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: 0947441
Sex: U
Age:
State: CO

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: patient inadvertently received a dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history. On 11-JAN-2021, the patient was inadvertently vaccinated as the patient's sibling had a very similar name with hepatitis a vaccine, inactivated(VAQTA) lot # T013205 with expiration date on 03-DEC-2021, 0.5 milliliter for prophylaxis (route of administration was not reported). There was no missed dose. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 0947442
Sex: U
Age:
State: ME

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: No additional AE/PQC reported.; Admisnistration of VARIVAX and PROQUAD at the same time.; This spontaneous report was received from a certified medical assistant and refers to a 1-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were provided. On 08-JAN-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (for both lot #, expiration date, route and site of administration were not provided) at the same time for prophylaxis (Overdose). The vaccines were reconstituted with sterile diluent (STERILE DILUENT) (dose, route of administration, lot # and expiration date were not provided). The reporter did not know, if there were any adverse event, however no additional adverse event was reported at that time. The outcome of the overdose was unknown.

Other Meds: STERILE DILUENT

Current Illness:

ID: 0947444
Sex: F
Age:
State: VA

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

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

Lab Data:

Allergies:

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

Symptoms: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient experinced sore arm For 2nd dose refer case US2021000525. Did not consent to follow-up. ; Sender's Comments: US-GLAXOSMITHKLINE-US2021000525:Same reporter

Other Meds:

Current Illness:

ID: 0947445
Sex: F
Age:
State: RI

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Administered vaccine from vial which has been punctured for more than 6 hours; A spontaneous report (Un was received from a nurse concerning a 51-year old, female patient who received Moderna's COVID-19 Vaccine and experienced administered vaccine from vial which has been punctured for more than 6 hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered vaccine from vial which has been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, lot # 026L20A. There were no reported AEs associated with this case of expired product administered.

Other Meds:

Current Illness:

ID: 0947447
Sex: U
Age: 17
State: KS

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/15/2021
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, Injection site warmth

Symptoms: administered vaccine to a 17 years old; A spontaneous report was received from a rep concerning a 17-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate age at vaccine administration. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch 025J20-2A) and was administered vaccine to a 17 year old. The patient did not experience any symptoms. No treatment information was provided. Action taken with mRNA-1273 in was not reported. The outcome of the event, inappropriate age at vaccine administration, was resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 025J20-2A), reporting Product administered to patient of inappropriate age without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947448
Sex: F
Age:
State: PA

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Female patient 17 years of age received the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced female patient 17 years of age received the vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On 31 Dec 2020, approximately 0 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 31 Dec 2020, a 17 year old female patient was administered the vaccine. No additional information was provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event(s) was not reported. The event, female patient 17 years of age received the vaccine, was considered resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 0947449
Sex: U
Age:
State: NM

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947450
Sex: U
Age:
State: NM

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947451
Sex: U
Age:
State: NM

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947452
Sex: U
Age:
State: NM

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947453
Sex: U
Age:
State: NM

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

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

Lab Data:

Allergies:

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

Symptoms: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947454
Sex: U
Age:
State: NM

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947455
Sex: U
Age:
State: NM

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

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

Lab Data:

Allergies:

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

Symptoms: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947456
Sex: U
Age:
State: NM

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

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

Lab Data:

Allergies:

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

Symptoms: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947458
Sex: U
Age:
State: NM

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
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: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947459
Sex: U
Age:
State: NM

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
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: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947460
Sex: U
Age:
State: NM

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
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: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947461
Sex: F
Age: 32
State: NY

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies: Sensitivity to Codeine

Symptom List: Ear pain, Hypoaesthesia

Symptoms: - hot at injection and upper arm. - itching - red (red circle) - swollen

Other Meds: Ventolin

Current Illness: none

ID: 0947463
Sex: U
Age:
State: NM

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0947464
Sex: F
Age:
State: AZ

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/15/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Abdominal discomfort; Abdominal pain; Lightheaded/Dizzy; Having trouble taking deep breaths/couldn't breath; Sweating; Hyperventilating; Developed blotchy skin; Shaking; Headache; Vomited; A spontaneous report (United States) was received from a health care professional concerning a 50-year-old, female patient who received Moderna's COVID-19 vaccine and experienced abdominal discomfort, abdominal pain, lightheaded/dizzy, having trouble taking deep breaths/couldn't breathe, sweating, hyperventilating, developed blotchy skin, shaking, headache, and vomited. The patient's medical history included current conditions of mild osteopenia, gastroesophageal reflux disease, anemia, and allergic reaction (anaphylaxis) to metoclopramide. Concomitant products known to have been used by the patient, within two weeks prior to the event, included cefixime, ibuprofen, omeprazole, estradiol, and hydrocodone bitartrate, paracetamol. On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) in their left arm for prophylaxis of COVID-19 infection. On 22 Dec 2020, the patient told a medical assistant in the waiting area that she felt ill to her stomach and she was having trouble taking deep breaths. The patient was found in a nearby bathroom sitting on the floor. She had vomited, reported she was lightheaded, couldn't breath, was shaking, had abdominal discomfort, and was sweating. It was attempted to move the patient to a wheelchair, but she did not respond well to the transfer. The patient reported the symptoms worsening: headache, abdominal pain, and developed blotch skin, hyperventilating, and was dizzy. A code blue was called and the patient was given a 0.5mg Epinephrine injection. The patient was sent to the emergency room. Treatment for the event included 0.5mg Epinepherine injection, famotidine, ondansetron HCl, prednisone 60mg, and lorazepam 1mg intravenously. Action taken with mRNA-1273 in response to the events was not provided. The events abdominal discomfort, abdominal pain, lightheaded/dizzy, having trouble taking deep breaths/couldn't breathe, sweating, hyperventilating, developed blotchy skin, shaking, headache, and vomited were considered not resolved.; Reporter's Comments: This case concerns a 50 year old female patient with medical history of mild osteopenia, gastroesophageal reflux disease, anemia, and allergic reaction (anaphylaxis) to metoclopramide, who experienced events of Abdominal discomfort, Abdominal pain, Dizziness, Dyspnoea, Hyperhidrosis, Hyperventilation, Rash macular, Tremor, Headache, and Vomiting following their first of two planned doses of mRNA-1273 (Lot number: 011J20A). The patient was found ill in the waiting room after leaving clinic prior to completing 15 minute observation time. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.

Other Meds: FLEXERIL [CEFIXIME]; ADVIL 12 HOUR; PROTONIX [OMEPRAZOLE]; ESTRACE; VIVELLE DOT; NORCO

Current Illness:

ID: 0947465
Sex: U
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/15/2021
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: Incorrect product administered; A spontaneous report was received from a Moderna employee concerning a patient who received Regeneron's COVID-19 monoclonal antibody treatment instead of Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, product administration error. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received Regeneron's COVID-19 monoclonal antibody treatment intramuscularly instead of Moderna's COVID-19 vaccine (mRNA-1273). No treatment information was provided. There was no change planned to the dosing schedule of mRNA-1273 in response to the event. The patient would receive priority access to the first dose of mRNA-1273. The event, product administration error, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of Product administration error (incorrect product administered) for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Product administration error (incorrect product administered).

Other Meds:

Current Illness:

ID: 0947466
Sex: F
Age:
State: KY

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Like an anaphylactic reaction; Tested positive for Covid 19; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced the events, tested positive for COVID-19 and like an anaphylactic reaction. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the next day following vaccine administration, the patient began to experience increased pulse, acceleration in her heart beat, difficulty breathing, and other symptoms like an anaphylactic reaction. The patient also tested positive for COVID-19, although she was asymptomatic prior to receiving the mRNA-1273 vaccine. Treatment for the event included intramuscular Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The events, tested positive for COVID-19 and like an anaphylactic reaction, were unknown.; Reporter's Comments: This case concerns a female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of Anaphylactic reaction and the non-serious unlisted event of SARS-CoV-2 test positive. Very limited information regarding this event of anaphylactic reaction has been provided at this time. Based on improvement of symptoms after treatment with Benadryl and temporal association between the use of the product and the start date of the event on the day following vaccination, a causal relationship cannot be excluded making the event of anaphylactic reaction possibly related to the vaccine. Based on the latency of infection with SARS-CoV-2 prior to testing positive for the virus, the temporal association between the use of the product and the start date of the event tested positive for COVID-19 on the day following vaccination, the event is assessed as unlikely related to mRNA-1273.

Other Meds:

Current Illness:

ID: 0947467
Sex: F
Age: 56
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: Allergic reaction; Rash on the left side of face; A spontaneous report was received from a consumer, who was a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, allergic reaction and rash on the left side of face. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included hydroxychloroquine. On 02 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 02 Jan 2021, within a few minutes of vaccine administration, the patient developed an allergic reaction. She had a rash on the left side of her face that was still ongoing. Treatment for the event included 50mg diphenhydramine. Action taken with mRNA-1273 in response to the events was unknown. The patient inquired whether she should get the second dose or not, since she was scheduled for second dose on 30 Jan 2021. The outcome of the events, allergic reaction and rash on the left side of face, was considered not resolved.; Reporter's Comments: Company comment: This case concerns a 56-year-old female patient, who experienced unexpected events of allergic reaction and rash on the left side of her face. The event occurred on the same day within a few minutes after the administration of the first dose of the Moderna COVID-19 vaccine administered. De-challenge and re-challenge were not applicable. Based on the strong temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.

Other Meds: HYDROXYCHLOROQUINE

Current Illness:

ID: 0947469
Sex: F
Age:
State: OR

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Muscle pain, from lower back down.; I had no feeling at all below the waist; fatigue; Muscles would feel like they were seizing up and clenching throughout the night; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration in left arm on 07Jan2021 18:30 at a single dose for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included Von Willebrand's disease. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ibuprofen. On 07Jan2021 23:00, the patient experienced muscle pain, from lower back down, Muscles would feel like they were seizing up and clenching throughout the night, for a short time she had no feeling at all below the waist and incredible fatigue. The outcome of the events was not recovered. The patient was not tested for COVID-19 post vaccination. The events was assessed as non-serious by the nurse. The patient did not received any treatment for the events.

Other Meds:

Current Illness:

ID: 0947470
Sex: F
Age:
State:

Vax Date: 01/06/2021
Onset Date: 01/01/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Cold- sore throat; Cold- sore throat; Sick/ She is sick as a dog; This is a spontaneous report from a contactable consumer (patient). This female patient with unspecified age received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 06Jan2021 (age was unknown at the time of vaccine) as single dose, for immunization. Medical history included she is in between major surgeries (unspecified) and ongoing, and when she took the vaccine she was already coming down with a cold - sore throat. Concomitant medications were reported. On Jan2021 patient feels 'more sick/sick as a dog' following vaccination. She knew she probably shouldn't have taken the vaccine given she felt a cold coming on but she took it anyway. She believes it is only a cold as her husband came down with a cold as well and tested negative for Covid. She states she doesn't believe the vaccine has anything to do with her cold. She was asking if she took an 'antibx' (if prescribed by her hcp) would it interfere with vaccine at all. The outcome of events Cold was unknown, for sore throat was unknown, and for Sick/ She is sick as a dog was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Cold - sore throat worsened is not related to the vaccine use but represents the progression of the pre-existing medical condition.

Other Meds:

Current Illness:

ID: 0947471
Sex: M
Age:
State:

Vax Date: 12/23/2020
Onset Date:
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: mild headache/splitting headache; soreness; soreness/progressive muscle soreness in the posterior chain (shoulder, back, traps); soreness/progressive muscle soreness in the posterior chain (shoulder, back, traps); lack of energy; soreness/progressive muscle soreness in the posterior chain (shoulder, back, traps); This is a spontaneous report from a contactable other healthcare professional (patient). A male patient of an unspecified age (28, unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose of the Covid vaccine on 23Dec2020, initial symptoms include mild headache and soreness. In the next 5 days symptoms got worse, including progressive muscle soreness in the posterior chain (shoulder, back, traps), splitting headache, lack of energy. Got better in the following 5 days. Outcome of events was recovering. This report is considered as non-serious. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 0947472
Sex: F
Age:
State: NH

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: it hard to inject; some came out and squirted down her arm; some came out and squirted down her arm; he did not get the full 0.3mL dose; This is a spontaneous report from a contactable nurse (patient). A 74-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via Intramuscular on 05Jan2021 13:00 at single dose in the left arm for COVID-19 immunisation. Medical history included COPD and high cholesterol. Concomitant medications included Symbicort for COPD. Patient took COVID vaccine (Verbatim) since precaution as frontline healthcare worker. On Tuesday, she received the first dose of the Pfizer COVID Vaccine. The nurse who was injecting found it hard to inject, and at the end of the injection, it came back and squirted down her arm. It was a decent amount. She is unable to say if she got 0.1ml, 0.2ml, but she certainly did not get full 0.3ml. The hospital said they are just going to go ahead and give her the second dose, but she wanted to call and find out what would be the safest thing. Would it be best to receive another dose or go ahead with the second dose or get a third dose. She is due in 2 1/2 weeks to get second dose. She also has COPD and is a little more concerned than if she were 25 years old. There was no prescriber provided. When asked about other medications, she stated she has a list of medications, but did not think they were relevant. She was diagnosed with COPD last year and had a series of test. Reporter seriousness for "it came back and squirted down her arm" is medically significant. Outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available.

Other Meds: SYMBICORT

Current Illness:

ID: 0947473
Sex: F
Age:
State: NY

Vax Date: 01/02/2021
Onset Date: 01/03/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: fever; body aches; severe nausea; This is a spontaneous report from a contactable healthcare professional reporting for self. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Jan2021 at 12:00 PM (Dose 1) as a single dose in the left arm (age at vaccination: 45 years old) for COVID-19 immunization. There was no relevant medical history. She did not have COVID prior to vaccination. There were no allergies to medications, food, or other products. The patient's concomitant medications were not reported; there were no other medications taken in the 2 weeks prior. The patient received the COVID vaccine at 12:00 PM on 02Jan2021. Exactly 12 hours later, on 03Jan2021 at 12:00 AM, she began having a fever, body aches, and severe nausea. This had continued all week. The patient was COVID tested post-vaccination on 04Jan2021 via nasal swab with a negative result. "Yesterday" (as of 08Jan2021) she went to immediate care (physician office) and the doctor said that she had a bad reaction to the vaccine and shouldn't be having fevers every day and if they continue she may need to go to the emergency room. She was tested for other illnesses and everything was negative. Therapeutic measures were taken as a result of severe nausea and included ondansetron (ZOFRAN). The outcome of the events fever, body aches, and severe nausea was recovering. She reported the events as non-serious and confirmed there was no hospitalization. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0947475
Sex: F
Age:
State: TN

Vax Date: 12/30/2020
Onset Date: 01/01/2021
Rec V Date: 01/15/2021
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: almost like a thrush in her mouth, white tongue/ believes she had thrush; almost like a thrush in her mouth, white tongue; felt a little cold; legs were sore; headache; Sore arms; severe sore throats; back ache; low grade temp/Low grade fever; coughing; body aches/ whole body was achy; it was sore to swallow; lethargy; This is a spontaneous report from a contactable consumer reporting for self. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number: EL1284, Expiry Apr2021, intramuscularly on 30Dec2020 02:15 (Dose 1), right arm as a single dose (age at vaccination 64 years old) for COVID-19 immunization. Medical history included allergy (usually in the fall she has allergy problems). Her age is considered high risk, works in medical profession (Surgical Tech). Concomitant medication included levocetirizine (Walgreen's generic) 5mg, tablet, by mouth, at night for allergy. The patient had the first dose of the vaccine last 30Dec(2020) and after 2 days (on 01Jan2021) she developed symptoms: Sore arms, severe sore throats, back ache/ back was sore, temperature was up / low grade temp (never high), coughing, body aches. Her back and her legs were sore. Her whole body was achy. It was "like flu-ish kinda." She also had a headache. She started getting the sore throat and headache on 01Jan2021, and she felt a little cold on 02Jan2021. On 02Jan(2021), her first temperature was 100.5 degrees Fahrenheit. She states she had everything except for the GI issues. Around 02Jan(2021) or 03Jan(2021), her symptoms were progressively getting worse. She was told to get COVID tested. There were three exposures since Christmas Eve. So, she went and got a rapid COVID test (04Jan2021) and it came back negative. They also sent out a test that day. She was also tested for Strep (04Jan2021) too because her throat was so sore. It was almost like she had like thrush along with it. She states it was almost like a thrush because she had like a white tongue (onset 03Jan2021). Her throat was so sore, but it was a different kind of sore throat compared to a sore throat she has had before. She explains where the nasopharynx was at the top, it's almost like it was sore from there. It was sore to swallow, it was "a bizarre sore throat." She clarified she noticed the "thrushy" part of her throat around 03Jan2021. The strep test ended up being negative but she believes she had thrush because she was given medication and the medication was clearing that up. However, she still had the symptoms. Because her symptoms only started a few days before, they thought she should maybe wait a couple of days and if she is not feeling any better, she should be retested (for COVID). She went back again yesterday (07Jan2021). She had another Rapid COVID test and also a flu swab and both tests came back negative. She mentions they also did another COVID test (the send out type) and she should get that back around 1pm to find out the results of that. They also did a CBC (07Jan2021) and everything was normal. Her white count was at 7. She was waiting for the 3rd COVID test result today (08Jan2021). She reported that about three days afterwards, she didn't notice the soreness in /her arm. Her throat has improved. Her fever was down to 98 degrees Fahrenheit yesterday (07Jan2021). She states she was feeling better today (08Jan2021). She commented "the lethargy, though." She emptied the dishwasher yesterday (07Jan2021) and had to sit down after emptying it. She states her symptoms have her a little worried. She recovered from the sore arms in Jan2021. The patient was recovering from the severe sore throat, back ache, low grade temp, coughing, body aches/ whole body was achy, believes she had thrush, white tongue, legs were sore, headache, and felt a little cold. The outcome of the event lethargy was not recovered. She was wondering if this was a reaction to the vaccine.

Other Meds:

Current Illness:

ID: 0947476
Sex: F
Age:
State: AL

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: headaches; headache was not that bad, it was kind of a tension headache; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for Covid-19 immunization. The patient received her second dose of the Covid vaccine and was told not to take Tylenol. She was not told anything of what not to take on the first dose. She was currently having headaches and wanted to know what she can take since she was told not to take Tylenol. The patient informed that her headache was not that bad, it was kind of a tension headache. The patient did not think it was involved with the vaccine. Her headache was not that bad and she can live with it. The patient just wanted to know if it was not recommended to take Tylenol. The patient was advised to contact healthcare professional. The events was considered non-serious. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on the information provided, the possible contribution of suspect BNT162B2 to the events headache and tension headache cannot be totally excluded.

Other Meds:

Current Illness:

ID: 0947477
Sex: F
Age:
State:

Vax Date: 12/23/2020
Onset Date: 12/31/2020
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose on 23Dec2020 and was subsequently exposed at work to the virus and became symptomatic and tested positive on 31Dec2020. Her next scheduled dose is on Sunday, they may have to reschedule. The patient queried on how long should they delay the next dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Dec2020. The outcome of the events was unknown. Information about Lot/Batch number is requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of suspected Covid-19 infection and suspected LOE 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: 0947478
Sex: M
Age:
State: CT

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
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: intense headache; achiness; fever; This is a spontaneous report from a contactable consumer. A 33-year-old male patient started to receive bnt162b2, via an unspecified route of administration in the right arm from 06Jan2021 13:00 at a SINGLE DOSE for covid-19 immunization. Patient has no relevant medical history. Historical vaccine included bnt162b2 on16Dec2020 for covid-19 immunization (1st dose). The patient's concomitant medications were not reported. About 12 hours after 2nd dose on 07Jan2021, intense headache, achiness, and fever which lasted acutely for another 24 hours, and continues to persist moderately. Resulted in needing to take day off of work. The outcome of events was recovering. No treatment received due to events. Information about Lot/batch number is requested.

Other Meds:

Current Illness:

ID: 0947479
Sex: F
Age:
State: OH

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Ringing in ears; Nausea; Heart palpitations; heart rate elevated to 163; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the right arm on 07Jan2021 12:30 at single dose for COVID-19 immunisation. Medical history included asthma. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT), levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR), and paracetamol (TYLENOL). The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported) in the left arm on 17Dec2020 at 12:30 at single dose for COVID-19 immunisation. The patient previously took amoxicillin and experienced allergies. On 07Jan2021 16:45, the patient experienced ringing in ears, nausea, heart palpitations, and heart rate elevated to 163. Clinical outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: SYMBICORT; SYNTHROID; SINGULAIR; TYLENOL

Current Illness:

ID: 0947480
Sex: F
Age:
State: NC

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: fainting spell; almost passed out; dizzy spells; weak; This is a spontaneous report from a contactable consumer (patient herself). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), via an unspecified route of administration on 07Jan2021 in right upper arm shoulder area at single dose for prevent covid. Medical history included ongoing acne. Concomitant medication included doxycycline from 2020 (taking it 6 months ago) and ongoing for acne. Patient stated that she got the Covid vaccine yesterday 07Jan2021 and almost passed out in her kitchen after a couple hours. Patient stated got in shower had dizzy spells and was weak 07Jan2021, she felt better now. Patient stated that she was a small girl of 105 pounds and the dose could have made her sick. She wanted to make sure she did not need to go and be seen. Patent had another spell in shower this morning and stated that the fainting spell and feeling weak started at 9:00 yesterday evening on 07Jan2021. Outcome of dizzy spells was recovering, and outcome of other events were unknown.

Other Meds:

Current Illness: Acne

ID: 0947481
Sex: F
Age:
State: CA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Body chills; fever that went up to 100.4 degrees F.; fatigue; excess mucus; bone pain 10/10; muscle pain 8/10; other vaccine same date vaccine date 05Jan2021; This is a spontaneous report from a contactable other health professional (patient). A 66-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included DM type 2, hypertension (HTN), fibromyalgia, chronic asthma, Covid prior vaccination, No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other vaccine same date included other vaccine same date product was Pfizer, other vaccine same date vaccine date 05Jan2021. On 06Jan2021, the patient experienced Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. No treatment received for the adverse events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. The events were non-serious per the reporter. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus was recovering. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bone and muscle pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. 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: 0947482
Sex: M
Age:
State: PA

Vax Date: 01/06/2021
Onset Date: 01/01/2021
Rec V Date: 01/15/2021
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: didn't have any energy /doing nothing/could not work; didn't have appetite; did not feel well; soreness in left shoulder from injection site; Dizzy; Fever/temperature was 100.8; severe muscle aches; pain all over his body/Feels like a sunburn all over back; pain all over his body/Feels like a sunburn all over back; lost his balance twice; severe headache/Headache came back worse and couldn't open eyes; burning in his back and skin; burning in his back and skin; felt like his body was getting warm and had heat over his eye; felt like his body was getting warm and had heat over his eye; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at site of left deltoid (anatomical location: reported as left shoulder) at 10:30 on 06Jan2021 at single dose for COVID-19 immunization. Medical history included COVID symptoms from 12Mar2020 and COVID tested positive by swab from 24Mar2020. There were no concomitant medications. Clinical course: patient was fine on the 06Jan2021, when he got the vaccine. He did not feel well on 07Jan2021, He had soreness in left shoulder from injection site. In the morning, when he woke up, he felt dizzy and had severe muscle aches and pain all over his body, felt like a sunburn all over his back. His skin and arm were very sore. He took a shower and lost his balance twice in the shower because he was dizzy. He was able to make it to work. At work, he started having a headache. It started to get worse. The burning in his back and skin got worse. He took some paracetamol (TYLENOL) in the morning and the headache started to go down. It came back again worse, so he took paracetamol again. He took two tablets of 500mg paracetamol and he tried to go rest on his break. He took a nap on his break for 15 minutes. When he got up from his nap, he found his achiness was much better. The burning was still there. It was getting less but still there. The headache was less when he woke up from the nap. Headache came back worse and he couldn't open eyes. He took paracetamol. He took two 500mg tablets again. He didn't have any energy sitting at his desk doing nothing. He was not able to look at his computer because of the headache. He could not work on 08Jan2021. He left work and got home and was having headache on the ride home. When he got home, he didn't have appetite. He ate a banana and an orange. He felt like his body was getting warm and had heat over his eye. His temp was 100.8. last night on 07Jan2021. Headache started on 07Jan2021 and he continued to have headache. Fever was coming down, but he was still warm today. He didn't feel that like a sunburn all over his back today. Severe muscle aches and pain all over his body were still there, but less than 07Jan2021. He took ibuprofen (ADVIL) last night on 07Jan2021 and another dose of paracetamol this morning on 08Jan2021. He saw the medical team at the nursing home where he works which were nurses and doctors. They suggested he go home and rest. It was mentioned that patient developed COVID symptoms on 12Mar2020 and tested positive for COVID by swab on 24Mar2020. Could he take the second dose? He didn't know if it is an allergic reaction. He thought that burning over the skin is an allergic reaction. He knew they didn't know a lot about the vaccine. He didn't think he should take the second dose because it would make him miss more work and he already missed work today. Is the second dose recommended if it is an allergic reaction such as burning over the skin? Will Pfizer reimburse him for missing work? Vaccination Facility Type in nursing Home. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No adverse events required a visit to Emergency Room or Physician Office. No prior vaccinations within 4 weeks. No adverse events following prior vaccinations. The outcome of event did not feel well, soreness in left shoulder from injection site, Dizzy, lost his balance twice, didn't have any energy /doing nothing/could not work, didn't have appetite and felt like his body was getting warm and had heat over his eye was unknown; of event headache was not recovered; while of other events was recovering. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0947483
Sex: M
Age:
State: TX

Vax Date: 01/04/2021
Onset Date:
Rec V Date: 01/15/2021
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: done in his left arm, and it was a little sore; slight headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date were not reported) via an unspecified route of administration on the left arm on 04Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: dust, pollen, grass, and trees. The patient's concomitant medications were not reported. He received first shot on 04Jan2021, 5 days ago. He has had no bad reactions. He was happy to report. He then stated it was done in his left arm, and it was a little sore. He also had a slight headache that first evening which was unusual for him. So far so good. He was due for his regular allergy shot which he generally gets every 2-3 weeks for dust, pollen, grass, and trees. He lived in (City) and has pretty good allergies. It is said on the allergy shot not to have a flu shot within 72 hours of getting the allergy shot, so he was just wondering if it will be safe for him to have the allergy shot within approximately 120 hours of receiving the Pfizer COVID vaccine. "Is it safe or advisable to have his allergy shot done today when it has only been 5 days since getting the COVID vaccine? Is he putting himself at any kind of risk?" He did not have the name of the allergy shot to provide. He said it is just an injection of a little bit of the allergen. He is not a health provider. He was on the early receiving end of the vaccine because he was a hospital volunteer and works in PACU. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0947484
Sex: F
Age:
State: PA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Joint pain; Low grade fever; Nausea; Redness at injection site; Pain at injection site; Warmth at injection site; Mild swelling in distal hand of injection; Moldy swollen axillary lymph nodes; received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021; received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021; This is a spontaneous report from a contactable Nurse(patient). A 35-year-old female patient received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021 16:00 at the 35 years old at single dose for COVID-19 immunization. The medical history included PCOS, depression. The patient was not Allergies to medications, food, or other products. The concomitant medications were bupropion and venlafaxine. The patient previously took first dose BNT162B2 (lot number EK5730) on 21Dec2020 at 35 years old at Left arm for COVID-19 immunization. On 08Jan2021 08:00 the patient experienced Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes. There was no treatment received for the adverse events Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes was not recovered. The information on the batch number has been requested.

Other Meds: ;

Current Illness:

ID: 0947485
Sex: M
Age:
State: AR

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/15/2021
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: Chills; aches; lethargy; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL0142 ), intramuscular in the left arm on 07Jan2021 18:15 at a single dose for covid-19 immunization. The patient had no medical history included. Patient has no allergies to medications, food, or other products. There were no concomitant medications. On 08Jan2021, the patient experienced chills, aches and lethargy. The outcome of the events was recovering on 08Jan2021 at 11:00. The patient was vaccinated in a hospital. Patient has no other medications received within 2 weeks of vaccination. Patient has not been diagnosed with COVID-19 prior to vaccination and has not been been tested for COVID-19 since vaccination.

Other Meds:

Current Illness:

ID: 0947487
Sex: M
Age:
State:

Vax Date: 12/19/2020
Onset Date:
Rec V Date: 01/15/2021
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: cough; headache; feel cold; fever; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller said he should get the second dose tomorrow 09Jan2021, asked if the date was correct. Caller said he received the 1st dose on 19Dec2020.At the end of the call he mentioned he "had symptoms", had a "headache, feel cold and fever". Caller confirmed he no longer had these side effects "but have cough". The outcome of the event cough was not recovered on an unspecified date. The outcome of the other events was recovered on an unspecified date. No follow-up attempts are possible; information about batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0947488
Sex: F
Age:
State: NJ

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizziness; fast heartbeat; tiredness; Had a hard time swallowing at night from the dryness; bitter taste; her mouth went completely dry; patient received 0.45 mL, single dose (225mcg) of PFIZER-BIONTECH COVID-19 VACCINE; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 23Dec2020 15:00 at 0.45 mL, single dose (225mcg) at left arm to prevent COVID. Medical history included a bout of dry mouth about 7 years ago, no other relevant medical history (including any illness at time of vaccination). The patient's concomitant medications were not reported. There's no adverse events following prior vaccinations. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. From the time she got the vaccine her mouth went completely dry on 23Dec2020 and she kept thinking it would go away and she still had it. Event was reported as serious per medically significant. Had a hard time swallowing at night from the dryness. Patient had the bitter taste was also on 23Dec2020, but it went away. It lasted about 5-6 hours. Then after that the dry mouth started right after. It is tolerable but she still had it. Mentioned she had a bout of dry mouth about 7 years ago and it did go away, but she never got a diagnosis for it. Patient thought that something underlying may have triggered it again. Patient also experienced burning of the tongue, tiredness, headaches, pressure in the chest area similar to difficulty in breathing, nausea, dizziness, and a fast heartbeat on unspecified date. Outcome of event dry mouth was not recovered, outcome of event bitter taste was recovered on unspecified date in Dec2020, outcome of other events was unknown. No family medical history relevant to adverse events. No relevant tests. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Relatedness of Pfizer BioNTech Covid-19 vaccine with dry mouth and bitter taste per primary source reporter with method of assessment of global Introspection was related. Reporter seriousness for event bitter taste was not serious.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of dry mouth 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: 0947489
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/15/2021
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: During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage; During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage; This is a spontaneous report from a non-contactable healthcare professional. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), 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. The patient received her first dose of bnt162b2 on an unknown date at a single dose for covid-19 immunization. On an unknown date, during her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage. The he denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient received antihistamines as treatment for the event until stable to go home and follow up with. The outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0947490
Sex: F
Age:
State: NY

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

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

Symptoms: Large erythematous area over site of injection 7cm x 5cm; Large erythematous area over site of injection 7cm x 5cm, blanching; Large erythematous area over site of injection 7cm x 5cm, Pruritic; Large erythematous area over site of injection 7cm x 5cm, Tenderness (mild)/Area painful for first 24 hours after injection; Large erythematous area over site of injection 7cm x 5cm, Induration (mild); Generalized fatigue; Joint pain; Slight increased temperature 99.3F for about 12 hours; This is a spontaneous report from a contactable physician (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via intramuscular on 05Jan2021 08:45 at single dose in left arm for covid-19 immunisation. Medical history included asthma, diabetes. Concomitant medication included metformin, rosuvastatin, empagliflozin (JARDIANCE), omeprazole, vitamin c (ascorbic acid), ergocalciferol (VITAMIN D), paracetamol (TYLENOL), ibuprofen (MOTRIN), naproxen (NAPROSYN) and Multivitamin. The patient had known allergies to sulfamethoxazole, trimethoprim (BACTRIM) and experienced rash; raltegravir potassium (ISENTRESS) and experienced rash; emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and experienced rash. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular on 15Dec2020 13:30 at single dose in right arm for covid-19 immunisation. It was reported that on 07Jan2021 the patient experienced large erythematous area over site of injection 7cm x 5cm, blanching, pruritic, + tenderness (mild), + induration (mild). Area painful for first 24 hours after injection, that has gotten better, area of erythema is slowly getting larger, pruritus started 1 day ago and is slightly worsening (also starting to have slight generalized pruritus). After injection on 05Jan2021, the next morning (on 06Jan2021) had slight increased temperature 99.3F for about 12 hours with generalized fatigue and joint pain for about 24 hours on 07Jan2021. The area in question started to get red and indurated after that time period. The fatigue and joint pain have resolved completely. The patient received treatment for events included topical 1% hydrocortisone ointment, diphenhydramine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had been tested for COVID-19, included nasal swab and SARS-COV-2 RNA PCR on 22Dec2020 with negative result. The outcome of the events area painful for first 24 hours after injection was recovering, the outcome of the events fatigue and joint pain were recovered on 08Jan2021, the outcome of the event slight increased temperature 99.3F was unknown, the outcome of the rest events was not recovered.

Other Meds: ; ; JARDIANCE; ; VITAMIN C [ASCORBIC ACID]; VITAMIN D [ERGOCALCIFEROL]; TYLENOL; MOTRIN [IBUPROFEN]; NAPROSYN [NAPROXEN]

Current Illness:

ID: 0947491
Sex: F
Age:
State:

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/15/2021
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: Severe dizziness; almost blacked out; Nausea; Elevated heart rate.; This is a spontaneous report from a non-contactable health care professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: EK5730), via an unspecified route of administration on 08Jan2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took penicillin and experienced allergies. The patient was vaccinated in a hospital. The patient was not administered any other vaccine in four weeks and had no other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. It was reported that the patient experienced severe dizziness, almost blacked out, nausea and elevated heart rate on 08Jan2021 at 4:00 PM. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The events were reported to be non-serious.

Other Meds:

Current Illness:

ID: 0947492
Sex: F
Age:
State:

Vax Date: 12/18/2020
Onset Date: 01/01/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: she just just found out that 7 days ago she was exposed to covid; headache; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 18Dec202, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient is scheduled to receive the 2nd dose but she just found out that on 01Jan2021, 7 days ago, she was exposed to COVID, now she wanted to know if she could go along to get the vaccine or have her tested first. She does not recall any symptoms aside from headache on an unspecified date. Outcome of the events was unknown. Information about lot/batch has been requested

Other Meds:

Current Illness:

ID: 0947493
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: throat tightness; This is a spontaneous report from a non-contactable other healthcare professional (HCP). An 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on Jan2021 at a single dose in the left deltoid muscle for COVID 19 vaccination. Medical history and concomitant medications were not reported. The patient denied any history of previous adverse reactions to vaccines and denied reaction to her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID 19 vaccination on an unspecified date. The patient was seen at a COVID vaccine clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience throat tightness on Jan2021. Treatment included: Benadryl 25mg po (orally) and Solumedrol 125mg IM. The event did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch has been obtained. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of throat tightness cannot be excluded, considering the plausible temporal relationship. Sever allergic reaction is the known risk for the product. 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: 0947494
Sex: F
Age:
State: FL

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed; chest pain; chest pain, going into her back, on her left side; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, NDC number: 5926710001), intramuscular on 07Jan2021 (around 10ish in the morning) at single dose at right arm for covid-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. At the beginning of the week, patient had some vertigo but when she went in for her second vaccine, the vertigo was gone already. There were no concomitant medications. There was no adverse event following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC: 59267100002 Lot: EH9899) intramuscular on 17Dec2020 at single dose at right arm for covid-19 immunization. Patient received the second dose of the vaccine in the morning, around 10 something on 07Jan2021 at the hospital she worked at. She started feeling badly around 7:00 at night 07Jan2021 with chills, 101.6 fever, terrible muscle aches, a headache. Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed. She was having chest pain, going into her back, on her left side. When probed for the outcome of these symptoms, patient stated she had a fever, but not quite as high. She had been taking paracetamol (TYLENOL) and it was not helping. Patient provided the following product information for the paracetamol she was taking: TYLENOL, 500mg NDC: 6984270778 Lot: 9MR0454 Expiry date: Oct2021. The back pain/muscle pain was still there. She had chills but not as badly. The soreness in her arm had improved. Her arm was still sore, but not like it was yesterday. Outcome of events feeling badly, headache and chest pain was unknown, outcome of events chills, fever/ 101.6 fever, arm was so sore she couldn't even move it was recovering, outcome of events back pain/muscle pain was not recovered. The report is considered as non-serious. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. History of all previous immunization with the Pfizer vaccine considered as suspect. No further information was provided or obtained.

Other Meds:

Current Illness:

ID: 0947495
Sex: F
Age:
State: WI

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1686) via an unspecified route of administration on 06Jan2021 11:00 AM at a single dose in the left arm for Covid vaccine. Medical history included GERD. Concomitant medication included omeprazole (received within 2 weeks of vaccination). The patient had known allergies to erythromycin and hydrocodone bitartrate/paracetamol (VICODIN). The patient was not pregnant at the time of vaccination. She was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She did not receive other vaccines within four weeks prior to the COVID vaccine. On 06Jan2021 16:00 (04:00 PM), the patient experienced extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours), it started 5 hours after injection and lasted 48 hours. Treatment was not received for the events. The events were non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 since the vaccination (post vaccination). The outcome of the events was recovered on 08Jan2021 16:00.

Other Meds:

Current Illness:

ID: 0947496
Sex: F
Age:
State: NM

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Itching/redness at injection site; Itching/redness at injection site; Itching/redness up neck; Itching/redness up neck; This is spontaneous report from a contactable pharmacist. A 39-year-old female patient (unknown if pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the Left arm on 06Jan2021 at 08:15 PM (at the age of 39-years-old) as a single dose for COVID-19 immunization, lot number: EL0142. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included anxiety and depression, coronary artery spasm, hyperlipidemia. Known allergies included latex allergy (anaphylaxis). Concomitant medications in two weeks prior to the vaccination included atorvastatin 20mg, isosorbide mononitrate 60mg extended release (ER), multivitamin, omperazole 20mg, sertraline 50mg and tizanidine 2mg for muscle spasm. On 06Jan2021 h 08:15 PM patient experienced Itching/redness at injection site and up neck. Oral (PO) diphenhydramine hydrochloride (BENADRYL) 50mg was given to treat the events. Rapid Response called and observed for 30 min. Discharged to husband's care. It was unknown if, since the vaccination, patient has been tested for COVID-19. Outcome of the events was unknown.

Other Meds: ; ; ; ;

Current Illness:

ID: 0947498
Sex: F
Age:
State:

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 01/15/2021
Hospital:

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Lab Data:

Allergies:

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

Symptoms: sharp spams on the right side on the bottom/back of my head; some puffiness and swelling under my eye; some puffiness and swelling under my eye; swelling and pain in my arm; swelling and pain in my arm; sharp pain; This is a spontaneous report from a contactable Other Health Professional (patient) reported that a (44 unknown unit) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included had fillers or Botox under eyes as it was injected with that 5 months before Jan2021. The concomitant medications were not reported. Patient experienced normal side effects like swelling and pain in arm, but (about 2 days before 08Jan2021) on 06Jan2021 she experienced some puffiness and swelling under eye. This Saturday (09Jan2021) patient started experiencing sharp spams on the right side on the bottom/back of my head. Persistent for 3 days. The sharp pain lasts for a few seconds then goes away and then randomly comes again. Patient was experiencing symptoms and wanted to see if others have been reporting this as well. The outcome of events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am