VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer

Incidents per State

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

ID: 0993164
Sex: F
Age: 34
State: TX

Vax Date: 01/25/2021
Onset Date: 01/28/2021
Rec V Date: 02/02/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Lymph edema started 3 days post injection. Started under arms. Day 4 it moved to left breast. Day 5 the swelling continued to left lower abdomen area and left labia. Skin is very tender to the touch in swollen areas

Other Meds:

Current Illness: Thrush after dose 1 of Moderna vaccine

ID: 0993293
Sex: F
Age: 48
State: PR

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 02/02/2021
Hospital:

Vax Type:
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Lab Data:

Allergies: Kiwiii

Symptom List: Anxiety, Dyspnoea

Symptoms: Chills Fever Pain in the middle of the chest Arthralgia Headache. Tylenol and Advil depending on the severity of symptoms at the moment

Other Meds: Plaquemil

Current Illness: Discoid lupus

ID: 0993296
Sex: F
Age: 51
State: WA

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

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

Allergies: Keflex, Sulfa, ibuprofen, penicillin

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

Symptoms: Developed chills with aching long bones (thighs, low back, upper arms) early evening after injection. Profound malaise and fatigue with same pain and chills next day and continuing until 2/1/2021.

Other Meds: Monteleukast, Wixela, Sertraline, pramiprexole, omeprazole, albuterol

Current Illness: None

ID: 0993298
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 01/20/2021
Rec V Date: 02/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Chils, headache, body ache ,diarreah, fever up to 104 Took 4 days to get better feels like if I had covid again very painful scare to take the2nd dose

Other Meds: When I got the vaccine and I got sick i was taking Tylenol evey 8hrs I got the chills and fever up to 104 headache body pain couldn't breath chest pain all that with the first dose still arm hurts and chest too..had covid june 24 2020

Current Illness:

ID: 0993302
Sex: M
Age: 26
State: IN

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 02/02/2021
Hospital:

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

Allergies: Sulfa medications, adhesive

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

Symptoms: Extreme headache within 30 minutes of injection. Rash/skin redness- didn?t notice until 7 hours later; chest and entire face going into part of neck. Fatigue. I took some Tylenol and fell asleep. When I woke up, only my chest was slightly red and the headache had dulled some.

Other Meds: Lamictal, amitriptyline, atomoxetine, topiramate, testosterone, propranolol, cyclobenzoprine, sumatriptan

Current Illness: N/A

ID: 0993304
Sex: F
Age: 36
State: HI

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

Vax Type:
Manufacturer:
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Lab Data:

Allergies: Pneumonia vaccine: arm and neck swelling on side of injection.

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

Symptoms: Flu like symptoms approximately 8 hours following. Chills, headache, body aches. Large, hard lump at injection site. 12 hours following vaccine, severe edema in Left Axilla. Multiple swollen lymph nodes and general edema. Unable to put arm down. Symptoms subsided after 48 hours, but are pain and mild swelling are still present.

Other Meds: Humalog insulin via insulin pump Multi-vitamin

Current Illness: None

ID: 0993468
Sex: F
Age:
State: PR

Vax Date: 12/17/2020
Onset Date: 12/24/2020
Rec V Date: 02/02/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: facial paralysis; stress; facial pain; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on an 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history includes ongoing facial paralysis (it was reported that the patient experienced facial paralysis caused by stress a couple of year ago and then again after the vaccination). Concomitant medications were not reported. The reporter felt worried about the patient (partner) that had facial paralysis and asked if they could administer the second dose of the vaccine of COVID-19 from Pfizer. The paralysis it was previous from the fist dose of the vaccine, a consequences of the stress, the partner had 42 years. The reporter considered that the event was non-serious. As of 15Jan2021, it was reported that the patient experienced facial paralysis caused by stress a couple of years ago and then again after the vaccination (24Dec2020). The patient also experienced pain in face on 24Dec2020. The patient underwent MRI on an unspecified date. Treatment was given for the events facial paralysis and pain in face (Anti-inflamatories). The outcome of the stress was unknown while not recovered for the other events. Information on the lot/batch number has been requested. Amendment: This follow-up report is being submitted to amend previously reported information: country of incidence was updated. Additional information received on 15Jan2021 from a contactable nurse includes: patient details (medical history and lab data), product details (therapy dates), reaction data (additional event: pain in face) and clinical course details.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of facial paralysis cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 0993483
Sex: U
Age:
State: WA

Vax Date: 12/11/2020
Onset Date: 12/11/2020
Rec V Date: 02/02/2021
Hospital:

Vax Type:
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Symptom List: Pharyngeal swelling

Symptoms: No other AE reported; pediatric patient received an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant and refers to a pediatric patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not provided. On 11-DEC-2020, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S017630, expiration date 06-DEC-2020, administered orally (dose and strength were not provided) for prophylaxis. No other adverse event was reported. The outcome was unknown.

Other Meds:

Current Illness:

ID: 0993484
Sex: F
Age: 32
State:

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 02/02/2021
Hospital:

Vax Type:
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Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: a pregnant patient received VARlVAX/ she is pregnant after administration of VARlVAX; The patient did not experience and adverse events.; This spontaneous prospective pregnancy report was received from a 32-year-old female patient who was referring to herself. The patient had no pertinent medical history, drug reactions or allergies or concomitant medications. The patient became pregnant with last menstrual period (LMP) calculated as 10-NOV-2020 and estimated date of delivery (EDD) as 17-AUG-2021, based on pregnancy gestation reported as 8 weeks and 2 days at the time of the report. On 07-JAN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T021821, expiration date not reported, but upon internal validation established as 25-JUN-2022, subcutaneously (exact dose not reported) for prophylaxis. The patient did not experience any adverse events. No lab diagnostics or studies were performed. The pregnancy outcome was pending.

Other Meds:

Current Illness:

ID: 0993485
Sex: U
Age: 1
State: KS

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/02/2021
Hospital:

Vax Type:
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Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: VARIVAX administered during a temperatute excursion; No additional adverse events reported; This spontaneous report was received from a physician regarding to a 14 month old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided. On 13-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S025608, expiration date 18-AUG-2021, 0.5 milliliter for prophylaxis (route of administration was not provided). The improperly stored suspect vaccine experienced a temperature of 0.0 degree Celsius (?C) for 2 hours and 11 minutes with no previous temperature excursion. The call was made due to a digital data logger. No adverse symptoms were reported.

Other Meds:

Current Illness:

ID: 0993486
Sex: M
Age: 9
State: PA

Vax Date: 07/13/2015
Onset Date: 01/14/2021
Rec V Date: 02/02/2021
Hospital:

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

Symptoms: expired dose of VAQTA was administered to a patient; This spontaneous report was received from a licensed practical nurse and refers to a 15-year-old male patient. His concurrent conditions included migraine without aura and myopia of both eyes. The patient's concomitant therapies included propranolol and sumatriptan succinate. There was no information about the patient's pertinent medical history or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 13-JUL-2015, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis. On 14-JAN-2021, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe injection, 0.5 milliliter, via intramuscular route in the left deltoid, lot # S032359, expiration date 11-JAN-2021 for prophylaxis. The vaccine was purchased with private funds at private doctor's office/ hospital. On 14-JAN-2021, the patient was in the physician's office for his annual physical, which required second hepatitis a vaccine, inactivated (VAQTA) vaccination. The vaccine was pulled from storage location and given to a physician (M.D.) to verify that correct vaccine was retrieved to administer, expiration date was not checked. Expired vaccine was sent back to distributor (McKesson). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: No; reasonfornoneval: 02 Device evaluation anticipated, but not yet begun; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: propranolol; sumatriptan succinate; VAQTA SYRINGE (DEVICE)

Current Illness: Migraine; Migraine without aura; Myopia

ID: 0993487
Sex: M
Age: 70
State: CA

Vax Date: 10/25/2017
Onset Date: 07/27/2019
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: no adverse reaction; hearingVaccination dates: 25-OCT-2017; 27-JUL-2019; 06-MAR-2020; 14-MAY-2020; This spontaneous report has been received from a lawyer and a 72-year-old male patient via a Plaintiff Fact Sheet. On 25-OCT-2017, the patient was vaccinated with hepatitis b vaccine (recombinant)(manufacture unknown) (strength, dose, route, lot #, expiration date were unknown) for prophylaxis. Then the patient also received the hepatitis b vaccine (recombinant)(manufacture unknown) vaccines on following dates: 27-JUL-2019; 06-MAR-2020 and 14-MAY-2020 (inappropriate schedule of product administration). There were no adverse reaction or side effects for the patient. This is one of several reports split from a case in litigation (MARRS# 2010USA001766).; Sender's Comments: US-009507513-2010USA001766: US-009507513-2101USA012802: US-009507513-2101USA012803:

Other Meds:

Current Illness:

ID: 0993488
Sex: U
Age:
State: PA

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

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

Allergies:

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

Symptoms: an expired dose of PROQUAD that was accidently administered to a 4 year old patient today, 1/27 /21.; This spontaneous report was received from a nurse and refers to a 4-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # S022917, expiration date: 19-JAN-2021, 0.5mL SQ x 1 dose (formulation, strength, frequency, route of administration were not reported) for prophylaxis. On 27-JAN-2021, an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was accidently administered to the patient.

Other Meds:

Current Illness:

ID: 0993489
Sex: F
Age:
State:

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

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

Allergies:

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

Symptoms: she has a bleeding disorder/ a cardiac procedure in the groin to stop bleeding; Hashimotos' Disease; Mixed Connective Tissue Autoimmune Disease; allergies (experienced rashes and hives) to contrast dyes; allergies to adhesive, and polymers; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (Manufacturer Control Number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-005628), license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021040024) on 18Jan2021 and was forwarded to BMS on 19Jan2021. This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE THYROIDITIS (Hashimotos' Disease), MIXED CONNECTIVE TISSUE DISEASE (Mixed Connective Tissue Autoimmune Disease) and HAEMORRHAGE (she has a bleeding disorder/ a cardiac procedure in the groin to stop bleeding) in 72-year-old female patient who received apixaban (ELIQUIS) for an unknown indication. The occurrence of additional non-serious events is detailed below CO-SUSPECT PRODUCTS included COVID-19 VACCINE for an unknown indication. On an unknown date, the patient started ELIQUIS (unknown route) and COVID-19 VACCINE (Intramuscular). On an unknown date, the patient experienced AUTOIMMUNE THYROIDITIS (seriousness criterion medically significant), MIXED CONNECTIVE TISSUE DISEASE (seriousness criterion medically significant), HAEMORRHAGE (seriousness criterion medically significant), CONTRAST MEDIA ALLERGY (allergies (experienced rashes and hives) to contrast dyes) and DERMATITIS CONTACT (allergies to adhesive, and polymers). The action taken with ELIQUIS (Unknown) was unknown. At the time of the report, AUTOIMMUNE THYROIDITIS, MIXED CONNECTIVE TISSUE DISEASE, HAEMORRHAGE, CONTRAST MEDIA ALLERGY and DERMATITIS CONTACT outcome was unknown. Consumer reported that she had read the EUA Fact Sheet for Recipients and have some questions to the "What should you mention to your vaccination provider". Caller mentioned that she has allergies (experienced rashes and hives) to contrast dyes, adhesive, and polymers such as the angio-seal that was used on her for a cardiac procedure in the groin to stop bleeding. She has irritation from the polymer and described it as a sponge that was meant to be absorbed for a month. Her first question was does the COVID-19 vaccine contain latex, mold (polymers) and adhesive? Response: For latex. For mold (polymer) and adhesive: "A review of the ingredients list on the product label show that mold (polymer) and adhesive are not part of the formulation, however, Pfizer does not specifically manufacture the vaccine to be free of mold (polymer) and adhesive, therefore, we cannot assure that it was "mold (polymer)-free and adhesive free". We cannot guarantee that minute amounts of substances are not contained in raw materials obtained from our suppliers. She had the PPSD23/Pneumonia 23 vaccine last 05Jan2021 and was told not to get the COVID-19 vaccine for 14 days. Is it because of the injection site or is it for systemic reasons? Consumer mentioned that she was on ELIQUIS. She has Hashimoto's Disease and Mixed Connective Tissue Autoimmune Disease. She said that she was not immunocompromised. She mentioned that she has a bleeding disorder. The Pfizer- BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection For ELIQUIS (Unknown), the reporter did not provide any causality assessments. Reporter's causality assessment was not provided. Bristol-Myers Squibb Causality assessment for ELIQUIS: Events: Hashimoto's disease, Contrast media allergy, Topical adhesive allergy, Mixed connective tissue disease were considered unrelated while bleeding was considered related. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: BMS Medical Evaluation Comment: This patient had autoimmune thyroiditis, mixed connective tissue disease and hemorrhage after receiving apixaban therapy. This patient also had COVID-19 vaccination. Based on the anticoagulant action of apixaban, its role in the event hemorrhage is considered as possible. Based on the etiology of the reported events, auto immune thyroiditis and mixed connective tissue disorder are considered not related to apixaban.

Other Meds:

Current Illness:

ID: 0993490
Sex: U
Age:
State: WI

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

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

Lab Data:

Allergies:

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

Symptoms: fever; chills; red; swollen; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced fever, chills, erythema and swelling. On an unknown date, the outcome of the fever, chills, erythema and swelling were recovered/resolved. The reporter considered the fever, chills, erythema and swelling to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced fever, chills, so red and swollen for about a week. The patient had bad reaction to Influenza vaccine Quadrivalent unspecified season vaccine. The reporter did not consent to follow up. This case has been linked with US2020AMR249292, reported by same reporter for same patient for Shingles vaccine..; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR249292:same reporter

Other Meds:

Current Illness:

ID: 0993491
Sex: F
Age: 66
State: AR

Vax Date: 12/11/2020
Onset Date: 12/11/2020
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: experienced nausea / started the next day; chills /started the next day; drowsiness/ started the next day; sore arm / started the next day; dizziness that started the next day; accidentally received a third dose / on Friday 12/11/2020; This case was reported by a consumer and described the occurrence of nausea in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 27th May 2022) for prophylaxis. Previously administered products included shingrix with an associated reaction of pain in extremity (1st dose received on 12th December 2019, reference case US2020AMR248211) and shingrix with an associated reaction of pain in extremity (2nd dose received on 11th February 2020, reference case US2020AMR248212). On 11th December 2020, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 11th December 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On 12th December 2020, the patient experienced nausea, chills, drowsiness, pain in arm and dizziness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, chills, drowsiness, pain in arm and dizziness were recovering/resolving and the outcome of the extra dose administered was unknown. The reporter considered the nausea, chills, drowsiness, pain in arm and dizziness to be related to Shingrix. Additional details were provided as follows: The patient had reported the case for herself. The patient accidentally received a third dose of Shingrix, which led to extra dose administered. The patient experienced nausea, chills, drowsiness, sore arm and dizziness that started the next day from vaccination. The patient mentioned that all of these side effects were resolving at the time of reporting and she was started to feel better. The reporter asked if there are any special instructions since she did receive a third dose. The reporter was provided with phone number to medical information and advised her to have her health care professional call for further information. The reporter consented to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR248212:Same reporter US-GLAXOSMITHKLINE-US2020AMR248211:Same reporter

Other Meds:

Current Illness:

ID: 0993492
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: tingling feeling down her legs; joint pain in her legs; raised bumps/rash that appeared chicken pox-like on her face, neck, arms, thighs, legs, and shoulders / rash on chest / rash on back; This case was reported by a consumer and described the occurrence of tingling of extremity in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced tingling of extremity, joint pain and papular rash. The patient was treated with gabapentin. On an unknown date, the outcome of the tingling of extremity, joint pain and papular rash were not recovered/not resolved. It was unknown if the reporter considered the tingling of extremity, joint pain and papular rash to be related to Shingrix. Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The patient experienced rash that appeared chicken pox-like on her face, neck, arms, thighs, legs and shoulders. The patient was seen by several dermatologists and the raised bumps were biopsied and proved negative. The patient also reports that she experienced joint pain in her legs, and tingling feeling down her legs. The patient was given Gabapentin to help alleviate symptoms which were still present at the time of reporting. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 0993493
Sex: F
Age: 58
State: UT

Vax Date: 12/16/2020
Onset Date: 12/16/2020
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: stomach pain; needle came off of the syringe and she only received part of the dose / given another full dose; This case was reported by a nurse and described the occurrence of stomach pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 16th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) and Shingrix (intramuscular). On 16th December 2020, less than a day after receiving Shingrix and Shingrix, the patient experienced stomach pain and accidental underdose. On 17th December 2020, the outcome of the stomach pain was recovered/resolved. On an unknown date, the outcome of the accidental underdose was unknown. It was unknown if the reporter considered the stomach pain to be related to Shingrix and Shingrix. Additional details were provided as follows: The patient was a nurse. The patient received the second dose of Shingrix vaccine in the left arm and while it was being administered the needle came off of the syringe and she only received part of the dose, which led to accidental underdose. The patient was then given another full dose of the Shingrix vaccine on the same day in the right arm. Patient did not have lot number or expiration date information to provide. The patient had stomach pain that lasted 1 day, started a day before reporting and finish 17th December 2020. The reporter did not consent to follow up and did not give consent to follow up with health care professional.

Other Meds:

Current Illness:

ID: 0993494
Sex: F
Age: 58
State: ID

Vax Date: 12/03/2020
Onset Date: 12/01/2020
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: she had to call out from work the next day; Vomiting; Myalgia; Shivers; she was still very tired; injection site was Red; injection site was / Swelling; injection site was / hot from injection site to the elbow; This case was reported by a other health professional and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 3rd December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced vomiting, myalgia and shivers. On 4th December 2020, the patient experienced activities of daily living impaired. In December 2020, the patient experienced injection site erythema, injection site swelling, extremities hot feeling of and fatigue. On an unknown date, the outcome of the injection site erythema, injection site swelling, extremities hot feeling of, vomiting, myalgia, shivers, fatigue and activities of daily living impaired were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, extremities hot feeling of, vomiting, myalgia, shivers, fatigue and activities of daily living impaired to be related to Shingrix. Additional details were provided as follows: The patient was a health care professional. On the night after receiving the Shingrix vaccine, the patient had shivers, myalgia and vomiting. The patient stated that she had to call out from work the next day. Patient was able to get out of bed on the third day, but she was still very tired. She also stated that the injection site was red, swollen, and hot from the injection site to the elbow. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 0993495
Sex: F
Age: 16
State: TX

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pregnant; Vaccine was given to 16 years of age patient; A report was received from a nurse concerning a 16-year-old, female patient who was participating in the mRNA-1273program and the patient received the vaccine at inappropriate age and while pregnant. The patient's medical history was not provided. No relevant concomitant medications were reported. On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 027L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. The reporter called and stated that their office had given the first dose of Moderna vaccine to a 16 year old girl who was pregnant. The patient's due date is April 2021. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events, vaccine exposure to patient of inappropriate age while pregnant, were considered resolved.; Reporter's Comments: This spontaneous case concerns a 16-year-old female who received the vaccine at inappropriate age (inappropriate age at vaccine administration) and while pregnant for mRNA-1273 (Lot number 027L20A, expiration date unknown). No medical history, obstetric or gynecological history was provided. Estimated date of delivery is April 2010. There were no reported AEs associated with the event of inappropriate age at vaccine administration.

Other Meds:

Current Illness:

ID: 0993496
Sex: M
Age:
State: MA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Low count platelets; Convulsions after vaccination without lose of consciousness; A spontaneous report was received from a pharmacist concerning a 22-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced convulsions without loss of consciousness and low platelet count. The patient's medical history was not reported. Concomitant medications were not provided. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection. On 28 Dec 2020, after getting vaccinated, the patient immediately started to experience tremors and shaking all over his body which was described as convulsions without losing consciousness. On 05 Jan 2021, the patient had a blood test that showed a low platelet count. No treatment information was provided. Action taken for the event was not reported. The outcome of the events, convulsions without loss of consciousness and low platelet count, was considered unknown.; Reporter's Comments: This case concerns a 22-year old male patient. The medical history is not provided. The patient experienced a medically significant and unexpected medically significant event of Convulsions without losing consciousness immediately after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Additionally, the patient experienced an unexpected non-serious event of Platelet count decreased. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 0993497
Sex: M
Age: 85
State: FL

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/02/2021
Hospital:

Vax Type:
Manufacturer:
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Lot:
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Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Blood clot; Swelling at the injection site; Redness at the injection site; A spontaneous report was received from a consumer concerning a 85-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced swelling at the injection site, redness at the injection site and blood clot. The patient's medical history was not reported. The patient current condition included chronic obstructive pulmonary disease (COPD). No relevant concomitant medications were reported. On 11 Jan 2021, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient's wife called his doctor as he was experiencing swelling and redness. They were referred to the emergency room (ER) by their doctor for a suspected infection. In the ER they were told it may be a blood clot and the patient was given prednisone. Treatment for the events included prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcomes of the events swelling at the injection site, redness at the injection site and blood clot were unknown.; Reporter's Comments: This case concerns a 85 year-old, male patient, who experienced events of swelling at the injection site, redness at the injection site and blood clot. The events occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds:

Current Illness: COPD

ID: 0993498
Sex: F
Age: 82
State: FL

Vax Date: 01/10/2021
Onset Date: 01/10/2021
Rec V Date: 02/02/2021
Hospital:

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

Allergies:

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

Symptoms: Looks like cellulitis; Injection site swollen; Injection site red; Arm was just sore; A spontaneous report was received from a consumer concerning a 82-year old, female, mother who received Moderna's COVID-19 vaccine and experienced sore arm, red and swollen injection site and looks like cellulitis. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10 Jan 2021, after receiving the vaccine the patient's arm was sore. On 19 Jan 2021, the injection site is all red and swollen, looks like cellulitis. No treatment for events. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events was unknown.; Reporter's Comments: This case concerns an 82-year-old female patient, who experienced a serious unexpected event of cellulitis, and non- serious expected event of pain in extremity, injection site swelling, and injection site erythema. The event of pain in extremity occurred 1 day (same day) after first dose of mRNA-1273, lot # 039K20A. The event of cellulitis, injection site swelling, and injection site erythema occurred 10 days after first dose of mRNA-1273, lot # 039K20A. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 0993499
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: All of the face paralyzed immediately after getting the shot; Tongue was numb; A report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273)and experienced the serious adverse event of whole face paralyzed and tongue numbness. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. The reporter experienced facial numbness after 30 minutes of receiving the vaccine and mentioned two other patients that suffered the same adverse event. This case was to document the event for one of those other patients. This patient had all of the face paralyzed immediately after vaccination. The tongue was also numb. No treatment information was provided. Action taken with mRNA-1273 in response to the event(s) was not reported. The outcome of the events was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 0993500
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Face paralysis that lasted 2 hours; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed face paralysis that lasted 2 hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, approximately 30 minutes prior to the onset of the event, the patient received their a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. 30 minutes following vaccination, the patient began to experience facial numbness. They experienced facial paralysis for 2 hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, face paralysis that lasted 2 hours, was considered resolved on an unknown date.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of facial paralysis. The event of facial paralysis occurred 30 min (same day) after first dose of mRNA-1273, lot # unknown. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 0993502
Sex: F
Age: 60
State: AZ

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sloughing in her mucosa; immune systen going haywire/feeling pretty bad; Tachycardia; received 5cc or 33cc of Moderna COVID-19 vaccine; Dizzy; muscle aches; Injection site hard; Injection site is swollen; feet and hands were white and cold; Nasal drainage; fingers turned blue; A spontaneous report was received from a physician concerning a 60-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced tachycardia, immune system going haywire, felt pretty bad, dizziness, muscle pain, nasal drainage, feet and hands white/blue, heart rate 100 bpm and 5cc or 33cc of Moderna COVID-19 vaccine. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 16 Jan 2021, approximately 6 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 16 Jan 2021, patient Patient states having tachycardia and felt "pretty bad" about 12 hours later, which she knows is normal after immunization. Continued to have tachycardia, and yesterday began to feel incredibly dizzy and like every single muscle was aching. Reports the injection site is hard and swollen but not red. States she could hardly see because of the dizziness and tachycardia. Also reports experiencing sloughing in her mucosa similar to when she was on chemotherapy for lymphoma. Reports no cough, no fever. Patient states that on Saturday which had tachycardia, her feet and hand were white and cold and temp was 95 degrees F. Her fingers turned blue and were white, but she had no shivers, no fevers. Also reports nasal drainage every time she gets an episode of the tachycardia. Physician state she was able to control tachycardia by drinking an enormous amount of fluid. Her heart rate was about 100 bpm, normal average is 65 bpm. Treatment for the event included Tylenol 500mg x 2 and OTC Advil. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events tachycardia, immune system going haywire, felt pretty bad, dizziness, muscle pain, nasal drainage, feet and hands white/blue, heart rate 100 bpm and 5cc or 33cc of Moderna COVID-19 vaccine was not reported.; Reporter's Comments: This refers to a case of product administration error for mRNA-1273 (Lot number 025L20A), where 5cc or 3cc of the vaccine was administered to the patient. The adverse events of tachycardia, feeling abnormal, dizziness, myalgia, peripheral coldness, cyanosis, rhinorrhea, mucosal exfoliation, vaccination site swelling and vaccination site induration were reported associated with this case of incorrect dose of vaccine administered.

Other Meds:

Current Illness:

ID: 0993503
Sex: U
Age:
State:

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: The way in which vaccine was administered made her bleed; injection site was bleeding a lot; injection site swelling; A spontaneous report was received from a consumer concerning an unspecified patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the way in which vaccine was administered made her bleed, injection site was bleeding a lot, and injection site swelling. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Jan 2021, approximately 0 days prior to the onset of the events, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 12 Jan 2021, the patient reported the way the vaccine was administered made her bleed profusely and she stated she had never seen that much blood. She also reported the injection site was swelling because of the way the vaccine was administered. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event, the way in which vaccine was administered made her bleed, was considered on 12 Jan 2021. The outcomes of the events, injection site was bleeding a lot, and injection site swelling were unknown.; Reporter's Comments: This case concerns a female patient of an unknown age. The patient's medical history and concomitant medications were not provided. The patient experienced a non serious event of the way in which vaccine was administered made her bleed, injection site was bleeding a lot, and injection site swelling.The event occurred on the same day as the first dose of the mRNA-1273. Very limited information regarding these events have been provided at this time. Based on temporal association between the use of mRNA-1273 and the events, a causal relationship cannot be excluded. Additional information is required for further assessment.

Other Meds:

Current Illness:

ID: 0993504
Sex: F
Age:
State: IL

Vax Date: 01/08/2021
Onset Date: 01/12/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; severe abdominal pain; Nausea; Injection site pain; This is a spontaneous report from contactable other hcps (including patient herself). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid19, lot number EL3248) , via an unspecified route of administration 08Jan2021 17:30 at single dose on left deltoid for covid-19 immunisation. Medical history included covid-19 the first time in Oct2020 to an unknown date , then from 16Nov2020 to an unknown date and experienced "every symptom except for vomiting". The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 18Dec2020 for covid-19 immunisation and experienced neck hurting, Shingrix Vaccine on 04Dec2020 for immunization and experienced no adverse effect. The patient experienced severe abdominal pain, nausea, Injection site pain on 12Jan2021, headache, fatigue, feeling of total lack of energy on 13Jan2021, fever on 16Jan2021. She had severe abdominal pain and nausea for three days (as reported). The caller stated she took Zofran for her nausea. The caller stated she had a rapid COVID-19 Virus test that was negative, but continued to feel queasy. She stated she had 100.5-101.8 degree fevers over the weekend, and has been sleeping a lot. Reported she woke at 4:00AM on Tuesday, 12Jan2021, with severe abdominal pain. She said the abdominal pain is better but not completely gone. Abdominal Pain Treatment: Declined any. Reported she hasn't discussed with her doctor the adverse events she has been experiencing since receiving the second COVID-19 Vaccine dose. She stated she had injection site pain for 2-3 days after receiving the second COVID-19 Vaccine dose. She said she didn't have any injection site soreness with the first COVID-19 Vaccine dose. She said she thought she was good after receiving the second COVID-19 Vaccine dose, but then on Tuesday, 12Jan2021, she woke at 4:00AM with severe abdominal pain. She said the abdominal pain came in waves. She described the abdominal pain as an 8 out of 10, clarifying the abdominal pain would be sharp and then fade away, and then the abdominal pain would cycle back around. She said she found herself standing over her toilet a few times because the abdominal pain was so severe, she thought she was going to throw-up. She clarified she had nausea and took and old prescription of Zofran she had received for vertigo years ago. She stated she did not have the Zofran NDC, Lot, and Expiration Date. Reported her abdominal pain and nausea went away by Thursday, 14Jan2021, saying the abdominal pain and nausea was less and less each day. She clarified the abdominal pain and nausea were intermittent, saying all of a sudden she would not feel good. She said her nausea has been better for the past 2-3 days. She clarified she called off work on Tuesday, 12Jan2021, and on Wednesday, 13Jan2021, she had a Rapid COVID-19 Virus Test before she started work that day (13Jan2021) to make sure that she wasn't positive for the COVID-19 Virus. She said she had a headache, no energy, and felt fatigued at work on Wednesday (13Jan2021), and Thursday (14Jan2021), but didn't take her temperature during that time. She said she didn't work on Friday (15Jan2021), but continued to have the headache, fatigue, and feeling like she had no energy. She said she didn't check her temperature until Saturday, 16Jan2021. She said she woke up Saturday (16Jan2021) at 9:40AM and went back to sleep until 11:30AM. She said she woke back up at 1:42PM and her husband told her she felt hot to the touch. She said she checked her temperature and it was 101.8 degrees. She said she checked her temperature first thing this morning (18Jan2021) because she could tell she sweated overnight, and her temperature was 100.3. She said she just checked her temperature again, and her temperature was now 99.3 degrees. She said by this afternoon, her temperature will be in the 101 range. Headache & Fever Treatment: Reported she took Naproxen (clarified as a prescription Naproxen 500mg tablet), and Tylenol (clarified as Equate brand Acetaminophen 500mg tablet) for her headache and fever on Saturday (16Jan2021). She said she took the Naproxen and Acetaminophen 500mg once in the morning, and again at night, before bed. She stated she did not take any Naproxen or Acetaminophen on Sunday, 17Jan2021. Acetaminophen 500mg tablet (Equate Brand): UPC Number: Unknown, Lot Number: 0HV1335, Expiration Date: May2022 Naproxen 500mg tablet (Prescription dispensed in round, pharmacy bottle): No NDC, Lot, or Expiration Date Reported she had another COVID-19 Virus test performed on Sunday, 17Jan2021, at 11:40AM at a drive-thru test site at Pharmacy. She clarified it was a "send-out" PCR COVID-19 Virus test, and she had not received her test results yet. She said her belly doesn't hurt anymore. She said she doesn't have a gallbladder and appendix. She said if she had the flu, the flu lasts for 3-5 days, and she is not coughing. She said she feels like now, what she felt like when she had the COVID-19 Virus the first time in Oct2020. She said she had a 12 days of severe fatigue when she had COVID-19 in Oct2020. She said her COVID-19 Virus symptoms started on 14Oct2020 with nasal congestion, and by 16Oct2020 she couldn't taste her yogurt. She said she got tested later in the day on 16Oct2020 for the COVID-19 Virus. She clarified she definitely had no sense of smell or taste on Friday, 16Oct2020. She said on Thursday, 15Oct2020, she kept falling asleep in the evening, saying that never happens. She said on Friday, 16Oct2020, she had a fever of 100.3, as well. The outcome of the events severe abdominal pain, nausea was resolved on 14Jan2021, of Injection site pain was resolved on an unspecified date, of sleeping a lot and she sweated overnight was unknown, of other events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of abdominal pain, nausea and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0993505
Sex: F
Age:
State: FL

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Yesterday and still today it felt like I burnt the tip of my tongue; poking my tongue with needles, very painful; My tongue was numb for 2-3 hours; Arm hurt; This is a spontaneous report from a contactable consumer (patient). A 70-year old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at 10:21 at single dose in left arm for COVID-19 immunisation at the age of 70-year-old. Lot number was EL1284. Medical history included blood pressure, COVID-19 in Mar2020, loss of smell and taste in Mar2020, diarrhea in Mar2020, ongoing headache since Mar2020 (started with eyes, thought the patient had pink eye, she had a headache right at the time of report), chills in Mar2020. Concomitant medications included ongoing olmesartan for blood pressure. The patient received flu vaccine in Oct2020. The patient received her vaccine on 15Jan2021; she was informed to wait 15 minutes after getting the vaccine and she did. When she left the park about 2-3 minutes after waiting the 15-minute observation period she started to feel a sharp needle poking type feeling on her tongue, it was painful. Her daughter asked if she wanted to turn back around, but they did not. The feeling did not last long. She then added, later that day it felt like the tip of her tongue was numb. It stayed that way for at least 2 hours and then went away. On 17Jan2021, she woke up and she has the feeling on her tongue as if she drunk something hot and burnt the tip of his tongue. She has this burnt feeling sensation on her tongue and she had not eaten or drunk anything yet. Poking sensation on tip of tongue that was painful occurred like 17 minutes after she got the injection. It is like her tongue was being poked with needles. She later had numbness on her tongue, this lasted like 2 hours. It seemed like a numbing solution was administered with the vaccine. The way her tongue felt, it was as if there was a numbing solution in the needle with the vaccine. Her tongue was very numb for a while, but it then went away. On 17Jan2021, she started to feel the tip of her tongue was burnt. She looked at her tongue on 17Jan2021 and it was red. She has not looked at it the day of report so she did not know what it looked like. The patient initially stated, besides the tongue issue, she had no issues. However, she then later stated and clarified the only other issue she had was her arm hurt a little; it was not bad, but it did hurt; it did not hurt at the time of report, it started the same day she got the vaccine during the night. The patient recovered from Poking sensation on tip of tongue that was painful, Tongue numb on 15Jan2021, patient was recovering from Tip of tongue feels like it was burned, the outcome of arm pain was unknown.

Other Meds: OLMESARTAN

Current Illness: Headache (headache, started with eyes, thought she had pink eye, had a headache right at the time of report)

ID: 0993506
Sex: M
Age:
State: FL

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: the doctor was concerned that it might be a mini stroke; couldn't think of what he wanted to say; This is a spontaneous report from a contactable consumer reporting for the father. An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 08:45 at single dose in right arm because of his age group /mass senior vaccination order. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medications included blood pressure medicine since recent years. The patient previously had a flu shot (INFLUENZA VACCINE) but had that in early Nov2020. He kept saying it was the shot, but that he was fine. There were no additional vaccines administered on same date of the Pfizer Suspect. The patient got vaccinated with the Pfizer COVID vaccine on 14Jan2021. He was feeling great with no problems. He sat and waited 15 minutes, and felt fine. When they were driving home after breakfast, her mother said she was talking asking him a question, and he wouldn't respond. Her father could hear her mother asking the question, but he said he could not think of what he wanted to say. He told her he couldn't think of what he was thinking on 14Jan2021. It probably started 1 hour to 1 hour 15 minutes after vaccination, and lasted 15-20 minutes. He kept trying to think of stuff. He kept repeating this for a little bit. His wife thought he was just trying to think of something, but couldn't remember. He was 81. He was very healthy and in shape. He still rides his bike every day. He walks in the morning to play golf too. When they got home and woke up from the nap, and he felt fine. He did say it was the weirdest thing, and that it had to have come from the shot. Since then, he has felt perfectly fine. He had nothing more going on that would indicate any side effect. Her concern was that it sounded like possibly a mini stroke. Upon checking with an HCP (Healthcare professional), the doctor was concerned that it might be a mini stroke and scheduled him for a CAT (Computerised axial tomography) scan. He kept saying it had to be the shot because he has been fine ever since. He had no issues with soreness at site or anything. He didn't have a prescribing doctor. He was driving when it happened. He didn't have a slur or anything. His second appointment is on the 04Feb2021. The event did not require a visit to Emergency Room, but required a visit to Physician Office in the morning of 18Jan2021. The outcome of the event couldn't think of what he wanted to say was recovered, and of the other event was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0993507
Sex: M
Age:
State: OH

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: He tested positive for Sars-CoV-2 in the interim; He tested positive for Sars-CoV-2 in the interim; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included exposure to a patient who was positive. The patient's concomitant medications were not reported. The patient received his first Pfizer-Biontech Covid19 vaccine on 30Dec2020, and was scheduled to receive his second dose today, 18Jan2021. He tested positive for Sars-CoV-2 in the interim and is looking for guidance on receiving the second dose. He was exposed to a patient who was positive. The patient has also tested positive. He wanted to know when he should get the second vaccine. The patient should have gotten the second dose today and was told they could get him in on Thursday which was in that 4-day window. Now, he has just been informed that they can't get him in for the second dose until Monday, which is outside to of the 4 days window and he wants guidance on this since his hospital was unsure. The outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: The patient received only one dose of BNT162B2 injection and then tested positive SARS-COVID-2 on an unspecific date. Given the incomplete protection from single dose of vaccine BNT162B2 , the COVID infection is unlikely related to suspect BNT162B2 administration, but may be pre-existing/intercurrent condition.

Other Meds:

Current Illness:

ID: 0993508
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: ulcerative colitis; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). This female patient of an unspecified received bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at SINGLE DOSE for COVID-19 immunization. Medical history included she was allergic to sulfa. The patient's concomitant medications were not reported. She had ulcerative colitis and asked if that would impact anything. Outcome of the event was unkonwn. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0993509
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: received first dose of vaccine and slept for two days straight; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient slept for two days straight on an unspecified date. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 0993510
Sex: F
Age:
State: AZ

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 02/02/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: 24 hours after receiving the vaccine, I passed out while walking. I do not have any other new medications; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Arm Left on 13Jan2021 at 08:00 AM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included bronchiectasis. Patient had no known allergies. Concomitant medications in two weeks prior to the vaccination included olodaterol hydrochloride, tiotropium bromide monohydrate (STIOLTO RESPIMAT), salbutamol (ALBUTEROL HFA) and multi vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 10:00 AM patient passed out while walking, 24 hours after receiving the vaccine, patient did not have any other new medications. Event resulted in emergency room/department or urgent care and hospitalization for one day. Treatments received included cast on hand, computerised tomogram (Ct) scans, electrocardiogram (EKG) and echocardiogram on unknown date with unknown results. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the event, at the time of the report.

Other Meds: STIOLTO RESPIMAT; ALBUTEROL HFA

Current Illness:

ID: 0993511
Sex: F
Age:
State: AZ

Vax Date: 01/16/2021
Onset Date: 01/17/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Went to living room shaky then pass out 2-3 minutes.; chills all day; Cold sweats; little lightheaded/ feeling dizzy; Headache; feels like someone put ice cold on both ears and face; Nauseous; Feverish at night with 99.9 oral temp; Sore on in the injection site; Blurry vision; shaky; thirsty; This is a spontaneous report from a contactable other HCP reported for self. This 49-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 16Jan2021 09:15 AM on Right arm at single dose (Lot # EL1283) for covid-19 immunisation. Medical history included high Blood pressure, Known allergies: Amlodipine, Seasonal allergy. Prior to vaccination, was the patient did not diagnosed with COVID-19. Concomitant medications included Chlorthalidone 25 mg, Magnesium 500mg. No other vaccine in four weeks. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Dec2020 08:30 AM for covid-19 immunisation, experienced sore on in the injection site. On 17Jan2021, waking up 06:00 AM with headache, thirsty, little lightheaded, went to kitchen turn on coffee maker start feeling dizzy, nauseous, blurry vision, went to living room shaky then pass out 2-3 minutes. Cold sweats again, went to bathroom was sitting there then feels like someone put ice cold on both ears and face, cold sweats, nausea, and blurry again. Cold sweats and chills all day, feverish at night with 99.9 oral temp. Sore on in the injection site both doses. No COVID tested post vaccination. No treatments were received. Outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the loss of consciousness and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: CHLORTHALIDONE; MAGNESIUM

Current Illness:

ID: 0993512
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: Felt pricked by shoulder and has a scab there now; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age (Age: 65; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I felt pricked by shoulder and has a scab there now, could this happen due to the vaccine? The site which she received her vaccine is rescheduling people for after 21 days. The patient felt two pricks. She got a scab on her shoulder. She thinks he accidently poked her. The patient stated, "If the person that gave the vaccination pricked her shoulder before the shot could it have caused a little irritation on her shoulder? Whenever the man gave the shot, she wasn't looking at him, but he told her to hold her sleeve up. She was just trying to hold her sleeve up. He pushed his sleeve way up on her shoulder. She felt it way up on her shoulder, and thought it was strange. He squeezed her arm, and said he thought there would be good. She felt two pricks. She got a scab on her shoulder. She thinks he accidently poked her. He tried to say he thought he poked himself, but she is pretty sure he poked her. He gave the shot in her arm. He thought he had pricked himself but pricked her. Her question is, if that happens and the needle pricks the surface of the skin, can it make it blister the skin? Her main reason for calling is that she is signed up to get the second round. Now, the city she lives in is having trouble getting the vaccine. People that were supposed to get the first vaccine Monday and Tuesday had to be pushed to Wednesday because they didn't get their shipment. So now everyone will get them on Wednesday. The day she went it was very organized so she feels bad for these people. Since Pfizer is having trouble getting this shipped, then what is going to happen on 5 Feb 2021 which is the day she is supposed to get her second dose. What will happen if they don't have vaccines?". She would just like her questions answered. Her brother said he heard somewhere the vaccine doesn't have to be given at exactly 21 days like they originally said. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0993513
Sex: F
Age:
State: FL

Vax Date: 01/16/2021
Onset Date: 01/17/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient (not pregnant), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration, on left arm on 16Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included Diverticulosis, hypothyroid, osteoarthritis, vitiligo, psoriasis, anxiety/depression, known allergies: Iodine, sulfa, bivalve shellfish, garlic, onions. Concomitant medications included first dose of pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 23Dec2020 on left arm, celecoxib (CELEBREX), sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL). The patient experienced fatigue, sore arm the day after vaccine was administered on 17Jan2021. Two days after administration on 18Jan2021, patient experienced fatigue, headache, nausea. No treatment received for all events. The outcome of the events were resolving.

Other Meds: CELEBREX; SERTRALINE; ADDERALL; SYNTHROID; CYTOMEL

Current Illness:

ID: 0993514
Sex: F
Age:
State:

Vax Date: 01/11/2021
Onset Date: 01/01/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: She had a head to toe body ache 14 hours after she got the vaccine; had fever that went up to 100.8 F; had swollen lymph node on the same arm as the injection site; full body rash; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration in arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 from 12Dec2020 (States that before she got the vaccine she was positive for Covid, but her positive result came back on 12Dec2020). The patient's concomitant medications were not reported. Caller got the COVID-19 vaccine on 11Jan2021. She had a head to toe body ache 14 hours after she got the vaccine (11Jan2021 14:00). She also had fever that went up to 100.8 Fahrenheit and had swollen lymph node on the same arm as the injection site, and a full body rash in Jan2021. She has had all these symptoms for a week now. The outcome of the events was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 0993515
Sex: F
Age:
State: FL

Vax Date: 01/08/2021
Onset Date: 01/18/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 10 days after shot platelets have now dropped from 245000 to 94000; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (left arm) first dose on 08Jan2021 08:00 at single dose for covid-19 immunisation. The patient's medical history included thrombocytopenia. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. On 18Jan2021 11:00, ten days after shot platelets have now dropped from 245000 to 94000. The patient was very concerned platelets will drop below 30000 and will require hospitalization. The patient wanted guidance on what protocol to follow to avoid a further drop in platelets. No treatment was given to the event. The event resulted in emergency room visit physician office visit. The outcome of the event was not recovered. The patient underwent nasal swab on 18Jan2021, and the result was negative. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0993516
Sex: F
Age:
State: MI

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: discomfort in my sternum; trouble breathing; chest congestion; increased weakness; shakiness in my legs; Within 10mins I was feeling dizzy; increase palpitation; I told the nurse she checked my blood pressure. It was 157/87; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on the right arm on 15Jan2021 15:45 at a single dose for an COVID-19 immunization at a hospital. Medical history included GERD. There were no concomitant medications. On 15Jan2021 at 15:45 (reported as within 10 mins), the patient felt dizzy and increase palpitation. The patient told the nurse and she checked her blood pressure, it was 157/87. After 15 mins of vaccine infusion (16:00), she came back home and increased weakness with shakiness in legs noted. After 2 hrs. (18:00) all symptoms were gone. The next morning (16Jan2021), the patient had discomfort in her sternum. By late afternoon, she had trouble breathing with chest congestion. The patient took 3 puffs of inhaler so she can breathe. The patient mentioned that her inhaler is expired, it was given to her 3 years ago. She didn't want to use it but used it anyway so she can sleep. The events dizzy, palpitation, blood pressure high, weakness, shakiness, and discomfort in sternum were not treated. The outcome of the events weakness and shakiness was recovered on 15Jan2021 at 18:00 while the other events were unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0993517
Sex: F
Age:
State: CT

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Anaphylactic reaction; This is a spontaneous report from a contactable Nurse (patient). This is the second of two cases and refers to events occurred with the second dose of the vaccine. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EL1283), on 11Jan2021 at 11:00 at single dose in Deltoid Left for COVID-19 immunization. Medical history included asthma, shellfish allergy, allergy lobster (used steroids). Patient was not pregnant.The patient's concomitant medications were not reported. Previously on 22Dec2020 at 12:30 PM patient took the first dose of the vaccine (Lot EJ1685) at single dose in Deltoid Left for COVID-19 immunization and couple of days after she had nausea and something stuck in her throat. On 11Jan2021, 5 minutes after the 2nd dose (at 11:05), the patient experienced anaphylactic reaction, that required Emergency room visit. Patient was not hospitalized and was treated with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLUMEDROL) and "Pepcid": she was prescribed 3-day course of oral prednisone and H2 antihistamine oral "Pepcid". After finished it, she felt it was coming back therefore she took diphenhydramine hydrochloride for 2 nights in a row. She did not experience any respiratory, cardiovascular, dermatological or gastrointestinal manifestation. She completely recovered in Jan2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of anaphylactic reaction due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0993518
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: asymptomatic but positive; asymptomatic but positive; This is a spontaneous report from a contactable Other HCP (patient's parent). A male patient (son) of unknown age received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Caller states his son went back to school and initially tested negative for SARS-Cov-2 following first dose, now is asymptomatic but positive. Asking if second dose would exacerbate. Outcome is unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the limited information available, a causal relationship between event "asymptomatic but positive" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become available.

Other Meds:

Current Illness:

ID: 0993519
Sex: F
Age:
State: AZ

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

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

Lab Data:

Allergies:

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

Symptoms: high platelets; fatigue; sharp muscle pains in hands and elbows; Headaches; nausea; Canker sore on my tongue; had a sizable bruise; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 09Jan2021 11:45 AM at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient is not pregnant. Patient previously took the first dose of BNT162B2 at single dose for COVID-19 immunization. Patient have had a lot of fatigue, sharp muscle pains in hands and elbows at day 9 post injection (17Jan2021). Patient was now developing a Canker sore on her tongue as a fellow coworker had the same reaction (Jan2021). Patient have high platelets and have had a sizable bruise for 9 days. Headaches and nausea were present at three hours post injection (09Jan2021). AE resulted in doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. No COVID tested post vaccination. covid test type post vaccination included Nasal Swab on 12Jan2021 with test result of Negative. No treatment received for the events. Outcome of the events was unknown. Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0993520
Sex: F
Age:
State:

Vax Date: 10/01/2018
Onset Date:
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swollen shoulder to her elbow; slight fever; it was a little red. Like palm size redness; white count was elevated a little bit; skin reaction; This is a spontaneous report from a contactable Pharmacist. A 65-year-old female Pharmacist (patient) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, Batch/lot number: Not Provided) via an unspecified route of administration in Oct2018 at single dose for immunization. Historical vaccine included flu shot (Most of the time with the flu shot she has muscle pain) for immunization and had muscle pain. Concomitant medications were not reported. She got the Prevnar 13 shot two years ago and had a bad reaction. It was a week later she had a reaction. She experienced a swollen shoulder to her elbow on an unspecified date in 2018. She went to the doctor for the check up and was provided with two antibiotics. The doctor said that it could be an infection, but not at the injection site. She went to her doctor recently to see if she can take the COVID vaccine. She was asking if it was safe and if she was able to take the COVID vaccine. She was 65 years of age. She was a pharmacist. Caller states in Oct2018 she received Prevnar 13 shot and it was made by Pfizer. She had the shot on Monday. Most of the time with the flu shot she has muscle pain. When she got the Prevnar shot on Monday, on Tuesday she had a slight fever and it was a little red on an unspecified date in 2018. Like palm size redness on an unspecified date in 2018. She let it go because previously some other shots would have the same thing. On Friday, she had concern because her doctor wasn't going to be available, so he ordered a CBC and everything was ok. She went to the ER on Saturday because the swelling got bigger. The white count was elevated a little bit on an unspecified date in 2018. They said to wait and see. They drew the line and she went home. On Sunday, it was still there and the area was quite big. She went back to the ER. They gave her Septra DS, two BID (twice a day). She was still concerned and she called doctor. He added Keflex, 1 gram QID (four times a day). He advised her if it wasn't better to go see him on Wednesday. By Tuesday it had gone down. Her dad was sick and she rushed back to (address). With COVID she was concerned. Her doctor thinks she could have just been getting an infection and he doesn't think it is an allergy reaction. She was still concerned. Were there any documentation of issues with allergies to Prevnar 13 with COVID vaccine? Lot of people have skin reactions with Prevnar 13, she googled it and from chatting with friends and family. It depends on the degree. This kind of skin reaction was the first time for her on an unspecified date in 2018. Normally it would stay there for a couple of days. It just happened to be a Pfizer vaccine. She doesn't think there are any components that are similar to that. She wants to know if she can get the COVID vaccine. Are there any precautions she should watch for or wait? Apparently it was not an allergy to use Epipen or things like. Caller states her reaction to Prevnar 13 was two years and three months ago. She feels lots of people have skin reactions. She wants to be transferred to Medical Information. Caller declined to report. Should she wait for more safety report to come out? It was mRNA, lipid, and PEG. She doesn't have problems with Miralax. Caller was a pharmacist, retired 2 months ago, who asks should she get the vaccine? Caller reports that she was 67 yo who has a history of a skin reaction on her left arm after receiving the Prevnar 13 vaccine. She reports that this occurred 27 months ago. She reports that her doctor said it looked like an infection from the injection, she states that she "was prescribed Septra DS 2 BID (twice a day) and it got better". She was concerned about getting the covid vaccine after having that reaction but also reports that her MD doesn't think she should worry about it. She calls today for additional guidance. Outcome of events swollen shoulder to her elbow was not recovered, slight fever, it was a little red. Like palm size redness, skin reaction was recovering; while with other event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: There is a reasonable possibility that the events pyrexia and vaccination site erythema was related to PREVNAR 13 use based on known drug safety profile. Based on the temporal relationship, the association between the other events with PREVNAR 13 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0993521
Sex: F
Age:
State: FL

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative. Medical history included high blood pressure from 2016 and ongoing. Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.

Other Meds: CHLORTHALIDONE

Current Illness: Blood pressure high

ID: 0993522
Sex: F
Age:
State: CT

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/02/2021
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Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Exhausted; sore; headache; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced Exhausted, sore, headache on 18Jan2021. Outcome of events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

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Current Illness:

ID: 0993523
Sex: F
Age:
State: NY

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/02/2021
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Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Fever; body aches; severe exhaustion; dizziness; sweating; cold chills; shortness of breath; sore swollen throat; sore swollen throat; This is a spontaneous report from a contactable health professional, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL32A) via an unspecified route of administration in the left arm on 18Jan2021 at 16:00 (at the age of 25-years-old) for COVID-19 immunization. Medical history included gastroparesis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included celecoxib (CELEXA), alprazolam (ATARAX), ethinylestradiol/levonorgestrel (AVIANE). The patient did not receive other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient previously took amoxicillin and experienced allergies; and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK5730) on 28Dec2020 at 14:30 (at an unspecified age) in the left arm for COVID-19 immunization. On 19Jan2021 at 01:00, the patient experienced fever, body aches, severe exhaustion, dizziness, sweating, cold chills, shortness of breath, sore swollen throat. The patient did not receive any treatment for the events. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 19Jan2021 with negative results. The clinical outcome of Fever, body aches, severe exhaustion, dizziness, sweating, cold chills, shortness of breath, sore swollen throat was not resolved.

Other Meds: CELEXA [CELECOXIB]; ATARAX [ALPRAZOLAM]; AVIANE

Current Illness:

ID: 0993524
Sex: F
Age:
State: TX

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/02/2021
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Symptom List: Injection site swelling, Limb discomfort

Symptoms: Fatigue; chills; body aches; headache; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Ej1686), in a hospital intramuscularly in the left arm on 18Jan2021 at 09:00 at 49-years-old at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus (Dm2 controlled) from an unknown date and unknown if ongoing. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), levothyroxine (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), Pro tonic (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; first dose -Lot Number: Ek9231, intramuscularly in the left arm) on 28Dec2020 at 49-years-old. On 18Jan2021 at 16:00, the patient experienced fatigue (non-serious), chills (non-serious), body aches (non-serious), headache (non-serious); with no treatment received. The clinical outcome of the events was not recovered. The patient did not receive any other vaccine in four weeks prior to the COVID-19 vaccine. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination..

Other Meds: EFFEXOR; LEVOTHYROXINE; IBUPROFEN

Current Illness:

ID: 0993525
Sex: F
Age:
State: PA

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/02/2021
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Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Nausea; Vomiting; Severe myalgias; Headache; This is a spontaneous report from a contactable physician reporting for herself. A 29-years-old female pregnant patient received the second dose of bnt162b2 (BNT162B2), lot number EL0142, via an unspecified route of administration from 18Jan2021 15:00 (at the age of 29-years-old) as a single dose in the left arm for COVID-19 vaccination. Historical vaccine included first dose of bnt162b2 (BNT162B2), lot number EL1284 in the left arm. The patient's medical history was not reported. Concomitant medication included multivitamin. The patient previously took clarithromycin(BIAXIN) and experienced Known allergies: BIAXIN. No other vaccine was given in four weeks. The patient received the vaccine at a hospital. The patient's last menstrual date was 23Nov2020. Her Delivery date is 01Sep2021. Gestational period is 6. The mother was 8 Weeks pregnant at the onset of the event. On 19Jan2021 at 03:00 the patient experienced nausea, vomiting, severe myalgias and headache. Treatment included acetaminophen (TYLENOL) and antiemetic. The clinical outcomes of the events nausea, vomiting, severe myalgias and headache was recovering. The clinical outcome of the event "Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event" was unknown. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.

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ID: 0993526
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/02/2021
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Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Extreme weakness; gastro issues; she had a low grade fever; This is a spontaneous report from a contactable consumer. This consumer reported for a 73-year-old female patient received first dose of bnt162b2 (COVID 19, Pfizer), via unknown route of administration on Jan2021 at single dose for covid-19 immunisation. Medicla history was unknown. No Known allergies. Concomitant medications included other vaccine in 4 weeks product for Shingles. Facility type vaccine was other. The patient experienced Extreme weakness and gastro issues from Jan2021. She had a low grade fever (100 degrees) from Jan2021. Yesterday she mentioned she is feeling better than the initial reaction but not yet 100%. The outcome of the event was recovering. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Information about Lot/Batch number is requested.

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Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am