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: 1739971
Sex: U
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: Test Name: Imaging procedure; Result Unstructured Data: No Sinus blood clots were found

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: SWEATING; OTHER SYMPTOMS; CHILLS; FEVER; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 71 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not in the age group for blood clots. 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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sweating, other symptoms, chills, fever, and severe headache. Laboratory data (dates unspecified) included: Imaging procedure (NR: not provided) no Sinus blood clots were found. The action taken with covid-19 vaccine was not applicable. The patient recovered from sweating, other symptoms, chills, fever, and severe headache. This report was non-serious. This case, from the same reporter is linked to 20210950596 and 20210949951.

Other Meds:

Current Illness:

ID: 1739972
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 09/28/2021
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: RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 65 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: 202A21A, and batch number: 202A21A 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 received an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949990.

Other Meds:

Current Illness:

ID: 1739973
Sex: M
Age:
State: KS

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 09/28/2021
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 pharmacist 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: 201A21A 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 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 20210950001 and 20210949993.

Other Meds:

Current Illness:

ID: 1739974
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; This spontaneous report received from a pharmacist 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, subcutaneous, 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 off label use, and inappropriate route of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate route of vaccination was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739975
Sex: U
Age:
State: IL

Vax Date:
Onset Date: 09/22/2021
Rec V Date: 09/28/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 34 year old of unspecified 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: 201A21A, and 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 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: 1739976
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 09/28/2021
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: EXPIRED DOSE ADMINISTERED; This spontaneous report received from a health care professional concerned a 36 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient have no known drug allergies and no significant past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced expired dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739977
Sex: F
Age:
State: CO

Vax Date:
Onset Date: 09/17/2021
Rec V Date: 09/28/2021
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: SEVERE MIGRAINE; GENERAL NOT FEELING WELL/ BEGAN TO FEEL POORLY AGAIN; SUBJECTIVE FEVER; HEADACHE; ACHY BODY; STIFF JOINTS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-SEP-2021, the patient experienced stiff joints. On 17-SEP-2021, the patient experienced achy body. On 17-SEP-2021, the patient experienced subjective fever. On 17-SEP-2021, the patient experienced headache. On 23-SEP-2021, the patient experienced severe migraine. On 23-SEP-2021, the patient experienced general not feeling well/ began to feel poorly again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff joints, achy body, subjective fever, and headache on 20-SEP-2021, and had not recovered from severe migraine, and general not feeling well/ began to feel poorly again. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739978
Sex: U
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: Test Name: Lab test; Result Unstructured Data: No sinus blood clots were found; Comments: There was a concern regarding severe headache so patient went through imaging and no sinus blood clots were found.

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: SWEATING; OTHER SYMPTOMS; CHILLS; FEVER; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not allergic to the J&J Vaccine. 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 sweating, other symptoms, chills, fever, and severe headache. Laboratory data (dates unspecified) included: Lab test (NR: not provided) No sinus blood clots were found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, other symptoms, chills, fever, and severe headache. This report was non-serious. This case, from the same reporter is linked to 20210950596 and 20210949900.

Other Meds:

Current Illness:

ID: 1739979
Sex: F
Age:
State:

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 09/28/2021
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: UNABLE TO TALK; NOT FEELING WELL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 24-SEP-2021, the patient experienced unable to talk. On 24-SEP-2021, the patient experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unable to talk and not feeling well was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739980
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 09/11/2021
Rec V Date: 09/28/2021
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: SORE ARM; 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 pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-SEP-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 24-SEP-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739981
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/28/2021
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: ARM SORENESS; FATIGUE; MUSCLE ACHE; 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 SEP-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 SEP-2021, the patient experienced arm soreness. On SEP-2021, the patient experienced fatigue. On SEP-2021, the patient experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, fatigue, and muscle ache on SEP-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739982
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 09/28/2021
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: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 47 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: 202A21A, 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 used. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949219, 20210949881, 20210949901 and 20210949251.

Other Meds:

Current Illness:

ID: 1739983
Sex: M
Age:
State: KS

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 09/28/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist 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: 201A21A, 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 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 20210950001.

Other Meds:

Current Illness:

ID: 1739984
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/28/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 43 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: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine 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 20210949302, 20210949322, 20210949808, 20210949974, 20210950004, 20210950006 and 20210950120.

Other Meds:

Current Illness:

ID: 1739985
Sex: M
Age:
State: KS

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 09/28/2021
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 pharmacist 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, and batch number: 201A21A 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 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 20210949993 and 20210949906.

Other Meds:

Current Illness:

ID: 1739986
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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 Name: Body temperature; Result Unstructured Data: 102 (unit not reported)

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: LITTLE SORE ARM; CHILLS; 102 TEMPERATURE; MUSCLE ACHES; FELT KIND OF 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 request for this case. No concomitant medications were reported. On an unspecified date, the patient experienced little sore arm, chills, 102 temperature, muscle aches, and felt kind of tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 (unit not reported). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, 102 temperature, muscle aches, and felt kind of tired, and had not recovered from little sore arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739987
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/28/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 57 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 and batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 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 20210949302, 20210949996, 20210949974, 20210949322, 20210950120, 20210949808 and 20210950006.

Other Meds:

Current Illness:

ID: 1739988
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/28/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 25 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 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 20210949302, 20210949996, 20210949974 and 20210950004.

Other Meds:

Current Illness:

ID: 1739989
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 09/28/2021
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: LIGHT HEADED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of light headed was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739990
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 09/28/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. 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.

Other Meds:

Current Illness:

ID: 1739991
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: FEW SIDE EFFECTS; FELT A LITTLE TIRED; This spontaneous report received from a consumer concerned an adult of unspecified 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. On an unspecified date, the patient experienced few side effects, and felt a little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the few side effects and felt a little tired was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739992
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 09/22/2021
Rec V Date: 09/28/2021
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: EXPIRED VACCINE USED; This spontaneous report received from a pharmacist 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: 201A21A 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 expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739993
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 09/28/2021
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: Expired vaccine used; 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, intramuscular, batch number: 1808982 and 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 used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739994
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: VACCINE ADMINISTERED OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine administered outside of recommended storage conditions, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of recommended storage conditions and incorrect product storage was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739995
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
Hospital:

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

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

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: FLU-LIKE SYMPTOMS (FEVER); This spontaneous report received from a consumer concerned a 71 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced flu-like symptoms (fever). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms (fever). This report was non-serious.

Other Meds:

Current Illness:

ID: 1739996
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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 Name: Body temperature; Result Unstructured Data: fever of 101.4

Allergies:

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

Symptoms: BODY ACHES; STIFFNESS; FELT BAD ENOUGH TO STAY IN BED; CHILL; FEVER OF 101.4; HEADACHE; This spontaneous report received from a patient via a company representative 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. 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, stiffness, felt bad enough to stay in bed, chill, fever of 101.4, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) fever of 101.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, stiffness, felt bad enough to stay in bed, chill, fever of 101.4, and headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739997
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: COUGH; LOSS OF TASTE; SOME BREATHING ISSUES; LOSS OF SMELL; JOINT PAIN; FEVER; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced cough, loss of taste, some breathing issues, loss of smell, joint pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough, fever, loss of taste, joint pain, some breathing issues and loss of smell was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1739998
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: PRETTY SICK FOR A WEEK; BAD HEADACHES; MUSCLE PAIN; This spontaneous report received from a consumer via a company representative 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 (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 pretty sick for a week, bad headaches, and muscle pain. The action taken with covid-19 vaccine was not applicable. The outcome of the pretty sick for a week, bad headaches and muscle pain was not reported. This report was non-serious. .

Other Meds:

Current Illness:

ID: 1739999
Sex: F
Age:
State: WI

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 09/28/2021
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: FEELING DIZZY; PAIN IN THE BACK OF BOTH LEGS (BOTH CALVES) AND FEELING PAIN ON THE OTHER ARM (RIGHT ARM); HEADACHE; This spontaneous report received from a patient concerned a 57 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: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced feeling dizzy. On 23-SEP-2021, the patient experienced pain in the back of both legs (both calves) and feeling pain on the other arm (right arm). On 23-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from feeling dizzy, and headache on SEP-2021, and had not recovered from pain in the back of both legs (both calves) and feeling pain on the other arm (right arm). This report was non-serious.

Other Meds:

Current Illness:

ID: 1740000
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: BODY ACHES; HORRIBLY SICK; CHILLS; FEVER; BAD HEADACHE; This spontaneous report received from a parent 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. 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, horribly sick, chills, fever, and bad headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from horribly sick, and the outcome of fever, chills, body aches and bad headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1740001
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 headache, and nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache, and nausea. This report was non-serious.

Other Meds:

Current Illness:

ID: 1740002
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: NIGHT OF FLU LIKE SYMPTOMS; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 night of flu like symptoms. The action taken with covid-19 vaccine was not applicable. The patient recovered from night of flu like symptoms. This report was non-serious.

Other Meds:

Current Illness:

ID: 1740003
Sex: M
Age:
State: MD

Vax Date:
Onset Date: 09/25/2021
Rec V Date: 09/28/2021
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: SHAKING; BODY SORE FROM SHAKING; CHILLS; This spontaneous report received from a consumer concerned a 22 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: 212A21A expiry: UNKNOWN) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021, the patient experienced shaking. On 25-SEP-2021, the patient experienced body sore from shaking. On 25-SEP-2021, the patient experienced chills. The action taken with covid-19 vaccine was not applicable. The patient recovered from shaking, and chills on 25-SEP-2021, and the outcome of body sore from shaking was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1740004
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: FLU-LIKE SYMPTOMS; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1740005
Sex: F
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: BODY ACHES; CHILLS; VERY SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, chills, and very slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and very slight fever. This report was non-serious. This case, from the same reporter is linked to 20210950993.

Other Meds:

Current Illness:

ID: 1740006
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: This spontaneous (non-serious) report received from a patient, concerned a patient, of unspecified age and sex. The patient's height, weight, past medical history, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, batch/lot# unknown), route of admin, dose and start therapy date not reported, for immunization. Per procedure, no follow-up will be requested for this case. On an unspecified date, patient experienced chills and fever. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from chills and fever.

Other Meds:

Current Illness:

ID: 1740007
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: BODY ACHES; CHILLS; VERY SLIGHT FEVER; This spontaneous report received from a consumer via a company representative 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: not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, chills, and very slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and very slight fever. This report was non-serious. This case, from the same reporter is linked to 20210950782.

Other Meds:

Current Illness:

ID: 1740008
Sex: M
Age:
State:

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 09/28/2021
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: SWEATING; THROAT FEELS ACIDY FROM THROWING UP; DIARRHEA; VOMITING/THROWING UP; 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 and has been requested. No concomitant medications were reported. On 24-SEP-2021, the patient experienced sweating. On 24-SEP-2021, the patient experienced throat feels acidy from throwing up. On 24-SEP-2021, the patient experienced diarrhea. On 24-SEP-2021, the patient experienced vomiting/throwing up. The action taken with covid-19 vaccine was not applicable. The outcome of the diarrhea, vomiting/throwing up, sweating and throat feels acidy from throwing up was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1740009
Sex: U
Age:
State: NJ

Vax Date:
Onset Date: 09/22/2021
Rec V Date: 09/28/2021
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 Date: 20210922; Test Name: COVID-19 virus test; Result Unstructured Data: Positive

Allergies:

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

Symptoms: COVID-19 TEST POSITIVE; 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, and batch number were not reported) dose was not reported, administered on 31-MAR-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 covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20210940935.

Other Meds:

Current Illness:

ID: 1740010
Sex: U
Age:
State: ME

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 09/28/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist 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: 203A21A, 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.

Other Meds:

Current Illness:

ID: 1740011
Sex: F
Age: 79
State: FL

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 09/28/2021
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: joint pain wrist and shoulder pain; fatigue; muscle aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain wrist and shoulder pain), FATIGUE (fatigue), MYALGIA (muscle aches) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis, Drug allergy (Allergic to sulfa drugs), Hypothyroidism, Asthma, COPD and Allergic reaction to antibiotics (allergic to cefin). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, METHOTREXATE and ETANERCEPT (ENBREL) for Rheumatoid arthritis, SALBUTAMOL (ALBUTEROL HFA), DILTIAZEM HYDROCHLORIDE (DILTIAZEM CD) and LEVOTHYROXINE for an unknown indication. On 26-Feb-2021 at 11:13 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ARTHRALGIA (joint pain wrist and shoulder pain), FATIGUE (fatigue), MYALGIA (muscle aches) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 3 Tab. At the time of the report, ARTHRALGIA (joint pain wrist and shoulder pain), FATIGUE (fatigue), MYALGIA (muscle aches) and PYREXIA (fever) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-114888, MOD-2021-114888 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up was received on 07-MAY-2021. Patient's race and ethnicity, medical history- COPD, Asthma, Hypothyroidism and allergies- sulfa, cefin were added. Second dose details were added. Concomitant medications- Enberel, diltiazem, albuterol, levothyroxine were added.

Other Meds: METHOTREXATE; ENBREL; PLAVIX; ALBUTEROL HFA; DILTIAZEM CD; LEVOTHYROXINE

Current Illness: Allergic reaction to antibiotics (allergic to cefin); Asthma; COPD; Drug allergy (Allergic to sulfa drugs); Hypothyroidism; Rheumatoid arthritis

ID: 1740012
Sex: F
Age: 80
State: WY

Vax Date: 01/22/2021
Onset Date: 02/01/2021
Rec V Date: 09/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data: Test Date: 20210916; Test Name: CAT scan of lungs; Result Unstructured Data: it shows there was covid-19; Test Date: 202103; Test Name: Heart rate; Result Unstructured Data: rapid pulse since March 2021; Test Date: 20210619; Test Name: Heart rate; Result Unstructured Data: irregular heart rate; Test Name: f I do something, my oxygen falls down/ my oxygen goes down/ oxygen went from 96 to down 85; Result Unstructured Data: Decreased; Test Date: 20210916; Test Name: f I do something, my oxygen falls down/ my oxygen goes down/ oxygen went from 96 to down 85; Result Unstructured Data: 96 to down 85

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: CAT scan of my lungs on 16Sep2021, and it shows there was covid-19; congestive heart failure; irregular heart rate; fast pulse/ rapid pulse/ heart rate goes up; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Asthma (Occasionally, weather related, in the spring and the fall the patient would have asthma). Concurrent medical conditions included Sjogren's (autoimmune condition called Sjogren's) and Pulmonary hypertension. Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DYSPNOEA (shortness of breath). In March 2021, the patient experienced HEART RATE INCREASED (fast pulse/ rapid pulse/ heart rate goes up). On 19-Jun-2021, the patient experienced HEART RATE IRREGULAR (irregular heart rate). On 21-Jul-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criteria disability and medically significant). On 16-Sep-2021, the patient experienced SUSPECTED COVID-19 (CAT scan of my lungs on 16Sep2021, and it shows there was covid-19). At the time of the report, CARDIAC FAILURE CONGESTIVE (congestive heart failure), HEART RATE INCREASED (fast pulse/ rapid pulse/ heart rate goes up) and DYSPNOEA (shortness of breath) had not resolved and HEART RATE IRREGULAR (irregular heart rate) and SUSPECTED COVID-19 (CAT scan of my lungs on 16Sep2021, and it shows there was covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: abnormal (abnormal) rapid pulse since March 2021. On 19-Jun-2021, Heart rate: irregular heart rate (abnormal) irregular heart rate. On 16-Sep-2021, Computerised tomogram: it shows there was covid-19 (abnormal) it shows there was covid-19. On 16-Sep-2021, Oxygen saturation: 96 to down 85 (Low) 96 to down 85. On an unknown date, Oxygen saturation: decreased (Low) Decreased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment information was provided. The patient had the second shot in February, and since then, she had trouble with shortness of breath. She had rapid pulse since March 2021. She did an echo with the heart doctor and nothing showed up. However, on 19Jun2021, she did an EKG, and this showed that I have an irregular heart rate. On 21Jul2021, she ended up with congestive heart failure. She just got the results from the CAT scan of her lungs on 16Sep2021, and it shows there was covid-19. She never tested for covid, she never had a fever. The only thing that could have done this was the vaccine. Now, she can't do anything. If she does something, her oxygen falls down. She had been with oxygen ever since she had the heart failure. She still needs the oxygen. She had fatigue, and her oxygen goes down, and her heart rate goes up. On 16Sep2021 was the first time she had dinner. Oxygen went from 96 to down 85. In the end, she couldn't get the dinner done. On unknown date the patient experienced fatigue and decreased activity. Company Comment: This case concerns a 80-year-old female patient with a previous relevant medical history of Sjogren's disease, Asthma and Pulmonary hypertension, who experienced the unexpected events of Heart rate irregular and Cardiac failure congestive after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, Suspected COVID-19 was also reported. The onset of the event Heart rate irregular occurred approximately 4 months and 29 days after the second dose of Spikevax and Cardiac failure congestive 6 months after the second dose. COVID-19 was suspected because of an abnormal computerised tomogram performed 7 months and 26 days after the second dose, but the diagnosis was not confirmed. The rechallenge was not applicable, as the events were reported exclusively after the second dose. Previous history of pulmonary hypertension remains a confounder. The benefit-risk relationship of Spikevax vaccine is not affected by Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received on 17-SEP-2021 contained significant information, events were added, lab tests were added, historical condition and current conditions were added, onset date of events were added.; Sender's Comments: This case concerns a 80-year-old female patient with a previous relevant medical history of Sjogren's disease, Asthma and Pulmonary hypertension, who experienced the unexpected events of Heart rate irregular and Cardiac failure congestive after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, Suspected COVID-19 was also reported. The onset of the event Heart rate irregular occurred approximately 4 months and 29 days after the second dose of Spikevax and Cardiac failure congestive 6 months after the second dose. COVID-19 was suspected because of an abnormal computerised tomogram performed 7 months and 26 days after the second dose, but the diagnosis was not confirmed. The rechallenge was not applicable, as the events were reported exclusively after the second dose. Previous history of pulmonary hypertension remains a confounder. The benefit-risk relationship of Spikevax vaccine is not affected by this report.

Other Meds: LOSARTAN; AMLODIPINE

Current Illness: Pulmonary hypertension; Sjogren's (autoimmune condition called Sjogren's)

ID: 1740013
Sex: F
Age:
State: MN

Vax Date: 07/10/2021
Onset Date: 07/10/2021
Rec V Date: 09/28/2021
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: tenderness that was in the upper left arm deltoid muscle; soreness on injection site upper deltoid muscle; weakness on injection site upper deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MUSCLE WEAKNESS (weakness on injection site upper deltoid muscle), TENDERNESS (tenderness that was in the upper left arm deltoid muscle) and INJECTION SITE PAIN (soreness on injection site upper deltoid muscle) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. NDC# 80777027315) for COVID-19 vaccination. No Medical History information was reported. On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced INJECTION SITE MUSCLE WEAKNESS (weakness on injection site upper deltoid muscle). On 11-Jul-2021, the patient experienced INJECTION SITE PAIN (soreness on injection site upper deltoid muscle). On 12-Jul-2021, the patient experienced TENDERNESS (tenderness that was in the upper left arm deltoid muscle). On 13-Jul-2021, INJECTION SITE MUSCLE WEAKNESS (weakness on injection site upper deltoid muscle), TENDERNESS (tenderness that was in the upper left arm deltoid muscle) and INJECTION SITE PAIN (soreness on injection site upper deltoid muscle) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drug details were reported. No treatment details were reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up contains no new information but added secondary contact details in general tab that were missed to capture initially and also updated Batch number that was not fully captured.

Other Meds:

Current Illness:

ID: 1740014
Sex: M
Age: 38
State: MI

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 09/28/2021
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: Twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Twitching) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 040A21A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included MINOCYCLINE and CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]) for an unknown indication. On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (Twitching). At the time of the report, MUSCLE TWITCHING (Twitching) had resolved. Treatment information was not provided. This case was linked to MOD-2021-059968 . Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received contains Initiative

Other Meds: MINOCYCLINE; TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]

Current Illness:

ID: 1740015
Sex: F
Age:
State:

Vax Date: 08/18/2021
Onset Date:
Rec V Date: 09/28/2021
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: Im not feeling good / something running around at my back and tummy; not feeling well; felt heat inside my body; headache; heavy on my chest; pain in arms; Feelings of weakness; side effects; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Im not feeling good / something running around at my back and tummy), MALAISE (not feeling well), FEELING HOT (felt heat inside my body), HEADACHE (headache) and CHEST DISCOMFORT (heavy on my chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Im not feeling good / something running around at my back and tummy), MALAISE (not feeling well), FEELING HOT (felt heat inside my body), HEADACHE (headache), CHEST DISCOMFORT (heavy on my chest), PAIN IN EXTREMITY (pain in arms), ASTHENIA (Feelings of weakness) and VACCINATION COMPLICATION (side effects). At the time of the report, FEELING ABNORMAL (Im not feeling good / something running around at my back and tummy), MALAISE (not feeling well), FEELING HOT (felt heat inside my body), HEADACHE (headache), CHEST DISCOMFORT (heavy on my chest), PAIN IN EXTREMITY (pain in arms), ASTHENIA (Feelings of weakness) and VACCINATION COMPLICATION (side effects) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: The follow-up information received contain significant information- New events added.

Other Meds:

Current Illness: Hypertension

ID: 1740016
Sex: F
Age: 30
State: AZ

Vax Date: 09/08/2021
Onset Date: 09/08/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was given by reporter. No treatment medication was given by reporter Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Added reporter information: first name, last name, occupation, reporter type, address, postal code.added patient detail: Date of birth, pregnancy status no. On 14-Sep-2021: Non-significant follow-up appended; Sender's Comments: This case concerns 30 -year-old female patient with no medical history, who experienced the unexpected event of Expired product administered. First dose of mRNA-1273, Moderna COVID-19 was administered after exposure to room temperature more than 24 hours. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was considered unknown. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1740017
Sex: F
Age: 74
State: FL

Vax Date: 01/05/2021
Onset Date: 09/08/2021
Rec V Date: 09/28/2021
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: Hives; Lump; Redness; Itch that is driving her crazy; Dose did not go into the deltoid muscle, it went into the tissue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MASS (Lump), ERYTHEMA (Redness), PRURITUS (Itch that is driving her crazy), URTICARIA (Hives) and PRODUCT ADMINISTRATION ERROR (Dose did not go into the deltoid muscle, it went into the tissue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066D21A, 029K20A and 039K20A) for COVID-19 vaccination. The patient's past medical history included Hives (numerous issues with hives thought the years- giant hives-- cause in determined - treated with steroids) since 10-Jan-1990, Breast cancer (multiple surgeries due to implant rejection-- 4 surgeries) since 12-Jan-2016, Osteoporosis (Prolia stopped due to severe bone and muscle pain 10/01/2020) since 15-Feb-2005 and Leukopenia (Remains chronic---- in depth invertigation finds no direct cause) since 10-Mar-2000. Concurrent medical conditions included Immunocompromised, Allergy (allergic to several antibiotics-face and neck rash - at time on the trunk and back) since 10-Jan-1980 and Allergy (allergic to sulpha-swelling redness pain) since 15-Jan-1990. Concomitant products included DENOSUMAB (PROLIA) from 15-Feb-2005 to 01-Oct-2020 for Osteoarthritis NOS, PANTOPRAZOLE from 15-Jan-2021 to an unknown date, HYDROXOCOBALAMIN ACETATE (VITAMIN B12 [HYDROXOCOBALAMIN ACETATE]) from 01-Jun-1995 to an unknown date, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 06-May-2006 to an unknown date and CALCIUM from 01-Jun-2006 to an unknown date for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 08-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION ERROR (Dose did not go into the deltoid muscle, it went into the tissue). On 09-Sep-2021, the patient experienced MASS (Lump), ERYTHEMA (Redness) and PRURITUS (Itch that is driving her crazy). On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, MASS (Lump), ERYTHEMA (Redness), PRURITUS (Itch that is driving her crazy) and URTICARIA (Hives) outcome was unknown and PRODUCT ADMINISTRATION ERROR (Dose did not go into the deltoid muscle, it went into the tissue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. treatment medication includes steroids Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up received includes- Patient route of administration-Subcutaneous tissue On 16-Sep-2021: ADR Received on 16 Sep 2021,include Patient details, Medical History and concomitants mediations added

Other Meds: PROLIA; PANTOPRAZOLE; VITAMIN B12 [HYDROXOCOBALAMIN ACETATE]; VITAMIN D [COLECALCIFEROL]; CALCIUM

Current Illness: Allergy (allergic to sulpha-swelling redness pain); Allergy (allergic to several antibiotics-face and neck rash - at time on the trunk and back); Breast cancer (multiple surgeries due to implant rejection-- 4 surgeries); Hives (numerous issues with hives thought the years- giant hives-- cause in determined - treated with steroids); Immunocompromised; Leukopenia (Remains chronic---- in depth invertigation finds no direct cause); Osteoporosis (Prolia stopped due to severe bone and muscle pain 10/01/2020)

ID: 1740018
Sex: F
Age: 78
State: CA

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 09/28/2021
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 Name: blood pressure; Result Unstructured Data: blood pressure was 200; Test Name: pulse; Result Unstructured Data: pulse 91

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: horrible reaction/really bad reaction; felt she dislocated her brain; rash across the top of her forehead that looked like she was having shingles; red bumps in forehead; disoriented; lethargic; Rash over arms; heart started pumping/heart started racing really hard/heart was throbbing/heart was racing; could not breathe; did not feel good; really tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (horrible reaction/really bad reaction), HEADACHE (headache), FEELING ABNORMAL (felt she dislocated her brain), MALAISE (did not feel good) and PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (She had had heart surgery in 2012 to repair a hole in her heart, doctors put a patch there) in 2012. Concurrent medical conditions included Penicillin allergy. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (headache) and FATIGUE (really tired). On 10-Feb-2021, the patient experienced MALAISE (did not feel good). On 11-Feb-2021, the patient experienced PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing) and DYSPNOEA (could not breathe). On an unknown date, the patient experienced ADVERSE REACTION (horrible reaction/really bad reaction), FEELING ABNORMAL (felt she dislocated her brain), HERPES ZOSTER (rash across the top of her forehead that looked like she was having shingles), RASH ERYTHEMATOUS (red bumps in forehead), DISORIENTATION (disoriented), LETHARGY (lethargic) and RASH (Rash over arms). At the time of the report, ADVERSE REACTION (horrible reaction/really bad reaction), HEADACHE (headache), FEELING ABNORMAL (felt she dislocated her brain), MALAISE (did not feel good), PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing), DYSPNOEA (could not breathe), HERPES ZOSTER (rash across the top of her forehead that looked like she was having shingles), RASH ERYTHEMATOUS (red bumps in forehead), DISORIENTATION (disoriented), LETHARGY (lethargic), FATIGUE (really tired) and RASH (Rash over arms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200 (High) blood pressure was 200. On an unknown date, Heart rate: 91 (High) pulse 91. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and Treatment was not specified.

Other Meds:

Current Illness: Penicillin allergy

ID: 1740019
Sex: M
Age: 63
State: IL

Vax Date: 05/11/2021
Onset Date:
Rec V Date: 09/28/2021
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: Have not had a second dose/did not recomment to get the second dose since they were in error/deviation of the 21-42 day time frame; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Have not had a second dose/did not recomment to get the second dose since they were in error/deviation of the 21-42 day time frame) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. No Medical History information was reported. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Have not had a second dose/did not recomment to get the second dose since they were in error/deviation of the 21-42 day time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Have not had a second dose/did not recomment to get the second dose since they were in error/deviation of the 21-42 day time frame) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatments were reported. Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Event verbatim updated.

Other Meds:

Current Illness:

ID: 1740020
Sex: M
Age: 15
State: PA

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: They gave a first dose of Moderna COVID19 Vaccine to a 15 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (They gave a first dose of Moderna COVID19 Vaccine to a 15 year old) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (They gave a first dose of Moderna COVID19 Vaccine to a 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (They gave a first dose of Moderna COVID19 Vaccine to a 15 year old) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.; Sender's Comments: This case concerns a 15 year-old male patient with no reported medical history, who experienced the unexpected event of Product administered to patient of inappropriate age. The event occurred on the same day as the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am