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: 1000504
Sex: F
Age:
State: NC

Vax Date: 01/16/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; fogginess/Foggy brain was described as she was not able to focus very well; Strong chills was not going away almost like a feeling of ice in her veins; Arm ache at the site; She was not able to get work done due to extreme fatigue and foggy brain/It was very disturbing and interfering with ability to do work; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had her first COVID19 vaccine dose. Immediately, on 16Jan2021, she felt very cold and unwell. She also experienced dizziness, headache that started right after the shot, extreme fatigue that started later in the day and fogginess that started right after the shot. Strong chills was not going away almost like a feeling of ice in her veins. She is taking paracetamol (TYLENOL) and ibuprofen for these. The events were not improving. She was just surprised, she was ok with a day's worth, but it was hanging on dizziness (not enough to fall down), but she has to hold onto a rail to go upstairs which was not normal. She doesn't feel like she is real anchored. Headache was described as very bad and is not changing. Foggy brain was described as she was not able to focus very well. She was not able to get work done on Jan2021 due to extreme fatigue and foggy brain. She also experienced arm ache at the site on 06Jan2021 for which the patient expected. It is reducing some, the ache is not as bad as it was while the other things seem to be growing and it is still there. She had to be set aside when she took the shot, because she had these reactions after she got the shot. She had to be watched because of her almost immediate reactions. The patient wants an advice on what to do now, if there is any help for the side effects, and if this will go away. It was very disturbing and interfering with ability to do work. Outcome of the vaccination site pain was recovering while of the remaining events was not recovered.

Other Meds:

Current Illness:

ID: 1000505
Sex: F
Age:
State: MI

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: I broke out in shingles; Relevant medical history: type 1 diabetes mellitus and lupus; Relevant medical history: type 1 diabetes mellitus and lupus; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 08Jan2021 at 11:00 to 11:45 (as reported), at single dose, for COVID-19 immunization, in the hospital. Medical history included ongoing type 1 diabetes mellitus (diagnosed at 8 years old, maybe around 1993-1994), lupus from 2004 and ongoing, TTP (blood clotting disorder) from 2019 and ongoing and allergies to sulfa drugs. There were no concomitant medications. Historical vaccine included flu shot for immunization which she believes that was well before 4 weeks. The patient stated, 'My doctor wanted me to call and get information. I received my first vaccine but a week later I broke out in shingles and I'm due to get my second dose in a week or so. Any advice on that? My doctor suggesting putting the second dose off for a few weeks. Does it become ineffective? Is there a timeline? What is the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine, and can I receive it earlier or later than 3 weeks?". The patient reported that she received the first dose of the COVID vaccine. A week after, she came down with shingles. She was wondering if she could get the second dose after coming down with shingles. She clarified that on 15Jan2021 (Friday), she went with what she initially thought was a pinched nerve. She had radiating pain starting from her shoulder coming down into her hands and fingers. She had the rash probably on Friday (22Jan2021). She then started getting a small blister/rash on 23Jan2021. On 24Jan2021, she returned to the Urgent Care and the rash had spread at that point and they were pretty sure it was the shingles virus. She reported she had gone to Urgent Care over the weekend twice, they suspected that was what it was. She saw the doctor on 19Jan2021 (yesterday) and gave the official diagnosis of shingles. The outcome of the events was unknown.

Other Meds:

Current Illness: Clotting disorder; Lupus erythematosus; Type 1 diabetes mellitus (Diagnosed at 8 years old, maybe around 1993-1994)

ID: 1000506
Sex: F
Age:
State: IN

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Temp 100; malaise; body aches; very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK5730), via an unspecified route of administration (left arm), on 22Dec2020 19:00, at single dose, for covid-19 immunization. Medical history included asthma and; Covid (prior to vaccination). The patient has no known allergies. Concomitant medications included niacin; colecalciferol (D3); cyanocobalamin (B12); loratadine and; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). The patient was also taking ginger. The patient experienced temp 100, malaise, body aches, and very sore arm - all on 23Dec2020 10:00. The patient recovered from all the events on an unspecified date. No treatment was received for all the events reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination and; have not been COVID tested post vaccination.

Other Meds: NIACIN; D3; B12 [CYANOCOBALAMIN]; LORATADINE; BREO ELLIPTA

Current Illness:

ID: 1000507
Sex: F
Age:
State: OH

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
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: Skin redness/hands were red/red patches; hands were red and itchy; hands were red and itchy, burning.; extensive hives starting over dorsal hand surface, then wrists,eventually covering entire arms and patches over knees and lower legs; This is a spontaneous report from a contactable nurse (patient). This 45-year-old female patient received the fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date unknown), via an unspecified route of administration on 19Jan2021 09:15 at a single dose on the left arm for COVID-19 immunization. Medical history included COVID-19 and allergies: PCN. Concomitant medication included colecalciferol (VITAMIN D). The patient received no other vaccine in four weeks. Patient is not pregnant. On 20Jan2021 08:30, the patient developed skin redness, her hands were red, itchy, and burning. This was followed by extensive hives starting over dorsal hand surface, then wrists, and eventually covering entire arms. The patient also had patches over knees and lower legs. The events resolved with 20 mg prednisone and Allegra after a couple hours, except for the flat red patches which remained over the knees and surrounding skin. The patient has not been tested for COVID-19 post-vaccination. Outcome of the event "skin redness/hands were red/red patches" was not recovered and of the other events was recovered on an unspecified date.

Other Meds: VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1000508
Sex: F
Age:
State: MA

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Soreness in arm at injection, 24 hrs; Day after debilitating lower back pain; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration on 18Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included psoriasis, hypothyroidism and insomnia. Patient has no known allergies. No COVID prior vaccination. Concomitant medications (Other medications in two weeks) included levothyroxine, trazodone (reported as "Trazadone"), phentermine and ergocalciferol (VIT D). No other vaccines in four weeks. Facility type vaccine was Workplace clinic. The patient experienced "soreness in arm at injection, 24 hrs. Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day. Pain in walking, sitting & movement", all on 19Jan2021 11:00 AM which resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for the events, also reported a s "Call into pcp but was not helpful". Outcome of the events was not recovered. Patient was not tested for COVID since the vaccination.

Other Meds: LEVOTHYROXINE; TRAZODONE; PHENTERMINE; VIT D

Current Illness:

ID: 1000509
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: her arm got really really sore for several days up into her shoulder; her arm got really really sore for several days up into her shoulder; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 80, no unit) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. The patient has a lot of unspecified underlying conditions. The patient had a flu shot on an unknown date and she stated even with the regular flu shot it makes her arm sore at the site every time. The patient was on unspecified blood thinners. On an unspecified date, her arm got really really sore for several days up into her shoulder. Investigation assessment was not provided. The outcome of the events was unknown. Information on the batch/lot number was requested.

Other Meds:

Current Illness:

ID: 1000510
Sex: F
Age:
State: KY

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: rapid heart rate; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient would like to know if there's anything in the ingredients of the COVID vaccine that will stimulate the heart, she states she takes medication because she has a rapid heart rate. The patient states her niece received the second shot of the vaccine today and she didn't know that she should not take Tylenol or Ibuprofen and she took two Tylenol or Ibuprofen, patient would like to know if her niece should receive the second dose again. Patient heard that several people died after receiving the vaccine, she would like to know if this is true. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000511
Sex: F
Age:
State: GA

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 02/04/2021
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: flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ache; changes from her lower extremities freezing and sometimes it was her whole body; changes from her lower extremities freezing and sometimes it was her whole body; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 at a single dose for covid-19 prophylaxis; apixaban, oral from an unspecified date and ongoing at 5 mg, twice daily as blood thinner medication and atrial fibrillation. Medical history was not reported. Concomitant medication included ongoing dronedarone hydrochloride (MULTAQ) for blood pressure and heart beat, ongoing pravastatin for cholesterol, and dronedarone for blood pressure. For the past couple of days, she had had flu like symptoms. She has had a headache, body aches and chills. It changes from her lower extremities freezing and sometimes it was her whole body. Patient also had a pain in arm. Her left arm was bruised - still black and blue. All of these occurred on 13Jan2021. She did not have a fever. Today (20Jan2021), she was ok. When they went through the check in they asked if patient was on a blood thinner and she was. The patient's husband was wondering if the reactions had anything to do with the vaccine and if the blood thinner medication (Apixaban) she was taking would have caused the bruise. The patient was supposed to get the second vaccine 02Feb2021. Reporter was asking if it is ok to get the second dose. The action taken in response to the event for apixaban was unknown. Outcome of event chills was recovered on 19Jan2021, after 6 days; events flu like symptoms and lower extremities freezing and sometimes it was her whole body was unknown while recovering for other events.

Other Meds: MULTAQ; PRAVASTATIN; DRONEDARONE; APIXABAN

Current Illness:

ID: 1000512
Sex: F
Age:
State:

Vax Date: 12/26/2020
Onset Date: 12/30/2020
Rec V Date: 02/04/2021
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: Caller got the first dose of the pfizer covid 19 vaccine on 26Dec2020 and tested positive for covid on 30Dec2020.; Caller got the first dose of the pfizer covid 19 vaccine on 26Dec2020 and tested positive for covid on 30Dec2020.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL5738)on 26Dec2020 at single dose into right arm for COVID-19 immunization. Medical history was none. Concomitant medication included gummy bear vitamins, no further details provided. Patient did her first COVID test on 16Dec2020, prior to getting the vaccination, and was negative. Patient got the first dose of the vaccine on 26Dec2020 and on 30Dec2020 tested positive (via COVID-19 PCR test) for Covid . She was tested negative on 03Jan2021 and 04Jan2021 (both via COVID-19 PCR tests). She clarified that she went to a nursing home and was tested every 14 days when she went to see her mom and all times prior to getting the vaccine doses she was negative. She said her first dose of the vaccine was on 26Dec2020, then four days after that it was time to go get tested to go see her mom and the test was positive within no time it lights up. She said as a medical worker (she was a patient registration clerk at the emergency room- ER) she can wait 5 days after that for it to come up after being positive and after that if it was showing up negative she had to wait 24 hours to confirm negative test and repeated the test within 24 hours, which was negative too. Patient stated that other than having positive tests for COVID she has had no symptoms. Outcome of the event was unknown. Patient wanted to know if this was a herd immunity vaccine and if the vaccine had covid in it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021077994 same patient, different dose

Other Meds:

Current Illness:

ID: 1000513
Sex: F
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/04/2021
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: Elevated heart rate immediately after vaccine; shortness of breath with 90 minutes that's persisted on and off for 5 days so far; This is a spontaneous report from a non-contactable healthcare professional reporting on behalf of the patient. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration), intramuscular in left arm on 15Jan2021 at 09:30 AM at a single dose for COVID-19 immunization in a hospital. Medical history included asthma. The patient has no known allergies to medications, food, or other products. Concomitant medications included antibiotics, prenatal vitamins, and probiotics. On 15Jan2021, the patient experienced elevated heart rate immediately after vaccine and shortness of breath with 90 minutes that's persisted on and off for 5 days so far. The patient received albuterol for the event. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID post vaccination. The patient recovered from the events with sequelae. The events were assessed as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: PROBIOTICS

Current Illness:

ID: 1000514
Sex: F
Age:
State: NC

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 02/04/2021
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: fever; dizziness; aching joints; headache; shortness of breath; swollen and painful lymph nodes in left armpit only; swollen and painful lymph nodes in left armpit only; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 39-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date: unknown), intramuscular on the left arm on 30Dec2020 at 15:00 at a single dose for COVID-19 immunization. Medical history included gastroparesis, low thyroid, iron anemia, and known allergies: latex, apples, kiwi and avocado. Concomitant medications included bifidobacterium infantis (ALIGN), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), duloxetine hydrochloride (CYMBALTA), ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), folic acid (FOLIC ACID), levothyroxine (LEVOTHYROXINE), omeprazole (OMEPRAZOLE), and pantoprazole (PANTOPRAZOLE). The patient had no other vaccine in four weeks. On 30Dec2020, the patient experienced (first shot) fever, dizziness, aching joints, headache, shortness of breath, swollen and painful lymph nodes in left armpit only, 24 hours after the shot and lasted for two weeks. The patient had no COVID prior vaccination and tested negative post-vaccination through nasal swab on 13Jan2021, which resulted negative. No treatment was administered for the events. The event swollen and painful lymph nodes in left armpit only resolved on 14Jan2021 while the rest of the events had not resolved. Information on the lot/batch number has been requested.

Other Meds: ALIGN; VITAMIN D [COLECALCIFEROL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CYMBALTA; LO LOESTRIN FE; FOLIC ACID; LEVOTHYROXINE; OMEPRAZOLE; PANTOPRAZOLE

Current Illness:

ID: 1000515
Sex: M
Age:
State: PA

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
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: more arthralgias than usual/ developed arthralgias in his DIP joints of his left hand/ pain was about 3-4/10. Mostly 3rd and 4th digit/ persisted for more than a day or two; This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 31Dec2020 15:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included hand arthralgias from an unknown date and unknown if ongoing. The patient's known allergies indicated codeine. There were no concomitant medications. The patient did not receive any other medication within two weeks and did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. It was reported that after vaccination, almost three weeks ago, on 01Jan2021, the patient felt more arthralgias than usual. He developed arthralgias in his DIP joints of his left hand (vaccine was in left arm), pain was about 3-4/10. Mostly 3rd and 4th digit. No warmth or swelling that he can discern. It was odd to him because he has had hand arthralgias, but nothing that has persisted for more than a day or two. It seems to be a bit better now. Therapeutic measures which includes administration of Ibuprofen was done in response to the event. The outcome of the event was not recovered Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000516
Sex: F
Age:
State: AZ

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
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: chills; fatigue; muscle aches; fever of 101; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 1284 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 14:30 at a single dose for COVID-19 immunization. There were no medical history. Patient was not pregnant at the time of vaccination. There were no other medications received within 2 weeks of vaccination, and no other vaccine in 4 weeks. The patient chills, fatigue, muscle aches and fever of 101 on 20Jan2021 11:00. No treatment was received. Outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1000517
Sex: F
Age:
State: NY

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
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: Severe vomiting and diarrhea 2 hours following vaccination; Severe vomiting and diarrhea 2 hours following vaccination; This is a spontaneous report from a contactable consumer (patient reported for herself). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were not reported), via an unspecified route of administration at the left arm on 20Jan2021 at 16:00 (04:00 PM) at single dose for Covid-19 immunization, administered in a hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included prior malignancy s/p chemo and targeted therapy (last dose approximately 3 years ago). The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe vomiting and diarrhea 2 hours following vaccination on 20Jan2021 at 18:30 (06:30 PM). Therapeutic measures were taken as a result of the events which included ondansetron, oral fluids, and lorazepam. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000518
Sex: F
Age:
State: AZ

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 02/04/2021
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: Dizziness; extreme fatigue (unable to drive and doze off during conversations); headache; muscle aches; vomiting still after 8 days.; This is a spontaneous report from a contactable healthcare professional (patient herself). A 40-year-old female patient received first 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 12Jan2021 09:00 at single dose for COVID-19 immunisation. Medical history included bipolar disorder and ovarian cyst. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included trazodone, desvenlafaxine succinate (PRISTIQ), and oxcarbazepine (TRILEPTAL). The patient previously took morphine sulfate and experienced allergies. On 12Jan2021 19:00, the patient experienced dizziness, extreme fatigue (unable to drive and doze off during conversations), headache, muscle aches and vomiting still after 8 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.

Other Meds: TRAZODONE; PRISTIQ; TRILEPTAL

Current Illness:

ID: 1000519
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: A patient who has received the first dose, and then tests positive for COVID-19; A patient who has received the first dose, and then tests positive for COVID-19; This is a spontaneous report from a contactable pharmacist reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist asked if there any information available for scheduling the second vaccine dose of the series in a patient who has received the first dose, and then tests positive for COVID-19 after already receiving the first dose. The outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. 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: 1000520
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: Having some on and off pain like body aches; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration, on an unspecified date, at a single dose for COVID-19 immunization. Medical history included COVID-19 from Apr2020 to an unknown date as she had COVID in Apr2020 and she has had after effect symptoms long term, diabetes, blood pressures (blood pressure abnormal) and cholesterol (blood cholesterol abnormal). Concomitant medication included lisinopril for blood pressures, metformin for diabetes and simvastatin for cholesterol. The patient reported that she received the first dose of the COVID vaccine on Sunday (unspecified date). She mentioned that she has been having some on and off pain like body aches on an unspecified date. She added that she had COVID in Apr2020 and she has had after effect symptoms long term. She stated that she thought these symptoms would disappear after first dose of COVID vaccine, but this did not happen, and she is hoping it will happen after the second dose. She inquired if she can take ibuprofen (MOTRIN) for body aches. The outcome of the event was unknown. The following information on the batch/lot number has been requested.

Other Meds: LISINOPRIL; METFORMIN; SIMVASTATIN

Current Illness:

ID: 1000521
Sex: M
Age:
State:

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/04/2021
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: swollen lymph node; Pain started on Sunday, 17Jan2021. 5/10 pain scale on Sunday.; felt a tickle behind his left ear; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported age was 62 without unit) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were not reported), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During the injection on 16Jan2021, the patient felt a tickle behind his left ear. Pain started on Sunday, 17Jan2021. 5/10 pain scale on Sunday. He stated that "it hurts more after 8 hours of work, in the morning it is good." The patient believes it is a "swollen lymph node." Outcome of the events was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1000522
Sex: M
Age:
State: AZ

Vax Date: 01/16/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
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: pain in right groin; difficulty walking; arm soreness; redness on the toe of his left foot; This is a spontaneous report from a contactable consumer (patient himself). An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1284, expiration date was unknown), via an unspecified route of administration on the left arm on 16Jan2021 at a single dose for COVID-19 immunization; it was offered to him and he was in the Phase 1B category. Relevant medical history included ongoing type 2 diabetes mellitus, which was diagnosed 10-15 years prior reporting, had a watchman procedure on an unspecified date, and had used a cane to walk before. Concomitant medication included clopidogrel as a blood thinner from 15Jan2021 and ongoing, which he would take for 6 months. The patient previously took apixaban (ELIQUIS). It was reported that he had a watchman procedure and they took him off of apixaban and started him on clopidogrel. In 6 months, he would not have to take any blood thinners and would make an appointment with his physician. On 18Jan2021, at noon, the patient was experiencing pain in his right groin. As the day progressed it got worse. By night (18Jan2021), he was in extreme pain and had difficulty walking. He had to use a walker to walk. It had let up, but he still had pain in the groin of his right leg. The patient was asking if there were certain doctors that could assist him with this problem. He was no longer using a walker. He was using a cane instead. He used a cane to walk with before this, but not for this reason. He never had any real serious aching. He had a little soreness in his arm on an unspecified date in Jan2021, but nothing out of the ordinary. He didn't know his arm was sore until he rubbed it. He though it might have been on Sunday when he noticed it. He was not sure. Prior to this, he had redness on the toe of his left foot on an unspecified date in Jan2021. He was prescribed an antibiotic that he was still taking. He was unable to provide the name of the antibiotic. Therapeutic measures were taken as a result of "difficulty walking and redness on the toe of his left foot. The patient had no investigation assessment. The patient was recovering from the event "pain in right groin," he was not recovered from the event "difficulty walking," while the outcome of the events "arm soreness and redness on the toe of his left foot" was unknown.

Other Meds: CLOPIDOGREL

Current Illness: Type 2 diabetes mellitus (Diagnosed 10-15 years ago)

ID: 1000523
Sex: F
Age:
State: LA

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/04/2021
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: Headache; vascular rash on toes; This is a spontaneous report from a contactable consumer (patient). A 63 year-old female patient received first dose of BNT162B2 (lot number: 3246), via an unspecified route of administration on 16Jan2021 14:30 at single dose in the left arm for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia from an unknown date. The patient has no known allergies. Concomitant medication included metformin extended release. On 16Jan2021, the patient experienced headache and vascular rash on toes. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The 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. It was unknown if the patient received any treatment for the events. The patient underwent lab tests and procedures which included PCR and nasal swab: both unknown results on 20Jan2021. The outcome of the events was not recovered.

Other Meds: METFORMIN

Current Illness:

ID: 1000524
Sex: F
Age:
State: FL

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tends to have low blood pressure; Dizziness; she lies down and then gets up she is dizzy; tired; she might have almost fainted as the room was spinning; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284, expiration date 0Apr2021), via an unspecified route of administration in the left arm on 18Jan2021 at 09:30 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history included Reflux esophagitis, COPD and a root canal on 14Jan2021. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020. Past drug history includes sore arm after COVID-19 vaccination on 28Dec2020. It was unknown if the patient has any allergies to medications, food, or other products. The patient's concomitant medications included oral famotidine (FAMOTIDINE) 20mg twice daily for reflux, (tiotropium bromide) SPIRIVA 2.5mcg, two puffs once daily by mouth for COPD, latanaprost (LATANAPROST)125mcg; one drop each eye at night for Glaucoma, (TIMOLOL) 5% one drop twice daily to each eye and (LORATADINE) 10mg; take once daily by mouth as needed for allergy. The patient did not receive any other vaccine within four (4) weeks prior to the vaccine. The vaccine was administered to the patient at the hospital. On 19Jan2021 the patient experienced dizziness and feeling tired. The patient further described that she had the vaccine on Monday and since yesterday, when she woke up, she has a lot of dizziness; and again this morning when she woke up. Also, when she lies down and then gets up she is dizzy. Mentions she didn't see dizziness on the list of side effects. She knows that is a side effect of COVID. She is asking is dizziness is a side effect of the vaccine wants to know if she should call her doctor. She continued and mentioned that she noticed when she was waking up on 19Jan2021 she was so dizzy that she couldn't get out of bed. Adds she thinks she might have almost fainted as the room was spinning. Mentions she tends to have low blood pressure but this is not typical. As far as side effects from the vaccine she mentions she is tired. The tiredness started after the second dose and has continued through today but not as bad. The clinical outcome of dizziness was reported as not recovered, the outcome of fatigue was recovering and the outcome of almost fainted and low blood pressure was unknown.

Other Meds: FAMOTIDINE; SPIRIVA; LATANOPROST; TIMOLOL; LORATADINE

Current Illness:

ID: 1000526
Sex: F
Age:
State: NC

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/04/2021
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: Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/dizzy; lightheaded/dizzy like she was going to pass out; Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on; Had a heavy feeling in her chest; Tingling sensation on her lips; Tingling sensation on the right side of her face, and cheek; Severe burning in her right ear; Sore throat on the right side; When she was speaking it sounded like she had a thick tongue; Tongue feels swollen; Pain at the base of her skull on the right side; Pain on the right side of her forehead; Pinpoint pain that went down the right side of her spine; Metallic taste in her mouth; felt off; Pain at the injection site; It was so bad that it would wake her up if she rolled over; This is a spontaneous report from a contactable Nurse reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3248), via an unspecified route of administration on 15Jan2021 at single dose (Once by injection in the right arm) for COVID-19 immunisation. The patient medical history was not reported. Historical vaccine included Hepatitis B vaccine. There were no concomitant medications. On 15Jan2021, after 15 minutes of monitoring she was fine. 5 minutes later or so (after 20 minutes), she had a flushed feeling and was lightheaded/dizzy like she was going to pass out. She returned to her office. She had someone check her blood pressure which was fine. It was 110/60. Normally it runs low in the 90s. Again, she thought she looked flushed. It was reported she had a heavy feeling in her throat and chest and on her face. She had removed her mask but it still felt like she still had it on. She had brought Benadryl with her, as she has had a reaction to the Hepatitis B vaccine before. She took the Benadryl since she felt off. She thinks this first part of what she experienced triggered everything else. By the time she got home, she had a tingling sensation on the right side of her face, on her lips and cheek. She had severe burning in her right ear. She also had a sore throat on the right side. Heaviness in her throat and chest- resolved late Saturday to early Sunday (Jan2021). Her husband noticed on Friday evening (15Jan2021) when she was speaking it sounded like she had a thick tongue. Saturday morning it was more normal. Her tongue does feels swollen. She also developed pain at the base of her skull on the right side. This started about 2 hours after the vaccine. She had pain on the right side of her forehead. She had pinpoint pain that went down the right side of her spine. She also developed a metallic taste in her mouth. She had pain at the injection site. It was so bad that it would wake her up if she rolled over. On 17Jan2021, she slept all day Sunday and also had extreme fatigue. On 18Jan2021, her right eyelid feels heavy on 18Jan2021. She does not think any of these are serious, but stated they are concerning. Vaccination card does not have the NDC or expiration date on it. Patient asked is getting the second dose of the injection recommend. She is leaning towards no but wanted to see what was recommended. She has reached out to her primary care about this. Outcome of the events flushed feeling, lightheaded/dizzy, lightheaded dizzy, like she was going to pass out was recovered on 15Jan2021. Outcome of the events when she was speaking it sounded like she had a thick tongue was recovered on 16Jan2021; Outcome of the events pain at the base of her skull on the right side, pain on the right side of her forehead, pinpoint pain that went down the right side of her spine, extreme fatigue, pain at the injection site was recovered on 17Jan2021; Outcome of the events Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on, and Had a heavy feeling in her chest was recovered on Jan2021. Outcome of the events severe burning in her right ear, sore throat on the ride side, tingling sensation on her lips, tingling sensation on the right side of her face and cheek was recovering. Outcome of the events tongue feels swollen, metallic taste in her mouth, right eyelid feels heavy was not recovered. Outcome of the events it was so bad that it would wake her up if she rolled over, she slept all day Sunday, and felt off was unknown. The reporter considered the events as non-serious. Causality assessment for events for felt off, she slept all day Sunday, It was so bad that it would wake her up if she rolled over was not reported. Causality assessment for all other events was reported as related.

Other Meds:

Current Illness:

ID: 1000527
Sex: F
Age:
State: MN

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I was so faint/nearly passed out; so hot; very chilled for about 15 or 20 minutes; feeling sort "off"; weak; fatigued/very drained/exhausted; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176), via an unspecified route of administration on 19Jan2021 at 08:15 AM at single dose in right arm for COVID-19 immunisation. Patient age at time of vaccination was years 30 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. The patient had no relevant medical history and received no concomitant medications. The patient reported the following: 'About 5 minutes after receiving the vaccine I was so faint I nearly passed out and was so hot I was given an ice pack to try and cool me down. It took about 45 minutes for me to be able walk across one room. I then was very chilled for about 15 or 20 minutes, and very drained. The rest of the day I was back and forth between feeling sort "off" and feeling like I was weak, exhausted, and fatigued'. Adverse events onset date was reported as 19Jan2021 at 08:15 AM. No treatment was received for the events other than ice pack for feeling hot. The patient was recovering from the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1000528
Sex: M
Age:
State: GA

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 02/04/2021
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: arm was a little blue after receiving injection; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EK9231, expiration date unknown), via an unspecified route of administration in the left arm on 12Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 vaccination. Medical history included "cholesterol." The patient's concomitant medications included rosuvastatin calcium (CRESTOR) 10 mg daily. It was unknown if the patient has any allergies to medications, food, or other products. It was unknown if the patient had received any other vaccines within four (4) weeks prior to the vaccine. On 13Jan2021 the patient added that his arm was "a little blue" after receiving the injection. Treatment information, if any, was not provided. The clinical outcome of vaccination site discoloration was reported as recovered on 13Jan2021.

Other Meds: CRESTOR

Current Illness:

ID: 1000529
Sex: F
Age:
State: WA

Vax Date: 01/04/2021
Onset Date: 01/10/2021
Rec V Date: 02/04/2021
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: rash broke out all over my neck; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231; expiration date not provided), via an unspecified route of administration in the left arm on 04Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included Mild anxiety, Sjogrens, Perimenopausal, and Allergies to tree nuts. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram and estradiol (ESTROGEN). On 10Jan2021 06:00, 6 days after injection, the patient had rash broke out all over her neck which has not fully resolved after treatment with oral prednisone 20 mg for 10 days. The outcome of the event was not recovered. The patient has not been tested for COVID post vaccination.

Other Meds: ESCITALOPRAM; ESTROGEN

Current Illness:

ID: 1000530
Sex: F
Age:
State: OH

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
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: I felt as if I head a fever; sweats; needed to vomit; felt pretty dizzy; This is a spontaneous report from a contactable consumer. A 20-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 18:45 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history included ulcerative colitis. The patient was not pregnant at the time of vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. After my vaccine, on 20Jan2021 19:00, the patient felt as if I "head" a fever and sweats and needed to vomit I also felt pretty dizzy, I know this was in the side effects but just wanted to make sure I was going to be okay to receive my second dose. The patient did not receive treatment for the events. The patient recovered from the events on Jan2021. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000531
Sex: F
Age:
State: CT

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
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: painful axillary lymphadenopathy; fever over 102.5; piercing headache; chills; dizziness; vertigo with movement; severe fatigue; sore throat; I felt so unwell; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9261, via an unspecified route of administration on Left arm from 19Jan2021 14:45 to 19Jan2021 14:45 as SINGLE DOSE (dose 2) for COVID-19 immunisation. Medical history included alpha thalassemia, chronic anemia, lactose intolerant, ADD. Historical vaccine includes first dose of BNT162B2 (lot number: EK9231), on 28Dec2020 at 01:15 PM, Left arm and experienced chills, piercing headache, fatigue, and vertigo. Concomitant medication included colecalciferol (VITAMIN D), and escitalopram oxalate (LEXAPRO). On 20Jan2021 2:00 AM, the patient experienced painful axillary lymphadenopathy, fever over 102.5, piercing headache, chills, dizziness and vertigo with movement, severe fatigue, sore throat, muscle aches. It took hours just for the patient to get out of bed in the morning, the patient felt so unwell. This all took place on the day after she got her second vaccine. The outcome of the events was recovering. Therapeutic measure has been given in response to the event which includes Tylenol 1000mg. The patient is not pregnant at the time of vaccination.

Other Meds: VITAMIN D [COLECALCIFEROL]; LEXAPRO

Current Illness:

ID: 1000532
Sex: F
Age:
State: CA

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/04/2021
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: Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and chest; Slight itching; This is a spontaneous report from a contactable healthcare professional (the patient). A 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 18Jan2021 at 10:30 (at the age of 38-years-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient was allergic to penicillin. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685) on 28Dec2020 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ALERTEC), both for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jan2021 at 11:00, the patient experienced bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching. Treatment was given when seen by paramedics with an emergency room visit which included a second dose of allergy medication. The clinical outcome of the events bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The reported events were likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering the plausible temporal relationship and clinical course of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: LEVOTHYROXINE; ALERTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1000533
Sex: F
Age:
State: FL

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
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: Swelling of left lymph node under left armpit; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 19Jan2021 12:45 at a single dose for COVID-19 immunization. Medical history was none. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), colecalciferol (VITAMIN D), and ethinylestradiol, norgestimate (SPRINTEC). Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 29Dec2020 12:30 PM in the left arm for COVID-19 immunization when the patient was 32 years old. The patient was not pregnant. The patient had not received any other vaccine prior to covid vaccine. The patient experienced swelling of left lymph node under left armpit on 20Jan2021 22:15 with outcome of not recovered. Therapeutic measure was taken as a result of swelling of left lymph node under left armpit (lymphadenopathy) with OTC ADVIL.The patient had no covid prior vaccination nor was he tested post vaccination. Information on Lot/Batch number has been requested.

Other Meds: ADDERALL; VITAMIN D; SPRINTEC

Current Illness:

ID: 1000534
Sex: M
Age:
State: CA

Vax Date: 01/07/2021
Onset Date: 01/17/2021
Rec V Date: 02/04/2021
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: pain is very severe, includes all over the scrotum; includes all over the scrotum, with redness , induration , and kissing of the first layer of the skin; includes all over the scrotum, with redness , induration , and kissing of the first layer of the skin; kissing of the first layer of the skin all over the scrotum; inflammation of the scrotum; Got worse every day; This is a spontaneous report from a contactable physician. A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284), via an unspecified route of administration on the Right arm on 07Jan2021 at a [SINGLE DOSE] for COVID-19 immunisation. Medical history included hyperlipidaemia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had the first dose on 19Dec2020. On 17Jan2021, the patient noticed inflammation of the scrotum which got worse every day. On 20Jan2021, the pain was very severe which included all over the scrotum, with redness and induration and kissing of the first layer of the skin. Therapeutic measures (Eli on ointment, triple antibiotic ointment Kenalog) were taken as a result of the events. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1000535
Sex: F
Age:
State: AR

Vax Date: 01/09/2021
Onset Date: 01/12/2021
Rec V Date: 02/04/2021
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: felt a tinge of pain in my sacral area/It got worse each hour/ It worsen daily/It became painful; Became limited in movements such trying to picking up items from the floor; difficulty running or walking fast as I usually do; Lots of spasms in the sacral area; Difficulty sleeping; Difficulty sleeping and going from sitting to standing; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), via an unspecified route of administration in the left arm, on 09Jan2021 15:30, at single dose, for COVID-19 immunization, at the pharmacy. There was no medical history and no known allergies. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN), diphenhydramine hydrochloride (BENADRYL), herbal nos, minerals nos, nutrients nos, vitamins nos (CATALYST) and "Muscle Strength". The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not have other vaccines in four weeks. The patient reported that on 12Jan2021 at 14:00, "I ardently felt a tinge of pain in my sacral area. Then it got worse each hour. Then I became limited in movements such trying to picking up items from the floor and difficulty running or walking fast as I usually do. It worsened daily. I would workout and then I experienced lots of spasms in the sacral area. It became painful. The patient experienced difficulty sleeping and going from sitting to standing." The events resulted to "Doctor or other healthcare professional office/clinic visit". Treatment for the events included prescription muscle relaxants (unspecified), ibuprofen and "topi". The patient was recovering from the events.

Other Meds: EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]; BENADRYL; CATALYST

Current Illness:

ID: 1000536
Sex: F
Age:
State: IL

Vax Date: 12/20/2020
Onset Date: 12/20/2020
Rec V Date: 02/04/2021
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: Blurred vision; fatigue; dizziness; tachycardia; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ 1685), via an unspecified route of administration in the left arm on 20Dec2020 08:00 at a single dose for covid-19 immunization. Medical history included prediabetes, spinal stenosis of right back, allergies in penicillin, sulfa and yellow jacket venom. Concomitant medication included gabapentin, metformin, paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc and vitamins. On 20Dec2020 20:00, 12 hours after vaccine administration, the patient experienced blurred vision, fatigue, dizziness, tachycardia and arm soreness. The patient did not receive treatment for the events. The patient had not tested positive for COVID post vaccination. The outcome of the events was recovered on unspecified date.

Other Meds: GABAPENTIN; METFORMIN; TYLENOL; DICLOFENAC; ZINC

Current Illness:

ID: 1000537
Sex: F
Age:
State: MI

Vax Date: 01/13/2021
Onset Date: 01/15/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Administration date=13Jan2021, dose number=2/ administration date=21Dec2020, dose number=1; Starting 36 hr after 2nd dose had 4 days of whole body systemic hives, itching; Starting 36 hr after 2nd dose had 4 days of whole body systemic hives, itching; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on the Right arm on 13Jan2021 07:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient had the first dose of BNT162B2 on 21Dec2020. On 15Jan2021 03:00 PM, starting 36 hours after 2nd dose, the patient had 4 days of whole body systemic hives and itching. There were no respiratory symptoms. Therapeutic measures (Pepcid, Zantac, Benadryl oral and cream) were taken as a result of hives and itching. The outcome of the events was recovered on an unspecified date.

Other Meds: SYNTHROID

Current Illness:

ID: 1000538
Sex: M
Age:
State: ME

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Slight muscle discomfort; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (Lot number: EL3247), via an unspecified route of administration from 20Jan2021 11:15 to 20Jan2021 11:15 at single dose in the left arm for COVID-19 immunization. Medical history included blood pressure (BP) abnormal and high density lipoprotein abnormal (HDL). The patient has no known allergies. Concomitant medication included rosuvastatin calcium (CRESTOR), acetylsalicylic acid (ASP), losartan, ubidecarenone (COQ 10), ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) and isosorbide mononitrate (FLO). The patient experienced slight muscle discomfort on an unspecified date with outcome of unknown. The patient did not receive any treatment for the event. The 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. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds: CRESTOR; ASP; LOSARTAN; COQ 10; AREDS; FLO

Current Illness:

ID: 1000539
Sex: M
Age:
State: NJ

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
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: Moderate pain and swelling in the injection site; Moderate pain and swelling in the injection site; moderate headache; chills; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK4176), via an unspecified route of administration on 20Jan2021 at 14:00 at single dose on left arm for COVID-19 immunisation. Medical history and concomitant medications were none. No COVID prior vaccination. No COVID tested post vaccination. Known allergies: None. The patient experienced moderate pain and swelling in the injection site started abought 5 hours after receiving the vaccine and experienced moderate headache and chills as well, on 20Jan2021 at 21:00. No treatment was received for the events. Outcome of the events was resolving.

Other Meds:

Current Illness:

ID: 1000540
Sex: M
Age:
State: FL

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
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: Left arm soreness progressively increasing now 18 hours after injection difficulty raising arm; Left arm soreness progressively increasing now 18 hours after injection difficulty raising arm; Night sweats last night, soaked sheets/pillow/mattress; This is a spontaneous report from a non-contactable pharmacist who reported for self. A 39-year-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration on 20Jan2021 14:30 at single dose on left arm for COVID-19 immunisation. Medical history was none. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. Concomitant medications included ascorbic acid (VIT C) at 1 g once daily, ubidecarenone (COQ10 [UBIDECARENONE]) at 100 mg once daily, valaciclovir hydrochloride (VALTREX) at 500 mg once daily, all from unknown date for unknown indication. On 20Jan2021 at 16:30, patient experienced left arm soreness progressively increasing 18 hours after injection difficulty raising arm and night sweats last night, soaked sheets/pillow/mattress. No treatment was received. Outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: VIT C; COQ10 [UBIDECARENONE]; VALTREX

Current Illness:

ID: 1000541
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 01/12/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: fever 101; headache; chills; muscle pain; weakness; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on an unspecified date at 10:00 at single dose on left arm for COVID-19 immunisation. Medical history included depression/anxiety, back pain, COVID prior vaccination and known allergies: sulfa and penicillin. Concomitant medication included naproxen, sertraline HCL (ZOLOFT), fish oil, ospemifene (OSPHENA) and docusate sodium (COLACE), all from unknown date for unknown indication. On 12Jan2021 at 17:00, patient experienced fever 101, headache, chills, muscle pain, weakness, nausea and fatigue. Events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. Nasal Swab on 14Jan2021 was negative. Patient recovered in Jan2021. Information on the lot/batch number has been requested.

Other Meds: NAPROXEN; Zoloft; FISH OIL; OSPHENA; COLACE

Current Illness:

ID: 1000542
Sex: M
Age:
State: NC

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Triggered mild asthma attack; wheezing; Continued pain at injection site; Triggered a fibromyalgia episode; body pains; headache; fatigue; dizziness; This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 19Jan2021 08:45 at single dose for COVID-19 immunisation. Medical history included fibromyalgia and asthma. On 19Jan2021 16:00, the patient experienced triggered mild asthma attack, wheezing, continued pain at injection site, triggered a fibromyalgia episode, body pains, headache, fatigue, and dizziness. No therapeutic measure was taken as a result of the events. Clinical outcome of injection site pain was not recovered while for the other events was recovered on Jan2021.

Other Meds:

Current Illness:

ID: 1000543
Sex: M
Age:
State:

Vax Date: 01/06/2021
Onset Date: 01/12/2021
Rec V Date: 02/04/2021
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: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer(patient). A male patient of an unspecified age first dose received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization . The patient medical history and concomitant medications were not reported. The patient experienced tested positive for COVID on 12Jan2021 with outcome of unknown. Patient was scheduled for second dose on 27Jan2021, while doctors can't agree on whether he should et that second dose or not. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000544
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: allergic to the first dose; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 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 reporter was asking if there was any desensitization protocol for a second dose for someone allergic to the first dose. The outcome of the event was unknown. Information about Lot/Batch has been requested.

Other Meds:

Current Illness:

ID: 1000545
Sex: F
Age:
State: NY

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
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: Fatigue; Pain at location of vaccine injection when pressing and lifting arm; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 23-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3247), via an unspecified route of administration on 19Jan2021 at 14:00 at single dose on left arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. The patient experienced pain at location of vaccine injection when pressing and lifting arm on 19Jan2021 15:00 with outcome of recovering. Fatigue and trouble getting out of bed the morning after the shot on 20Jan2021 with outcome of recovering. This case was reported as non-serious.

Other Meds:

Current Illness:

ID: 1000546
Sex: M
Age:
State: TN

Vax Date: 01/08/2021
Onset Date: 01/11/2021
Rec V Date: 02/04/2021
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: Continued total body myalgias; weakness; This is a spontaneous report from a contactable Other Health Professional, the patient. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3246), via an unspecified route of administration in the left arm on 08Jan2021 at 13:00 PM (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had sars-cov-2 test on 04Jan2021 which was negative. Concomitant medication taken within two weeks of vaccination included dexlansoprazole (DEXILANT). The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), left arm on 19Dec2020 for COVID-19 immunization. The patient reported that he continued total body myalgias and weakness 11 days post injection. The events began on 11Jan2021. The events was reported as non serious. The patient did not receive treatment for the events. The clinical outcome of the events continued total body myalgias, and weakness was not recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19.

Other Meds: DEXILANT

Current Illness:

ID: 1000547
Sex: F
Age:
State: NC

Vax Date: 12/28/2020
Onset Date:
Rec V Date: 02/04/2021
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: muscle aches; joint pain; chills; nausea; This is a spontaneous report from a contactable consumer reporting for self. A 29-years-old female patient received Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EK9231, via an unspecified route of administration on 28Dec2020 12:15 (at age 29 years old), as a single dose in left arm; and Dose 2, Lot# EL3247, via an unspecified route of administration on 20Jan2021 10:15 (at age 29 years old) as a single dose, left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included generalised anxiety disorder, obsessive-compulsive disorder, asthma, and food allergy (citrus, berries, tropical fruits, ascorbic acid, dill, crab, tree nuts, peanuts). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO), alprazolam (XANAX), diphenhydramine hydrochloride (BENADRYL), and ibuprofen. The patient did not receive any other vaccines in the 4 weeks prior to COVID vaccination. On unspecified dates after both first and second doses, she had muscle aches, joint pain, chills, and nausea. There was no hospitalization or treatment received for the events. The events were reported as non-serious. The patient was recovering from muscle aches, joint pain, chills, and nausea. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: LEXAPRO; XANAX; BENADRYL; IBUPROFEN

Current Illness:

ID: 1000548
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: I received the first vaccine and donated blood 17 days later but I showed no antibodies.; This is a spontaneous report from a contactable consumer received from Pfizer sponsored program. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration from 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 the first vaccine and donated blood 17 days later but showed no antibodies. The patient was interested in knowing if blood should show antibodies 17 days after 1st vaccine. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1000549
Sex: F
Age:
State: NJ

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 10:15 AM at single dose in left arm for COVID-19 immunisation. The most recent COVID-19 vaccine was administered at workplace clinic. Patient age at vaccination is 65 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 06:15 PM, at single dose in right arm. Medical history included high blood pressure and high cholesterol. The patient has no allergies to medications, food, or other products/known allergies. The patient received unspecified concomitant medications. On 20Jan2021 on 01:00 PM the patient experienced a headache after second dose, it started about 24 hours after the 2nd dose. Still have it on day 2, but is not severe. Using generic Tylenol to treat it. The event was reported as non serious. The event was resolving. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 SR008138-Salivary, SARS-COV-2 COVID-19 test on 14Jan2021 with negative result.

Other Meds:

Current Illness:

ID: 1000550
Sex: F
Age:
State: NY

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: fatigue; slight headache; nausea; sore arm (left); swollen lymph nodes -left arm; This is a spontaneous report from a contactable consumer. A 28-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm left on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at arm left on 30Dec2020 at single dose for COVID-19 immunization. On 20Jan2021, the patient experienced fatigue, slight headache, nausea, sore arm (left) and swollen lymph nodes (left arm). The patient outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1000551
Sex: F
Age:
State: KS

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
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: Headache; Body aches; Diarrhea; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received bnt162b2 (brand: Pfizer), lot/batch no. and expiration date not provided, intramuscular on 20Jan2021 at a single dose for COVID-19 immunization. Medical history included diagnosed with COVID-19 prior to vaccination. Concomitant medications included unspecified vaccine/s. The patient received other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered at a nursing home/senior living facility. The patient was not pregnant at the time of vaccination. The patient experienced headache, body aches, diarrhea on 20Jan2021. No treatment received for the adverse events. All events were assessed as non-serious (did not result to death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, and no congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000552
Sex: M
Age:
State:

Vax Date: 01/20/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
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: heavy tired; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021, at 10:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After vaccine the patient had no fever but feels really tired, 'heavy tired'. Has taken two aspirins for symptoms. The outcome of the event was unknown. The information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000553
Sex: F
Age:
State: AL

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Nausea; Chills; Headache; Cough; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on left arm on 19Jan2021 14:15 at single dose for covid-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol, lisinopril, estradiol, sertraline and tramadol hydrochloride (TRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, chills, headache, cough, all on 19Jan2021. The events were assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was recovering.

Other Meds: METOPROLOL; LISINOPRIL; ESTRADIOL; SERTRALINE; TRA

Current Illness:

ID: 1000554
Sex: F
Age:
State: CA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: dizziness; severe injection site pain and swelling; severe injection site pain and swelling; swollen neck glands; scattered itching; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 12Jan2021 at 14:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included end-stage renal failure and bipolar and the patient had known allergies to penicillin, sulfa, fish, shellfish, broccoli, and cauliflower. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medication included apixaban (ELIQUIS) from an unknown date at an unknown dose for an unknown indication. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 12Jan2021 at 01:15 (as reported) the patient experienced severe injection site pain and swelling, swollen neck glands, scattered itching, and dizziness. The patient was treated for the arm pain with paracetamol (TYLENOL). The clinical outcome of the severe injection site pain and swelling, swollen neck glands, scattered itching, dizziness was recovered on an unknown date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.

Other Meds: ELIQUIS

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm