VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 1021860
Sex: F
Age: 79
State: LA

Vax Date: 02/04/2021
Onset Date: 02/08/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: None

Allergies: none

Symptoms: COVID ARM. Huge red area below the injection site of the Deltoid muscle darkening all the way down to the elbow and pooling there as a huge red arc. Painless with no itching.

Other Meds: curcumin

Current Illness: n0ne

ID: 1021864
Sex: M
Age: 65
State: MI

Vax Date: 01/31/2021
Onset Date: 02/07/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies: No known allergies

Symptoms: On day seven after receiving the vaccination, a rash appeared on the back of the neck that progressed around the entire neck by day eight. On day nine rash appeared on the back of both arms and significant left arm pain distal to the injection site accompanied by inflammation. The inflammation appears to be present all over.

Other Meds: Synthroid, multivitamin, glucosamine/chondroitin, coq10

Current Illness: None

ID: 1021867
Sex: F
Age: 35
State: IN

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: none

Allergies: Septra- hives

Symptoms: headache, lightheadedness, and muscle soreness

Other Meds: SlimVance Multivitamin

Current Illness: none

ID: 1021871
Sex: F
Age: 38
State: HI

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies: Crustaceans.

Symptoms: Client reported being anxious prior to vaccination, but did some deep breathing which she felt helped calm her down. After the injection, she felt dizzy, "the room was spinning" and she was not able to focus on what the vaccinator was saying. She reported feeling dizzy to the vaccinator who kept her seated and provided bottled water. Clinic Manager and Vaccine Group Supervisor took initial vital signs. Client also appeared to be shaking. 10:20am: BP: 130/96, HR: 90. At about 10:25am, client reported feeling better. VGS moved client to a seat near the clinic staff area to complete her 30 minute waiting period. VGS took vital signs. 10:30am: BP: 120/90, HR: 88. Client was no longer visibly shaking. She reported that her husband was waiting in the car to take her home. Client's condition improved and was released from the clinic to return to her home. Client was escorted to her car by the Deputy Safety Officer.

Other Meds:

Current Illness:

ID: 1021874
Sex: F
Age: 35
State: CA

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

Lab Data:

Allergies: Penicillin Sulfa drugs

Symptoms: Hard, itchy bump at injection site. Cannot see if discolored due to tattoo. Bump is approximately 1cm wide.

Other Meds: Triamcinolone .1%

Current Illness: None

ID: 1021878
Sex: F
Age: 30
State: GA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Severe right arm pain, chills, low grade fever, body aches, nausea. Most severe symptoms lasting 24 hours

Other Meds: Adderall, escitalopram

Current Illness:

ID: 1021881
Sex: M
Age: 84
State: CO

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: none

Allergies: Zestril, Tramadol

Symptoms: Nausea, Night sweats, Joint Pain in legs and lower back, Headache, fever (99.3 to 100.9), fatigue. Treated with Tylenol , Naproxen , Lidocaine patch, fluids, heating pad and rest. Reduced fever, reduced joint pain, headache persisted. Time course: 24 hour period

Other Meds: Atorovastin Lemoelthyroxin Flomax Vit C Multi Vitamin

Current Illness: Melanoma

ID: 1021884
Sex: F
Age: 65
State: CA

Vax Date: 02/03/2021
Onset Date: 02/10/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Redness, itching, swelling (hardness) at injection site

Other Meds: Levothyroxine; ibuprofin; vitamin D3; zinc; potassium; magnesium; multivitamin

Current Illness: None

ID: 1021888
Sex: F
Age: 24
State: GU

Vax Date: 02/02/2021
Onset Date: 02/10/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies: No

Symptoms: Rash and bruised appearance around injection site, one week after vaccine was administered. Experiencing tight muscles and soreness.

Other Meds: No

Current Illness: No

ID: 1021890
Sex: F
Age: 53
State: WI

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: None

Allergies: Bee venom

Symptoms: Terrible headache that lasted 3 days

Other Meds: None

Current Illness: None

ID: 1021894
Sex: F
Age: 77
State: CA

Vax Date: 02/01/2021
Onset Date: 02/07/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Red and itches

Other Meds: Statin

Current Illness:

ID: 1021896
Sex: F
Age: 37
State: OR

Vax Date: 02/02/2021
Onset Date: 02/08/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Days 1-3: Headache, nausea, weakness, low-grade fever, chills, limited neck movement, limited left arm movement, bone pain in both legs and hips, full back pain Days 4-6: Headache, nausea, fatigue and poor activity tolerance Days 7-9: Hives/rash first appeared on upper arms, then progressed to lower arms and neck. Hives increased to mid and upper back, and both legs. Leg rash not raised, look like petechiae. Pruritus most severe in shoulders, neck, back.

Other Meds: Melatonin

Current Illness: None

ID: 1021898
Sex: M
Age: 36
State: HI

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: None

Allergies: Shellfish (reaction: hives)

Symptoms: Client in post vaccination waiting area. Approximately 6 minutes after arriving, a felt flushed, anxious feeling. Reports dizziness and lightheadedness. Patient requests to use nearby cot. Staff escorted patient to cot to lie down. BP on palpation 100. At 10:20am, BP 108/76 HR68 R18. Requests to stay lying down. At 10:38am, patient is ready to sit up. BP120/76 HR72 R 72. Patient reports "feeling normal." Continues to sit and drink offered water. Reports did not eat breakfast this AM. Ready to depart at 1050. Final BP 110/76 HR 76, R18. No complaints

Other Meds: Venlofaxin QD

Current Illness: None

ID: 1021899
Sex: F
Age: 78
State: CA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: none

Allergies: Allergies to sulfur and sulfides. Asthma to wood fires, hay

Symptoms: Exhaustion onset about 8:00 PM 1/26/21 lasting over 36 hours before starting to feel better. I literally slept all of the next day only getting up occasionally and most of the day after that. I started to become more normal feeling the late afternoon of 1/28/21. I also felt very stiff and uncomfortable. Sore neck and joint pain and a slight headache. I had a sore area across my arm (felt like a bruise although there was no discoloration) about 1 inch inch below the injection sight which was on my upper left arm. That persisted for several days. I slept and took 1 800 mg Ibuprofen (on 1/27/2021). Am feeling better but still not feeling 100 %. That may be due to increased allergies due to time of year of etc a

Other Meds: 1 ea Dextroamphetamine ER 15 mg cap am, hyaluronic acid, MSM,

Current Illness: No other illnesses.

ID: 1021903
Sex: M
Age: 70
State: IN

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

Lab Data:

Allergies: no

Symptoms: chills, aches, and nausea.

Other Meds: crestor, blood pressure medication

Current Illness: none

ID: 1021911
Sex: U
Age:
State: VA

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

Lab Data:

Allergies:

Symptoms: Caller reports administration of ROTATEQ after temperature excursion; This spontaneous report was received from a reporter and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided. On 11-JAN-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter oral route, lot # 1742457 and expiration date 06-JAN-2022 administered as prophylaxis. The improperly stored dose of the suspect vaccine experienced a temperature excursion of 1.3 degree Celsius (?C) for 19 minutes on an unknown date; no previous temperature excursion were reported. The call was made due to a digital data logger. Lot No. 1742457 has been verified to be a valid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), expiration date reported as 16-FEB-2022, but upon internal validation established as 06-JAN-2022.

Other Meds:

Current Illness:

ID: 1021912
Sex: U
Age:
State: VA

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

Lab Data:

Allergies:

Symptoms: administration of rotateq after temperature excursion; This spontaneous report was received from an other reporter (unspecified) and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 15-JAN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, po (orally), lot # 1691141 (valid lot #), expiration date reported and also validated as 01-NOV-2021, for prophylaxis. It was detected by the data logger, that the vaccine had temperature excursion (product storage error). It was stored at the temperature of 1.3 degree Celsius (C) for 19 minutes. No previous temperature excursion reported.

Other Meds:

Current Illness:

ID: 1021913
Sex: U
Age:
State: FL

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: NO ADVERSE EVENT; product storage error; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 05-FEB-2021, the patient received improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T031820 with expiration date of 10-MAY-2022, 0.5 milliliter for prophylaxis. The vaccines experienced temperature excursi?n of 47.7 degrees F for 30 minutes. No previous temperature of excursion. Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T031820; expirationdate: 10-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness:

ID: 1021914
Sex: M
Age:
State: FL

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: having trouble bending his right elbow; swollen right elbow; very painful; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-010782), license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021102713) on 26-Jan-2021 and was forwarded to BMS on 02-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of arthropathy (having trouble bending his right elbow), joint swelling (swollen right elbow) and pain (very painful) in 79-year-old male patient who received apixaban (ELIQUIS) tablet for cerebrovascular accident prophylaxis. Co-suspect products included COVID-19 vaccine injection for prevention. Concurrent medical conditions included congestive heart failure, type II diabetes mellitus and hypertension. On an unknown date, the patient started ELIQUIS (oral), 1 tab twice a day. On 21-Jan-2021, the patient started COVID-19 vaccine (intramuscular). On 22-Jan-2021, an unknown time after starting ELIQUIS, the patient experienced arthropathy (having trouble bending his right elbow), joint swelling (swollen right elbow) and pain (very painful). The dose of ELIQUIS (oral) was not changed. At the time of the report, arthropathy outcome was unknown, joint swelling did not resolve and pain was resolving. For ELIQUIS (oral), the reporter did not provide any causality assessments.

Other Meds: ALLOPURINOL; SPIRONOLACTONE; BUSPIRONE HYDROCHLORIDE; FINASTERIDE; GLIPIZIDE; VALSARTAN; DOXAZOSIN MESILATE; LOPERAMIDE; COLECALCIFEROL; PRAVASTATIN SODIUM; FUROSEMIDE; CARVEDILOL

Current Illness: Congestive heart failure; Hypertension; Type II diabetes mellitus

ID: 1021915
Sex: U
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: felt dizzy; VIRAL INFECTION FOLLOWING; This case was reported by a physician via sales rep and described the occurrence of dizziness in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and MENACTRA for prophylaxis. On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Influenza vaccine Quadrivalent unspecified season and MENACTRA. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Influenza vaccine Quadrivalent unspecified season, the patient experienced dizziness and viral infection. On an unknown date, the outcome of the dizziness and viral infection were unknown. The reporter considered the dizziness and viral infection to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the reporter considered the dizziness and viral infection to be related to Influenza vaccine Quadrivalent unspecified season. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The case was reported by the mother. The age at vaccination was not reported. The patient felt dizzy, followed by viral infection. The mother of the patient looked up Meningococcal B and was convinced that it was pulled up adverse reaction. She did not want to report it because it was 3 vaccines. It was unknown if the reporter considered the dizziness and viral infection to be related to Menectra. This case had been linked with US2020AMR261157 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR261157:Same reporter

Other Meds:

Current Illness:

ID: 1021916
Sex: M
Age: 91
State: NJ

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 02/11/2021
Hospital: Y

Lab Data: Test Date: 20201230; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptoms: Stomach bleed from blood thinners; Tested positive for COVID-19; A spontaneous report was received from a consumer concerning a 91-year-old, White, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a positive Covid-19 test and the serious adverse event of stomach bleed from blood thinners. The patient's medical history, as provided by the reporter, included dialysis three times a week with a port in his left arm, broken hip, and stomach bleed. No medication allergies reported. Concomitant medications reported included acetylsalicylic acid and multiple medications not otherwise specified. On an unknown date prior to receiving the vaccine, the patient began to experience stomach bleed. He was hospitalized and discharged before the vaccination. On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot number 025J20A, expiration date 29 Jun 2021) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, after the injection, the patient was tested for Covid-19, and the results were positive. On an undisclosed date purported to be two weeks after vaccination, the patient was hospitalized due to a stomach bleed from blood thinners, and an unknown blood vessel procedure was performed. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, tested positive for Covid-19 and stomach bleed from blood thinners, was not reported.; Reporter's Comments: A spontaneous report concerns a 91-year-old, White, male, patient, with medical history of dialysis three times a week with a port in his left arm, broken hip, and stomach bleed, who experienced a positive Covid-19 test and the serious event of stomach bleed from blood thinners. The event of positive Covid-19 test occurred on the same day after the administration of the first dose of mRNA-1273 (Lot number 025J20A, expiration date 29 Jun 2021) and stomach bleed occurred on an unknown date after the vaccine administration. Treatment for stomach bleed included blood vessel procedure. Based on the information provided, there is not a definite association between the vaccine administration and the reported events. Use of blood thinners could have contributed to the event of Stomach bleed, also confounded by the patient's medical history of stomach bleed and concomitant use of acetylsalicylic acid. COVID positive test was obtained on the same day as vaccination and unlikely to have resulted from mRNA-1273 administration.

Other Meds: BABY ASPIRIN

Current Illness: Dialysis (three times a week, port in left arm); GI bleed

ID: 1021917
Sex: M
Age:
State: NY

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/11/2021
Hospital: Y

Lab Data: Test Date: 20210127; Test Name: Echo; Result Unstructured Data: No results provided.

Allergies:

Symptoms: Syncope; Shaking; Struggling to breathe; A spontaneous report was received from a consumer concerning a 90-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed syncope, shaking, and struggling to breathe. The patient's medical history was not provided. Concomitant medications reported included warfarin, ezetimibe, bupropion, finasteride, tamsulosin, furosemide, potassium chloride, rosuvastatin, and nitrofurantoin. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, after vaccine administration, the patient stayed at the vaccination site for fifteen minutes to watch for any reaction, he had none, so he left. Later that night the patient began shaking and struggling to breathe, so 911 was called. At the hospital, the patient was diagnosed with syncope. He spent overnight in the hospital and had an echocardiogram the following day. No results were provided for the echo, but the patient was cleared to go home after a sixteen-hour hospital stay. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events, syncope, shaking, and struggling to breathe, was resolved.; Reporter's Comments: This case concerns a 90 year-old, male patient, who experienced events of syncope, shaking, and struggling to breathe. The events occurred the same night after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds: WARFARIN; EZETIMIBE; BUPROPION; TAMSULOSIN; FINASTERIDE; FUROSEMIDE; POTASSIUM CHLORIDE; CRESTOR; NITROFURANTOIN

Current Illness:

ID: 1021918
Sex: F
Age: 58
State: CA

Vax Date: 01/13/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Flushed; Body aches; Red rashy spot; Fatigued; The site on my left arm got to a baseball size; Headaches; Felt like I would throw up; Ended up fainting/ went down for a second time; Diarrhea; Light headed; Discombobulated; A spontaneous report was received from a 58 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea, felt that she would throw up, light headed, fainted, discombobulated, site on her left arm got to a baseball size, and in the middle was a red rashy spot, flushed, fatigued, had body aches and headaches. The patient's medical history included high blood pressure. Relevant concomitant medications included unknown blood pressure medication. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, around three, the patient experienced diarrhea, she thought it was food poisoning. While on the "pot" with diarrhea she felt that she would throw up. She mentioned that she became lightheaded but did not throw up and ended up fainting. She fell off the pot and decided to lay down in her bed. She got lightheaded again and went down for a second time. She stated she had a difficult time getting up; she crawled to the bed. When she attempted to stand up, she could feel she was lightheaded again. The patient mentioned that maybe she was down 45 minutes before getting to lay on her bed. She felt discombobulated. She felt very clumsy when trying to dial her sister's number; she left a message on the machine and was struggling to get her words together. The site on her left arm got to a baseball size, and in the middle was a red rashy spot. On Friday evening, 26 Jan 2021, the patient stated she started feeling better. She mentioned that she was flushed, fatigued and had body aches. The patient stated she hasn't tried any treatments but took paracetamol for headaches and tried to rest. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, diarrhea, felt that she would throw up, light headed, fainted, discombobulated, site on her left arm got to a baseball size, and in the middle was a red rashy spot, were resolving. The outcome of the events, headaches, flushed, fatigued and body aches, were unknown.; Reporter's Comments: This case concerns a 58 year old female patient with medical history of high blood pressure, who experienced a serious unexpected event of Syncope and NS unexpected events of diarrhea, nausea, dizziness, confusional state, injection site swelling, rash erythematous, flushing , fatigue, pain and headache. The events occurred approximately 8 days after first dose of the study medication administration. she only took paracetamol for headaches and tried to rest without any other treatment. 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.

Other Meds:

Current Illness: Hypertension

Date Died: 01/20/2021

ID: 1021919
Sex: F
Age: 86
State: FL

Vax Date: 01/06/2021
Onset Date: 01/17/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Death; kidney failure (unable to urinate); shortness of breath; required oxygen; A spontaneous report was received from consumer concerning an 87-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, kidney failure and death. The patient's medical history included advanced kidney and heart disease. No relevant concomitant medications were reported. On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 17 Jan 2021, the husband reported that the patient experienced adverse events. Symptoms included shortness of breath and kidney failure (unable to urinate). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. Action taken with mRNA-1273 in response to the events was not applicable. On 20 Jan 2021, the patient died. The cause of death was unknown. Autopsy details were unknown.; Reporter's Comments: This case concerns a 87-year-old, female patient with the medical history of advanced kidney and heart disease, who experienced fatal unexpected event of dyspnea, renal failure and death. The events of dyspnea and renal failure occurred 12 days and the event of death occurred 15 days after the first dose of mRNA-1273 (Lot: unknown). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. The cause of death was unknown. Autopsy details were unknown. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the history of advanced kidney and heart disease may remain as confounder. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness: Heart disease, unspecified; Renal disease

ID: 1021920
Sex: F
Age: 66
State: GA

Vax Date: 01/26/2021
Onset Date: 02/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Also gagged a couple of times, but not really a stomachache; little bit of a headache; temperature of 101 with first shot; Cellulitis really bad right now; A spontaneous report was received from a consumer who was also a 66-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis really bad right now, gagged a couple times, but not really a stomachache, temperature of 101 degrees Fahrenheit and a little bit of a headache. The patient's medical history included what she described as having reactions to things sometimes, and has an Epi-Pen, however has never ever used it. On 26 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 31 Jan 2021, the patient increase in body temperature to 101 degrees Fahrenheit. On 01 Feb 2021, approximately one week after receiving the mRNA-1273 vaccine, the patient reported a visit to her physician. She has cellulitis really bad right now. She also reports a little bit of a headache and that she had gagged a couple times but not really a stomachache. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, cellulitis really bad right now, gagged a couple times, but not really a stomachache, temperature of 101 degrees Fahrenheit and a little bit of a headache were not reported.; Reporter's Comments: This case concerns a 66 year-old, female patient, who experienced events of a temperature of 101 degrees Fahrenheit, cellulitis really bad right now, a little bit of a headache, and also gagged a couple times. The events occurred approximately 1 week after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds: EPIPEN

Current Illness:

ID: 1021921
Sex: M
Age: 56
State: NJ

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/11/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Heart rate dropped to 30; A spontaneous report was received from consumer concerning a 56 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient's heart rate had dropped to 30. The patient's medical history was organ transplant. Concomitant product use was not provided. On 22-Jan-2021, the patient received the first of two planned doses of mRNA-1273, Batch number 011J20A, intramuscularly for prophylaxis of Covid-19 infection. On an unknown date, the patient's "heart rate was dropped to 30". He was hospitalized for 6 days. Treatment medication was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown.; Reporter's Comments: This case concerns a 56 year old male patient with relevant medical history of organ transplant who received the first of two planned doses of mRNA-1273 (Batch number 011J20A) intramuscularly for prophylaxis of Covid-19 infection and experienced a serious unlisted event of decreased heart to 30 and was hospitalized for six days. Treatment details not provided. Very limited information regarding this event has been provided at this time which precludes a proper medical assessment and in addition, patient's history of organ transplant may provide an alternative explanation and the event is unlikely related to the vaccine. Further follow has been requested.

Other Meds:

Current Illness:

ID: 1021922
Sex: M
Age: 35
State: KY

Vax Date: 12/29/2020
Onset Date: 12/31/2020
Rec V Date: 02/11/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Chest pain; Acute Myocarditis; Fever; A spontaneous report was received from a healthcare professional concerning a 35-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed chest pain, myocarditis, and fever. The patient's medical history included COVID-19 in Oct of 2020. No relevant concomitant medications were reported. On 29 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (lot number or batch number not provided) intramuscularly (in the left arm) for prophylaxis of COVID-19 infection. On an unknown date after receiving vaccine the patient developed a fever and chest pain. On 31 Dec 2020 the patient was admitted to the hospital where a heart catheterization was done-negative results. The patient was diagnosed with myocarditis. He was scheduled to receive his second dose of vaccine on 03 Feb 2021. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events chest pain, myocarditis, and fever were not reported.; Reporter's Comments: This case concerns a 35-year-old, male patient with a medical history of COVID-19, who experienced a serious unexpected event of chest pain, myocarditis and an expected event of pyrexia. The events of chest pain and pyrexia occurred on an unspecified date and the event of myocarditis occurred 3 days after the first dose of mRNA-1273. A heart catheterization was done-negative results.Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1021923
Sex: M
Age: 71
State: GA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210119; Test Name: Temperature; Test Result: 104 {DF}; Result Unstructured Data: 104 Fever; Test Date: 20210119; Test Name: Xray; Result Unstructured Data: Diagnosed with pneumonia

Allergies:

Symptoms: Pneumonia; 104 Fever; A spontaneous report was received from a consumer who was also a 71-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 104 fever and pneumonia. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, after receiving the vaccination, the patient reported a 104 degrees Fahrenheit fever. The patient went to his health care provider (HCP). X-ray was taken. Pneumonia was diagnosed. Treatment included prednisone, antibiotic and nebulizer. The patient was also prescribed albuterol but did not use. On 21 Jan 2021, the fever had resolved. On 29 Jan 2021, the subject returned to the doctor. On the same day, pneumonia was gone. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the event was reported 104 fever was resolved on 21 Jan 2021. The outcome for the event pneumonia was reported resolved on 29 Jan 2021.; Reporter's Comments: This case concerns a 71-year-old male subject, who experienced a serious unexpected event of Pneumonia, and non-serious expected event of Pyrexia. The events occurred same day after the first dose of the mRNA-1273 administration. Treatment included prednisone, antibiotic and nebulizer. Pyrexia resolved 2 day after, and Pneumonia resolved 10 days after first dose of vaccination. Since Pneumonia has insidious onset rather than acute onset, the event was possibly caused by underlying condition confounded by elderly age of patient. Very limited information regarding these events have been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event of Pneumonia and Pyrexia, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1021924
Sex: F
Age: 71
State: FL

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/11/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Anaphylactic shock; A spontaneous report was received from a consumer who is also a 71-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 27 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, after the mRNA-1273 vaccine was being given, the patient noted anaphylaxis symptoms, was rushed to the hospital and hospitalized for 24 hours. Treatment information included hospitalization, epinephrine and breathing treatments. Action taken with mRNA-1273 will be discussed with her physician. The outcome of the event anaphylaxis was unknown.; Reporter's Comments: This case concerns a 71-year-old female patient. The medical history is not provided. The patient experienced a serious unexpected event of Anaphylactic reaction on the same day after receiving their first of two planned doses of mRNA-1273 (Lot # 029L20A). Treatment included epinephrine and breathing treatments. Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 1021925
Sex: F
Age: 88
State: SC

Vax Date: 01/12/2021
Onset Date: 01/23/2021
Rec V Date: 02/11/2021
Hospital: Y

Lab Data: Test Date: 20210129; Test Name: SARS-COV-2 test; Result Unstructured Data: Positive

Allergies:

Symptoms: Broke Hip at Assisted Living; Fell; Tested positive for COVID-19; A spontaneous report was received from a daughter concerning a 88-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and fell and fractured hip, and tested positive for COVID-19. The patient's medical history, as provided by the reporter, included Alzheimer's and behavioral problems. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient fell and fractured her hip at her assisted living facility, and was hospitalized. Treatment for hip fracture was not provided. On 29 Jan 2021, at the hospital, she subsequently tested positive for COVID-19. Treatment included oxygen through 30 Jan 2021. On 01 Feb 2021, it was reported that the patient was not on a ventilator. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events fell and fractured hip and tested positive for COVID-19 were unknown at the time of this report.; Reporter's Comments: This case concerns a 88 year old female with medical history of Alzheimer's and behavioral problems, who experienced a serious unexpected events of fall and hip fracture 12 days after the first dose of mRNA-1273. Information on treatment not provided. On 29-Dec-2021, she had a serious unexpected event of COVID-19 18 days after mRNA-1273, requiring supplemental oxygen. Based on the current available information and temporal association between the of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Alzheimer's disease; Behavior abnormal (Behavioral problems)

Date Died: 01/18/2021

ID: 1021926
Sex: F
Age:
State:

Vax Date: 01/05/2021
Onset Date: 01/08/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210108; Test Name: Covid-19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptoms: Passed away; Positive result; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19 and passed away. The patient's medical history was not provided. Concomitant product use was not reported. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient had a positive COVID-19 test. On 18 Jan 2021, the patient passed away. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 18 Jan 2021. The cause of death was not reported.; Reporter's Comments: This spontaneous report concerns a female patient who experienced COVID-19 and passed away. The event of COVID-19 occurred 4 days after the first and only dose of the mRNA-1273 vaccine administered and death occurred 14 days after administration of the mRNA-1273 vaccine. Based on the information provided and the known etiology of COVID-19, it is unlikely to be associated with mRNA-1273 vaccine administration. With no definite information on the clinical details of the death, it is difficult to adequately assess a causal association with mRNA vaccine. Main field defaults to ?possibly related'; Reported Cause(s) of Death: unknown cause of death

Other Meds:

Current Illness:

ID: 1021927
Sex: M
Age:
State:

Vax Date: 01/11/2021
Onset Date: 01/14/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Severe lip swelling; Body rash; Chills, rigors; Muscle aches; Nausea; Generalized weakness; This is a spontaneous report from a contactable physician (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Arm Left on 11Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EK5730. Medical history and concomitant medications were not provided. Patient had no known allergies. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at Left arm for COVID-19 immunisation, lot number: ELO142. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 14Jan2021 at 04:00 PM patient experienced severe lip swelling, body rash, chills, rigors, muscle aches, nausea, generalized weakness. The events were treated with fexofenadine hydrochloride (ALLEGRA), diphenhydramine hydrochloride (BENADRYL) and presnosone. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient had not tested for COVID-19 since having the vaccine. Patient was recovering from the events, at the time of the report.

Other Meds:

Current Illness:

ID: 1021928
Sex: F
Age:
State: FL

Vax Date: 01/08/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: developing a diffuse rash on her body/it is a maculopapular rash mostly on her torso, chest, abdomen and it is now extending to her upper thighs; lesions on her chest; This is a spontaneous report from a contactable physician (patient). A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899, expiry date: unknown), intramuscular on 08Jan2021 09:00 at single dose (left upper arm) for COVID-19 immunization (prevent covid). Medical history included ongoing Hypertension (diagnosed a couple of years ago), ongoing Osteoporosis (diagnosed about 5 or 10 years ago, she does not take any medication for this), ongoing Grover's disease (diagnosed about 5 or 10 years ago). There were no concomitant medications. The patient received her first dose of bnt162b2 on 18Dec2020 around 13:30, in the upper left arm for COVID-19 immunization. She confirms she received the same lot number for both doses. Vaccination facility type was hospital. The patient received vaccine about 10 days ago. She is developing a diffuse rash on her body (Jan2021). She would like to know if there is any guidance on how to treat rash. She has a history of Grover's and she had lesions on her chest about a week ago (Jan2021), she put some cortisone cream on it. She noticed that her whole abdomen had the rash, states it is not itchy. She really noticed the rash yesterday. She stated that it is a maculopapular rash mostly on her torso, chest, abdomen and it is now extending to her upper thighs. States the lesions occurred about one or two weeks ago and she is not sure if that was before or after the second dose of the vaccine. She clarified that she received the second dose of the vaccine twelve days ago, not ten days ago. When querying causality, states there is no other reason for the rash, so it is probably related to the vaccine. The outcome of the event developing a diffuse rash on her body/it is a maculopapular rash mostly on her torso, chest, abdomen and it is now extending to her upper thighs was not recovered, while for other event was unknown. Therapeutic measures were taken as a result of lesions on her chest.

Other Meds:

Current Illness: Grover's disease (Diagnosed about 5 or 10 years ago.); Hypertension (diagnosed a couple of years ago); Osteoporosis (diagnosed about 5 or 10 years ago, she does not take any medication for this)

ID: 1021929
Sex: F
Age:
State: SC

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210123; Test Name: Fever; Result Unstructured Data: Test Result:102 degrees

Allergies:

Symptoms: Fever of 102 degrees; Chills/rigors; Fatigue; Headache; Body aches; Injection site redness; Injection site pain; Injection site swelling; This is a spontaneous report from a contactable healthcare professional. A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9262, via an unspecified route of administration at left arm on 22Jan2021 13:00 at a single dose for COVID-19 immunisation. Medical history included allergy to metals, cervix carcinoma from 2014, hysterectomy from 2014, chemotherapy from 2014, radiotherapy from 2014, Lyme disease from 1991 and mononucleosis from 1980's. Concomitant medication included bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]). The patient previously took codeine and experienced allergy. Historical vaccine included first dose of bnt162b2 on 22Dec2020. On 23Jan2021, the patient experienced fever of 102 degrees, chills, rigors, fatigue, headache, body aches, injection site redness, injection site pain and injection site swelling. The patient took ibuprofen as rest as treatment. The outcome of the events was recovering.

Other Meds: PROBIOTIC [BIFIDOBACTERIUM LACTIS]

Current Illness:

ID: 1021930
Sex: F
Age:
State:

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: shingles; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. Therapeutic measures were taken as a result of shingles which included treatment with acyclovir. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1021931
Sex: F
Age:
State: NY

Vax Date: 01/22/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: fever; Result Unstructured Data: Test Result: temp was normal; Test Date: 202101; Test Name: fever; Result Unstructured Data: Test Result:101.5

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown), via an unspecified route of administration on 22Jan2021 at 14:00 (at the age of 65-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Covid in Mar2020 during which the patient suffered with symptoms and fever for 17 days followed by several weeks of feeling weak. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jan2021 at 19:00, after taking the first dose, the patient experienced tiredness, joint pain, headache, muscle pain, chills, fever of 101.5, and nausea, which the patient stated were the same symptoms the patient had experienced when the patient was diagnosed with COVID-19 in Mar2020. The patient did not receive any treatment for the events. The patient sated these symptoms lasted 2 1/2 days until temp was normal and symptoms started to fade. The clinical outcome of fever was recovered on an unknown date in 2021.The clinical outcomes of tiredness, joint pain, headache, muscle pain, chills, nausea were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1021932
Sex: F
Age:
State: MA

Vax Date: 01/18/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: Nasal Swab; Result Unstructured Data: Test Result:unknown

Allergies:

Symptoms: started menstrual cycle after not having it for 8+ years; This is a spontaneous report from a contactable Healthcare Professional, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3302), via an unspecified route of administration in the left arm on 18Jan2021 at 10:00 (at the age of 59-years) as a single dose for COVID-19 immunization. Medical history included asthma, diabetic, and known allergies to all penicillin's and macadamia nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included dulaglutide (TRULICITY), metformin, bupropion hydrochloride (WELLBUTRIN), trazodone, terbinafine hydrochloride (LAMATER). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021 at 16:00, the patient reported her menstrual cycle started after not having it for 8+ years. Post vaccination, on 25Jan2021 the patient was tested for COVID-19 via nasal swab with an unknown result. The clinical outcome of the event, menstrual cycle started after not having it for 8+ years, was unknown.

Other Meds: TRULICITY; METFORMIN; WELLBUTRIN; TRAZODONE; LAMATER

Current Illness:

ID: 1021933
Sex: U
Age:
State: MD

Vax Date: 01/24/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st dose of the COVID-19 vaccine "yesterday" (24Jan2021) and developed severe sore throat in the middle of the night (Jan2021). The patient woke up last night with a severe sore throat, and "today" (25Jan2021), about 18 hours after getting the vaccine, the patient developed headache and malaise, also reported as "body malaise," and generally didn't feel well. The outcome of the events severe sore throat, headache, malaise/body malaise, and generally didn't feel well was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1021934
Sex: F
Age:
State: NY

Vax Date: 01/07/2021
Onset Date: 01/09/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: Bakers cyst test; Result Unstructured Data: Test Result:fluid leaked into area that formed into this area

Allergies:

Symptoms: The left calf is swollen 3/4 inch; Left knee effusion/ she got the Bakers cyst test, the fluid leaked into the area that formed into this area; swollen cervical and supraclavicular lymph nodes on the left side/ swollen axillary lymph nodes on both sides; This is a spontaneous report from a contactable healthcare professional (Physician Assistant) reporting for self. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EL0142, Dose 1, intramuscularly on 07Jan2021 07:15 (at the age of 48 years old) as a single dose in left arm for COVID-19 immunization. Medical history included ongoing undifferentiated spondyloarthropathy diagnosed more than 10 years ago. Concomitant medication included golimumab (SIMPONI), 0.5mg subcutaneous injection once a month for undifferentiated spondyloarthropathy. There were no prior vaccinations in the past 4 weeks. There were no adverse events with prior vaccinations. Two days after the vaccine on 09Jan2021 she experienced swollen cervical and supraclavicular lymph nodes on the left side. On 12Jan2021 by 09:00 she developed left knee effusion and swollen axillary lymph nodes on both sides. It was worse "now" (as of Jan252021); she states she got the Bakers cyst test, the fluid leaked into the area that formed into this area. On an unspecified date, the left calf was swollen 3/4 inch. The events did not require a visit to the Emergency Room. The events did require a visit to her rheumatologist on Friday, 22Jan2021. There reporter declined having had treatment for the events. The outcome of the left knee effusion was not recovered; left knee effusion was reported as worsened. The outcome of swollen on axillary lymph nodes on both sides, swollen cervical and supraclavicular lymph nodes on the left side was recovering. The outcome of left calf was swollen 3/4 inch was unknown. Her rheumatologist was asking if he can drain it or send fluid for any studies prior to any treatment, and for any advice or if any special markers need to be drawn in case Pfizer would like more information on this.

Other Meds: SIMPONI

Current Illness: Spondyloarthropathy (undifferentiated; diagnosed more than 10 years ago)

ID: 1021935
Sex: M
Age:
State: OK

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: back pain/soreness in his lower back/had bad lower back pain; injection site pain on his arm that traveled to his shoulder; joint pain/injection site pain on his arm that traveled to his shoulder; nausea; had a sore left arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration in his left arm on 19Jan2021 at single dose for COVID-19 immunization. Medical history included PTSD (Post-traumatic stress disorder), anxiety, is a disabled veteran, has had different cancers, had stage III lung cancer, brain surgery and brain cancer before the Covid vaccine. The patient's concomitant medications reported as he had great medicines and was doing good that. The patient reported that on 23Jan2021 he started having a lot of back pain/soreness in his lower back. He stated on the day he received the injection, he experienced injection site pain on his arm on 19Jan2021 that traveled to his shoulder. He also reported having nausea and joint pain since the vaccine on 19Jan2021. Patient stated that his arm was sore where he got the shot, had a sore left arm on 19Jan2021. Stated day before yesterday (23Jan2021) noticed travelled down arm. Stated that he had bad lower back pain, he never had back pain before. Stated that it hit him all at once the day before yesterday (23Jan2021). The outcome of the events was unknown. Serious reported as no. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1021936
Sex: M
Age:
State: NY

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer reporting for her husband. A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 24Jan2021 at 05:44 PM or 05:45 PM (at the age of 65 years old) as a single dose in the arm for COVID-19 IMMUNIZATION. Relevant medical history was not provided. The concomitant medication included acetylsalicylic acid (ECOTRIN) 81mg, potassium chloride (KLOR-CON M10) 750 mg, 2x/day, olmesartan 40-25 mg, 1x/day, rosuvastatin calcium 5mg and other non-prescribed supplements. On 24Jan2021, the patient experienced bump in his arm and was a little stiff and sore. The patient did not receive any treatment for these events. The outcome of the events bump in his arm and was a little stiff and sore was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds: ECOTRIN; KLOR-CON M10; OLMESARTAN; ROSUVASTATIN [ROSUVASTATIN CALCIUM]

Current Illness:

ID: 1021937
Sex: F
Age:
State: NH

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right axillary lymph node swelling; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell; Received the first dose of vaccination on 21Dec2020/second dose on 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the right arm on 22Jan2021 (16:00) at a single dose for COVID-19 immunization at the workplace clinic. Medical history included hypertension; obstructive sleep apnea; had used continuous positive airway pressure (CPAP); obesity; polycystic ovarian syndrome; and had COVID-19. Concomitant medications included spironolactone, ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), metformin, acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S), vitamin D, echinacea, cranberry, melatonin and black elderberry. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) intramuscularly on the right arm on 21Dec2020 (when the patient was 40 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021 (16:00), the patient had received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020. On 23Jan2021 (13:00), the patient had right arm injection site swelling, red circle and pain; right axillary lymph node swelling; tiredness; headache; muscle pain; chills; fever; and was feeling unwell. The patient did not receive any treatment for the reported events. The outcome of the events was recovering for 'right arm injection site swelling, red circle and pain', 'right axillary lymph node swelling', 'tiredness', 'headache', 'muscle pain', 'chills', 'fever' and 'feeling unwell'; and was unknown for 'received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020'. The patient had not been tested for COVID-19 since the vaccination.

Other Meds: SPIRONOLACTONE; JUNEL FE; METFORMIN; ONE-A-DAY WOMEN'S; VITAMIN D [VITAMIN D NOS]; ECHINACEA; CRANBERRY; MELATONIN

Current Illness:

ID: 1021938
Sex: F
Age:
State: WA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20200120; Test Name: body temperature; Result Unstructured Data: Test Result:100-101; Test Date: 20210119; Test Name: COVID Nasal Swab PCR test; Test Result: Negative

Allergies:

Symptoms: A few days later period started, and it's literally the heaviest period I've ever had. I'm perimenopausal, and haven't had a period in 5 months; 100-101 fever; Inappropriate schedule of vaccine administration; This is a spontaneous report from a contactable consumer, the patient. This 51 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3302), dose 2 , single dose via an unspecified route of administration in the left arm on 19Jan2021 at 01:45 PM (at the age of 51 years-old) for COVID-19 vaccination. Medical history included a nickel allergy and perimenopausal (hasn't had a period in 5 months). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), single dose, dose 1 in the left arm on 02Jan2021 at 01:00 PM. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 19Jan2021, the patient received the second dose of PFIZER-BIONTECH COVID-19 MRNA VACCINE. On 20Jan2021, the patient had a 100-101 fever starting at 12 hours after and lasting for 24 hours. A few days later on 23Jan2021, her period started, and "it's literally the heaviest period I've ever had." She is perimenopausal, and hasn't had a period in 5 months. Laboratory data included a COVID polymerase chain reaction (PCR) test (nasal swab) post vaccination on 19Jan2021 that was negative. The clinical outcome of heaviest period was not recovered, recovered from 100-101 fever on an unknown date and unknown for received the second dose of PFIZER-BIONTECH COVID-19 MRNA VACCINE. Treatment was not received for the event. It was also reported that since the vaccination, the patient had been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1021939
Sex: F
Age:
State: NM

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

Lab Data:

Allergies:

Symptoms: she stated that the injection hurt; coughing a lot; when the nurse pulled out the needle she continued to shoot out some vaccine left in the syringe; from a Pfizer-sponsored program. A contactable consumer (patient). This 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that the injection hurt and when the nurse pulled out the needle she continued to shoot out some vaccine left in the syringe, coughing a lot on an unspecified date with outcome of unknown. She is asking if she should get a third vaccine. Information of lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1021940
Sex: F
Age:
State: WI

Vax Date: 01/21/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: awoke to not being able to breathe; coughing in my sleep most of the night; I ended up having to go sit up in a chair until my wheezing stopped; I was very fatigued; my insides hurt, my stomach was nauseated; my insides hurt, my stomach was nauseated; asthma; I had a headache; I felt sick; This is a spontaneous report from a contactable consumer, the patient. This 47- year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), dose 1 , single dose via an unspecified route of administration in the right arm on 21Jan2021 at 01:45 PM (at the age of 47- years-old) for COVID-19 vaccination. Medical history included asthma, seasonal allergies, allergy to general anesthetic and melon and hiatal hernia. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included albuterol inhaler and pantoprazole. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021 at 07:00 PM the patient had a headache. She went to bed and the next day, (Friday 22Jan2021) was very fatigued, had a pounding headache, insides hurt, stomach was nauseated and had trouble with asthma. In the early morning hours of Saturday, 23Jan2021 at 2:30am, she awoke to not being able to breathe. She had to use her rescue inhaler 3 times & her husband said she was coughing in her sleep most of the night. She ended up having to go sit up in a chair until the wheezing stopped and she could breathe again. She had to drink a Tea to help clear her lungs. She felt sick until Saturday afternoon, 23Jan2021. Treatment received for asthma and not being able to breathe included a rescue inhaler. The clinical outcome of asthma, not able to breathe, headache, fatigued, insides hurt, stomach was nauseated, wheezing and coughing was recovered on an unknown date in Jan2021 and recovered on 23Jan2021 for sick. Treatment was not received for events headache, fatigued, insides hurt, stomach was nauseated, sick, wheezing and coughing. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ALBUTEROL SULFATE; PANTOPRAZOLE

Current Illness:

ID: 1021941
Sex: F
Age:
State: MI

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report received from a contactable physician (who is also the patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm, on 18Jan2021 08:00 (lot number: el3248, expiry date: unknown), at single dose; and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm, on 18Jan2021 14:00 (lot number: EL0140, expiry date: unknown), at single dose, for covid-19 immunization, at the hospital (this was also reported as received the first dose on 18Jan2021 14:00 and the second dose on 18Jan2021 08:00, pending clarification). The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient experienced shoulder tenderness, joint pain, chills and lethargy on 18Jan2021 at 17:30. No treatment was given for the events. The patient recovered from the events on an unspecified date. The events were assessed as non-serious. No follow-ups attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1021942
Sex: F
Age:
State: NC

Vax Date: 01/22/2021
Onset Date: 01/24/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Cough; itchy; getting rashes; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL9261), via an unspecified route of administration on 22Jan2021 at single dose at arm right for COVID-19 immunization. Medical history included Reflux, and fatty tumor. Concomitant medication included pantoprazole from 11Jan2021 and ongoing for reflux. On 24Jan2021, the patient experienced itchy, getting rashes. On an unspecified date, the patient experienced cough. The outcome of the event cough was not recovered while unknown for the other events. Therapeutic measures were taken as a result of itchy (pruritus), getting rashes (rash), cough (cough).

Other Meds: PANTOPRAZOLE

Current Illness:

ID: 1021943
Sex: F
Age:
State: OH

Vax Date: 01/21/2021
Onset Date: 01/24/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210108; Test Name: COVID-19 virus test; Test Result: Negative; Comments: More information available (Y/N): No.

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer. A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: 31May2021), via an unspecified route of administration on 21Jan2021, 09:30 at a single dose on left arm for COVID-19 immunization. Medical history included oesophageal dilation procedure from 11Jan2021 to an unknown date and had trouble swallowing from an unknown date and unknown if ongoing. There were no concomitant medications. The patient received the first dose of the vaccine on 21Jan2021 and everything was pretty good. Nothing bothered her until yesterday, Sunday morning. Her throat is not sore but swollen. She feels it is in her tonsils, like her tonsils are swollen. When she gets ready to swallow it is hard sometimes, she can swallow but it feels like something is in the back of her throat like her tonsils are swollen. She has had headaches off and on. She asked if these were normal symptoms after the vaccine. Reported her second COVID-19 Vaccine is scheduled for 11Feb2021 at 9:30AM. Reported she had 3 negative COVID-19 virus tests before. She said each time she had the COVID-19 virus test done was before a scheduled procedure. She said her last negative COVID-19 virus test was on 08Jan2021 before a procedure on 11Jan2021. She clarified she had trouble swallowing and had an esophageal dilation on 11Jan2021. She said she was put to sleep for the procedure. Clarified she has had an off and on headache, a sore throat that feels like her tonsils are swollen, and a pain that shoots through her ear occasionally. She said all her symptoms started late on Saturday (23Jan2021) or early Sunday (24Jan2021). Reported she took 1 Tylenol Extra Strength 500mg capsule yesterday evening (24Jan2021). She said she does not have the box with the UPC number for the Tylenol Extra Strength 500mg capsule, providing: Lot Number: PBA023, and Expiration Date: Dec2022. Reported she left her COVID-19 vaccine paperwork at her daughter's house. She said her daughter read some of the COVID-19 vaccine side effects over the phone to her, but sore throat wasn't one of the listed vaccine side effects. She said she was calling Pfizer to find out if a sore throat was a side effect of the COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Jan2021. More information available (Y/N): No. Therapeutic measures were taken as a result of throat is not sore but swollen, headaches off and on and pain that shoots through her ear occasionally. The outcome of the event "throat is not sore but swollen", "headaches off and on" and "pain that shoots through her ear occasionally" was not recovered while of the other events was unknown.

Other Meds:

Current Illness:

ID: 1021944
Sex: M
Age:
State: GA

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable healthcare professional, the patient. A 49-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 on 18Jan2021 at 09:00 (at the age of 49-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included high blood pressure and tachycardia. The patient does not have allergies to medications, food, or other products. The vaccination was administered to the patient in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. The patient's historical vaccinations include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown) on an unspecified date. Concomitant medications were not reported. On 18Jan2021 at 15:00 (reported as six hours after the shot), the patient experienced a headache. On 18Jan2021 at 21:00 (reported as twelve hours post shot) the patient experienced chills. The patient did not receive any treatment for the events. The clinical outcomes of headache and chills were reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1021945
Sex: F
Age:
State: TX

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283, expiration date 30Apr2021), via an unspecified route of administration on 21Jan2021 14:00 at single dose for COVID-19 immunization. The patient had no medical history and no concomitant medications. Patient stated she took the first dose of the vaccine on 21Jan2021 at 14:00 and she felt fine, no problem at all. On 21Jan2021, her arm felt "a little sore" after and then at 21:00 she experienced a lower back rash and itching that resulted in a 1/4-inch-high welt that was about 3 inches long. Her back was itchy and it was just like lower back and she looked in the mirror and had a little bit of a rash back there and just like kind of like one small welt. Her husband (physician), said that it looks like she have a little bite there but she do not think she had a bite. Patient was trying to decide that possibly and that was many hours later from 2-9, she noticed that and it was odd to get a rash on lower back as allergic reaction as it was usually on the trunk and forearms. The patient described welt as a raised area something like rash. There was like one small welt and then there was an area kind of raised and red and itchy. She took Benadryl to treat the symptom and was asking if she should go ahead and take the second dose of the vaccine. Patient was asking if she can pre-medicate with Benadryl for her second dose of the vaccine. Outcome of events was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm