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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1665405
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: SORE ARM; SLIGHT 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 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 requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and slight headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665406
Sex: F
Age:
State: TN

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 09/02/2021
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: DIFFICULTY BREATHING/CANNOT CATCH MY BREATHING/BREATHING IS TOUGH/LABORED BREATHING; HEAVINESS IN CHEST; FELT TERRIBLE/FELT AWFUL; ACHES; TIRED/WAS DOWN FOR THE COUNT YESATERDAY; BLISTERING HEADACHE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and there was 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced heaviness in chest. On 25-AUG-2021, the patient experienced felt terrible/felt awful. On 25-AUG-2021, the patient experienced aches. On 25-AUG-2021, the patient experienced tired/was down for the count yesterday. On 25-AUG-2021, the patient experienced blistering headache. On 27-AUG-2021, the patient experienced difficulty breathing/cannot catch my breathing/breathing is tough/labored breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blistering headache on 27-AUG-2021, was recovering from aches, and tired/was down for the count yesterday, had not recovered from heaviness in chest, and difficulty breathing/cannot catch my breathing/breathing is tough/labored breathing, and the outcome of felt terrible/felt awful was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcoholic (Social consumption on occasion.); Asthma (Had asthma brought on by pregnancy with first child which resolved upon delivery.); Non-smoker

ID: 1665407
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 09/02/2021
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: GREEN MUCOUSY DISCHARGE IN URINE; SWEATING; CHILLS; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 22 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 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-AUG-2021, the patient experienced green mucousy discharge in urine. On 25-AUG-2021, the patient experienced sweating. On 25-AUG-2021, the patient experienced chills. On 25-AUG-2021, the patient experienced fever. On 25-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, sweating, green mucousy discharge in urine, and chills. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665408
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: BAD SIDE EFFECTS; SLEPT ALL DAY; SORE ARM; CHILLS; HEADACHE; FEVER; NAUSEAS; EXTREME FATIGUE; 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 bad side effects, slept all day, sore arm, chills, headache, fever, nauseas, and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, headache, fever, chills, nauseas, extreme fatigue, bad side effects and slept all day was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665409
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data: Test Name: SARS-CoV-2 test; Result Unstructured Data: negative; Test Name: CT scan; Result Unstructured Data: negative for blood clot

Allergies:

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

Symptoms: FELT VERY SICK; VOMITING; DIARRHEA; HEADACHE; NAUSEOUS/GOING TO THROW UP; POSSIBLE PNEUMONIA IN RIGHT LOWER LUNG; STRUGGLING TO WORK; SOMETHING LIKE VERTIGO ( IT WAS NOT VERTIGO); COLD; FELT SHAKY; EARS GOT HOT; FELT SO DIZZY; UNABLE TO READ; DEPRESSED; VERY UPSET; CHILLS; This spontaneous report received from a patient concerned a 62-year-old White female ,not Hispanic or Latino. The patient's weight was 186 pounds, and height was 65 inches. The patient's concurrent conditions included: hypertension, alcohol consumption (once in a great moon holidays) and non-smoker, and other pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1820096 and expiry: 21-Oct-2021) dose was not reported,1 total administered on 05-Aug-2021 to left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for hypertension, amlodipine for hypertension, losartan for hypertension, ascorbic acid, and zinc. After one week of vaccination patient felt very sick. She was struggling to work. She stated that she was experiencing something like vertigo (but stated it was not vertigo), and had to intentionally think about her steps. She was experiencing cold, chills, headache and felt shaky. When she was at the hospital, a Computerized Tomography (CT) scan was negative for blood clots, and she was negative for COVID. She was given a Z-pak (azithromycin) for possible pneumonia in the right lower lung. She was currently on day 4 of the Z-pak and had diarrhea and was nauseous. She was also experiencing vomiting, which she described as happening before starting the Z-pak. She was upset that the only treatment she got was for pneumonia, and not for the other symptoms. Patient stated that she had never been this sick in her entire life and stated it as horrible and bad. The hospital wrote her a note that she is not better. Patient was upset and her ear was getting hot, and she continued to feel so dizzy that she felt like she was going to throw up. Patient stated that the eye movement of reading made her sicker and felt very depressed. She was drinking plenty of water and orange juice (OJ). She also started taking Zinc and Vitamin C when she got her Z-pak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt very sick, struggling to work, something like vertigo (it was not vertigo), cold, chills, headache, felt shaky, possible pneumonia in right lower lung, diarrhea, nauseous/going to throw up, vomiting, ears got hot, felt so dizzy, unable to read, depressed and very upset was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210857125-covid-19 vaccine ad26.cov2.s-Possible pneumonia in the right lower lung. 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).

Other Meds: LOSARTAN; AMLODIPINE; ASA; ZINC; VITAMIN C [ASCORBIC ACID]

Current Illness: Alcohol use; Hypertension; Non-smoker

ID: 1665410
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: HEART PALPITATIONS; WEAKNESS; 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: Unk and expiry date: 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 heart palpitations, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations, and weakness. This report was non-serious. This case, from the same reporter is linked to 20210856064.

Other Meds:

Current Illness:

ID: 1665411
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: BODY ACHES; CHILLS; FATIGUE; 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 body aches, chills, and fatigue. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, body aches, and fatigue. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665412
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: LITTLE HEADACHE; TIREDNESS; This spontaneous report received from a consumer concerned multiple patients 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 and have been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little headache and tiredness was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665413
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: BURNING STOMACH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, 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 burning stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning stomach. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665414
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: STOMACH PAIN; HEARTBURN; SWELLING; LEG PAIN; ANKLE PAIN; RASH ON FACE, NECK AND ARMS; FEVER; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stomach pain, heartburn, swelling, leg pain, ankle pain, rash on face, neck and arms, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach pain, heartburn, rash on face, neck and arms, fever, leg pain, ankle pain and swelling was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665415
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SEMIPAINFUL HEADACHE THAT CAME IN WAVES; BRUISING AT INJECTION SITE; SHE IS PALE; SHE IS VERY PRONE TO BRUISING; This spontaneous report received from a patient concerned a 40 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: Unk) dose was not reported, administered on 12-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 she is very prone to bruising. On 12-AUG-2021, the patient experienced bruising at injection site. On 12-AUG-2021, the patient experienced she is pale. On 23-AUG-2021, the patient experienced semipainful headache that came in waves. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruising at injection site, semipainful headache that came in waves, she is pale and she is very prone to bruising was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665416
Sex: M
Age:
State: GA

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/02/2021
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: REAL BAD MUSCLE ACHES; FATIGUE; FEVER; ACHY; This spontaneous report received from a patient concerned a 46 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: Unk) dose was not reported, administered on 25-AUG-2021 00:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced achy. Treatment medications included: paracetamol. On 25-AUG-2021, the patient experienced fatigue. On 25-AUG-2021, the patient experienced fever. On 26-AUG-2021, the patient experienced real bad muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and real bad muscle aches, and had not recovered from fatigue, and achy. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665417
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/16/2021
Rec V Date: 09/02/2021
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: FUNGUS; ALL BODY PAIN/BODY HURTING; NOT ABLE TO WALK; BILATERAL FOOT PAIN/BILATERAL LEG PAIN; FELT TIRED; MISSING TOE NAIL; BILATERAL FOOT NUMBNESS; This spontaneous report received from a patient concerned a 47 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 drug abuse or illicit drug usage. The patient have unspecified allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: paracetamol. On 16-APR-2021, the patient experienced bilateral foot numbness. On 23-APR-2021, the patient experienced missing toe nail. On 23-APR-2021, the patient experienced felt tired. On 23-AUG-2021, the patient experienced bilateral foot pain/bilateral leg pain. On an unspecified date, the patient experienced fungus, all body pain/body hurting, and not able to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bilateral foot numbness on 23-APR-2021, had not recovered from bilateral foot pain/bilateral leg pain, felt tired, and missing toe nail, and the outcome of all body pain/body hurting, not able to walk and fungus was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1665418
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/26/2021
Rec V Date: 09/02/2021
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: BODY PAINING/BODY ACHE; FEELING VERY COLD; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a 23 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: Unk) dose was not reported, administered on 26-AUG-2021 11:00 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 26-AUG-2021, the patient experienced feeling very cold. On 26-AUG-2021, the patient experienced body paining/body ache. On 26-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, feeling very cold, and body paining/body ache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665419
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/02/2021
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: BODY ACHES; SORE GLANDS; SORE ARM; CHILLS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-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 body aches. On AUG-2021, the patient experienced sore glands. On AUG-2021, the patient experienced sore arm. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore glands, sore arm, chills, and headache on AUG-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665420
Sex: U
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: SWELLING; ITCHING; RASH; 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: 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 swelling, itching, and rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, swelling and itching was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665421
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: LOSS OF APPETITE; FLU LIKE SYMPTOMS; COULD NOT SLEEP; SWEAT IT OUT; 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 loss of appetite, flu like symptoms, could not sleep, and sweat it out. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of appetite, flu like symptoms, could not sleep and sweat it out was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665422
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: MUCH WORSE OFF; This spontaneous report received from a patient via a company representative 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 much worse off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of much worse off was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665424
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/27/2021
Rec V Date: 09/02/2021
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: RIGHT LOWER LEG SWELLING; This spontaneous report received from a patient via a company representative concerned a 54 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, intramuscular, batch number: 204b21a, and expiry: UNKNOWN) dose was not reported, administered on 19-AUG-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced right lower leg swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of right lower leg swelling was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665425
Sex: U
Age:
State:

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Low grade fever

Allergies:

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

Symptoms: EXACERBATED VERTIGO A BIT; CHILLS; SORE ARM; LOW GRADE BARELY FEVER.; 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. The patient's concurrent conditions included: vertigo. 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 exacerbated vertigo a bit, chills, sore arm, and low grade barely fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from exacerbated vertigo a bit, chills, sore arm, and low grade barely fever. This report was non-serious.

Other Meds:

Current Illness: Vertigo (The patient had undiagnosed sporadic spinning over the years.)

ID: 1665426
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: CHILLS; DEAD TIRED; 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 chills, and dead tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and dead tired. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665427
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: TIRED; 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, 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 tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665428
Sex: F
Age:
State: NH

Vax Date:
Onset Date: 08/27/2021
Rec V Date: 09/02/2021
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: RIGHT ARM SWELLING AROUND INJECTION SITE; RIGHT ARM PAIN; 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: non alcohol user, and non smoker, and other pre-existing medical conditions included: Patient does not have any known drug allergies and 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, treatment medications included: paracetamol. On 27-AUG-2021, the patient experienced right arm pain. On 28-AUG-2021, the patient experienced right arm swelling around injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, and right arm swelling around injection site. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1665429
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: SUPER SLEEPY; FATIGUED; 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 super sleepy, and fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the super sleepy and fatigued was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665430
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: SLIGHT SORE ARM; A SLIGHT HEADACHE; TIRED; 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 slight sore arm, a slight headache, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, a slight headache and slight sore arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665431
Sex: M
Age:
State: ID

Vax Date:
Onset Date: 08/16/2021
Rec V Date: 09/02/2021
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: 20210816; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: POSITIVE

Allergies:

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

Symptoms: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 47 year and 9 months old white male, ethnicity unknown. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: Unknown) 0.5 ml, frequency 1 total, administered on 20-MAY-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that on an unspecified date the patient experienced fever, headache and diarrhea. On 16-Aug-2021, SARS-CoV-2 PCR test was performed, and result was positive (confirmed clinical vaccination failure and confirmed covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846649.; Sender's Comments: V0-20210858816-Covid-19 Vaccine AD26.COV2.s-Confirmed Clinical Vaccination 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: 1665432
Sex: U
Age:
State: AK

Vax Date:
Onset Date: 07/24/2021
Rec V Date: 09/02/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: PNEUMONIA; UNABLE TO WALK; SUSPECTED COVID-19 INFECTION; 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, and batch number were not reported) dose was not reported, 1 total, administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-JUL-2021, two weeks after vaccination the patient experienced suspected covid-19 infection. The patient then ended up in the hospital two weeks after that with pneumonia and was hospitalized on an unspecified date. The patient reported being out of work on disability, got daily headaches and could not walk a block without being wore out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to walk, and the outcome of suspected covid-19 infection and pneumonia was not reported. This report was serious (Hospitalization Caused / Prolonged). This report is associated with product quality complaint.; Sender's Comments: V0:20210858943-covid-19 vaccine ad26.cov2.s-Pneumonia. This event 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.

Other Meds:

Current Illness:

ID: 1665433
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 08/15/2021
Rec V Date: 09/02/2021
Hospital: Y

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

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

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: ABDOMINAL PAIN WHICH WAS REALLY UNCOMFORTABLE/STOMACH CRAMPING THAT WAS BRUTAL; TROUBLE SLEEPING; CONSTIPATED; FATIGUE; DEEP VEIN THROMBOSIS; STOMACH BLOATING; 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) dose, 1 total 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 15-AUG-2021, the patient experienced stomach bloating. The patient felt "blocked up", and thought it was just fatigue. The patient had stomach cramping that was brutal. The patient had a bowel movement the night before reporting that brought some relief, but then the pain started across his abdomen, which he described as really uncomfortable. It was reported that, he was given one dose on the day of discharge from the hospital, then was taking two XARELTO tablets daily for his deep vein thrombosis. The patient felt like someone took their fist and punched him hard in the stomach. On an unspecified date, the patient was constipated and had trouble sleeping. The patient took covid-19 test and it was negative. The patient was thinking to visit the emergency room, but was not certain if he should go. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach bloating on 19-AUG-2021, had not recovered from constipated, and the outcome of fatigue, abdominal pain which was really uncomfortable/stomach cramping that was brutal, trouble sleeping and deep vein thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210843197.; Sender's Comments: V0:20210859224-JANSSEN COVID-19 VACCINE Ad26.COV2.S - deep vein thrombosis, stomach bloating ,abdominal pain which was really uncomfortable ,constipated, trouble sleeping - 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). V0: 20210859224-JANSSEN COVID-19 VACCINE Ad26.COV2.S- fatigue-This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1665434
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/02/2021
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: Test Date: 20210825; Test Name: Diagnostic ultrasound; Result Unstructured Data: Blood clots

Allergies:

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

Symptoms: STARTED TO GET THE SAME FEELING IN LEFT FOOT TOO; SEVERAL BLOOD CLOTS BEHIND THE CALF AND BEHIND THE KNEE; AFFECTED HEART; AFFECTED ARM; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 290 pounds, and height was 66 inches. The patient's concurrent conditions included: fibromyalgia. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total administered on 15-AUG-2021 in afternoon for prophylactic vaccination on left deltoid (arm). No concomitant medications were reported. On an unspecified date in AUG-2021, it was reported vaccine affected heart, and arm. For arms effect lasted for 3-4 days and for heart 2 days. At the time of reporting, it was completely resolved. On 20-AUG-2021, the patient experienced several blood clots behind the calf and behind the knee. It started out with lot of pain on the right side of patient's foot. Patient took a picture of it on 20-AUG-2021. Patient saw a physician on 24-AUG-2021 as the ankle was bumpy, the physician sent patient for the ultrasound and on 25-AUG-2021 patient went for ultrasound. Laboratory data included: Diagnostic ultrasound (NR: not provided) Blood clots. Patient contacted her physician but was not available, so another physician had prescribed her to start blood thinner as soon as possible. Treatment medications included: apixaban. On 27-AUG-2021 patient saw healthcare professional and was told there was several blood clots behind the calf and behind the knee. On 29-AUG-2021 patient took picture of the leg because inside of the right leg had more bumps and was swollen. Patient woke up on 30-AUG-2021 morning and 6 inches pass right knee patient was getting pain in that area. Patient started to get the same feeling in left foot too. Pain comes and goes but most of the pain was above the knee. Patient had to worry about dying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from affected heart, and affected arm, and had not recovered from several blood clots behind the calf and behind the knee, and started to get the same feeling in left foot too. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210860050-covid-19 vaccine ad26.cov2.s-several blood clots behind the calf and behind the knee. 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).

Other Meds:

Current Illness: Fibromyalgia

ID: 1665435
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 09/02/2021
Hospital: Y

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

Lab Data: Test Date: 202104; Test Name: Cardiac catheterisation; Result Unstructured Data: everything looks fine with heart but have pericarditis; Test Date: 202104; Test Name: Electrocardiogram; Result Unstructured Data: not reported

Allergies:

Symptom List: Nausea

Symptoms: PERICARDITIS; HEADACHE; UNWELL FEELING; This spontaneous report received from a patient concerned a 70 year (69 year at the time of vaccination) old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure but under control, diabetes but under control, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient had no heart problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not feeling well for 3 weeks after vaccination. The patient indicated he was experiencing headaches and was not feeling well about 1 week prior hospitalization. The patient had thought that he had Covid and went to urgent care. Then patient had underwent an electrocardiogram test and everyone thought patient was had heart attack. After that patient underwent catheterization procedure which had indicated everything fine with patient's heart but diagnosed with pericarditis. On 9-APR-2021, patient was hospitalized for pericarditis, unwell feeling and headaches. On 10-APR-2021, the patient was discharged from hospital (Duration of hospitalization was 1 day). The patient had indicated that he was still taking colchicine twice a day for this condition. The patient had visited the cardiologist after he was released from hospital. He was told by his cardiologist that the pericarditis was a virus which can get anywhere in the body. The patient did not feel that the pericarditis was related to the vaccine and because patient believed it would had happened earlier. The patient had a follow up with his cardiologist in OCT-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pericarditis, and the outcome of unwell feeling and headache was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210860091-Covid-19 vaccine ad26.cov2.s-Pericarditis. 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). 20210860091-Covid-19 vaccine ad26.cov2.s-Unwell feeling, Headache. This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness: Alcohol use (consumption of beer); Blood pressure high; Diabetes; Non-smoker

ID: 1665436
Sex: U
Age:
State: MD

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

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: OUTBREAK IN J&J VACCINE RECEIPENT/KEY WEST OFFICIAL WHO HAD THE JANSSEN COVID-19 VACCINE WAS HOSPITALIZED; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer (via news/media) concerned multiple patients of unspecified age, race and ethnicity. The patient's height and weight was 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, 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 30-AUG-2021 , the reporter heard on news about the outbreak in Janssen vaccine receipent/official who had the Janssen covid-19 vaccine was hospitalized, and suspected clinical vaccination failure. The number of days hospitalized was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the outbreak in JNJ vaccine receipent/official who had the Janssen covid-19 vaccine was hospitalized and suspected clinical vaccination failure was not reported. This report was associated with a product quality complaint (PQC): 90000191560. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210860259.; Sender's Comments: V0 20210860115-covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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 20210860115-covid-19 vaccine ad26.cov2.s-breakthrough infections. 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).

Other Meds:

Current Illness:

ID: 1665437
Sex: F
Age:
State: TN

Vax Date:
Onset Date: 06/04/2021
Rec V Date: 09/02/2021
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: 20210604; Test Name: COVID-19 virus test; Result Unstructured Data: positive

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinusitis, high blood pressure, prediabetes, allergy to almonds, abstains alcohol, and non smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the patient tested positive to covid-19 (suspected clinical vaccination failure and suspected covid-19 infection) after receiving the vaccine. She stated that she walked in to a walk-in clinic thinking it as sinus and received some sinus treatment then the test came back as positive to Covid-19. Her symptoms were stuffy nose and cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191510.; Sender's Comments: V0: 20210860158-COVID-19 VACCINE AD26.COV2.S - Suspected clinical vaccination failure . This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness: Abstains from alcohol; Blood pressure high; Food allergy; Non-smoker; Prediabetes; Sinusitis

Date Died:

ID: 1665438
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: DEATH; This spontaneous report received from a consumer via social media (medical journal) concerned multiple patients of unknown race and ethnicity. 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, 1 total, 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. The reporter read in journal that 22 people died after receiving the vaccine. The cause of death was unknown. It was unknown if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210860032.; Sender's Comments: V0: 20210860177-Covid-19 vaccine ad26.cov2.s -Death. 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: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1665439
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 08/08/2021
Rec V Date: 09/02/2021
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: 20210808; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Date: 20210828; Test Name: COVID-19 virus test; Result Unstructured Data: Negative

Allergies:

Symptom List: Tremor

Symptoms: BREAK THROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. 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 expiry: unknown) dose was not reported, 1 total administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-AUG-2021, the patient experienced break through infection, and tested positive for covid-19. She also had suspected clinical vaccination failure on 08-AUG-2021. On 28-AUG-2021, the patient tested negative for covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough infection on 28-AUG-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191521. This case is a duplicate of 20210860224.; Sender's Comments: V0 2021086210-COVID-19 VACCINE AD26.COV2.S-breakthrough infection. 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). 2021086210-COVID-19 VACCINE AD26.COV2.S-suspected clinical 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: 1665440
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: CURRENTLY DISABLED; This spontaneous report received via social media from a patient concerned a female of 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, expiry date: unknown) dose was not reported, 1 total, administered and 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 after the vaccination, the patient became disabled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from currently disabled. This report was serious (Disability Or Permanent Damage). This case, from the same reporter is linked to 20210860570 and 20210860888.; Sender's Comments: V0: 20210860250-Covid-19 vaccine ad26.cov2.s-currently disabled. 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).

Other Meds:

Current Illness:

ID: 1665441
Sex: M
Age:
State: MD

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

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: This spontaneous report received from a consumer which she heard on the news (social media) concerned a male of unspecified age, race and ethnicity. 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 was not reported) dose, 1 total, 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 consumer reported that "she heard on the news that there were break through infections in 2 key west officials who received the Janssen covid-19 vaccine and one was hospitalized". The date of hospitalization was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breakthrough infections was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210860115. This report was associated with product quality complaint: 90000191561.; Sender's Comments: V0: 20210860259-: Covid-19 Vaccine Ad26.Cov2.S -Breakthrough infection. 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).

Other Meds:

Current Illness:

ID: 1665442
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: FAINTING AT NIGHT; LOW BLOOD PRESSURE AFTER VACCINATION; LIGHT SENSITIVITY; BLISTER LIKE LESIONS ON HER ARMS AND LEGS; INCREASED THIRST; ITCHY EYES; BURNING EYES; WATERY EYES; This solicited report received from a patient via PPSIMM000648: SPP Fee For Service Sponsored Communication- Humana concerned an elderly female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient was treated with Tremfya (guselkumab) (solution for infusion in pre-filled syringe, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for psoriatic arthropathy. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported frequency time 1 total prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case Concomitant medications included betamethasone, citalopram, (Dicyclomine) dicycloverine ,fenofibrate, folic acid, hydrochlorothiazide, methotrexate, nystatin, olmesartan medoxomil ,propranolol, and simvastatin for unknown indication. On an unspecified date, the patient experienced fainting at night, light sensitivity, blister like lesions on her arms and legs, increased thirst, itchy, burning and watery eyes and low blood pressure after vaccination. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with guselkumab was not reported. The patient had not recovered from low blood pressure after vaccination, light sensitivity, blister like lesions on her arms and legs, increased thirst, fainting at night, itchy eyes, burning eyes, and watery eyes. The reporter provided no causality assessment. Company causality between Covid-19 vaccine ad26.cov2.s, and fainting at night, low blood pressure after vaccination, light sensitivity, blister like lesions on her arms and legs, increased thirst, itchy eyes, burning eyes, and watery eyes was not related; and between guselkumab, and fainting at night, low blood pressure after vaccination, light sensitivity, blister like lesions on her arms and legs, increased thirst, itchy eyes, burning eyes, and watery eyes was not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210860397-COVID-19 VACCINE AD26.COV2.S-FAINTING AT NIGHT. This event is considered not related. The event 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. 20210860397- GUSELKUMAB-FAINTING AT NIGHT. This event is considered not related. The event 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.

Other Meds: BETAMETHASONE; CITALOPRAM; DICYCLOMINE [DICYCLOVERINE]; FENOFIBRATE; FOLIC ACID; HYDROCHLOROTH; METHOTREXATE; NYSTATIN; OLMESARTAN MEDOXOMIL; PROPRANOLOL; SIMVASTATIN

Current Illness: Psoriatic arthritis

ID: 1665443
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: BLOOD CLOTS; This spontaneous report received from a health care professional via social media concerned multiple patients of unspecified race, ethnic origin and 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, 1 total ,start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient stated that people reported blood clots and two other events that the reporter could not remember but it was reporter opined that the blood clots were the major thing that made the vaccine to get paused. The reporter was wondering if the vaccine was still available or on pause. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210860561-covid-19 vaccine ad26.cov2.s- blood clots.This event 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.

Other Meds:

Current Illness:

ID: 1665444
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: STILL'S FLARE MINUS HIGH FEVER; INFLAMMATION OF PERIPHERAL NERVES (ITCHING BETWEEN SHOULDER BLADES); MEDICATION ERROR; This spontaneous report received from a patient 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 admin not reported, batch number: Unknown) dose were not reported, 1 total, 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. Concomitant medication included Moderna vaccine (mRNA) for prophylactic vaccination. On an unspecified date, the patient experienced still's flare minus high fever, joint pain, rash, headache. The patient experienced itching between shoulder blades that was told which was an inflammation of peripheral nerves and the patient experienced medication error. The patient received two different vaccines (medication error) (Moderna vaccine and JANSSEN COVID-19 VACCINE) the patient was afraid of it. As per reporter Moderna vaccine side effects were fever, achy muscles and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the still's flare minus high fever, inflammation of peripheral nerves (itching between shoulder blades) and medication error was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210860595- Covid-19 vaccine ad26.cov2.s-still's flare minus high fever. 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).

Other Meds: MRNA 1273

Current Illness:

ID: 1665445
Sex: F
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: SARS-CoV-2 antibody test; Result Unstructured Data: Negative

Allergies:

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

Symptoms: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer survivor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose were not reported, 1 total, 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, patient had done an antibody test and it was negative test (suspected immunological vaccine failure) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210860781 and 20210860500. This report was associated with product quality complaint.; Sender's Comments: V0: 20210860607- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected 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: Cancer

ID: 1665447
Sex: M
Age:
State: MN

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

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

Lab Data: Test Name: Antibody test; Result Unstructured Data: NEGATIVE

Allergies:

Symptom List: Pain in extremity

Symptoms: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer 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) 1 in Total dose were not reported, 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 had negative antibodies test (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210860607 and 20210860500.; Sender's Comments: V0: 20210860781-COVID-19 VACCINE AD26.COV2.S- suspected immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1665448
Sex: F
Age:
State: AR

Vax Date:
Onset Date: 08/29/2021
Rec V Date: 09/02/2021
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: BILATERAL LEG SWELLING; FEELING HOT; SWEATY; RANDOM CHEST PAIN; BILATERAL LEG PAIN; WEAKNESS; NAUSEA; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant at the time of reporting. Patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 29-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-AUG-2021, the patient experienced bilateral leg swelling. On 29-AUG-2021, the patient experienced feeling hot. On 29-AUG-2021, the patient experienced sweaty. On 29-AUG-2021, the patient experienced random chest pain. On 29-AUG-2021, the patient experienced bilateral leg pain. On 29-AUG-2021, the patient experienced weakness. On 29-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from bilateral leg pain, bilateral leg swelling, feeling hot, sweaty, nausea, weakness, and random chest pain. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665449
Sex: U
Age:
State: NM

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: BOTH ARMS WERE TURNING BROWN AND BLOTCHY; 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 MAR-2021 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 both arms were turning brown and blotchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from both arms were turning brown and blotchy. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665450
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 08/17/2021
Rec V Date: 09/02/2021
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: 20210817; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210817; Test Name: EKG; Result Unstructured Data: Normal; Test Date: 20210817; Test Name: Urine analysis; Result Unstructured Data: Normal

Allergies:

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

Symptoms: This spontaneous report received from a 34 year old African American, not Hispanic or Latino female patient. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A expiry: unknown) dose was not reported, administered, 1 total, to left deltoid on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, 5-10 minutes after receiving the injection patient fainted and was rushed to the ER (Emergency room) by paramedics. Laboratory data included: Blood test (NR: not provided) normal, EKG (Electrocardiogram) (NR: not provided) normal, and Urine analysis (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on 17-AUG-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210900241-COVID-19 VACCINE AD26.COV2.S-Fainted. 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).

Other Meds:

Current Illness:

ID: 1665451
Sex: U
Age:
State: FL

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

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

Lab Data: Test Name: COVID-19 antibody test; Result Unstructured Data: Negative (No antibodies)

Allergies:

Symptom List: Vomiting

Symptoms: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; 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: not reported) dose was not reported, 1 total, 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 received the Janssen covid-19 vaccine and had no antibodies/negative antibody test (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative (No antibodies). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210900383. ; Sender's Comments: V0:20210900277-covid-19 vaccine ad26.cov2.s-suspected 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: 1665452
Sex: M
Age:
State: TN

Vax Date:
Onset Date: 08/26/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data: Test Date: 20210826; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: negative; Comments: does not give numerical results.

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: This spontaneous report received from a health care professional (Nurse) concerned a 59 year old white and unknown ethnicity of male. The patient's weight was 290 pounds, and height was 75 inches. The patient's concurrent conditions included: non alcohol user, non smoker, and blood pressure, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included allopurinol 300 mg, enalapril 20mg, hydrochlorothiazide 25mg, and levothyroxine100mcg once a day. On 26-AUG-2021, the patient's blood sample was collected. 30-AUG-2021, the laboratory test results received for SARS-CoV-2 IgG antibody test (SARs Covid - IgG spike test (does not give numerical results) -semi QN test) was found to be negative (units unspecified) which was concluded as confirmed immunological vaccine failure. 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). This report was associated with a product quality complaint: 90000191666.; Sender's Comments: V0:20210900292-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: ENALAPRIL; HCTZ; LEVOTHYROXINE; ALLOPURINOL

Current Illness: Abstains from alcohol; Blood pressure; Non-smoker

ID: 1665453
Sex: M
Age:
State: TN

Vax Date:
Onset Date: 08/28/2021
Rec V Date: 09/02/2021
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: VACCINE ADMINISTERED TO A 16 YEARS OLD; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old male. The patient's height, and weight were not reported. The patient's 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, and batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-AUG-2021, the patient experienced vaccine administered to a 16 years old. On 28-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to a 16 years old and off label use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665454
Sex: F
Age:
State: MO

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: ANXIETY; HYPOTENSION; DIZZINESS AND LIGHT HEADED; This spontaneous report received from a health care professional concerned a 24 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, 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 anxiety, hypotension, and dizziness and light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety, hypotension and dizziness and light headed was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665455
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: BAD 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. 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 bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad reaction. This report was non-serious.

Other Meds:

Current Illness:

ID: 1665456
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: Body temperature; Result Unstructured Data: 98.6; Test Name: Body temperature; Result Unstructured Data: 99.8

Allergies:

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

Symptoms: SLIGHTLY ESCALATED HEART RATE; ESCALATED BLOOD PRESSURE; SLIGHT LIGHTHEADEDNESS; CHANGE IN FINGER NAILS COLOR (DARK PINK/PURPLE); CHANGE IN FINGER COLOR (PALE); BLOOD SHOT EYES; TOUGH TO FOCUS; BACK PAIN; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient does not smoke weed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 slightly escalated heart rate, escalated blood pressure, slight lightheadedness, change in finger nails color (dark pink/purple), change in finger color (pale), blood shot eyes, tough to focus, back pain, and chills. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.8, 98.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly escalated heart rate, and slight lightheadedness, had not recovered from tough to focus, and chills, and the outcome of blood shot eyes, change in finger color (pale), change in finger nails color (dark pink/purple), back pain and escalated blood pressure was not reported. This report was non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am