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: 1740071
Sex: F
Age: 61
State: FL

Vax Date: 03/09/2021
Onset Date: 09/16/2021
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: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: didn't feel well for two days; hot and itchy; still sore; bakers cyst; hot and itchy; very large bullseye rash at the injection site; not considered immunocompromised/Received 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel well for two days), PRURITUS (hot and itchy), PAIN IN EXTREMITY (still sore), SYNOVIAL CYST (bakers cyst) and VACCINATION SITE WARMTH (hot and itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F2119, 026B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Lyme disease. Concomitant products included LABETALOL for Blood pressure high. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced OFF LABEL USE (not considered immunocompromised/Received 3rd dose). On an unknown date, the patient experienced MALAISE (didn't feel well for two days), PRURITUS (hot and itchy), PAIN IN EXTREMITY (still sore), SYNOVIAL CYST (bakers cyst), VACCINATION SITE WARMTH (hot and itchy) and VACCINATION SITE RASH (very large bullseye rash at the injection site). At the time of the report, MALAISE (didn't feel well for two days), PRURITUS (hot and itchy), VACCINATION SITE WARMTH (hot and itchy) and OFF LABEL USE (not considered immunocompromised/Received 3rd dose) outcome was unknown, PAIN IN EXTREMITY (still sore) had not resolved and SYNOVIAL CYST (bakers cyst) and VACCINATION SITE RASH (very large bullseye rash at the injection site) was resolving. No treatment details were reported. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Significant Follow up contains added events: Malaise, pruritus, pain in extremity, synovial cyst, vaccination site warmth, vaccination site rash

Other Meds: LABETALOL

Current Illness:

ID: 1740072
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
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: some doses that might have been administered up to 50 days after being in the refrigerator; 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 (some doses that might have been administered up to 50 days after being in the refrigerator) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) 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 EXPIRED PRODUCT ADMINISTERED (some doses that might have been administered up to 50 days after being in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (some doses that might have been administered up to 50 days after being in the refrigerator) 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 drug details were reported. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1740073
Sex: F
Age: 36
State: AR

Vax Date: 09/17/2021
Onset Date: 09/18/2021
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: bad migraine; dizziness; Vaccination site red; painful to touch; swollen site - nickel; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (bad migraine), DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (painful to touch) and VACCINATION SITE SWELLING (swollen site - nickel) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Allergic to Cinnamon, Aspirin, Penicillin, Morphine). On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, the patient experienced MIGRAINE (bad migraine), DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (painful to touch) and VACCINATION SITE SWELLING (swollen site - nickel). At the time of the report, MIGRAINE (bad migraine), DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (painful to touch) and VACCINATION SITE SWELLING (swollen site - nickel) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No information on concomitant medication were reported.

Other Meds:

Current Illness: Drug allergy (Allergic to Cinnamon, Aspirin, Penicillin, Morphine)

ID: 1740074
Sex: M
Age: 34
State: MI

Vax Date: 08/20/2021
Onset Date: 09/19/2021
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: Arm pain; Headache; Lymph node on right side of collar bone swell up; Lymph node on right side of collar bone painful; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node on right side of collar bone swell up), LYMPH NODE PAIN (Lymph node on right side of collar bone painful), VACCINATION SITE PAIN (Arm pain) and HEADACHE (Headache) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced LYMPHADENOPATHY (Lymph node on right side of collar bone swell up) and LYMPH NODE PAIN (Lymph node on right side of collar bone painful). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm pain) and HEADACHE (Headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of UNK dosage form; IBUPROFEN at a dose of UNK dosage form and HYDROCODONE at a dose of UNK dosage form. At the time of the report, LYMPHADENOPATHY (Lymph node on right side of collar bone swell up), LYMPH NODE PAIN (Lymph node on right side of collar bone painful), VACCINATION SITE PAIN (Arm pain) and HEADACHE (Headache) outcome was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1740075
Sex: F
Age: 31
State: CA

Vax Date: 01/16/2021
Onset Date: 02/01/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: Test Name: BLOOD TEST; Result Unstructured Data: normal; Test Name: CT SCAN; Result Unstructured Data: normal; Test Name: MRI; Result Unstructured Data: normal; Test Name: THYROID FUNCTION TEST; Result Unstructured Data: normal

Allergies:

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

Symptoms: extreme heartburn on a daily basis; Migraine Headache; extreme brain fatigue; cranial nerve palsy in my left eye/Double vision switched to my right eye; severe headache; developed a fever; acidic vomiting; sweating; extreme nausea which would get worse in the evening; double vision returned after second dose; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMOPLEGIA (cranial nerve palsy in my left eye/Double vision switched to my right eye) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-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 DIPLOPIA (double vision returned after second dose) and NAUSEA (extreme nausea which would get worse in the evening). In August 2021, the patient experienced HYPERHIDROSIS (sweating), HEADACHE (severe headache), PYREXIA (developed a fever) and VOMITING (acidic vomiting). On an unknown date, the patient experienced OPHTHALMOPLEGIA (cranial nerve palsy in my left eye/Double vision switched to my right eye) (seriousness criterion medically significant), DYSPEPSIA (extreme heartburn on a daily basis), MIGRAINE (Migraine Headache) and FATIGUE (extreme brain fatigue). The patient was treated with PROPRANOLOL for Migraine, at a dose of 20 milligram; PREDNISONE on 12-Aug-2021 at a dose of 6 days of Prednisone and PYRIDOSTIGMINE BROMIDE (MESTINON) on 17-Sep-2021 at a dose of 60 milligram. At the time of the report, OPHTHALMOPLEGIA (cranial nerve palsy in my left eye/Double vision switched to my right eye), DIPLOPIA (double vision returned after second dose), DYSPEPSIA (extreme heartburn on a daily basis), MIGRAINE (Migraine Headache), HYPERHIDROSIS (sweating), NAUSEA (extreme nausea which would get worse in the evening), FATIGUE (extreme brain fatigue), HEADACHE (severe headache), PYREXIA (developed a fever) and VOMITING (acidic vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, Thyroid function test: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug details were reported. Company comment: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected serious (IME) event of OPHTHALMOPLEGIA, the unexpected events of DYPLOPIA, DYSPEPSIA, MIGRAINE, SWEATING, and the expected non-serious events NAUSEA, PYREXIA, VOMITING, FATIGUE and HEADACHE. The events occur between days and 6 months after the second dose of Spikevax. The events were considered related to the product per the reporter's assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-323388 (Patient Link).; Sender's Comments: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected serious (IME) event of OPHTHALMOPLEGIA, the unexpected events of DYPLOPIA, DYSPEPSIA, MIGRAINE, SWEATING, and the expected non-serious events NAUSEA, PYREXIA, VOMITING, FATIGUE and HEADACHE. The events occur between days and 6 months after the second dose of Spikevax. The events were considered related to the product per the reporter's assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1740076
Sex: M
Age:
State: OH

