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

Incidents per State

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

ID: 1034618
Sex: F
Age: 49
State:

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies: clindamycin, vicodin

Symptom List: Dysphagia, Epiglottitis

Symptoms: SECOND DOSE. Side effects stared about 16 hours after the vaccine. Started with slight soreness in left arm. This remained a slight discomfort. Body tingling sensation turned into body aches. Most were in the lower back and shoulders. Random shooting pains in thigh muscles. First temperature check at 8:00 am was 101.1 it increased throughout the day, peaking at 102.6. I took 500 mg of Extra Strength Tylenol at 3:30 pm . The fever dropped to 100.1 by 6:30 pm. I took another 500 mg. At 11:00 pm, the fever was up slightly to 101.6. By 7:30 the next morning, the fever was down to 99.8. It was gone a few hours later. Headache associated with fever, but not severe. NO fatigue, so I could not sleep off the fever. I was wide awake and miserable. Felt fine by 8:00 am, so side bad side effects lasted approximately 24 hours. By approximately 40 hours after the vaccine, I felt fine. Very minimal soreness in arm remaining.

Other Meds: lisinopril

Current Illness:

ID: 1034619
Sex: F
Age: 20
State: TN

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies: Sulfa drugs Gluten free and dairy free Hair care chemicals

Symptom List: Anxiety, Dyspnoea

Symptoms: Red rash at injection site for now almost two weeks.

Other Meds: Remicade 10 mg infusion. Steroid 65 mg infusion Omeprazole Vitamin D Vitamin c Iron tab Boost

Current Illness: Autism Pancolitis/IBD

ID: 1034620
Sex: M
Age: 31
State: MA

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

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

Lab Data:

Allergies: None

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

Symptoms: Unable to lift arm. Severe chills, virus dreams, dry mouth despite being well hydrated, unusual night time hunger, unusual insomnia. All symptoms currently happening at 0345 hours. Not going to the doctor as this does not seem life threatening at this time.

Other Meds: Fish oil, Glucosamine

Current Illness: None

ID: 1034621
Sex: M
Age: 35
State:

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Pain at injection site, tenderness, swelling, fatigue, muscle pain

Other Meds:

Current Illness:

ID: 1034622
Sex: M
Age: 39
State:

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies: Shellfish

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

Symptoms: Tenderness/ Pain on site of the injection for over 48 hours. Feeling un-well for 24 hours. Stomach ache, muscle aches, weakness, fatigue.

Other Meds: Vitamins B-12/C / D Magnesium

Current Illness: none

ID: 1034623
Sex: F
Age: 43
State: CA

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies: Sulfites; sulfates; penicillin; amoxicillin; sulfa drugs; pomegranate; avocado; bananas; latex; tetracycline; biaxin; aspirin; ibuprofen; red dye 40

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

Symptoms: Violent side efdects after injection: 103 degree fever, vomiting, diarrhea, headache, dizziness, low blood pressure, weakness, chills, muscle pain, joint pain, nausea, fatigue.

Other Meds: Levothyroxine; atenolol; iron; vitamin D3; vitamin C; metformin; berberine; vitamin B12; selenium; folic acid

Current Illness: None

ID: 1034624
Sex: M
Age: 80
State:

Vax Date: 02/13/2021
Onset Date: 02/14/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies: Iodine contraxt

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Fever, chills and fatigue that lasted about 24 hours

Other Meds: balanced vitamins

Current Illness:

ID: 1034979
Sex: F
Age: 75
State: TX

Vax Date: 01/11/2021
Onset Date: 01/15/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Chest started getting tight; Coughing; Fever; Pneumonia; Positive for covid; A spontaneous report was received from Healthcare Professional concerning a 75-year-old, female patient who received Moderna's COVID-19 vaccine and experienced fever/ pyrexia, cough, tested positive for covid/ COVID-19, pneumonia, and chest started getting tight/ chest discomfort. The patient's medical history was not provided. Concomitant product use was not provided. On 11 Jan 2021 prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an undisclosed date, the patient experienced fever and cough. Her chest started getting tight when doing breathing exercises at home. On 15 Jan 2021, the patient tested positive for COVID-19. On 18 Jan 2021, the patient also tested positive for pneumonia. The treatment included bamlanivimib. The action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, fever, cough, chest started getting tight, tested positive for covid, and tested positive for pneumonia, was unknown.; Reporter's Comments: Although a temporal association exist, based on the known etiology for COVID-19, a causal association between the product use and events of cough, COVID-19, pneumonia and chest discomfort is considered unlikely. The patient most likely had pre-existing COVID infection and the other events are complications from the disease. Fever is consistent with the safety profile of the product and a causal association cannot be excluded.

Other Meds:

Current Illness:

ID: 1034980
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Hallucinations; A spontaneous report was received from a consumer concerning 72-year-old male. The patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hallucinations, seeing ghost. The patient's medical history was not provided. Concomitant product use was not provided. Prior to the onset of symptoms, on an known date, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided), for prophylaxis of Covid-19 infection. On 01 Feb 2021 the patient left a voicemail message to Safety stating that he began having, "what I guess you would call hallucinations" after receiving his first dose of Covid -19 vaccination. He further stated, " I've seen ghosts". "I've never seen ghosts in my life before". The patient then went on to ponder whether the event was vaccine related or possibly related to the fact that he experienced a problem in his eye some years ago that caused him to "see weird things". No treatment or other relevant information was provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event hallucinations was unknown at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1034981
Sex: U
Age:
State: PR

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Administered with 0.3 ml of the vaccine.; A spontaneous report was received from a pharmacist concerning sixty-seven patients who received Moderna's COVID-19 vaccine (mRNA-1273) and were administered with 0.3 ml of the vaccine. The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, prior to the onset of the event, the patients received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. While administering the vaccine, the reporter stated that the patients received less than the 0.5 ml dose of the Moderna COVID-19 vaccine. The reporter also mentioned that the syringe was set to 0.3 ml instead of 0.5 ml. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not provided. The event, administered with 0.3 ml of the vaccine, was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of Underdose for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 1034982
Sex: F
Age: 33
State: MA

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Possibly Mastitis; Breast was hard, red, and sore; Milk production dropped; Clogged duct; Flu like symptoms; Received vaccine while breastfeeding; A spontaneous report was received from a consumer who was also a 33-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced received vaccine while breastfeeding (maternal exposure during breast feeding), clogged duct (galactostasis), possible mastitis (mastitis), flu like symptoms (influenza like illness), milk production dropped (suppressed lactation), and breast was hard, red, and sore (breast tenderness). The patient's medical history included eczema. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins. The patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) on 31 Dec 2020. On 28 Jan 2021, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (batch number 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received the vaccine while breastfeeding and reported having a clogged duct and possible mastitis. She began to experience flu like symptoms on 29 Jan 2021. She had a fever and missed pumping breast milk. On 30 Jan 2021 her milk production was about half of the typical amount. The flu like symptoms resolved on 31 Jan 2021. On 01 Feb 2021 her breast became hard, red, and sore. On 02 Feb 2021 her breast symptoms resolved; however, her milk production was 65-70% of normal. She treated the events with acetaminophen and magnesium sulfate dissolved in water. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the events clogged duct, possible mastitis, milk production dropped, and were not reported. The outcome of the event, received vaccine while breastfeeding, was considered resolved on 28 Jan 2021. The outcome of the event, flu like symptoms, was considered resolved on 31 Jan 2021. The outcome of the event, breast was hard, red, and sore, was considered resolved on 02 Feb 2021.; Reporter's Comments: 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.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1034983
Sex: M
Age:
State: MO

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: high temperature of 99.1 F; Patient is under 18 years of age; A spontaneous report was received from a consumer concerning a 15-year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced temperature of 99.1 degree Fahrenheit. The patient is handicapped, and his medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2021, patient's mother called and informed that her son was administered Moderna covid-19 vaccine 1st dose on 05 Jan 2021 and 2nd dose on 02 Feb 2021. The patient experienced high temperature of 99.1degree Fahrenheit on 03 Feb 2021. Patient was given Tylenol to treat symptoms. Action taken with Moderna Covid-19 vaccine was not applicable as patient already received both doses of vaccine. The outcome of the events temperature of 99.1 degree Fahrenheit was reported as unknown and inappropriate age at vaccination was consider as resolved.; Reporter's Comments: This case concerns a 15 year old male who received 1st dose on 05 Jan 2021 and 2nd dose on 02 Feb 2021 of the Moderna Covid-10 vaccine and experienced the non-serious listed event of fever on 03Feb2021 one day later. There were no other reported adverse events in this case of product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 1034984
Sex: F
Age:
State: CA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 17 years old and 11 months and was given the 1st dose of Moderna COVID vaccine; A spontaneous report was received from a nurse concerning a 17 year old, female patient who was administered a COVID vaccine at an inappropriate age. She was given the 1st dose of Moderna COVID vaccine. She came to the vaccine site for her 2nd dose, and they administers need some guidance regarding it. She might have gotten her first dose on 07 Jan 2021. The patient's medical history was not provided. On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) possibly intramuscularly for prophylaxis of COVID-19 infection. Treatment information was unknown. Action taken with mRNA-1273 in response to the event was unknown. The outcome of event vaccine at an inappropriate age was considered as resolved on 07 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

Date Died:

ID: 1034985
Sex: U
Age:
State: KY

Vax Date: 01/04/2021
Onset Date:
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 4 Nurshing home patients Died; A Spontaneous report was received from a pharmacist concerning 4 nursing home patients of unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and died. The patients' medical histories were not provided. No relevant concomitant medications were reported. On unspecified dates, 4 nursing home patients received their first of two planned doses of mRNA-1273 (Lot # 039K20A) for prophylaxis of COVID-19 infection. A pharmacist reported that they just learned 4 nursing home patients died after the first dose of the Modern vaccine. The patients were buried, and no autopsies were conducted. The pharmacist suspected latent Covid-19 on the patients and that the vaccine precipitated this outcome. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not applicable. The event 4 nursing home patients died was fatal.; Reporter's Comments: This case concerns 4 nursing home patients of unspecified age and gender who received their first dose of Moderna's COVID-19 vaccine (mRNA-1273)Lot # 039K20A) and died. Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: died

Other Meds:

Current Illness:

ID: 1034986
Sex: M
Age: 71
State: IL

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Ringing in left ear; Hearing loss in right ear; Ear ringing in right ear; Mild soreness at the site of injection; A spontaneous report was received from a consumer, a 71 year-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hearing loss in right ear/deafness unilateral, ear ringing in right ear/tinnitus, ringing in left ear/tinnitus, and mild soreness at the site of injection/injection site pain. The patient's medical history included a kidney transplant. Concomitant product use was not provided. On 19 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: 029L20A) in the left arm for COVID-19 infection prophylaxis. The patient had some mild soreness at the site of the injection which lasted one to two days. On 21 Jan 2021, he experienced some ear ringing in his right ear which was followed by hearing loss that lasted six hours. Both the ear ringing and hearing loss resolved by the next morning. On 24 Jan 2021, the patient had ringing in his left ear, but it was not associated with hearing loss. The patient stated he thinks the tromethamine hydrochloride in the vaccine may have induced his hearing loss. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events, hearing loss in right ear and ear ringing in right ear, were considered resolved on 22 Jan 2021. The event, mild soreness at the site of injection, was considered resolved on an unknown date Jan 2021. The outcome for the event, ringing in left ear, was unknown.; Reporter's Comments: This case concerns a 71- year old male patient who experienced hearing loss in right ear/deafness unilateral, ear ringing in right ear/tinnitus, ringing in left ear/tinnitus, and mild soreness at the site of injection/injection site pain, all within 4 days after administration of Moderna's COVID-19 Vaccine (mRNA-1273). 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.

Other Meds:

Current Illness:

ID: 1034987
Sex: F
Age:
State: IL

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Diverticulitis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age 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 15Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient took her first dose on 15Jan2021 and is scheduled for 05Feb2021. After the first shot, she got sick with diverticulitis and was put on antibiotics. The round of antibiotics will be done 02Feb2021 and on 03Feb2021 she will go through another test. She wanted to know if it is ok to get the second shot after finishing with the antibiotics. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1034988
Sex: F
Age:
State: LA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she hasn't been eating like she should; lost eye sight for 5 minutes, everything was grey; could hear her niece, but that her niece sounded far away; very nauseated/wanted to throw up but couldn't; This is a spontaneous report from a contactable consumer, reporting for herself. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 29Jan2021 14:00 at a single dose to prevent getting COVID-19. Medical history included cholesterol, high blood pressure, arthritis, medications for her heart, and medication for her stomach. Concomitant medication included amlodipine for high blood pressure and atorvastatin for cholesterol. The patient has been on amlodipine in a good while, 7-8 years and atorvastatin for 5 years. The patient had the COVID shot on Friday, 29Jan2021 at 14:00, and about 4 hours afterward, she had a bad experience. She became very nauseated and lost her sight for 5 minutes. Everything was grey. She was wondering if there is anything she can take afterward. She was scheduled for her next one on 19Feb2021. She was wondering if she will experience the same thing. She has lost about 11 pounds because she has been on a diet. She gave up sugar. After getting the vaccine, she was on her way back. She began to feel very nauseated in the car. Then, all the sudden she wanted to throw up, but couldn't. She couldn't hear her niece or say anything to her. She clarified she could hear her niece, but that her niece sounded far away. She couldn't respond. She rolled the window down to get air in her face. She hadn't eaten. In about 25-30 minutes got better. Since then, she hasn't been eating like she should, so she was still a little nauseated. It has improved though. She got the vaccine in her left arm. Her right arm is mostly metal. She decided to get it because she is over 70 and wanted to prevent getting COVID-19. It was also reported that she was also on an arthritis medication, medications for her heart and a medication for her stomach. She has had no problems with those medications though. The patient underwent lab tests and procedures which included weight: lost on an unspecified date. She has lost about 11 pounds because she has been on a diet. She gave up sugar. The outcome of the events "lost eye sight for 5 minutes, everything was grey", "could hear her niece, but that her niece sounded far away" and "very nauseated/wanted to throw up but couldn't" was recovered on 29Jan2021 while the outcome of all other events was unknown.

Other Meds: AMLODIPINE; ATORVASTATIN

Current Illness:

ID: 1034989
Sex: M
Age:
State: NY

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Bells Palsy - Left sided; This is a spontaneous report from a contactable physician. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9263) intramuscular in left arm on 23Jan2021 at single dose for COVID-19 immunization. Medical history included DMII (Type II diabetes mellitus), Parkinson's disease, and CAD (coronary artery disease). Concomitant medications were not reported. The patient previously took metformin and experienced allergy. Prior to vaccination, patient was not diagnosed with COVID-19; and since vaccination, patient has not been tested. Facility where the most recent COVID-19 vaccine was administered: Other (Public Health Department). On 24Jan2021, the patient experienced Bells Palsy - Left sided. The event required physician office visit (Doctor or other healthcare professional office/clinic visit). No treatment was received for the event. Outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1034990
Sex: M
Age:
State: CA

Vax Date: 01/30/2021
Onset Date: 01/31/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: ER to bring down temperature and blood pressure; ER to bring down temperature and blood pressure; Stomach cramps; nausea; sever body shakes( uncontrollable); This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunization. Medical history included A-fib. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS), metoprolol, rosuvastatin, furosemide sodium (LASIX) and spironolactone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin [acetylsalicylic acid] but had allergies. On 31Jan2021 02:00 AM, the patient experienced stomach cramps, nausea and severe body shakes (uncontrollable). They had to call 911 and the patient had to be taken to hospital. The adverse events stomach cramps, nausea and severe body shakes (uncontrollable) resulted in doctor or other healthcare professional office/clinic visit and emergency room (ER)/department or urgent care. The patient received treatment for the adverse events and the patient received treatment in the ER to bring down temperature and blood pressure. The reporter considered the events as non-serious. The patient has been tested for COVID-19 since the vaccination, nasal swab (sars-cov-2 test) with the result of negative on 31Jan2021. The outcome of the events stomach cramps, nausea and severe body shakes (uncontrollable) were recovering while the outcome of the other events was unknown. The following information on the batch/lot number has been requested.

Other Meds: ELIQUIS; METOPROLOL; ROSUVASTATIN; LASIX [FUROSEMIDE SODIUM]; SPIRONOLACTONE

Current Illness:

ID: 1034991
Sex: F
Age:
State:

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: a cold that is in her chest; feels as if she has caught the flu; very fatigue; chills; headache; dry throat (feeling as if something is stuck in her throat); dry throat (feeling as if something is stuck in her throat); runny nose; cough; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 60 no unit reported) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that ever since she received the vaccine, she felt as if she has caught the flu. She experienced symptoms such as chills, headache, dry throat (feeling as if something is stuck in her throat), a cold that is in her chest, runny nose, cough, and very fatigue. She stated that she has been taking cold medicine, but it doesn't seem to be working. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1034992
Sex: F
Age:
State: SC

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/17/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: shortness of breath; throat tightening; Increased HR over 120 bpm; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 29Jan2021 14:30 in left arm, at single dose for covid-19 immunization. Medical history included known allergies: sulfa, and peanuts. Concomitant medication included prednisone. The patient previously took iodine and experienced allergy, and previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 08Jan2021 15:30 in left arm, at single dose for covid-19 immunization and experienced facial swelling within a couple hours of the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the 2nd dose within 30 minutes, 29Jan2021 15:00, the patient had Increased HR over 120 bpm, shortness of breath, dizziness and throat tightening, which all caused hospitalized and Emergency room. Epinephrine injection, fluid, and rest was received as treatment. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Amendment: This follow-up report is being submitted to amend previous reported information: historical vaccine information was added.; Sender's Comments: Based on the compatible time association, the events shortness of breath, dizziness ,throat tightening and heart rate increased are possibly related to suspect vaccine BNT162B2 administration. 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: PREDNISONE

Current Illness:

ID: 1034993
Sex: M
Age:
State: VA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: loss of muscle tone of my cheek and inability to smile on the left side; Loss of sensation of my left cheek from under my eye to my mouth; loss of muscle tone of my cheek and inability to smile on the left side; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), via an unspecified route of administration in the left arm, on 29Jan2021 07:30, at single dose, for COVID-19 immunization, at the hospital. Medical history included hypertension, diabetes, increased cholesterol and COVID-19 prior to vaccination. The patent has no allergies to medications, food, or other products. Concomitant medication included enalapril, hydrochlorothiazide, atorvastatin (LIPITOR), and metformin. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient was not tested for COVID-19 since the vaccination. The patient experienced "loss of sensation of my left cheek from under my eye to my mouth. My wife noted loss of muscle tone of my cheek and inability to smile on the left side" on 29Jan2021 at 08:30. Symptoms started about one hour after the injection and resolved after 3 hours. No treatment was received for the events. The outcome of the events was resolved on 29Jan2021 at 11:30. The reporter assessed the events as non-serious.

Other Meds: ENALAPRIL; HYDROCHLOROTHIAZIDE; LIPITOR [ATORVASTATIN]; METFORMIN

Current Illness:

ID: 1034994
Sex: M
Age:
State:

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 02/17/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: not feeling well; tremors (symptom of Parkinson's which he has but they had been under control with medicine); Gout which has flared occasionally but had not caused problems recently; tremors (symptom of Parkinson's but they had been under control with medicine), and gout which had flared occasionally but had not caused problems recently; This is a spontaneous report from a non-contactable consumer. An 84-year-old male patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included Parkinson's and gout. The patient didn't have COVID prior to vaccination. Concomitant medications were not reported. The patient with other health problems got vaccinated. Next day was not feeling well and the day after was admitted to the hospital complaining of tremors (symptom of Parkinson's which he had but they had been under control with medicine), and gout which had flared occasionally but had not caused problems recently. Adverse events started from 30Jan2021. The events resulted in emergency room/department or urgent care and hospitalization for 1 day. Treatment received included medication for tremors. The outcome of the events was recovering. COVID was not tested post vaccination. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1034995
Sex: F
Age:
State: NJ

Vax Date: 01/24/2021
Onset Date: 01/27/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: hearing loss/Cannot hear in right ear very well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration in left arm on 24Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high. Concomitant medication included levamlodipine besilate for blood pressure high. On 27Jan2021, the patient experienced hearing loss in the right ear, she started to feel like she could not hear very well in her right ear. It was like she was underwater or something. Patient went to see the family doctor on 31Jan2021 because of her ear and the doctor looked in ear and did not see anything wrong. The doctor prescribed an allergy medication, something basic that could be picked up over the counter.

Other Meds: LEVAMLODIPINE BESYLATE

Current Illness: Blood pressure high

ID: 1034996
Sex: F
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/20/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: hemorrhagic shingles on opposite arm 4 days after vaccine; This is a spontaneous report from a contactable consumer reported for herself. An 86-year-old female patient (not pregnant at the time of vaccination) received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 15Jan2021 09:00 at single dose in right arm for covid-19 immunisation. Medical history included hypertension, diabetes type 2, depression, no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. The patient received some other medications within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced hemorrhagic shingles on opposite arm 4 days after vaccine on 20Jan2021. The event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included valtrex and medrol pack. The outcome of the event was recovered with lasting effects. The reporter considered the case as non-serious. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1034997
Sex: M
Age:
State: CA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Disorientated; in a lot of pain in his chest and rib area; in a lot of pain in his chest and rib area; hurt to breathe and move; shaken up; Short of breath/It hurt to breathe; Concomitant medication:ongoing prednisone for immunotherapy; Concomitant medication:ongoing prednisone for immunotherapy; This is a spontaneous report from a contactable nurse. A 93-year-old male patient (reporter's father) received first does of BNT162B2 (Lot#: EN5318), via intramuscular on 28Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included ongoing prostate cancer metastatic diagnosed a few years ago and immunotherapy. Concomitant medication included ongoing abiraterone acetate (ZYTIGA) at 1g, once a day for prostate cancer and ongoing prednisone at 5 mg, tablet, twice a day, by mouth for immunotherapy. The caller stated she is reporting a reaction her father had to Pfizer's COVID-19 vaccine. The patient experienced disorientated, in a lot of pain in his chest and rib area, hurt to breathe and move and short of breath/it hurt to breathe on 29Jan2021. The reporter seriousness for the events was medically significant. The events didn't require a visit to emergency room or physician office. The patient did go to urgent care. The caller explained her father became disoriented. He received the first vaccine on 28Jan2021. The next day, her father began to move his car around 12 pm and he became disoriented and stated he wasn't going to drive. Caller stated they were not aware of this disorientation until Friday, 29Jan2021. Her father was not sleeping and was up the night before because he was in a lot of pain in his chest and rib area. It hurt to breathe. He was short of breath. It hurt to move. Caller clarified further her woke up feeling so bad he thought he was going downhill. He thought his cancer got worse over night. He told the caller's brother after he became so disorientated that he was no longer going to drive because he was so shaken up. He was taken to urgent care on Friday, 29Jan2021. He was prescribed Naproxen, 500 mg Friday evening and he slept all night for the first night in years. He usually gets up in the middle of the night to use the bathroom. He woke up on Saturday morning, 30Jan2021, and he was feeling 100% better. He recovered completely. He was up moving around and in no pain. Caller verified she has no NDC, Lot number and expiry date for the Naproxen her father was prescribed. She didn't see any of that written on the discharge papers, that may be with the pharmacy. She wanted to put a chest x-ray was done. He has Metastatic Prostate Cancer and the pain was coming from the lesions on his lung and rib. Caller explained the Chest X-Ray showed the mets (metastasis) but no new lesions, no infiltrates or anything. It showed nothing related to the COVID-19 vaccine.The patient underwent lab tests and procedures which included Chest X-ray: showed the mets (metastasis) but no new lesions, no infiltrates or anything on 29Jan2021 and EKG: essentially normal on 29Jan2021. The outcome of the events disorientated, in a lot of pain in his chest and rib area, hurt to breathe, shaken up and move and short of breath/it hurt to breathe was recovered on 30Jan2021. The reporter's assessment for all the events was related.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to all events disorientation, chest pain, musculoskeletal chest pain, movement disorder, shaking, and shortness of breath cannot be excluded. The ongoing prostate cancer metastatic status and immunotherapy may be major cofounders. 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: ZYTIGA; PREDNISONE

Current Illness: Prostate cancer metastatic (Diagnosed a few years ago)

ID: 1034998
Sex: F
Age:
State: HI

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: colitis flare up/soft stools and abdominal pains; my joints were aching: ankles, hips, elbows, shoulders, wrist.; Also my allergies seemed to be bothering me more; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EJ1686), via an unspecified route of administration into the right arm on 11Jan2021 08:30 at a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, osteoporosis, ulcerative colitis, ongoing colitis and ongoing allergies to mites, mold, pollen, environmental and rubber. Patient was not pregnant. Concomitant medication included venlafaxine (VENLAFAXINE), zolpidem (ZOLPIDEM) and levothyroxine (LEVOTHYROXINE). The patient was previously administered with first dose of zoster vaccine recombinant, adjuvanted (SHINGRIX) via an unspecified route of administration into the right arm on 04Dec2020 for immunization. On 12Jan2021, the patient's allergies seemed to be bothering her more. On 13Jan2021 09:00, patient woke up with her joints aching: ankles, hips, elbows, shoulders and wrist. On 14Jan2021, patient experienced colitis flare up with soft stools and abdominal pains. The patient did not receive treatment for the events reported. Outcome of events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: VENLAFAXINE; ZOLPIDEM; LEVOTHYROXINE

Current Illness: Allergy to molds; Colitis; Environmental allergy; Latex allergy; Mite allergy; Pollen allergy

ID: 1034999
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); shortness of breath; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247 and expiry date unknown) on 16Jan2021 at 11:00 via an unspecified route of administration into right arm at a single dose for COVID-19 immunization. The patient had known allergies to penicillin, erythromycin, garlic. Other medical history included asthma. She was not pregnant. The patient had not had COVID prior to the vaccination. Nasal Swab (for COVID) tested on 19Jan2021 was negative. Concomitant medications in two weeks included venlafaxine and ceirizine hydrochloride (ZYRTEC). No other vaccine received in four weeks. The patient experienced chest discomfort (fluttering, thud feeling, tightness), shortness of breath, fatigue since 17Jan2021 11:00, and injection site pain since 01Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and formoterol fumarate;mometasone furoate (DULERA) as treatment for the adverse events. The patient had not recovered from the events.

Other Meds: VENLAFAXINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1035000
Sex: F
Age:
State: NJ

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 16% loss of hearing; Fullness in ear on the injection side (left); This is a spontaneous report from a contactable consumer. A 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 13Jan2021 at 11:30 at a single dose on left arm for COVID-19 immunisation. Medical history included breast cancer, lymphedema (right arm) and asthma from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (SINGULAIR). The patient experienced 16% loss of hearing and fullness in ear on the injection side (left) on 14Jan2021 at 17:00. The patient underwent lab tests and procedures which included acoustic stimulation tests: 16 % (16% loss of hearing) on 14Jan2021. Therapeutic measures were taken as a result of 16% loss of hearing and fullness in ear on the injection side (left). The outcome of the events was not recovered.

Other Meds: SINGULAIR

Current Illness:

ID: 1035001
Sex: F
Age:
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears; headache; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper left arm on 01Feb2021 at 04:30 PM at single dose for COVID-19 immunization. Medical history included asthma (exercise induced) and menstruating. Concomitant medications included Ibuprofen because she was menstruating. No other vaccine in four weeks. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper right arm on 11Jan2021 at 04:30 PM at single dose for COVID-19 immunization. The patient was not pregnant. The skin of the patient's jaw and chin started to feel numb about 20 minutes after receiving the vaccine, headache came and went rapidly on 01Feb2021 17: 00. The sensation progressed rapidly to include numbness of her cheeks, eyebrows, and ears. The symptoms appeared rapidly after leaving the clinic as the patient was driving away on her from work. Both sides of her face were impacted equally. She went to an urgent care facility to be evaluated. An Urgent Care Physician's Assistant evaluated the patient. They looked inside her throat to see if it was closing up (it wasn't). They used a swab to test her sensory ability on her face by pressing with either the fuzzy-side or the blunt (wooden) side. When the patient asked the PA how she did, she indicated that she failed the test. They gave her Benadryl. At home, the patient went to bed, woke up normally, and did a "frown test" in front of the mirror. Her left side of face wasn't working the same way as the right side. She may have a mild case of Bell's Palsy in the morning of 02Feb2021. The patient had no covid prior vaccination, no covid tested post vaccination. Benadryl was received as treatment for the events. Outcome of the event "skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears" and "mild case of Bell's Palsy" was recovering, of the event "headache" was recovered.

Other Meds: IBUPROFEN

Current Illness:

ID: 1035002
Sex: F
Age:
State: MA

Vax Date: 01/29/2021
Onset Date: 02/02/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: jaw spasms on the left side of face near TMJ; Involuntary jaw closing; This is a spontaneous report from a contactable consumer (patient) reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right arm on 29Jan2021 17:45 at a single dose for covid-19 immunization. The vaccine was administered at the Health Department. The patient also received the first dose of other vaccine (reported as Pfizer brand) via an unspecified route of administration on the right arm on 29Jan2021. Medical history included tinnitus from an unknown date, and allergy from quinoa. Patient is not pregnant at the time of the vaccination. Concomitant medications included ergocalciferol (VIT D), and fexofenadine hydrochloride (ALLEGRA). The patient previously took, neosporin [neomycin sulfate;polymyxin b sulfate] and experienced drug allergy. On 02Feb2021 08:00, the patient experienced jaw spasms on the left side of face near TMJ, and involuntary jaw closing when teeth were very close to each other. The reported events was resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds: VIT D; ALLEGRA

Current Illness:

ID: 1035003
Sex: F
Age:
State: NV

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

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

Lab Data:

Allergies:

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

Symptoms: Atrial fibrillation; This is a spontaneous report from a contactable consumer (reported for herself). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN5318; expiry date: not known), via an unspecified route of administration in the left arm on 01Feb2021 10:45 at single dose for COVID-19 immunization. Medical history included deep vein thrombosis (DVT) and allergies to sulfa drugs. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient previously took amoxicillin, clavulanate potassium (AUGMENTIN) and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced atrial fibrillation on 01Feb2021 17:45. No treatment received for this event. The outcome of the event was recovered on an unspecified date in Feb2021.

Other Meds:

Current Illness:

ID: 1035004
Sex: F
Age:
State: MN

Vax Date: 01/05/2021
Onset Date: 01/23/2021
Rec V Date: 02/17/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: sensation change (pins and needles) in left arm; Tested positive for COVID 23Jan2021/headache; Tested positive for COVID 23Jan2021/headache; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 05Jan2021 13:00 at single dose in right arm for COVID-19 immunisation. Medical history included known allergies: coconut. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient was tested positive for COVID (test name was reported as COVID-19/SARS COV2, PCR (COVOO)) on 23Jan2021. Patient was asymptomatic at the time and was tested due to positive household members. Patient developed symptom (headache) on 25Jan2021. Patient developed sensation change (pins and needles) in left arm on 31Jan2021. Patient was seen in Emergency Room and kept overnight for observation. No obvious cause for symptoms was found. No treatment was received for the events. Outcome of the events was reported as resolving. This case was reported as serious with seriousness criteria: caused/prolonged hospitalization.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1035005
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funny; Head spinning; Weakness; nerve pain; stomach nausea; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration, in the right arm, on 16Jan2021 14:15 at a single dose for covid-19 immunization. Medical history included left-sided breast cancer from 2005 and lymph nodes removed on her left side. Concomitant medications included pravastatin and a lot of vitamins. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccine administered on same date of the Pfizer suspect. It was reported that the patient took first shot and got anxious on 16Jan2021. The patient also experienced a lot of fatigue on 16Jan2021, went home and got worse then was hospitalized. The patient had a virtual visit with her doctor and wanted some advice, and her doctor didn't give her any prescriptions. The patient also felt something in her chest area on 16Jan2021, after receiving the COVID-19 vaccine. Events anxious and fatigue required emergency room visit. The patient was hospitalized from 25Jan2021 to 27Jan2021 for the events anxious and fatigue. The patient also experienced head spinning, chest feeling funny, weakness and stomach nausea on unspecified date in Jan2021. Reported she was given all kinds of medicine in the hospital. She said as long as she was laying down, she was good. She said once she got up, and moved around, she felt the weakness again. She said she was put on depression medicine (Jan2021) while in the hospital, and was given 4 different prescriptions at discharge. She said the only thing that helps her go to sleep at night is a 1/2 tablet of generic alprazolam for anxiety. She said she knows she can't stay on the generic alprazolam forever, clarifying that is why the doctor put her on the depression medicine. Reported she was given the following medications in the hospital, as well as, prescriptions to continue the medications at home after her hospital discharge: escitalopram 10mg for depression. She said she is to take one escitalopram 10mg every evening for 30 days. She said she was given escitalopram 10mg for the two days she was in the hospital. Generic gabapentin 100mg for nerve pain (Jan2021) and she is to take 1 capsule nightly for 30 days. She said she started the gabapentin 100mg while she was in the hospital. Pantoprazole 40mg, she was given a one-time small IV bag of pantoprazole 40mg for her stomach while she was in the hospital (clarified she was given on 27Jan2021 at 05:26). She said she was having some stomach nausea (Jan2021), and the pantoprazole 40mg was to protect her stomach. She said she told the doctor she didn't want to take the pantoprazole 40mg any longer because she thought she was being given too many different medicines. Reported her fatigue is not the same as it was when she went to the hospital, but the fatigue is still there. Reported her lab work (Jan2021) was good, and her test results were fine when she was in the hospital. She said she was told she was 30% from being on the verge of having heart disease. She said her doctor told her the heart disease was preventable if she eats right, and makes some other changes. She said her cholesterol has gone done. She said she just has the fatigue, and that was why she was put on medicine. Therapeutic measures were taken as a result of the event anxious, fatigue, nerve pain and stomach nausea. Outcome of the event fatigue was recovering while it was unknown for all the other events.

Other Meds: PRAVASTATIN

Current Illness:

ID: 1035006
Sex: F
Age:
State: NC

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Passed out and fell to the floor before daylight; Passed out and fell to the floor before daylight; Dizziness; This is a spontaneous report from a contactable consumer (patient's spouse). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265) on 01Feb2021 at 13:15 at single dose intramuscular COVID-19 immunization. Relevant medical history included Alzheimer's disease diagnosed about 5-6 years ago, seizure (diagnosed 40 years ago) and ongoing high blood pressure. Concomitant medications were not reported. On 02Feb2021 patient passed out and fell before daylight morning, it may be around 06:00-07:00 (as reported). Patient's spouse informed that got up early and was already up when she called him to tell him she had fallen. She sleeps a lot anyway, so she was just put back to bed. Reporter didn't known exactly when she was up again. It was also informed that several of the medications that she took have side effects like dizziness (as reported). At the time of the reporting event outcome was unknown.

Other Meds:

Current Illness: Blood pressure abnormal

ID: 1035007
Sex: F
Age:
State: FL

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Face was swollen; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips started swelling; Itching around my neck ears and eyes; Itching around my neck ears and eyes; Itching around my neck ears and eyes; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 28Jan2021 14:00 at a single dose in the left arm for COVID-19 immunisation. Medical history included multiple sclerosis and environmental allerges. Concomitant medications included ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, acetylcysteine (NAC), montelukast, and other unspecified medications. Patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of bnt162b2 (brand: Pfizer, lot number: EL3246) on 07Jan2021 11:00 on the left arm. After the first dose, the patient formed a sty on her right eye and it is still there three weeks later. After second dose, the patient started itching around her neck, ears, and eyes on the day after injection, on 29Jan2021 10:00. By the third day, on 30Jan2021, when she woke up, her face was swollen, especially eyes and then her mouth and lips started swelling and the itching worsened. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient recovered from the events on an unspecified date. Treatment received for the adverse events was Depo-Medrol Injection. The events were reported as non-serious.

Other Meds: VIT C; VIT D3; ZINC; NAC [ACETYLCYSTEINE]; MONTELUKAST

Current Illness:

ID: 1035008
Sex: F
Age:
State: AZ

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

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

Lab Data:

Allergies:

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

Symptoms: Syncope; Passed out within minutes of second dose.; Urination and emesis upon waking up; Urination and emesis upon waking up; This is a spontaneous report from a contactable Pharmacist (patient). A 26-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 26-year-old) on 17Jan2021 at 09:30 AM as a single dose for COVID-19 immunisation, lot number: EL1283. Medical history was not provided. Patient had no known allergies. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Dec2020 at 09:30 AM via an unspecified route of administration in Left arm (at age of 26-year-old) for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 17Jan2021 at 09:45 AM patient experienced syncope. Passed out within minutes of second dose. Urination and emesis upon waking up. Brought to hospital, given 1L nacl and 1 dose of ondansetron (ZOFRAN). Events considered serious due to hospitalization. Events resulted in Emergency room/ department or urgent care. Patient was treated with fluids and ondansetron (ZOFRAN). Patient was not tested for Covid post vaccination. Patient recovered from the events on unknown date.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1035009
Sex: F
Age:
State: MN

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 02/17/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: embryonic demise/loss of pregnancy; patient was pregnant at the time of vaccination of the second dose; patient was pregnant at the time of vaccination of the second dose; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284), intramuscular in the left arm on 12Jan2021 at 08:00 at a single dose, received in the Doctor's office/urgent care for covid-19 immunisation. Medical history included anxiety and allergies: gets hives from anything cold (fluid, food, air) that touches her. Concomitant medication included venlafaxine for anxiety. The patient was pregnant at the time of vaccination of the second dose, last menstrual date was 23Nov2020, delivery date was 30Aug2021, gestation period was 7 weeks. The patient experienced embryonic demise/loss of pregnancy in Jan2021, patient was hospitalized for 1 day and treatment was received for the event. The patient underwent lab tests and procedures which included didn't see a fetal heartbeat at 6 week on u/s, and 7 weeks still no heartbeat on u/s, HCG didn't go down until second u/s, so fetal demise occurred between 6 -7 weeks, D&C performed and no genetic abnormalities were found in fetal tissue. Doctor and patient, who is a nurse, do not think the fetal demise is related to the vaccine, but wanted to document the loss for data in case they would start to see a trend. The patient does not intend to pursue further investigation into the vaccine as a cause. After the first dose (received on 21Dec2020 at 08:00, the patient had a sore arm and then two days later found out she was pregnant. The doctor discussed with patient and pharmacist whether to get second dose. Patient is a nurse and decided to get second dose. No major symptoms were reported after second dose until the miscarriage. The patient recovered from the event with lasting effects/sequel.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: VENLAFAXINE

Current Illness:

ID: 1035010
Sex: F
Age:
State: OH

Vax Date: 01/13/2021
Onset Date: 01/16/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 45-year-old) on 13Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included penicillin allergy. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Jan2021 at 06:00 PM patient experienced nausea, vomiting, shortness of breath, fainting and hand spasms. Events resulted in Emergency room/department or urgent care. Patient was treated at emergency room (ER) with diphenhydramine hydrochloride (BENADRYL), Steroid and Anti nausea. Patient was not tested for Covid post vaccination. Patient recovered on unknown date in 2021 from the reported events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1035011
Sex: M
Age:
State: WA

Vax Date: 01/12/2021
Onset Date: 01/14/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: a loss of vision in left eye that lasted for about three minutes; Dizzy sell; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 12Jan2021 08:15 at single dose in left arm for COVID-19 immunisation. Medical history included had surgery for a torn rotator cuff on 07Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) only at night a few days before taking the shot for post-operative pain control. Two days after BNT162B2 (14Jan2021 14:00), patient had a loss of vision in left eye that lasted for about three minutes and had a dizzy sell that lasted for forty-five minutes after getting out of the hot tub. It was unknown if treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. Doctors had no explanation at this time and had no idea if it was related to the injection. Outcome of the events was resolved on 14Jan2021.

Other Meds: PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]

Current Illness:

ID: 1035012
Sex: F
Age:
State: PA

Vax Date: 01/29/2021
Onset Date: 02/02/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; This is a spontaneous report from a contactable nurse (reporting for herself). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3302), at age 35 years, via an unspecified route of administration on the left arm, second dose on 29Jan2021, at single dose, for COVID-19 immunization. Medical history included breast feeding from an unknown date and unknown if ongoing, and COVID-19 on unspecified dates diagnosed prior to vaccination. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient previously took BNT162B2 on 08Jan2021 at age 35 years for COVID-19 immunization. On 02Feb2021, 4 days after the second dose, the patient experienced dizziness, nausea and was diagnosed with vertigo when seen in ER. The adverse event resulted in emergency room/department or urgent care visit. Treatment received for the adverse event includes IV fluids and meclizine. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The outcome of the event was recovering/resolving. Case was reported as non-serious.

Other Meds:

Current Illness:

ID: 1035013
Sex: M
Age:
State: MI

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: has an autoimmune disease/Myasthenia gravis and was given bnt162b2 vaccine; has an autoimmune disease/Myasthenia gravis and was given bnt162b2 vaccine; General feeling of malaise; Prickly feeling through body; General Flu-type feeling; Fever of 101 degrees; This is a spontaneous report from a contactable other healthcare professional (patient). A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9251), via an unspecified route of administration on 20Jan2021 07:00 at 0.3 mL, single on left arm to prevent COVID virus (COVID-19 immunization). Medical history included myasthenia gravis, and an ongoing autoimmune disorder. Patient has no family medical history. There were no concomitant medications. The patient did not receive any other vaccines 4 weeks prior to COVID vaccination. The patient did not receive additional vaccines on the same date as Pfizer suspect. On 20Jan2021, the patient experienced general feeling of malaise, prickly feeling through his body, which lasted a few hours and fever of 101 degrees. On the same day (20Jan2021), patient had general flu-type feeling that lasted the whole day. He was fine the next morning (21Jan2021), when he woke up. The events were considered serious and medically significant by the reporter. The events did not require a visit to a physician or to an emergency room. The patient underwent Gammunoglobulin blood test with unknown results on an unspecified date. The patient recovered from general malaise, prickly feeling through the body, general flu-type feeling, and fever of 101 degrees on 21Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness: Autoimmune disorder

ID: 1035014
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: sick; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a lawyer in the. This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE. It is unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was also reported that patient got one flu shot around seven years ago, never been that sick in life. Have not got a flu shot since and have not got that sick so. It is unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was reported as unknown. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1035015
Sex: U
Age:
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: allergies; Initial information regarding an unsolicited valid non-serious case was received from physician (Reference number- 00448644) and transmitted to Sanofi on 27-Jan-2021. This case involves patient (age and gender not specified) who had allergies (hypersensitivity), while patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious allergies (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Laboratory data was not provided. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was unknown. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1035188
Sex: M
Age: 43
State: AZ

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

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

Lab Data:

Allergies: Lactose, gluten

Symptom List: Vomiting

Symptoms: Mild soreness at site of injection.

Other Meds: Prozac, clonidine

Current Illness:

ID: 1035189
Sex: M
Age: 51
State: GA

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies: none

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: chills and muscle aches about 16 hours after injection continued chills and myalgia along with headaches about 24 hours after injection at 30 hours after injection symptoms persist

Other Meds: none

Current Illness: none

ID: 1035191
Sex: F
Age: 71
State: IN

Vax Date: 02/02/2021
Onset Date: 02/14/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Started with slight itching Sunday afternoon. By Monday evening swelling and warm to touch at injection site. Tuesday morning,swelling area hard to touch and some pain around swelling.

Other Meds: TRULICITY, VALTASSA, CARVEDILOL, SIMVISTATIN, XARELTO, ENTRESTO, B COMPLEX, D3, MAGNESIUM

Current Illness:

ID: 1035192
Sex: F
Age: 37
State:

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: A red bump about 2 inches long and 1 inch wide. Hot to the touch. Its been over two weeks and I still have a bruise

Other Meds: Motrin in the morning

Current Illness:

ID: 1035193
Sex: F
Age: 78
State: CT

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies: sulfa drugs

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

Symptoms: Received shot on Friday, February 12 around 1PM. Saturday, February 13:Approximately 30 hours after receiving shot, 8:00 pm, Saturday, Feb 13, developed stomach cramps. Over the next 4/5 hours, diarrhea, vomiting, cramps, chills. Felt very hot at times, but never ran a fever. Sunday, February 14, felt tired and weak, periodic cramps. No nausea or diarrhea. Monday, February 15, more energy, some cramps, By

Other Meds: amlodipine besylate 10mg atorvastatin calcium 40 mg valsartan & hydrochlorithiazide 160/25 mg calcium 600 mg + D3

Current Illness: none

ID: 1035194
Sex: M
Age: 53
State: FL

Vax Date: 02/12/2021
Onset Date: 02/16/2021
Rec V Date: 02/17/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Chills, fever, fatigue

Other Meds: Vitamins C, D, E

Current Illness: None

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm