VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1384357
Sex: F
Age:
State: CA

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Extreme fatigue; malaise / Unwell feeling; congestion; cough; headaches; nausea; diarrhea; chest rash; thumb and side of hand became red and itched; thumb and side of hand became red and itched; hand spasm; 99.2 fever once; This is a spontaneous report from a contactable other HCP (patient). A 71-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN5318) via an unspecified route of administration in right arm on 03Feb2021 at 11:00 AM as 1st dose, single dose for COVID-19 immunization. Medical history included hypothyroidism, allergic to Penicillin, Sulfa drugs, dust, hay fever. Concomitant medications were not reported. Patient was not pregnant. Patient did not receive any other vaccine in four weeks. Patient took other medication in two weeks. Patient was not diagnosed COVID prior vaccination. On 04Feb2021 at 10:00 AM, patient experienced Extreme fatigue, malaise, unwell feeling, congestion, cough, headaches, nausea, diarrhea, chest rash, thumb and side of hand became red and itched, hand spasm, 99.2 fever once. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. Patient had not been COVID tested post vaccination. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1384358
Sex: F
Age:
State: WA

Vax Date: 02/11/2021
Onset Date: 02/13/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Aching muscles; headache; Light red rash on both facial cheeks; This is a Spontaneous report from a Contactable Consumer (Patient). An 89-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810, Expiration date was not reported), via unknown route in the Arm left on 11Feb2021 at 13:30 (at the age of 89-year-old non-pregnant) as UNKNOWN, SINGLE DOSE, for COVID-19 immunization. The patient medical history included rheumatoid arthritis (Diagnosed one year ago), high blood pressure, historical vaccination included shingrix (Lot_number: NDC58160-082311, in left arm). Past drug included hyzaar for hives in mouth. Allergic to methotrexate, Sulpha, hyzaar. The patient's concomitant medications included amlodipine besilate, benazepril hydrochloride (LOTREL [AMLODIPINE BESILATE; BENAZEPRIL HYDROCHLORIDE]); Omeprazole ; levothyroxine sodium (THYROXIN) daily for unspecified indications, Prednisone 10 mg per daily for unspecified indications. On 13Feb2021, the patient experienced light red rash on both facial cheeks. Did not itch nor painful, it had brighter red center almost looked like an insect bite. On an unspecified date the patient experienced aching muscles and headache. The patient did not receive any treatment for the event, 'light red rash on both facial cheeks'. All the events were non-serious. The outcome of the event light red rash on both facial cheeks was not recovered. The outcome of the events aching muscles and head-ache was unknown.

Other Meds: LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]; OMEPRAZOLE; PREDNISONE; THYROXIN

Current Illness:

ID: 1384359
Sex: F
Age:
State: MI

Vax Date: 02/16/2021
Onset Date: 02/18/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 16Feb2021 at 17:15 (lot number and expiration date were not reported), as second dose, single for COVID-19 immunisation. Medical history included asthma, osteoarthritis (OA), rhuematoid factor positive, coagulation problem, high cholesterol, COVID prior vaccination and had known allergies: latex, peaches, and nuts. Concomitant medications included sertraline hydrochloride (ZOLOFT); omeprazole (PRILOSEC [OMEPRAZOLE]); montelukast; beclometasone dipropionate (QVAR); and diclofenac. The patient previously took morphine sulfate and experienced allergy and BNT162B2 dose 1 administered in left arm on 25Jan2021 for COVID-19 immunisation (vaccine in four weeks). On 18Feb2021, 35 hours after injection, at 4.15 AM, the patient had itching, burning, and redness at site, that woke her from sleep. By 17:40 the itching returned, more redness, ruby colour, more swelling with a lump beneath blue area given, and warm. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient was not COVID tested post vaccination. The outcome of all the events was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: ZOLOFT; PRILOSEC [OMEPRAZOLE]; MONTELUKAST; QVAR; DICLOFENAC

Current Illness:

ID: 1384360
Sex: M
Age:
State: MO

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: I got a sinus headache; body ached; Terrible feeling; lost all energy; was cold; This is a spontaneous report from a contactable consumer(patient). A 61-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581) via an unspecified route of administration, administered in right arm on 18Feb2021 12:00 as single dose for COVID-19 immunization. Patient medical history included Early Onset Alzheimers, high blood pressure, acid reflux, diverticulitis, and allergies to pollen and ragweed. Past drug event included Lipitor orifarm, amlodipine for allergies (Hypersensitivity). The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via intramuscular, administered in arm Left on 28Jan2021 12:00 as single dose for COVID-19 immunization. Patient stated that on 19Feb2021 01:00 when she was in store, she had terrible feeling came over her. She lost all her energy, she got a sinus headache, she was cold, her body ached all over. She had to leave the store. Barely had enough energy to walk from the car into her house. The patient did not receive any other vaccines prior to the COVID vaccine in four weeks. Patient received other medications in two weeks after vaccination. Patient did not receive any treatment for AE. Patient was not tested covid prior vaccination or post vaccination. The clinical outcome of events was not recovered.

Other Meds:

Current Illness:

ID: 1384361
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: fever 101.1 to 102.2; migraine/headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced fever 101.1 to 102.2, slight headache and migraine. Patient called-in saying that she joined the clinical trial and there are some minor side effects such as fever 101.1 to 102.2 and slight headache which she considers normal because she is a migraine patient normally experiencing migraine every 20 to 25 days. She is also reporting that there is something today that happened wherein they are supposed to open the actual vaccination soon but they have opened today without her presence and this is very odd for her. A caller wants to understand the standard protocol because we are paying her. The event fever 101.1 to 102.2 was found to be medically significant. The patient underwent lab tests and procedures which included body temperature: 101.1 to 102.2 on unspecified date. The outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1384362
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Allergic reaction to the Prevnar vaccine a couple of years ago; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) SINGLE DOSE for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the experienced allergic reaction to the Prevnar vaccine a couple of years ago. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1384363
Sex: F
Age:
State: NY

Vax Date: 02/13/2021
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: after the first dose, the patient had herpes outbreak,she had herpes before and after the vaccine; after the first dose, the patient had herpes outbreak,she had herpes before and after the vaccine; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 20Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Feb2021 as a single dose for covid-19 immunisation. Medical history included herpes. Concomitant medications were not reported. On an unspecified date in 2021, after the first dose, the patient had herpes outbreak. Patient enquired whether she could take medication (Valaciclovir) because she had herpes before and after the vaccine. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1384364
Sex: F
Age:
State:

Vax Date: 02/06/2021
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Herpes Simplex; Caller expressed her frustration; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 06Feb2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had herpes simplex and frustration. Outcome of the events was unknown. The patient was due for her 2nd dose on 27Feb2021. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1384365
Sex: F
Age:
State: CA

Vax Date: 02/08/2021
Onset Date: 02/09/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: had mild foggy head; upset tummy; diarrhea; just not feeling right; This is a spontaneous report received from a contactable consumer (Patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection and Lot Number: EN6201) via an unspecified route of administration in Arm Left on 08Feb2021 16:45 (age at vaccination: 67 years) as single dose for COVID-19 immunization. Medical history included Reiters syndrome and mild food allergy to turkey. Concomitant medications were reported as none. Patient did not received other vaccines in four weeks. Patient did not had other medications in two weeks. Patient did not had COVID prior vaccination. She was not tested for COVID post vaccination. On 09Feb2021 24 hours after receiving vaccine she had mild foggy head, upset tummy, diarrhea and just not feeling right. Lasted about 36 hours. All the events were considered as non-serious. No treatment was received for the events. The outcome of events was recovered on an unspecified date in 2021. Follow-up (24May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1384366
Sex: F
Age:
State: TX

Vax Date: 01/28/2021
Onset Date: 01/01/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable consumer (patient) or other non hcp reported. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on 28Jan2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation (the patient works for Doctor's office). The patient received the first dose of BNT162B2 on 06Jan2021, and had headache and was tired. The patient medical history and concomitant medications were not reported. The patient experienced lost taste and smell on an unknown date in Jan2021 (3 days after she lost taste and smell and are still gone. The patient feel fine. The patient just wish she could taste food and smell the perfume). She was wondering if we have any information on how long this might last. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1384367
Sex: M
Age:
State:

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: loss of smell; lost his sense of taste; difficulties listening; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration as first dose on 13Jan2021 and second dose on 3Feb2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced loss of smell, lost his sense of taste and difficulties listening. The events assessed as non-serious. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384368
Sex: F
Age:
State: CA

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Her heart was beating faster; Part of her face was flushed; Her chest and arms had a rash; Blotches all over; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; batch/lot number was not reported), via an unspecified route of administration on 23Feb2021 (at the age of 75-years-old) as 1st dose, single dose for COVID-19 immunization. Medical history included family history of Bell's palsy (her mother had it). The patient's concomitant medications were not reported. The patient got the first dose of BNT162B2 on 23Feb2021. After 15 minutes, the patient noticed her heart was beating faster. She didn't know whether it was because she was nervous or what. When she got home, she happened to look in the mirror for some reason and she saw that part of her face was flushed, her chest and arms had a rash, and had blotches all over. The patient called and explained it to her doctor, the doctor told her that she could take an antihistamine before the second dose or skip it. The patient reported that she looked online, and she read that one should not take antihistamine as it could affect the efficacy of the vaccine. The patient was scheduled for the second dose on 16Mar2021. The patient will be 76-years-old in a couple of weeks, she lives alone and doesn't know what to do if she should she take an antihistamine before the second dose. In reading some literature, the patient saw that there's a slight possibility for Bell's palsy, her mother had Bell's palsy and she watched her face get worse and worse. The patient mentioned that she may not go back to get the second dose, and wonders what the efficacy of the first dose alone is. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384369
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: she had arthritis/shoulder problems and pain/that her shoulder got so bad "I couldn't move my shoulder"; she had arthritis/shoulder problems and pain; Worsening shoulder pain with need for cortisone injection following administration of her first vaccine dose/it got significantly worse after her first dose; I'm very stressed; This is a spontaneous report from a contactable consumer (patient) reported for herself. An 80-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller asked whether a Cortisone shot that she just got in her shoulder would interfere or interact with the second dose of the vaccine she will be getting tomorrow. The caller reported that she received her first vaccine dose about 3 weeks ago, specific date unknown at the time of this call. She reported that she had been having shoulder problems and pain but it got significantly worse after her first dose, although she stated that she don't think the shoulder had anything to do with the shot. The caller reported that her shoulder got so bad, she couldn't move her shoulder and she was told she had arthritis and was administered a Cortisone shot to the shoulder for pain. The caller now reported, she was very stressed because she doesn't know if she messed up the effectiveness of the vaccine by getting the cortisone shot in her shoulder. The caller reported that she spoke with the doctor who said there shouldn't be an issue but she worried about her second dose tomorrow. Worsening shoulder pain with need for cortisone injection following administration of her first vaccine dose. The caller asked whether there was any difference in effectiveness if the second dose was given later than 3 weeks. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384370
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: lost his smell for 2 weeks; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. On unspecified date, after the second dose, patient lost his smell for 2 weeks. 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: 1384371
Sex: F
Age:
State: MD

Vax Date: 02/03/2021
Onset Date: 02/05/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: lost my sense of taste; I lost my sense of smell; This is a spontaneous report from a Non contactable Consumer. This 31-Years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL9264, Expiry date 31Aug2021)(At the age of 31 years-old), via an unspecified route of administration into left arm on 03Feb2021 at 14:00 PM as a single dose for COVID-19 immunisation. Medical history included Migraines. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, patient was not tested for COVID-19 Patient did not receive any other medications within four weeks. Patient stated that 2 days after receiving the first dose , On 05Feb2021 at 17:00 PM, I lost my sense of smell. On the 3rd day, I lost my sense of taste. My taste was gone for 5 days.No treatment was given for the events. The outcome of the events was reported as recovered on unknown date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1384372
Sex: F
Age:
State:

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: made us ill like we had covid; had an increase in her fibromyalgia pain; high fever; body ache; no energy; headache; This is a spontaneous report from a contactable consumer (patient's husband) via Medical Information Team. A female patient (Age: 63; Unit: Unknown) (reporter's wife) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Solution for injection) via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunisation. The patient's medical history included Covid-19 in Oct2020 and Covid infection turned into pneumonia in Oct2020. Concomitant medications were not reported. Caller (male, age 64 will be 65 in (birth month withheld)) stated, "his wife (female, age 63) and he received their first dose of the Pfizer vaccine on Friday and it made them ill like they had Covid. They had Covid in Oct. We had high fever, body ache, no energy and headache. There was no way he was going to take the second shot. He felt like the dickens. Everything was fine. The storm hit Friday night, lasted all day yesterday. He had the headache and weakness, low energy. He was a stage 4 lung cancer survivor. For both, the Covid infection turned into pneumonia. That shot made them feel like we got Covid like we did in Oct. His wife also had an increase in her fibromyalgia pain. He heard people who had Covid have real bad reactions after the second dose than the first. If it did not make him feel like he had Covid then he would take the second dose. It was terrible." Caller wanted information regarding efficacy of 1 dose. No PQC present. Seriousness was reported as no. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384373
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

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

Symptoms: chest pains; It scared me; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Sponsored Program. A female patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as an unknown, single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced developed chest pains and it scared her. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384374
Sex: F
Age:
State: NJ

Vax Date: 03/05/2021
Onset Date: 03/07/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: allergic reaction with runny eyes and nose; allergic reaction with runny eyes; allergic reaction with runny nose; itchy face; sore left shoulder muscle; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 74-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: en6205), via an unspecified route of administration, in the right arm on 05Mar2021 at 09:15 (age at the time 74-year-old) at a 2nd dose, as single dose for covid-19 immunisation. The patient's medical history included esophagitis, possibly reacting to dairy (dairy intolerance), and left breast cancer. The patient had known allergies included very minor dairy allergy. Concomitant medication included levothyroxine, unspecified eye drops-cataract surgery and unspecified statin. The patient previously received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: em9809), via an unspecified route of administration, in the left arm on an unknown date in Feb2021, at a 1st dose, as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient experienced allergic reaction with runny eyes and nose, itchy face, sore left shoulder muscle on 07Mar2021 at 07:30 AM. Therapeutic measures were taken as a result of the events included benadryl (1 at 4pm, 2nd at 7pm). The outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1384375
Sex: F
Age:
State: GA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: First dose soreness in arm (left); This is a spontaneous report from a contactable consumer reporting for herself. A 52-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318, expiration date not reported), via an unspecified route of administration, in Arm Left on an unknown date in Feb2021 (01:00 PM, as reported) (at the age of 52-years-old), as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, known allergies to sulfa. Concomitant medications included lisinopril; elderberry [sambucus nigra]; vitamin D NOS; ascorbic acid (VIT C). Patient did not receive other vaccines in four weeks of Covid vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On unknown date in Feb2021, the patient experienced first dose soreness in arm (left). Patient did not received treatment for adverse event. Outcome of the event was recovered approximately on unknown date in 2021 (that lasted more than two weeks, as reported). No follow-up attempts are possible. No further information is expected.

Other Meds: LISINOPRIL; ELDERBERRY [SAMBUCUS NIGRA]; VITAMIN D NOS; VIT C

Current Illness:

ID: 1384376
Sex: F
Age:
State: TX

Vax Date: 02/25/2021
Onset Date: 03/01/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

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

Symptoms: Nausea; Food intolerance; Smell also affected-lingering 10 days after vaccine admin; This is a spontaneous report from a contactable other Health Professional. A 18-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in left arm on 25Feb2021 at 10:00 am (at the age of 18-year-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history includes Polycystic ovarian syndrome (PCOS), obesity and COVID-19, the patient had covid prior vaccination. The patient not tested covid post vaccination. No known allergies reported. concomitant medications includes Metformin and Oral contraceptive, which were received by patient in two weeks. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in left arm on 04Feb2021at 04:00 pm (at the age of 18-year-old) as 1st dose, single dose for COVID-19 immunisation. The facility type for vaccine was Hospital. The patient was not received other vaccine in four weeks. On 01Mar2021, the patient experienced nausea and food intolerance. Smell also affected-lingering 10 days after vaccine administration. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with antiemetics. The outcome of the events was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds: METFORMIN; ORAL CONTRACEPTIVE NOS

Current Illness:

ID: 1384377
Sex: F
Age:
State: FL

Vax Date: 02/22/2021
Onset Date: 03/07/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: experiencing headaches; Also short memory lapses; This is a spontaneous report from a contactable consumer. A 66-year-old female (same age at vaccination) non-pregnant patient received first dose of bnt162b2 (BNT162B2, Solution for injection, lot: EN6200) via unspecified route of administration on 22Feb2021 at 02:30 PM as single dose in arm right for COVID-19 immunization. Medical history reported was allergies to Sulfa. Concomitant medications reported was citalopram hydrobromide (CITALOPRAM HBR, tablet) as 20 mg and Lisinopril Tablet as 2.5mg. Patient did not receive any other vaccine in four weeks. Patient didnt have covid prior vaccination nor tested post vaccination. On 07Mar2021, patient was experiencing headaches daily since Sunday and also short memory lapses. No treatment was received by patient in response to the events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: CITALOPRAM HBR; LISINOPRIL

Current Illness:

ID: 1384378
Sex: F
Age:
State: FL

Vax Date: 02/20/2021
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: She is worried; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Feb2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced she is worried. Patient mentioned that she was scheduled to get the second dose on saturday. She was worried that she might not get it since they mixed up names and showed up her in another location that is a 5h drive from her home, in the other cost. She wanted to know what happened if she do not get it in 21 days, do she have to repeat the doses. She sentenced that if she do not get the second dose in time, she would get another vaccine from another manufacturer and wanted to know if she was going to have stock within 42 days (away from the date she got the first dose) in the location she was going to go for the second dose. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384379
Sex: M
Age:
State: NC

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Slightly swelling; Pain; This is a spontaneous report from a contactable consumer (reported for himself). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 15Feb2021 (at the age of 72-year-old) 10:15 as 1st dose, single dose for covid-19 immunization. Medical history included hypothyroidism. patient had allergic to Pollen, variety of food. Concomitant medications included levothyroxine sodium (SYNTHROID); fluoxetine hydrochloride (PROZAC); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); calcium (CALCIUM); docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3 [DOCOSAHEXAENOIC ACID; EICOSAPENTAENOIC ACID; TOCOPHEROL]). It was reported that, 45 minute later the patient experienced slightly swelling, pain on 15Feb2021 11:00 . He was exposed 24 hours a day for 10 days to his husband 8 days after he had the vaccine. He (Husband) had a positive Covid test on 22Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 01Mar2021. Patient did not receive any treatment for events. On an unspecified date in 2021, the patient had recovered from the events. No follow-up attempts are possible; information about lot/batch number cannot been obtained

Other Meds: SYNTHROID; PROZAC; ADDERALL; CALCIUM; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]

Current Illness:

ID: 1384380
Sex: F
Age:
State: MA

Vax Date: 02/23/2021
Onset Date: 03/02/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Nausea; Moderate to Severe myalgia and arthralgia; Moderate to Severe myalgia and arthralgia; Low grade fever; This is a spontaneous report from a contactable other Health Care Professional reported (Patient). A 47-year-old non- pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via intramuscular route of administration, administered in Arm Left on 23Feb2021 at hospital (at the age of 47-year-old) as second single dose for COVID-19 immunisation. The patient medical history was not reported. No known drug allergy was reported. Concomitant medications received in two weeks of vaccination included escitalopram 5mg once a day taken for an unspecified indication, start and stop date were not reported. Patient previously received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261), via intramuscular route of administration, administered in Arm Left on 03Feb2021 at 10:15 (at age of 47 Year of age), as a single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. On 02Mar2021, the patient experienced moderate to severe myalgia and arthralgia, low grade fever, nausea. It was reported that adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events included muscle relaxers. On 03Mar2021, the patient underwent Covid test (Covid tested post vaccination) which included, Covid test type post vaccination: nasal swab/ COVID 19 PCR (Polymerase chain reaction) with result: negative. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: ESCITALOPRAM

Current Illness:

ID: 1384381
Sex: F
Age:
State: CA

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: my face started swelling in my lower right cheek and a little bit on my upper neck. Then within 15-20 min my left lower cheek started swelling slightly; right side of my tongue started to tingle; This is a spontaneous report from contactable consumers (one of them was patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: EN6260), dose 1 via an unspecified route of administration, administered in right arm on 05Mar2021 16:45 (at the age of 39-year-old) as single dose for COVID-19 immunization. The patient medical history included allergic to shellfish and iodine. Concomitant medications included levothyroxine, colecalciferol (VITAMIN D 3) and prenatal vitamins; all the concomitant medications were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 Vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 05Mar2021 16:45, the patient received first dose of the vaccine within 5 minutes her face started swell and she had tingling on her tongue. The patient stated that "I received my first does of the vaccine and within 5 min my face started swelling in my lower right cheek and a little bit on my upper neck. Then within 15-20 min my left lower cheek started swelling slightly. The right side of my tongue started to tingle as well". From the onset of the reaction to the when it started to go away was around an hour. She stated that they observed her and she didn't got into anaphylactic shock or need emergent care. She stated that she filed an online report and wanted to speak to someone in person regarding her reaction and whether or not she should get the second vaccine. She stated that her physician didn't know whether she should or not and did not give her guidance on getting the second dose. The patient wanted to know if she can get the second dose. No treatment was received for the events. Outcome of the events was reported as resolved. No follow-up attempts are needed. No further information is expected

Other Meds: LEVOTHYROXINE; VITAMIN D 3

Current Illness:

ID: 1384382
Sex: F
Age:
State: CA

Vax Date: 03/06/2021
Onset Date: 03/08/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Sore throat; fatigue; head ache; head congestion; Diarrhoea; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient(non-pregnant) received unknown dose of BNT162B2 (PFIZER-BOTECH COVID-19 VACCINE, solution or injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether patient had other vaccine in four weeks, other medications in two weeks. The patient was not tested covid positive prior vaccination. The patient did not have covid prior vaccination. It was reported that on 08Mar2021 the patient experienced sore throat, fatigue, headache, head congestion, diarrhea. outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384383
Sex: F
Age:
State: NY

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Dizziness; Chills; Headache; body aches; nausea; loss of Appetite; general malaise; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 28Feb2021 10:15 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included Minor digestive difficulties. Concomitant medication(s) included Lipitor 10 mg, vitamin C, calcium supplement. Known allergies reported as amoxicillin, sulfa drugs. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 07Feb2021 18:15, administration site (left arm) for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received. The patient was not tested positive prior vaccination. The patient experienced dizziness, chills, headache, body aches, nausea, loss of appetite, general malaise on 28Feb2021 22:00. The outcome for all events was recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds: LIPITOR [ATORVASTATIN]; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1384384
Sex: F
Age:
State: CA

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Itchiness on the throat, core of the body, and scalp; Hives on the throat; Itchiness on the throat, core of the body, and scalp; This is a spontaneous report from a contactable other hcp (patient). A 37-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 04Mar2021 12:15 (Batch/Lot Number: EN6199) as single dose for COVID-19 immunisation. Medical history included Subclinical hypothyroidism. Known allergies of various foods but not top 8. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM); ashwagandha (ASHWAGANDHA); ergocalciferol (VIT D); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient had no Covid prior vaccination. Since 05Mar2021 02:30 AM, the patient experienced Itchiness on the throat, core of the body, and scalp. Hives on the throat. AE resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment. The patient had not tested Covid post vaccination. Outcome of the events was recovering. No follow-up attempts are Possible. No further information is expected.

Other Meds: LEVOTHYROXINE SODIUM; ASHWAGANDHA; VIT D; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1384385
Sex: F
Age:
State: MN

Vax Date: 02/17/2021
Onset Date: 02/22/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: increased blood pressure; pressure center sternum; tingly limbs; bottoms of feet felt slapped/burned; pain behind r. knee; dehydration; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6201) via an unspecified route of administration on 17Feb2021 at 15:00 (age at vaccination 57-year-old) at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient's medical history was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL3302) on 27Jan2021 via an unspecified route of administration in right arm at single dose for covid-19 immunization. On 22Feb2021 at 14:00 patient experienced increased blood pressure, pressure centre sternum, tingly limbs, bottoms of feet felt slapped/burned, pain behind right knee and dehydration. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included computerised tomogram of abdomen and pelvis, electrocardiogram and ultrasound gallbladder (Right Upper Quadrant) RUQ. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 22Feb2021, computerised tomogram of abdomen and pelvis: unknown results, electrocardiogram: unknown results, sars-cov-2 test: negative on 01Mar2021, ultrasound Gallbladder right upper quadrant (RUQ): unknown result. The outcome of event was not recovered. No follow-up attempts are possible. No further information expected.

Other Meds:

Current Illness:

ID: 1384386
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: after being intimate with him, she started to have sore knee joints; after being intimate with him, she started to have sore knee joints; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that her fiance received both doses of Pfizer COVID vaccine and stated that after being intimate with him, she started to have sore knee joints. First she thought her knees were just acting up, but then it started being more sore. The patient asked why she was more sore and did she have the vaccine in her body now. The patient further asked what was the duration of immunity of the vaccine and if the next round of shots would be given next year. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384387
Sex: F
Age:
State: VA

Vax Date: 02/25/2021
Onset Date: 03/03/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: painful sensation on her nose; swelling on the left part of the nose; inhaled she feel everything irritated within; malaise; She had her throat dry; This is a spontaneous report from a contactable consumer. This female consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on 25Feb2021 as 1 ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 03Mar2021 the patient experienced painful sensation on her nose, swelling on the left part of the nose and it began to drop liquid out of it, she had her throat dry and when she inhaled she feel everything irritated within and also she had malaise. On the day of report (09Mar2021), the patient did not have the symptoms anymore, but her nose ended up a little sensitive. The patient mentioned that she had the same pain on the same side of the nose cartilage. She would like to know if this might be caused by the vaccine. The patient was scheduled to get the second dose on 18Mar. The patient was recovered from the events in Mar2021 where as painful sensation on her nose was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1384388
Sex: F
Age:
State: IN

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Headache that started the following day and had proceeded to get worse; This is a spontaneous report from a contactable consumer (reporting on herself). A 50-years-old Non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number: EN6205 and Expiration Date was not reported), via an unspecified route of administration in Arm Right on 04Mar2021 13:00, as 1st dose, single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19, and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that headache that started the following day (on 05Mar2021 at 07:00) and has proceeded to get worse. Adverse event was resulted in Doctor or other healthcare professional office/clinic visit. Patient did not received any treatment. Patient did not tested covid post vaccination. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1384389
Sex: F
Age:
State: CA

Vax Date: 02/14/2021
Onset Date: 02/20/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Severe right burning thigh pain; Severe right burning thigh pain; Severe right burning thigh pain and paresthesia; This is a spontaneous report from a contactable Physician. This Physician reported for a 65-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL92666) via intramuscularly, administered in arm right on 14Feb2021 14:45 as single dose for covid-19 immunisation. Medical history included graves disease and prediabetes. The patient had known allergies to Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and metformin were received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient experienced severe right burning thigh pain and paresthesia on 20Feb2021, this resulted in clinical visit (Physician office visit). The patient did not receive the treatment for the events. The patient did not underwent COVID test post vaccination. The outcome of events was resolving. No follow-up attempts are possible. No further information is expected.

Other Meds: SYNTHROID; CYTOMEL; METFORMIN

Current Illness:

ID: 1384390
Sex: F
Age:
State:

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: redness of the eyes; blurred vision; headache; muscle pain; body chills; blueish discoloration in hands; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 03Mar2021 as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Mar2021, the patient experienced redness of the eyes with blurred vision, headache, muscle pain, body chills & blueish discoloration in hands. Caller asked if she should receive the second Pfizer Covid vaccine The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384391
Sex: M
Age:
State:

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: headache; diarrhea; joint hurting; not feel good; sore muscles; ears ringing; This is a spontaneous report from a contactable consumer (Patient). An unspecified age male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: unknown; Expiration date: unknown), via an unspecified route of administration on 08Mar2021 as first dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Mar2021, the patient experienced headache, diarrhea, joint hurting, not feel good, sore muscles, ears ringing. It was reported that the patient did not take Tylenol or Aspirin to mess up the shot. The outcome of the events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384392
Sex: F
Age:
State: TX

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

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

Symptoms: feel very tired; pain at the injection site; feel very thirsty; This is a spontaneous report from a contactable consumer (patient herself). This 27-Year-old female consumer reported for herself that received BNT162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and expiry date Unknown) via an unspecified route of administration in left arm on 08Mar2021 16:30(at the age of 27-years-old) as unknown, single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included depression and anxiety. Patient was allergic to zyrtec, adhesives. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), ethinylestradiol, norgestimate (ESTARYLLA), doxylamine succinate (UNISOM [DOXYLAMINE SUCCINATE]), Ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date 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. No other vaccines in 4 weeks. On 09Mar2021 08:15 (Timeframe between vaccine start and event onset date was 15 hrs 45 min) patient experienced feel very tired, some pain at the injection site, and feel very thirsty. Therapeutic measures were not received as a result of adverse events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds: TRINTELLIX; ESTARYLLA; UNISOM [DOXYLAMINE SUCCINATE]; IBUPROFEN

Current Illness:

ID: 1384393
Sex: F
Age:
State: FL

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Pain in injection sight; Tingling and bumps on tongue; Tingling and bumps on tongue; Tiredness/Fatigue; This is a spontaneous report from a contactable consumer (Patient) reporting herself. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 at 11:00 (39-years age at the time of vaccination) as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient had no known allergies. Patient did not receive other vaccine in four weeks. No other medications was received in two weeks. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. It was reported that, patient has experienced pain in injection sight, tiredness/fatigue, tingling and bumps on tongue. Patient was not received any treatment for the events. The outcome of events was recovering. No follow-up attempts are possible, No further information is expected.

Other Meds:

Current Illness:

ID: 1384394
Sex: M
Age:
State: IN

Vax Date: 01/30/2021
Onset Date: 03/01/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: fever over 101 for 5 consecutive days; This is a spontaneous report from a contactable Other Health Care Professional (Patient). An adult male patient (Age: 50, Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: el9263), dose 2 via an unspecified route of administration, administered in Arm Left on 30Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number=ek9231), dose 1 via intramuscular administration in Left arm on 09Jan2021 at 08:00 AM for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced fever over 101 for 5 consecutive days on 01Mar2021 at 09:00. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on post vaccination which included body temperature: over 101 on 01Mar2021, sars-cov-2 test: negative on 02Mar2021, sars-cov-2 test: negative on 04Mar2021. Therapeutic measures were taken as a result of the event included fever reducer. The outcome of event was recovering.

Other Meds:

Current Illness:

ID: 1384395
Sex: F
Age:
State: IL

Vax Date: 03/06/2021
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: cold; hoarse voice; running nose; cough; bad headache; This is a spontaneous report from a contactable consumer (patient). A 72 (Unit: Unknown) female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported), via an unspecified route of administration on 06Mar2021 as a single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. Patient had previously received first dose of vaccine. On an unknown date, patient experienced cold, hoarse voice, running nose ("like crazy"), cough, she also had a bad headache but it went away. The outcome of the headache was resolved and for other events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384396
Sex: F
Age:
State: CT

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: She's just experiencing now pain in the right arm, at the injection site; bilateral rash four inches up from my hip bone; numbness in the back of her throat like when shot up with Novocaine; she could barely move her jaw, her jaw was tight; her jaw was tight and she couldn't swallow that well; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration in right outer upper arm on 08Mar2021 10:30 at 1st dose, 0.3 ml single for COVID-19 immunization. Medical history included shingles a year ago, allergy to latex gloves and allergy to newspaper ink. She takes no medications and doesn't have any conditions that she knows of. She didn't take medicine at all. Concomitant medication not reported (No other medication within 2 weeks of vaccination). previously she took influenza vaccine. She had no reaction at all. She usually gets the flu vaccine because she traveled a lot prior to COVID (flu vaccine in Nov 2020 or Dec 2020). No other vaccines within 4 weeks prior to the COVID vaccine. After receiving the first dose on her way back to home, she started feeling "numbness in the back of her throat, she could barely move her jaw, her jaw was tight, and she couldn't swallow that well" on 08Mar2021. She says it eventually subsided. She's just experiencing pain in the right arm, at the injection site on unspecified date, but nothing else. Additional Context included She had the vaccine yesterday. She waited 15 minutes, and drove about 10 minutes to go home. She got to where her throat felt like Novocaine was put in the back of her mouth. She could barely move her jaw and then it had a dead feeling. She waited 10 minutes or so and then it lead into 20 minutes before it relieved a bit. She drank coffee and waited another 10 minutes before she drove on. She was not sure if she should get the second vaccine. She is familiar with the process. Caller clarified event. The back of her throat felt numb like when shot up with Novocaine. Caller clarified that she had not received any Novocaine. Her appointment was at 11:30AM and the vaccine was pretty quick. She waited 15 minutes and drove down the road about 10 minutes. She pulled over because she knew something was happening. She waited it out there. She didn't know if it would get worse. Caller doesn't see a lot number on the paperwork. It has that she checked in Monday 10:55. There is the number 59267-1000-01 quantity 0.3 on the paperwork. Reported Event: She had vaccine on 08Mar, waited 15 minutes, nothing. She drove and had to pull over to the side of the road as it felt like someone shot novocaine in the back of my throat. She waited about 20-30 minutes till that subsided. Then on 15Mar2021, had a bilateral rash four inches up from my hip bone. The rash was hot (like a burn). It was four inches wide by 3 inches on either side. running horizontally. She took photos and don't know if she have had COVID before. She was sick and got a nasal swab over a year ago but that was reported as non-positive. My physician suggested that if she goes for the vaccine that she get the second shot in a hospital setting. She was trying to get that arranged. It has not been easy to do. No treatment received for the adverse event. It was unknown if prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event numbness throat, tightness in jaw and swallowing difficulty was resolved on 08Mar2021 and unknown for other all events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384397
Sex: M
Age:
State:

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: chills; nausea; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age (reported as Age: 69; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on 08Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient had received first dose on 08Mar2021 and he was scheduled for second dose on 31Mar2021. Caller wanted to know what to expect for his second dose of the vaccine, regarding the chills and nausea that he had experienced from the first dose injection of Pfizer-BioNTech COVID-19 Vaccine. The outcome of events was unknown. No follow-up attempts are possible; information on lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1384398
Sex: M
Age:
State:

Vax Date: 03/05/2021
Onset Date: 03/07/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Vomiting; diarrhea; fever; chills; extreme stomach cramps; This is a spontaneous report from a non-contactable consumer or other non-hcp (Patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: En6202) via an unspecified route of administration (Age at vaccination 36-year) in Left Arm on 05Mar2021 14:15 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not received any other vaccine in four weeks. Patient does not have covid prior vaccination. On 07Mar2021 06:00 the patient experienced vomiting, diarrhea, fever, chills and extreme stomach cramps. The seriousness of all the event was reported as non-serious. Patient not covid tested post vaccination. The clinical outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384399
Sex: F
Age:
State: KY

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: feeling a bit woozy; weak; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6199, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date in Mar2021 at 10:45 (at the age of 60-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history included asthma and arthritis. The patient had known allergies to sulpha drugs, keflex, levoquin, and codeine. Concomitant medications included desloratadine (CLARINEX [DESLORATADINE]), montelukast sodium (SINGULAIR), lansoprazole (LANSOPRAZOLE), diltiazem (DILTIAZEM), and estradiol (ESTROGEN). The patient received no other vaccine in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient was not tested for COVID post vaccination. On an unspecified date in Mar2021 at 11:00 reportedly, the patient started feeling a bit woozy and weak about 5 min after the shot and that feeling continued 2 hours later. No treatment was given for the events. The outcome of the events was reported as not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: CLARINEX [DESLORATADINE]; SINGULAIR; LANSOPRAZOLE; DILTIAZEM; ESTROGEN

Current Illness:

ID: 1384400
Sex: F
Age:
State: VA

Vax Date: 03/02/2021
Onset Date: 03/03/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: fever; Pain at injection site; Headache; Runny nose; itchy eyes; Body aches; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 16:00 (at the age of 55-years-old) as single dose for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive other vaccines in 2 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 03Mar2021 at 07:00, the patient experienced pain at injection site, headache, runny nose and itchy eyes, body aches, swollen glands. On 07Mar2021 at 07:00, after day 6, the patient started running a 102 fever. Adverse events resulted in doctor or other healthcare professional office or clinic visit. Post vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Fever: 102 on 07Mar2021, Nasal swab test on 09Mar2021: Result pending. The clinical outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1384401
Sex: F
Age:
State: OR

Vax Date: 03/07/2021
Onset Date: 03/08/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: day after vaccine dizzy spells as soon as I got out of bed.Still having when bend down or move to fast on second day after.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-years-old non-pregnant elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Right Arm on 07Mar2021 at 11:15 (at the age of 67-years old) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included seasonal allergy and had known allergies of morphine and Claritin. The concomitants includes (other medications within 2weeks) omeprazole, cetirizine hydrochloride, pravastatin and CoQ10. The patient did not suffer from COVID prior vaccination. The patient did not test COVID positive post vaccination. The patient did not receive any other vaccine within 4weeks of COVID vaccination. On 08Mar2021 06:00, (a day after vaccine), patient had dizzy spells as soon as she got out of bed, still having when bend down or move to fast on second day after. The patient did not receive treatment for the events. The outcome for the event was not recovered/not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: OMEPRAZOLE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PRAVASTATIN; COQ10 [UBIDECARENONE]

Current Illness:

ID: 1384402
Sex: F
Age:
State: AZ

Vax Date: 03/02/2021
Onset Date: 03/03/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Gallbladder attack; This is a spontaneous report from a contactable Other-HCP (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 02Mar2021 at 08:30 (at the age of 30-year-old) as single dose for COVID-19 immunisation. Patient had no known allergies or other medical history. Patient did not receive any other vaccine in four weeks of vaccination. Other medications (concomitant) administered within two weeks of vaccination included Spironolactone and desogestrel, ethinylestradiol [Azurette] both administered on unspecified dates for unspecified indication. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. On 03Mar2021, at 13:15, patient had a gallbladder attack. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient was treated in response to the event with pain medication: unspecified. Outcome of the event was recovering. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Other Meds: SPIRONOLACTONE; AZURETTE

Current Illness:

ID: 1384403
Sex: F
Age:
State: CA

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: a tightness on both ankles; legs swell up, both of her legs at the ankle level; legs swell up, both of her legs at the ankle level; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration was not reported, as she does not have vaccination card handy), via an unspecified route of administration, administered in arm left on 26Feb2021 as single dose for covid-19 immunization. The patient took COVID-19 Vaccine because her husband insisted. The patient medical history and concomitant medications were not reported. No other products and no investigation assessment done. The patient had no other vaccines on the same day as her COVID vaccine. The patient was calling regarding the COVID-19 Vaccine shot. The patient was trying to find out if something she was experiencing, was a side effect of the product. The patient stated that her legs swell up, both of her legs at the ankle level on an unspecified date in 2021 and that had never happened to her before. The patient received her vaccine on 26Feb2021, and she did not know the exact day the swelling started, but she noticed it shortly after getting the shot. The patient confirmed the swelling was ongoing, she was concerned because it had not gone away. When queried regarding outcome, the patient stated that it was still about the same, it was a tightness on both ankles (start date: unspecified) and they were swollen and she thought at first that maybe it was because she walked so far from the parking lot to the facility to get the shot, but it had not receded at this point, so she did not know what was going on, because she usually did not have swollen ankles. The patient had her first dose of the Pfizer vaccine and was asking if ankle or leg swelling as a side effect of the vaccine. The outcome for tightness on both ankles was unknown and for rest both events was not recovered. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1384404
Sex: F
Age:
State: CA

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: mild itching on the left side of the body 10 minutes after receiving the injection. The itching disappeared after about three hours.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6199) via an unspecified route of administration in left arm on 06Mar2021 13:45 (at 42 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There was no relevant medical history. The patient had no known allergies. Concomitant medications included atorvastatin 20 mg and fluoxetine 40mg, both daily for unspecified date for unspecified indication. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient experienced mild itching on the left side of the body 10 minutes after receiving the injection. The itching disappeared after about 3 hours. The event was non-serious on 06Mar2021 at 14:00. No treatment was given due to the event. Outcome of the event was recovered on 06Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: ATORVASTATIN; FLUOXETINE

Current Illness:

ID: 1384405
Sex: M
Age:
State: MI

Vax Date: 02/23/2021
Onset Date: 03/04/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Diffuse red splotches that appeared like severe sunburn; Rash appeared as red, raised areas causing itching and burning; Rash appeared as red, raised areas causing itching and burning; Raised hive like areas; itching - mostly on face, neck and head which were the areas most recently to erupt; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200), via an unspecified route of administration, administered in right arm on 23Feb2021 (at the age of 85 years old), at second dose, single dose for COVID-19 immunisation. Medical history included atrial fib, CAD, DM type 2, implanted pacer/defib, gout, and known allergies to Sulfa. Concomitant medications included glipizide, amiodarone, apixaban (ELIQUIS), propranolol hydrochloride (INDERAL), levothyroxine, atorvastatin, furosemide (LASIX), and lisinopril. On 04Mar2021, rash developed in groin area and forearms 9 days after the second injection. Rash appeared as red, raised areas causing itching and burning. Rash continued to evolve migrating to abdomen, chest, legs, buttocks, back, face and head between 05Mar2021 and 09Mar2021. Raised hive like areas would morph into diffuse red splotches that appeared like severe sunburn, usually within 24-48 hrs. The patient consulted his physician on 05Mar2021, and cortisone 120 mg injection was administered with further direction to take diphenhydramine (BENADRYL).On 08Mar2021, cetirizine (ZYRTEC) was added to the regimen. As of report date, the patient was still experiencing itching - mostly on face, neck and head which were the areas most recently to erupt. The patient has no other symptoms other than those related to the rash. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, and treatment received included cortisone injection, BENADRYL, and ZYRTEC. The patient had no COVID prior vaccination and was not COVID tested post vaccination. The patient experienced only soreness in arm following first injection of BNT162B2 given for COVID-19 immunisation. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: GLIPIZIDE; AMIODARONE; ELIQUIS; INDERAL; LEVOTHYROXINE; ATORVASTATIN; LASIX [FUROSEMIDE]; LISINOPRIL

Current Illness:

ID: 1384406
Sex: F
Age:
State: NY

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 06/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Stevens-Johnson syndrome; upper lip started to swell/lips were swollen/both lips swollen bad/top and bottom lips were very, very swollen/swollen lips; swollen lips and throat; hives on chin, shoulders and back/ had itchy hives all over/bad hives/hives on are the rest of the body/hives all over torso; This is a spontaneous report from a contactable consumer (patient) and other HCP (nurse). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in Arm Right on 06Mar2021 18:15 (Lot Number: EN6199) (at the age of 28 years old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history included bipolar disorder and depression, both from an unknown date. Concomitant medications included lithium; venlafaxine; hydroxyzine embonate (VISTARIL [HYDROXYZINE EMBONATE]); lithium carbonate; propranolol; venlafaxine hydrochloride (EFFEXOR); all were taken for an unspecified indication, start and stop date were not reported. The patient previously took lamictal and experienced allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 07Mar2021 (Sunday), that day after Pfizer COVID vaccine, patient had bad hives, woke up with hives on chin, shoulders and back. The hives continued on Monday (08Mar2021) to get worse, hives continued to get worse and then on Tuesday, woke up and lips were swollen. It was reported that 2 days after vaccine, her upper lip started to swell. Then 3 days after (on Wednesday), woke up and both of her lips were swollen, top and bottom lips were very, very swollen, both lips swollen bad. Stated that it was getting worse. And had itchy hives all over her body, hives on are the rest of the body, the hives have continued over the rest of her body. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Also reported by the other HCP that the adverse events: hives all over torso, swollen lips and throat started on 06Mar2021, which resulted in Emergency room/department or urgent care, the reported treatment received for the adverse event were Benadryl, steroids. When probed if the product was prescribed by any healthcare professional. Further stated, that she also had hives on her abdomen and on her legs. She tried taking Advil allergy and now she was taking a different allergy medication. Patient stated that one of the things her doctor was worried about was Stevens-Johnson syndrome. With the current symptoms that the patient had that were getting worse not better. She was wondering if she needed to go to a hospital for any assistance. The outcome of the event Stevens-Johnson syndrome was unknown while for the other events was recovering. Follow-up attempts are needed. Additional information is requested.; Sender's Comments: A possible causal relationship between BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the reported events, including swollen lips and throat and suspected Stevens-Johnson syndrome cannot be excluded, considering temporal relationship. 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: LITHIUM; VENLAFAXINE; VISTARIL [HYDROXYZINE EMBONATE]; LITHIUM CARBONATE; PROPRANOLOL; EFFEXOR

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm