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
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1631064
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 07/28/2021
Rec V Date: 08/25/2021
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: NERVE PAIN; INTENSE HEAT IN BACK AND BACK HOT TO TOUCH; COULD NOT SLEEP; COULD NOT BEND FINGERS ON SIDE RECEIVED INJECTION; HEART RACING IN HEAD AND EARS INTENSELY; ARM SWOLLEN; LEG PAIN ,SEVERE PAIN WHOLE ARM AND INTENSE PAIN FROM LEGS UP HER BACK; ARM WAS NUMB; UPPER ARM HARD TO THE TOUCH AND PAIN IN BICEPS AND TRICEPS; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A,expiry: 21-SEP-2021) dose was not reported, administered on 28-JUL-2021 10:00 for prophylactic vaccination. Concomitant medications included ibuprofen for leg and back pain. On 28-JUL-2021, the patient experienced could not sleep. On 28-JUL-2021, the patient experienced could not bend fingers on side received injection. On 28-JUL-2021, the patient experienced heart racing in head and ears intensely. On 28-JUL-2021, the patient experienced arm swollen. On 28-JUL-2021, the patient experienced leg pain, severe pain whole arm and intense pain from legs up her back. On 28-JUL-2021, the patient experienced arm was numb. On 28-JUL-2021, the patient experienced upper arm hard to the touch and pain in biceps and triceps. On 29-JUL-2021, the patient experienced nerve pain. On 29-JUL-2021, the patient experienced intense heat in back and back hot to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerve pain, and intense heat in back and back hot to touch on 01-AUG-2021, could not sleep, and heart racing in head and ears intensely on 31-JUL-2021, could not bend fingers on side received injection on 02-AUG-2021, and arm swollen on 20-AUG-2021, was recovering from arm was numb, and the outcome of upper arm hard to the touch and pain in biceps and triceps and leg pain ,severe pain whole arm and intense pain from legs up her back was not reported. This report was non-serious.

Other Meds: IBUPROFEN

Current Illness:

ID: 1631065
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: SLIGHT HEADACHE; TIRED; This spontaneous report received from a patient via a company representative concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced slight headache, and tired. The action taken with covid-19 vaccine was not applicable. The patient recovered from slight headache, and tired. This report was non-serious. This case, from the same reporter is linked to 20210843246.

Other Meds:

Current Illness:

ID: 1631066
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: ULCERATIVE COLITIS FLAIR UP; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age with unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 1 total dose administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced ulcerative colitis flair up, and fever. The patient said he was 100 percent while reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ulcerative colitis flair up and fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210843019- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Ulcerative colitis flair up. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE.

Other Meds:

Current Illness: Ulcerative colitis

ID: 1631067
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/25/2021
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: LOSS OF APPETITE; NECK ACHE AT BASE; FELT HOT TO THE TOUCH; CHILLS; HEADACHE, IT WAS LIKE WHOLE HEAD HURT ALL OVER AND BACK OF HEAD; A LITTLE BIT OF NAUSEA FEELING; A LITTLE TIREDNESS BUT NOTHING EXTREME; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non smoker, and sulfa allergy, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced shortness of breath. On 17-AUG-2021, the patient experienced loss of appetite. On 17-AUG-2021, the patient experienced neck ache at base. On 17-AUG-2021, the patient experienced felt hot to the touch. On 17-AUG-2021, the patient experienced chills. On 17-AUG-2021, the patient experienced headache, it was like whole head hurt all over and back of head. On 17-AUG-2021, the patient experienced a little bit of nausea feeling. On 17-AUG-2021, the patient experienced a little tiredness but nothing extreme. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, loss of appetite, neck ache at base, chills, headache, it was like whole head hurt all over and back of head, a little bit of nausea feeling, and a little tiredness but nothing extreme on AUG-2021, and the outcome of felt hot to the touch was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (A glass of wine once a year); Non-smoker; Sulfonamide allergy

Date Died:

ID: 1631068
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: DEATH; This spontaneous report received from a consumer via social media and concerned two male patients of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients died from unknown cause. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died (due to unknown cause) on an unspecified date. This report was serious (Death).; Sender's Comments: V0: 20210843032- Covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1631070
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: RASH; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious. This case, from the same reporter is linked to 20210840767.

Other Meds:

Current Illness:

ID: 1631071
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 08/16/2021
Rec V Date: 08/25/2021
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: LOW GRADE HEADACHE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with phenytoin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced low grade headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade headache on 16-AUG-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631072
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 08/25/2021
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: RASH THAT SHE HAS NEVER HAD BEFORE WITH ITCHY WHICH APPEARED ON BOTH LEGS NEAR HER ANKLES; RED SPOT WHICH APPEARED ON BOTH LEGS NEAR HER ANKLES; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was not reported and height was 61 inches. The patient's concurrent conditions included: hypertension, sleep apnea, and thyroid issues. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, and oxybutynin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: 23-AUG-2021) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the patient experienced rash that she has never had before with itchy which appeared on both legs near her ankles. On 01-MAY-2021, the patient experienced red spot which appeared on both legs near her ankles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash that she has never had before with itchy which appeared on both legs near her ankles, and had not recovered from red spot which appeared on both legs near her ankles. This report was non-serious. This case, from the same reporter is linked to 20210843037.

Other Meds:

Current Illness: Disorder thyroid; Hypertension; Sleep apnea

ID: 1631073
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 08/20/2021
Rec V Date: 08/25/2021
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: JANSSEN COVID-19 VACCINE WAS ADMINISTERED TO THE PATIENT AS A BOOSTER DOSE, IN ERROR.; This spontaneous report received from a pharmacist concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 20-AUG-2021 12:45 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 20-AUG-2021, the patient experienced janssen covid-19 vaccine was administered to the patient as a booster dose, in error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of janssen covid-19 vaccine was administered to the patient as a booster dose, in error. was not reported. This report was non-serious.

Other Meds: MRNA 1273

Current Illness: Immunocompromised

ID: 1631074
Sex: F
Age:
State: MN

Vax Date:
Onset Date: 08/17/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 20210817; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: Negative; Test Date: 20210820; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: Negative.

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 23-AUG-2021) dose was not reported, administered on 07-MAR-2021 on left arm around 13:00 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-21 patient had an antibody test with her healthcare professional. On 19-AUG-2021 her doctor called her and told she had no antibodies, the test came back negative (confirmed immunological vaccine failure). On 20-AUG-21 patient had another antibody test was performed. The results from the second test came back on the day of report as negative and with no antibodies. Both tests were SARS COV2 Spike Protein and IGG antibody tests. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210843278-covid-19 vaccine ad26.cov2.s -Confirmed Immunological Vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1631075
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 08/20/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Negative

Allergies:

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

Symptoms: SHORTNESS OF BREATH (SOB); SHALLOW BREATHING; SOME COUGHING; SINUS CONGESTION; WHEEZING; MASSIVE HEADACHE; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. Non-company suspect drugs included: interferon beta-1a (injection, route of admin, and batch number were not reported) dose and frequency were not reported from 19-AUG-2021 for drug used for unknown indication. No concomitant medications were reported. On 20-AUG-2021, the patient experienced shortness of breath (sob). On 20-AUG-2021, the patient experienced shallow breathing. On 20-AUG-2021, the patient experienced some coughing. On 20-AUG-2021, the patient experienced sinus congestion. On 20-AUG-2021, the patient experienced wheezing. On 20-AUG-2021, the patient experienced massive headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (sob), shallow breathing, massive headache, some coughing, sinus congestion, and wheezing. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631076
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: MINOR CHILLS FOR 15 MINUTES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced minor chills for 15 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor chills for 15 minutes. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631077
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/25/2021
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: LARGE, NICKEL TO QUARTER SIZED, HARDENED AREA UNDER THE SKIN ON LEFT ARM AT THE SITE OF INJECTION; BRUISING ON LEFT ARM; NORMAL SYMPTOMS; FEW RASHES ON LEFT ARM; PAINFUL TO TOUCH; This spontaneous report received from a consumer concerned a 26 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced large, nickel to quarter sized, hardened area under the skin on left arm at the site of injection. On AUG-2021, the patient experienced bruising on left arm. On AUG-2021, the patient experienced normal symptoms. On AUG-2021, the patient experienced few rashes on left arm. On AUG-2021, the patient experienced painful to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from large, nickel to quarter sized, hardened area under the skin on left arm at the site of injection, painful to touch, few rashes on left arm, and bruising on left arm, and the outcome of normal symptoms was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631078
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/18/2021
Rec V Date: 08/25/2021
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: VOILENT HALLUCINATION; FULL BODY TREMORS; CONFUSION; ANXIETY; VIVID DREAMS; HEADACHE; This spontaneous report received from a health care professional (Nurse) concerned a male of an unspecified, age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown ) dose was not reported, 1 total administered on 18-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 18-AUG-2021, 12 hours post vaccination, the patient experienced violent hallucination, confusion, vivid dreams, anxiety, full body tremors and headache. He went to physician office. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the full body tremors, violent hallucination, confusion, anxiety, vivid dreams and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210844101-COVID-19 VACCINE AD26.COV2.S - Violent hallucination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

Date Died:

ID: 1631079
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: DIED OF HEART ATTACK; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown)1 total frequency, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died of heart attack. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0 20210844140-COVID-19 VACCINE AD26.COV2.S-died of heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK

Other Meds:

Current Illness:

ID: 1631080
Sex: F
Age:
State: SC

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 08/25/2021
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: ITCH ON THE ARM; CHILLS; FEVER; FATIGUE; MUSCLES IN BOTH LEGS HURT; HEADACHE; LUMP (ABOUT ONE INCH NOT CIRCULAR BUT ELONGATED AND IT EXTENDS TO LEFT AND TO RIGHT) ON THE RIGHT ARM AT THE SITE OF THE INJECTION; DIZZINESS; REDNESS ON THE ARM; PAIN ON THE ARM; SWELLING ON THE ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, penicillin allergy, alcohol user, smoker, and mold allergy, and other pre-existing medical conditions included: The patient did not had any drug abuse/illicit drug use. The patient was previously treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide/lisinopril for high blood pressure. On MAR-2021, the patient experienced redness on the arm. On MAR-2021, the patient experienced pain on the arm. On MAR-2021, the patient experienced swelling on the arm. On 25-MAR-2021, the patient experienced lump (about one inch not circular but elongated and it extends to left and to right) on the right arm at the site of the injection. On 25-MAR-2021, the patient experienced dizziness. On 25-MAR-2021, the patient experienced chills. On 25-MAR-2021, the patient experienced fever. On 25-MAR-2021, the patient experienced fatigue. On 25-MAR-2021, the patient experienced muscles in both legs hurt. On 25-MAR-2021, the patient experienced headache. On 01-APR-2021, the patient experienced itch on the arm. Treatment medications (dates unspecified) included: cortisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, fever, muscles in both legs hurt, and headache on 28-MAR-2021, itch on the arm on APR-2021, and fatigue on 29-MAR-2021, had not recovered from lump (about one inch not circular but elongated and it extends to left and to right) on the right arm at the site of the injection, and the outcome of redness on the arm, pain on the arm and swelling on the arm was not reported. This report was non-serious.

Other Meds: LISINOPRIL AND HYDROCHLOROTHIAZIDE

Current Illness: Alcohol use (Occasionally); Allergy to molds; Blood pressure high; Penicillin allergy; Smoker

ID: 1631081
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: SWEATING; CHILLS; WEAKNESS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sweating, chills, weakness, and headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from sweating, chills, weakness, and headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631082
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: FELT LIKE CRAP; ARM WAS SORE AT THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced felt like crap, and arm was sore at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore at the injection site, and the outcome of felt like crap was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631083
Sex: F
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: SHORTNESS OF BREATH; CHEST TIGHTNESS; THROAT CLOSURE; FACIAL SWELLING (STARTED 20 MINUTES AFTER THE INJECTION); LITTLE LIGHT HEADED (STARTED 10 MINUTES AFTER THE INJECTION); TONGUE SWELLING (STARTED 20 MINUTES AFTER THE INJECTION); ALLERGIC REACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced shortness of breath, chest tightness, throat closure, facial swelling (started 20 minutes after the injection), little light headed (started 10 minutes after the injection), tongue swelling (started 20 minutes after the injection), and allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction, shortness of breath, chest tightness, throat closure, facial swelling (started 20 minutes after the injection), little light headed (started 10 minutes after the injection) and tongue swelling (started 20 minutes after the injection) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631084
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 08/25/2021
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: BODY REJECTING THE HORMONES AND STOPPED WORKING, SENDING HER INTO MENOPAUSE AGAIN; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included: hysterectomy, and concurrent conditions included: shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced body rejecting the hormones and stopped working, sending her into menopause again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body rejecting the hormones and stopped working, sending her into menopause again. This report was non-serious. This case, from the same reporter is linked to 20210844560.

