VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1141026
Sex: F
Age: 52
State: CA

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 03/27/2021
Hospital:

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Lab Data:

Allergies: slight reaction to sulfa drugs, rash

Symptom List: Dysphagia, Epiglottitis

Symptoms: Arm was swollen in a 3" diameter raised about 1/2 inch by 4:00 in the afternoon even though I had taken ibuprofen at 11:00. By 5:30 I was achy all over and had the chills. The tightness in my throat which had finally gone away, came back with a vengeance and my chest was tight and my lungs were achy as well. I took ibuprofen at 6:00, Tylenol at 10:00, ibuprofen at 3:00 am, and Tylenol at 7:30 am, and ibuprofen at 11:00 am this got me through work on Friday. I decided not to take anymore drugs because I had taken a lot. By 6:00 my throat was really tight and my lungs hurt, as well I had the chills again. So I took Tylenol at 6:00, Ibuprofen at 8:30, and Tylenol at midnight, and ibuprofen at 7:30 am. That was the last time I took medication. The chills did not come back, but the tightness in my throat did once the medication wore off.

Other Meds: Vitamin B, D, K, potassium, Turmeric

Current Illness: None

ID: 1141027
Sex: F
Age: 19
State: WY

Vax Date: 03/22/2021
Onset Date: 03/23/2021
Rec V Date: 03/27/2021
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Allergies: NA

Symptom List: Anxiety, Dyspnoea

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

Other Meds: NA

Current Illness: NA

ID: 1141028
Sex: F
Age: 60
State: FL

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 03/27/2021
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Allergies: Natural rubber latex Cat dander Azithromycin

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: My blood pressure shot up the first night. It came down for a while Wed and Fri, but shot back up to 181/102 Sat. I take Clonidine when it goes over 160. I have had several this week. My pulse has stayed in the 60s and 70s. My oxygen saturation has been above 95.

Other Meds: Metoperol ER Novolog Solostar Hydrochlorothiazide Isosorbide mono ER Metformin Iron 65mg

Current Illness:

ID: 1141029
Sex: F
Age: 44
State: CA

Vax Date: 03/25/2021
Onset Date: 03/26/2021
Rec V Date: 03/27/2021
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Allergies: Amoxicillin

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Warm, red, swollen rash approximately three inches in diameter around injection site.

Other Meds: Zoloft, Buspar, Multi-vitamin, Fish Oil, Coenzyme Q-10

Current Illness: None

ID: 1141030
Sex: F
Age: 59
State: IN

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 03/27/2021
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Lab Data:

Allergies: Mast cell Activation disease

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Immediate systemic effects: dizziness, fatigue,,headache, nasal congestion, flushing. I took two Benadryl and waited 30 minutes before going home and slept . I woke up to pain in my arm at shot location symptoms continued the next day and included a sore throat. I felt ill and weak.still symptomatic on 3/26 and 3/27; sleeping as much as possible. Arm no longer painful except when touched.

Other Meds: Levothyroxine, atorvastatin, amlodipine, cetirizine, chlorzoxazone, nabumetone, topiramate,,gabapentin, azelastine, estradiol patch, spironolactone, benadryl, ventolin

Current Illness: None

ID: 1321567
Sex: M
Age: 66
State: UT

Vax Date: 03/25/2021
Onset Date: 03/26/2021
Rec V Date: 03/27/2021
Hospital: Y

Vax Type:
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Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Fevers, diffuse myalgias and headache Syncope

Other Meds:

Current Illness:

ID: 1381457
Sex: U
Age:
State: FL

Vax Date:
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Rec V Date: 03/27/2021
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Allergies: codeine, Sulfadrugs; iodine (as in dye for CT's)

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Received vaccine 2-15-2021 about 7:00 pm. Early AM on 2-18-21, I awakened to find that I had muscle weakness and impairment on my left side from shoulder down through my foot. I lost dexterity on all left side- mainly fingers of left hand and food (including foot drop and impaired gait) My balance was also affected. I've regained most use

Other Meds: Premarin -. 0.3 - 15 per month Ketorolac Tromethamine Opthalmic Sol (.5%)

Current Illness: CLL

ID: 1406225
Sex: F
Age: 73
State: PA

Vax Date: 03/25/2021
Onset Date: 03/26/2021
Rec V Date: 03/27/2021
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Symptom List: Pharyngeal swelling

Symptoms: Covid vaccine 3/9/21 Patient woke up in unbearable pain in the right arm the morning after vacination (3/26/21); Took motrin 800mg and it took the pain away for a little. Took Tylenol later on during the day and it had no effect. Lidocaine patch & using ice had no effect. Took vicodin this morning (3/27/21) and it helped a little.

Other Meds:

Current Illness:

ID: 1406353
Sex: F
Age: 66
State: NY

Vax Date: 01/18/2021
Onset Date: 01/25/2021
Rec V Date: 03/27/2021
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Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: ON 1/22/21 ACHES/STUFFY NOSE ON 1/25/21 RED RASH BELOW INJECTION SITE 2X1 INCH - ITCHY USED BENADRYL CREAM/APAP - PATIENT HAD VIRTUAL VISIT WITH DR. MD PRESCRIBED EPIPEN ON 2/9221 - PATIENT DID NOT FILL - ON FILE AT PHARMACY. 1 MONTH AFTER SHOT RASH GONE - PAIN/ITCHNESS STILL FELT UNDER SKIN. SECOND SHOT NO BANDAID USED - GIVEN 2/15/21 RIGHT ARM ON 2/16/21 HIGH FEVER/ACHES CHILLS ON 2/18/21 DIZZINESS/OFF BALANCE -FOREHEAD AND SIDE OF HEAD PAIN, PATIENT STILL EXPERIENCING DIZZINESS - SEEING PRIMARY, ENT, HAVING MRI

Other Meds:

Current Illness:

ID: 1140656
Sex: U
Age:
State: FL

Vax Date: 11/29/2012
Onset Date:
Rec V Date: 03/28/2021
Hospital:

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Symptom List: Diarrhoea, Nasal congestion

Symptoms: multiple outbreaks of herpes, herpes zoster; postherpetic neuralgia; dysphonia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender who was approximately 75-year-old at the time of this report. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-NOV-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions at a pharmacy. On an unspecified date, the patient was treated by healthcare providers for multiple outbreaks of herpes, herpes zoster, postherpetic neuralgia, and dysphonia. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).

Other Meds:

Current Illness:

ID: 1140658
Sex: F
Age: 58
State: PA

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 03/28/2021
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Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Heat development; Cellulitis; Swelling the size of an orange; Itchy skin; Red skin covering upper arm; Arm pain; This spontaneous report was reported by a consumer concerning a 58-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore with restricted movement, swelling, site turned red and spread through entire upper arm, itchiness, heat and cellulitis. The patient's medical history was not reported. The concomitant medication included Metformin, Clonidine, Lisinopril, Metoprolol, Synthroid, Citalopram, Xanax and Vitamin D. On 2 Mar 2021, 1 day prior to the onset of the event, the patient received the first dose mRNA-1273 (Lot number -013A214) via intramuscular in left arm for prophylaxis of COVID-19 infection. On same day the patient reported the arm was sore with restricted movement. On 10 Mar 2021, patient reported swelling near orange size, the site turned red and spread through entire upper arm and itchy skin. On an unknown date heat developed and doctor believed patient developed cellulitis secondary to the vaccination. Action taken with the mRNA-1273 in response to the events was not provided. The outcome was recovered for swelling, arm pain and red skin and unknown for rest events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: METFORMIN; SYNTHYROID; CLONIDINE; LISINOPRIL; METOPROLOL; CITALOPRAM; ALPRAZOLAM; VITAMIN D [ERGOCALCIFEROL]

Current Illness:

ID: 1140659
Sex: F
Age: 70
State: TX

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 03/28/2021
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Symptom List: Rash, Urticaria

Symptoms: sweating; Pain in arm; Fever; Chest pain (left side); No bowel movement-watery; Labored breathing; Over sleeping; Passed out; Chills; Dizziness; Headache; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna COVID 19 vaccine and experienced pain in arm, dizziness, major chest pain (left side), pain in shoulder, neck, headache, no bowel movement-watery, chills, labored breathing, passed out, over sleeping, no urine, sweating, fever and sore throat. The patient's medical history included congestive heart failure, high blood pressure and gout and had 3 heart attacks in lifetime. No relevant concomitant medications were reported. On 12 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: 031A21A) intramuscularly for COVID-19 prophylaxis. On 12 Mar 2021, the patient experienced headache and dizziness. On 13 Mar 2021, the patient experienced pain in arm, major chest pain (left side), pain in shoulder, neck, no bowel movement-watery, chills, labored breathing, passed out, over sleeping, no urine, sweating, fever and sore throat. Treatment for the event included nitroglycerin and paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event dizziness was resolved on 12 Mar 2021. The outcome of the events chills, fever and headache was resolved on 14 Mar 2021. The outcome of the events pain in arm, major chest pain (left side), pain in shoulder, neck, no bowel movement-watery, labored breathing, passed out, over sleeping, no urine, sweating and sore throat was resolved on 15 Mar 2021.; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected loss of consciousness and NS unexpected dizziness, chest pain, dyspnea, gastrointestinal motility disorder, hypersomnia, hyperhidrosis, and expected pain in extremity, pyrexia, chills, headache. Event onset Day 1 after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Blood pressure; Congestive heart failure (Patient had 3 heart attacks in lifetime.); Gout

ID: 1140660
Sex: F
Age:
State:

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 03/28/2021
Hospital: Y

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Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Seizures; Swelling in left arm where she got the vaccine; A spontaneous report was received from a pharmacist concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced seizures and swelling in left arm where she got the vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (batch number: 044A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Mar 2021, the patient experienced swelling in left arm where she got the vaccine. On 15 Mar 2021, the patient had medically significant event of seizures and was hospitalized for less than 24 hours. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the event swelling in left arm where she got the vaccine was resolved on 12 Mar 2021. The outcome of the event seizure was resolved on 15 Mar 2021.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the start date of the reported events and excluding any other etiology, a causal relationship with the events cannot be excluded. Injection site swelling is consistent with the safety profile of the product

Other Meds:

Current Illness:

ID: 1140661
Sex: F
Age:
State: NY

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 03/28/2021
Hospital:

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Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: complete hearing loss in my left ear for about four hours/ noticed but undocumented hearing loss; headache; chills; hangover feeling; incredibly loud ringing in left ear/ intermittent throughout the day, lasting for several hours at some points/ constant dull ringing/ tinnitus/ ringing in both ears; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 22Mar2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable Other Health Professional (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot EN6201) via intramuscular at left deltoid on 19Feb2021 at 14:30 (30-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included bipolar disorder, ADHD, depression, and low Vit D. The patient had no COVID prior vaccination. There were no known allergies. Concomitant medications included lamotrigine (LAMICTAL) from 2016 and ongoing for bipolar, sertraline hydrochloride (ZOLOFT) from 2020 and ongoing for Bipolar, amfetamine/dexamfetamine (reported as amphetamine/dextroamphetamine salt extended) from 2015 and ongoing for ADHD and depression, Vitamin D3 from 2020 and ongoing for low Vit D, and cyanocobalamin (VITAMIN B12). The patient did not receive other vaccine in four weeks. Facility type was school or student health clinic; vaccine was administered at military facility. On 20Feb2021 at 21:00, patient had the normal headache, chills, "hangover feeling" in addition to an incredibly loud ringing in her left ear after her first dose. The ringing was intermittent throughout the day, lasting for several hours at some points. The intensity of it has subsided but there seems to be a constant dull ringing in her left ear now. She also had some weird effects with her medications the two days following her first dose. Not entirely sure if they're related but her medication seemed to be ineffective on Saturday and have little effect on Sunday. Severe tinnitus began around 10:00 (as reported) following her first vaccination, resulting in complete hearing loss in her left ear for about four hours. After that the severe ringing was intermittent for about five more hours. She now has ringing in both ears since, with noticed but undocumented hearing loss. There were no further complications after the second dose. The second dose (batch/lot number EN6205) was received via Intramuscular at left deltoid on 12Mar2021 at 14:00. The adverse events did not result in emergency room visit or physician office visit. The patient did not test COVID post vaccination. No therapeutic measures were taken as a result of the events. The outcome of tinnitus was not recovered; outcome of other events was recovered with sequel.

Other Meds: LAMICTAL; ZOLOFT; AMFETAMINE;DEXAMFETAMINE; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]

Current Illness:

ID: 1140663
Sex: F
Age:
State: NY

Vax Date: 02/27/2021
Onset Date: 03/01/2021
Rec V Date: 03/28/2021
Hospital:

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Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Bleeding of gums; unbake to stop bleeding from puncture site; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 27Feb2021 (at the age of 54-years-old) at 18:00 as a single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included amiloride taken for an unspecified indication, start and stop date were not reported. On 01Mar2021 at 06:00, the patient experienced bleeding of gums beginning less than 48 hours after dose, then 1 week after dose, donated blood, "unbake" to stop bleeding from puncture site on Mar2021, tourniquet applied and blood soaked through, was oozing for 5 hours after. There was no treatment received for the events. The outcome of the events was unknown.

Other Meds: AMILORIDE

Current Illness:

ID: 1140664
Sex: F
Age:
State: WI

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 03/28/2021
Hospital:

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Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: fuzzy; confused; got really hot; dizzy; flash of heat; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207) intramuscular in the right arm on 10Mar2021 (time the vaccination was given: 08:45-09:00) at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had no family medical history. There were no additional vaccines administered on same date of the Pfizer suspect. No previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations within 4 weeks. Adverse event (AE) following prior vaccinations were noted as none (never had a reaction to a vaccine before). It was reported that the patient would like to know if she should receive her second dose of the Pfizer BioNTech COVID-19 vaccine based on the side effects she experienced after receiving her first dose yesterday. She already has an appointment scheduled for second dose. She waited in store 10 minutes after receiving it and felt fine. On the drive home, she felt a little fuzzy or confused and then got really hot and felt a little dizzy, but that went away within 15 minutes. It was further stated that within 15 minutes of getting the vaccine on 10Mar2021, she "got kind of fuzzy" (felt fuzzy) and first confused 09:10, then felt hot and then dizzy 09:15; these events were assessed as serious medically significant. Additionally, she experienced a "flash of heat that went through her body" on 10Mar2021 which went away within 10 minutes. No ER or physician's office required. She felt like if she just got some water, she would be fine. No test was done. The feeling of confusion was what lasted the most and the dizziness did not last very long. The outcome of the events was recovered on 10Mar2021. The events felt fuzzy, confused, hot and dizzy was related to BNT162B2 per reporter.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events fuzzy, confused, feeling hot and dizzy. 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.

Other Meds:

Current Illness:

ID: 1140665
Sex: F
Age:
State: CA

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 03/28/2021
Hospital:

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Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: feel like I have a chest cold.; feeling like I had the flu; trouble breathing; fatigue; throat has been a little sore; cough; feel like allergies all flared environmental and food; nausea; felt horrible; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ENG199), via an unspecified route of administration in the left arm on 04Mar2021 at 17:30 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis, vestibular migraines, allergies to all tree nuts, sunflower oil 25 very high, milk and egg whites, environmental allergy, the patient was recently vegan due to an anaphylactic attack. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included hydroxychloroquine, varenicline tartrate (CHANTIX), escitalopram oxalate (LEXAPRO), lisdexamfetamine mesilate (VYVANSE), metronidazole (TRIAM). There was no other vaccine administered within 4 weeks of the vaccination. On 05Mar2021 at 00:00, the patient woke up feeling like she had the flu. She had trouble breathing and felt like she had a chest cold. She felt fatigue and horrible. This reminded her of how she felt when she had strep throat. Her throat had been a little sore, she had a cough and nausea. She also felt like her environmental and food allergies flared. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "feel like I have a chest cold", "feeling like I had the flu", trouble breathing, fatigue, throat has been a little sore, cough, "feel like allergies all flared environmental and food", nausea and felt horrible was resolving.

Other Meds: HYDROXYCHLOROQUINE; CHANTIX; LEXAPRO; VYVANSE; TRIAM [METRONIDAZOLE]

Current Illness:

ID: 1140666
Sex: F
Age:
State: WA

Vax Date: 03/09/2021
Onset Date: 03/10/2021
Rec V Date: 03/28/2021
Hospital:

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Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Meniere flare-up for 24 hours; Blurry vision; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 09Mar2021 at 09:00 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included allergy to Brazil nuts, buckwheat and shrimp. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3) and iron, all received from an unspecified date (within 2 weeks), at an unknown dose, for an unspecified indication. On 10Mar2021, the patient experienced blurry vision and Meniere flare-up for 24 hours. No treatment was received. The patient recovered from the events on 11Mar2021. Post the vaccination, the patient has not been tested for COVID-19. The information on the Lot number has been requested.

Other Meds: WELLBUTRIN; D3; IRON

Current Illness:

ID: 1140667
Sex: F
Age:
State: CO

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
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Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: neck and jaw pain; neck and jaw pain; has clicking in her jaw; concerned these symptoms following vaccine could be Bell's Palsy/Palsy; dull ear; She stated she could not walk on her left foot on 11Mar2021 but recovered the next day; This is a spontaneous report from a contactable consumer (the patient). This 39-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EN6204), via an unspecified route of administration, in the right arm on 10Mar2021 at 10:45 AM (at the age of 39 years) as a single dose for COVID-19 immunization. Medical history included skin wrinkling. Concomitant medication taken within two weeks of vaccination included botulinum toxin type a (BOTOX) taken for skin wrinkling, and unspecified birth control pills. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot # EN6200, on 18Feb2021, in the right arm COVID-19 immunization, and experienced fatigue. The patient reported that while she was sleeping last night on 11Mar2021 around 02:00-3:00, she had onset of dull ear, neck and jaw pain on left side. She had clicking in her jaw. The patient mentioned she never had a droopy face. She stated she could not walk on her left foot on 11Mar2021 but recovered the next day. She's concerned these symptoms following vaccine could be Bell's Palsy - what should I do. She looked online and saw that these are some of the first symptoms of Bell's palsy. She called to ask if these events could be Bell's palsy, and for information on events and Bell's palsy relative to the COVID-19 Vaccine. She informed that she had an upcoming appointment with her doctor "today" at 14:00 to see if she has Bell's palsy. The patient stated she went to the doctor on 11Mar2021 at 03:00 pm. Event term of Palsy with onset date of 11Mar2021 was reported. The physician did not prescribe medication, no treatment given. The clinical outcome of dull ear, neck and jaw pain, has clicking in her jaw, and palsy was recovered on 13Mar2021

Other Meds: BOTOX

Current Illness:

ID: 1140668
Sex: M
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 03/28/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Prolonged fever, leukocytosis; Prolonged fever, leukocytosis; This is a spontaneous report from a contactable physician. An adult male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced prolonged fever, leukocytosis on Feb2021 with outcome of unknown. The patient was hospitalized for prolonged fever and, leukocytosis for 7 days. Treatment was unknown. It was unknown if patient had COVID prior vaccination or if patient was COVID tested post vaccination. Information on the batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of fever and leukocytosis due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including blood cultures and chest x-ray, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1140669
Sex: M
Age:
State: MA

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Sudden onset of Atrial Fibrillation within 2 minutes; This is a spontaneous report from a contactable physician (patient). This 81-years-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6206, on 05Mar2021 10:45 in right arm as a single dose (at the age of 81 years) for COVID-19 immunization. The patient had dose 1 of BNT162B2 for COVID-19 immunization, Lot number EL9261, on 05Feb2021 10:45, in Left arm. Relevant medical history included GERD (gastrooesophageal reflux disease). There were no allergies reported. Concomitant medication included Omeprazole, Ursodiol, fexofenadine hydrochloride (Allegra), diphenhydramine hydrochloride (Benadryl). The patient had no other vaccine in four weeks. The patient experienced sudden onset of Atrial Fibrillation within approximately 2 minutes on 05Mar2021 reported as 10:45. The patient was seen at the physician's office. Treatment included EKG; Xeralto anticoagulant. The patient did not have COVID prior to vaccination and was not tested post vaccination. The outcome of sudden onset of Atrial Fibrillation was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event cannot be completely ruled out given the implied temporal association. However, underlying medical conditions may provide the alternate explanations. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: OMEPRAZOLE; URSODIOL; ALLEGRA; BENADRYL

Current Illness:

ID: 1140670
Sex: M
Age:
State: NY

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: heart attack; pass blood clots in his urine; nauseous; really tired; knocked him on his butt/did not get out of bed, did not do anything for 2 weeks; couldn't stay awake/ slept for two weeks; couldn't eat anything; the sight or smell of food made him gag; bruise on his arm about the size of a half dollar where he got the shot; This is a spontaneous report from a contactable consumer. A 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered on the right arm at the age of 69 years, on 18Feb2021 16:00 at a single dose for COVID-19 immunisation. Medical history included known for a history of heart disease, stage 4 kidney failure and polycystic disease. He had been bleeding from the kidneys for a week prior to receiving the vaccine, heart attack and cholesterol. He stated he needs some reassurance and added he has Stage 4 kidney failure with polycystic disease. He already consulted with his heart doctor and kidney doctor and they say get the vaccine. He mentioned that every now and then he gets blood from a cyst rupture. On the day of the first shot he was having a little bit of bleeding in his urine. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) taken for cardiac disorder; atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal; amlodipine (AMLODIPINE) taken for blood pressure abnormal and multivitamins. The first shot knocked him on his butt. He slept for two weeks then he started to pass blood clots in his urine. He read that the vaccine can cause clotting and he doesn't know if that might have caused the clots right after the shot. He just needs someone to hold his hand about getting the second shot. He has to leave in a couple of hours to get it. He was asking do we see a pattern where people have had a bad first reaction with the first shot and they don't have a bad a reaction the second time around. He clarified he received the first dose of the Pfizer COVID 19 vaccine on 18Feb2021 at 1600 in the right arm. He was fine until Saturday (20Feb2021) when he woke up nauseous; really tired; could not get out of bed; and then really didn't do anything for two weeks. He added he couldn't stay awake even sitting up in his chair. He couldn't eat anything because the sight or smell of food made him gag, even in the grocery store. He added he also noticed he started to get the blood clots in his urine the second day after the shot (20Feb2021). On 19Feb2021, he mentioned he had a bruise on his arm about the size of a half dollar where he got the shot and he usually does not bruise. He stated he felt like he had all the symptoms of COVID. All of these symptoms lasted two weeks. When he finally felt better the only thing he wanted to eat was a burger and fries. He is still bleeding but it is not clotting anymore. The clots only lasted about a week. He also thought he was having a heart attack, but was too tired to go to the hospital. After speaking to his physician/specialist, they encouraged him to go ahead and get the 2nd dose. The patient would like to know whether the benefits outweigh the risks for him to receive the 2nd dose of the Pfizer covid vaccine based on his medical history. The patient would like to know whether one dose of the Pfizer covid vaccine provides some protection. The patient was asking whether he might die from receiving the 2nd dose of the Pfizer covid vaccine. The outcome of the events heart attack was unknown; events bruise on his arm about the size of a half dollar where he got the shot and blood clot in urine was recovered on 27Feb2021 while other events were recovered on 06Mar2021.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]; ATORVASTATIN; AMLODIPINE

Current Illness:

ID: 1140671
Sex: F
Age:
State: OH

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 03/28/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: pneumonia; She is coming up on 60 days now; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 76-year-old, on Jan2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was due to get the second dose on 18Feb2021 but was in the hospital with pneumonia and was unable to get the second dose. She is coming up on 60 days now. Outcome was unknown. Information about lot/ batch number has been requested

Other Meds:

Current Illness:

ID: 1140672
Sex: M
Age:
State: PA

Vax Date: 03/08/2021
Onset Date: 03/11/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: neuropathy in left hand (pinky and ring finger)/Neuropathy consists of numbness and parasthesias; This is a spontaneous report from a contactable pharmacist (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 66-year-old, via an unspecified route of administration, administered in left arm (reported also as left shoulder) on 08Mar2021 12:45 (Lot Number: EN6199) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. On 11Mar2021 (reported as 3 days after the vaccination), the patient experienced neuropathy in left hand (pinky and ring finger) which consists of numbness and parasthesias. The patient took aspirin with no effect. As of 11Mar2021, the event was not recovered.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of neuropathy, cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1140673
Sex: F
Age:
State: FL

Vax Date: 03/01/2021
Onset Date: 03/10/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: She has not had a bowel movement; 20 hours of diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via unspecified route of administration on 01Mar2021 at 14:00 (at the age of 79 years) at a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medication were reported as none. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient called to report that her second dose is due on 25Mar2021 (24 days after the first dose) and wanted to know if this is ok to do. She stated that she had 20 hours of diarrhea yesterday (10Mar2021) and today (11Mar2021), she has not had a bowel movement. The events did not result to emergency room/ physician clinic visit. The outcome of the event 20 hours of diarrhea was recovered on 11Mar2021 while the other event was unknown.

Other Meds:

Current Illness:

ID: 1140674
Sex: F
Age:
State: FL

Vax Date: 03/05/2021
Onset Date: 03/06/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Bell's Palsy - right side of face is paralyzed, right eye doesn't close fully, teary right eye, blurry right eye, and headache; This is a spontaneous report from a contactable healthcare professional (patient). A 72-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in right arm on 05Mar2021 10:00 as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hypothyroid, chronic achilles tendonitis, pre-diabetic. The patient had no known allergies. Concomitant medications included losartan, metoprolol; thyroid (NATURE THROID) reported as 'Zinc Berberine Nature Throid.' The patient was not diagnosed with COVID prior to vaccination. She was not pregnant. No other vaccine was administered in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) via unspecified route in right arm on an unspecified date at 12:00PM. On 06Mar2021 12:00PM, the patient experienced Bell's palsy - right side of face was paralyzed, right eye doesn't close fully, teary right eye, blurry right eye, and headache. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received included CT scan of brain, prednisone 60 mg total, and valaciclovir (VALTREX) 1. Outcome of the events was not recovered. The patient had not been covid tested post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: LOSARTAN; METOPROLOL; NATURE THROID

Current Illness:

ID: 1140675
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: allergic vasculitis; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age (Age: 66; unit: unknown) received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had one dose of the pfizer covid 19 vaccine and had a body rash that was diagnosed as allergic vasculitis. The patient had been advised to not get the second dose. The patient wanted an opinion on getting the second dose and wanted to know how long the side effect might last and are there long term effects. The patient also asked if he can take the Johnson and Johnson vaccine after having taken the Pfizer covid 19 vaccine, is there an interaction between the vaccines and if after having one dose of the vaccine, what coverage does he have. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1140676
Sex: F
Age:
State: MA

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Brief loss of vision; Faint; Short of breath; Palpitations; This is a spontaneous report from a contactable other health professional. A 22-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in arm left, on 11Mar2021 at 13:00 (Lot Number EN6207), as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not have COVID-19 prior to vaccination. The patient experienced brief loss of vision (medically significant) on 11Mar2021 at 13:00 with outcome of unknown, faint (medically significant) on 11Mar2021 at 13:00 with outcome of unknown, short of breath (non-serious) on 11Mar2021 at 13:00 with outcome of unknown, palpitations (non-serious) on 11Mar2021 at 13:00 with outcome of unknown. Therapeutic measures were taken as a result of the events. It was reported that the events were evaluated and advanced life support (ALS) transported the patient to the emergency department (ED). It was unknown if patient was tested for COVID-19 post vaccination. Follow-up attempts are completed. No further information is expected.; Sender's Comments: The possibility that suspect drug may have contributed to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.

Other Meds:

Current Illness:

ID: 1140677
Sex: M
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Bell's Palsy; Arm sorness; This is a spontaneous report from a contactable consumer (wife) from a Pfizer Sponsored Program. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 51-year-old, administered in Arm Right on 01Mar2021 13:00 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm soreness in Mar2021 (after vaccination). The patient experienced bell's palsy/experienced no mobility in the left side of the face and was diagnosed with bells palsy on 08Mar2021. The patient went to the ER in response to bell's palsy. Outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1140678
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: paralysed for 10 hours, in both arms and legs; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), on an unspecified date for COVID-19 immunization. The patient took both doses of the Pfizer covid vaccine, but after the second dose he was paralysed for 10 hours, in both arms and legs on an unspecified date. Outcome of the event was recovered on an unspecified date. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1140679
Sex: M
Age:
State: NJ

Vax Date: 02/27/2021
Onset Date: 03/04/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: I discovered bleeding like bruise; I discovered bleeding like bruise; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included known allergies: penicillin. The patient's concomitant medications were not reported. The patient reported "I discovered bleeding like bruise in about 1 X 1 inches on my right fore arm" on 04Mar2021 at 14:30. Outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1140680
Sex: M
Age:
State: MI

Vax Date: 03/03/2021
Onset Date: 03/08/2021
Rec V Date: 03/28/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Extreme morning sickness and vomiting. Started on 08Mar, has continued persistently since; Extreme morning sickness and vomiting. Started on 08Mar, has continued persistently since; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6206, first dose) solution for injection intramuscular in the right arm on 03Mar2021 at 15:45 (at the age of 20-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medication included bupropion. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Mar2021 at 10:00, the patient experienced extreme morning sickness and vomiting. Started on 08Mar2021, has continued persistently since. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization in Mar2021 for 1 day. Lab test on 08Mar2021 included Nasal Swab SARS-COV-2 PCR was negative. Treatment for the events morning sickness and vomiting included IV fluids, prochlorperazine, diphenhydramine. The outcome of the events morning sickness and vomiting was not recovered.

Other Meds: BUPROPION

Current Illness:

ID: 1140681
Sex: F
Age:
State: TX

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: left scars to her left breast still, that look like white crust on them/scars on her left breast; left scars to her left breast still, that look like white crust on them; bumps on her chest that won't heal up; skin blistered up like shingles centered to her left breast in the middle; spots were white and puffy, and some left a bump around; pain in her left chest still from the middle to her arm down to her elbow; pain goes from her front to the back of her shoulder blade and around; nerve pain; every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping; bumps on the left side of the chest/still has lumps, some were white and some have busted open; broke out with what thought as a nurse was shingles; arm swelling after the injection; pain/stabbing pain/nagging pain; pain in her arm that went to her chest area/Under her arm and going down she feels a pinching sensation; Her left arm was swollen at the injection site; This is a spontaneous report from a contactable nurse (patient) from the medical information team. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 22Jan2021 at a single dose (at the age of 57-years-old) for COVID-19 immunisation. The patient was given the vaccine in a pharmacy/drug store. Medical history included diabetes and hypertension. There were no concomitant medications. The patient experienced arm swelling after the injection, then a little later on in the day experienced pain. The next day or so, she got bumps on the left side of the chest. Thought it was shingles and was given medicine for shingles but ended up not being shingles. She still has lumps, some were white and some have busted open, approximately 4. She still had arm pain and back. Arm was still swollen. Went back to doctor on 10Mar2021 and gave another round of antibiotics. Still has a stabbing pain from the from to the back. "1 cm to 1.5 cm." She had scheduled for a breast screening done. She was still having pain almost 2 months later. The patient provided further information: the patient only got her first dose of the vaccine. Her side effects began that day then gradually got worse. Her left arm was swollen at the injection site since 22Jan2021 and was still swollen at the time of the report. A couple of hours afterwards as the day went on, she had pain in her arm that went to her chest area. The next day (23Jan2021), she broke out with what thought as a nurse was shingles, but was just in one little spot, so she went to the doctor and gave her medicine, antibiotics, and then she took those for 7 days three times a day. The first antibiotic she was on when they thought it was shingles was azithromycin (ZITHROMAX). After then, the pain would not go away and has left scars to her left breast still, that look like white crust on them. She has pain in her left chest still from the middle to her arm down to her elbow. She has two different types of pain, and when she went back to the doctor a day before (10Mar2021), she was given more antibiotics. The pain goes from her front to the back of her shoulder blade and around and was a stabbing pain. Under her arm and going down she feels a pinching sensation that won't go away, and was all the time. They wouldn't give her the second vaccine dose while she was on antibiotics that appointment reached its due. The pharmacist came on 05Mar2021 which would be her third appointment to get the vaccine and told the pharmacist her reaction to the COVID shot. The pharmacist asked to look at her injury and then wouldn't give the vaccine to her. Her doctor gave her some pain medication that would be good for nerves. She can't take gabapentin and doesn't like to take pain pills for the nerve pain, so she does paracetamol (TYLENOL) and ibuprofen every other time to relieve the pain. She says she has been taking paracetamol 500mg extra strength twice a day by mouth, and ibuprofen 400mg twice a day by mouth. She was wondering if there was any information on if her pain would get better since she doesn't want to stay the same or for it to get worse that what it is. It was a nagging pain that she can't seem to get rid of and every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping. The gabapentin for her nerve pain gave her side effects, she was taking 300 mg one pill four times a day. She took about three days worth and starting in Feb2021 she thought. The new antibiotic given on 10Mar2021 that she takes for the bumps on her chest that won't heal up was cefdinir 300 mg. She says after her vaccine her skin blistered up like shingles centered to her left breast in the middle, which she thought originally would spread all around but it didn't, it stopped right there. She says that the spots were white and puffy, and some left a bump around in them where they healed up. She says her doctor wanted her to get a mammogram done, which is scheduled for the first Monday in Apr2021. No labs were done, "they just looked at them". The patient felt bumps on the left side of the chest was medically significant because the scars and bumps have been there a while and several were not healing well. The patient has not recovered from the events. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1140682
Sex: F
Age:
State: OH

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar; platelets have also dropped down to 59 11Mar from 80 on 06Mar; She had a max AST 206 09Mar down to 118 11Mar; ALT 93 10Mar now 86 11Mar; Coombs negative hemolytic anemia; Within minutes of 2nd dose of vaccine, pt had urination of dark brown urine; migraine; fever; nausea; diarrhea; This is a spontaneous report from a contactable physician. A 22-year-old female patient received second dose of BNT162B2 (BNT162B2) intramuscular, administered in Arm Left on 04Mar2021 at 11:30 (Batch/Lot Number: EN6205) as single dose for covid-19 immunization. Medical history included allergic rhinitis. Concomitant medications included ibuprofen (IBUPROFEN), cefuroxime (CEFUROXIME), clarithromycin (MACROBID [CLARITHROMYCIN]), ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), spironolactone (SPIRONOLACTONE), acetaminophen (ACETAMINOPHEN), ondansetron (ZOFRAN [ONDANSETRON]) and topical tretinoin, oil of oregano, Olly probiotic/prebiotic. The patient received first dose on 11Feb2021 (lot number EL9267), 11:45 AM, Intramuscular to left arm. The patient experienced coombs negative hemolytic anemia (medically significant) on 04Mar2021 at 11:45, within minutes of 2nd dose of vaccine, pt had urination of dark brown urine on 04Mar2021 11:45, migraine on 04Mar2021 11:45, fever on 04Mar2021 11:45, nausea on 04Mar2021 11:45, diarrhea on 04Mar2021 11:45, her hgb has been dropping from 11.9 06Mar down to 8.3 11Mar on 11Mar2021, platelets have also dropped down to 59 11Mar from 80 on 06Mar on 11Mar2021, she had a max ast 206 09Mar down to 118 11Mar on 11Mar2021, alt 93 10Mar now 86 11Mar on 11Mar2021. It was reported that Within minutes of 2nd dose of vaccine, pt had urination of dark brown urine. This turned to dark red/bloody urine. She felt migraine, fever, nausea, diarrhea. She started having a very heavy period which is not normal for her. She was treated twice for presumed UTI but cultures were negative. UA had no RBCs, but Hgb urine was 3+. Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar and it appears she has a Coombs negative hemolytic anemia (haptoglobin undetectable). Her platelets have also dropped down to 59 11Mar from 80 on 6Mar. WBC/diff are normal. Her LDH was 2019 10Mar, improved today 1728. Blood smear had no schistocytes, but ADAMTS13 is pending. Her creatinine remains normal and electrolytes are largely normal. She had a max AST 206 9Mar down to 118 11Mar and ALT 93 10Mar now 86 11Mar. Alk phos was 137 mild elev 09Mar, now normal. Her symptoms are slowly improving but she still feels poorly. Several other tests are pending and we are checking daily labs right now. The patient underwent lab tests and procedures which included alanine aminotransferase: 93 (unit unspecified) on 10Mar2021, alanine aminotransferase: 86 (unit unspecified) on 11Mar2021, aspartate aminotransferase: 206 (unit unspecified) on 09Mar2021, aspartate aminotransferase: 118 (unit unspecified) on 11Mar2021, blood alkaline phosphatase: 137 (unit unspecified) on 09Mar2021, blood creatinine: normal on an unspecified date, blood electrolytes: largely normal on an unspecified date, blood lactate dehydrogenase: 2019 (unit unspecified) on 10Mar2021, blood lactate dehydrogenase: 1728 (unit unspecified) on 11Mar2021, haemoglobin: 11.9 (unit unspecified) on 06Mar2021, haemoglobin: 8.3 (unit unspecified) on 11Mar2021, haemoglobin urine: 3+ (unit unspecified) on an unspecified date, adamts-13: with pending results on an unspecified date, platelet count: 80 (unit unspecified) on 06Mar2021, platelet count: 59 (unit unspecified) on 11Mar2021 and WBC: Normal on an unspecified date. Therapeutic measures were taken as a result of the events Coombs negative hemolytic anemia, Within minutes of 2nd dose of vaccine, pt had urination of dark brown urine, Migraine, Fever, Nausea, Diarrhea, Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar, She had a max AST 206 09Mar down to 118 11Mar and ALT 93 10Mar now 86 11Mar. Outcome of all the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Coombs negative hemolytic anemia and other events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: IBUPROFEN; CEFUROXIME; MACROBID [CLARITHROMYCIN]; JUNEL FE; SPIRONOLACTONE; ACETAMINOPHEN; ZOFRAN [ONDANSETRON]; TRETINOIN

Current Illness:

ID: 1140683
Sex: F
Age:
State: MI

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: symptoms of liver failure. Liver seems to be shutting down.; began to feel ill, illness continued over time; Jaundice; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 68-years-old via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on an unspecified date for covid-19 immunisation. It was reported that within 24hrs of receiving the vaccine on 20Feb2021, the patient began to feel ill, illness continued over time, eventually when to doctor and presented symptoms of liver failure. Liver seems to be shutting down. Jaundice has set in over the past 5 days. It was unknown if the patient received any treatment for the events. The patient did not recover from the events. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1140684
Sex: M
Age:
State: VA

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 03/28/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: I went to hospital on 04Feb2021 and was diagnosed with TIA.; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EM9810, expiry date not reported) as SINGLE DOSE for covid-19 immunization. Medical history included atrial fibrillation (Afib), high blood pressure, pacemaker, type 2 diabetes and high cholesterol. Concomitant medications included apixaban (ELIQUIS), metformin (METFORMIN), levothyroxine sodium (SYNTHROID) and valsartan (VALSARTAN). The patient reported "I went to hospital on 04feb2021 and was diagnosed with tia. (transient ischaemic attack)" on 04Feb2021. The patient was hospitalized for the event from 04Feb2021 to an unknown date. The patient received first dose of BNT162B2 on 14Jan2021 First dose (lot number EL3248, vaccine location= Left arm). Therapeutic measures were taken which was reported as AE treatment Jardiance. Outcome of the event was recovered.

Other Meds: ELIQUIS; METFORMIN; SYNTHROID; VALSARTAN

Current Illness:

ID: 1140685
Sex: F
Age:
State: CT

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.

Other Meds: SERTRALINE; FERRO-SEQUELS

Current Illness:

ID: 1140686
Sex: M
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 03/28/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: throwing blood clots within a few weeks of final vaccine.; This is a spontaneous report from a contactable consumer (patient's daughter) via a Pfizer-sales representative. A male patient of an unspecified age received the second dose (reported as final dose - pending clarification) of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. Medical history included history of blood clots and transient ischemic attacks (TIAs). The patient's concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On an unspecified date, the patient experienced throwing blood clots within a few weeks of final vaccine. The patient and the daughter are concerned about the vaccine having this effect. The outcome of the event was unknown. Information about the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1140687
Sex: M
Age:
State:

Vax Date: 02/26/2021
Onset Date: 03/09/2021
Rec V Date: 03/28/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: fever and was hospitalized with gastrointestinal bleeding.; fever and was hospitalized with gastrointestinal bleeding.; abdominal pain; vomiting with blood; This is a spontaneous report from a non-contactable consumer. A 77-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot: unknown), via an unspecified route of administration on 26Feb2021 at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient's medical history was not reported. Concomitant medication included dabigatran etexilate mesilate (PRADAXA) taken for a year. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot: unknown) on 05Feb2021 for COVID-19 immunisation. On 09Mar2021, the patient experienced fever and was hospitalized with gastrointestinal bleeding, abdominal pain, and vomiting with blood. The events caused hospitalization on an unspecified date. It was reported that patient had COVID test post vaccination on 10Mar2021 with unknown results. Therapeutic measures were taken as a result of all events. The outcome of all events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds: PRADAXA

Current Illness:

ID: 1140688
Sex: M
Age:
State: FL

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: diagnosed as having AFIB.; light headed; I had some aches; I was completely down in bed with no energy/physically weak; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6202), via an unspecified route of administration administered in left arm on 23Feb2021 00:15 as SINGLE DOSE for COVID-19 immunisation. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Medical history included hypertension. The patient had no known allergies. Concomitant medications included atenolol, oxybutynin, and tamsulosin. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date (at the age of 79-year-old) for COVID-19 immunisation. The patient stated that in the past her pulse rate was in the low 60's. The patient lost energy gradually from 23Feb2021 until 26Feb2021 and 27Feb2021. The patient was completely down in bed with no energy. The patient had some aches on 25Feb2021 at 07:00 AM, but the pulse rate went up to 80 to 100. The patient went to the Cardiologist he believes on 08Mar2021 and was diagnosed as having atrial fibrillation (AFIB) on 08Mar2021. The patient was being treated for AFIB now and have been light headed and physically weak since 25Feb2021 at 07:00 AM. Therapeutic measures were taken as a result of diagnosed as having afib. The patient had not yet recovered from the events.

Other Meds: ATENOLOL; OXYBUTYNIN; TAMSULOSIN

Current Illness:

ID: 1140689
Sex: M
Age:
State: AL

Vax Date: 02/27/2021
Onset Date: 03/04/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: it is still affecting him (Bell's palsy), his lip is still paralyzed; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided, expiration date: Jun2021) at the age of 66-years-old, via an unspecified route of administration on 27Feb2021 at 14:00 at single dose for COVID-19 immunization. Medical history included diabetes, high triglycerides, and allergy to beef product. Concomitant medication included lisinopril and ongoing unspecified medications. He did not have any other vaccines within four weeks prior to the COVID vaccine. The patient was administered with COVID vaccine in a pharmacy or drug store. The reporter stated that they read quite a bit about Bell's palsy affecting some people after the second COVID shot but the patient experienced Bell's palsy after his first COVID shot on 04Mar2021 at 06:00 and it was still affecting him, his lip was still paralyzed. This required a physician office visit and the patient was treated with an antiviral drug that did not work therefore he was prescribed prednisone on 14Mar2021. He is supposed to get his second COVID shot on Saturday, they were concerned as far as to whether it was safe for him to get the other shot. The patient underwent lab tests and procedures which included triglycerides which were high on an unspecified date; and blood sugar on an unspecified date and blood work for diabetes on 03Mar2021, both with unknown results. The outcome of the event was not recovered. Information about lot/batch number has been requested

Other Meds: LISINOPRIL

Current Illness:

ID: 1140690
Sex: M
Age:
State: CA

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: I thought I was having a heart attack; I had severe left arm pain; I didn't get much sleep that night; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration at left upper arm on 08Mar2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib) and high blood pressure. Concomitant medications included unspecified medications. The patient was taking loads of medications. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 86-years-old, via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization and reported that he had no problems with the first dose. The patient experienced severe left arm pain at the arm where the shot was given on 08Mar2021, the night after he received his second COVID vaccine dose. He almost called a number because he thought he was having a heart attack. What he did was he got up to walk around and the pain went away and when he sat down on his recliner, the pain came back so he didn't get much sleep that night. He was fine the next day. The patient took an ASPIRIN 325 mg coated pill because he thought he might be having a heart attack. If he had known, he would have taken the vaccine on his right arm. His arm hurt the night of 08Mar2021 until 6:00 AM the following day. The patient then stated that his recommendation was to tell the people who are administering the shot that a left arm pain may possibly occur because anybody who has the left arm hurting is afraid and can think they have a heart attack. The outcome of the event pain in arm was recovered on 09Mar2021 at 06:00 AM, and recovered on 09Mar2021 for all other events.

Other Meds:

Current Illness:

ID: 1140691
Sex: M
Age:
State: NJ

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: cardiac arrhythmia; Atrial fibrillation; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of bnt162b2 (BNT162B2, Batch/Lot Number: EL8932), via an unspecified route of administration, administered in the left arm on 21Jan2021 as a single dose for covid-19 immunization. The patient's medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing , Defibrillator/pacemaker insertion from 2015 to an unknown date. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported. The next day after 1st dose the patient experienced a 7hr period of atrial fibrillation (all recorded on a cardiac monitor), he stated he was dizzy, light headedness and periods of shortness of breath. He just became aware of this cardiac arrhythmia from his Cardiologist. He has an internal heart monitor and the Doctor was able to see this report. He was now taking medication for A-FIB. It was reported that patient never had it until the night he got the shot. The outcome of the events was unknown.

Other Meds: INSULIN

Current Illness:

ID: 1140692
Sex: F
Age:
State: CA

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
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Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: possible diagnosis of lung cancer or walking pneumonia; possible diagnosis of lung cancer or walking pneumonia; she had a high temperature; This is a follow up spontaneous report. This is a report from a contactable consumer (patient). This female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown, on 18Feb2021 via unspecified route as a single dose for COVID-19 immunization. Relevant history and concomitant medications were not reported. Following first dose and on an unspecified date the patient got a possible diagnosis of lung cancer or walking pneumonia. Her doctor advised her to cancel her appointment for her second dose and reschedule it for later, she had a high temperature and she missed her 2nd dose of the vaccine. She wants to reschedule the 2nd dose of her vaccine. Patient declined to confirm contact information or provide address, or email and wanted to only reschedule her second appointment. Outcome of event possible diagnosis of lung cancer or walking pneumonia and high temperature was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1140694
Sex: M
Age:
State: TX

Vax Date: 02/10/2021
Onset Date: 02/14/2021
Rec V Date: 03/28/2021
Hospital:

Vax Type:
Manufacturer:
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Lot:
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Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Heart arrhythmia and palpitations 96 hrs post-vaccine; Heart arrhythmia and palpitations 96 hrs post-vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 09:00 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunization. Medical history of the patient was reported as none. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 16Jan2021 09:00 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunization. On 14Feb2021 14:00 patient experienced heart arrhythmia and palpitations 96 hrs post-vaccine. Treatment included EKG, cardio. Consult, Holter Monitor, stress test. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. Patient did not had COVID prior vaccination and didn't tested covid post vaccination. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected

Other Meds:

Current Illness:

ID: 1140695
Sex: F
Age:
State: NY

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 03/28/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: A-Fib; cardiologist saw it on the computer, an arrhythmia; hard poundings that were very bad, clarifies like fist continually pounding in her chest; feeling something strange, like a flurry by the heart; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6198, Expiration Date: Not reported) via an unspecified route of administration on arm on 19Feb2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included ongoing bronchiectasis (At least a year but not sure). Concomitant medication included ongoing tiotropium bromide (SPIRIVA; 18 ug, capsule) via nasal route at 18 ug, once a day (inhalation/At least a year but not sure) for bronchiectasis. It was reported that, the patient had her first vaccine on 19Feb2021. On 20Feb2021, she started feeling something strange, clarifies like a flurry by her heart, she doesn't know what really. She states that on 21Feb2021 and 22Feb2021 she had hard poundings that were very bad, clarifies like fist continually pounding in her chest. On 23Feb2021, she saw the cardiologist and he put her in the hospital. She states that it was probably a reaction from the vaccine, it was A-Fib. It was probably a reaction, but nobody can say, she was 83 but healthy, no diabetes, high blood pressure or anything except one little thing. Today was the date for the second dose, and she was reluctant to get it. Caller clarifies that the pounding subsided on 21Feb2021 and started again on 22Feb2021 and on 23Feb2021 she went to the cardiologist. Treatment included Aleve hard poundings that were very bad, clarifies like fist continually pounding in her chest AE: clarifies that it was going for quite a while, it was undeniable on 21Feb2021. States on 22Feb2021, it lasted a few minutes. feeling something strange, like a flurry by the heart AE: states that it was there for a minute. A-Fib: states that the cardiologist saw it on the computer, an arrhythmia. States they saw it at the doctor's office on the computer, she didn't feel it on 23Feb2021. States it is unknown if it started on 21Feb2021, 22Feb2021, 23Feb2021. States she doesn't know when it ended, she was put in the hospital. States she didn't feel it to know so she couldn't identify it, but it showed on the computer. Treatment with Aleve, but no other treatment, she was afraid to take anything. Hospitalization: Caller states that she went to the cardiologist on 23Feb2021 and states he saw on the computer the AFIB and admitted her. Clarifies that he sent her to the emergency room and then she was put upstairs into a room and may have been admitted when she went upstairs, she was there for a couple of days. She states that they didn't have a room at the time, they had lots of people with Covid. States she was admitted on 23Feb2021. She states she was released on she believes the 26Feb2021 but could be 26Feb2021 or 28Feb2021 but believes 26Feb2021. States the was put on medications to monitor to see what would coincide with each other, she is not sure. Patient was started on the following medications during her hospitalization and prescribed them. Metoprolol 25mg once a day by mouth, started when admitted to the hospital. Dofetilide 250mg capsule twice a day by mouth, started after admission to hospital. Blood thinner called Eliquis 2.5mg twice a day by mouth, started during hospitalization. Clarifies that she was not on these medications before the vaccine, she started them when she was at the hospital and takes them now. States she was one medication, but she stopped taking it right away and it has nothing to do with this. For event A-Fib, which results in Emergency Room visit and Physician Office visit. The seriousness of the events was reported as hospitalization. The event Feeling abnormal was recovered on 20Feb2021, Chest discomfort was recovered on 22Feb2021, Arrhythmia was recovered on an unspecified date in 2021, whereas unknown for another event.

Other Meds: SPIRIVA

Current Illness: Bronchiectasis (At least a year but not sure)

Date Died: 02/23/2021

ID: 1140696
Sex: F
Age:
State: MI

Vax Date: 02/02/2021
Onset Date: 02/04/2021
Rec V Date: 03/28/2021
Hospital: Y

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Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021. An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage

Other Meds: VITAMIN C [ASCORBIC ACID]; CALCIUM CITRATE + D3; GLUCOSAMINE; MAGNESIUM CITRATE; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]; TURMERIC [CURCUMA LONGA]

Current Illness:

Date Died:

ID: 1140697
Sex: F
Age:
State: VA

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Rec V Date: 03/28/2021
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Symptom List: Injection site swelling, Limb discomfort

Symptoms: She passed one to two days after the shot; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient died after receiving the COVID vaccine. She passed one to two days after the shot. It was not expected. Waiting on the autopsy. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: She passed one to two days after the shot

Other Meds:

Current Illness:

ID: 1141031
Sex: F
Age: 76
State: WA

Vax Date: 01/25/2021
Onset Date: 02/08/2021
Rec V Date: 03/28/2021
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Allergies: tetracycline, erythromycin, macrolides, naproxen, analgesic-a anti-inflammatory

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: she did not have a reaction to first. After the second she got very cold and felt miserable like her legs had weights on them- this only lasted 1-2 days. Then two weeks later she got a ring around the injection site- and developed intense itching, burning, and erythema and warmth at the site and axillary lymph node swelling. The muscle on her arm were tender and swollen as well. The lymphadenopathy, and arm pain and swelling lasted for over a month. Pfizer : Lot: 12831/8/21 Lot 9261 1/25/21

Other Meds: Levothyroxine, pravastatin, lisinopril, chlorthalidone, vitamin d

Current Illness: none

ID: 1141032
Sex: F
Age: 37
State: AZ

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 03/28/2021
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Allergies: None

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Chills, aches, joint pain, headache, fatigue lasting around 12 hours. Headache and fatigue for 24 hours.

Other Meds: Multivitamin

Current Illness: None

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am