VAERS 2021 Database www.vaers.hhs.gov

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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: 1810305
Sex: F
Age: 50
State: PA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 10/23/2021
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: Metallic taste in my mouth; This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (Metallic taste in my mouth) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in December 2019. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced DYSGEUSIA (Metallic taste in my mouth). On 28-Dec-2020, DYSGEUSIA (Metallic taste in my mouth) had resolved. 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 Concomitant medication was reported. No Treatment information was reported. This case was linked to MOD-2021-353361 (Patient Link).

Other Meds:

Current Illness:

ID: 1810306
Sex: U
Age:
State: CA

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/23/2021
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: Patients received Moderna Covid-19 vaccine after the 30 day beyond use date in the refrigerator; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received Moderna Covid-19 vaccine after the 30 day beyond use date in the refrigerator) 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. In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received Moderna Covid-19 vaccine after the 30 day beyond use date in the refrigerator). In October 2021, EXPIRED PRODUCT ADMINISTERED (Patients received Moderna Covid-19 vaccine after the 30 day beyond use date in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1810307
Sex: F
Age: 64
State: TN

Vax Date: 08/17/2021
Onset Date: 08/01/2021
Rec V Date: 10/23/2021
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: Immediately killed her arm/arm got so bad/she could not use it or anything; Maybe needle went in wrong spot/needle went pretty high; Felt like HCP stabbed a rock in her arm; Arm in pain, could not use her arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Immediately killed her arm/arm got so bad/she could not use it or anything), INJURY ASSOCIATED WITH DEVICE (Maybe needle went in wrong spot/needle went pretty high), PAIN IN EXTREMITY (Arm in pain, could not use her arm) and VACCINATION SITE PAIN (Felt like HCP stabbed a rock in her arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Arm in pain, could not use her arm). On 17-Aug-2021, the patient experienced LIMB DISCOMFORT (Immediately killed her arm/arm got so bad/she could not use it or anything), INJURY ASSOCIATED WITH DEVICE (Maybe needle went in wrong spot/needle went pretty high) and VACCINATION SITE PAIN (Felt like HCP stabbed a rock in her arm). At the time of the report, LIMB DISCOMFORT (Immediately killed her arm/arm got so bad/she could not use it or anything), INJURY ASSOCIATED WITH DEVICE (Maybe needle went in wrong spot/needle went pretty high), PAIN IN EXTREMITY (Arm in pain, could not use her arm) and VACCINATION SITE PAIN (Felt like HCP stabbed a rock in her arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was reported. Patient went to see an orthopedic doctor, and doctor said her arm looks okay but may the needle went in the wrong spot, it went pretty high. This case was linked to MOD-2021-353568 (Patient Link).

Other Meds: SYNTHROID

Current Illness:

ID: 1810308
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: 8 patients received doses past the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients received doses past the expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients received doses past the expiration date). In 2021, EXPIRED PRODUCT ADMINISTERED (8 patients received doses past the expiration date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Vaccines were administered to 8 patient and these were the dates of administration. On 24 Sep 2021 (3 patients), 1 Oct 2021 (2 patients), 8 Oct 2021 (3 patients) No concomitant products were reported. No treatment information was reported by the reporter.

Other Meds:

Current Illness:

ID: 1810309
Sex: U
Age:
State: ME

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/23/2021
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: approximately 10 doses administered past 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (approximately 10 doses administered past 30 day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. No Medical History information was reported. In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (approximately 10 doses administered past 30 day use by date). In October 2021, EXPIRED PRODUCT ADMINISTERED (approximately 10 doses administered past 30 day use by date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1810310
Sex: F
Age: 64
State: TN

Vax Date: 08/17/2021
Onset Date: 10/01/2021
Rec V Date: 10/23/2021
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: Patient received first dose on 17Aug2021, second dose on 12Oct2021; sweats; headache, splitting headache; Fever; felt exhausted, really tired; a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.; This spontaneous case was reported by a consumer and describes the occurrence of MASS (a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.), HYPERHIDROSIS (sweats), HEADACHE (headache, splitting headache), PYREXIA (Fever) and FATIGUE (felt exhausted, really tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MASS (a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.). In October 2021, the patient experienced HYPERHIDROSIS (sweats), HEADACHE (headache, splitting headache), PYREXIA (Fever) and FATIGUE (felt exhausted, really tired). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 17Aug2021, second dose on 12Oct2021). In October 2021, HEADACHE (headache, splitting headache), PYREXIA (Fever) and FATIGUE (felt exhausted, really tired) had resolved. At the time of the report, MASS (a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.) and HYPERHIDROSIS (sweats) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 17Aug2021, second dose on 12Oct2021) had resolved. Treatment information was not provided. Patient developed a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm. This case was linked to MOD-2021-353465 (Patient Link).

Other Meds: SYNTHROID

Current Illness:

ID: 1810311
Sex: M
Age: 25
State: CA

Vax Date: 09/10/2021
Onset Date: 10/14/2021
Rec V Date: 10/23/2021
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: Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medication were provided.

Other Meds:

Current Illness:

ID: 1810312
Sex: F
Age: 34
State: IL

Vax Date: 10/13/2021
Onset Date: 10/13/2021
Rec V Date: 10/23/2021
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: diarrhea; sore arm; headache; at midnight they throw up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and VOMITING (at midnight they throw up) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and VOMITING (at midnight they throw up). On 14-Oct-2021, VOMITING (at midnight they throw up) had resolved. At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient stated that they didn't took any medication and that aren't taking any concomitant medication. No concomitant medication was reported No treatment drug was reported.

Other Meds:

Current Illness:

ID: 1810313
Sex: M
Age: 22
State: CA

Vax Date: 09/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/23/2021
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: Given the vaccine on day 31 days of expiry; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient received the first and second dose of the vaccine in the left. No treatment medication was reported. No Concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1810314
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: A lot of severe side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A lot of severe side effects) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (A lot of severe side effects). At the time of the report, VACCINATION COMPLICATION (A lot of severe side effects) outcome was unknown. The patient had a lot of severe side effects since Monday when she had the second dose of the vaccine. No concomitant medication was provided. No treatment medication was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1810315
Sex: F
Age: 29
State: CA

Vax Date: 09/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/23/2021
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: Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1810316
Sex: M
Age:
State: CA

Vax Date: 09/15/2021
Onset Date:
Rec V Date: 10/23/2021
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: More fatigue after 3rd dose than the others; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (More fatigue after 3rd dose than the others) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (More fatigue after 3rd dose than the others). At the time of the report, FATIGUE (More fatigue after 3rd dose than the others) had resolved. No Concomitant medications were provided No treatment medications were provided. This case was linked to MOD-2021-353899, MOD-2021-353900 (Patient Link).

Other Meds:

Current Illness:

ID: 1810317
Sex: F
Age: 70
State: CA

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 10/23/2021
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: fatigue; light headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and HEADACHE (light headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-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 FATIGUE (fatigue) and HEADACHE (light headache). At the time of the report, FATIGUE (fatigue) and HEADACHE (light headache) outcome was unknown. No concomitant medication was reported . No treatment medication was reported .

Other Meds:

Current Illness:

ID: 1810318
Sex: M
Age:
State:

Vax Date: 09/13/2021
Onset Date: 10/01/2021
Rec V Date: 10/23/2021
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: pharmacist who administered the 2nd dose missed deltoid injection site and went too South; 2 inch circle at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (2 inch circle at injection site) and VACCINATION ERROR (pharmacist who administered the 2nd dose missed deltoid injection site and went too South) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 048F21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION ERROR (pharmacist who administered the 2nd dose missed deltoid injection site and went too South). In October 2021, the patient experienced VACCINATION SITE REACTION (2 inch circle at injection site). On 11-Oct-2021, VACCINATION ERROR (pharmacist who administered the 2nd dose missed deltoid injection site and went too South) had resolved. In October 2021, VACCINATION SITE REACTION (2 inch circle at injection site) had resolved. Concomitant medication details were not provided. Treatment details were not provided. This case was linked to MOD-2021-354180 (Patient Link).

Other Meds:

Current Illness:

ID: 1810319
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: ache; fever; chills; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (ache), PYREXIA (fever) and CHILLS (chills) in an 18-year-old male 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, the patient experienced PAIN (ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN (ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information not provided. Treatment information not provided. This case was linked to MOD-2021-353342.

Other Meds:

Current Illness:

ID: 1810320
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: doses administered from vaccine stored in unmonitored freezer temperatures; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (doses administered from vaccine stored in unmonitored freezer temperatures) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 PRODUCT STORAGE ERROR (doses administered from vaccine stored in unmonitored freezer temperatures). At the time of the report, PRODUCT STORAGE ERROR (doses administered from vaccine stored in unmonitored freezer temperatures) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported. No treatment information was reported by the reporter. The reporter stated that for 13 nonconsecutive days the maximum temperature ranged from -12 to -14 for an unknown period of time. The vaccine was utilized by 2/6/21. Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow-up contains non-significant information includes reporter contact details.

Other Meds:

Current Illness:

ID: 1810321
Sex: M
Age:
State:

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 10/23/2021
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: patient was in bed and can't call himself; one of the shots was no good/ one of the shots was not potent like it was supposed to; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient was in bed and can't call himself) and POOR QUALITY PRODUCT ADMINISTERED (one of the shots was no good/ one of the shots was not potent like it was supposed to) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient was in bed and can't call himself) and POOR QUALITY PRODUCT ADMINISTERED (one of the shots was no good/ one of the shots was not potent like it was supposed to). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient was in bed and can't call himself) outcome was unknown and POOR QUALITY PRODUCT ADMINISTERED (one of the shots was no good/ one of the shots was not potent like it was supposed to) had resolved. No Concomitant Medication was provided. No treatment was provided.

Other Meds:

Current Illness:

ID: 1810322
Sex: M
Age: 19
State: VA

Vax Date: 10/03/2021
Onset Date: 10/03/2021
Rec V Date: 10/23/2021
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: The vial was punctured for more than 12 hours, doses were administered after the 12 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was punctured for more than 12 hours, doses were administered after the 12 hours) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination. No medical history was reported. Concomitant products included TRAZODONE for an unknown indication. On 03-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was punctured for more than 12 hours, doses were administered after the 12 hours). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The vial was punctured for more than 12 hours, doses were administered after the 12 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication were reported. No concomitant medication were reported. HCP reported that a nurse gave 4 patients expired Moderna COVID-19 vaccines. The vial was punctured for more than 12 hours, doses were administered after the 12 hours.

Other Meds: TRAZODONE

Current Illness:

ID: 1810323
Sex: F
Age: 86
State: CA

Vax Date: 02/06/2021
Onset Date:
Rec V Date: 10/23/2021
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: feel very bad; terrible reaction; chills; vomiting; body aches; headaches; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel very bad), VACCINATION COMPLICATION (terrible reaction), CHILLS (chills), VOMITING (vomiting) and MYALGIA (body aches) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048cz1, 036421a and 00013m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CARVEDILOL for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel very bad), VACCINATION COMPLICATION (terrible reaction), CHILLS (chills), VOMITING (vomiting), MYALGIA (body aches), HEADACHE (headaches) and FATIGUE (feeling tired). At the time of the report, FEELING ABNORMAL (feel very bad), VACCINATION COMPLICATION (terrible reaction), CHILLS (chills), VOMITING (vomiting), MYALGIA (body aches), HEADACHE (headaches) and FATIGUE (feeling tired) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication included hbp medicine. No treatment medication was reported. No lab data was provided.

Other Meds: CARVEDILOL

Current Illness:

ID: 1810324
Sex: F
Age: 74
State: FL

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 10/23/2021
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: Felt strange after second Moderna COVID-19 vaccine; Felt tired after second Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt strange after second Moderna COVID-19 vaccine) and FATIGUE (Felt tired after second Moderna COVID-19 vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (Felt strange after second Moderna COVID-19 vaccine) and FATIGUE (Felt tired after second Moderna COVID-19 vaccine). At the time of the report, FEELING ABNORMAL (Felt strange after second Moderna COVID-19 vaccine) and FATIGUE (Felt tired after second Moderna COVID-19 vaccine) outcome was unknown. Patient received Moderna vaccine at Health Department. No concomitant medication was provided. No treatment medication was provided. Patient received first Moderna Covid-19 vaccine on 15JAN2021 and had not experienced any adverse reactions to report.

Other Meds:

Current Illness:

ID: 1810325
Sex: M
Age:
State: CA

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 10/23/2021
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: more fatigue after 3rd dose than the others; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (more fatigue after 3rd dose than the others) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (more fatigue after 3rd dose than the others). At the time of the report, FATIGUE (more fatigue after 3rd dose than the others) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-353605, MOD-2021-353900 (Patient Link).

Other Meds:

Current Illness:

ID: 1810326
Sex: M
Age:
State: CA

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 10/23/2021
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: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown. No Concomitant medications were provided No treatment medications were provided. This case was linked to MOD-2021-353899, MOD-2021-353605 (Patient Link).

Other Meds:

Current Illness:

ID: 1810327
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Her friends had stronger side effects with the second dose; People get body aches; People get joint pains; People get fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Her friends had stronger side effects with the second dose), MYALGIA (People get body aches), ARTHRALGIA (People get joint pains) and PYREXIA (People get fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Her friends had stronger side effects with the second dose), MYALGIA (People get body aches), ARTHRALGIA (People get joint pains) and PYREXIA (People get fever). At the time of the report, VACCINATION COMPLICATION (Her friends had stronger side effects with the second dose), MYALGIA (People get body aches), ARTHRALGIA (People get joint pains) and PYREXIA (People get fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not reported. Treatment information was not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1810328
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Her husband had stronger side effects with the second dose; Little bit of body aches and muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Her husband had stronger side effects with the second dose) and MYALGIA (Little bit of body aches and muscle aches) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Her husband had stronger side effects with the second dose) and MYALGIA (Little bit of body aches and muscle aches). At the time of the report, VACCINATION COMPLICATION (Her husband had stronger side effects with the second dose) and MYALGIA (Little bit of body aches and muscle aches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information not provided. Treatment information not provided.

Other Meds:

Current Illness:

ID: 1810329
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 02/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: He had the same side effects as with the first two shots (which he had in February; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February) in an 87-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February). At the time of the report, VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter. This case was linked to MOD-2021-354097, MOD-2021-354098, MOD-2021-353213 (Patient Link).

Other Meds:

Current Illness:

Date Died:

ID: 1810330
Sex: F
Age:
State:

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: started going downhill; sick; becoming slow; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (started going downhill) and ILLNESS (sick) 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. No Medical History information was reported. In August 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 GENERAL PHYSICAL HEALTH DETERIORATION (started going downhill) (seriousness criterion death), ILLNESS (sick) (seriousness criterion death) and BRADYKINESIA (becoming slow). The patient died on an unknown date. The reported cause of death was started going downhill and Illness. It is unknown if an autopsy was performed. At the time of death, BRADYKINESIA (becoming slow) outcome was unknown. No concomitant medication provided. No treatment information mentioned. Caller reports the vaccine was Poison and the talked to so many people who have loved ones that are dead. Caller reports patient was perfectly fine then noticed becoming slow and sick overtime but caller states patient did not want to tell her exactly how patient was feeling. Caller says patientr's blood was on Moderna's hands. Caller did not want to provide any information on the adverse event and hung up on the agent. This case concerns a female patient of unknown age, no relevant medical history disclosed (very limited information), who experienced the unexpected serious events of General physical health deterioration and illness with fatal outcome. The events occurred on unknown date after the second dose of Spikevax (Moderna COVID-19 vaccine), with fatal outcome occurring on unknown date. The rechallenge was not applicable as the events occurred after the second dose and the patient died. Very limited information regarding patient's medical history and concurrent conditions is provided. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. This case was linked to MOD-2021-354152 (Patient Link). Reporter did not allow further contact; Sender's Comments: This case concerns a female patient of unknown age, no relevant medical history disclosed (very limited information), who experienced the unexpected serious events of General physical health deterioration and illness with fatal outcome. The events occurred on unknown date after the second dose of Spikevax (Moderna COVID-19 vaccine), with fatal outcome occurring on unknown date. The rechallenge was not applicable as the events occurred after the second dose and the patient died. Very limited information regarding patient's medical history and concurrent conditions is provided. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: started going downhill; illness

Other Meds:

Current Illness:

ID: 1810331
Sex: M
Age: 87
State: FL

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 10/23/2021
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: Had the same side effects as with the first two shots (which he had in February; He had the same side effects as with the first two shots (which he had in February; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February) and VACCINATION SITE PAIN (Had the same side effects as with the first two shots (which he had in February) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February). On an unknown date, the patient experienced VACCINATION SITE PAIN (Had the same side effects as with the first two shots (which he had in February). At the time of the report, VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February) and VACCINATION SITE PAIN (Had the same side effects as with the first two shots (which he had in February) outcome was unknown. No concomitant and treatment information provided. This case was linked to MOD-2021-354077, MOD-2021-354098 (Patient Link).

Other Meds:

Current Illness:

ID: 1810332
Sex: M
Age: 29
State: NY

Vax Date: 02/07/2021
Onset Date: 09/24/2021
Rec V Date: 10/23/2021
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: Received 3rd shot, but not immunocompromised; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Received 3rd shot, but not immunocompromised) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 032M20A and 024M20A) for COVID-19 vaccination. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN D NOS for an unknown indication. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Received 3rd shot, but not immunocompromised). On 24-Sep-2021, OFF LABEL USE (Received 3rd shot, but not immunocompromised) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient case is crosslinked to MOD21-152897 She discloses that they are both overweight. Her son has asthma, and she has COPD and has two small nodules in the base of her right lung. No treatment medication information was provided

Other Meds: MULTIVITAMINS [VITAMINS NOS]; VITAMIN D NOS

Current Illness:

Date Died:

ID: 1810333
Sex: F
Age:
State:

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 10/23/2021
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: her mother got the Moderna vaccine and started going downhill afterwards and died; becoming slowand sick overtime; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (her mother got the Moderna vaccine and started going downhill afterwards and died) 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. No Medical History information was reported. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 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 DEATH (her mother got the Moderna vaccine and started going downhill afterwards and died) (seriousness criteria death and medically significant) and ILLNESS (becoming slowand sick overtime). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ILLNESS (becoming slowand sick overtime) outcome was unknown. Relevant concomitant medications were not reported. Patient daughter reported that her mother was perfectly fine, then she noticed her becoming slow and sick overtime but states her mother did not want to tell her exactly how she was feeling. She reported that her mother got the Moderna vaccine and started going downhill afterwards and died. Treatment information was not provided. Company Comment: This is a spontaneous case concerning a female patient of an unknown age, with no relevant medical history reported, who experienced serious unexpected event of Death. The event occurred on an unknown date after receiving first and second dose of mRNA-1273. Rechallenge is not applicable. Cause of death was unknown. It is unknown if an autopsy was performed. Patient daughter reported that her mother was perfectly fine, then she noticed her becoming slow and sick overtime but states her mother did not want to tell her exactly how she was feeling. She reported that her mother got the Moderna vaccine and started going downhill afterwards and died. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-354092 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age, with no relevant medical history reported, who experienced serious unexpected event of Death. The event occurred on an unknown date after receiving first and second dose of mRNA-1273. Rechallenge is not applicable. Cause of death was unknown. It is unknown if an autopsy was performed. Patient daughter reported that her mother was perfectly fine, then she noticed her becoming slow and sick overtime but states her mother did not want to tell her exactly how she was feeling. She reported that her mother got the Moderna vaccine and started going downhill afterwards and died. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1810334
Sex: F
Age: 60
State: TX

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 10/23/2021
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: Arm pain; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and MYALGIA (Arm sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 48F21A) for COVID-19 vaccination. The patient's past medical history included High cholesterol. Concurrent medical conditions included Thyroiditis and Vaginal infection. Concomitant products included LEVOFLOXACIN HEMIHYDRATE (LEVOFLOXACIN [LEVOFLOXACIN HEMIHYDRATE]), IBUPROFEN and LEVOTHYROXINE for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) and MYALGIA (Arm sore). At the time of the report, PAIN IN EXTREMITY (Arm pain) and MYALGIA (Arm sore) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was reported. Atorvastatin 40 mg

Other Meds: LEVOFLOXACIN [LEVOFLOXACIN HEMIHYDRATE]; IBUPROFEN; LEVOTHYROXINE

Current Illness: Thyroiditis; Vaginal infection

ID: 1810335
Sex: M
Age:
State:

Vax Date: 09/13/2021
Onset Date:
Rec V Date: 10/23/2021
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: Arm was achy and warm for 24 hrs; Arm was achy and warm for 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was achy and warm for 24 hrs) and FEELING HOT (Arm was achy and warm for 24 hrs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was achy and warm for 24 hrs) and FEELING HOT (Arm was achy and warm for 24 hrs). At the time of the report, PAIN IN EXTREMITY (Arm was achy and warm for 24 hrs) and FEELING HOT (Arm was achy and warm for 24 hrs) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medication was provided. No treatment medication was provided. This case was linked to MOD-2021-353625, MOD-2021-353625 (Patient Link).

Other Meds:

Current Illness:

ID: 1810336
Sex: U
Age:
State: SD

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/23/2021
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: 5 Patients received an expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Patients received an expired dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Patients received an expired dose). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. The vial was initially stored in the refrigerator on 15-sep-2021 and the vial did not undergo any temperature excursions.

Other Meds:

Current Illness:

ID: 1810337
Sex: M
Age: 67
State: MN

Vax Date: 02/04/2021
Onset Date: 09/29/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 20210929; Test Name: Blood pressure; Result Unstructured Data: Increased

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Aching in his neck; One time episode of seeing green dots on the television; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Aching in his neck), VISUAL IMPAIRMENT (One time episode of seeing green dots on the television) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. Previously administered products included for an unreported indication: FLU VACCINE VII. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced NECK PAIN (Aching in his neck), VISUAL IMPAIRMENT (One time episode of seeing green dots on the television) and HEADACHE (Headache). At the time of the report, NECK PAIN (Aching in his neck), VISUAL IMPAIRMENT (One time episode of seeing green dots on the television) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2021, Blood pressure measurement: increased (High) Increased. Concomitant information was not provided. Treatment information was not provided. This case was linked to MOD-2021-354331, MOD-2021-354332 (Patient Link).

Other Meds:

Current Illness:

ID: 1810338
Sex: U
Age: 43
State: AZ

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/23/2021
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: dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-355109, MOD-2021-354515 (Patient Link).

Other Meds:

Current Illness:

ID: 1810339
Sex: M
Age: 64
State: SD

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/23/2021
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 doses were administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses were administered) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses were administered). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired doses were administered) had resolved. 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. This case was linked to MOD-2021-354462, MOD-2021-354659 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow-up received: Added Patient details.

Other Meds:

Current Illness:

ID: 1810340
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: nerve problems in left side; twitching in the eye; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (nerve problems in left side) and BLEPHAROSPASM (twitching in the eye) in a female patient of an unknown age 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 NERVOUS SYSTEM DISORDER (nerve problems in left side) and BLEPHAROSPASM (twitching in the eye). At the time of the report, NERVOUS SYSTEM DISORDER (nerve problems in left side) and BLEPHAROSPASM (twitching in the eye) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment information was unknown.

Other Meds:

Current Illness:

ID: 1810341
Sex: F
Age: 81
State: OH

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: mammogram; Result Unstructured Data: A discretion about a mark on the breast.

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: discretion about mark on the breast; This spontaneous case was reported by a consumer and describes the occurrence of MAMMOGRAM ABNORMAL (discretion about mark on the breast) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A, 029L20A and 006M20A) for COVID-19 vaccination. The patient's past medical history included Breast cancer (Patient reports she had breast cancer 20 years ago.) and Surgery. Concurrent medical conditions included Immunocompromised. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MAMMOGRAM ABNORMAL (discretion about mark on the breast). At the time of the report, MAMMOGRAM ABNORMAL (discretion about mark on the breast) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) A discretion about a mark on the breast.. No concomitant medication was reported. No treatment was reported. Patient recently went for a mammogram, there was a discretion about a mark on the breast. Biopsy of breast was performed, results not provided. This case was linked to MOD-2021-022507.

Other Meds:

Current Illness: Immunocompromised

ID: 1810342
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Surgery (The patient said that in December had breast cancer and had surgery). Concurrent medical conditions included Breast cancer (The patient said that in December had breast cancer and had surgery and radiation for it.). Concomitant products included METOPROLOL for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. This case was linked to MOD-2021-354379, MOD-2021-354380 (Patient Link).

Other Meds: METOPROLOL

Current Illness: Breast cancer (The patient said that in December had breast cancer and had surgery and radiation for it.)

ID: 1810343
Sex: M
Age: 67
State:

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore injection site arm after first Moderna Covid-19 dose; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm after first Moderna Covid-19 dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm after first Moderna Covid-19 dose). At the time of the report, VACCINATION SITE PAIN (sore injection site arm after first Moderna Covid-19 dose) 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 concomitant medication were reported by the reporter, No treatment medication were reported by the reporter. This case was linked to MOD-2021-354302, MOD-2021-354332 (Patient Link).

Other Meds:

Current Illness:

ID: 1810344
Sex: M
Age: 67
State: MN

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 10/23/2021
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: sore injection site arm after second Moderna Covid-19 dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm after second Moderna Covid-19 dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: flu shot. On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm after second Moderna Covid-19 dose). At the time of the report, VACCINATION SITE PAIN (sore injection site arm after second Moderna Covid-19 dose) outcome was unknown. It was reported that the patient received a flu shot and asked the nurse if she had the Moderna booster dose. The patient received his third full dose of the Moderna Covid-19 vaccine on 29-Sep-2021 with lot number 021C21A. Concomitant medications were not reported. No treatment information was reported. This case was linked to MOD-2021-354302, MOD-2021-354331 (Patient Link).

Other Meds:

Current Illness:

ID: 1810345
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Diagnosed with complex regional pain syndrome , had pretty severe arm pain into my wrist and underarm for three days , my injection site is still tender over 2 weeks later. As time progressed I got sever body and joint pain; Diagnosed with complex regional pain syndrome and fibromyalgia; This spontaneous case was reported by a consumer and describes the occurrence of COMPLEX REGIONAL PAIN SYNDROME (Diagnosed with complex regional pain syndrome , had pretty severe arm pain into my wrist and underarm for three days , my injection site is still tender over 2 weeks later. As time progressed I got sever body and joint pain) and FIBROMYALGIA (Diagnosed with complex regional pain syndrome and fibromyalgia) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COMPLEX REGIONAL PAIN SYNDROME (Diagnosed with complex regional pain syndrome , had pretty severe arm pain into my wrist and underarm for three days , my injection site is still tender over 2 weeks later. As time progressed I got sever body and joint pain) and FIBROMYALGIA (Diagnosed with complex regional pain syndrome and fibromyalgia). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, COMPLEX REGIONAL PAIN SYNDROME (Diagnosed with complex regional pain syndrome , had pretty severe arm pain into my wrist and underarm for three days , my injection site is still tender over 2 weeks later. As time progressed I got sever body and joint pain) and FIBROMYALGIA (Diagnosed with complex regional pain syndrome and fibromyalgia) had not resolved. Batch number of the suspect product is unknown. Action taken of suspect product is not applicable. reporter's causality is not provided. Concomitant information was not provided. It was reported that patient was experienced severe arm pain in wrist and under arm for three days and injection site is still tender over 3 weeks later. As time progressed that patient got severe body and joint pain. The patient could barely stand and walk and was worse on the right side opposite from shot side and that was continued for 7 days. Patients spine, shoulder ,hips ache like a toothache at about a 7 to 8 pain level. The patient was diagnosed with regional pain syndrome and fibromyalgia. Patient took opioids as treatment medication for pain apart from Tylenol.; Sender's Comments: This is a case of a patient of an unknown age and gender with no medical history provided, who experienced non serious unexpected events of complex regional pain syndrome and fibromyalgia The events developed after the patient had received the third dose of Moderna COVID-19 Vaccine, however, the exact temporal relationship was not specified, having in mind that the exact dates were not provided. The patient had symptoms of severe arm pain in wrist and under arm for three days, and the injection site was still tender over 2 weeks later. As time progressed that patient got severe body and joint pain, could barely stand and walk, and the patient's spine, shoulder and hips ache like a toothache at about a 7 to 8 pain level. The final diagnosis was complex regional pain syndrome and fibromyalgia. The event did not resolve at the time of the report. The rechallenge is considered not applicable, as the events occurred after the third dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1810346
Sex: M
Age: 85
State: PA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 10/23/2021
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: Local reaction on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Local reaction on the arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE, LEVOTHYROXINE, PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), LORAZEPAM (ATIVAN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE REACTION (Local reaction on the arm). At the time of the report, VACCINATION SITE REACTION (Local reaction on the arm) 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 details were reported. This case was linked to MOD-2021-354362 (Patient Link).

Other Meds: LEVOTHYROXINE; LEVOTHYROXINE; PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]; FLOMAX [MORNIFLUMATE]; ATIVAN; CYMBALTA

Current Illness:

ID: 1810347
Sex: U
Age: 61
State: AZ

Vax Date: 10/06/2021
Onset Date: 10/06/2021
Rec V Date: 10/23/2021
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: Incorrect product storage; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Incorrect product storage) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Incorrect product storage). On 06-Oct-2021, PRODUCT STORAGE ERROR (Incorrect product storage) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1810348
Sex: U
Age: 46
State: AZ

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/23/2021
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: received dose from vial more than 30 days refrigerated; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial more than 30 days refrigerated) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vial more than 30 days refrigerated). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vial more than 30 days refrigerated) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow up received contains significant information. Added patient details, start date of drug.

Other Meds:

Current Illness:

ID: 1810349
Sex: U
Age: 65
State: AZ

Vax Date: 10/06/2021
Onset Date: 10/06/2021
Rec V Date: 10/23/2021
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: Dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1810350
Sex: U
Age:
State: IA

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/23/2021
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: one patient received expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (one patient received expired doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (one patient received expired doses). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (one patient received expired doses) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter has updated that expired vaccine administration was done in single patient, which was previously stated as administration in two person. Concomitants were not provided. Treatment was not given. Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow up received on 18-oct-2021 contains non significant information.

Other Meds:

Current Illness:

ID: 1810351
Sex: F
Age: 74
State: FL

Vax Date: 10/14/2021
Onset Date: 10/15/2021
Rec V Date: 10/23/2021
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: Itch in the injection site; Redness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Itch in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site). The patient was treated with ALCOHOL for Itchy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itch in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) outcome was unknown. Patient took unknown concomitant medication for blood pressure.

Other Meds:

Current Illness:

ID: 1810352
Sex: M
Age: 86
State: PA

Vax Date: 09/12/2021
Onset Date: 09/12/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: very fatigued/very exhausted; Got the 3rd dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very fatigued/very exhausted) and OFF LABEL USE (Got the 3rd dose without being immunocompromised) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE, PROPRANOLOL, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), LORAZEPAM (ATIVAN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 12-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced OFF LABEL USE (Got the 3rd dose without being immunocompromised). On 13-Sep-2021, the patient experienced FATIGUE (very fatigued/very exhausted). On 12-Sep-2021, OFF LABEL USE (Got the 3rd dose without being immunocompromised) had resolved. At the time of the report, FATIGUE (very fatigued/very exhausted) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medications were reported. This case was linked to MOD-2021-354336 (Patient Link).

Other Meds: LEVOTHYROXINE; PROPRANOLOL; FLOMAX [MORNIFLUMATE]; ATIVAN; CYMBALTA

Current Illness:

ID: 1810353
Sex: F
Age: 68
State: PA

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 10/23/2021
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: chills; fever; first dose > 25 days ago; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and PRODUCT DOSE OMISSION ISSUE (first dose > 25 days ago) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (she had COVID really badly and it took her 5 weeks to get off and lost lot of her hair.) on 14-Jan-2021. Concurrent medical conditions included Antiphospholipid syndrome (Also known as Hughes disease, which is a sick blood disease) and Drug allergy (She does take warfarin since March 2019 because she is allergic to all heparin products). On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 25 days ago). On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Chills and Fever, at an unspecified dose and frequency. On 27-Apr-2021, PRODUCT DOSE OMISSION ISSUE (first dose > 25 days ago) had resolved. At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown. 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 medications was reported.

Other Meds:

Current Illness: Antiphospholipid syndrome (Also known as Hughes disease, which is a sick blood disease); Drug allergy (She does take warfarin since March 2019 because she is allergic to all heparin products)

ID: 1810354
Sex: M
Age:
State: NV

Vax Date: 01/01/2021
Onset Date: 02/01/2021
Rec V Date: 10/23/2021
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: Arm swelled up; Lymph nodes swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled up) and LYMPHADENOPATHY (Lymph nodes swelled up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 PERIPHERAL SWELLING (Arm swelled up) and LYMPHADENOPATHY (Lymph nodes swelled up). At the time of the report, PERIPHERAL SWELLING (Arm swelled up) had resolved and LYMPHADENOPATHY (Lymph nodes swelled up) had not resolved. Patient arm swelled up- 3 days later his lymph nodes swelled up and up. Patient arm swelling went away but lymph nodes are still swollen. Patient declined to share any other information. No concomitant medications were provided. No treatment medications were provided Reporter did not allow further contact

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am