Other Meds:

Current Illness: Shellfish allergy

ID: 1631085
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Test Name: Body temperature; Result Unstructured Data: 103

Allergies:

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

Symptoms: 103 FEVER FOR LIKE A DAY; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced 103 fever for like a day. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 103 fever for like a day. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631086
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: Pain scale; Result Unstructured Data: 10 plus

Allergies:

Symptom List: Unevaluable event

Symptoms: FEELS LIKE A TOOTHACHE TIME 10X; LEFT LEG PAIN; LEFT LEG NUMBNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the patient experienced feels like a toothache time 10x. On JUL-2021, the patient experienced left leg pain. On JUL-2021, the patient experienced left leg numbness. Laboratory data included: Pain scale (NR: not provided) 10 plus. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from left leg pain, and left leg numbness, and the outcome of feels like a toothache time 10x was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631087
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/20/2021
Rec V Date: 08/25/2021
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: ARM IS JUST A BIT SORE; BODY WAS SORE; CHILLS; EXHAUSTED; AWFUL HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 20-AUG-2021, the patient experienced chills. On 20-AUG-2021, the patient experienced exhausted. On 20-AUG-2021, the patient experienced awful headache. Treatment medications included: paracetamol. On 21-AUG-2021, the patient experienced body was sore. On 22-AUG-2021, the patient experienced arm is just a bit sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body was sore, had not recovered from awful headache, and arm is just a bit sore, and the outcome of exhausted and chills was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631088
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 08/25/2021
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: TIRED; LITTLE SORENESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced little soreness. On 14-MAR-2021, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little soreness on 13-MAR-2021 and tired on 15-MAR-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631089
Sex: F
Age:
State: ID

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/25/2021
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: PERSISTENT HEADACHE PAIN; AUDIBLY DISTRESSED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced audibly distressed. On 18-AUG-2021, the patient experienced persistent headache pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent headache pain, and the outcome of audibly distressed was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631090
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 20210809; Test Name: Body temperature; Result Unstructured Data: 102

Allergies:

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

Symptoms: WAS IN BED THE WHOLE DAY; TEETH SHATTERING; CHILLS/SHIVERS; FEVER; PREVENTING FROM SLEEP; ITCHING (PREVENTING HER FROM SLEEP); RASH; GET BUMPS EVERYWHERE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and didn't change anything in diet or anything other than the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, expiry: UNKNOWN) dose was not reported, administered on 08-AUG-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced preventing from sleep. On AUG-2021, the patient experienced itching (preventing her from sleep). On AUG-2021, the patient experienced rash. On AUG-2021, the patient experienced get bumps everywhere. On 08-AUG-2021, the patient experienced teeth shattering. On 08-AUG-2021, the patient experienced chills/shivers. On 08-AUG-2021, the patient experienced fever. On 09-AUG-2021, the patient experienced was in bed the whole day. Laboratory data included: Body temperature (NR: not provided) 102. On 22-AUG-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teeth shattering, chills/shivers, and fever on 09-AUG-2021, was recovering from itching (preventing her from sleep), had not recovered from rash, and the outcome of get bumps everywhere, was in bed the whole day and preventing from sleep was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631091
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/25/2021
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: SYMPTOMS AFTER RECEIVING VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced symptoms after receiving vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms after receiving vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631092
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 08/20/2021
Rec V Date: 08/25/2021
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: SHARP CHEST PAIN; COULD NOT CATCH BREATH (HARD TIME TAKING A DEEP BREATH); EXTREME BACK PAIN; BAD CHILLS THAT WONT GO AWAY (FEELING OF FREEZING COLD); FEVER; HEADACHE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 20-AUG-2021, the patient experienced sharp chest pain. On 20-AUG-2021, the patient experienced could not catch breath (hard time taking a deep breath). On 20-AUG-2021, the patient experienced extreme back pain. On 20-AUG-2021, the patient experienced bad chills that wont go away (feeling of freezing cold). On 20-AUG-2021, the patient experienced fever. On 20-AUG-2021, the patient experienced headache. Treatment medications (dates unspecified) included: ibuprofen, acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not catch breath (hard time taking a deep breath), extreme back pain, bad chills that wont go away (feeling of freezing cold), fever, and headache on 21-AUG-2021, and had not recovered from sharp chest pain. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1631093
Sex: M
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: WHEN HE TOUCHES ARM HE HAS SHARP PAIN; CHRONIC FATIGUE; This spontaneous report received from a pharmacist concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced when he touches arm he has sharp pain, and chronic fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from when he touches arm he has sharp pain, and chronic fatigue. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631094
Sex: U
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: HEALTH PROBLEMS/HINDERING HEALTH; THEY ARE HINDERING HEALTH AND PERFORMANCE AT WORK; HARD TIME WALKING; LEFT HAND ALL OF FINGERS STAY NUMB EXCEPT PINKY FINGER; LEFT FOOT CONSTANTLY HURTING ABOVE HEEL, ANKLE, AND ACHILLES TENDON; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced health problems/hindering health, they are hindering health and performance at work, hard time walking, left hand all of fingers stay numb except pinky finger, and left foot constantly hurting above heel, ankle, and achilles tendon. Treatment medications (dates unspecified) included: permethrin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left hand all of fingers stay numb except pinky finger, hard time walking, left foot constantly hurting above heel, ankle, and achilles tendon, health problems/hindering health and they are hindering health and performance at work was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631095
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: SORE ARM; This spontaneous report received from a patient concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210846404.

Other Meds:

Current Illness:

ID: 1631096
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: FELT WEIRD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced felt weird. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt weird was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631097
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: SHINGLES RASH ON LEFT ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced shingles rash on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles rash on left arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631098
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: SLIGHTLY TIRED; NAUSEA; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included: reaction to the shingles shot, and concurrent conditions included: colitis, hashimotos, blood pressure, and anxiety, and other pre-existing medical conditions included: Got unspecified shingles shot 3 years ago and was not on Xelganz at the time and she did have a reaction to the shingles shot. She was B+ blood type. Took unspecified medications for high blood pressure and anxiety. The patient experienced drug allergy when treated with benzoyl peroxide, and ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 002A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included tofacitinib citrate for colitis. On an unspecified date, the patient experienced slightly tired, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and the outcome of slightly tired was not reported. This report was non-serious.

Other Meds: XELJANZ

Current Illness: Anxiety (Patient have anxiety and takes medication.); Blood pressure (Patient have High blood pressure and takes medication.); Colitis; Hashimoto's disease

ID: 1631099
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: A LITTLE BIT OF PAIN; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced a little bit of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little bit of pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631101
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 07/22/2021
Rec V Date: 08/25/2021
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: CHILLS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUL-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631102
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 08/25/2021
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: FELT TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt tired on JUL-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631103
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 08/19/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 20210823; Test Name: COVID-19 virus test; Result Unstructured Data: Negative

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: SYMPTOMS OF FEVER; FATIGUE; This spontaneous report received from a patient concerned a 39 year old male. The patient's weight was 332 pounds, and height was 75 inches. The patient's past medical history included: cigarette smoker, and concurrent conditions included: allergic to mushroom, and non alcohol user, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-AUG-2021, the patient experienced symptoms of fever. On 19-AUG-2021, the patient experienced fatigue. On 23-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the symptoms of fever and fatigue was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631104
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: FELT LIKE FLU FOR ONE WEEK; FEVER FOR 3 DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced felt like flu for one week, and fever for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like flu for one week, and fever for 3 days. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631105
Sex: M
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Test Name: CT brain scan; Result Unstructured Data: nothing came wrong; Test Name: X-ray of nasal sinuses; Result Unstructured Data: nothing came wrong

Allergies:

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

Symptoms: LOSS OF SMELL; LOSS OF TASTE; This spontaneous report received from a patient concerned an 83 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: neuropathy in legs, elevated cholesterol, alcohol use, and non smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse or illicit drug use. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin calcium for elevated cholesterol, pregabalin for neuropathy in legs, and esomeprazole magnesium. On an unspecified date, the patient experienced loss of smell, and loss of taste. Laboratory data (dates unspecified) included: CT brain scan (NR: not provided) nothing came wrong, and X-ray of nasal sinuses (NR: not provided) nothing came wrong. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of smell, and loss of taste. This report was non-serious.

Other Meds: NEXIUM [ESOMEPRAZOLE MAGNESIUM]; LYRICA; LIPITOR

Current Illness: Alcohol use (1 Cocktail a week on Sunday); Cholesterol high; Neuropathy peripheral; Non-smoker

ID: 1631106
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: ADVERSE EVENTS (AES); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adverse events (aes). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse events (aes) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631107
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/25/2021
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: CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced headache. On AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea and chills was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631108
Sex: F
Age:
State: NV

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: PERIOD HAS BEEN SO HEAVY SINCE/NEVER SOAKED THROUGH A TAMPON IN 2 HOURS/BLED SO MUCH; PAIN; SWEATING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced period has been so heavy since/never soaked through a tampon in 2 hours/bled so much, pain, and sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the period has been so heavy since/never soaked through a tampon in 2 hours/bled so much, pain and sweating was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631109
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 20210413; Test Name: Sonogram; Result Unstructured Data: negative

Allergies:

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

Symptoms: PAIN ON LEFT LEG IN THE BACK OF CALF INTO THE KNEE AND INTO THE LOWER THIGH; CHILLS; This spontaneous report received from a patient via a company representative concerned a 64 year old female. The patient's weight was 145 pounds, and height was 64 inches. The patient's concurrent conditions included: alcohol user occasionally, non smoker, and thyroid, and other pre-existing medical conditions included: The patient had no known allergy and no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 20-JUL-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for thyroid disorder. On 01-APR-2021, the patient experienced chills. On 07-APR-2021, the patient experienced pain on left leg in the back of calf into the knee and into the lower thigh. On 13-APR-2021, Laboratory data included: Sonogram (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 02-APR-2021, and was recovering from pain on left leg in the back of calf into the knee and into the lower thigh. This report was non-serious.

Other Meds: LEVOTHYROXINE

Current Illness: Alcohol use; Non-smoker; Thyroid disorder

ID: 1631110
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 08/11/2021
Rec V Date: 08/25/2021
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: VACCINATED WITH THE JANSSEN COVID-19 VACCINE FOR THE 2ND TIME IN ABOUT 3 MONTHS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAY-2021, and dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-AUG-2021, the patient experienced vaccinated with the janssen covid-19 vaccine for the 2nd time in about 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccinated with the janssen covid-19 vaccine for the 2nd time in about 3 months was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631111
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: FEVER FOR ABOUT 12 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced fever for about 12 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever for about 12 hours. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631112
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: VACCINATION SITE NODULE; VACCINATION SITE PAIN; This spontaneous report received from a patient concerned a 7 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced vaccination site nodule, and vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination site pain and vaccination site nodule was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1631113
Sex: M
Age: 50
State: TN

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 08/25/2021
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: Test Date: 202012; Test Name: COVID-19 positive; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Body aches; Fluctuation in his temperature; Extremely thirsty; Severe weakness; Diarrhea; Stiff neck; Bone pain feels worse than when he had covid; Fever; Nausea; Muscle pain feels worse than when he has covid; A spontaneous report was received from a nurse reporting on behalf of himself, a 50-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches, fluctuation in his temperature, fever, extremely thirst, severe weakness, nausea, diarrhea, stiff neck, muscle pain and bone pain. The patient's medical history included COVID-19 infection. Concomitant product use was not provided by the reporter. On 22 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 23 Dec 2020, in the early morning, the patient experienced body aches, fluctuation in his temperature, fever, extreme thirst, severe weakness, nausea, diarrhea and a stiff neck. Additionally, the patient reported experiencing muscle and bone pain that felt worse than when he had COVID-19. Treatment for the event included ondansetron for nausea and acetaminophen for his stiff neck. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, body aches, fluctuation in his temperature, fever, extremely thirst, severe weakness, nausea, diarrhea, stiff neck, muscle pain and bone pain, was not reported.; Reporter's Comments: This case concerns a 50-year-old male patient with a medical history of COVID-19, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the listed events of diarrhea, fever, nausea, and muscle pain, and the unlisted events of body aches, fluctuation in temperature, fever, thirst, weakness, stiff neck, and bone pain. The events were considered possibly related to the vaccine due to the temporal relationship with onset of events the day after the first dose.

Other Meds:

Current Illness:

ID: 1631114
Sex: F
Age: 51
State: NV

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 08/25/2021
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: Very Hard raised red spot; Achiness in arm and shoulder; A spontaneous report was received from a healthcare facility staff member concerning a 51-year-old, female patient who received Moderna's COVID-19 vaccine and experienced a very hard raised red spot and achiness in arm and shoulder. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 22 Dec 2020, approximately 36 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT # 011JZ0A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. After 36 hours of receiving the vaccine, the patient noticed a very hard raised red spot at the injection site. Treatment provided for the events included naproxen for achiness in arm and shoulder. On 24 Dec 2020, the patient reported the spot on her arm had grown. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, very hard raised red spot and achiness in arm and shoulder, were unknown; Reporter's Comments: This case concerns a 51 year old female patient. The patient's medical history is not provided. The patient experienced an expected event of injection site very hard red raised spot and achiness in arm and shoulder of injection. The event occurred on 36 hours after receiving first dose of mRNA-1273 (LOT # 011JZ0A) on 22 Dec 2020. The reporter causality assessment for the event was not provided. The sponsor assessed the event as possibly related to the mRNA-1273 vaccine. Swelling and Pain at the site of injection is listed on the company's fact sheet for the healthcare providers.

Other Meds:

Current Illness:

ID: 1631115
Sex: M
Age: 61
State: CT

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Name: temperature; Result Unstructured Data: 101 fever; Test Name: temperature; Result Unstructured Data: 99.9; Test Date: 20201222; Test Name: temperature; Result Unstructured Data: 98-99 fever; Comments: before vaccination; Test Date: 20201223; Test Name: temperature; Result Unstructured Data: below 99F; Test Name: O2 levels; Result Unstructured Data: normal; Test Date: 20201223; Test Name: COVID-19 swab test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: sore arm at injection site; COVID-19; Fever; Chills; drenching sweats; general feeling "similar to the flu"; A spontaneous report was received from a physician concerning a 61-year old, male patient who experienced fever, chills, drenching sweats, sore arm at injection site, general feeling "similar to the flu", and COVID-19 swab test which was positive. The patient's medical history included current conditions did not feel quite normal on 22 DEC 2020, myalgia on 22 DEC 2020, and temperature of 98-99 which is high. The patient's medical history included ongoing current conditions of occasional dry cough beginning on 22 DEC 2020 and fatigue beginning on 22 DEC 2020. Concomitant product use was not provided by the reporter. On 22 DEC 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the Right Deltoid for prophylaxis of COVID-19 infection. On 22 DEC 2020, the patient woke up and did "not feel quite normal." He experienced myalgia, occasional dry cough, fatigue, and a temperature of 98-99 which was high for him. At approximately 18:30 on 22 DEC 2020, the patient received the first dose of mRNA-1273. After receiving the vaccine, he experienced a temp of 99.9F, reaching a maximum of 101F, fever, chills, drenching sweats, sore arm at site of injection, and a general feeling similar to the flu. He received a positive COVID-19 swab test on 23 DEC 2020. On 24 DEC 2020, the patient continued to feel much better. His temperature had been below 99F since the evening of 23 DEC 2020. He continued to experience a slight cough and slight fatigue. He continued to take ibuprofen occasionally, and he continued to monitor his O2 levels which remained normal. Treatment for the events included ibuprofen, paracetamol, aspirin, acetylsalicylic acid, risperidone, quercetin, and turmeric. Action taken with mRNA-1273 in response to the events was not reported. The events chills, drenching sweats, sore arm at injection site, general feeling "similar to the flu", and COVID-19 swab test which was positive were considered resolving on 24 DEC 2020. The event fever was considered resolved on 23 DEC 2020.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of COVID-19 is assessed as unlikely related. The patient had cough, fever, fatigue and myalgia before the administration of vaccine.

Other Meds:

Current Illness: Dry cough (onset before vaccination); Fatigue (onset before vaccination)

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am