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: 1751764
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958423 and 20210958321. This case, from the Others is linked to 20210958425.

Other Meds:

Current Illness:

ID: 1751765
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 41 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958425.

Other Meds:

Current Illness:

ID: 1751766
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 09/29/2021
Rec V Date: 10/01/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a physician 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: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 09:37 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751767
Sex: M
Age:
State: AZ

Vax Date:
Onset Date: 09/22/2021
Rec V Date: 10/01/2021
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: FELT A LITTLE BIT IF SOMETHING; RECEIVED AN EXPIRED VACCINE; FATIGUE; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: high blood pressure, arthritis, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse/illicit drug use. 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 22-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-SEP-2021, the patient experienced felt a little bit if something. On 22-SEP-2021, the patient experienced received an expired vaccine. On 22-SEP-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received an expired vaccine, fatigue and felt a little bit if something was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Unknown amount.); Arthritis; Blood pressure high; Non-smoker

ID: 1751768
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 10/01/2021
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: WARM ON THE SECOND DAY AFTER THE SHOT; MILD ACHE; SWEATING ON THE SECOND DAY AFTER THE SHOT; SORE ARM THE FIRST DAY AFTER THE SHOT; This spontaneous report received from a patient concerned a 90 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, abstains from alcohol, sore arm and other pre-existing medical conditions included: Patient was healthy. 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 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 APR-2021, the patient experienced warm on the second day after the shot. On APR-2021, the patient experienced mild ache. On APR-2021, the patient experienced sweating on the second day after the shot. On APR-2021, the patient experienced sore arm the first day after the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm the first day after the shot, warm on the second day after the shot, mild ache and sweating on the second day after the shot was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker; Pain in arm

ID: 1751769
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 09/28/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 32 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958348, 20210958321, 20210958423, 20210958993 and 20210958806.

Other Meds:

Current Illness:

ID: 1751770
Sex: U
Age:
State: CA

Vax Date:
Onset Date: 09/26/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF VACCINE 40-110 HOURS POST EXPIRY; This spontaneous report received from a physician 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: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 26-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-SEP-2021, the patient experienced administration of vaccine 40-110 hours post expiry. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from administration of vaccine 40-110 hours post expiry. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751771
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 09/28/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 54 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958249, 20210958321, 20210958892, 20210958366, 20210958993, 20210958405, 20210958502 and 20210933076. This case, from the Others is linked to 20210959351 and 20210958518.

Other Meds:

Current Illness:

ID: 1751772
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 48 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958371, 20210958806, 20210958566, 20210959351, 20210958518, 20210959620, 20210959581, 20210958977, 20210958348, 20210958321, 20210958525 and 20210959909. This case, from the Others is linked to 20210958366.

Other Meds:

Current Illness:

ID: 1751773
Sex: M
Age:
State: ND

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: RACING HEART FEELING FOR 4 TO 5 TIMES; RASH AT SITE OF INJECTION LIKE RED DOTS ALONG ALL THE ARM; This spontaneous report received from a consumer concerned a 53 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) 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. No concomitant medications were reported. On an unspecified date, the patient experienced racing heart feeling for 4 to 5 times, and rash at site of injection like red dots along all the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the racing heart feeling for 4 to 5 times and rash at site of injection like red dots along all the arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751774
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 09/26/2021
Rec V Date: 10/01/2021
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: BLOOD CLOTS; This spontaneous report received from a patient concerned a 63 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: 205A21A expiry: unknown) dose was not reported, frequency time 1 total was administered on 13-SEP-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-SEP-2021, (2 weeks after the vaccination) the patient had blood clots, about 6 on upper arm near the injection site and they travelled down the arm. The patient stated that, on the day of report one clot was appeared on the finger. The patient had not been gone to the doctor because it still appeared to be superficial and one of them felt like little lump that patient could feel it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210958476-COVID-19 VACCINE AD26.COV2.S-Blood clots. 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: 1751775
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 49 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958423, 20210958321, 20210958993 and 20210958249.

Other Meds:

Current Illness:

ID: 1751776
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 09/28/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional 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, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958566, 20210958806, 20210959351, 20210958321, 20210958348, 20210958371, 20210958425, 20210958977, 20210959620, 20210958525, 20210959581 and 20210959909.

Other Meds:

Current Illness:

ID: 1751777
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 09/27/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 49 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 (suspension for injection, route of admin not reported and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958806, 20210958566 and 20210959351. This case, from the Others is linked to 20210958716.

Other Meds:

Current Illness:

ID: 1751778
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 09/26/2021
Rec V Date: 10/01/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 61 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 26-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958564, 20210958570, 20210958784 and 20210959706.

Other Meds:

Current Illness:

ID: 1751779
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: FEVER; FELT WEAK; 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, and felt weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and felt weak was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751780
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a physician concerned a 63 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958784, 20210958534 and 20210958570.

Other Meds:

Current Illness:

ID: 1751781
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 09/27/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 24 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958425, 20210958525, 20210958716, 20210958371, 20210958806, 20210958977, 20210958518 and 20210958348.

Other Meds:

Current Illness:

ID: 1751782
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 09/25/2021
Rec V Date: 10/01/2021
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: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional 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: 2052A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958564, 20210958534, 20210958784 and 20210959706.

Other Meds:

Current Illness:

ID: 1751783
Sex: M
Age:
State: KS

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 10/01/2021
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: SHIVERING AND CHILLS; This spontaneous report received from a parent concerned a 24 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: Unknown) dose was not reported, administered on 28-SEP-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 shivering and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shivering and chills. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751784
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 10/01/2021
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: WARM; SWEATING (ON THE SECOND DAY); SORE ARM THE FIRST DAY AFTER THE SHOT; This spontaneous report received from a consumer concerned an 18 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 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 APR-2021, the patient experienced warm. On APR-2021, the patient experienced sweating (on the second day). On APR-2021, the patient experienced sore arm the first day after the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm the first day after the shot, warm and sweating (on the second day) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751785
Sex: M
Age:
State: WA

Vax Date:
Onset Date: 09/17/2021
Rec V Date: 10/01/2021
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: THROAT SWELLING; MINOR HEADACHE; EXCRUCIATING SHOULDER PAIN (LEFT); This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included: excruciating pain in different body areas, and concurrent conditions included: sulfa drug allergies, non smoker, non alcoholic, and penicillin allergy. The patient was previously treated with varicella zoster vaccine rge (cho) for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 17-SEP-2021 19:00 for prophylactic vaccination. Concomitant medications included gabapentin for shingles flareup. On 17-SEP-2021, the patient experienced excruciating shoulder pain (left). On 20-SEP-2021, the patient experienced throat swelling. On 20-SEP-2021, the patient experienced minor headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat swelling, and minor headache on SEP-2021, and excruciating shoulder pain (left) on 20-SEP-2021. This report was non-serious.

Other Meds: GABAPENTIN

Current Illness: Abstains from alcohol; Allergic reaction to antibiotics (allergies to sulfa drugs and any -cillins (penicillin,); Non-smoker; Penicillin allergy

ID: 1751786
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: ADVERSELY AFFECTED BY THE JANSSEN COVID-19 VACCINE; 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 (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 adversely affected by the Janssen covid-19 vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of adversely affected by the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210960302.

Other Meds:

Current Illness:

ID: 1751787
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 09/27/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 45 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958566, 20210958321, 20210958525 and 20210958993.

Other Meds:

Current Illness:

ID: 1751788
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 09/14/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Date: 20210918; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Negative; Test Date: 20210924; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto's disease, seasonal allergies, and irritable bowel syndrome. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced confirmed covid-19 infection. On 18-SEP-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On 24-SEP-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious. This case, from the same reporter is linked to 20210958772.

Other Meds:

Current Illness: Hashimoto's disease; Irritable bowel syndrome; Seasonal allergy

ID: 1751789
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 09/15/2021
Rec V Date: 10/01/2021
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: 20210917; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive; Test Date: 20210919; Test Name: Body temperature; Result Unstructured Data: 103.8 F; Test Date: 20210920; Test Name: Body temperature; Result Unstructured Data: 102 F

Allergies:

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

Symptoms: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, and other pre-existing medical conditions included: Patient was healthy, did not have any chronic conditions and medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-SEP-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, in the morning the patient had bad fever. On 17-SEP-2021, the patient had a tele-visit with his doctor who suggested patient to take a COVID-19 PCR (coronavirus 19 polymerase chain reaction) test, which came back to positive (confirmed covid-19 infection) with symptoms of cough, headache, fatigue and fever. On 19-SEP-2021, Laboratory data included: Body temperature (NR: not provided) 103.8 F. Treatment medications included: ibuprofen, and paracetamol (given every 4-6 hours to keep fever down) and fever went at 9 to 10. On 20-SEP-2021, the patient went to hospital/clinic where patient received antibiotics, inhaler, CIPAP (continuous positive airway pressure therapy), and a monoclonal infusion as corrective treatment. On the same day, Laboratory data included: Body temperature (NR: not provided) 102 F. The patient was not hospitalized, just stayed at the clinic located in the hospital for a few hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210958723.; Sender's Comments: V0: 20210958772-COVID-19 VACCINE AD26.COV2.S-Confirmed covid-19 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: Seasonal allergy

ID: 1751790
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 09/25/2021
Rec V Date: 10/01/2021
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: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 50 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 (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry:21-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958564, 20210958534, 20210958570 and 20210959706.

Other Meds:

Current Illness:

ID: 1751791
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 09/28/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 52 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 (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958348, 20210958425, 20210958525, 20210958566, 20210958518, 20210959351, 20210959620, 20210958977, 20210959581, 20210958371 and 20210959909. This case, from the Others is linked to 20210958405.

Other Meds:

Current Illness:

ID: 1751792
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 09/22/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 49 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 (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-20201) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958321, 20210958423, 20210958716, 20210958502, 20210958405, 20210958366, 20210958249, 20210958993. .

Other Meds:

Current Illness:

ID: 1751793
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 09/27/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Date: 20210928; Test Name: Body temperature; Result Unstructured Data: 101 F

Allergies:

Symptom List: Nausea

Symptoms: COULD NOT CONTROL HANDS OR FEET, HANDS WERE FORMING A FIST (NAILS INTO PALMS); COULD NOT MOVE HANDS OR FEET; COULD NOT WALK; TINGLING OF EXTREMITIES (UP TO KNEE, ARMS, FEET AND HAND) AND UPPER LIP AREA; NAUSEOUS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. Patient had no history of drug abuse or illicit drug usage. Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced nauseous. On 27-SEP-2021, the patient experienced fever. On 27-SEP-2021, the patient experienced headache. On 28-SEP-2021, the patient experienced could not control hands or feet, hands were forming a fist (nails into palms). On 28-SEP-2021, the patient experienced could not move hands or feet. On 28-SEP-2021, the patient experienced could not walk. On 28-SEP-2021, the patient experienced tingling of extremities (up to knee, arms, feet and hand) and upper lip area. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nauseous, fever, headache, could not control hands or feet, hands were forming a fist (nails into palms), tingling of extremities (up to knee, arms, feet and hand) and upper lip area, could not walk, and could not move hands or feet. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (On occasion.); Non-smoker

ID: 1751794
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 09/27/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 38 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958566, 20210959351, 20210958518, 20210959620, 20210958321, 20210958806, 20210958425, 20210959581, 20210958371 and 20210958525.

Other Meds:

Current Illness:

ID: 1751795
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 09/29/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 62 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958321, 20210958423, 20210958716, 20210958502, 20210958405, 20210958366, 20210958249, 20210958892 and 20210959620.

Other Meds:

Current Illness:

ID: 1751796
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: SKIN DISORDER; SWOLLEN LEFT LEGS; ANKLE SWELLING; LEFT BREAST WAS BIGGER THAN IT WAS BEFORE; LEFT ARM SWOLLEN; ITCHY SPOTS ON HEAD; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, and other pre-existing medical conditions included: The patient had no known allergies and relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 25-MAY-2021 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: risankizumab (subcutaneous, batch number: 1152570, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced skin disorder, swollen left legs, ankle swelling, left breast was bigger than it was before, left arm swollen, and itchy spots on head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient recovered from skin disorder on JUL-2021, and swollen left legs, and ankle swelling on 26-JUL-2021, had not recovered from left arm swollen, and itchy spots on head, and the outcome of left breast was bigger than it was before was not reported. This report was non-serious.

Other Meds: SKYRIZI [RISANKIZUMAB]

Current Illness: Plaque psoriasis

ID: 1751797
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: NOT FEELING WELL; SEVERE HEADACHE; FEVER; 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, and batch number were not reported) 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 not feeling well, severe headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, fever, and not feeling well. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751798
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 09/28/2021
Rec V Date: 10/01/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 29 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958348, 20210958371, 20210958425, 20210958518, 20210958566, 20210958806, 20210958321, 20210958525, 20210958977, 20210959581, 20210959620 and 20210959909. This case, from the Others is linked to 20210958423.

Other Meds:

Current Illness:

ID: 1751799
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 05/31/2021
Rec V Date: 10/01/2021
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: EARS PLUGGED UP, NOT ALL THE TIME BUT MORE THAN NORMAL (AROUND 3 TIMES A WEEK); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: bad hearing. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the patient experienced ears plugged up, not all the time but more than normal (around 3 times a week). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ears plugged up, not all the time but more than normal (around 3 times a week). This report was non-serious.

Other Meds:

Current Illness: Hearing impaired

ID: 1751800
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: SHAKING; OVERBEARING HEAT; CHILLS VERY BAD FOR A FEW HOURS AT NIGHT; 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, 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 shaking, overbearing heat, and chills very bad for a few hours at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills very bad for a few hours at night, and the outcome of shaking and overbearing heat was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1751801
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 09/22/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 38 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210959351, 20210959620, 20210958348, 20210958371, 20210958425, 20210958566, 20210958518, 20210958977, 20210958321, 20210958806 and 20210959909.

Other Meds:

Current Illness:

ID: 1751802
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Increase

Allergies:

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

Symptoms: JOINT PAIN GOT WORSE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, psoriatic arthritis, and latex allergy. The patient was previously treated with azithromycin; and experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 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 (suspension for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced joint pain got worse. Laboratory data (dates unspecified) included: Erythrocyte sedimentation rate (NR: not provided) Increase. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain got worse. This report was non-serious.

Other Meds:

Current Illness: Latex allergy; Penicillin allergy; Psoriatic arthritis

ID: 1751803
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 45 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: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958534, 20210958564, 20210958570 and 20210958784.

Other Meds:

Current Illness:

ID: 1751804
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/01/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 25 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958366, 20210958321 and 20210958423.

Other Meds:

Current Illness:

ID: 1751805
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: ADVERSELY AFFECTED BY THE JANSSEN COVID-19 VACCINE; 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 (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 adversely affected by the janssen covid-19 vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of adversely affected by the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958633.

Other Meds:

Current Illness:

ID: 1751806
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: minimal discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (minimal discomfort) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (minimal discomfort). At the time of the report, DISCOMFORT (minimal discomfort) outcome was unknown. No concomitant medication was reported. No treatment information was provided. This case was linked to MOD-2021-335308, MOD-2021-329830 (Patient Link).

Other Meds:

Current Illness:

ID: 1751807
Sex: F
Age:
State: IL

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: blood pressure been low; Oxygen up and down; She sets down and falls off to sleep; I am having my heart situation looked into as well as my wife; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (blood pressure been low), OXYGEN SATURATION ABNORMAL (Oxygen up and down), SOMNOLENCE (She sets down and falls off to sleep) and CARDIAC DISCOMFORT (I am having my heart situation looked into as well as my wife) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (blood pressure been low), OXYGEN SATURATION ABNORMAL (Oxygen up and down), SOMNOLENCE (She sets down and falls off to sleep) and CARDIAC DISCOMFORT (I am having my heart situation looked into as well as my wife). At the time of the report, BLOOD PRESSURE DECREASED (blood pressure been low), OXYGEN SATURATION ABNORMAL (Oxygen up and down), SOMNOLENCE (She sets down and falls off to sleep) and CARDIAC DISCOMFORT (I am having my heart situation looked into as well as my wife) outcome was unknown. Concomitant medications were not reported. Treatment information was not provided. Reporter reported that the patient had not much problem with the first shot. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received on 22-Sep-2021 contains new event (Cardiac discomfort) was updated. Reporter email and contact details were updated and patient gender updated as per narrative.

Other Meds:

Current Illness:

ID: 1751808
Sex: F
Age: 62
State: CA

Vax Date: 06/25/2021
Onset Date:
Rec V Date: 10/01/2021
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: scratchy throat; felt lightheaded; rash flare up to a medication which stopped after the vaccine.; big knot on arm near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (scratchy throat), DIZZINESS (felt lightheaded), RASH (rash flare up to a medication which stopped after the vaccine.) and INJECTION SITE MASS (big knot on arm near the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 040B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (scratchy throat), DIZZINESS (felt lightheaded), RASH (rash flare up to a medication which stopped after the vaccine.) and INJECTION SITE MASS (big knot on arm near the injection site). At the time of the report, THROAT IRRITATION (scratchy throat) and DIZZINESS (felt lightheaded) outcome was unknown and RASH (rash flare up to a medication which stopped after the vaccine.) and INJECTION SITE MASS (big knot on arm near the injection site) had resolved. Consumer states it also opened up her sinuses where she could smell better. consumer reports that she felt lightheaded after 2nd dose of the vaccine No concomitant medication reported. No treatment medication reported. This case was linked to MOD-2021-272980 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Sig- Follow Up received-TCR--Events outcome was updated.

Other Meds:

Current Illness:

ID: 1751809
Sex: M
Age: 48
State: TX

Vax Date: 04/13/2021
Onset Date: 05/11/2021
Rec V Date: 10/01/2021
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: 20210804; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Tested positive for Covid-19

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Tested positive for Covid-19 on Wednesday (04Aug2021); Lack of drug effect; Low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19 on Wednesday (04Aug2021)), PYREXIA (Low-grade fever) and DRUG INEFFECTIVE (Lack of drug effect) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (Low-grade fever). On 04-Aug-2021, the patient experienced COVID-19 (Tested positive for Covid-19 on Wednesday (04Aug2021)) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for Covid-19 on Wednesday (04Aug2021)), PYREXIA (Low-grade fever) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19. Concomitant product use was not provided by the reporter. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received and lack of drug effect added as per latest guidelines and outcome of COVID-19 updated.; Sender's Comments: This case concerns a 48 year-old, male with no relevant medical history , who experienced the unexpected events of COVID19, DRUG INEFFECTIVE . The event occurred approximately 3 month and 23 days after the most recent dose (second dose) of mRNA-1273 Moderna vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.

Other Meds:

Current Illness:

ID: 1751810
Sex: F
Age: 64
State: WA

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 10/01/2021
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: Kind of did not feel right after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Kind of did not feel right after the first vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The patient's past medical history included Brain injury. Concurrent medical conditions included Allergy (Allergic to an injection during surgery about 50 years ago.) and Hypertension. Concomitant products included OXYCODONE for Pain, DICLOFENAC SODIUM, LOSARTAN POTASSIUM, AMLODIPINE, ATORVASTATIN and GABAPENTIN for an unknown indication, NAPROXEN. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION COMPLICATION (Kind of did not feel right after the first vaccine). On 13-Mar-2021, VACCINATION COMPLICATION (Kind of did not feel right after the first vaccine) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other concomitant medication include Prenatal vitamin + iron Treatment information was not provided. This case was linked to MOD-2021-281253 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Added, patient DOB and concomitant medication

Other Meds: OXYCODONE; NAPROXEN; DICLOFENAC SODIUM; LOSARTAN POTASSIUM; AMLODIPINE; ATORVASTATIN; GABAPENTIN

Current Illness: Allergy (Allergic to an injection during surgery about 50 years ago.); Hypertension

ID: 1751811
Sex: F
Age: 36
State: FL

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 10/01/2021
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: 20210804; Test Name: Heart rate; Result Unstructured Data: around 100 heart beats per minute

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Heart was beating so fast as they were lying down they could almost here it pounding; Pain was irradiating from the shoulder to their breast; Terrible shoulder pain / pain was sharp and deep bellow the tissue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was beating so fast as they were lying down they could almost here it pounding), PAIN (Pain was irradiating from the shoulder to their breast) and ARTHRALGIA (Terrible shoulder pain / pain was sharp and deep bellow the tissue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No medical history information was reported. Concomitant products included IBUPROFEN for an unknown indication. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PAIN (Pain was irradiating from the shoulder to their breast) and ARTHRALGIA (Terrible shoulder pain / pain was sharp and deep bellow the tissue). On 04-Aug-2021, the patient experienced PALPITATIONS (Heart was beating so fast as they were lying down they could almost here it pounding). On 05-Aug-2021, PAIN (Pain was irradiating from the shoulder to their breast) and ARTHRALGIA (Terrible shoulder pain / pain was sharp and deep bellow the tissue) had resolved. At the time of the report, PALPITATIONS (Heart was beating so fast as they were lying down they could almost here it pounding) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, Heart rate: 100 heart beats per minute (High) around 100. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were reported

Other Meds: IBUPROFEN

Current Illness:

ID: 1751812
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: Some swelling by my elbow; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Some swelling by my elbow) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Some swelling by my elbow). At the time of the report, JOINT SWELLING (Some swelling by my elbow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1751813
Sex: F
Age:
State: MA

Vax Date: 12/27/2020
Onset Date:
Rec V Date: 10/01/2021
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: Lyme titer; Result Unstructured Data: Lyme titer was unremarkable; Test Name: anti-neutrophil cytoplasmic antibody; Result Unstructured Data: anti-neutrophil cytoplasmic antibody was unremarkable.; Test Name: antinuclear antibody; Result Unstructured Data: antinuclear antibody was unremarkable; Test Date: 202102; Test Name: Cerebrospinal fluid test; Result Unstructured Data: Serum glucose- 131 mg/dL; Test Date: 202102; Test Name: Cerebrospinal fluid test; Result Unstructured Data: Glucose- 94 mg/dL; Test Date: 202102; Test Name: IgG index (CSF/serum); Result Unstructured Data: elevated IgG index (CSF/serum) at 1.27; Test Date: 202102; Test Name: Cerebrospinal fluid test; Result Unstructured Data: Lymphocytes- 91%; Test Date: 202102; Test Name: Cerebrospinal fluid test; Result Unstructured Data: Monocytes- 5%; Test Date: 202102; Test Name: Cerebrospinal fluid test; Result Unstructured Data: Neutrophils- 0%; Test Date: 202102; Test Name: Cerebrospinal fluid test; Result Unstructured Data: Oligoclonal bands-0; Test Date: 202102; Test Name: Cerebrospinal fluid test; Result Unstructured Data: Total protein- 19 mg/dL; Test Date: 202102; Test Name: Cerebrospinal fluid test; Result Unstructured Data: RBC- 7 /uL; Test Date: 202102; Test Name: Cerebrospinal fluid test; Result Unstructured Data: WBC count- 19 /uL; Test Name: MRI; Result Unstructured Data: MRI showed multiple T2 hyperintense periventricular, subcortical, posterior fossa, and spinal cord lesions with morphology suggesting MS. After gadolinium administration, two of the lesions enhanced (one each in the brain and spinal cord). New brain T2 lesions was 9 and New spinal cord T2 lesions was >2; Test Name: RAPD/Color desaturation; Result Unstructured Data: relative afferent pupillary defect (RAPD) and color desaturation OD.; Test Date: 202109; Test Name: positive serum SARS-CoV-2 spike antibody; Test Result: Positive ; Result Unstructured Data: showed a positive serum SARS-CoV-2 spike antibody, suggesting humoral immunity to the SARS-CoV-2 virus, when checked 8 months after completing COVID-19 vaccination (608.70 U/mL?negative < 0.80 U/mL).; Test Date: 20210126; Test Name: COVID-19 nasal PCR test; Test Result: Negative ; Result Unstructured Data: Patient had a negative COVID-19 nasal PCR test one day after the second vaccine dose; Test Name: visual acuity; Result Unstructured Data: decreased visual acuity (20/50); Test Name: Visual field assessment; Result Unstructured Data: Visual field assessment showed a monocular central/inferior monocular deficit; Test Date: 202102; Test Name: Neurologic examination; Result Unstructured Data: At follow-up visit, 14 days after symptom onset, she had returned to baseline and neurologic examination was normal.; Test Name: EDSS score at baseline; Result Unstructured Data: EDSS score at baseline was 0 and EDSS score after treatment was also 0

Allergies:

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

Symptoms: newly diagnosed RRMS; This literature-study case was reported in a literature article and describes the occurrence of RELAPSING-REMITTING MULTIPLE SCLEROSIS (newly diagnosed RRMS) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RELAPSING-REMITTING MULTIPLE SCLEROSIS (newly diagnosed RRMS) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE (intravenous) in February 2021 for Relapsing-remitting multiple sclerosis, at a dose of 1000 milligram. At the time of the report, RELAPSING-REMITTING MULTIPLE SCLEROSIS (newly diagnosed RRMS) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: negative (Negative) Patient had a negative COVID-19 nasal PCR test one day after the second vaccine dose. In February 2021, Blood glucose (70 mg/dl-110 mg/dl): 131 mg/dl (High) Serum glucose- 131 mg/dL. In February 2021, CSF glucose (50 mg/dl-75 mg/dl): 94 mg/dl (High) Glucose- 94 mg/dL. In February 2021, CSF immunoglobulin (Unknown-= 0.85): 1.27 (High) elevated IgG index (CSF/serum) at 1.27. In February 2021, CSF lymphocyte count (0-100%): 91% (normal) Lymphocytes- 91%. In February 2021, CSF monocyte count (0-100%): 5% Monocytes- 5%. In February 2021, CSF neutrophil count (0%-Unknown): 0% Neutrophils- 0%. In February 2021, CSF oligoclonal band: 0 (normal) Oligoclonal bands-0. In February 2021, CSF protein (5 mg/dl-55 mg/dl): 19 mg/dl (normal) Total protein- 19 mg/dL. In February 2021, CSF red blood cell count (0 /ul-5 /ul): 7 /ul (High) RBC- 7 /uL. In February 2021, CSF white blood cell count (0 /ul-5 /ul): 19 /ul (High) WBC count- 19 /uL. In February 2021, Neurological examination: normal (normal) At follow-up visit, 14 days after symptom onset, she had returned to baseline and neurologic examination was normal.. In September 2021, SARS-CoV-2 antibody test: positive (Positive) showed a positive serum SARS-CoV-2 spike antibody, suggesting humoral immunity to the SARS-CoV-2 virus, when checked 8 months after completing COVID-19 vaccination (608.70 U/mL?negative < 0.80 U/mL).. On an unknown date, Antibody test: unremarkable (normal) Lyme titer was unremarkable. On an unknown date, Antineutrophil cytoplasmic antibody: unremarkable (normal) anti-neutrophil cytoplasmic antibody was unremarkable.. On an unknown date, Antinuclear antibody: unremarkable (normal) antinuclear antibody was unremarkable. On an unknown date, Expanded disability status scale: 0 EDSS score at baseline was 0 and EDSS score after treatment was also 0. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) MRI showed multiple T2 hyperintense periventricular, subcortical, posterior fossa, and spinal cord lesions with morphology suggesting MS. After gadolinium administration, two of the lesions enhanced (one each in the brain and spinal cord). New brain T2 lesions was 9 and New spinal cord T2 lesions was >2. On an unknown date, Ophthalmological examination: abnormal (abnormal) relative afferent pupillary defect (RAPD) and color desaturation OD.. On an unknown date, Visual acuity tests: decreased decreased visual acuity (20/50). On an unknown date, Visual field tests: abnormal (abnormal) Visual field assessment showed a monocular central/inferior monocular deficit. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RELAPSING-REMITTING MULTIPLE SCLEROSIS (newly diagnosed RRMS) to be possibly related. Concomitant product use was not provided by the reporter. Patient did not have history of COVID-19 infection and no significant past medical history. Patient presented with 2 days of new visual symptoms involving the right eye. Her symptoms began with mild blurring, which progressed over the next few days to worsening blurriness and pain with eye movement OD (right eye). Patient received the second dose 29 days after the first dose without any significant immediate side effects after vaccination. Lumbar puncture was performed 4 days after symptom onset. The CSF was otherwise normal on protein and glucose, without oligoclonal bands. Patient received 5 days of 1000 mg IVMP, 3 days after symptom onset, leading to gradual improvement of her symptoms. Given her clinical presentation and MRI findings, she was diagnosed with RRMS and started MS disease-modifying therapy. Company Comment: This literature report concerns a 26 year old female patient with no relevant medical history who developed a new onset unexpected serious event of relapsing-remitting multiple sclerosis (RMMS) 14 days after vaccination with second dose of mRNA-1273. The patient was treated with 5 days of 1000 mg IV Methylprednisolone with gradual improvement of her symptoms and return to baseline (at 14 days after the symptom onset). The patient was also put on multiple sclerosis (MS) disease-modifying therapy. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-318375, MOD-2021-318474. Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow up received by safety on 15-Sep-2021 included an Email received from Team and does not contain any new information.; Sender's Comments: This literature report concerns a 26 year old female patient with no relevant medical history who developed a new onset unexpected serious event of relapsing-remitting multiple sclerosis (RMMS) 14 days after vaccination with second dose of mRNA-1273. The patient was treated with 5 days of 1000 mg IV Methylprednisolone with gradual improvement of her symptoms and return to baseline (at 14 days after the symptom onset). The patient was also put on multiple sclerosis (MS) disease-modifying therapy. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of mRNA-1273 is not affected by this report.

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