology and prescribed prednisone 40mg daily for 7 days. Returned to the ER on 5/21/2021 for continued progression of the rash, started on clobetasol ointment, a higher dose steroid than what he was previously on. Presented 5/23/2021 of burning, itching, flaking off of rash and uncontrolled pain. States it hurts to sit due to the rash behind his thighs and buttocks.

On the first day of the adverse effects I woke up to a rash on my legs. It was minor and I thought nothing of it. On the second day it had spread to my arms and was now a serious irritation. I rubbed Aloe Vera on it and that helped a little but wore off in an hour. By day three the rash was now spreading to my chest but I still wasn't sure if it was the vaccine. I took some Benedryll as an antihistamine and the rash completely dissapeared within an hour. 24 hours later at the time I had taken the Benedryll the night prior the rash reappeared and I he only possible explanation is some sort of allergic reaction to the vaccine. I have been allergic to it consistently and if it doesn't dissapeared entirely without me needing to take Benedryll I will be very concerned. The rash when it is present covers almost my entire body, spare my groin, head, neck, and some of my chest and back luckily. It itches very badly and constantly, and is very much visually present in large red splotches.

Constant headache from Monday to Wednesday night, with fever, chills, body aches, and a large rash that broke out on the left side of my neck and shoulder. This rash tensed my neck muscles and had a sunburn like sensation on the skin. Medications were taken throughout, like excedrin migraine, ibuprofen, and benedryl.

Intense chills about 10 hours after shot, leading to overnight fever with a high of 102.4 degrees. Headache and sore arm the day afterwards, minor fever persisted. Two days after, fever was gone, headache remained, and red spots appeared on the palms of my hands (not painful, disappeared after a day).

Client received the 1st dose of the COVID vaccine (Pfizer Lot #EW0186 expiration date 07/12/2021) at 1309. At 1326, the client called EMT over and said "I'm having itching and something in my chest." PHN responded. The client stated, "I'm not having any trouble breathing or any swelling. When I breathe in, I feel something in my chest. It comes and goes. I have itching in my left palm but its already going away." Client was alert and oriented times four. EMT and PHN escorted the client to the zero gravity chair. Vital signs taken at 1329 (blood pressure 130/60, heart rate 83, oxygen 97%). At 1330, PHN offered the client Benadryl which he refused and stated, "I don't feel the itchiness anymore." Client stated, "I don't like needles. I was nervous about getting the vaccine." Client denies any medical conditions and allergies. The client is taking Zyrtec and prescription eye drops. At 1338, client stated, "I haven't felt the feeling in my chest since we moved over here." Vital signs taken at 1340 (blood pressure 132/78, heart rate 76, oxygen 96%). At 1345, the client stated, "my chest feels fine." Vital signs taken at 1351 (blood pressure 130/74, heart rate 82, oxygen 97%). PHN provided client with education on when to seek emergency services, and to follow up with his primary care provider. Client left unassisted with a steady gait at 1356.

2 hours after my first injection, I began to develop small hives along my abdomen. 2 weeks later this rash has spread all over my back and across my entire torso. Leading me to admit myself to the ER, where they gave me an IV of hydroxyzine & famotidine. The next day my rash was completely gone and I felt much better.

Hives over upper body and back of neck. It then spread to lower body, forearms, and forehead; This is a spontaneous report received from a contactable consumer, the patient. A 19-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The medical history included myopia and astigmatism. The concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021 at 21:00 the patient developed hives. The patient reported that he developed hives over upper body and back of neck which started 32 hours after vaccination around 21:00 and it subsided a little after he went to bed. It then spread to lower body, forearms and forehead at 20:00 on 25Mar2021. The hives were nearly gone on the morning of 26Mar2021. At no point did the hives reached his throat or other vital areas to breathing. The patient received BENADRYL, ALLEGRA and PEPCID as treatment for the reported event hives. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of the event hives was resolving at the time of this report. No follow-up attempts are needed. No further information expected.

Petechia/Bruising began within a week, July 14, 2021 labwork showed a platelet count of 7,000. Admitted to hospital through ER on July 15. ITP is likely diagnosis. No other contributing factors (No other illnesses, medication, health problems, etc)

Soreness in arm at injection site.; This is a spontaneous report from a contactable consumer. A 19-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 27Mar2021 at 13:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 28Mar2021 at 17:00 the patient experienced soreness in arm at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The clinical outcome of the event vaccination site pain was recovering at the time of reporting. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Pfizer-BioNTech COVID-19 Vaccine: patient presented to clinic for follow-up reporting syncope and emergency department (ED) evaluation immediately after immunization and bruising and bleeding where the vaccine was administered. Patient was discharged from the ED stable and the provider documented the injection site as a healing bruise with no intervention necessary.

The Patient had just sat down in chair outside the pharmacy after receiving his first doe of the Pfizer Covid vaccine from the technician and he fainted and fell forward onto the floor. The technician who had gave the shot and I rushed out help him. He regained consciousness right away but he had bit his lip which made his lip bleed a little and the glasses gave him a small cut under his eye. We had him lay down for a few minutes afterward and cleaned and bandaged his small cut. His mom did mention afterward that he sometimes get dizzy when he has blood drawn. This was never stated on the patient questionnaire. The patient waited the required time after the vaccine and said he no longer felt dizzy and felt fine. We put notes on patient's file of the event and to walk him to his seat and observe him closely with his 2nd dose.

Immune Thrombocytopenia (ITP) diagnosis with very low platelets. Bruising and petecchae started to develop several weeks after second Pfizer covid vaccine.

headaches; fatigue; bruising all over body; undetectable platelets; Immune thrombocytopenia; petechiae; Arm pain at site; This is a spontaneous report received from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left on 28Apr2021 (Lot Number: ER8735) at the age of 19 years old, at single dose for covid-19 immunisation. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There was no other vaccine in four weeks or other medications in two weeks. The patient experienced arm pain at site in 2021, headaches in May2021, fatigue in May2021, bruising all over body in May2021, undetectable platelets in 2021, immune thrombocytopenia in 2021, petechiae in 2021. Arm pain at site, mid-May: headaches, fatigue, bruising all over body. Hospitalized with undetectable platelets and Immune thrombocytopenia and petechiae. The patient was hospitalized for all events for 3 days. All events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included Nasal Swab: negative on 23Jun2021. The outcome of the all events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Pfizer-BioNTech COVID-19 Vaccine EUA The vaccine was administered to the writer at 0800 on 1/5/2021. No immediate reactions were noticed for the 30 minutes observation period immediately after. The writer's muscle that received the vaccine began to become increasingly sore throughout the day; however, that was similar to the first dose of the same vaccine a few weeks prior. The pain was described as constant (2/10) but aggravated with motion. The pain did interfere with the writer's normal range of motion (specifically raising the writer's arm above shoulder height). From 0800-2200 on 1/5/2021 no noticeable symptoms except for the injection site pain occurred. At 2200, the writer rapidly developed chills, body aches, a headache, fatigue, and a fever of 100.8. These symptoms were left untreated and continued through the night (the symptoms did not interfere with sleep). The writer woke up at 1300 on 1/6/2021; all previous symptoms had resolved by this time except for the injection site pain. By 1400 on 1/6/2021, the writer noticed pain near the right axillary lymph nodes. The pain can be described as moderate (1/10) and generally occurred only with motion. The writer was unable to palpate any swelling in the area. Around 1800 on 1/6/2021, the writer noticed it felt weird to swallow. Specifically, it felt as if there was a slight internal swelling 1-inch subhyoidally and 1-2 inches laterally within the right side of his neck when he swallowed. The swelling was not palpable from the skin's surface. The writer did not seek medical attention as breathing/eating/drinking were not made more difficult but monitored this closely. The swelling in the neck resolved by 2000 on 1/6/2021. The lymph node pain in the right arm resolved over the course of a few days and was no longer present by 1/9/2021 at 1300.

Extreme nausea, vomiting and petechiae under eyes. Continued nausea/vomting for four (4) days. Nausea is received by ondansetron

Patient received injection 1/11/2021 and noticed a rash on the evening of 1/12/2021 around the injection site. Rash spread down his arm, trunk, hip and thigh. He took Benadryl without relief. Patient presented to ED on 1/14/2021. Given dexamethasone and methylprednisolone. Discharged as hives were resolving.

injection site pain; nausea; diarrhea; feeling unwell; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 20-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3247, via an unspecified route of administration on 19Jan2021 at 12:30 (at the age of 20 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 20Jan2021 at 08:00AM, the patient experienced injection site pain, nausea, diarrhea, feeling unwell. The patient did not receive treatment for the events. The clinical outcome of injection site pain, nausea, diarrhea, feeling unwell was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

I had all of the common side effects of getting vaccinated, headache, muscle pain, drowsiness etc. Then around 12hrs later I started having a light allergic reaction. I got hives on the right arm (injection arm) and itchiness around my whole body (top of head, arms, legs) I took a Benadryl and put some Benadryl anti itch cream on the hives and all symptoms stopped.

Bell's palsy; jaundice looking legs; inability to communicate clearly; Seems to be experiencing numerous seizures; This is a spontaneous report from a non-contactable consumer. A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot and expiry unknown), via an unspecified route of administration on 26Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Bell's palsy, jaundice looking legs, inability to communicate clearly and seems to be experiencing numerous seizures on 04Mar2021. The events were considered serious due to hospitalization. The patient was hospitalized on 04Mar2021. It was unknown if patient received treatment for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Muscular pain on left arm and ribs muscles while having a deep breath. Very light fever. Took1g of paracetamol every day to help. (Doliprane) Fatigue. Left arm pain started 3/4 hours after injection the rest came the morning after.

Dose given 1804, band aide placed, patient states feels a little light headed 1806, as laying flat LOC for 2 seconds, BP 90/50, pale, patient states small amount of nausea, left flat, talking throughout, A/Ox4, 1815 BP 90/56, patient states feels fine, skin color pink/dry, sat up slowly, sat for another 5 minutes then ambulated to chair, states feels well, waited another 15 minutes for observation, patient states after, previous blood draw, passed out

Patient called into Services on April 6 to report a suspected "allergic reaction related to his Covid19 Vaccine received March 30. He said that beginning 24-48 hours after his vaccine he began to experience "a sore throat, swollen lips, conjunctivis in both eyes, pain and muscle aches, and hives/boils all over his body. He asked if he should go to an urgent care center. His mother had suggested an urgent care. He wanted us to complete the form and was going to the Urgent Care. Couldn't find his vaccine card, so called him with Lot # and expiration of dose. Advised to call us back after being seen to update his condition.

No symptoms from first dose. Immediately after second dose, injected arm felt numb/tingly. When seated at observation area, began to feel nauseous, dizzy, and began sweating. Rose to ask site staff for help, felt very uneven. Taken to back observation room and laid down on a cot. Blood pressure observed at 85/30, significantly lower than normal. Rested for approximately 15 minutes, then sat up. Nausea and blurry vision returned. No change in blood pressure. Blood was drawn, sugar and other indicators normal. Sat up again, feelings returned. Drank two water bottles and began to feel better, blood pressure returned to low end of normal after around 15 minutes. General weakness persisted throughout day, along with mild pain at injection site and in neck.

Dizziness upon standing and walking, nausea, clamy and warm skin, sweaty, pale, tunnel vision, loss of acute memory, vision, and hearing. Patient was watched from 3pm (right after dose) to 3:30pm. He was feeling these symptoms from 3pm to about 3:15pm. He was given water after 5 minutes and cold wash rags to put on his forehead and neck. He was also told to breath deep breaths slowly. He said his throat felt sore and was provided with a throat lozenge. Color in his face returned after roughly 10 to 15 minutes and he verbally said he was feeling much better. Pharmacy associates watched him for another 15 minutes to make sure he was okay.

20 yo healthy male with onset of severe urticarial reaction, swelling of face, hands and feet, fever on 4/11, hospitalized 4/16/2021, resembles serum sickness.

Patient was given dose 1 of the vaccine and instructed to wait at least 15 minutes in the chairs in front of the RPH for observation. He waived at us and sat down. We asked if he was ok and he waived again stating he didn't feel well. He sat back down and we proceeded to check on him. As we were coming to check on him, he fainted and fell face forward on to the floor. We called 911 and rolled him gently to his back. He had a laceration above his eye from the fall. EMT came and assessed the patient. After observation, he was allowed to be picked up from his friend and taken to a clinic for stitches.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: Patient's face turned very pale/yellow. His blood pressure and pulse were very low.

Reason for visit: Pfizer vaccine reaction HPI 20 year old 1st dose of Pfizer vaccine 6:15 PM mon 4/5/21 observed for 15" and mild pain at injection site Tuesday 4/6/21 noticed that his lips were feeling "sensitive" But didn't notice any swelling-sometimes gets similar feeling when he is fatigued Wednesday 4/7/21 noticed swelling of his lips. Called parents. Lips were swollen and he noticed some drainage of clear fluid-if he took a tissue and pressed against his lips would be a small amount of fluid. No blister. Took 200mg of ibuprofen once. Right now lips are dry. Today still feels like lips are swollen top and bottom and feels dry and "hard" Admits to cracks at angle of lips No swelling tongue or throat. No rash, flushing, rash, dizziness, lightheadedness, presyncope, syncope, n/v/d, difficulty swallowing or breathing, itching, diaphoresis No hx cold sores. No prior history of allergy No known allergies. No allergy or reaction to vaccines, food, medications, stings/insects No seasonal allergies, asthma, ecezma ACTIVE PROBLEMS: There are no active problems to display for this patient. REVIEW OF SYSTEMS: Per HPI No fevers, chills, loss taste or smell, myalgia/arthralgia, chest pain, dyspnea, cough, conjunctivitis PERSONAL HISTORY: No cig/vaping/marijuana No ETOH Not kissing anyone, not sharing drinks, not sexually active CURRENT MEDS: ibuprofen Allergies: Allergies Allergen Reactions ? Pfizer Covid-19 Vaccine (Eua) [Covid-19 Vacc,Mrna(Pfizer)(Pf)] Lip Swelling Patient reported vitals/weight: There were no vitals filed for this visit. Weight lbs. Exam: + dry skin upper and lower lips, + lesions with yellow crusting, largest left upper lip and along lower border ASSESSMENT AND PLAN: o Swelling of both lips (primary encounter diagnosis) Suspect delayed allergic reaction to the 1st dose Pfizer vaccine Lip swelling Still with mild swelling, dry peeling skin, and yellow crusting Start zyrtec 10mg daily Start mupirocin three times a day Report any new or worsening symptoms Student knows to call Acute Care. Gave Dr.'s cell phone number if he cannot get thru to AC Follow up with me Monday Forward visit note to EH Refer to Allergy clinic for recommendations regarding 2nd dose Pfizer vaccine I have reminded them of our office number should they need a more urgent appointment. Return in about 3 days (around 4/12/2021) for in person visit for follow up allergic reaction. No orders of the defined types were placed in this encounter. Requested Prescriptions Signed Prescriptions Disp Refills ? mupirocin (BACTROBAN) 2 % cream 15 g 0 Sig: Apply topically 3 (three) times daily for 7 days. I spent 25 minutes with the patient, of which 15 minutes were spent reviewing data, counseling and coordination of care. Specifically we discussed my impression of the etiology of the patient's symptoms, interpretation of test results, management plan, and acute symptoms for which to seek immediate medical attention.

First noted some itchiness two days after the second dose, but merely shrugged it of as bug bites. The morning of the third day, I had woken up at 1:30 am with hives all over my body. Almost an hour later, my lips began to swell up, doubling in size.

Initial presentation Patient was in his usual state of good health until 4/19 when he received his first dose of the Pfizer COVID-19 vaccine. Two hours after the injection he became nauseous and vomited multiple times. Overnight he experienced diffuse myalgia and suprapubic pain. He awoke the next day to a pustular rash on his chin, forehead, chest and back. The patient describes similar previous rashes that have resolved spontaneously. The next day he began to experience gross hematuria and presented to the ED with a temperature of 98.9, blood pressure of 100/69mmHg, heart rate of 110bpm, respiratory rate of 18 breaths per minute and an O2 saturation of 97% on room air. On examination, patient was ill-appearing with diffuse pustules on his face, chest and back, periorbital edema, and leukoplakia of the tongue and buccal mucosa. His abdomen was soft and tender to palpation in the suprapubic area and at both costovertebral angles. Hospital course In the ED the patient was found to have a metabolic acidosis of pH 7.33 with an anion gap of 16, lactate 2.6, neutrophilic leukocytosis (22k), acute renal insufficiency with a BUN of 45 and creatinine 3.81 (baseline is 0.76). The patient?s urine demonstrated packed RBCs and 5-10 WBCs. He was admitted to the medicine service for further management. On the medicine floor he was initially found to have rhabdomyolysis (CK 584), worsening renal failure (Creatinine 8), follicular conjunctivitis by skin biopsy, a low CD3/CD4 count (CD4 91, CD3 47, CD8 258) with normal complement, and bilateral tinnitus. CT A/P without contrast showed increased attenuation of renal pelves and ureters consistent with hemorrhage, but no renal stones or hydronephrosis was seen. The patient was treated with pulse dose 500mg IV Methylprednisilone for 3 days and then transitioned to 60mg Prednisone. The patient?s pustular rash and oral leukoplakia greatly improved while on pulse dose steroids, but his kidney function continued to decline (Creatinine rising from 8 to 11), and the patient?s bilateral tinnitus progressed to bilateral sensorineural deafness over 2 days. Bilateral hearing loss prompted an MRI of the brain which identified several punctate infarcts across multiple vascular territories in bilateral cortices and left cerebellum. The patient?s kidney function has continued to decline, with progressive hyperkalemia and hemodialysis was begun.

Today, I had this weird metallic taste in my mouth. I saw some other people online had noticed this after their shot too, so I wanted to let y'all know. When I got the shot at first, my arm really hurt at the site of the shot and as I walked back home afterwards, my whole left side felt weird. That evening, I was extraordinarily tired. Now I feel better, but that was a doozy

At 6 minutes post vaccine, while in the observation area, patient had a vasovagal episode. He fell to the ground from the observation chair and immediately came to. Patient has small abrasion under right eye, some right shoulder pain. Prior to vaccination, patient disclosed fear of needles. Patient arrived around 2:30p initially, vaccinator prepared him to be vaccinated laying down on cot. Patient was nervous and decided to reschedule. Patient returned at 4pm and decided to receive vaccine. Patient did not want to be vaccinated laying down. Patient refused EMS and refused to be evaluated by physician in Emergency Department and stated he would follow up with his physician. Patient observed for extended period and released.

broke out in hives/rashes on elbows, eyelids, stomach, arms, legs (head to toe). Took benedryl 5/6/21 7:30 am. Went to urgent care 8:10 am 5/6/21 given steroid injections and told to continue benedryl nightly, sent home. No c/o SOB/difficulty breathing, only skin reaction.

First 3 days I had a sense of minor fatigue, on the 6th day I noticed that the injection area had a circular yellowish green rash. Not feeling any other side effects internet sources said that this was rare enough to report. I did some weight lifting the day before I noticed this.

FIVE MINUTES AFTER TAKING THE VACCINE, PT EXPERIENCED BLURRY VISION WHICH PROGRESSED TO LOSS OF VISION AFTER FEW MINUTES. PT APPEARED PALE, SKIN HOT TO TOUCH THEN HAD A LOT OF SWEATING, THEN HEADACHE. BUT VISION CAME BACK AFTER 30 MINUTES.

Patient experienced some numbness locally at injection site and surround areas. Patient was put under observation. for 25 minutes. Patient then felt better and left the site. Patient was instructed to contact physician or seek medical care if symptoms get worse or unable to move arm due to the numbness.

Broke out in hives around both arms and the thigh/upper legs. None on the body/neck/face/lower legs. Appeared as if it was an allergic reaction, but this would be a first.

9:35 c/o feeling really tired + continuously yawning, no resp. distress, skin W/D. BP 110/60-82, 99%. Advised to wait an additional 5 mins. Left observation area. Stated he still felt tired. In no distress. Mom driving.

In the middle of the night he stood up to go to the bathroom, turned the light on, felt dizzy and light headed. Passed out and woke up confused unable to speak correctly and unstable when trying to stand up. Eyes were dilated. After he layed down for a few minutes he was ok, could walk and talk fine. Migraine Chills Slightly warm

Rashes on wrists, ankles, knees, elbows and other spots. Appears as a lot of small red dots that make a trail on my skin

During the day of the vaccination the only side effects was a soreness at the treatment sight. When I woke up the next day I had a slight fever, severe headaches, and had a lack of energy. This persisted during the course fo the day. Two days after the shot the side effects had mostly abated.

Sore vaccine site first 2 days, had sore joints next day, woke up the third morning and vomited every 20-30mins. Was too dizzy to walk or move , lost sense of taste and smell, headache, cough, tiredness, high fever of 104, and chills. Had redness and pain at injection site the whole time and other symptoms lasted 3 days.

Pt had very low white blood cell count and also had effects to his liver. Admitted to hospital after being found to have significant blood abnormalities reflective of bone marrow dysfunction and/or hemolysis. He was jaundiced and had evidence of acute hepatitis. Later on he tested positive for COVID and was placed at a negative pressure room at the hospital. His white count got as low as 1.6 but has improved to2.7 when he was discharged. His platelets at the time of discharge were 120. his hemoglobin was 10.9. his liver function tests were improving down about 200 points the following day compared to when he was admitted.

Soreness from the first injection and that was all; This is a spontaneous report received from a contactable consumer. A 20-year-old male patient received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EW0176), via intramuscular route of administration in Arm Left 03May2021 at 16:00 (at the age of 20 years old) as 1st dose single, dose for covid-19 immunisation at school. Medical history included seasonal allergy. Family medical history included "his mom has Meniere's disease, it comes in rare spurts". Concomitant medication included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for seasonal allergy, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for seasonal allergy. The patient experienced soreness from the first injection and that was all in May2021. The events assessed as non-serious. Outcome of the event were unknown.

For 2 days he had arm pain and hot flashes. Day 3 he felt better but had some arm cramping. 84 hours after the vaccine he woke with tremors for several hours overnight; he then continue to experience muscle twitching but the tremor resolved the next morning. That day he noticed he felt very fatigued. The twitching and spasms lasted about 3 or 4 days. The legs will still spasm at nighttime and he still feels fatigued with less exercise tolerance. His baseline was 2-3 miles walking without difficulty prior to the vaccine, lately a mile will wipe him out. He also noticed intermittent midline pain around his breastbone that has improved. He hasn't had any shortness of breath. He had poor circulation to his hands and were cold and white but that resolved. He did not have sensory changes. His symptoms overall have been improving.

Headache; Soreness at vaccine site; Fever; Myalgias; Mouth ulcers; This is a spontaneous report received from a contactable consumer, the patient. A 20-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on18Mar2021, at 08:30 AM as a single dose for COVID-19 immunisation. Medical history included ADD and genetic inflammatory fever syndrome. It was reported that no allergies to medications, food or other products. Concomitant medications included FOCALIN and LEXAPRO. It was reported that, 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. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 14:00 the patient experienced mouth ulcers, headache, myalgia, fever and soreness at vaccination site. Therapeutic measures were taken as a result of mouth ulcers, headache, myalgia, fever and soreness at vaccination with mortin (MANUFACTURER UNKNOWN). The clinical outcome of the events mouth ulcers, headache, myalgia, fever and soreness at vaccination site was resolving. Information about lot/batch number cannot be obtained. No further information is expected.

Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Additional Details: It seemed that patient was experiencing anxiety and mild syncope from the vaccine. His BP was 106/57 with pulse 59. I had him stay seated until the color came back in his face and he stopped sweating. He was much better by the time he left the store.

Hives; Itchier; This is a spontaneous report from a contactable consumer, the patient. A 20-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in left arm on 28Mar2021 at 17:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medication was not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021at 12:00 (after receiving the first dose of the vaccination), the patient experienced hives and had slowly spread more around the body and had gotten itchier over time, started around elbows on both arms but were the worst around the hips and there were a few patches on the chest, legs, and back as well. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient receive treatment for the reported events. The clinical outcome of the events hives and itchy were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Left sided chest pressure (concern of myocarditis); Left sided chest pressure (concern of myocarditis); Left sided chest pressures, like a chest pain on the left side; Shortness of breath; Chills; Wasn't feeling good with joint pain; Wasn't feeling good with joint pain/Wasn't feeling good after he received the vaccine; Not feeling well; Whole time from the time he got the dose till now he is been not feeling good; Fatigued/Still feeling fatigued; A lot of congestion; Sick; Muscle injection site was painful, arm was sore; Arm pain, the site of injection was really painful; Muscle injection site was painful, arm was sore; Arm pain, the site of injection was really painful; He didn't looked good at all, he just looked white; Ear infection; This is a spontaneous report from a contactable other healthcare professional . A 20-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0178; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration, administered in Arm Left (at the age of 20-years-old) on 02Jun2021 as single dose for COVID-19 immunization. Medical history included asthma from an unknown date and ongoing. Concomitant medication(s) included salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]) taken for an unspecified indication, start and stop date were not reported. Nurse stated, Initially when he has a dose of the first dose like two three days after he was experiencing, he also had a muscle that was given, he had a muscle injection site was painful, that arm was sore that was given, but he also started experiencing shortness of breath and same left sided chest pressure and I called his pediatrician and that's why we are just watching him because it wasnt to the point where he was full blown shortness of breath, full blown chest pressure stayed last for a couple of days then getting it worst. But he had the chills, he had fatigue is still there and it started to subside and then couple days after since it subside, fatigue never left but then he started to get chills again and fatigue was even more pronounce and then started more congestion and then he has ear infection, which we took him to doctor 2 days ago and he has started antibiotics. So the whole time from the time he got the dose till now he is been not feeling good, so now with the antibiotics he is feeling a little better and on 04Jun or 05Jun, like Friday to Saturday he was expecting little shortness of breath and then he was having a little bit of left side chest pressure, he had the arm pain initially and the site of injection was really painful and then the fatigue probably started the same time Friday Saturday he just, he didn't looked good at all, he just looked white. The patient experienced left sided chest pressure (concern of myocarditis), like a chest pain on the left side, shortness of breath, chills on an wasn't feeling good with joint pain wasn't feeling good with joint pain/wasn't feeling good after he received the vaccine; not feeling well; whole time from the time he got the dose till now he is been not feeling good, fatigued/still feeling fatigued on an unspecified date, ear infection on 19Jun2021 and a lot of congestion, muscle injection site was painful, arm was sore; arm pain, the site of injection was really, muscle injection site was painful, arm was sore; arm pain, the site of injection was really painful, he didn't looked good at all, he just looked white on an unspecified date. The patient was treated with antibiotics for ear infection. The patient underwent lab tests and procedures which included sars-cov-2 test result: negative. Caller stated His sons next dose (of Pfizer COVID vaccine) is due Wednesday. But until now he has not been feeling good. I don't want to give him the vaccine when he's sick. Does that make a difference with the effectiveness if I delay the second dose and she heard people had worse side effects for the first few days with fevers, body aches, nausea, fever and subsided and then they take their 2nd dose and are better after the 2nd dose, also stated her sons symptoms were not acute, but is not sure if it is coincidental if his ear infection was due to the vaccine. The outcome of the events were reported as unknown.; 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 myocarditis cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Intense neck pain; Upper back pain; soreness in the arm where I received the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732), via an unspecified route of administration in the left arm on 28Mar2021 at 14:45 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had not received any concomitant medications within 2 weeks of vaccine. The patient had no known allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 08:30, the patient woke up with intense neck and upper back pain, in addition to soreness in the arm where he received the vaccine in the next morning. That was still ongoing. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as the result of adverse events. The clinical outcome of neck pain, upper back pain and vaccination site pain was not resolved. No follow-up attempts are needed. No further information is expected.

Diarrhea; Fever of roughly 38.5C; Mild tiredness; Loss of appetite; Mild injections site tenderness; This is a spontaneous report received from a contactable consumer, the patient. A 20-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route of administrated on 26Mar2021 at 17:45 (at the age of 20-years-old) as a DOSE 1, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to unknown date. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient did not received any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 27March2021 at 15:00 the patient experienced Fever of roughly 38.5C, mild tiredness, loss of appetite and mild injections site tenderness and at 15:45 after 22 hours of the first dose of vaccine, the patient experienced diarrhea. All foods consumed within the timeframe were unassociated with incidents of diarrhea in the past, though not frequently consumed. These included rye and mushroom soup, neither of which are associated with allergies or intolerances. The patient stated that this was not to say that there was a definitive connection with the first dose of the vaccine, but a correlation was present. The patient did not received any treatment for the reported events. The patient underwent lab tests or procedure, which include body temperature on 27Mar2021 and tested with a temperature of 38.5C. The clinical outcome of the events diarrhea, fever, mild tiredness, loss of appetite and mild injections site tenderness were recovering. No follow-up attempts are needed. No further information expected. Amendment: This follow-up report is being submitted to amend previously reported information: The date for Lab data captured as: 27Mar2021, Narrative 'The patient underwent lab tests or procedure, which include body temperature on an unknown date and tested with a temperature of 38.5C' update as 'The patient underwent lab tests or procedure, which include body temperature on 27Mar2021 and tested with a temperature of 38.5C' and Dose description was updated in narrative.

tenderness at the shot site; very tired; This is a spontaneous report from contactable consumer(parent) reported for a 20-year-old male patient (reporter's son). A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on (age at the time of vaccination 20-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not report any adverse events prior to vaccination. The caller was calling about the Pfizer COVID vaccine on behalf of her son. The patient was 20 years old and was extremely healthy. The patient was very strict on his health. The patient was a vegetarian, he was very health conscious. It was reported that after the first dose the patient had some tenderness at the shot site and felt very tired on an unspecified date. The patient underwent lab tests and procedures which included EKG: heart attack on 20May2021, troponin: elevated on 20May2021, troponin: elevated on 20May2021. Outcome of the event tenderness at the shot site was reported as recovering and other event outcome was unknown at this time of the report. Information on the lot/batch number has been requested.

injection site pain; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received BNT162B2 (batch/lot number: EH9899) first dose on 15Dec2020 13:00 Intramuscular Deltoid Left at single dose for COVID-19 prophylaxis. Medical history and concomitant medications were none. Prior Vaccinations (within 4 weeks) None. AE(s) following prior vaccinations None. Family Medical History Relevant to AE(s) None. He said that he had no side effects with the first dose except for injection site pain. Vaccination Facility Type was Hospital. Vaccine not Administered at Facility. No events require a visit to: Emergency Room or Physician Office. The outcome of the event was unknown.

high fever (102.3), muscle aches, local injection site reaction, head ache and shortness of breath and chest discomfort

Vaccinee noted mild soreness at injection site on day of vaccine. Next day vaccinee noted fever to 101.5 and tender axillary adenopathy, fatigue and malaise. Two days after injection noted headaches with come and go

Injection site soreness; fever; chills; headache; weakness; This is a spontaneous report from a contactable consumer (patient self). A 21-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6201, expiration date: unknown), via an unspecified route of administration (location: Left arm) on 26Feb2021 13:00 at age of 21-year-old at single dose for COVID-19 immunization. Medical history included depression, anxiety, obesity, liver disease, avoidant/ restrictive food intake disorder (ARFID). The patient was in the hospital with COVID in April2020. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. Facility where the most recent COVID-19 vaccine was administered was doctor's office/ urgent care. Concomitant medication included fluoxetine hydrochloride (PROZAC), metformin and melatonin. The patient experienced injection site soreness, fever, chills, headache and weakness, all on 27Feb2021 04:00 AM. The patient received acetaminophen (TYLENOL) as treatment. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of events was recovering.

Extremely sore right arm, long-lasting headache, achiness, fatigue, sore shoulder muscles. Headache and achiness began overnight, fatigue set in about 24 hours after vaccination.

ED Visit 3/11/21 History of Present Illness 21 year old man pmhx of autism, recurrent abscesses, presents with complaint of L axilla swelling and drainage. Pt received COVID vaccine in L arm on 3/1. Pt did well until 3/5 when he started to complain of pain in the L armpit. Mother examined the area and did not see anything concerning. The pain continued through the weekend, no fevers. Pt felt warm on Monday, no temperature taken. Mother then noted a few "bump" near the L armpit. The bumps continued to swell and be painful on Tuesday, went to pediatrician and was prescribed Keflex. Pt has been taking Keflex but continues to spike fevers, Tmax 102F on Wednesday. Pt had fevers yesterday and today of "about 100." Pt took a nap today, and woke up with the area draining. Mother states that the drainage was smelly pus. Called PCP who recommended evaluation. ED course: Patient observed in the emergency department of antipyretics and did not have any further fever. I will switch his treatment to clindamycin and provide topical bacitracin and provide strict criteria to come back if pt became febrile instructions provided to mom. Patient safe for discharge to home. Discharged in improved condition. Written instructions reviewed with family. 3/18/2021 Discharge Summary History of Present Illness 21yo man with h/o autism and multiple soft tissue infections including cellulitis and pilonidal cyst who presented to the ED 3/13/2021 after axillary drainage and fever. He had been treated outpatient with keflex, but continued to have fevers at home. Re-evaluated at ED and placed on clindamycin. Cultures from outpatient showing skin flora. Mother has been doing several dressings of drainage at home and ongoing fevers up to 102 so was brought to the ED for evaluation. No cough, rhinorrhea, diarrhea, recent travel, known sick contacts. Summary of hospitalization: He re-presented to ED on 3/13/2021 and was started on vanc/cefepime/flagyl. A CT scan with contrast done to determine extension of abscess, which was fortunately limited to the subcutaneous plane (no infiltration near bone or into muscle fascia). In the ED, patient's creatinine was 1.5. Patient received IVF and his creatinine downtrended to 0.75 on 3/18/21. The surgical course was uneventful. Successful debridement of the left axillary abscess was performed on 03/4/21. Wound cultures grew Actinomyces Europaeus and S. Epidermidis and Infectious Disease was consulted. Their antibiotic recommendations to discontinue the cefepime/flagyl and start vanc/CTX were followed. Sensitivity analyses showed S. Epidermidis was sensitive to linezolid, tetracyclin, tigecyclin, bactruim and vancomycin. The Actinomyces Europaeus sensitivities have not yet resulted at time of discharge. Per ID recommendations, the vanc and CTX were discontinued and oral doxycycline was started, which should be continued for 6 months. It could be considered to switch to PO amoxicillin after 2 weeks and finish the 6 month course with amoxicillin. This will be discussed during outpatient follow-up. Per ID recommendations, the following labs should be checked 2 weeks after discharge (on 3/29/21) and could be spaced out to every 4 weeks thereafter if normal: CBC with differential, CRP, ESR, BUN, creatinine, AST, ALT. The patient is scheduled to see (ID) on 5/5/21. Dermatology was consulted per ID recs for evaluation of spots on the chest and back. Per dermatology these spots are keloid, not suspicious for hidradenitis suppurative, there is no need for biopsy. For pilonidal cyst spot dermatology recommends rec hibicleans cream. Immunology was consulted for recurring abscesses and recommended the following tests, which were ordered, in addition to outpatient followup: IgG, IgA, IgM, IgE, specific Ab titers: for strep pneumo IgG (23 serotypes) and tetanus IgG, lymphocyte subsets, T cell memory panel, B cell memory panel, neutrophil DHR, CH50. A wound VAC was placed on the left axillary wound bed on 03/15/21 and exchanged on 3/17/21. Patient tolerated the wound vac changes well with 5mg of oxycodone taken 1 hour prior to the vac change. On 03/18/21 patient was discharged with a home wound vac and VNA. At the time of discharged patient was afebrile, his pain was well controlled, his oxygen saturations were >94% on room air, he was tolerating a regular diet and voiding/stooling without issues.

tongue swelling, upper exteremity splotchyness, c/o mild difficulty breathing; treated with epi 0.3mg, Pepcid 20mg, Benadryl 50mg, transported to Hospital per EMS

Muscular pain at site, day of shot and day after. Runny nose, 2 days after shot, ongoing. Extensive sneezing, 2 days after shot, ongoing. Nausea, 3 days after shot, ongoing. No medical visits scheduled currently. Patient began taking DayQuil 60 hours after shot, and has taken a dose approximately every 6 hours subsequently.

Low-grade fever, headache, loss of appetite, fatigue, dizziness, moderate pain at the site of injection. Symptoms began approximately 12h after inoculation.

Patient presents post vaccination complaining of heart palpitations, new sore throat, redness and pain at injection site and reporting "feeling different". RN triaged patient and took patient to ER for further evaluation.

15 minutes after receiving vaccine, throat closing, itchiness, chest tightness. EPI injected and given Benadryl. 911 called Transferred to ED via EMS. In ED given Solumedrol and an additional EPI SQ. Observed in ED for several hours. Advised not to get 2nd vaccine. Discharged home in stable condition

I did not have an immediate reaction on the same. The next day I noticed red hives disperse on my torso: stomach, upper back, lower back, upper buttocks, legs, and penis. On Sunday, I got a burning red rash on my anterior arm, but it went away in a hour. By Wednesday, when I visited my doctor, the hives were not red, only a small dot was left.

45 minutes after injection my forearm of the injection arm became bright red, 5:30 pm: Small hives on my neck line formed and lasted for 3 hours. At roughly 7:30 pm I became itchy all over. Taking an antihistamine solved these problems. I was fine the next day. No irritation or reaction around the injection site.

Systemic: Allergic: Itch Generalized-Mild, Systemic: Abdominal Pain-Mild, Systemic: Headache-Severe, Additional Details: After being vaccinated, patient experienced some ear pain likely associated with a migraine as well as some itching but not enough for antihistamines. Patient was monitored at for 30 min with no issues. When patient arrived home, he went to sleep. When he woke up, mother states patient was having feelings of wanting to hurt himself so he was taken to the ER. All reactions have subsided.

Chills and cold sweats the night after receiving the vaccine. Next day had fatigue and soreness in the left shoulder. Also had swollen lymph nodes under my left armpit which led to an inflamed lump there.

weird rash on hand; 13 Days after 1st dose, redness appeared on left and right hand.; 24 hours after that, blisters and increased redness occurred in the area. Tested negative for COVID19. Took a bacteria culture of the; This is a spontaneous report from a contactable consumer. A 21-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 13Mar2021 at 13:30 (Batch/Lot Number: EN6204) at the age of 21 years-old, as SINGLE DOSE for covid-19 immunisation . Medical history included from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. On 28Mar2021, at 0900, 13 Days after 1st dose, redness appeared on left and right hand. 24 hours after that, blisters and increased redness occurred in the area. Tested negative for COVID19 on 27Mar2021. Took a bacteria culture of the area which grew NO bacteria. Taking antibiotics which have no observed effect. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: pt was fasting from past 2 days before getting vaccine

Pruritic rash on hands, legs, groin and stomach <24 hours following vaccination that persists for 1 week.

My hands began to swell, turned red, itched, and felt a burning sensation, and it hurt but then it went away. I don?t know what happened.

started with soreness/stiffness in injection site, which I expected as it was how I reacted with the first shot. however, I then started experiencing mild dizziness/visual impairment (feeling like my vision was shifting or "glitching") that started around two hours after the shot, slow onset of sore/achy back muscles that hit peak pain at around 3am, and intense chills/shivers that started around 11pm, getting progressively worse as the night went on. Attempted to stop the chills by wrapping in several blankets, but only continued to feel colder and colder. Despite the chills starting around 11pm, fever did not present itself until around 1am, hitting 99.8°F by 1:30am. It was around this time that I took an ibuprofen and acetaminophen, which did not kick in until around 2:30am. Once the chills stopped, my hands and feet only got hotter, keeping me awake for an additional 2 1/2 hours.

bruises around injection site and all around the left arm; bruises around injection site and all around the left arm; severe fatigue; This is a spontaneous report from a contactable consumer(patient). A 21-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8733; Expiration Date: 31Jul2021), first dose via an unspecified route of administration, administered in left arm on 07Apr2021 as SINGLE DOSE for covid-19 immunization. Patient was 21 years old at the time of vaccination. Patient's medical history and concomitant medications were not reported. Patient did not receive any prior vaccinations within 4 weeks of first administration of vaccination. On 08Apr2021 patient experienced severe fatigue, stated it was really bad. On 11Apr2021 patient had bruises around injection site and all around the left arm, a lot of them. States the fatigue has improved some but he was just so exhausted. Wanted to also know is there any chance he is having low platelet counts. The outcome of the event bruises around injection site and all around the left arm was unknown and severe fatigue was reported as recovering. No follow-up attempts are needed; No further information is expected.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: walking in store, vision went black and could not hear. sat down, head down , we took blood pressure, blood pressure was low 87/56. called ems. he started to feel better. started sitting up straight again. ems took blood pressure and it had started to improve. Mother came to pharmacy. went home with mom. Did not go to hospital. (pt had eaten prior to vaccine and drank water)

patient was nauseated 10 minutes after dose, proceeded to have tingling in feet first, then legs and arms that moved into abdomen as well. Pain and extreme heaviness in arm shot was administered in. Ice packs were placed on arm and back of neck. Patient then stated after another 10-15 minutes that breathing was becoming labored and then both hands drew in and locked unable to move them. EMS was called at this time and EPIPEN was readied but not administered. Patient continued to communicate tingling was coming and going and after another 10 to 15 minutes breathing eased up and tingling in lip and body was fading along with able to move fingers but not thumbs. EMS arrived and took all vitals and cleared patient. About 15 minutes after patient was able to leave on own accord.

Friday 4/30/21 Experienced throbbing headaches, cold sweats, chills, nausea, low grade fever, and small red rash and dryness on my face. Saturday 5/1/21 Experienced throbbing headaches, weakness, cold sweats, chills, 102-103 fever, and small red rash and dryness on my face. Sunday 5/2/21 Experienced throbbing headaches, weakness, cold sweats, chills 102-103 fever, and red rash and dryness spreading to my chest. Monday 5/3/21 Experienced throbbing headaches, weakness, cold sweats, chills, 102-103 fever, and red rash and dryness on my face, chest, and neck. Tuesday 5/4/21 Experienced weakness, cold sweats, low grade fever, and red rash and dryness on my chest, neck, back, face, and groin. Wednesday 5/5/21 Experienced weakness, cold sweats, and red rash and dryness on my chest, neck. face, and groin.

Petechial rash developed to thighs one week after receiving vaccine. Rash progressed to cover more of thighs and trunk over the following days/weeks with addition of pruritic raised lesions.

POST VACCINE ADMIN, PATIENT REPORTED HE FELT LIGHTHEADED, QUEEZY, STARTED TO GET TUNNEL VISION. REPORTS HE ATTEMPTED TO GET UP AND LEAVE, AND STARTED TO PASS OUT, COULD NOT REMEMBER IF HE LOST CONSCIOUSNESS, HAD UNWITNESSED, UNASSISTED FALL TO FLOOR, REGAINED AWARENESS, AND GOT SELF BACK IN CHAIR, NOTEABLY DIAPHORETIC AND PALE. STAFF ASSISTED PATIENT BACK TO FLOOR AND RAISED LEGS IN AIR. ASSISTED TO STRETCHER AND PLACED IN TRENDELENBERG, TAKENE TO OBS. STATES RELIEF ONCE ON STRETCHER. ORTHOSTATIC HOTN NOTED ONCE STANDING WITH DIZZINESS REPORTED, ASSISTED BACK TO STRETCHER AND SNAKC/WATER/JUICE PROVIDED. R KNEE ABRASION/BRUSHBURN NOTED FROM FALL, CLEANSED BY ON SITE MD, NO OTHER INJURIES NOTED OR REPORTED BY PATIENT. ONCE S/S RESOLVED AND BP MAINTAINED IN STANDING POSITION, PATIENT ESCORTED TO EXIT WITH NO ISSUES AT 0955. PER ON SITE MD, CLASSIC VASOVAGAL REACTION, RESOLVED. 0936 LYING BP 106/73 HR 70 RR 18 SATS 100% RA 0940 SITTING BP 118/73 HR 65 RR 18 SATS 100% RA 0942 STANDING BP 110/66 HR 71 RR 18 SATS 100% RA; REPORTS SOME DIZZINESS RETURNED, SAT BACK ON STRETCHER 0948 STANDING BP 98/67 HR 74 RR 20 SATS 100% RA; ASSYMPTOMATIC 0950 STANDING BP 88/58 HR 70 RR 18 SATS 100% RA; REPORTS MILD DIZZINESS BUT IMPROVING 0954 STANDING BP 109/72 HR 75 RR 18 SATS 100% RA; REPORTS S/S RESOLVED, AMBULATING WITH STEADY GAIT AND REQUESTING TO LEAVE, NO FURTHER ISSUES.

21yoM states that on 25 March 2021, he noted 25 minutes after his 1st dose of Pfizer vaccines, he noted a throat tightness, feels tight, scratchy, noted a hoarse throat with some voice changes. He felt throat tightness made it hard to breath, he had associated lightheadedness, felt anxious, almost like a wheezing sound when breathed in and out in his upper neck. When he stood up, he did feel like he needed to hold onto something to steady himself, had some tunnel vision, improved with sitting down and closing his yes and taking deep breaths. He felt warm at the time, not cold or clammy. His friend said he looked ghostly white, no flushing, no hives, no angioedema. No sense of impending doom. He did take Zyrtec the day that he received the vaccine. He waited the 15 minutes after vaccine without symptoms, and had walked back to class by the time it started. Between the vaccine and symptoms onset, he denies eating anything, being stung by anything. He told a friend about his symptoms, and he returned to the hospital via base taxi arrived at ER. Symptoms were still occurring about 60 minutes after vaccination when he arrived at the ER. In the ER, he underwent exam, was given oral Benadryl. His symptoms of scratchy throat lasted for 2 days afterwards with some associated fatigue, post-nasal drip. He denies other symptoms. No fevers or chills. Small amount of pain and a ?knot? at the injection site the next day, but minimal according to the paitent. Denies hives, angioedema, SOB, wheezing, nausea/vomiting, no diarrhea, abdominal pain, nasal pruritus/congestion, ocuarl itching/redness, no syncope. No h/o vaccine reactions before. No h/o passing out before at all, specifically not to needles, blood draws, or vaccines before. No h/o venom or drug allergy. He does report a history of apple allergic reaction 1 year previous when eating a raw apple, felt his throat close within 15-30 minutes, no hives or other systemic symptoms. He took oral Benadryl and went to ER. He was given oral Benadryl, no Epipen. He followed up with his PCM regarding possible apple allergy and was told to avoid apples, but was never tested for apple allergy. Since then, when he drinks apple juice, his throat will start hurting, but otherwise, he has avoided raw and cooked allergies. He does report seasonal rhinitis symptoms that are worse in the fall. He takes allegra as needed to treat these symptoms. He is not carrying an Epipen currently

Starting the day after the second dose of Pfizer mRNA, he developed prodrome with fever/chills, N/V/D, systemic macular rash, and fatigue that persisted until presenting to the ED 9 days later. He was noted to be tachycardic and hypotensive with a severe leukocytosis, elevated inflammatory markers and + troponin, and an LVEF 35-40%. He was referred to tertiary care center, had a cardiac MRI that showed little inflammation but LVEF now 12%. On 5/21/21 he was started on high dose steroids and placed on mechanical circulatory support with VA ECMO. Cardiac function quickly improved and he is ready to come off VA ECMO 5/29 with an LVEF improved to > 40% during weaning trials.

Told by his doctor to not get the second dose; Hives on and off all over his body; Liver values were elevated 100 points; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number: EL9267 Expiration Date: 31May2021) via an unspecified route of administration in left deltoid on 11Feb2021 around noon as 1ST DOSE SINGLE DOSE for covid-19 immunisation. The patient medical history included Attention deficit hyperactivity disorder (ADHD) Diagnosed around July2020 or Aug2020. Of course, he thinks it has been lifelong and they did not know, nobody else in my family had it and they were like why is he crazy and sickle cell carrier (has known about this since birth). The allergic history of the patient included allergic to penicillin, He does have a history of sickle cell anemia. The concomitants medications of the patient included METHYLPHENIDATE HYDROCHLORIDE 5 mg less than a year. He does not use it a lot for ADHD. He stopped using it for a hot minute. He confirms that the medication is only taken as needed. The family medical history of the patient is reported as his aunt had a reaction to penicillin and his mother has heart issues and sickle cell, he got it from her. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The list of all vaccines administered on same date with the Pfizer vaccine considered as suspect and history of all previous immunization with the Pfizer vaccine considered as suspect are reported as none. He received the first dose of the Pfizer COVID 19 vaccine on 11Feb2021 and began having symptoms on 13Feb2021. He has been experiencing hives on and off all over his body since having then. He states that he has opted not to have the second dose due to these side effects and he does not wish to take the risk of potential increase adverse effects. He does have a history of sickle cell anemia. He has spoken with a physician who stated that maybe he shouldn't received the second dose of the vaccine. He states that he has made up his mind and it not receiving it. His question is in regards to his vaccination card. He states that now that things are beginning to open up again vaccine cards are starting to be check and he would like to know if we have any guidance on what he needs as far as documentation that he can not receive the second dose of the vaccine. States he thought he would most likely need documentation from his doctor but wanted to make sure that there wasn't a form or anything he needed to have filled out. who received his first dose of the Pfizer Covid-19 Vaccine and had an extremely bad reaction, such a bad reaction that he was told by his doctor to not get the second dose of the Pfizer Covid-19 Vaccine. Hives: Patient stateed that with his bad reaction, it happened 13Feb2021. It was two days after he got the vaccine, which was on 11Feb2021 when he received his first dose. He started having these reactions. He has hives all over randomly every day, every day, since 13Feb2021. He will get them in his mouth, gums, eyelids. He can't talk. He will get them in his armpits and if he sweats they are on his back. Treatment: they just gave him over the counter Allegra and it worked for a few days but then he had a bad one where it was half his body. Patient added they gave him an allergy injection, but it was the same thing where it only worked for a few days and then he had a bad one where it did not work anymore. Received Allergy injection as treatment. Liver values were elevated 100 points: patient added that so when at first he did not know if this was related or not, he went to the doctor the first time and his liver values were elevated 100 points as well. He had to change his diet and get back to a normal level as well. Patient added that he would also like to point out that there were non healthcare people giving the vaccine. He had a questionnaire about health stuff and they did not look at it until after he received the vaccine and they were like oh you have a blood thing. Patient told them yes, he is a carrier for sickle cell. He told them he hopes that it does not react, and he does not know if this is from the sickle cell or what it is. If they had looked at it, it would have been different. He was very pissed off they did not look at this health questionnaire until after he received the vaccine. Allegra: He stated that it is Fexofenadine, it has an expiration date of 21Apr2021 and the Manufacturer. Investigations: he has had three blood tests, an echocardiogram, a liver ultrasound, and a chest X-ray. The blood was all normal, no hepatitis A or B. Other than the liver thing he mentioned earlier but that resolved. His liver was normal. He has a recheck today and they are going to give him the echo and xray results back. patient does not specify dates or have any additional information. He does not yet know the results to the echocardiogram or X-ray. Any AE(s) require a visit to Physician Office: Yes. He wants to know if since he is going to the doctor today, does he need a note from the doctor saying he should not have the second dose of the vaccine. With things opening up there, people are asking about the vaccine card. He wants to say he got a reaction but people might think he is making it up. Description of Product Complaint: Allegra: While discussing treatment for his hives, patient stated they just gave him over the counter Allegra and it worked for a few days but then he had a bad one where it was half his body. Patient stated that it is Fexofenadine, it has an expiration date of 21Apr2021 and the Manufacturer. He does not have any additional details to provide. The outcome of the events was reported as unknown for all and recovered for Liver disorder. No follow-up attempts are needed. No further information is expected.

Patient stated that developed itchy, red rash on the injection site 3 days after vaccination. It is not hot, or hard, just itchy with some discharge. The rash is not painful. Noticed that arm was itchy after cutting the grass outside (he is allergic to pollen). Recommend for him to take benadryl and call pcp if does not resolve.

PATIENT WENT INTO SYNCOPE 5 MINUTES AFTER RECEIVING THE VACCINATION AND HAD SEIZURES. HE TURNED RED AND STARTED SWEATING . HE SAID HE HAD NUMBNESS IN HIS HANDS AND FEET AND THEN HE HAD A TINGLY SENSATION AND WAS FEELING WOOZY. THE PARAMEDICS WALKED HIM NEXT DOOR TO THE IMMEDIATE CARE AND THE ATTENDING DOCTOR CALLED AND ME AND INFORMED ME THE REACTION WAS VASOVAGAL AND WAS MOST LIKELY FROM ANXIETY.

Flushing skin, numbness, itching, urticaria, burning of eyes. 50mg Benadryl given and EMS called, pt transported by EMS to ED.

2nd Dose: - Pain in the injection arm roughly ~9 hours after. - Pain escalated from a 1-2 to a 4-5 throughout the night. - Pain on left arm, near first injection site returned. Unsure if correlation or just early signs of body fatigue/soreness starting. - Minor swelling on right arm & was warm to touch. Applied ice pack and went to sleep. - Pain escalated to a 5-6 the following morning (6/16) at ~8-10am. - Full body fatigue started around 10-11am on 6/16. (No mental fog present, fatigue incl. soreness & general pain) - Throughout the day, chills are present intermittently. - Throughout the day, nausea is present intermittently. - At time of writing (9:05pm 6/16) pain is at a 3-4 on right arm, pain throughout body is a 2-3 depending on location. OTC pain medication such as Tylenol has limited effect. 1st Dose: (not sure if you want this but I will add it anyway) Received 5/13/2021 @ 1:40pm @ Clinic (same location as above; lot # above as well) - Pain in the injection arm roughly ~3-4 hours after. - Pain remained a low level 2-3 on a general pain index throughout the day. - Following morning, at ~8am (5/14) pain was a 3-4. Responded to OTC Tylenol immediately. - Arm was tender for 3-4 days, until it resolved.

Tightness in throat for 15 minutes; light fever; feeling very sluggish; pain when the vaccine was administered.; This is a spontaneous report from a contactable consumer (patient). A 21-years-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration, in left arm on 30Apr2021 at 16:30 (at the age of 21-years-old) as First dose , single dose for covid-19 immunisation. Medical history included crohn's disease, coeliac disease, asthma and Bactrim allergy. Concomitant medications included amoxicillin (AMOXIL), codeine phosphate, paracetamol (TYLENOL WITH CODEINE) and ibuprofen (IBUPROFEN) taken for an unspecified indication. Patient has not received any other vaccine in four weeks. Prior vaccination, patient was not diagnosed with covid-19. Since the vaccination, patient has not tested positive for covid-19. On 30Apr2021 at 16:30, the patient experienced tightness in throat for 15 minutes, light fever, feeling very sluggish and pain when the vaccine was administered. Therapeutic measures were taken as a result of tightness in throat for 15 minutes, light fever, feeling very sluggish and pain. Treatment received for the events included Tylenol 500 mg. Outcome of events was recovering. No follow-up attempts needed. No further information is expected.

Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Severe, Systemic: Shakiness-Severe, Additional Details: patient described an uncontrollable shaking for approximately 1/2 hours

Blisters on the hands, feet, and inside mouth. Doctor said they are seeing this in some people with the 2nd Pfizer shot. Told us it should disappear in 10 days maximum.

Rash on skin, face, mouth, legs; This is a spontaneous report from a contactable consumer (patient) or other non health care professional. A 21-years-old male patient received bnt162b2 (Covid-19 vaccine, Formulation: Solution for injection), via an unspecified route of administration on 12Jul2021 as dose 2, single for covid-19 immunisation The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 for Covid-19 immunization (Dose 1). On an unspecified date, the patient experienced rash on skin, face, mouth, legs. Treatment received for the adverse events. The outcome of the event was unknown. Information about batch/ lot number has been requested.

Red rash on face, neck, chest and arm; difficulty swallowing; This is a spontaneous report from a contactable nurse (patient). A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ELO140) intramuscular on 26Dec2020 18:30 (06:30 PM) at a single dose on the right arm as COVID-19 vaccine. Medical history included previously diagnosed with COVID-19 prior to vaccination. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient had adverse events of red rash on face, neck, chest and arm; and difficulty swallowing, both on 26Dec2020 19:00 (07:00 PM) assessed as non-serious. It did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. There was no treatment for the events. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). He had no other vaccine within four weeks prior to the COVID vaccine, no other medications within two weeks of vaccination. He did not have Covid tested post vaccination. The outcome of the events was recovered on Dec2020.

Injection site pain - present Tiredness - 24hrs Headache - 24 hrs Muscle pain - 24 hrs Chills - 24 hrs Joint pain - 24 hrs Fever (101.2°f) - 24 hrs Nausea - 24 hrs Malaise - 24 hrs Swollen lymph node (left armpit only) - present

After receiving the second round of my Pfizer COVID vaccine, approximately an hour and a half later I received a rash on my right bicep and across my abdomen going slightly onto my back and I became itchy.

Symptoms: Started with a rash in the left axillary region. Itching spread across all of upper torso. Itchy rash with hives. Diagnosed as unknown urticaria. Prednisone 20mg 1 time per day and hydroxyzine 10mg 3-4 times a day. After 1 days, symptoms have improved but not resolved

Extreme sensitivity to cold contact on skin. Routine icing after physical therapy (only 8-10 minutes) resulted in severe pain at site of icing along with swelling and redness that has persisted for 4 days. It has evolved now into itchy boils.

Slight fever (99.4); Fatigue; Aches; shoulder where shot was administered ached; This is a spontaneous report from a contactable consumer reported for himself. A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route at left arm on 26Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included Covid-19 infection. Since the vaccination the patient has not been tested for COVID-19. Concomitant medications were not reported. On 26Jan2021 at 20:00 the patient experienced slight fever (99.4),fFatigue, ache and shoulder where shot was administered ached. The outcome of the events was recovered on unknown date. The patient did not receive any treatment. Information on the lot/batch number has been requested.

Patient experienced hives shortly after vaccination was administered. Benadryl was administered and the hives resolved

Conducting Covid Vaccine Clinic. Patient had already received his vaccination. At 2:74PM Staff yelled to nursing staff for help. Patient was passed out, hyper extended in chair. He jerked once and staff got him on the floor. He took 15 seconds to speak at which time he refused Epinephrine. Staff got him up into chair once he was alert and oriented. He was able to speak clearly, stating he felt tingling in his right arm and then throughout the rest of his body before passing out. Blood pressure was 118/82. At 3:05PM, he was up, walking around, alert and oriented x3. Staff drove him home and instructed him to contact his physician. Follow up today, 2/24/21 patient states injection site is sore but he is ok an d has an appointment to speak with his physician.

fever, headache, full-body muscle aches, generalized joint pain, injection-site pain, chills, purple, speckled rash bilateral arms, eczema flare on left arm around injection site

Swelling in both hands, more in the left hand as it was vaccination arm. Tingling through body. Multiple Hives (about 5) formed on my arms and upper body. Took 50mg benadryl to manage. Was already on Zyrtec at the time in case of reaction. Slight congestion and sinus irritation but no feeling of anaphylaxis or much in the throat. Symtoms stopped worsening and were gone by the next day.

- palms and wrists extremely itchy about an hour after getting the vaccine - overall body itchiness for the next week - 6 days after getting the vaccine, hives on face, chest, arms

Approximately 24 hours after vaccination patient developed chills, then hives over multiple areas of his body.

Pruritic morbilliform eruption also with few scattered punctate pustules with predilection for intertriginous sites and groin that developed 24 hours after Pfizer mRNA COVID vaccine without other identifiable trigger and spread over next week. - Antifungal cream - ineffective - single dose of prednisone 60 mg - improved pruritus and swelling - Started on topical corticosteroid and oral H1 antihistamine today

Back was itchy, normal for him, no hives visible. Allergy to grasses, normally itchy with runny nose and eyes. Itchiness deteriorated after sitting. released at 5:05pm

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Patient complained of \" numbness \" around his lips, 5 minutes after dose given ( 1905 hours ) T 97.7 temporal, p-80 reg, R 20\r\nsaturation 97% room air. BP 110/70. Benadry 25 mg PO given per PharmD. Patient sx subsided, went home, T 98, P 76\r\nreg, R 20, saturation 99%. Instructed to report to PCP MD, call 911 if sx returned or condition worsened

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Additional Details: Pt was sitting for observation and suddenly fell to lateral side. Staff RN and technician responded immediately.

Syncope Forehand abrasion/laceration BP from 152/81 to 132/94 HR 88 to 97 History of Guillen barre syndrome

Patient was in waiting area after vaccine. He started feeling faint and nausea. He sat down on floor and motioned for help. Ran to help. he was hot and clammy. applied cold hand to back of neck till able to get cold cloth, gave him bag in case of vomit, gave him a water. started feeling better , gave him several Hershey kisses. He sat for 10 minutes then felt normal and left

Erythema chest, abd, back, both upper extremities. Urticaris decranon regions both arms 8 hours after vaccine

Patient called back after about 6 hours from administration reporting pain in upper left arm and loss of mobility in shoulder and elbow.

My arm went completely numb immediately and then it started itching and then about an hour later my throat started to close and I could see my heart beating out of my chest and I ended up having to go to the emergency room and then over the next three weeks I have experienced every side effect that is listed With the worst being fatigue muscle ache and abdominal cramps

First dose: -moderate arm soreness/injection site pain for 3 days ~8:00 PM 4/7/2021 (day of dose 2): -mild dizziness (30 min) ~4:00 PM 4/8/2021 -?brain fog? spaced out and very tired, trouble focusing (~30 min) -tiredness continued throughout the rest of the day ~5:00 AM 4/9/2021 -vivid bad dream -slight head ache -mild injection site pain/arm soreness since 4/8/2021

1330 recevied pfizer covid vaccine, lot # EW0153 right deltoid 1345 walked to tent, due to lightheadedness, anxiety, feels itchy at throat, VSS 1352 scratchy throat, rash at throat, ENT clear , HR RR,lungs clear A&P 1355 worsening symptoms , clearing throatt, sob, wheals on neck, epinephrine 1:1000 0.5ml IM given , 02 10 L via mask, 1402 throat symptoms resolved, no sob, pulse ox 100 , VSS ENT : clear, cardio rr without murmur,lungs clear A&P diphenhydramine 50mg IM left deltoid, IV hep lick Right antecubital 1413transported via ambulance sse progress note scanned into chart

Patient was sitting upright in chair looking down at phone. Had a syncopal episode, fell to floor, had seizure activity that lasted 5-10 secs. Patient awakened on his own, confused. Tried to get off of floor. Asked to stay on right side of floor. Vitals obtained. A/Ox2. Patient diaphoretic, pale, with shivering. Abrasions to right side of forehead and right posterior shoulder. BP 89/56, HR 56, O2 99% at 1257. Patient able to go from sitting to standing position to be sat in chair. Father notified of events. Father wanted patient to stay here at site for one hour. Within 5 mins of sitting in chair, patient became diaphoretic and pale again with focal stare. Per patient, "I can't hear or see you at the moment." EMS activated. BP obtained again, 78/52, HR 63, O2 at 99%. EMS arrived and assessed patient. Decided to take to Hospital. Father called and notified. Father will meet son at emergency dept.

On 3/24/21 received vaccine and then on 3/31 began breaking out in hives on face/hands front and back and in between fingers/hives on arms/elbows/legs/knees/feet too and bottom hives also around eyes.Pain really bad in hands and feet. Swelling around eyes/face/hands/some fingers in the joint area. Itching was all over except back and tummy. Priority Care seen by said serum sickness but had never seen from vaccine recommended to follow up with family Dr . I contacted Dr 's office was told no need to see him as Priority care diagnosed and prescribed predisone 10 mg. I still wanted some answers call back next day and we went in 4/12/21 was told need to get with Infectious disease dr at major hospital spoke with his nurse on 4/12/21 and she said I would get call back about a referral appt. I did get call back from Family Dr and they said they spoke with Dr and he said no need to see him it's very common and he can get the 2nd shot. Never saw him or anything. So we are finishing up predisone script on Saturday 4/17/21 and he is also taking benadryl and the hives disappear but come right back and sometimes worse. Please help

Felt fine day of vaccine, Sunday, just minor arm pain. Woke up the next morning with pretty severe fatigue and more arm pain. Around 11am I had pretty bad chills that lasted about an hour, along with minor nausea. Additionally, throughout most of the day my heart rate was usually between 90-100 bpm, even while lying down and doing nothing. Going to sleep on Monday night I woke around 3 times during the night with cold sweats. Waking up on Tuesday morning, my heart rate is still elevated, arm is still sore, but the fatigue isn't as bad. However, at around 9am on Tuesday morning I started to develop itchy hives and a rash on the back of my legs. After the first dose I only had a sore arm, no symptoms like these, and I do not have any known allergies.

Confirmed Shingles treated with Val acyclovir and gabapentin. Rash (scaring) is still present but pain has subsided

develop red, swollen fingers that were tender to the touch, and were "cold at first but now they're pretty hot" to the touch and "they were a little bit itchy, as well; develop red, swollen fingers that were tender to the touch, and were "cold at first but now they're pretty hot" to the touch and "they were a little bit itchy, as well; develop red, swollen fingers that were tender to the touch, and were "cold at first but now they're pretty hot" to the touch and "they were a little bit itchy, as well; develop red, swollen fingers that were tender to the touch, and were "cold at first but now they're pretty hot" to the touch and "they were a little bit itchy, as well; develop red, swollen fingers that were tender to the touch, and were "cold at first but now they're pretty hot" to the touch and "they were a little bit itchy, as well; develop red, swollen fingers that were tender to the touch, and were "cold at first but now they're pretty hot" to the touch and "they were a little bit itchy, as well; inflammation; swelling; allergic reaction; This is a spontaneous report received from a contactable male consumer (patient). This 22-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration in the on 05Apr2021 at 12:45 as a single dose for COVID-19 immunisation. The patients familial history included a reaction to unknown vaccine to patients mother. The patients medical history included allergy to gantrisin, sulfa drug and penicillin. Concomitant medications were not reported. No other vaccine in four weeks. On Tuesday 06Apr2021 at around 15:00, the patient developed red, swollen fingers that were tender to touch and were cold at first but later were pretty hot to touch and were a little bit itchy. It was unknown if the redness has gone down but on 07Apr2021, it started blistering is still red and itchy. The events resulted in a visit to the ER and they believe he is having an allergic reaction to the vaccine and was seen by his primary care physician. The patient went to the Emergency Room on 06Apr2021. The patient was prescribed treatment as Benadryl and Prednisone. The outcome of the events was unknown. The patient wants to know if he will be contacted, or where he can find more information about the symptoms he experienced, when that information would be available. No follow-up attempts are needed. No further information is expected.

Tiny "bumps" covering both arms, both legs below the knee, collarbone area, back, and shoulders. Bumps are extremely itchy. I have unknowingly itched my arms until the bumps begin to bleed. Best described as hundreds of small mosquito bites.

Patient received second Pfizer vaccine- no reaction to first vaccine. Patient placed on 30 minute observation for anaphylaxis to pistachio nuts. Received vaccine at 1440. At approximately 1450 patient complained of feeling bad and having a rapid heart rate; placed on pulse oximetry HR 103 (validated with radial pulse of 104/min) and O2 Sat 98%. Patient requested to void; patient stated he felt very anxious. Patient escorted to BR; became lightheaded enroute. Placed supine on sofa; legs elevated; encouraged slow deep breaths; with purse lips. VS- at 1455 = 184/80, 99%, 147 Reg/tachycardic. RR 24/min. Patient continued to feel more lightheaded with warm clammy skin. States his heart rate was worsening. VS at 1500 = 180/90, HR 145, RR 24 with unlabored breathing, o2Sat 98%. Arms tingling, lips pink, skin pale, no circumoral edema; no hives-speech controlled and unlabored. 911 called for further evaluation and clinical support. Patient agreed with plan of care. No LOC throughout event.

Numbness/loss of sensation in toes began around 4/16/2021: Sensation reduced from the toes up to the hip bilaterally (R<L). Strength 5/5 bilaterally. 2+ reflexes in lower extremities. 2-3 beats of clonus bilateral ankle jerk. Mottling on feet, interior ankles, kneecaps. Decreased cap refill in feet, knees, and interior ankles. Feet extremely cold. Presented to urgent care 4/26/2021. While there, noticed purplish discoloration over knees and feet as well as diminished sensation up to both hips as well as over the right arm and right side of face. Subsequently transferred to emergency department from urgent care for further evaluation. Neurology consulted after examination was notable for brisk lower extremity reflexes and bilateral ankle clonus. CRP mildly elevated at 12.5.

Developed pruritic hives on buttocks, thighs, and arms, with bilateral hand swelling over 72 hours after vaccine administration. Hives resolved with Benadryl administration. Had temperature of 99/100F and myalgias for 48 hours after vaccine administration which resolved prior to onset of hives.

Pinched nerve pain, dizziness, swelling of throat, numbness/tingling right arm, nausea, difficulty swallowing. Arrived nauseous and listed symptoms -- verbalized improvement. Stable, released from vaccination site.

Woke up with pain and swellig base of left neck with a firm, slightly cystic feeling, rounds and slightly tender mobile mass (3 cm) anterior to left clavicle

Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Additional Details: Pt states they hadn't eaten and were dehydrated. pt definitley fell to ground from seated position. possible seizure activity for <1 mins

Slight headache and ache near injection area; Slight headache and ache near injection area; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9265) at right arm on 05Feb2021 01:00 PM, at single dose for COVID-19 immunization in Pharmacy or Drug Store. Medical history included Asthma. Known allergies was None. Concomitant medications were not reported. No other vaccine in four weeks. Patient experienced slight headache and ache near injection area on 05Feb2021 01:45 PM. No covid prior vaccination. No covid tested post vaccination. Treatment for the events included ibuprofen. Outcome of the event was recovered. No follow-up attempts are possible; No further information is expected.

Shoulder pain; Neck pain; Pulled a muscle; Blisters appeared on the arm; Shingles; Some residual pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266; Expiration date was not reported) on the upper right arm on 13Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included acid reflux, anxiety, insomnia, and was stressed out. Concomitant medications included pantoprazole for acid reflux; and hydroxyzine HCl for insomnia and anxiety. On 21Feb2021, the patient had shoulder pain; neck pain; had pulled a muscle; blisters appeared on the arm; had shingles; and some residual pain. The patient had received prednisone and valacyclovir as treatment for shingles. The outcome of the evens was recovering for blisters; was recovered on an unspecified date in 2021 for shingles; and was unknown for all the other events. The patient wanted to make sure if it would be safe to receive the second dose of vaccination.

Rash; redness; This is a spontaneous report from a contactable nurse reporting for himself. This 22-year-old male patient received on 09Feb2021 04:00 PM BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm as a single dose at the age of 22-years for COVID-19 immunization. Medical history and concomitant medication were not reported. No other vaccinations have been administered within 4 weeks before. On 09Feb2021 09:00 PM, the patient had rash and redness. No treatment was provided. Outcome was recovering. Information on the batch number has been requested.

Acute onset exhaustion, Passing nausea. Vital Signs: BP 118/70 HR 80 Resp 18 O2Sat 96% Skin Signs: Diaphoretic Circulation: Cap refill <2sec Initial Treatment: Observation. Patient denies recent illness, exposure, or ill family members. Scanned in at 100.1 temp on arrival. 3:14 PM Vital Signs: BP 116/68 HR 78 Resp 16 O2Sat 98% Skin Signs: Warm and dry Circulation: Cap refill <2sec Follow up Treatment: Drinking water. Reports feeling better D/C home by self. Complete recovery.

Slow cap refill in feet, knees, inside ankle -L/R sides; Numbness, starting in toes, ascending to knees, thighs.; Mottling on feet, interior ankles, kneecaps; Bilateral decreased sensation from the toes up to the hip, with intact strength, with 2-3 beats of clonus bilaterally.; Mottling on feet, interior ankles, kneecaps, along with blanching redness.; Mottling on feet, interior ankles, kneecaps, along with blanching redness.; with 2-3 beats of clonus bilaterally; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 09:30 (Lot Number: ER8734) as 1st dose, single for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medications included paroxetine taken for an unspecified indication, within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Slow cap refill in feet, knees, inside ankle - L/R sides; Numbness, starting in toes, ascending to knees, thighs; Mottling on feet, interior ankles, kneecaps, along with blanching redness; Bilateral decreased sensation from the toes up to the hip, with intact strength, with 2-3 beats of clonus bilaterally, 2+ reflexes in lower extremities, No cold sensation below the ankles bilaterally. Adverse events started on 16Apr2021. The adverse events result in Emergency room/department or urgent care. The patient was hospitalized for the reported events for 3 days. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included COVID-19 PCR-Nasal Swab: negative on 13Apr2021, COVID-19 rt-PCR-Nasal Swab: negative on 27Apr2021. There was no treatment received. The outcome of events was not recovered.

I experienced headaches, fever, redness at the injection site, dizziness, weakness, chills, dehydration, low blood pressure, nausea and diarrhea. I went to the ER because of my symptoms, they did EKG, vital signs, lab work. I can say I am not having any of my these symptoms today. I do not have lot # at this moment.

Received on 5/17, developed rash on left arm and hand, then rash on left chest and to right arm and hand. Rash moved to upper legs. Left ear rash started late 5/18, then developed right ear rash 5/18-5/19

Client received his first dose of the Pfizer Covid-19 vaccine (Lot # EW0185 Exp. 08/2021) on 5/27/21 at 1036 AM. At approximately 1045 the client walked up to the EMT asking for water and stating that he felt lightheaded. " Client was a 22-year-old male alert and tracking with his eyes and beginning to stumble. The client had a chief complaint of syncope. EMT managed to assist the client to the observation bed while an additional EMT and RN arrived for further assistance. The client was positioned supine on the cot and proceeded to lose consciousness. The client did not fall or injure himself in any way. He regained consciousness after approximately 15 seconds. He was alert and oriented to person, place, time, and situation immediately upon regaining consciousness. Client stated that he did not have anything to eat or drink before arriving at the vaccination site. The client had no known allergies and denied any medical history. The client was negative for hives, swelling, discoloration, signs or symptoms of shortness of breath, or other signs of anaphylaxis. The client's airway, breathing, and circulation were intact. The first set of vital signs were taken at 1045 and are as follows: blood pressure 110/76, pulse 52, O2 saturation 96%, skin pale, sweaty and hot. The client consented to stay an additional 30 minutes after his initial vitals were taken and his vitals were reassessed every five minutes until his symptoms resolved. After approximately 10 minutes, the client was fully pink in his face and denied any further lightheadedness. At 1051 the second set of vital signs were: bp 122/82, p 56, O2 96%, skins pink, normal, and warm. Client was assisted to an upright seated position and was given Pringles and juice. At 1059 clients vitals were - 124/84 BP, 74HR O2 99%, Resp 16. At 1109 vitals: bp 122/82, p 68, O2 97%, skins pink, normal and warm. At the completion of his additional 30-minute observation, the client stated that he was feeling better. All pertinent information was given to client by EMT and RN and he was encouraged to follow up with his primary before his next dose. The client was also instructed to call 911 if a severe allergic reaction occurred later in the evening and was reminded to eat before his next vaccination. RN educated client about the possible signs and symptoms of an allergic reaction. The client at 1115 in positive disposition with his mother.

cut in the finger and had to go to ER/cut his finger at work; He could not get bleeding to stop/ cutting his finger at work; This is a spontaneous report from a contactable other healthcare professional (also the mother of the patient) from a Pfizer-sponsored program. A 22-years-old male patient (reported as weight: 140-145pounds) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left (reported as around between 11 or 12) on 10May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (Pfizer Covid 19 vaccine) on 18Apr2021 (Sunday) for COVID-19 immunization. It was reported that the patient had the second dose on 10May2021 (Monday) of the covid 19 vaccine had to go to ER and was hospitalized due to cutting his finger at work on 12May2021. The patient took a tetanus shot last night and she wants assurance that he should not be receiving other vaccines after the second dose. She is also concerned and asking if the tetanus will interfere with the efficacy of the vaccine. It was clarified that the patient was not admitted to the hospital, he went to emergency room late last night into the early morning. Confirms he went to ER on 12May2021.She thinks it was probably administered in his left deltoid because he is right handed. He is a healthy young man. For the treatment tetanus shot and gauze bandage with anticoagulant in it since he could not get stitched. He could not get bleeding to stop and then went to ER. Not life threatening. The events resulted in emergency room visit. The events were considered medically significant by the reporter. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Within minutes of receiving covid-19 vaccine, I became very excessive sweaty (my shirt was wet), felt eyesight was dimming, space perception was completely off, very pale, dizziness and unable to hear when being spoken too, felt faint. Both of my arms had a very tingly feeling and felt heavy and then became completely numb and I was unable to move to either arm for approximately 45 minutes. Movement slowly came back throughout the evening and over the next week. My legs felt tingly and heavy. I continue to have periodic tingly feeling in my joints through out my body. My chest felt heavy. I felt like I was doing to die. Large red swollen area where shot was given. I have COVID 19 in Feb, 2021. Health care profession suspects the reaction may have been related to having COVID-19, second dose not recommended. Likely to have antibodies. I have not felt 100 percent since receiving vaccine.

Patient developed hives about the body after leaving the clinic. Patient has not recovered from reaction.

Red sore arm with the bump 22 hours after the shot he went from a normal temperature to chills and 103.4 instantly temperature headache aches pains

Sudden allergy to Sunlight, Polymorphous Light Eruption present on areas of skin exposed to sunlight. No prior history of sensitivity to sunlight. Appeared 24 hours after prolonged exposed to sunlight with sunscreen on. Broke out in red, itchy hives on backs on hands, forearms and back and front of thighs and legs. First appeared a week after first dose administered, went away and the reappeared after prolonged exposure (90+ minutes) two weeks later. First event treated with steroid cream, second event treated with prednisone

Patient experienced Myocarditis-like symptoms beginning 05/20/2021, 3 days after Dose 2 vaccination. See Continuation Page for Item 18 information details. Additional information for Item 18: Day 1 (5/18) Patient had typical dose 2 reactions of low fever (100-101 degF), headache, soreness at injection site, mild dizziness. Day 2 (5/19) he felt much better. On Day 3 (20 May 2021 9:00AM) Patient experienced notable chest pain (level 5-6 on scale of 10) lasting about 30 minutes. Pain then decreased to level 1-2 for the next several hours. Patient said this felt exactly like the pain he experienced when he had Myocarditis in Nov 2017, only less severe. (The 2017 event required 4 days of hospitalization and temporarily left patient with heart failure in one ventricle (Ejection Fraction <40%) although EJ returned to normal after a few months). patient was seeing his Primary Care Physician on another matter later this same morning (5/20) and mentioned the pain. PCP listened to his heart and did not note any irregularities. Patient had no additional pain episodes for the next 3 days so we did not worry. But daily chest pain episodes resumed 5/24, 1 to 3 times a day, mostly level 1-2, sometimes level 3, typically lasting 30 min to 2 hrs, through 6/3. From 6/4 and on episodes have been less frequent. On 5/25 patient contacted his 2017 Cardiologist who ordered a Troponin-I lab. Labs were done 5/26 and were normal so we were advised to monitor but go to the ER if severe chest pain occurred. Patient has an office visit scheduled with his Cardiologist July 2. As of 6/12 (date of report) episodes tend to occur after moderate physical activity but clear after rest. This pattern is similar to what patient experienced during the first 3 months following his 2017 illness. Accordingly patient has reduced his physical activity, using chest pain episodes as an indicator of too much activity. The 2017 illness appeared to be completely resolved after April 2018 with normal ECG, Echo, EJ and no further reports of chest pain even with normal activity levels. May 20, 2021 was the first time this type of chest pain reoccurred.

Patient received the 1st dose of the COVID vaccine (Pfizer Lot # ER8735 expiration date 07/05/2021) at 1547. At 1559, EMT noticed the client rubbing his arm in the location where he received the vaccine. EMT asked him how he was doing. The client stated that he was feeling "tingling at the injection site." PHN and EMT assisted the client to the zero gravity chair at 1600. The client sated that he was not feeling any other symptoms but he has had similar reactions after receiving the flu vaccine, and stated, "my arm swells up, and gets stiff and it's hard to move." Client also stated, "I'm very afraid of needles." Skin around the injection site was the appropriate color to race and was free from erythema and discoloration. Vital signs were taken at 1601 (blood pressure 112/64, oxygen 96%, heart rate 88). Client stated at 1602, "I'm feeling hot now." Client removed his hat. PHN encouraged the client to drink his water, which he complied. PHN offered the client Benadryl at 1605, which he refused. At 1605, client stated, "I do not feel hot anymore." Client has no medical conditions, and is not taking any medications. Client stated that he has no known allergies other than the reaction to the flu vaccine. At 1611, client stated that the "tingling at the injection site was gone." Vital signs taken at 1611 (blood pressure 110/64, oxygen 97%, heart rate 88). Vital signs taken at 1621 (110/54, oxygen 97%, heart rate 80). Vital signs taken at 1629 (blood pressure 112/58, oxygen 97%, heart rate 75). Client stated at 1629, "I feel fine now." PHN provided education to the client on when to seek emergency services, and to follow up with his primary care provider and to see an allergist before receiving his second dose. Client left the facility at 1629, unassisted and with a steady gait.

First week: Chills & headaches. Second week: Heartburn & chest pain. Third week until now: Rashes (pimple-like) & reddish and itchy face and chest.

Moderately sore arm; very mild drowsiness; Mildly sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP6955; Expiration date was not reported), via an unspecified route of administration in the left arm on 22Apr2021 15:30 (at the age of 22-years-old) as first dose, single dose for COVID-19 immunization at a facility or Health Clinic. Medical history included grass allergy, pollen allergy and other allergy (reported as etc.); all from an unknown date and unknown if ongoing. Concomitant medications included fluticasone nasal spray taken for an unspecified indication, start and stop date were not reported. No other vaccine was received by the patient in four weeks. 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 experienced mildly sore arm at injection site on 22Apr2021 and moderately sore arm and very mild drowsiness on 23Apr2021. The outcome of the events was unknown. The patient was vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8731; Expiration date was not reported), via an unspecified route of administration in the left arm on 13May2021 15:30 (at the age of 22-years-old) as second dose, single dose for COVID-19 immunization at a facility or Health Clinic.

The patient is a 22 yo male with a history of asthma who reports onset of dermatitis limited to the vaccinated arm, one day after receipt of COVID vaccine #1 (lot #ER8730). He denies any immediate reaction symptoms to suggest IgE mediated reaction (e.g. oral/face/throat swelling/wheezing etc). He reports he awoke with a highly pruritic tender dermatitis limited to his vaccinated arm from axilla to wrist. No lesions to hands, other extremities, trunk or face. Lesions were papular, discrete, varying in size, and all in the same stage of development. He denies confluence, targetoid appearance, vesicles or pustules. He denies oral or other mucosal lesions, fissures or cracks. He reports the local injection site was tender and erythematous. He denies systemic symptoms such as fever, chills, malaise, cough, CP, HA, n/v/d. He denies illness symptoms prior to vaccine receipt. He denies any history of AE after vaccine receipt. He has no photos, but reports residual discoloration suggestive of post-inflammatory hyperpigmentation. He did not seek care.

body aches; Dizziness; Nausea; loss of appetite; chills; fatigue; itching; This is a spontaneous report from a contactable consumer or other non hcp. A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: unknown; Expiration Date: unknown), via an unspecified route of administration, administered in Arm Right on 28Jan2021 (22-year-old at the time of vaccination), as a single dose for covid-19 immunization. The patient's medical history included non-sustained ventricular tachycardia diagnosed at birth, pacemaker and defibrillator. The reporter stated that her son has a serious heart condition, pacemaker/defibrillator- first was in 6th grade, currently on his fourth and drug hypersensitivity states they monitored them both longer than the 15 minutes because they have a history of serious allergic reactions to ACE inhibitors. The patient's concomitant medications were not reported. The patient continues taking his low dose aspirin prior to the vaccine but did not take any Tylenol. On 28Jan2021, the patient experienced dizziness, nausea, loss of appetite, chills, body aches, fatigue, and itching. The outcome of all the events was recovered on 29Jan2021. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Patient passed out immediately after receiving Pfizer COVID 19 vaccine with recovery within 1 minute. Sustain skin abrasions on left forehead and upper outside of face. Noted by nurse was at party 6/28/21 and drinking. Drove 2 hours from other state prior to receiving vaccine. Probably dehydrated.

Tightness in chest Very irregular heartbeats Feeling of "enlarged" heart muscle Can't breathe properly Lump in throat Burning sensation in chest Severe lack of stamina Being active causes intense heart pressure to the point of fainting Swelling at injection site Symptoms started less than an hour after the first shot, still ongoing, getting worse ER visit on day 3, no clear diagnosis, no treatments. Still ongoing

I started feeling flu-like symptoms around 14 hours after the second vaccine. Each symptom occurred at the same time at 03:37 AM on July 14, 2021. The symptoms included achiness, cold shivering, slightly elevated temperature (100.8 °F), and almost complete muscular tension in arms and legs. It made it difficult to walk. I took a mixture of Tylenol (acetaminophen) and Advil available in one tablet. I took 2x of these, drank plenty of fluids, and went to bed around 05:15 AM on Wednesday, July 14, 2021. I had a heating blanket along with a microwave bean bag to keep myself warm. I woke up at 1:45 PM with most side effects subsiding, besides vaccine injection site still remaining sore.

arm felt sore; muscle aches; fatigue; feeling an itching sensation under myskin around my torso; slight cough; soreness all over; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWOISO) via unspecified route of administration in the right arm on 31Mar2021 at 12:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma. The patient was allergic to any and all molds, molds in food, medications such as penicillin, augmentin, etc. and latex. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), salbutamol (ALBUTEROL), vitamin D (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN) all for an unknown indication and from an unknown date. 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. On 31Mar2021 at 16:00, patient experienced sore arm, muscle aches, fatigue, soreness all over, itching sensation under skin around torso, and a slight cough. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events sore arm, muscle aches, fatigue, soreness all over, itching skin, and cough was resolving. No follow-up attempts are needed. No further information is expected.

Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732), via an unspecified route of administration in the right arm on 25Mar2021 at 15:45 (at the age of 22-years-old), as a single dose for Covid-19 immunisation. Medical history was not reported. Concomitant medications included men multi-vitamin (MANUFACTURER UNKNOWN) and calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS); both taken for unknown indication started from an unknown date. The patient was allergic to cefpodoxime (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On 26Mar2021, the patient experienced soreness at the injection site (vaccination site pain). In Mar2021, the patient was tested for SARS-CoV-2 test which resulted in negative. No therapeutic measures were taken as a result of soreness at injection site. The clinical outcome of the event soreness at injection site was resolved in Mar2021. No follow-up attempts are needed. No further information is expected.

allergic urticaria of fingers, palms, arms, legs, abdomen developed 32 hours post 2nd dose of Pfizer vaccine. patient treated in clinic today with Benadryl and systemic corticosteroids

Itchy red hives, sometimes all over body, mainly been arms and legs and during the evening. Recently, swelling has occurred near mouth. Pressure on body parts can result in large swelling (arm pushed on edge of table while using a electronic device). Been taking Benadryl to relieve symptoms.

light headed; heart was racing; itchy in one part of my right arm (back of the shoulder)/Itching like all over my body; abdomen were itchy and bumps/rashes and some bumps in my body; some rashes; it is like an allergy/like the allergic reaction the medication that causes it; This is a spontaneous report from a contactable Nurse reporting for himself. A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left deltoid on 28Dec2020 15:00 at single dose for prevention for Covid-19. The patient medical history included electrolyte imbalance. Concomitant medications included ascorbic acid, rosa canina (VITAMIN C WITH ROSE HIPS), zinc, vitamin D3, all started from Dec2020 (18 or 19Dec2020) and ongoing for "immune system". At 3pm yesterday (28Dec2020) he received the vaccine. He experienced feeling light headed and his heart was racing a minute after receiving the vaccine. Around 11-12pm he was itching on his arm, abdomen and back. He took an allergy pill and rubbed hydrocortisone cream on his back, arm and armpit. After taking the medication and rubbing the cream the bumps went down 30 minutes to an hour later. He woke today and everything was clearing. These symptoms usually hit him from having an electrolyte imbalance. He had missed the past 2 doses of Vitamin C, Zinc and Vitamin D3. He had 2 Covid test prior to getting the vaccine. His height was 6 feet 3 or 6 feet 4. He started like itching like all over his body. He noticed some rashes and some bumps in his body, it was like an allergy. He was just wondering if this was like the allergic reaction the medication that causes it. The outcome of the events light headed and heart was racing was recovered on 28Dec2020 15:01 and the outcome of the other events was recovered on an unknown date in Dec2020.

Symptoms began Monday 21st- headache, body aches, injection site sore; couldn't taste or smell -went Emergency Room - Medical Center; was given Tylenol and ibuprofen and was given Covid Test - test result positive.

I had injection site pain about 4 or 5 hours after my injection. Around 9:15 at night I felt slightly warm and could tell that I was becoming febrile, but I wasn't completely there yet. Around 12:45AM on January 9th, I had massive chills and uncontrollable shivering and muscle aches. I took 1000 mg of acetaminophen. I took another 1000 mg of acetaminophen at 6:00AM when my chills came back. At 10:45AM I was feeling febrile again, and took 600 mg of ibuprofen followed by an hour and a half nap. I had slight malaise afterwards but did not feel febrile. By 5PM, I was feeling almost completely normal and was fever free. On the morning of 1/10, I am completely recovered.

Site: Redness at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild; symptoms lasted 0 days

Slight swelling and moderate pain from the axillary lymph nodes started: Friday morning, swelling disappeared Sunday morning; pain still persists

same day pain at injection site. next day headache, extreme fatigue, body aches including top of my feet with tingling sensation. I felt miserable and very sick manage with Ibuprofen

loss of smell; Loss of taste; feeling like a sinus infection; pain at the injection site; muscle pain; Headache; Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 23-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248, expiration date: Nov2021), via an unspecified route of administration on 11Jan2021 at 11:00 AM in the left deltoid at single dose for work as behavioral technician. Medical history included Chronic headaches predates his treatment with bnt162b2. Family Medical History was none. There were no concomitant medications. There were no prior vaccinations (within 4 weeks). Patient reported he got the first dose of the bnt162b2 on 11Jan2021. He noticed one and a half hours later (12:30) pain at the injection site and muscle pain; then 12Jan2021, the next day lost his sense of smell and taste and it felt like a sinus infection. Added he didn't know exactly what a sinus infection felt like but he felt like he had jumped into a pool without holding his nose. Added twelve later (on 12Jan2021) the muscle pain resolved; his injection site was still a little painful and he still couldn't smell or taste. He was planning to get the second dose of the vaccine on 03Feb2021. Added he took ibuprofen for a headache later the night of the vaccine 11Jan2021. He had headache multiple times a week. This headache started that day. After taking the ibuprofen his headache resolved that same day. There were not any events require a visit to physician or ER. Therapeutic measures were taken as a result of events headache. No investigation assessment. The outcome of the event headache was recovered on 11Jan2021, muscle pain was recovered on 12Jan2021; outcome of events pain at the injection site and feeling like a sinus infection was recovering; outcome of the other events was not recovered.

Red, dry circular spot next to injection site. It popped up a few days after the vaccine. I received the vaccine on Saturday and noticed the red spot Thursday. I'm not sure if it came earlier than that.

Pfizer-BioNTech COVID-19 Vaccine EUA The day after the injection, in the afternoon (so about 36 hours after the injection of the second dose), I started to develop slight chills and fatigue, but no fever. This was accompanied by a mass that developed under my right armpit, about 4-5 cm in diameter and bulging out to the point that I felt it touching my upper arm before I even saw it in a mirror. It was not red, and it was malleable with a small, hard nodule in the center. I used an ice compression and some ibuprofen over a few days, and it has receded about 95% of the way, almost back to normal.

Pfizer COVID-19 Vaccine EUA 1-12-21 Pfizer Covid 19 vaccine given left deltoid Seen at Employee Health on 1-21-21 Pfizer initial dose given on 1-12-21 56-60 hrs later, bilateral cervical adenopathy incl. submandibular. Then 6 hrs later, awoke with constitutional symptoms of myalgias, felt feverish/chilled, headache, night sweats, fatigue, thinks had some arthralgias when symptoms were peaking late on 1-15-21 or early 1-16-21; currently sx improving but persistent. Arm was sore at vaccine site, but no localized itching type reaction noted. Additional symptoms are pharyngitis/expectorate yellow phlegm. No h/o Covid 19. Has enrolled in the V-safe CDC monitoring program Rapid strep/rapid mono/Covid 19 PCR/Flu PCR negative. Throat culture negative for strep. Diagnosis: Adverse reaction to vaccine, moderate 1-26-21: symptoms are resolving. There is no contraindication to booster vaccination. Patient needs to decide if risks of adverse reaction to booster outweighs benefits of vaccination to determine if he will proceed with booster.

rash on his right arm and right leg; it is like little red bumps that kind of itch; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK9231, via an unspecified route of administration in left arm (top of shoulder) on 12Jan2021 at a single dose for Covid-19 immunization. The patient had no relevant medical history, stated that he is perfeclty healthy. There were no concomitant medications. There were no prior vaccination within 4 weeks.The patient received the first dose of the Covid 19 vaccine on 12Jan2021. It was administered in his left arm; however, he has developed a rash on his right arm and right leg. It's kind of large but it is not oozing or anything. The patient wanted to know if this is a normal side effect. He wanted to know if this a serious allergic reaction. He stated that he got the first dose Tuesday and he is beginning to have, he does not know if it is a mild allergic reaction or just a symptom but he has a rash on his right arm right around the elbow and one his leg it is like little red bumps that kind of itch. In his paperwork it is saying one symptoms that could be severe allergic reaction is a rash all over the body so he is wondering if this is a mild reaction of some sort and also if there are any other cases like this. He first noticed the rash on his arm yesterday (14Jan2021) after he took a shower he looked on his arm and seen a trail going down and today he noticed one on his leg. He noticed the area on his arm yesterday and today he noticed the area on his leg. He says they are little red bumps that itch. He does not know if it was kind of wet but there was a little trail going down and its itchy, it is only the 2 spots that he has noticed are really bad. He says is has persisted he thinks it has remained about the same, he definitely won't say they have gotten worse, they may have swelled up a little bit, he is trying not to scratch but he has scratched a little bit so that is probably why it has swollen up a little bit. The patient has not taken anything for the events; other than using lotion, he was putting lotion on when he first noticed it. The patient had not recovered from the events.

After patients second covid vaccine, patient states feeling confusion, tight throat, itchiness, weakness. Patient went to the ED for monitoring. VSS stable and discharged. no pharmacologic or laboratory interventions taken.

soreness on his arm/He said his left arm was barely sore after receiving the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer reporting for himself. A 23-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1283/expiration date: Apr2021), via an unspecified route of administration, on 18Jan2021 16:00 (at the age of 23 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were reported as none. Past vaccine history included the patient received a flu vaccine injection on Oct2020 and he could barely lift his arm up after receiving a flu vaccine injection and on Nov2020 approximately 5 weeks ago, the patient received PPSV23 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Jan2021, the patient experienced soreness on his arm, started slowly, about 2 hours post COVID-19 vaccination. He said his left arm was barely sore after receiving the COVID-19 Vaccine. The soreness went away completely on 19Jan2021. The patient did not receive any treatment for the event. The outcome of the event soreness on his arm was recovered on 19Jan2021.

Patient presented with a no health hx except for hives to PCN as a child and "passed out" with a childhood vaccine x 7 years ago. Vaccine given without incident, doctor present to distract patient while I gave vaccine. 3-5 min post vaccine patient c/o of nausea and trash can provided. Patient became silent while talking, head fell forward and clonic tonic posturing noted in upper extremities. Called to doctor and patient lowered to floor and placed in recovery position, MSE lasted approximately 30 seconds, EMS called. Post seizure: Patient very pale and diaphoretic, oriented to person quickly, no signs of facial swelling, resp distress or symptoms of a severe allergic reaction. B/P 134/50 HR 80 and regular, patient at this time shares that he had a MSE 3 or 4 years ago with friends. States came around after eating and drinking. States he did not share this information with his health care provider. Patient was AA&O x3 but with dismissed LOC from pre-vaccine state. 1200-EMS arrived, B/P 110/7, glucose 88/EMS, attempted to sit patient up/EMS, became dizzy and pale. Lowered to recovery position and waited for second team. Attempted to sit patient up again when second team arrived and again he became pale and dizzy. 1212- patient consented to be transported to hospital at this time/EMS.

Date of Vaccines: #1 on 1/4/21, #2 on 1/29/21 Adverse event: On 1/5/21 had nasal congestion, rhinorrhea, allergy flareup. On 1/30/21 for 1 week had fatigue, chest pain, then had shingles at Left chest starting 2/4/21. Took Zyrtec for symptoms and is on Valacyclovir for shingles

1/11/21 COVID Pfizer vaccine #1 = no issues (given at Clinic = screening form marked all no but had a 30 min watch post vaccine 1/29/21 Covid Pfizer vaccine #2 EL0261 left arm at Clinic, 2/20/2021: medical sent to local ER on 2/20 for 2 day c/o worsening left hand/forearm numbness, coldness, discoloration to left hand and pain (purple appearance). Was seen at clinic with negative DVT r/o US, nl imaging and labs. 2/21 sent to ER c/o UE pain and weakness x 5 days (woke up with bicep pain that progressed to numbness, tingling, swelling and discoloration of hand (cyanosis pallor and cold LUE x 3 days). Severity is moderate. Quality dull pain. Currently invo 1/11/21 COVID Pfizer vaccine #1 = no issues (given at Clinic = screening form marked all no but had a 30 min watch post vaccine 1/29/21 Covid Pfizer vaccine #2 EL0261 left arm at Clinic - no c/o reported 2/20/2021: medical sent to local ER on 2/20 for 2 day c/o worsening left hand/forearm numbness, coldness, discoloration to left hand and pain (purple appearance). Was seen at clinic with negative DVT r/o US, nl imaging and labs. 2/21 sent to ER c/o UE pain and weakness x 5 days (woke up with bicep pain that progressed to numbness, tingling, swelling and discoloration of hand (cyanosis pallor and cold LUE x 3 days). Severity is moderate. Quality dull pain. Currently involves entire left arm (arm, elbow forearm wrist hand).. Did have some swelling and motor loss, NO CP, SOB or sensory loss, no redness, no injury, no fever, chills, ha, depression sore throat, cough, rash, lymphadenopathy, abd pain, GI distress, no trauma or recent illnesses. 2/21: admitted clinic w/rhabdomyolysis: no preceding workouts, increased activity on ship, back sleeper, no alcohol, no trauma,. nsp: skin intact, no erythema. Mild edema to upper arm around triceps. Mild purple discoloration to dorsum of hand. Palp: TTP about triceps. TTP anterior shoulder. TTP biceps. Able to palpate triceps tendon and biceps tendon. NTTP throughout the rest of hand and forearm. Hand is cooler relative to contralateral side. NTTP cervical spine. ROM: Full passive ROM of the shoulder and elbow with pain. No micromotion pain with any joint in the upper extremity. Painless cervical spine ROM. Motor: 3/5 strength to OP/FPL/2nd FDP, EIP/EPL, 1st and 2nd DIO. 3/5 deltoid, biceps, triceps, wrist extensors, wrist flexors. Sens: Decreased sensation throughout entirety of forearm and hand distal to the elbow. Above the elbow, sensation is intact. Vasc: 2+ radial pulse, symmetric to contralateral side. BCR <3 sec. Hand is cooler than contralateral side. Lab: CRP <5, ESR 4, CK 31,924, PT 14, INR 1.1, D-dimer 0.46, AST 610, ALT 186, Cr 0.94, WBC 6.3 Imaging: Radiographs of the chest, shoulder, elbow, wrist, and hand demonstrate no fracture. The shoulder is well located. CTA starting at the heart demonstrate no vascular abnormalities. Assessment: unlikely that he has compartment syndrome or a cervical spine pathology. His exam does not localize to one specific innervation or muscle group. His paresthesias and diffuse 3/5 weakness on exam may be related to parsonage turner syndrome (post viral neuritis) versus edema. While he does have a cool hand and mild/moderate edema on exam, his CTA is normal and his exam is very reassuring that this is not compartment syndrome. He likely has rhabdomyolysis based on upper arm swelling in the setting of CK of 31924. Discharge 2/22/2021: He received a total of 3 liters of IV fluids and was encouraged to drink large amounts of water. Repeat CK levels showed to be down trending as were his AST and ALT enzymes. Plain radiographs of his left arm and shoulder were unremarkable as was CT angiography of his chest. Electrolytes and renal lab work was within normal limits throughout the hospitalization.On the day of discharge, he was tolerating a PO diet, ambulating without difficulty, and hemodynamically stable. LUE w/ minimal swelling, no erythema. TTP over L triceps belly, No TTP over the distal LUE. Somewhat decreased sensation to light touch over distal LUE. 2+ radial pulses b/l. LUE ROM somewhat limited 2/2 pain, but intact. ---- to f/u with HCP in 2 weeks, sooner if worse (medical officer) CK 2/22/21 was down to 14653

Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Pt called for follow up s/p covid-19 vaccination done on 02/24/21. He reports that he feels well. Sore at injection site but no other c/o. He voices appreciation for our call. APRN Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosigned by: MD at 2/28/2021 7:35 AM Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Date: 2/24/2021 Subjective Patient is a 23 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness. He denied difficulty breathing, difficulty swallowing, throat tightness and nausea. He states he always gets lightheaded when he gets a shot. He denies any episodes of syncope in the past. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to collapse, hypotension and rapid progression of symptoms. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, facial swelling, chest tightness, shortness of breath, wheezing, vomiting and headaches +lightheaded: Previous Reactions: Always gets lightheaded after getting a shot. Denies other symptoms or syncope. Objective Vitals Vitals: 02/24/21 1406 BP: 119/67 Pulse: 58 SpO2: 100% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Assessment/Plan Treatment included: no therapy Follow up response to treatment: Good. Lightheadedness resolved prior to discharge. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) PA-C Electronically Signed 2/24/2021 2:07 PM

Headaches; Nausea; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL3248) via an unspecified route of administration in the left arm on 09Feb2021 at 07:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient relevant medical history and concomitant medication were not reported. The patient previously took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3248) in the left arm on 19Jan2021 at 07:00 for COVID-19 immunisation. 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. 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. The patient experienced headaches, nausea, soreness at injection site on 09Feb2021 at 20:00. The patient did not receive any treatment for the events. The events were reported as non-serious by the reporter. The outcome of the events headaches, nausea, soreness at injection site was recovered on an unknown date in Feb2021.

At approximately 3:28 pm, Patient reported feelings of nausea, skin color was grey and clammy to touch within minutes of receiving dose 1 Pfizer. Moved to the adverse reaction area via wheelchair with girlfriend by his side. Patient denies any medical history. Girlfriend reported that he had a fear of needles. Initially vitals were taken, O2 sat was 90 and his heart was in the 40's. PA was present and felt patient needed to be sent to the ED for further evaluation. Within minutes the vitals stabilized and patients color returned to normal but continued to report mild nausea and dizziness, consulted Dr who suggested if symptoms persisted to send him to the ED. EMS called for transport at 3:45. Pt was transported to the ED at 4pm.

Fatigue, mild headache, radiating pain from forearm through the shoulder lasting roughly 4 hours. Soreness persisting at injection site 24+ hours after injection.

Several hours of brain fog for the remainder of the day, starting about an hour after injection. Soreness at injection site starting the following day.

23 year old male with a history of 31 allergic reactions, Mast cell activation syndrome, Addisons disease, and POTS, developed anaphylactic reaction after receiving first Pfizer COVID-19 vaccine. Patient took 50 mg benadryl 30 minutes before arriving at vaccine clinic in anticipation of possible reaction per physician's recommendation. Per pt he asked multiple physicians regarding receiving the covid vaccine and was given the permission to proceed. Also took 20mg hydrocortisone in the morning, then 10mg this afternoon for Addison's disease. 1603 - Pt received 1st dose of Pzifer covid-19 vaccine and during the first 5 minutes of observation complained of feeling itchy and wheezing, light headed, nauseous. 1608 - 0.3mg epi given at - self administered right thigh. 1613 - 90 mg of hydrocortisone (solu-cortef), patient's own medication, given by RN through pt's PICC line RUE; line was flushed with NS before and after and cleaned with alcohol swab. 1615 - Self-administered 4 mg Zofran (patient's own medication) at 1615 into the RUE PICC; cleaned with alcohol swab. 1615- Second 0.3mg of epi given- self administered left thigh. 1617 - Fire department arrived. 1621- pt complains of itchiness still but wheezing is reduced. BP 118/83 at 4:25 PM, normal O2 sat and pulse, normal respiratory rate. 1626 - patient placed in gurney, escorted out by Fire Dept en route to Hospital Physician assistant and five other RN were with the patient and his mother.

After receiving the "Pfizer-BioNTech COVID-19 Vaccine EUA" I woke up the next day with swelling in the lymph nodes on the back of my neck, as well as swelling in the face, the appearance of facial hives and a severe headache. The swelling persisted for 5 days after the injection and the hives on my face and scalp have persisted beyond five days. On day 4 I experience uncontrollable facial spasms originating from a swollen lymph node.

Pt reports development of hives on bilateral hands, chest and leg. Denies other contact. No prior reaction to vaccinations.

I got a rash on my right arm (but I took the COVID vaccine on my left arm...). Had a rash on April 3rd that was itchy. Went to the pharmacy today April 4th to get an itch cream and the pharmacist told me I was the third or fourth person reporting rash after the vaccination and oriented me to report to CDC. She told me to use hydrocortizone and avoid sun exposure. I used it but still feel itchy.

Rash developed on thigh about 2 weeks after the 1st Pfizer vaccine; NOTHING else in life is novel, ie, no new foods, detergents, soaps; no traveling, no guests, and the patient abhors the outdoors so insect involvement is extremely unlikely. Rash was reported to me (Mom) on Thursday, April 1st. There was one spot/lesion that was oval and larger than the others, with a somewhat blanched center. No itch or pain. Friday the 2nd, patient reported around 5:00 p.m. that it had spread to his sides, so I called the nurse healthline.. Saturday a.m. per recommendation I took him to Urgent Care; it had by then also spread to his stomach. The doctor there didn't have any "A-HA!!" moment, but sent us off with a prescription for a clotrimazole/betamethasone topical cream. The rash is now heavily populating his stomach, is on his back and there are a couple spots on his arm. I contacted his primary care manager this morning as we are to receive our 2nd Pfizer vaccines day after tomorrow (Wed, 4/7) and I'm wondering if he should get his as planned or whether that might be a bad idea.

Patient had red, flat rash on forearm and bicep of the vaccinated arm. Monitored patient for a half hour. The patient had no rash on trunk, difficulty breathing, or tingling in mouth or throat. Rash started to lighten and patient reports to feel fine. Advised patient to keep on eye on rash and to take Benadryl if it worsened and seek immediate medical attention if he had difficulty breathing. Followed up with patient and per sister the rash has resolved.

I got a few blood spots in my inner elbow region soon after and I wasn't sure if it was related. Also, I normally don't bruise easily but I got a bruise on my right top part of thigh 2 days after.

Approximately 7-10 days or so after receiving the first dose of the pfizer Covid vaccine I started to develop this red, nodule-like, painful "rash" on both of my forearms. Not only the left arm where the vaccine was administered. This did not go away after a couple of days, and I was instructed by a physician to being taking Benadryl. This appeared to alleviate the symptoms (no visible red nodules anymore) 4-5 days prior to my second dose, so I stopped the medication and presumed it was done. Then, within 4-5 hours of receiving my second Pfizer covid vaccine, I broke out into the same red, painful, nodule-like "rash" along both of my forearms. This time was worse than the previous reaction. I was instructed to take Allegra at the time by a physician, which I did for approximately 4 weeks. This seemed to get rid of the symptoms I was experiencing, and I could not visualize the nodules on my forearms anymore. However, after approximately 2 weeks, I noticed a painful and swollen vein in my right forearm, opposite arm to the one I received the vaccine in. I did not think much of it at the time, since I had no other associated symptoms. Then, over the next couple of weeks, it appeared to become more swollen and painful. Also, I saw another swollen vein near my knee. On April 6, I had labs drawn and CBC, CMP, TSH, and ESR came back normal, but the CRP was elevated. Thus, I was instructed to begin aspirin 325mg, which I took for 4 days beginning April 8th and ending April 12th. On April 13th, an official ultrasound confirmed a DVT in my right popliteal vein, a superficial thrombus in my proximal great saphenous vein, and a superficial thrombus in my right forearm where the pain originated from weeks prior. The initial presumption at this time is that the clots are vaccine-related, but could be linked to an underlying blood disorder that was triggered by the vaccine. Blood hyper coagulation labs have not yet come back. I was initiated on Eliquis starting April 12th for the DVT.

Patient reports symptoms starting about 30 minutes after 2nd dose of vaccine. Started with headache, then progressed to severe chills, and fever. On 4/11 patient had severe weakness and was unable to walk or sit, altered mental status, high fever 104, nausea, diffuse, red bumpy rash on face, neck, torso. Orbital and facial swelling. Mother took to urgent care and patient was transported to ER and was admitted.

can not walk, or eat by himself needs help; his sputum is thick and brown; low platelets; Elevated liver enzymes; low sodium and unstable phenotypes; rashes all over his body; fever of 100.8 next day friday the 9th woke up with a 104 temp; headache; coughing and his sputum is thick and brown; felt like flue symptoms; extreme body ache; his eyes are unable to open for most times; can not walk, or eat by himself needs help; This is a spontaneous report from a contactable consumer (parent). A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiry date were not reported), via an unspecified route of administration on 08Apr2021, as single dose for COVID-19 immunization. Patient medical and concomitant medications were not re-ported. On 08Apr2021, patient same day developed a fever of 100.8 next day friday the 9th woke up with a 104 temp and ever since (5 days) has had a fever, rashes all over his body, today he started coughing and his sputum is thick and brown, felt like flu symptoms within an hour, extreme body ache, his eyes are unable to open for most times, cannot walk, or eat by himself needs help and headache. Also reported his condition was low platelets, elevated liver enzymes, low sodium and un-stable phenotypes. Treatment received at hospital includes cortisone, paracetamol (TYLENOL), ceftriaxone sodium (ROCEPHIN) and azithromycin. On 08Apr20212 underwent body temperature measurement and result was fever of 100.8 next day friday the 9th woke up with a 104 temp, on unknown date low sodium and unstable phenotypes was done and result was low sodium, underwent liver enzymes test and result was elevated liver enzymes, had platelet count test and result was low platelets and had sputum test and result was sputum is thick and brown. The outcome of the events was un-known. Information on the lot/batch number has been requested.

Sore arm at injection site; This is a spontaneous report from two contactable consumer (one of them is parent). A 23-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at age of 23-year-old at arm on 03Apr2021 12:30 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient hadn't allergies to medications, food, or other products. The 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 in Pharmacy or Drug Store. The patient experienced sore arm at injection site in Apr2021. No treatment received for event. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

On 4/27, the pt's arm was really sore. It was still sore on 4/28. On 4/28, the pt also started to feel extremely tired, had 100.2?F fever, ear pressure, & chills. He took Tylenol & the fever, ear pressure, and chills subsided. On 4/28 near bedtime, he developed itchy hives on his right inner forearm (his 2nd Covid-19 Vaccine dose arm) and on the lower half of his back. He had corizone cream applied to the areas before going to bed. By the next day, 4/29, all symptoms resolved.

Developed red rashes (spots): beginning from hip area, then spread to abdomen, chest, thighs, arms, and legs.

Regular shoulder & arm soreness for the arm of injection at night of vaccination (had the same symptom for the first shot, was no big deal). Shoulder upper body (muscle) soreness started around the second day, and I felt easily tired because of it. The real shoulder pain (both shoulders) came on 5/3 early morning, and I was not able to sleep because of it.

Patient returned to office this c/o itching noted to scattered areas of his body. Patient noted with scattered red, slightly raised areas to back of thighs, behind bilateral knees, one area to right forearm (inner), noted to left antecubital area as well. Patient also noted with some patchy areas of redness to abdominals folds and below navel area. Patient alert and oriented. Denies shortness of breath. Talking to staff without difficulty. Benadryl 25mg administered in doctor's office.

Patient collapsed onto floor from standing about 5 minutes after his injection. Was unresponsive for about 1 minute then came to. Head laceration with light bleeding to the back of his head. 911 was called immediately and patient was transported to a hospital ED.

Tiny pruritic papules located dorsum of hands and proximal medial arms began 30min post vaccination and are still lasting today. Noticed eyelid papules day 6 post vaccination.

Reports 1 hr after vaccine developed hives on his chest, +itching, no breathing problems. Did not take medication, hives worsened day 2. Resolved spontaneously on day 3. Advised patient receive J&J.

Sensitive skin, everything that touched me hurt. Clothes, air, water, etc. 9:00am Aching bones, 5pm, knees, arms, shoulders. Everything felt like i was a 90 year old man. I?m 23.

After the second dose my injection site was painful and around 8 pm I started getting a headache then came the chills which I then went to bed my sleep was awful I woke up every 5 minutes with a terrible headache. At about 4:40 am I ended up vomiting. Since then I have just been lethargic and the headache is consistent

Skin rashes on my right arm, upper shoulder area, and a little circle on my chest about a day after taking the second shot. No pain, rather experienced itchiness and redness. I waited a week until going to the dermatologist, where they performed a biopsy. The dermatologist was able to identify that it was Shingles, and the biopsy results two weeks later confirmed it. I have been taking Valacyclovir HCL twice a day, with putting Triamcinolone cream on the skin rashes twice a day as well. It?s been fading over the last two weeks.

23 year old healthy active male s/p first dose of Pfizer COVID vaccine fell forward off chair from sitting position, loss of consciousness x 30 seconds, forehead and face hit floor. Once returned to consciousness AOx4, but diaphoretic. BP 110/58 HR 50 RR 20 SpO2 98%. 1 inch laceration noted on bridge of nose and small abrasion noted on forehead.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe

Pt. developed arm site pain, fever chills and muscle aches day after 2nd dose, 05/14/2021 symptoms resolved by night time. He awoke on 5/15/2021 with waxing and waning chest pain/ burning and chest pressure, seemed too improve but by 5 AM on 5/16/21 was more intense and he presented to E.D. where EKG showed diffuse ST elevations and PR interval depressions. Troponin was elevated at 0.494, increased in next hour to 0.569 and patient was admitted. TTecho showed normal E.F. of 60-65%, nl valves and trace pericardial effusion. CXR was negative for pulmonary infiltrates, (no Hx of Covid Dx) P.E. showed no conjunctivitis, no rashes, all else also WNL

Patient was administed the pfizer covid-19 vaccine 1:24pm. After the vaccine was administered patient went to a designated chair to wait for 15 minutes post-vaccine. Pharmacist monitored patient, noticed patient sitting talking on the phone shortly after vaccine. However, after a couple minutes patient passed out and fell off of chair. After yelling patient's name he came to and did not lose consciousness again. Patient suffered injury on head with a substantial laceration on forehead above eye. Code white was called and patient was given an ice pack and advised to sit for 30 minutes following incident. Asked patient if he would like us to call 911, he refused. He sat with management while an incident report was filled out and while he didn't want us to call an ambulance it did seem as though his mom was going to take him to urgent care to have his cut examined.

3 days of pain at injection side, on the left shoulder. It hurts when lifting left arm. I also had left knee pain after 5-7 hours of receiving shot. Luckily, I had no fatigue, no headache or fever.

Yellow discoloration, like a bruise, over a week after the vaccine. No pain.; Yellow discoloration, like a bruise, over a week after the vaccine. No pain.; This is a spontaneous report from a contactable 23-year-old male consumer (patient himself). A 23-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0185) via an unspecified route of administration in left arm on 14May2021 13:30 as 2nd dose single and had previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8729) via an unspecified route of administration in left arm on 23Apr2021 13:30 as 1st single dose for COVID-19 immunization. Patient was 23-years-old at the time of vaccination. Patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23May2021 at 09:00, the patient experienced yellow discoloration, like a bruise, over a week after the vaccine with no pain. Patient did not receive any treatment for the adverse events. The outcome of the event was recovering.

Stiff joints, fatigued, rash on lower arms, swollen hands (itchy due to swollen ness) - 06/05/2021 7:00am to 8:00pm Rash continue to inner thighs and swollen feet (itchy due to swollen ness) - 06/06/2021 1:00am to present (around 5:45pm)

pt became lightheaded, sat in a chair, and fell forward lacerating his head after receiving the dose. Ems was called and transported the patient

Hives developed hives on his back and chest 3 days after vaccine that 'came and went" for a couple days. Patient had used a new soap which he feels was the cause.

mild blistering rash on the hands, starting on the index finger of the injected arm, and over a period of days beginning on the other hand as well. caused little change in daily routine, possibly helped by skin care regimen necessitated by eczema. cleared up by current date

PATIENT COMPLAINED OF FEELING DIZZY AND WARM. TINGLING IN RIGHT HAND AND BACK OF THROAT. RED AND BLOTCHY AROUND NECK. FEELING NAUSEA. BENADRYL 50MG IM GIVEN RT DELTOID.

Swelling of face, redness, excess sweating and overheating, allergy-type reaction, skin blotches compared to snake skin, eczema like reaction with no history of skin disorders. Painful to the touch

Spotty Rashes on both arms and legs. Benedril helped rash to calm down for a few hours but rashes came back for 3 days.; Palms and Feet are tingling and itchy; Palms and Feet are tingling and itchy.; This is a spontaneous report from a contactable consumer. A 23-year-old male consumer (patient) reported for himself that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0170, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 15:30 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medication included Benefiber (DEXTRIN) taken in two weeks. No known allergies reported. No other vaccine was taken in four weeks. No COVID prior to vaccination. No COVID tested post vaccination. The patient experienced spotty rashes on both arms and legs on 29Apr2021 at 8:00PM. Benedril helped rash to calm down for a few hours but rashes came back for 3 days. Palms and feet were tingling and itchy. No treatment received for "palms and feet were tingling and itchy". Outcome of rash macular was Recovered/Resolved with Sequel. The outcome of other events was not recovered. Follow-up attempts are needed. Further information is requested.

Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient after sitting down , experienced symcope after about 2 minutes post covid 19 vaccination,fell on face from chair, bruised face/rug burn

pt started to complain of itching to his left arm. pt was noticed to have a couple welps around the injection site and red raised hive on his upper lip

Patient developed hives on the Left elbow about 5 minutes after injection given. Benadryl 25 mg given, hives resolved

Site: Pain at Injection Site-Severe, Additional Details: Pain starting at injection site, expanding to include arm from elbow to sholder evening of 7/22, on 7/23 expanding to include hand and wrist, becoming more severe on 7/24. Patient visited emergency room on 7/25.

7pm 01/02/2021- Right hand became itchy: urticaria appeared across right hand, left wrist, elbow creases, right foot. 1pm 01/03/2021- went for a run while wearing a sterling silver necklace (which has been worn almost every day for past year) began to feel a burning sensation. Took off necklace and had urticaria all around neck where necklace had been. (took ice baths, used lotion, and took 2 tablets of hydroxyzine which all alleviated itchiness and most of the redness/bumps had disappeared when waking up on 01/04/2021).

Awoke at 7:30am with increased injection site soreness in upper L arm and a headache with fatigue, symptoms resolved after I took a single dose of naproxen sodium 220 mg at 2pm and currently feel no side effects

Injection Site Pain - 20:30 on 11/11 Fevers, chills, myalgias (specifically lower back), headache, nausea, vomiting

Hives appearing on chest/thighs/back after 30-48hrs, progressing on the 2nd day rapidly across whole body. Itchy and red. Went to urgent care evening of 2nd day, received 50mg diphenhydramine that suppressed itching enough to sleep. Woke up itching and red at 6am of 3rd day, took 25mg diphenhydramine. Took 40mg prednisone at 8am. Went to urgent care at 10am for worsening hives, spreading and covering torso and onto face. Received dexamethasone injection into glute and prednisone prescription was upped to 50mg daily for the next week. Took OTC Zyrtec and Pepcid once following the second urgent care visit. Hives responded well after 2hrs post visit, assuming due to prednisone and dexamethasone. Day 4 (1/12/20) woke up with widespread hives that became further inflamed until an hour after prednisone taken with breakfast. Also woke up with slight sore throat and wheezing, both of which subsided. Currently scheduled to see an allergist on 1/13/20. No known allergies and no other known introduction of allergens in the past week.

Headache (4/10 severity), fatigue, and pain at injection site (1/10 severity); Headache (4/10 severity), fatigue, and pain at injection site (1/10 severity); Headache (4/10 severity), fatigue, and pain at injection site (1/10 severity); This is a spontaneous report from a contactable other HCP. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at 06Jan2021 08:30 at SINGLE DOSE for covid-19 immunization. Vaccine location was left arm. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), calcium carbonate (TUMS), ibuprofen, tilactase (LACTAID). Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took minocycline and experienced drug hypersensitivity. The patient experienced headache (4/10 severity), fatigue, and pain at injection site (1/10 severity) on 06Jan2021 13:30 with outcome of not recovered. Patient didn't receive treatment for the adverse events. The events were reported as non-serious. Information on the lot/batch number has been requested.

Swollen lymph node in armpit for4 days, 99.8 temp for one day, chills, fatigue, headache, injection site pain and swelling, lymphadenopathy, malaise, new or worsened joint pain

Mild nausea started around 6pm, 10 hours after initial dose. Chills started around 10:30pm and progressed to a 103 degree fever by 12:00am. Fever and chills persisted for the next 12-14 hours preventing me from going in to work. Nausea became noticeable again as the chills subsided. Fever broke around 6:00pm the next day, 01/20/2021. Significant soreness at the injection site was present almost immediately and through 01/20/2021

Injection site pain, body aches, low grade fever, general malaise, mild fatigue. All adverse effects except injection site pain resolved after 24 hours.

Mild soreness at Injection site; This is a spontaneous report from a non-contactable consumer for himself. A 24-years-old male patient received bnt162b2 (BNT162B2; Lot # EL 3247) vaccine , via an unspecified route of administration in the left arm on 21Jan2021 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced mild soreness at injection site on 22Jan2021 with outcome of recovering. Follow up not possible. Lot number already received.

Developed a rash beginning in lower abdomen. Over the next two weeks the rash spread into lower arms, up the forearm, through the torso, and into the legs. Current on topical steroid cream (0.1% triamcinolone acetonide cream USP).

Slight shoulder pain around injection sight; Mild discomfort; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176; Expiration date was not reported) on 22Jan2021 (10:15) at a single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. On 22Jan2021 (12:30), the patient had slight shoulder pain around the injection "sight" (site) and mild discomfort. The pain around the injection site had lasted roughly 48 hours, and then was getting more painful over time, then slowly getting better. The patient did not receive any treatment for the reported events. The outcome of the events, pain around the injection site and discomfort, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.

24 y/o normally healthy male presents to the ED with c/o lip swelling which began a couple of mins after getting the Covid vaccination. No throat swelling, trouble breathing, hives. Has a slight rash on bilateral shoulders he attributes to the detergent used on the apron he wears at work. No other rash.

unable to bear weight on legs/could not walk or bear weight; shortness of breath; fever; nausea/nauseous; pain in left shoulder radiating to left chest 4/10; Chest pain at the side 5/10; tried to get up to walk but was very shaky and could not get up to walk/unable to walk/could not walk or bear weight; dizzy/light headed; almost instantly was sharp stinging in injection site; tried to get up to walk but was very shaky and could not get up to walk; WBC 14000, no unit of measurement, normal was 11000; This is a spontaneous report received from a contactable pharmacist and consumer (patient). A 24-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3302 and expiry date: May2021), via intramuscular route on deltoid left on 25Jan2021 15:57 at 0.3 ml single for COVID-19 immunization at hospital. Patient did not receive other vaccine in four weeks and in last two weeks. Patient's medical history, family medical history and concomitant medications were reported as none. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number; EL1284; expiry date: Apr2021) via intramuscular route on left deltoid on 04Jan2021 at 10:45 AM for COVID-19 immunization; Hep B Adult Energix-BPFS (HEPATITIS B VACCINE, lot number; 2793Z) on left deltoid on 12Jan2021. Patient received 3 previous doses of HEPATITIS B VACCINE. It was reported that, the patient complained of pain in left shoulder radiating to left chest 4/10 and nausea immediately following injection, Chest pain at the side 5/10 (on 25Jan2021 at 14;00, after second dose of COVID vaccine). Taken to the ED (emergency department) via wheelchair at 1700. No rash, no swelling of lips/tongue or throat. No treatment was given for the events nausea and pain in left shoulder. No COVID was presented prior vaccination and post vaccination. Patient stated almost instantly was sharp stinging in injection site, he felt nauseous, dizzy, light headed, and had chest pains, he tried to get up to walk but was very shaky and could not get up to walk on25Jan2021 at 14:00. Stated that he was wheeled to the emergency room, he was admitted to the emergency room for almost 8 hours. Clarified he was not admitted to the hospital that he did leave that night. He was able to stumble out of the emergency room to go home. Clarified he got the vaccine on 25Jan2021 (his second dose). Stated he woke up next morning on 26Jan2021, unable to bear weight on legs, chest pain, and shortness of breath, fever. HCP prescribed Arnuity for the chest pain. WBC 14000, no unit of measurement, normal was 11000. Patient was unable to walk, nausea, dizzy, lightheaded and having some chest pain and patient was not hospitalized, spent 8 hours in Emergency Room. Outcome of the event fever was recovered on 27Jan2021; nausea, dizziness, was recovered on 31Jan2021; Unable to walk, lower extremities weakness of, shortness of breath was recovering; the event chest pain was not recovered; and for remaining events it was unknown.

A quarter sized knot in the left axilla with erythema spreading toward the left hand and also swelling and pus exuding from the left middle finger of the left hand.

Itchy and puffy spots of swelling in various spots on whole body, lasted from 24-48 hours after vaccination before subsiding.

Minutes after receiving my vaccine my left arm began to go numb with a full head headache following soon after. I was then moved to the observation area where my chest got tight, I had difficulty breathing and my temperature fluctuated which made me shake. When hives began to show on my face, neck and ears the on-site medical staff gave me a shot of epinephrine and Benadryl and put me on oxygen, during this time an ambulance was called by the staff. When I got to the hospital my heart rate and blood pressure was high, I was given oral steroids to help my anaphylaxis. For days after being released from the hospital I continued to have deep muscle pain and weakness in my left arm as well as a very strong headache

Sore arm at injection site Mild malaise/fatigue/tiredness, appears to noticeably exacerbate with alcohol consumption. Only resting and hydration with plain water were employed. No medications were used.

8 days out from my first vaccine and I?m now having constant twitching around the vaccine site on my left arm.

Itching at site 5-12 hours post injection, severe muscle pain at sight 8-16 enough to wake from sleep in any pressure was applied, 12 hours post injection sever migrain, chills borderline hypothermic, immediate hot flashes as though I was in boiling water, sneezing. All subsided by 24 hours post injection beside migrain which became vary minor and at 24 hours full body soreness and fatigue equivalent to an extreme full body workout set in.

The vaccine was received through hospital at Community Health. Pt states that after he got his first Pfizer COVID shot 2 weeks ago he began having excessive fatigue, it got better after a week but pt states still "extremely tired". Pt states that he also had a rash develop the day after the vaccine and it was on his chest and back initially but has spread all over his body. The rash is not pruritic but is very tender to touch. Pt states increase amount of migraines, almost daily. Aleve helps the HAs. He had migraines years ago but they had virtually resolved. He also reports intermittent joint pain in the last few days and some central chest discomfort with deep breaths. He has a hx of chronic IBS like bowel issues after experiencing an infection abroad that took 4 rounds of antibiotics to treat. Treatment: 5 day course of Prednisone 20 mg BID. Tylenol 100 mg TID for aches and HAs. Follow up with PCP.

Excessive ear wax production; acne; immense pain at injection site and in shoulder of that arm; nausea; excessive hunger; feeling/acting inebriated

got up about 5:15AM to use the restroom, parents heard a huge crash and we came running - he had collapsed and fainted in the bathroom, against the toilet, (with shelves and glass crashing down him - he grabbed the shelves and had a few cuts and bruises), was unresponsive, no color in his face, could not stand or move, could barely speak - slumped against the toilet. Parents called 911 and tried to get him to respond, he was listless but opened his eyes - we lifted him and moved him to recliner in living room. Fire Dept./EMT's arrived within a few minutes, blood pressure was 87/43, glucose was normal. EMT's determined it was a reaction to the vaccine and asked if he wanted an ambulance or if parents should drive him for further care - he opted for us to drive him (his Mom called the Dr. on staff first - Dr. said it was a reaction to the vaccine and he should not get a 2nd dose). Patient's Dad took him to Urgent Care - they ran an EKG (normal), and stayed there until his blood pressure showed (although still low) normal/acceptable again. I looked at the CDC website for covid anaphylaxis and it appears it was an allergic reaction (cardiovascular), on the site, he had these symptoms: "Cardiovascular: fainting; hypotension (abnormally low blood pressure); pallor. ... Symptoms of anaphylaxis often occur within 15-30 minutes of vaccination, though it can sometimes take several hours for symptoms to appear."

Rash that started on front of chest but has spread to full torso front and back and also to neck, head and parts of face. Progression has taken place over the past 48 hours. Symptoms first noticed at 10am Tuesday the 30th.

04/03/2021 Itchiness on belly, arms, face, armpits Rashes Swellings like mosquito-bites wherever scratched, on right upper arms, and on hands at night when sleeping Tiredness which could be relieved by toileting Pain in hands from blood flow when clutching and moving 04/04/2021 Pain in upper arm, including left upper arm where dose 1 of Pfizer vaccine was given

Pt received Covid vaccine, was told you wait 15 minutes to be monitored. While waiting, he was adjusting his sweatshirt and was flailing with the sleeves and hood. It was witnessed that his face became red, he started to convulse and fell to the ground while pulling on the handle of his shopping cart. He was able to sit up on his own; at which time 911 was dispatched. Paramedics arrived quickly and assessed patients blood pressure and condition. They cleared him and they left at 11:40am. Pt was escorted to his truck by staff pharmacist and left before noon.

2:40pm red area visible, light red rash, P 62, O2Sat 98, BP 132/82. 2:50pm redden rash somewhat disappeared. Ice pack given for redness. 2:55pm EMS advised Benadryl for right deltoid redness. Stated feeling better. Allowed to leave observation with instruction to seek medical attention if rash or reddened area increases.

Pain at site of injection, high fever, shivering/chills, nausea, fatigue, slight congestion and heavy breathing, wet cough for a day and dry cough two days later after all other symptoms disappeared.

* First dose of Pfizer/BioNTech LOT: EP7534 on 03/14/2021 at 06:15 PM 6 minutes after injection a reaction of dizziness, chills, and paleness. 03/15/2021: Intense soreness near injection site on upper left arm muscle. * Second does of Pfizer/BioNTech LOT: EP7533 on 04/04/2021 Normal soreness near injection site on upper left arm muscle. 04/05/2021: Intense body ache. 04/17/21: At approximately 02:00 AM numb sensations covering entire left arm, left face and neck, and a phantom sensation of numbness near injection site. Left arm feels droopy with less energy compared to right arm.

I feel arm snoring, high temperature, dryness and fever. I feel tired and very cold and my bones hurts. This began after 3 hours of my shot and continue until the moment of reporting.

Purities. 50mg Benadryl given to patient by EMT. All vital signs normal. Symptoms resolved after 30 minutes. No need for additional medical care or treatment.

After first injection of Pfizer rash to one arm. Patient decided to have second vaccine and rash and throat itchiness, Complains of difficulty breathing

Left pinky toe itchy and swollen/inflamed, sometimes hurts. It's been only a week so far, just started applying Cortizone.

pt. got rash on lips next day in the morning and it started increasing every day and now he has all over body and its itching and now even eye is hard to open and rash not going away. patient using hydrocortisone and zyrtec for itching and rash.

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 massaged the area and the reaction became less severe (swelling went down and knot soften).

Patient is experiencing nerve pain. There is a jolting wave of pain every few minutes that starts at the injection site and goes down the arm into the palm of their hand. This started 2 weeks after the second dose of the Pfizer covid vaccine was administered. Symptoms have progressed since then.

Patient received first dose of covid vaccine at 12pm on 4/25. Patient broke out into a maculopapular rash and hives to left side behind left ear, and face. Patient with high blood pressure of 187/131. Patient has a history of high blood pressure and has not been on medication for high blood pressure.

Pt was found on floor after falling from chair. Pt was shaking and jerking while on the floor with possible seizure activity that lasted approx. 3-5 seconds. Patient sat up on his own and was confused and alert. Once patient became more coherent, he was able to answer questions. Alert and oriented x3. Abrasion noted to left side of face. Vital signs obtained with BP 110/78, HR57, 02 100% on room air. Patient was warm to touch. Cool compresses applied to neck and back areas. Patient stated he, "thought he fell asleep and when he awoke all the people around startled him." Patient refused EMS care and transportation to hospital. 2nd set of vital signs obtained with BP 106/78, HR 70, O2 100% on room air. Mother was contacted about incident. Patient was monitored for an additional 30 mins. After the additional monitoring, patient insisted that he felt better and ambulated to lobby to self. At time of exit, patient was alert and oriented x3.

After receiving the Pfizer vaccine the patient had a small drop of blood. I grabbed a cotton swab and asked the patient to hold still. He said that he did not handle blood well. About 5 minutes after receiving the vaccine the patient stated that he was feeling like he needed to lay down. I laid him down in the booth area and obtained a BP 102/48, HR 43 normal cuff, supine position, left arm. Technician and I then elevated the patient's feet on a chair as the patient was appearing pale. Technician and I placed a ice pack on the back of the patient's neck as he was feeling hot/clammy. After about 15 minutes the patient was feeling much better and his blood pressure returned to normal - 108/55 HR 53, normal cuff, supine position, left arm. Patient stated that he was a avid cardio exerciser. The patient was then instructed to wait another 10 minutes and then he checked in before leaving and said he was feeling great.

I administered 2nd dose of Covid vaccine to a patient. 23 yo male Vaccine was given at 08:56 AM Right Deltoid. At 8:58 pt c/o mild itching at the vaccine site. I accessed pt's arm, no redness, no inflammation, cool to touch. At 9:00 I administered 50 mg of oral benadryl. Monitored patient for an extra 30 mins. Pt respirations was at 20. At 9:30 before pt had left, pt felt fine, no itchiness, no redness, no inflammation, cool to touch. I advised pt if he does not feel well or if sx returns and feel shortness of breath, difficult breathing to go to the ER. Pt left with girlfriend and I advised the pt not to drive. Pt left stable and ambulatory. I notified my CM.

Several days after vaccine patient developed itching of ankle. A day or so later developed swelling, itching and redness in several areas of his body. On 5/9 he came to PF with swelling of upper lip and left hand. He had been having chest tightness the day before.

Extreme skin hypersensitivity. Became overwhelming for any sort of tactile stimulation on skin, such as showering, toweling off, and wearing a shirt. It lasted roughly 6 hours and then subsided. I also felt extreme fatigue.

my hives were getting very irritating; little rashes and kind of hives on my body; growing inwards; little rashes and kind of hives on my body; growing inwards; itching and hives on my wrist and my feet and it's like kind of growing toward my back; rashes I mean it's kind of red; This is a spontaneous report from a contactable consumer, the patient. This 24-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733; Expiration Date: 31Jul2021), via an unspecified route of administration on 26Mar2021 (at the age of 24-year-old) as single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient stated, "I wanted to call and report side effects so I got my vaccine on the 26Mar2021 and since Sunday (18Apr2021) I have been getting like little rashes and kind of hives on my body so started on my wrist just like growing inwards. Just wanted to report like it was itching and hives on my wrist and my feet and it's like kind of growing towards my back as well so I mean I can breath and everything, it's not like that I have like an anaphylactic reaction but I can, like it's very itchy and irritating. I am still getting like hives and rashes I mean it's kind of red, but it still growing a little bit. I did take like one antihistamine Zyrtec 10 mg only once a day yesterday (20Apr2021) for the little rashes and kind of hives, because my hives were getting very irritating. My second shot is scheduled for this Friday that's on 23Apr2021." Patient reported his height as 6 feet 1 inch (185 cm) and weight should be like 190 pounds on an unspecified date. The clinical outcomes of the events, "rashes I mean it's kind of red", "little rashes and kind of hives on my body; growing inwards", "itching and hives on my wrist and my feet and it's like kind of growing toward my back" and "my hives were getting very irritating" were not resolved as of 21Apr2021.

Patient called pharmacy 5/14/21 and stated he developed a rash from the vaccine 5/13/21; He stated the rash got worse and he developed hives by 5/14/21. Pharmacist consulted patient to seek medical attention right away since rash has worsen since vaccine.

Client received vaccine at 9:35am. Client was immediately syncopal and fell and hit head on floor. RN who administered vaccine noted possible brief tonic clonic activity during syncope. Patient pale and sweating. Client awoke within seconds after fall and was panicked and trying to stand back up. RNs reassured patient and helped patient back into safe lying position. Legs were elevated, VS assessed, ice applied to back of head. No bleeding noted. When patient felt ready and was alert/oriented, nurse raised patient to sitting position and moved into wheelchair. Patient still pale and sweating. Lead RN called EMS due to concern for potential head injury with fall. Patient states that he is lightheaded again and loses consciousness again in wheelchair as RN and EMT are wheeling patient out to be received by EMS squad. EMT supporting patient airway during second LOC - RN notes that airway support (with EMT hands) may be too tight as patient red faced and some throat gurgling. EMT adjusts grip. Patient regains consciousness within 1-2 minutes after second LOC. Patient disoriented - is able to say why he is there and what his name was but cannot remember his age. EMS arrives and takes over care. EMS assessed patient and recommended to transport patient to ED for further assessment. Patient refuses transport to the hospital. EMS squad waits with patient until family member arrives. Patient states family member will transport to hospital. Patient leaves clinic site with family member in car. First set of vitals/assessment after first LOC at 0940 142/96 BP; 74 pulse; 16 respirations; 97% spO2; 97.7 temp; PERRLA. No bleeding on head; scrape noted L elbow. EMS was called at 9:49am. EMS arrived at 9:54am. Patient states no major medical history, not on any meds. Patient has fainted one time previously after broken thumb.

Day after vaccine patient had chills and body aches. Patient also noticed arm swelling, redness, and warmth at the injection site that has persisted.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pt has history of vaso vagal syncope. Patient entered an episode of syncope and quickly recovered. Paramedics arrived to futher consult patient to recovery.

05/28/21 around 22:30 waves of convulsions including uncontrolled shacking of the hands and upper body followed by chills and high body temperature. This lasted for until about 03:00 05/29/21. 05/29/21 consisted of mainly being in a bedridden state of fatigue, sleeping, loss of appetite, swollen and inflamed lymph glands particularly under the armpit of the injection site arm, soreness and pain in the injection site arm, headache, aches and pains throughout the entire body, and the inability to walk or stand for long periods of time. 05/30/21 lymph glands are still inflamed and swollen (particularly as stated above under the armpit of the arm that got the injection), head stills persists, along with some fatigue, and loss of appetite.

This is a spontaneous report from a contactable consumer (Patient). A 24-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 22Mar2021 15:30 as second dose, single dose (at the age of 24-years-old); and previously took BNT162B2(Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 15:30 as 1st dose, single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to vaccination and not diagnosed with COVID-19 prior to vaccination. Medical history included chronic eczema. Concomitant medication included TACROLIMUS 0.1 ointment topical taken for an unspecified indication, start and stop date were not reported. On 26Mar2021, the patient experienced moderate/severe eczema flare-up. The patient underwent lab tests and procedures which included COVID19SS: negative (nasal swab) on 06Apr2021 after vaccination. No treatment received for event. Patient was not recovered from event. No follow-up attempts needed. No further information is expected.

Patient arrived on 03JUN2021 to receive 2nd dose of Pfizer. Patient reported that following 1st dose of Pfizer and completing standard observation period of 15min, he developed onset of Hives and SOB 1 hour (10am) following administration of the Pfizer vaccine at 0900. Patient reports that he did not seek medical attention and chose to wait out the symptoms. Patient reported that his SOB resolved 30min following onset without medical intervention. Patient reported that his Hives resolved 2hours following onset without medical intervention. Patient 2nd dose of Pfizer was not given due to potential adverse reaction to 1st dose.

I also got the second Pfiszer-BioNTech shot on January 9th. On April 2nd, I was laying on the couch watching a movie and I had petechaie on my back from the couch. I also had it in a few spots on my chest. I did not have any bleeding. During my work shifts, I was fatigued during most of them that month. I saw my primary care doctor on April 29th and got labs drawn. The next day he called saying that my platelets were 5,000 and I did not have petechaie or bleeding at that time. Treatment has been 4 consecutive days of 40 mg of dexamethasone. My platelets dropped back to a similar level, so I was placed on prednisone 60 mg with a taper once I started 4 weekly Rituxamab treatments. I just finished those and my hematologist is recommending a spleenectomy at this time.

allergic reaction- diffuse hives started 6/20/21, ER visit, arrived 1:59pm, symptoms started approximately 30 min prior to arrival. also took a tylenol but no prior issues with tylenol in the past

Patient had fever and body aches 1 day after receiving vaccine. Patient had pain, swelling and bruising near and around the injection site 2 days after injection, along with swelling and pain on chest near breast area. Patient is currently taking Tylenol and will begin using ice packs or cold compress as well.

Soreness near injection site weeks after second dose administered on 5/20/21. Becomes more noticable at night time. Perhaps worse after laying on it.

itchy full body hives; 102 degree fever; minorly ill (general body soreness/fatigue/headache); minorly ill (general body soreness/fatigue/headache); minorly ill (general body soreness/fatigue/headache)/low grade headache; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 12Jul2021 (at the age of 24-year-old) as single dose for COVID-19 immunisation. Medical history included season allergies for pollen. Concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. The patient previously received 1st single dose in left arm of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jun2021 (at the age of 24-year-old) for COVID-19 immunisation. Patient felt minorly ill (general body soreness/fatigue/headache) on Tuesday 13Jul2021 and felt better on Wed (14Jul2021) during the day with low grade headache as main symptom. Wed night, patient had a 102 degree fever which dissipated by noon on Thurs. Thursday night (15Jul2021 20:00), patient developed itchy full body hives which still had currently. Patent was taking diphenhydramine hydrochloride (BENADRYL) and prescribed prednisone steroid to prevent itchiness. Essentially stayed in bed the majority of the week and ate very basic meals - not aware of anything that would have triggered these hives and have never had hives before. AE resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. No covid tested post vaccination. The outcome of the event Hives was not recovered, of the event Fever was recovered on 15Jul2021, of other events was recovering. Information about Lot/Batch number have been requested.

Sharp throbbing pain in the left arm pit. Dull nerve pain shooting down left arm from shoulder to wrist. Pain started the morning after vaccination. Swollen and tender shoulder noted with limited mobility and range of motion. Had no other health condition or disability prior to this.

General Malaise; fatigue; light nausea; light headache; dizziness on and off; blotchy red itchy rash on neck, chest, sides, and back; blotchy red itchy rash on neck, chest, sides, and back; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm on 29Dec2020 at 01:45 PM at single dose for COVID-19 immunization. The relevant medical history included asthma and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes). Concomitant medications included emtricitabine, tenofovir alafenamide fumarate (DESCOVY), fish oil, vitamin b complex, lisdexamfetamine mesilate (VYVANSE), cetirizine hydrochloride (ZYRTEC), all from Dec2020. The patient experienced general malaise, fatigue, light nausea, light headache, dizziness on and off, several hours later blotchy red itchy rash on neck, chest, sides, and back, lasted for 3-4 hours, all on 29Dec2020 at 07:00 PM. The patient had the most recent COVID-19 vaccine administered at nursing home/senior living facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive treatment for the events. The patient had nasal swab test with unknown results on 30Dec2020. The outcome of the events was recovered with sequel. Information on the lot/batch number has been requested.

Pfizer-BioNTech COVID-19 Vaccine Site of injection is sore, slightly swollen. I woke up the day after the vaccination (vaccinated yesterday at 9 AM, adverse effects began at 7 AM the day after) with a headache, mild body aches, and general fatigue.

Rapid onset of headache, muscle aches, joint pain, and fever the evening after getting the shot. Injection arm soreness, general weakness. Minor cough, and possible throat swelling. Swollen lymph nodes. Treated fever with cool washcloth to the head all night . Fever reached a maximum of 103 °F at midnight. Around 5:30am took ibuprofen. All symptoms subsided by late morning around 9:30am, except for slight headache.

injection site soreness; chills; fever; hyperthermia; tachycardia; This is a spontaneous report from a non-contactable other HCP. A 25-year-old male patient received the first dose of BNT162b2 (lot number: ELI284), intramuscular at left arm on 04Jan2021 11:00 at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced injection site soreness several hours following administration. Approximately 12 hrs later, patient experienced severe chills and fever lasting for several hours, followed by several hours of hyperthermia and tachycardia. The all events were reported from 04Jan2021 23:00. No treatment received. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Developed a headache about 4 hours after injection. Face, neck, shoulder, upper arms were red in color which lasted about 8 hours. Took Benadryl and Tylenol felt better and redness went away.

Nausea; vomiting; Fever with chills; Myalgias; Upper respiratory tract congestion; Injection site pain; patient received the second dose of BNT162B2 on 05Jan2021; This is a spontaneous report from a contactable physician (patient himself). A 25-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248), via intramuscular on 05Jan2021 13:00 in left arm at single dose for covid-19 immunization. Medical history included none. Allergies to medications, food, or other products was no. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 18Dec2020 10:00 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. The most recent COVID-19 vaccine was administered was in hospital. The patient experienced nausea, vomiting, fever with chills, myalgias, upper respiratory tract congestion and injection site pain, all on 06Jan2021 03:00 with outcome of not recovered. Treatment of paracetamol (TYLENOL) was received for the events. All events were reported as non-serious.

Patient C/O left arm pain at site of injection as well as body aches and then felt dizzy. He was assessed and gradually felt better, was able to return to work but then returned again, 20 minutes after leaving to show that he had urticarial lesions on his left forearm. Vs remained stable, rash did not progress and he was sent home with instructions to return to the ER in the event of progression of symptoms.

Focal pain at injection site; chills/tremors; elevated body temperature; body aches; mechanical allodynia; neck/join pain and stiffness; substernal chest pain radiating to abdomen and right side of neck and jaw. All symptoms began to present approximate twelve hours after vaccine administration. As of 36 hours post-vaccination, symptoms have diminished, but not completely resolved.

Body aches, Awakening Shortness of Air around 0345, became cold quickly, unable to get warm, started to shake and shiver, then was super hot, began to have some sort of out of body phenomenon or hallucination, felt like was about to pass out but was able to sit up and check temperature and discovered a temperature of 103.5 at around 0600. Was able to take Tylenol around 0630 and take shower. Remained weak and exhausted until 1000hours on 1/27. Left arm has pain around injection site.

Rash on opposite chest and upper limb of injection; Behaves and looks like shingles; This is a spontaneous report from a contactable healthcare professional (patient). A 25-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on the left arm, on 13Jan2021 09:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient experienced rash on opposite chest and upper limb of injection which behaves and looks like shingles but not officially diagnosed on 14Jan2021 12:00. Outcome of the events was not recovered. No treatment was received for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information about batch/lot number has been requested.

pt had immediate chills and rigors after the shot Started with hives the day after. These have been progressive Face started to swell , went to ER twice Started on benedryl, pepcid and prednisone

Muscle tightness; soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 14Jan2021 13:15 at single dose for Covid-19 immunization. The patient's medical history included Penicillin allergy (reported "known allergies: Penicillin". 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 14Jan2021 (20:00), the patient experienced muscle tightness and soreness at the injection site up to 24 hours post injection. There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.

The night following 2nd vaccine, I experienced fever, chills, headache , injection site muscle soreness and overall myalgia.

I developed a full body rash which began on my left arm. It then progressed to my other arm, my chest and back and then down on to my legs. Benedryl helped a little bit but the rash didn?t fully go away until I went to Urgent Care and got a corticosteroid prescription. The rash wasn?t overly itchy. I have never had an allergy to any other medication, food, vaccine etc. in my life. I went to urgent care on Friday 1/22 and the rash was gone by the time I finished the dosages on 1/27. I had no other symptoms of any other kind and nothing onto my neck or face.

Started to have a localized rash/warm and swellingto touch on injection site about 5 minutes after receiving vaccine. Cold compress and Diphenhydramine 25mg PO @ 0928. Rash spread to upper back and a couple spots on forehead. No shortness of breath, any trouble breathing. Medication helped with reduction of rash and swelling.

Received dose 2 of COVID vaccine. Within 12 hours of receiving the vaccine, started to have intensifying symptoms all of a sudden: low grad fever of 100.0, cold chills, cold intolerance, a migraine, joint pain, muscle pain, injection site pain, increased hart rate and a heaviness in the chest that made it slightly more difficult to breathe. At 24 hour mark, only injection site pain and headache persisted. Reported injection site swelling 36 hour after vaccination.

8 hours post-injection: moderate arm soreness at injeciton site, mild headache 17 hours post-injection: moderate arm soreness, fever (100.6 F), chills, moderate-severe heache and body aches (lower back, legs), moderate fatigue, moderate dizziness, mild nausea Symptoms resolved completely 36 hours after injection.

Fever began overnight with chills, headache, fatigue and upset stomach. Did not resolve until about 12 hours later. Minor headache still present. Sore arm at injection site.

Beginning 0200 morning after vaccination: Chills, low-grade fever (TMax 100.6 as of 1745 the day after vaccination), lethargy, nausea, headache, injection site soreness. As of 1745 the day after vaccination, nausea has subsided, but headache, fever/chills, and lethargy remain.

Patient received his first dose of covid-19 vaccine. Patient came back 10 minutes later and complained that his right palm had turned yellow. Of note, left palm was of normal color. Patient was able to speak clearly. 911 was contacted and came. Patient was given a dose of epinephrine 0.3 mg in the right thigh. Patient went home after 20 minutes and declined hospital consultation.

Acute shoulder pain at site of shot, has spread underneath into armpit. Fever and acute tiredness for 12+ hrs the day after, low fever and tiredness second day after.

Client reports that he had a rash after first dose that was on his chest, neck, arms, legs and had a tongue were swollen within 15 minutes and received 25 mg of Benadryl. Client reports it took 2 days for the rash to dissipate. Client reports felling out of it for 2 days. Client states he has had an off and on temperature. Client reports an acne or small hives on chest on arms and back and his face is splotchy still today. Client reports a hypersensitivity sensation in last couple of years going thru diagnosis now.

Large hives that were itchy on my knees, elbows and face. These persisted for 4 days and were most active at night. I took Benadryl when this happened.

He received the vaccine and within the first hour he broke out into hives. The only place that he doesn't have them is on the bottom of his feet. Went to the work place clinic on 3/24/21 and they instructed him to take 50 mg. of Benadryl every 6 hours and is actually going to pick up a prescription for this reaction.

Patient had just finished recieving his covid-19 vaccination from vaccinator. At the time of patients fainting I was mixing up covid-19 vaccinations when the technicians said we need you to come out here because a patient is having a seizure, When arriving on the scene I found patient unconsious on the floor face down, while assessing the scene I noticed some blood on floor. I tried to look for any trauma, patient was breathing and I tried to awaken him. I told someone to call 911 and contact a store manager. Then all of a sudden he popped up and sat up like nothing happened. I then noticed the brusing on his nose and asked for an ice pack and a bottle of water. Patient knew his name, was coherent, and seemed to be fine. I stayed with patient until paramedics arrived. Paramedics did a thorough examination and everything checked out. Patient waited for parents to arrive instead of going with paramedics. Vaccinator stayed with patient till his parents arrived.

Adverse event started the morning of 3/10/21 around 08:00 am. Symptoms included headache, fatigue, brain fog, memory issues, feeling feverish, and itching on torso, arms, and legs . Symptoms seemed to improve over the next week or two before worsening again on 3/27/21 around 10:00 am. On the day of 3/27 /21 I experienced headaches, fatigue, brain fog, memory issues, muscle aches, diarrhea, and vision problems. Currently on 3/30/21 symptoms have improved but I am still experiencing dull headaches and brain fog, as well as itching on torso, arms and legs and some vision problems. I have not seen a provider for these issues but have an appointment scheduled for 3/31/21. Treatment includes ibuprofen as needed.

body aches; injection site soreness; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, in the left arm on 04Feb2021 at 12:00 PM (at the age of 25-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. 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 concomitant medications reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, in the left arm on 14Jan2021 at 12:00 PM (at the age of 24-years-old) as single dose for COVID-19 immunization. On 04Feb2021 at 08:00 PM the patient expereinced injection site soreness, body aches and fatigue. No treatment was received for the events. The clinical outcome of the events were recovering. Information on the lot/batch number has been requested.

nasal and chest congestion; nasal and chest congestion; Severe dyspnea; tiredness; wheezing; coughing; headache; fever-like symptoms; injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at arm left on 20Mar2021 at 14:00 at age of 25-year-old at single dose for COVID-19 immunisation. Medical history included severe asthma, rhinitis, allergies to grapseed, beans and legumes. Concomitant medications included budesonide, fluticasone propionate (FLOVENT), omeprazole, tiotropium bromide (SPIRIVA), levosalbutamol hydrochloride (XOPENEX). There was no other vaccine in four weeks. Patient experienced severe dyspnea, nasal and chest congestion, tiredness, wheezing, coughing, headache, fever-like symptoms, injection site soreness; all on 20Mar2021 at 02:45 PM. The events were reported as resulting in doctor or other healthcare professional office/clinic visit and disability or permanent damage. There was unspecified treatment for the events. Patient didn't have COVID prior vaccination. Patient was not tested COVID post vaccination. Outcome of the events was not recovered. Information on batch/lot number was requested.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient reported a shell fish allergy that produces similar reactions. Patient has not taken Benadryl before and dose not own an Epi-pen.

Pt had a syncopal episode 5 minutes after receiving the vaccine. He stood up to notify a staff member when he passed out and fell, hitting his head and sustaining abrasions to his right hand. Pt recalls what happened prior to the syncopal event. He experienced a similar event in the past after receiving the flu shot. Pt also did not eat or drink anything prior to coming here. EMS was notified and pt was brought to a ER.

Client received their vaccine in the vaccination room. Client ambulated independently to the observation room. Observation staff approached client and greeted them. Observation staff seated client and instructed them to notify staff if they are experiencing any symptoms. Client began to feel faint and lost consciousness before they could alert staff. Client fell forward resulting in a contusion and abrasion on their forehead and nose. EMS and Safety officer notified via radio. EMS arrived to the scene and placed client in supine position. Client regained consciousness. EMS began assessment. Vitals taken 1st BP: 98/45 Safety officer arrived to the scene. Client transferred to wheelchair and taken to EMS area. Vitals taken 2nd BP: 103/56 Client refused to be transferred to hospital. Client completed observation time in EMS area. Client able to ambulate independently to exit. Client transported home by friend. Time course, approximately 1 hour from start to finish.

Multiple bruises formed across body without physical injury. Both eyes, chest, left wrist, right knee and both thighs affected. Most formed within 24 hours, a few more by 48 hours and they started disappearing around 60 hours after the shot.

About 5 to 10 minutes after receiving vaccine (during observation period), patient became dizzy, lightheaded and his skin was very pale and clammy. His hands were red and warm to the touch. About 3 to 5 minutes after symptoms started, he passed out for about 10 seconds, but came to on his own. EMS was called and he was checked- out by paramedics, his blood pressure and blood sugar were all within normal range. They observed him for 5 to 10 minutes after which he signed a "refusal" to be transported to ER. He stated he was feeling better and would continue to self-monitor at home with his girlfriend.

Shingles; symptoms began on 4/13, test swab taken on 4/19, and positive results returned on 4/23. Completed 7-day course of Valtrex and symptoms currently on the mend.

PT HAD BEEN UP ALL NIGHT AND DYA STUDYING AND WORKING, WAS OVERLY TIRED AND HADN'T EATEN MUCH AT ALL THE DAY OF VACCINATION. PT TURNED GRAYISH IN COLOR AND PASSED OUT IN CHAIR, WAS CAUGHT BY WIFE AND LOWERED TO GROUND AND PLACED ON A MAT WITH PILLOW. PT CAME TO UPON SHAKING SHOULDER. PER WIFE WHO WAS NOT PHASED AT ALL WITH PT PASSING OUT REPORTED PT HAS HISTORY OF PASSING OUT AND HAS HAD THIS HAPPEN WITHIN THE PAST 2 WKS. PT WAS NOT IN ANY DISTRESS. WAS GIVEN WATER AND FOOD. COLOR REAPPEARED AFTER A FEW MINUTES AND PT WAS FEELING BETTER 10MINUTES LATER. CONTINUED TO MONITOR PATIENT FOR 30MINS.

We had a patient today that passed out after his covid vaccine. It was his 2nd covid immunization. He got his immunization at the pharmacy in the booth and then he sat down in one of the waiting chairs at the end of the cough and cold aisle. While he was sitting down, he began to feel unwell, he then got up off his chair and then was approaching the drop off window (he was going to let us know he didn't feel well) at that time he then passed out. He fell into the privacy screen of the imz booth. He did fall into the booth which did break some of his fall. He also knocked off one of the frames that we had on the wall, and then I think it fell on his nose. He did get a cut nose and he also bit his lip or mouth because his mouth was bleeding also. He reported that his nose did hurt, and he will have a prominent bruise on his nose. We did provide him with a couple of ice packs and a bottle of water. The patient (25 years old) and his mother both stated that he has passed out in the past when he has been around needles. He stated that he got to thinking about getting the shot and the needle going into his arm and that is when he started to feel unwell.

Redness at injection site, pain when moving injected arm, high level of fatigue, inability to get restful sleep, body aches, crying with no recognized physical or emotional cause

Patient called Clinic call center reporting generalized rashes covering 20% of his body. Patient denies any other symptoms at this time. PAtient is not in respiratory distress. Patient declined scheduling with Medical Center provider and stated will reach out to PCP for advice today.

The patient reported that they were experiencing tightness in their arm and believed it swelled initially. They left the pharmacy area and went to get Tylenol that was recommended by the pharmacist. They then began to get lightheaded and had syncope, attempted to get back up and the cashier asked to if they wanted to sit, but fell again. It was not clear initially to the employee who was helping them they had received the vaccine. 911 was called and the employee helping them let the pharmacist know they had just gotten their vaccine. The immunizing pharmacist went to check on the patient. EMTs were already helping the patient and had taken his blood pressure which was normal the lightheadedness had stopped and both sitting and standing blood pressure was the same. He had an elevated heart rate per the patient but didn't know any of the numbers the EMTs had taken. His father was driving him. He was not experiencing any symptoms and the injection site had no swelling and was otherwise unremarkable.

25-year-old Caucasian male with no significant past medical history, he was seen in the hospital on the 24th of March for right facial weakness, prescribed a week of steroid and antiviral, his symptoms started with an ear infection on the right side a month and a half ago, he did not have a rash in or around the ear but it was beet red, [he had the zoster vaccine as a child], 1 week later, he had drooping of the right side of the face, went to urgent care where he was given 3 days of amoxicillin, it did not help and he developed nausea, it was stopped, then he went to the hospital and was treated, there was no improvement, hence went to ENT where he was given a 12 day dose of tapering p.o. prednisone 60 mg and decreasing by 10 mg every 2 days to nothing and 14 days of repeat antiviral therapy, he finished them 3 days ago, right-sided facial weakness has not improved, there is no pain, when all this started, he had vertigo with spinning sensation all the time for about a week and a half with decreased balance, both have resolved, he had a brain MRI in the hospital that was unremarkable, his hearing is normal, denies any problems with speech, he thinks the right eye closes when he sleeps, he does not patch it or use artificial tears, no headache, no numbness or weakness reported, no facial pain, no prior history of similar problems, left side of the face is fine, 2 weeks prior to symptom onset, he had the first dose of the Pfizer Covid vaccine. No history of COVID-19.

Headache, Joint Pain, Eye Muscle Pain, Skin Sensitivity, Injection Site Pain. The joint pain and injection site pain lasted roughly two days after the vaccination. All other symptoms still ongoing as of two and a half days after vaccination but with less intensity than the first two days.

Vaccine was give at 10:35 . At 1040 patient c/o feeling warm at injection site, tired , dizzy and anxious. At 10:50 am Vital signs included 160/100, 126, 19, at 99%RA. Pt. Was helped to lay down in a supine position with legs eleveted. At 10:56 vitals were 140/90, 83, 20, 99%RA. Cold ice pack was applied at the back of his neck. At 11:15 am symptoms subsided with BP of 130 /85.

Fever, Chill, Body Aches, injection site pain - Tylenol 1000mg every 8 hrs for 24hrs - symptoms lasted 24hrs

8 hours later burning feeling all over body, rash across the forehead, 2 weeks later swollen gland/infection on left side of ear and face

Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted 5 min post-vaccination while sitting on chair in observation area,fell forward & hit floor, skinning his nose. PhD immediately attended & rolled patient into recovery position as he awoke CphT left scene to call 911. Pharmacists, stayed w/ patient until EMS arrived (5 minutes) & transported to local hospital for evaluation

At 3:00 AM on the day after I woke up with my right eyelid swollen and producing goop. Other than that I had fatigue, sore injection site, and a headache.

continues to have tenderness when he presses on the right deltoid; his pain is aggravated when he performs supine bench press so he avoids this as well; he is 6 weeks out from the dose that seemed to trigger this problem

An employee felt itchy within 15 minutes after his 1st dose shot. Patient experienced itchiness, no SOB, no swelling, skin was red and warm. We had Benadryl 50mg/ml and gave IM injection with the OK from the patient. He felt better and the itchiness feeling was gone.

Patient was given first COVID vaccine for a 9:45AM appointment by a certified immunizing pharmacy technician. The vaccine was given approximately around 10:00AM and was seated for 15 minutes in pharmacy waiting area after vaccine. At Around 10:15AM patient reported feeling very itchy all over his body, he felt his throat feeling a little tight, and his tongue felt swollen. Paramedics were called and on their way. Patient refused an EpiPen. Paramedics arrive on site around 10:30AM and took the patient with them..

The patient was escorted to the waiting room post vaccine injection. He reported feeling light-headed. At 1220 while the NP was by his side, he became clammy, lost color, and became unresponsive with eyes rolled. He maintained his breathing and became conscious at 1225 with color returning and alert and oriented x 3. Pulse 65 BPM, O2 Sat 97-98% RA. He was escorted to the exam room table with the NP and PCT and placed in the supine position. He reports feeling light-headed and nauseous but alert and oriented x 3; BP 102/65, P 65 BPM, RR 16, O2 sat 97-98%. Notified at 1238. The patient was observed by the NP and remained with continuous pulse ox monitoring. At 1309, HOB raised to 30 degrees and patient given sips of water; BP 104/60, P 61 BPM, RR 16, O2 sat 97% RA. At 1323, HOB raised to 45 degrees. Patient c/o dizziness and nausea but tolerating sips of water; BP 110/75, P 63 BPM, RR 16, O2 sat 100% RA. At 1330, HOB raised to 90 degrees. Patient c/o dizziness and nausea, tolerating sips of water, BP 110/75, P 60 BPM, RR 16, O2 sat 98%. Patient escorted to waiting room chair at 1330 with NP and PCT. He c/o dizziness and nausea with position change, BP 110/75, P 60 BPM, RR 16, O2 sat 98% RA. He remains in the waiting room chair with PCT observation. At 1335, he begins with vomiting x 1 episode. He reports that he feels better and denies dizziness at this time. At 1353 he reports that he is feeling better. Denies dizziness or nausea; BP 104/60, P 65 BPM, RR 18, O2 sat 100% RA. He was discharged at 1410 with his boss from work. He is alert and oriented x 3, denies SOB, dizziness, lightheadedness, or N/V.

Patient describes no immediate adverse event after vaccine receipt to suggest IgE reaction (e.g. oral/facial/throat/tongue edema, SOB, wheeze, CP, urticaria, pruritis, etc.) . He reports he felt ill the following day with weakness, cough, increased nasal drainage, decreased exercise tolerance resulting in SOB and elevated HR. He was seen in ER 29 APR (day 8) and diagnosis was URI vs. vaccine reaction. He states these symptoms have resolved. He reports 2 weeks ago (day 7) he was then in the field training and exposed to poison ivy. On day 14 he developed dermatitis to arms, abdomen and groin. He self treated with topical benadryl cream, which made symptoms much worse and produced a large plaque. He switched to calamine, and witch hazel. On day 17 he developed a targetoid erythematous dermatitis to his hands and arms. He was seen in ER and diagnosed with EM and contact dermatitis and treated with oral prednisone, and cetrizine and Bactroban for sites of secondary infection. He reports lesions to hands and arms are mostly resolved, and abdominal plaque is much improved. He is using cetrizine and pruritis is not significant. He had no oral lesions, oral pain, vesicles, vision changes.

The day after patient received the Pfizer 2nd dose he started having symptoms of Shingles. Symptoms persisted for a week until he was seen by a provider and he was diagnosed with Shingles.

I got shingles about a week after my second Pfizer COVID shot. It first presented as aching/pain in my right leg for about a week, and then several rashes/blistery areas appeared down the back of that leg which hurt in a burning + sharp pins way. I called my insurance's virtual urgent care line and the doctor diagnosed me with shingles and put me on a course of valacyclovir. We discussed possible triggers, but I had no major stressors or illness or anything else that would have caused shingles - so the doctor and I agreed that it was likely triggered by the COVID vaccine. I had chickenpox as a child and have never had shingles before. I'm a couple days into the antivirals but expect it will take a while for this to run its course.

Extreme headache shortly after, treated with water and Advil, no big deal. Woke up in the middle of the night with a horrible fever, headache, rash, and chest pains. Treated with nothing, and it eventually went away this morning, considered going to hospital.

Injection site pain: intense pain/soreness for day after injection, moderate soreness for 3 days Tiredness, severe headache, fever, chills, muscle pain, nausea from 10 hours after injection until ~48 hours after Mild headache for next 5 days

Urticarial rash to back of neck and upper back that started within 20 min of Covid-19 vaccine from Pfizer. Rash resolved with Benadryl and famotidine

It would be a GRADE 3 - Redness and swelling near the injection site. Is taking Tylenol and Motrin and using an ice pack on the swollen area.

pain at vaccination site; headache; Rash on entire chest area; Vaccination site redness; Rash on face; This is a spontaneous report received from contactable consumer, the patient. A 25-year-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on19Mar2021 at 15:45 (at the age of 25-year-old), as a single dose for COVID-19 immunisation. The patient did not had any medical history. The patient's concomitant medications included buspirone(MANUFACTURER UNKNOWN), ibuprofen(MANUFACTURER UNKNOWN), excedrin(MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received first dose of BNT162B2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot No:En6200),via an unspecified route of administration in the left arm on 26Feb2021 at 16:00 (at the age of 25-year-old)as a single dose for COVID-19 immunisation. The patient had allergies to thimerosal, T-Dap and tubersol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 16:30, the patient experienced rash on entire chest area within 45 minutes of shot, spread to face within an hour, pain at vaccination site along with redness and headache. Therapeutic measures were taken as the result of events was unknown. The clinical outcome of the event rash on entire chest area, pain at vaccination site along with redness and headache was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

A shingles like rash appeared on both legs. From knees to ankles. Extremely itchy and pimply looking. Home treatments of mainly calamine lotion to stop the itch

Fever Chills Aches/Joint Pain Headache Tiredness/Lack of Energy Nausea Diarrhea Injection Site Pain Arm Pain

sore arm at site of injection; brief headache; This is a spontaneous report from a contactable pharmacist. A 25-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via intramuscular route of administration in the right arm on 20Mar2021 at 10:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any known allergies. 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. The patient had not been tested for COVID-19 since having the vaccine. On 20Mar2021, the patient experienced sore arm at site of injection and brief headache. The date of awareness of this event was reported as 21Mar2021. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sore arm at site of injection and brief headache was unknown. Information about lot number cannot be obtained. No further information is expected.

Rash on neck, face, forearm; Rash on neck, face, forearm; Rash on neck, face, forearm; This is a spontaneous report from a contactable consumer, the patient. A 25-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 12Mar2021 at 09:15 (at the age of 25-year-old), as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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. The patient did not receive any other medications within 2 weeks of vaccination. On 16Mar2021, the patient experienced rash on neck, face and forearm. The patient did not receive any treatment for the reported event. The clinical outcome of rash on neck, face, forearm was not resolved at the time of reporting. Amendment: This follow-up report is being submitted to amend previously reported information: 1. recoded event term for "Rash on neck, face, forearm" 2. Updated final sentence as No follow-up attempts are possible; information about lot/batch number cannot be obtained No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Site of injection became red, swollen & patient reported itchiness within 5 minutes of administration of vaccine

Itchy; Red, bumpy skin around upper body; noticeable itchy, red, bumpyskin around my upper body, especiallyleft and right sides of upper body,neck, chest.; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 15:00(at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to cats, dusts and mite allergy. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), ascorbic acid (VITAMIN C), cannabidiol (CBD OIL) and THC, all from unknown dates and for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 23Mar2021, the patient underwent PCR(nasal swab) test and the result was negative. On 29Mar2021 at 13:00 6th day of vaccination, the patient experienced itchy, red, bumpy skin(skin lesions NOS) around upper body especially left and right sides of upper body, neck, chest. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported events which included benadryl once in the evening on 29Mar2021 and the symptoms were gone and returned mindly on the 30Mar2021.The patient took claritin instead for two extra days and stopped, all symptoms were gone. The clinical outcome of the event itchy, red, bumpy skin around upper body was recovered on unspecified date in 2021. No follow-up attempts are needed. No further information is expected.