Vax Date:
Onset Date:
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: premature exhaustion/ fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (premature exhaustion/ fatigue) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (premature exhaustion/ fatigue). At the time of the report, FATIGUE (premature exhaustion/ fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications information was reported. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1740077
Sex: F
Age: 70
State: FL

Vax Date: 02/14/2021
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: Pyrexia, White blood cell count decreased

Symptoms: My nose is very stuff; Upper respiratory problems; Tinnitus/Tinnitus is very aggravating; General malaise worst after the 2nd dose; Mendnebular nose; Runny nose; I am very scared; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (My nose is very stuff), RESPIRATORY DISORDER (Upper respiratory problems), TINNITUS (Tinnitus/Tinnitus is very aggravating), MALAISE (General malaise worst after the 2nd dose) and NASAL DISCOMFORT (Mendnebular nose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised, Blood pressure management and Diabetes. Concomitant products included AMLODIPINE and LOSARTAN for Blood pressure management, INSULIN DEGLUDEC (TRESIBA) for Diabetes, ADALIMUMAB (HUMIRA), SERTRALINE HYDROCHLORIDE (ZOLOFT), LORAZEPAM (ATIVAN) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (My nose is very stuff), RESPIRATORY DISORDER (Upper respiratory problems), TINNITUS (Tinnitus/Tinnitus is very aggravating), MALAISE (General malaise worst after the 2nd dose), NASAL DISCOMFORT (Mendnebular nose), RHINORRHOEA (Runny nose) and FEAR (I am very scared). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (My nose is very stuff), RESPIRATORY DISORDER (Upper respiratory problems), TINNITUS (Tinnitus/Tinnitus is very aggravating), MALAISE (General malaise worst after the 2nd dose), NASAL DISCOMFORT (Mendnebular nose), RHINORRHOEA (Runny nose) and FEAR (I am very scared) had resolved. Concomitant medication were reported. Treatment medication were reported. The patient had upper respiratory problems. The patient was immunocompromised and was very scared. The patient nose was very stuff, Tinnitus was very aggravated. Went away finally and came back immediately after 3rd dose. This case was linked to MOD-2021-324159 (Patient Link).

Other Meds: HUMIRA; ZOLOFT; ATIVAN; SEROQUEL; AMLODIPINE; LOSARTAN; TRESIBA

Current Illness: Blood pressure management; Diabetes; Immunocompromised

ID: 1740078
Sex: F
Age: 62
State: NY

Vax Date: 03/18/2021
Onset Date: 03/18/2021
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: Pharyngeal swelling

Symptoms: Breast cancer; Really bad reaction; My arm hurt; All my joints hurt; Nauseous; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Breast cancer) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 from March 2020 to April 2020. Concurrent medical conditions included Blood pressure abnormal, Cholesterolosis NOS and Diabetes. Concomitant products included METOPROLOL for Blood pressure management, ROSUVASTATIN and GEMFIBROZIL for Cholesterolosis NOS, METFORMIN for Diabetes mellitus, DULOXETINE HYDROCHLORIDE (CYMBALTA) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION COMPLICATION (Really bad reaction), PAIN IN EXTREMITY (My arm hurt), ARTHRALGIA (All my joints hurt), NAUSEA (Nauseous) and HEADACHE (Bad headache). In May 2021, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Surgery for Breast cancer. At the time of the report, BREAST CANCER (Breast cancer), VACCINATION COMPLICATION (Really bad reaction), ARTHRALGIA (All my joints hurt), NAUSEA (Nauseous) and HEADACHE (Bad headache) outcome was unknown and PAIN IN EXTREMITY (My arm hurt) 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. Patient stated that the symptoms were similar to COVID-19 which she had in Mar to Apr-2020 and found out that she still had antibodies from it. She also stated that she was as not aware of breast cancer at that time. Company Comment: This case concerns a 62-year-old, female patient with relevant medical history of diabetes, who experienced the unexpected event of breast cancer. The event occurred approximately 2 months after the first dose of COVID-19 vaccine mRNA was administered. The rechallenge was not applicable since the patient has not received the second dose yet. The benefit-risk relationship of COVID-19 vaccine mRNA is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, female patient with relevant medical history of diabetes, who experienced the unexpected event of breast cancer. The event occurred approximately 2 months after the first dose of COVID-19 vaccine mRNA was administered. The rechallenge was not applicable since the patient has not received the second dose yet. The benefit-risk relationship of COVID-19 vaccine mRNA is not affected by this report.

Other Meds: METOPROLOL; ROSUVASTATIN; CYMBALTA; GEMFIBROZIL; METFORMIN; MULTIVITAMINS [VITAMINS NOS]

Current Illness: Blood pressure abnormal; Cholesterolosis NOS; Diabetes

ID: 1740079
Sex: M
Age: 73
State: NY

Vax Date: 01/28/2021
Onset Date: 03/05/2021
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: After receiving 2nd dose, he had night sweats.; strong reaction to both doses; chills (lasted a couple of days); fever (lasted a couple of days); 1st dose on 28Jan2021 and 2nd dose on 05Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (After receiving 2nd dose, he had night sweats.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 28Jan2021 and 2nd dose on 05Mar2021), VACCINATION COMPLICATION (strong reaction to both doses), CHILLS (chills (lasted a couple of days)) and PYREXIA (fever (lasted a couple of days)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 28Jan2021 and 2nd dose on 05Mar2021). 05-Mar-2021, the patient experienced CHILLS (chills (lasted a couple of days)) and PYREXIA (fever (lasted a couple of days)). On an unknown date, the patient experienced NIGHT SWEATS (After receiving 2nd dose, he had night sweats.) and VACCINATION COMPLICATION (strong reaction to both doses). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 07-Mar-2021, CHILLS (chills (lasted a couple of days)) and PYREXIA (fever (lasted a couple of days)) had resolved. At the time of the report, NIGHT SWEATS (After receiving 2nd dose, he had night sweats.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 28Jan2021 and 2nd dose on 05Mar2021) had resolved and VACCINATION COMPLICATION (strong reaction to both doses) outcome was unknown. Concomitant medications included BP medicine. Treatment medications included Anti-histamines along with above mentioned medications. The caller reported he had a strong reaction to both Moderna COVID-19 injections. The caller stated the first Moderna COVID-19 dose (28Jan2021) "knocked me out" and "bothered me". This case was linked to MOD-2021-324078 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Significant follow up due to event has been updated

Other Meds:

Current Illness:

ID: 1740080
Sex: M
Age: 53
State: TX

Vax Date: 08/15/2021
Onset Date: 09/13/2021
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: Testicular pain; Pain with urination; sweating; Hives; Macular rash on his back; Dizziness; vomiting; chills; muscle aches/sores on his arms; fever; severe pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives) and RASH MACULAR (Macular rash on his back) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 059721A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives), RASH MACULAR (Macular rash on his back), DIZZINESS (Dizziness), VOMITING (vomiting), CHILLS (chills), MYALGIA (muscle aches/sores on his arms), PYREXIA (fever) and VACCINATION SITE PAIN (severe pain at the injection site). At the time of the report, TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives), RASH MACULAR (Macular rash on his back), DIZZINESS (Dizziness), VOMITING (vomiting), CHILLS (chills), MYALGIA (muscle aches/sores on his arms), PYREXIA (fever) and VACCINATION SITE PAIN (severe pain at the injection site) 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 treatment information was provided by the reporter. This case was linked to MOD-2021-324016 (Patient Link).

Other Meds:

Current Illness:

ID: 1740081
Sex: F
Age: 63
State: AZ

Vax Date: 04/16/2021
Onset Date: 06/16/2021
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: tinnitus (both ears)/buzzing sound/hazy/constant (both ears); This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus (both ears)/buzzing sound/hazy/constant (both ears)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055B21A and 045B21A) for COVID-19 vaccination. The patient's past medical history included Surgery (on left arm requiring physical therapy) in January 2021. Concurrent medical conditions included Hypothyroidism, Arthritis, Drug allergy (Becomes nauseated if she takes Codeine and Erythromycin) and Allergy to antibiotic. Concomitant products included LEVOTHYROXINE, CELECOXIB (CELEBREX) and RALOXIFENE for an unknown indication. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced TINNITUS (tinnitus (both ears)/buzzing sound/hazy/constant (both ears)). At the time of the report, TINNITUS (tinnitus (both ears)/buzzing sound/hazy/constant (both ears)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Approximately one month after the second dose, the patient noticed tinnitus in both ears. The patient described the tinnitus as a buzzing sound, and was hazy, and tinnitus was constant in both ears. No treatment medications were reported.

Other Meds: LEVOTHYROXINE; CELEBREX; RALOXIFENE

Current Illness: Allergy to antibiotic; Arthritis; Drug allergy (Becomes nauseated if she takes Codeine and Erythromycin); Hypothyroidism

ID: 1740082
Sex: F
Age: 98
State: AK

Vax Date: 09/17/2021
Onset Date: 09/17/2021
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 Moderna Covid-19 vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered to patient) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. No medical history was provided.,. On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered to patient). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered to patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment medication were reported. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up document contains updated reporter contact details

Other Meds:

Current Illness:

ID: 1740083
Sex: M
Age: 76
State: LA

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: his right arm was sore a little; This case was received via FDA VAERS on 20-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his right arm was sore a little) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (his right arm was sore a little). At the time of the report, PAIN IN EXTREMITY (his right arm was sore a little) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported No treatment medications were reported This case was linked to MOD-2021-324345 (Patient Link).

Other Meds:

Current Illness:

ID: 1740084
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: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Vaccination adverse reaction; Weakness; chest pain; chest inflammation; agitation; legs pain; sometimes weak; Muscle aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), ASTHENIA (Weakness), CHEST PAIN (chest pain), INFLAMMATION (chest inflammation) and AGITATION (agitation) in a patient of an unknown age and gender 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. 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 VACCINATION COMPLICATION (Vaccination adverse reaction), ASTHENIA (Weakness), CHEST PAIN (chest pain), INFLAMMATION (chest inflammation), AGITATION (agitation), PAIN IN EXTREMITY (legs pain), ASTHENIA (sometimes weak), MYALGIA (Muscle aches) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), ASTHENIA (Weakness), CHEST PAIN (chest pain), INFLAMMATION (chest inflammation), AGITATION (agitation), PAIN IN EXTREMITY (legs pain), ASTHENIA (sometimes weak), MYALGIA (Muscle aches) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication listed. No treatment information provided.

Other Meds:

Current Illness:

ID: 1740085
Sex: U
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: 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: most people are getting side effects after getting the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (most people are getting side effects after getting the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (most people are getting side effects after getting the vaccine). At the time of the report, VACCINATION COMPLICATION (most people are getting side effects after getting the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1740086
Sex: F
Age: 46
State: NC

Vax Date: 08/14/2021
Onset Date: 09/16/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Chills; Rash itches; Rash all over her body including her face that itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash itches), RASH (Rash all over her body including her face that itches) and CHILLS (Chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 033C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced RASH PRURITIC (Rash itches) and RASH (Rash all over her body including her face that itches). On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, RASH PRURITIC (Rash itches), RASH (Rash all over her body including her face that itches) and CHILLS (Chills) outcome was unknown. Concomitant medications were not provided. Treatment medications were not provided.

Other Meds:

Current Illness:

ID: 1740087
Sex: F
Age: 69
State: AZ

Vax Date: 08/19/2021
Onset Date: 09/16/2021
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: Was worried that she will not develop antibodies; Vaccinator gave it to her under the skin and not in her muscle; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Was worried that she will not develop antibodies) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccinator gave it to her under the skin and not in her muscle) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 021C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intradermal) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccinator gave it to her under the skin and not in her muscle). On an unknown date, the patient experienced ANXIETY (Was worried that she will not develop antibodies). On 16-Sep-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccinator gave it to her under the skin and not in her muscle) had resolved. At the time of the report, ANXIETY (Was worried that she will not develop antibodies) outcome was unknown. No Concomitant medication were reported. No Treatment medications were reported. The patient got second dose on 16-Sep-2021, however, the patient did not felt any injection at all. The patient had no soreness in arm, not even a tiny bit, not even anything that looks like a needle had been there, no bruising. The patient was positive the vaccinator gave it under the skin and not in muscle. The patient was worried that antibodies would not be developed. The patient states that her HCP is new, and had an appointment coming up on 28-Sep-2021. This case was linked to MOD-2021-322930 (Patient Link).

Other Meds:

Current Illness:

Date Died: 09/10/2021

ID: 1740088
Sex: F
Age: 87
State: CA

Vax Date: 06/17/2021
Onset Date: 07/30/2021
Rec V Date: 09/28/2021
Hospital: Y

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data: Test Name: elevated blood pressure; Result Unstructured Data: elevated blood pressure

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: stroke; UTI; sepsis; aspiration pneumonia; first dose on 17Jun2021 (048A21A) Second dose was administered on 27Jul2021; Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), CEREBROVASCULAR ACCIDENT (stroke), URINARY TRACT INFECTION (UTI), SEPSIS (sepsis), PNEUMONIA ASPIRATION (aspiration pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 17Jun2021 (048A21A) Second dose was administered on 27Jul2021) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 048A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI) (seriousness criteria hospitalization and medically significant), SEPSIS (sepsis) (seriousness criteria hospitalization and medically significant), PNEUMONIA ASPIRATION (aspiration pneumonia) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 17Jun2021 (048A21A) Second dose was administered on 27Jul2021) (seriousness criterion medically significant). The patient died on 10-Sep-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. At the time of death, URINARY TRACT INFECTION (UTI), SEPSIS (sepsis), PNEUMONIA ASPIRATION (aspiration pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 17Jun2021 (048A21A) Second dose was administered on 27Jul2021) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: elevated blood pressure (High) elevated blood pressure. No concomitant medications information was reported. No treatment medications were provided. This is a case of Inappropriate schedule of vaccine administered concerning an 88-year-old female patient with no reported medical history who experienced the fatal unexpected events of cerebrovascular accident, urinary tract infection, sepsis and aspiration pneumonia. The events of urinary tract infection, sepsis and aspiration pneumonia occurred on an unspecified date after CVA occurred 3 day after the second dose and the subject expired 1 month 4 days after the second dose of mRNA-1273 The rechallenge was not applicable as events occurred after second dose with a fatal outcome. Causality assessment for the event was not provided by the reporter. However, the subject is of an advanced age and UTI is of an infective origin which can lead to sepsis and thus assessment with product used is determined as unlikely. The benefit-risk relationship of mRNA-1273is not affected by this report; Sender's Comments: This is a case of Inappropriate schedule of vaccine administered concerning an 88-year-old female patient with no reported medical history who experienced the fatal unexpected events of cerebrovascular accident, urinary tract infection, sepsis and aspiration pneumonia. The events of urinary tract infection, sepsis and aspiration pneumonia occurred on an unspecified date after CVA occurred 3 day after the second dose and the subject expired 1 month 4 days after the second dose of mRNA-1273 The rechallenge was not applicable as events occurred after second dose with a fatal outcome. Causality assessment for the event was not provided by the reporter. However, the subject is of an advanced age and UTI is of an infective origin which can lead to sepsis and thus assessment with product used is determined as unlikely. The benefit-risk relationship of mRNA-1273is not affected by this report; Reported Cause(s) of Death: stroke

Other Meds:

Current Illness:

ID: 1740089
Sex: U
Age:
State:

Vax Date:
Onset Date:
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: pain; swelling; tummy aches; sore mouth; redness at the injection site; low dose of Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PAIN (pain), SWELLING (swelling), ABDOMINAL PAIN (tummy aches), ORAL PAIN (sore mouth) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a patient of an unknown age and gender 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. 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 PAIN (pain), SWELLING (swelling), ABDOMINAL PAIN (tummy aches), ORAL PAIN (sore mouth), VACCINATION SITE ERYTHEMA (redness at the injection site) and UNDERDOSE (low dose of Moderna vaccine). At the time of the report, PAIN (pain), SWELLING (swelling), ABDOMINAL PAIN (tummy aches), ORAL PAIN (sore mouth) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown and UNDERDOSE (low dose of Moderna vaccine) 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 were reported No treatment medication were reported

Other Meds:

Current Illness:

ID: 1740090
Sex: F
Age:
State:

Vax Date: 09/17/2021
Onset Date:
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: having a problem breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having a problem breathing) 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 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (having a problem breathing). At the time of the report, DYSPNOEA (having a problem breathing) outcome was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1740091
Sex: F
Age: 55
State: FL

Vax Date: 02/05/2021
Onset Date: 07/18/2021
Rec V Date: 09/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210724; Test Name: covid-19 virus test; Test Result: Positive; Result Unstructured Data: Positive.

Allergies:

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

Symptoms: Blood infection; Shortness of breath; lack of drug effect; Tested positive for covid; Ears were ringing; ear Stuff up; stuffy nose; Headaches/head hurt a lot; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Blood infection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Autoimmune disorder and Diabetes. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 21-Jul-2021, the patient experienced NASAL CONGESTION (stuffy nose) and HEADACHE (Headaches/head hurt a lot). On 24-Jul-2021, the patient experienced TINNITUS (Ears were ringing), EAR CONGESTION (ear Stuff up), DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (Tested positive for covid). On 25-Jul-2021, the patient experienced SEPSIS (Blood infection) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). The patient was hospitalized from 25-Jul-2021 to 06-Aug-2021 due to SEPSIS. On 06-Aug-2021, SEPSIS (Blood infection) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (stuffy nose), TINNITUS (Ears were ringing), EAR CONGESTION (ear Stuff up), DYSPNOEA (Shortness of breath), DRUG INEFFECTIVE (lack of drug effect), HEADACHE (Headaches/head hurt a lot) and COVID-19 (Tested positive for covid) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SEPSIS (Blood infection), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (stuffy nose), TINNITUS (Ears were ringing), EAR CONGESTION (ear Stuff up), DYSPNOEA (Shortness of breath), DRUG INEFFECTIVE (lack of drug effect), HEADACHE (Headaches/head hurt a lot) and COVID-19 (Tested positive for covid) to be possibly related. No relevant concomitant medications were reported. Treatment information was provided i.e., IV antibiotics. Unknown Infusion On 24 Jul 2021 consumer also went to the ER, they did covid-19 test and blood cultures. Company comment: This case concerns a 56-year-old, female subject with medical history of diabetes, who experienced the unexpected serious event of sepsis and non-serious event of COVID-19, lack of drug effect was considered as an additional event. The events occurred approximately 4 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was unknown since no information/no events reported following administration of the first dose was provided. The medical history of diabetes, which may cause complications including infections, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 56-year-old, female subject with medical history of diabetes, who experienced the unexpected serious event of sepsis and non-serious event of COVID-19, lack of drug effect was considered as an additional event. The events occurred approximately 4 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was unknown since no information/no events reported following administration of the first dose was provided. The medical history of diabetes, which may cause complications including infections, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness: Autoimmune disorder; Diabetes

ID: 1740092
Sex: F
Age:
State: MA

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: Unevaluable event

Symptoms: This spontaneous case reported by an other healthcare professional, describes the occurrence of urticaria (systemic hives and welts) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced urticaria (systemic hives and welts). At the time of the report, urticaria (systemic hives and welts) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-325440 (patient link).

Other Meds:

Current Illness:

ID: 1740093
Sex: M
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: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: son who is 16 received the first shot of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son who is 16 received the first shot of Moderna) in a 16-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. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son who is 16 received the first shot of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son who is 16 received the first shot of Moderna) had resolved.

Other Meds:

Current Illness:

ID: 1740094
Sex: U
Age:
State: MA

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: Product temperature excursion issue; 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) 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 product was provided by the reporter. No treatment medication was provided. She stated that when they received the vaccine, she looked at them and they looked frozen so she placed them in the freezer. HCP stated that it was brought to her attention that the data logger was not set properly and thus it was not alarming when the temp got below -15C. The data logger was set to alarm if it went above 7C, it was set for refrigerator. HCP stated that looking back at the temp data logger, the highest temperature the freezer reached is -11C for a period of approximately 3 hours. The vials remain in the freezer quarantined. 4 doses were administered since receipt of vaccine, two on 16Sep2021 and two on 09Sep2021.

Other Meds:

Current Illness:

ID: 1740095
Sex: F
Age: 63
State: LA

Vax Date: 04/01/2021
Onset Date: 04/20/2021
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: Test Name: Body temperature; Result Unstructured Data: High body temperature for 2 days

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: dizzy; gum infection; vertigo; was not able to walk for about four hours after the shot; feeling so weak; body ache all over; swollen lymph nodes on the right side by the upper neck under her chin; Second dose 19 days after the first; high temperature for 2 days/light temperature for 3 to 4 days at least; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), GINGIVITIS (gum infection), VERTIGO (vertigo), GAIT DISTURBANCE (was not able to walk for about four hours after the shot) and ASTHENIA (feeling so weak) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CALCIUM, FISH OIL and MAGNESIUM for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 19 days after the first). On an unknown date, the patient experienced DIZZINESS (dizzy), GINGIVITIS (gum infection), VERTIGO (vertigo), GAIT DISTURBANCE (was not able to walk for about four hours after the shot), ASTHENIA (feeling so weak), PAIN (body ache all over), LYMPHADENOPATHY (swollen lymph nodes on the right side by the upper neck under her chin) and PYREXIA (high temperature for 2 days/light temperature for 3 to 4 days at least). The patient was treated with PENICILLIN NOS (PENICILLIN [PENICILLIN NOS]) for Gum infection, at a dose of 500 mg. On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 19 days after the first) had resolved. At the time of the report, DIZZINESS (dizzy), GINGIVITIS (gum infection), VERTIGO (vertigo), GAIT DISTURBANCE (was not able to walk for about four hours after the shot), ASTHENIA (feeling so weak), PAIN (body ache all over) and LYMPHADENOPATHY (swollen lymph nodes on the right side by the upper neck under her chin) outcome was unknown and PYREXIA (high temperature for 2 days/light temperature for 3 to 4 days at least) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High body temperature for 2 days. This case was linked to MOD-2021-325583 (Patient Link).

Other Meds: CALCIUM; FISH OIL; MAGNESIUM

Current Illness:

ID: 1740096
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: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Felt real bad; Where I got the shot is all red; (Where I got the shot) is hot now; like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt real bad), VACCINATION SITE ERYTHEMA (Where I got the shot is all red), FEELING HOT ((Where I got the shot) is hot now) and INFLUENZA LIKE ILLNESS (like I had the flu) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (Felt real bad), VACCINATION SITE ERYTHEMA (Where I got the shot is all red), FEELING HOT ((Where I got the shot) is hot now) and INFLUENZA LIKE ILLNESS (like I had the flu). At the time of the report, FEELING ABNORMAL (Felt real bad), VACCINATION SITE ERYTHEMA (Where I got the shot is all red), FEELING HOT ((Where I got the shot) is hot now) and INFLUENZA LIKE ILLNESS (like I had the flu) outcome was unknown. No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1740097
Sex: M
Age: 32
State: CA

Vax Date: 09/20/2021
Onset Date: 09/20/2021
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: Nausea, Pain in extremity, Pyrexia

Symptoms: Dose was administered to patients after the 30 days use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant drug was not reported. Treatment medication was not reported. Nurse stated that patient received the 1st dose of the Moderna COVID 19 vaccine on 20SEPT2021 between 8:10-9:10am. The dose was administered to patients after the 30 days use by date. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Additional information received and Anatomical location was added

Other Meds:

Current Illness:

ID: 1740098
Sex: F
Age: 35
State: CA

Vax Date: 08/10/2021
Onset Date: 08/10/2021
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: had temperature; chills for 2 days; pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), PYREXIA (had temperature) and CHILLS (chills for 2 days) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm). On 11-Aug-2021, the patient experienced PYREXIA (had temperature) and CHILLS (chills for 2 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Aug-2021, PYREXIA (had temperature) and CHILLS (chills for 2 days) had resolved. On 14-Aug-2021, PAIN IN EXTREMITY (pain in the arm) 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. no concomitant and treatment drugs were provided. 10-15 min after she started feeling pain in the arm, the next day she had temperature and chills for 2 days and pain in the arm until the forth day; took 2 tylenols at the time. This case was linked to MOD-2021-315286 (Patient Link).

Other Meds:

Current Illness:

ID: 1740099
Sex: M
Age: 80
State: NY

Vax Date: 09/14/2021
Onset Date: 09/14/2021
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: lack of drug effect; Additional dose of Moderna after 2 pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Additional dose of Moderna after 2 pfizer) and DRUG INEFFECTIVE (lack of drug effect) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) 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) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 14-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Additional dose of Moderna after 2 pfizer). On an unknown date, the patient experienced DRUG INEFFECTIVE (lack of drug effect). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Additional dose of Moderna after 2 pfizer) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment information was not reported.; Sender's Comments: This case concerns an 80 year old male who had a complete series of Pfizer COVID-19 vaccine but did not develop antibodies. On the advice of this HCP he then received both doses of Moderna COVID-19 vaccine without apparent problems. There are no adverse events due to MODERNA COVID-19 vaccine associated with this case.

Other Meds:

Current Illness:

ID: 1740100
Sex: F
Age:
State: OR

Vax Date: 03/01/2021
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: Test Date: 20201128; Test Name: SARS COV-2; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Nausea

Symptoms: still in a fog; right arm pit the glands feel full of liquid, glands are still swollen under my arm.; arm hurts at injection site; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (still in a fog), LYMPHADENOPATHY (right arm pit the glands feel full of liquid, glands are still swollen under my arm.), VACCINATION SITE PAIN (arm hurts at injection site) and HEADACHE (slight headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 089A21A, 31A21A and 002A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 28-Nov-2020. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-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 FEELING ABNORMAL (still in a fog), LYMPHADENOPATHY (right arm pit the glands feel full of liquid, glands are still swollen under my arm.), VACCINATION SITE PAIN (arm hurts at injection site) and HEADACHE (slight headache). At the time of the report, FEELING ABNORMAL (still in a fog), LYMPHADENOPATHY (right arm pit the glands feel full of liquid, glands are still swollen under my arm.), VACCINATION SITE PAIN (arm hurts at injection site) and HEADACHE (slight headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided No relevant treatment medication were provided. Patient was home quarantined. Patient got better. Her taste and smell returned about 3 weeks later. Patient was reported to massage her right arm pit very gently once a day in the warm shower which she said helped her. Patient reported that the she had swollen glands under the arm after the booster dose which was not there after the first two vaccinations. This case was linked to MOD-2021-281964, MOD-2021-282508 (Patient Link).; Sender's Comments: This report concerns a 67 year old female patient with past medical history of COVID-19 who experienced non-serious unexpected events of abnormal feeling (reported as still in a fog), lymphadenopathy and non-serious expected events of headache, vaccination site pain. The events occurred after an unknown duration following vaccination with the third dose of mRNA-1273. The patient reports having received all the 3 doses of mRNA-1273, but had not experienced similar adverse effects with the previous 2 doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1740101
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: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Entire week of not being able to work for being sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Entire week of not being able to work for being sick) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Entire week of not being able to work for being sick). At the time of the report, ILLNESS (Entire week of not being able to work for being sick) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. The patient got the first round of the Moderna COVID vaccine a week ago.

Other Meds:

Current Illness:

ID: 1740102
Sex: F
Age: 30
State: DE

Vax Date: 04/16/2021
Onset Date: 04/16/2021
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 induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication information was reported. No Treatment medications were provided

Other Meds:

Current Illness:

ID: 1740103
Sex: M
Age: 36
State: DE

Vax Date: 03/17/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A - 025B21A and 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication information was reported. No Treatment medications were provided This case was linked to MOD-2021-326632.

Other Meds:

Current Illness:

ID: 1740104
Sex: F
Age: 49
State: DE

Vax Date: 05/16/2021
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: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A - 025B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1740105
Sex: F
Age: 68
State: DE

Vax Date: 06/09/2021
Onset Date: 06/09/2021
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: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). In 2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. In 2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) 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. Expiration dates are unknown, they only have the 30 day mark which was on 16May2021.

Other Meds:

Current Illness:

ID: 1740106
Sex: U
Age:
State: MA

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: people in hospital from vaccine adverse effects/shots doing more harm than good; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (people in hospital from vaccine adverse effects/shots doing more harm than good) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (people in hospital from vaccine adverse effects/shots doing more harm than good). At the time of the report, VACCINATION COMPLICATION (people in hospital from vaccine adverse effects/shots doing more harm than good) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment medication was provided. Consumer mentioned that most people in the hospital have had the COVID vaccine. People end up in the hospital with adverse effects from the vaccines, and these shots are doing more harm than good.

Other Meds:

Current Illness:

ID: 1740107
Sex: F
Age:
State: DE

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: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1740108
Sex: U
Age:
State: DE

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: Asthenia, Chills, Headache, Myalgia

Symptoms: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter considered EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) to be not applicable. No Treatment medication was reported. No concomitant medication was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1740109
Sex: U
Age:
State: DE

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: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: The vaccines were applied to patients after being refrozen; 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 PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen). At the time of the report, PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Treatment information was provided. No concomitant medication was provided

Other Meds:

Current Illness:

ID: 1740110
Sex: F
Age: 53
State: DE

Vax Date: 04/22/2021
Onset Date: 04/22/2021
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: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided Treatment medications were not provided Once they received the shipment, the vaccines were placed at freezer temperature, at around -20 degree Celsius After that, a vial was removed from the freezer to administer vaccine. Doses that were viable up to 14-Apr-2021, the 30 days since it was thawed were administered to the patient beyond that day.

Other Meds:

Current Illness:

ID: 1740111
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:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: miscarriage when she became sick from the first vaccine; became sick from the first vaccine; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (miscarriage when she became sick from the first vaccine) 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. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (miscarriage when she became sick from the first vaccine) (seriousness criterion medically significant), ILLNESS (became sick from the first vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (miscarriage when she became sick from the first vaccine) and ILLNESS (became sick from the first vaccine) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. This case concerns of a female patient with no age and no relevant medical history reported who experienced the unexpected events of spontaneous abortion, illness and Maternal Exposure during pregnancy. The occurrence of these events are unknown as well as the time to onset from the vaccine administration with Moderna since the date of the first dose of the vaccine is also unknown. Other details of the pregnancy was also not reported like the LMP and EDD. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns of a female patient with no age and no relevant medical history reported who experienced the unexpected events of spontaneous abortion, illness and Maternal Exposure during pregnancy. The occurrence of these events are unknown as well as the time to onset from the vaccine administration with Moderna since the date of the first dose of the vaccine is also unknown. Other details of the pregnancy was also not reported like the LMP and EDD. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

Date Died:

ID: 1740112
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: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Patient dies of covid-19 related illness weeks afetr receiving second covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient dies of covid-19 related illness weeks afetr receiving second covid vaccine) in a 36-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 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 ILLNESS (Pateint dies of covid-19 related illness weeks afetr receiving second covid vaccine) (seriousness criterion death). The reported cause of death was covid related illness. It is unknown if an autopsy was performed. No concomitant medications were provided. No treatment information was provided. This case concerns a 36-year-old patient of an unknown gender with no reported medical history of who experienced the unexpected fatal event of covid 19 related illness. The event occurred after an unspecified time after administration of the second dose of mRNA-1273. The rechallenge was not applicable as this event occurred after the second dose with a reported fatal outcome. Causality assessment for the event was not reported. However, covid 19 is considered as not applicable due biologically implausible based on known etiology. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 36-year-old patient of an unknown gender with no reported medical history of who experienced the unexpected fatal event of covid 19 related illness. The event occurred after an unspecified time after administration of the second dose of mRNA-1273. The rechallenge was not applicable as this event occurred after the second dose with a reported fatal outcome. Causality assessment for the event was not reported. However, covid 19 is considered as not applicable due biologically implausible based on known etiology. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: covid related illness

Other Meds:

Current Illness:

ID: 1740113
Sex: F
Age:
State: NC

Vax Date: 01/25/2021
Onset Date: 01/27/2021
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: Test Name: CT scans; Result Unstructured Data: Test Result:unspecified result; Test Name: MRI; Result Unstructured Data: Test Result:unspecified result

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Severe jaw pain; numbness rt side; numbness rt side hand and feet; rt eye blurriness; migraines; memory loss; Confusion; ringing rt ear.; This is a spontaneous report from a contactable consumer (patient reported for self). A 54-years-old female (non-pregnant) received first dose of bnt162b2 (COMIRNATY, Lot Number: EN5318), dose 1 via an unspecified route of administration, in the Right arm on 25Jan2021 12:00 (age at vaccination 54-years-old) as dose 1, single for COVID-19 immunisation. Other medical history and Known allergies were none. The patient was not tested for covid prior vaccination. The patient had not received any other vaccine within 4 weeks. Concomitant medications/Other medications in two weeks were none. Patient was not pregnant at time of vaccination. On 27Jan2021 00:00, the patient experienced Severe jaw pain, numbness rt (right) side of face, numbness rt side hand and foot, rt eye blurriness/ migraines, memory loss. Confusion, ringing rt ear. The adverse events resulted in healthcare professional office/clinic visit, Emergency room visit. The patient underwent lab tests and procedures which includes: Mri.Mra.CT scans (with unspecified results) on unspecified date(s). medications. neurologist. Patient was not tested for COVID post vaccination. Patient received (unspecified) treatment for the adverse events. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1740114
Sex: M
Age:
State: MA

Vax Date: 07/28/2021
Onset Date: 07/29/2021
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: Severe stomach pains; vomiting; fever; This is a spontaneous report from a contactable consumer (Patient). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 28Jul2021 13:00 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not provided), via an unspecified route of administration, administered in Arm Right on 07Jul2021 13:00 as dose 1, single for COVID-19 immunisation. On 29Jul2021 01:00, the patient experienced severe stomach pains, vomiting, fever. Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Outcome of all the events was not resolved. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1740115
Sex: M
Age:
State: TX

Vax Date: 07/27/2021
Onset Date: 07/27/2021
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: Test Name: Blood Pressure; Result Unstructured Data: Test Result:High

Allergies:

Symptom List: Vomiting

Symptoms: Was moderately sick for 4 days with hot and cold chills; Was moderately sick for 4 days with hot and cold chills; Was moderately sick for 4 days with hot and cold chills; mild dizziness; extreme fatigue; whole body aches and soreness; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; Had a fairly harsh headache about 3 hours; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA7484), via an unspecified route of administration in left arm on 27Jul2021 at 14:15 (at the age of 48-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veteran's administration facility. Medical history included diabetes from an unknown date and unknown if ongoing, high blood pressure from an unknown date and unknown if ongoing, penicillin (drug hypersensitivity) from an unknown date and unknown if ongoing, broccoli, avocados, bananas (food allergy) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 27Jul2021 at 17:30, was moderately sick for 4 days with hot and cold chills, mild dizziness, extreme fatigue and whole-body aches and soreness. Had a fairly harsh headache about 3 hours after injection that lasted about 4 hours. Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness. Still have the knot after 5 days. The patient underwent lab tests and procedures which included blood pressure was high on an unknown date. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved on an unknown date. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1740116
Sex: F
Age:
State: CA

Vax Date: 08/12/2021
Onset Date: 08/13/2021
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: I feel like vomiting, I have nausea; big headache; I feel like vomiting, I have nausea; This is a spontaneous report from a contactable consumer. A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: not reported), via an unspecified route of administration on 12Aug2021 (at the age of 56-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. It was reported that she received the Pfizer Covid 19 vaccine. At first, she was fine but after some time she feel like vomiting, nausea and a big headache. As a Treatment patient received Tylenol for the headache, but the only thing that works for me is ibuprofen, Tylenol makes me more nauseated. She asked, can I take ibuprofen? The clinical outcome of the events was unknown. Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2

Other Meds:

Current Illness:

ID: 1740117
Sex: M
Age:
State: GA

Vax Date: 08/14/2021
Onset Date: 08/14/2021
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: Migraine headache extreme; This is a spontaneous report from a contactable consumer (patient reported for himself). A 21-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, in left arm on 14Aug2021 at 09:00 AM (at the age of 21-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 14Aug2021 at 01:00 PM, the patient had experienced migraine headache extreme. Reporter stated that adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with medicine (unspecified) for the adverse event. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1740118
Sex: F
Age:
State: TX

Vax Date: 08/08/2021
Onset Date: 08/01/2021
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: IM
Vax Site: LA

Lab Data: Test Date: 202108; Test Name: fever; Result Unstructured Data: Test Result:between 99 and 101; Test Date: 20210814; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Unknown Results

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: cough; sinus pressure; fever between 99 and 101; loss of smell; headaches; drowsiness; This is a spontaneous report from a contactable consumer (patient). A 28-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 08Aug2021 at 14:00 (at the age of 28-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 13Aug2021 at 16:00, the patient experienced 5 days after shot started having cough and sinus pressure. On day 6 and 7 unspecified date of Aug2021 fever between 99 and 101, loss of smell, major sinus pressure and headaches, drowsiness. Patient visited to doctor or other healthcare professional office/clinic visit. Patient received treatment for events. The patient underwent lab tests and procedures which included fever between 99 and 101 on unspecified date of Aug2021 and nasal swab with unknown results on 14Aug2021. The outcome of the events was not resolved. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1740119
Sex: F
Age:
State: AZ

Vax Date: 08/12/2021
Onset Date: 08/01/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: my neck is all swollen; Diarrhea; my neck is all swollen and it hurts; I have been sick; Fever; Headache; just like been sleeping a lot; my body is achy; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 12Aug2021 (at the age of 49-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included heart problems. The other medication included baby Tylenol. On an unspecified date in Aug2021, the patient stated that not affecting her heart or giving her an infection or anything because she having every symptom that there was. She had diarrhea, have been sick and had a bad fever, she have a bad headache you know just like been sleeping a lot, body was achy and now even on the fourth day her freaking neck was all swollen and it hurts. The patient did not take treatment for the events. The outcome of events were unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1740120
Sex: F
Age:
State: IL

Vax Date: 08/14/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: Itching on both of her arms, not at the injection site, and on her neck; This is a spontaneous report from a contactable Nurse. A 59-year-old female patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 14Aug2021 (past Saturday) as dose 2, single for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not provided. On an unspecified date in 2021, after receiving the vaccination, patient experienced itching on both of her arms, not at the injection site, and on her neck since then. Nurse would like to know if that was normal or if they should be worried. As per attached cons document there will be a severe allergic reaction would usually occur with in a few minutes to one hour after getting a dose of the Pfizer vaccine. The outcome of the event was reported as unknown. The lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am