VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1824158
Sex: M
Age:
State: NJ

Vax Date: 10/16/2021
Onset Date: 10/16/2021
Rec V Date: 10/28/2021
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: 1 patient received a dose from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient received a dose from expired vial) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient received a dose from expired vial). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (1 patient received a dose from expired vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had reported that on 15Oct2021, the vaccine vial was moved to refrigeration. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Significant FU appended. Include updated patient demographics, dose details, Batch number. On 21-Oct-2021: Include no new information.

Other Meds:

Current Illness:

ID: 1824159
Sex: M
Age: 64
State: CA

Vax Date: 10/17/2021
Onset Date: 10/17/2021
Rec V Date: 10/28/2021
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: Administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment information were reported by the reporter

Other Meds:

Current Illness:

ID: 1824160
Sex: F
Age: 74
State: MI

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
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: received third dose from vial refrigerated for more than 30 days; received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2021-358921, MOD-2021-359183, MOD-2021-358773, MOD-2021-358799, MOD-2021-358800, MOD-2021-358841, MOD-2021-358865, MOD-2021-359032, MOD-2021-359764, MOD-2021-358773 (Patient Link).

Other Meds:

Current Illness:

ID: 1824161
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: patient receiving a vaccine that is expired/vaccine was given to a patient and it's expired; 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 (patient receiving a vaccine that is expired/vaccine was given to a patient and it's expired) 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 EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine that is expired/vaccine was given to a patient and it's expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine that is expired/vaccine was given to a patient and it's expired) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1824162
Sex: M
Age: 41
State: CA

Vax Date: 10/17/2021
Onset Date: 10/17/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: administered an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Dose administered after manufacturer date of expiry[11October2021Number of doses/vials:1 vial, 4 doses for 4 patients Date the vial was initially stored in the refrigerator: 17October2021 Date(s) of administration of vaccine: 17October2021 No concomitant medications were reported No treatment information was provided

Other Meds:

Current Illness:

ID: 1824163
Sex: M
Age: 95
State: MI

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
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: received third dose from vial refrigerated for more than 30 days/received third dose and it is unknown if patient is immunocompromised; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days/received third dose and it is unknown if patient is immunocompromised) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days/received third dose and it is unknown if patient is immunocompromised). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days/received third dose and it is unknown if patient is immunocompromised) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment reported. This case was linked to MOD-2021-358773 (Patient Link).

Other Meds:

Current Illness:

ID: 1824164
Sex: M
Age: 28
State: ID

Vax Date: 10/19/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Name: Blood Sugar level; Result Unstructured Data: in morning; Test Name: Blood Sugar level; Result Unstructured Data: later

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Almost Died/I've almost died due to the vaccine; Coma; Severe low blood sugar level; Dizziness; Blood sugar level fluctuations; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (Almost Died/I've almost died due to the vaccine), COMA (Coma), BLOOD GLUCOSE DECREASED (Severe low blood sugar level), DIZZINESS (Dizziness) and BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuations) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic (Since 12 years). On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (Almost Died/I've almost died due to the vaccine), COMA (Coma), BLOOD GLUCOSE DECREASED (Severe low blood sugar level), DIZZINESS (Dizziness), BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuations) and CONFUSIONAL STATE (Confusion). At the time of the report, NEAR DEATH EXPERIENCE (Almost Died/I've almost died due to the vaccine), COMA (Coma), BLOOD GLUCOSE DECREASED (Severe low blood sugar level), DIZZINESS (Dizziness), BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuations) and CONFUSIONAL STATE (Confusion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 40 (Low) in morning and 126 (High) later. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant drugs were reported. No treatment information was reported. Patient was diabetic and the day after getting vaccine experienced severe low level of blood sugar level and didn't take insulin per HCP. Patient took 450 gram of sugar and almost died and experienced Coma and dizziness and went to urgent care and no additional medication was administered, insulin level was adjusted and also reports confusion following his incident. patient reports no other condition, medication or allergy and has HCP appointment next month. Patient thinking what happened to him is Moderna Vaccine fault and like escalate his own case and talk to supervisor and like to be contacted by safety team on that day. Medical inquiry process was explained to caller and his case can escalated once HCP calls back and was informed go to urgent care if he has emergency medical needs. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Non significant follow up appended no new information.

Other Meds:

Current Illness: Diabetic (Since 12 years)

ID: 1824165
Sex: F
Age: 89
State: MI

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
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: Received third dose from vial refrigerated for more than 30 days; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (Product storage error) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (Product storage error) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Patient reported- The vaccine was defrosted in 30Aug2021 and it was administered on 01Oct2021. This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).

Other Meds:

Current Illness:

ID: 1824166
Sex: F
Age: 72
State: OH

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 10/28/2021
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: Stiffness; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1824167
Sex: F
Age: 55
State: NM

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product use was provided by the reporter. No treatment medication was provided. This case was linked to MOD-2021-358717, MOD-2021-358845 (Patient Link).

Other Meds:

Current Illness:

ID: 1824168
Sex: F
Age: 79
State: IL

Vax Date: 02/02/2021
Onset Date: 10/19/2021
Rec V Date: 10/28/2021
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: Not immunocompromised and received full third dose of 0.5ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Not immunocompromised and received full third dose of 0.5ml) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00F421A, 038K20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Not immunocompromised and received full third dose of 0.5ml). On 19-Oct-2021, ACCIDENTAL OVERDOSE (Not immunocompromised and received full third dose of 0.5ml) had resolved. Concomitant information was not provided. Treatment information was not provided. This case was linked to MOD-2021-358928 (Patient Link).

Other Meds:

Current Illness:

ID: 1824169
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
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: This spontaneous case was reported by a physician assistant and describes the occurrence of PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported No treatment Drug was reported This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).

Other Meds:

Current Illness:

ID: 1824170
Sex: M
Age: 89
State: MI

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
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: received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).

Other Meds:

Current Illness:

ID: 1824171
Sex: M
Age: 69
State: WI

Vax Date: 02/16/2021
Onset Date: 03/16/2021
Rec V Date: 10/28/2021
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: Second Vaccine affected all his left Leg muscles; Has to lift up the leg by hand; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISORDER (Second Vaccine affected all his left Leg muscles) and MUSCULAR WEAKNESS (Has to lift up the leg by hand) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Patient spent 10 days in the hospital, he could not move his body and 2 days in the nursing home post COVID Disease.) in 2020. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced MUSCLE DISORDER (Second Vaccine affected all his left Leg muscles) and MUSCULAR WEAKNESS (Has to lift up the leg by hand). At the time of the report, MUSCLE DISORDER (Second Vaccine affected all his left Leg muscles) and MUSCULAR WEAKNESS (Has to lift up the leg by hand) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication details was not provided. Treatment details was not provided by reporter. He was scared to take a third shot. The second vaccine affected all his left leg muscles. He has to lift up the left leg by hand for example to put shoes on. Company comment include This case concerns a 69 year-old male patient with no relevant medical history, who experienced the unexpected non-serious events of Muscle disorder and Muscular weakness. The event s occurred on the same day as the second dose of mRNA-1273 vaccine. The seriousness criteria of Medically significant and Disability are removed from this spontaneous case based on medical judgement and review of source document that does not include information supporting progressive or permanent disability requiring treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 69 year-old male patient with no relevant medical history, who experienced the unexpected non-serious events of Muscle disorder and Muscular weakness. The event s occurred on the same day as the second dose of mRNA-1273 vaccine. The seriousness criteria of Medically significant and Disability are removed from this spontaneous case based on medical judgement and review of source document that does not include information supporting progressive or permanent disability requiring treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1824172
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: Severe depression; Vaccine hit them hard; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Severe depression) and VACCINATION COMPLICATION (Vaccine hit them hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSION (Severe depression) and VACCINATION COMPLICATION (Vaccine hit them hard). At the time of the report, DEPRESSION (Severe depression) and VACCINATION COMPLICATION (Vaccine hit them hard) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication use was not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1824173
Sex: M
Age: 81
State: MI

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
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: Received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. This case was linked to MOD-2021-358735, MOD-2021-358800, MOD-2021-359032, MOD-2021-358753, MOD-2021-358773, MOD-2021-358799, MOD-2021-358841, MOD-2021-358865, MOD-2021-359183, MOD-2021-359764 (Patient Link).

Other Meds:

Current Illness:

ID: 1824174
Sex: F
Age: 72
State: FL

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 10/28/2021
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: Damage to her stomach; Heart and chest felling like burning/burning on the left side of her heart; Fogginess in her mind/wanting to disappear; Severe depression; Shingles on the left side 3of her mouth; Not being able to open her mouth; Diarrhea; Falling; Bbig ball in the injection site; Very high fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Damage to her stomach), CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression) and HERPES ZOSTER (Shingles on the left side 3of her mouth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high. Concomitant products included CARVEDILOL, VIT D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN E NOS for an unknown indication. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Damage to her stomach), CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression), HERPES ZOSTER (Shingles on the left side 3of her mouth), DYSKINESIA (Not being able to open her mouth), DIARRHOEA (Diarrhea), FALL (Falling), VACCINATION SITE SWELLING (Bbig ball in the injection site), PYREXIA (Very high fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Damage to her stomach) had not resolved and CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression), HERPES ZOSTER (Shingles on the left side 3of her mouth), DYSKINESIA (Not being able to open her mouth), DIARRHOEA (Diarrhea), FALL (Falling), VACCINATION SITE SWELLING (Bbig ball in the injection site), PYREXIA (Very high fever) and CHILLS (Chills) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Other concomitant medications included high blood pressure medicine. Treatment also included tea, ice pack and antibiotics. This case was linked to MOD-2021-358984.

Other Meds: CARVEDILOL; VIT D [VITAMIN D NOS]; VITAMIN C [ASCORBIC ACID]; VITAMIN E NOS

Current Illness: Blood pressure high

ID: 1824175
Sex: M
Age: 66
State: MI

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant drugs were not reported. Treatment medications were not provided. It was reported that 12 patients were administered dose. The vial was defrosted from 30-Aug-2021. This case was linked to MOD-2021-358921 (Patient Link).

Other Meds:

Current Illness:

ID: 1824176
Sex: M
Age: 72
State: OH

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 10/28/2021
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: Soreness in his arm after all three shots; Could not lift shoulder for a day and a half; Soreness in his shoulder; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness in his arm after all three shots), MOBILITY DECREASED (Could not lift shoulder for a day and a half) and ARTHRALGIA (Soreness in his shoulder) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02AL20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included CLONAZEPAM (KLONOPIN) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in his arm after all three shots), MOBILITY DECREASED (Could not lift shoulder for a day and a half) and ARTHRALGIA (Soreness in his shoulder). At the time of the report, PAIN IN EXTREMITY (Soreness in his arm after all three shots), MOBILITY DECREASED (Could not lift shoulder for a day and a half) and ARTHRALGIA (Soreness in his shoulder) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No treatment details were reported. This case was linked to MOD-2021-359056, MOD-2021-359053. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Patient date of birth updated and new reporter added.

Other Meds: KLONOPIN

Current Illness:

ID: 1824177
Sex: M
Age: 72
State: OH

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 10/28/2021
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: soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 02AL20A) for COVID-19 vaccination. No medical history was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm) outcome was unknown. He is not immunocompromised but received a third full dose. He had soreness in his shoulder and could not lift it for a day and a half. Concomitant product include Clonipin with unknown indication . He does not believe his sore arm was an adverse reaction and he is not interested in filling out the follow up form. He wantsto help Moderna by getting his antibody level checked, as a 3 dose recipient of the Moderna COVID-19 vaccine. This case was linked to MOD-2021-359056, MOD-2021-359050, MOD-2021-359050 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received included date of birth and new reporter added

Other Meds:

Current Illness:

ID: 1824178
Sex: F
Age: 19
State: MD

Vax Date: 04/13/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Name: Chest X-ray; Result Unstructured Data: Patient has nothing in her lung.

Allergies:

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

Symptoms: Chest pain; Tingling sensation in tongue; Extremely fatigue; Wheezing; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), PARAESTHESIA ORAL (Tingling sensation in tongue) and FATIGUE (Extremely fatigue) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 037B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), PARAESTHESIA ORAL (Tingling sensation in tongue) and FATIGUE (Extremely fatigue). On 19-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (Chest pain). In October 2021, WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain) and PARAESTHESIA ORAL (Tingling sensation in tongue) had resolved. At the time of the report, FATIGUE (Extremely fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) Patient has nothing in her lung.. No concomitant medications were provided. No treatment medications were provided. Patient was going for an echocardiogram and patient was waiting for an appointment. This case was linked to MOD-2021-358744, MOD-2021-358982, MOD-2021-358738 (Patient Link).

Other Meds:

Current Illness:

ID: 1824179
Sex: M
Age: 73
State: OH

Vax Date: 09/19/2021
Onset Date:
Rec V Date: 10/28/2021
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 was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not lift it for a day and a half), VACCINATION SITE PAIN (soreness in his arm after all three shots) and ARTHRALGIA (soreness in his shoulder) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included CLONIDINE for an unknown indication. On 19-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 MOBILITY DECREASED (could not lift it for a day and a half), VACCINATION SITE PAIN (soreness in his arm after all three shots) and ARTHRALGIA (soreness in his shoulder). At the time of the report, MOBILITY DECREASED (could not lift it for a day and a half), VACCINATION SITE PAIN (soreness in his arm after all three shots) and ARTHRALGIA (soreness in his shoulder) outcome was unknown. No treatment medications were reported. Patient reported that he is not immunocompromised but received a third full dose. This case was linked to MOD-2021-359050, MOD-2021-359053 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Patient demographics were updated.

Other Meds: CLONIDINE

Current Illness:

ID: 1824180
Sex: U
Age:
State: MD

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/28/2021
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: 12 patients were administered expired dose; 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 (12 patients were administered expired dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 patients were administered expired dose). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (12 patients were administered expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1824181
Sex: M
Age: 92
State: MI

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
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: received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The vaccine was defrosted in 30Aug2021 and was administered on 01Oct2021. Reporter stated that patient was fine. No concomitant medication were provided. No treatment information were provided. This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).

Other Meds:

Current Illness:

ID: 1824182
Sex: M
Age: 65
State: MI

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
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: Injection site pain, Menorrhagia

Symptoms: received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Administered vaccine to patient which was refrigerated for more than 30 days. Vaccine was defrosted on 30-AUG-2021 and administered on 01-OCT-2021. It was administered as a third dose but unknown if the patient is immunocompromised or not. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).

Other Meds:

Current Illness:

ID: 1824183
Sex: F
Age:
State: NJ

Vax Date: 10/16/2021
Onset Date: 10/16/2021
Rec V Date: 10/28/2021
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: The patient was administered with an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was administered with an expired vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was administered with an expired vaccine). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The patient was administered with an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. The date moved to refrigeration was 15-Oct-2021.

Other Meds:

Current Illness:

ID: 1824184
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/28/2021
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: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) had resolved. No concomitant and treatment medications was reported . This case concerns a patient of unknown age and gender, with unknown medical history, who experienced the non-serious unexpected AESI of SARS-CoV-2 TEST POSITIVE. The even occurred on an unknown date after receiving the second dose of Spikevax. The rechallenge is not applicable as causality for COVID 19 is not applicable. The benefit-risk relation of Spikevax is not affected by this report. This is a social media case, hence no further information is available for case assessment.; Sender's Comments: This case concerns a patient of unknown age and gender, with unknown medical history, who experienced the non-serious unexpected AESI of SARS-CoV-2 TEST POSITIVE. The even occurred on an unknown date after receiving the second dose of Spikevax. The rechallenge is not applicable as causality for COVID 19 is not applicable. The benefit-risk relation of Spikevax is not affected by this report. This is a social media case, hence no further information is available for case assessment.

Other Meds:

Current Illness:

ID: 1824185
Sex: F
Age:
State: CT

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 10/28/2021
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: Nausea started around 9 pm; Severe vomiting shortly after until 3am; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 06May2021 at 11:30 at the age of 42-years-old as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received ELIQUIS on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 11:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 21:00, the patient experienced nausea started around 21:00 and then had severe vomiting shortly after until 03:00. The shot was given at 11:30. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vomiting was resolved on 07May2021 at 03:00 and nausea was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1824186
Sex: M
Age:
State: KY

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 10/28/2021
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: Diarrhea; Incontinence; Light headed; Chills; Body sore; Arm hurts; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 06May2021 at 11:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06May2021 at 17:00, the patient experienced diarrhea, incontinence, light headed, chills, body sore and arm hurt. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, incontinence, light headed, chills, body sore and arm hurt was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1824187
Sex: F
Age:
State: FL

Vax Date: 05/04/2021
Onset Date: 05/05/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# 1045), at the age of 64, via an unspecified route of administration, in the left arm, on May 4, 2021, single dose, for COVID-19 immunisation. Medical history included COVID-19 (prior to the vaccination, patient diagnosed with COVID-19). The patient has no known allergies. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. On May 5, 2021, at 03:00, patient experienced left arm swelling/itch (dark red, almost black). The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of reported events. The outcome of left arm swelling/itch (dark red, almost black): not recovered (at the time of this report). No follow-up attempts needed. No further information expected.

Other Meds:

Current Illness:

ID: 1824188
Sex: M
Age:
State: OR

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 10/28/2021
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: Tired; Sleepy; Sore; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05May2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05May2021 at 13:00, the patient experienced tired, sleepy and sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tired, sleepy and sore was unknown at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1824189
Sex: M
Age:
State: MN

Vax Date: 04/28/2021
Onset Date: 04/29/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 20210506; Test Name: PCR; Test Result: Negative ; Comments: PCR (saliva)

Allergies:

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

Symptoms: Body aches; Hypertension; Chest tightness; Shortness of breath; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the arm left on 28Apr2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included antiphospholipid syndrome and possibly lupus. The patient was allergic to amoxicillin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included finasteride (MANUFACTURER UNKNOWN), hydroxychloroquine (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all taken for unspecified indication since an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 07Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 06:00, the patient experienced body aches (day 2 only), headache, hypertension, chest tightness, shortness of breath and chills. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events body aches (day 2 only), headache, hypertension, chest tightness, shortness of breath and chills. On 06May2021, the patient underwent PCR (polymerase chain reaction) test (saliva) and the result was negative. The clinical outcome of the events body aches was resolved on 29Apr2021 while the clinical outcome of the events headache, hypertension, chest tightness, shortness of breath and chills were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: FINASTERIDE; HYDROXYCHLOROQUINE; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1824190
Sex: F
Age:
State: FL

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 10/28/2021
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: Itching, swelling, redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles.; Swelling redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles.; redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles.; This is a spontaneous report from a contactable consumer, the patient. An 86-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 06May2021 at 14:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included lung cancer, diabetic, arthritis, diverticulosis and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), diclofenac (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN) four more (unspecified medications) & supplement (supplie) (unspecified) from an unknown start date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 17:00, the patient experienced itching, swelling, redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of itching, swelling, redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles and included self-treatment with lavender, ice packs and antihistamine (unspecified) from an unknown start date to an unknown stop date. The clinical outcome of the event itching, swelling, redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles was recovered at the time of reporting. No follow-up attempts are possible. No further information is expected.

Other Meds: AMLODIPINE; DICLOFENAC; LOSARTAN

Current Illness:

ID: 1824191
Sex: M
Age:
State: ND

Vax Date: 03/24/2021
Onset Date: 03/28/2021
Rec V Date: 10/28/2021
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 Date: 2021; Test Name: Nasal swab; Test Result: Negative

Allergies:

Symptom List: Tremor

Symptoms: Having a headache/migraine almost every day since around the time; Having a headache/migraine almost every day since around the time; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021. Medical history included ADHD (attention deficit-hyperactivity disorder), depression, hyperhidrosis and allergy to sulfa and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dexmethylphenidate (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) for unspecified indications, from an unknown date and unknown if ongoing. The patient previously received cefalexin (KEFLEX) and amoxicillin (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. From 28Mar2021, the patient has been having headache and migraine almost every day since around the time, the patient received first vaccination (24Mar2021) . The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events headache and migraine almost every day was not recovered at the time of report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 17Apr2021 at 12:45 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: DEXMETHYLPHENIDATE; ESCITALOPRAM

Current Illness:

ID: 1824192
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: Mouth ulcers & minor gum bleeding. It happened after the first dose as well / ulcers appeared after the second dose and they went away faster; however one has come up again, 2 weeks later; Mouth ulcers & minor gum bleeding. It happened after the first dose as well; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration on 21Apr2021 at 11:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included common variable immunodeficiency (CVID) - hypogammaglobulinemia. The patient was allergic to fluoroquinolone antibiotics. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medication within two weeks of vaccination. On 22Apr2021 at 12:00, the patient experienced mouth ulcers and minor gum bleeding. On an unknown date, the events happened after the first dose as well. She took ZICAM tablets when the ulcers appeared after the second dose and they went away faster, however one had come up again, 2 weeks later. Therapeutic measures were taken as a result of the events which included treatment with piroxicam (ZICAM) tablets. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mouth ulcers and minor gum bleeding which happened after the first dose as well and ulcers appeared after the second dose and they went away faster, however one had come up again, 2 weeks later was resolving at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1824193
Sex: F
Age:
State: NJ

Vax Date: 04/21/2021
Onset Date: 05/01/2021
Rec V Date: 10/28/2021
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: Migraine; intermittent pain in my head that goes from one ear to the other, like a string is inside my head and it connects to my ears or the place above your jaw.; intermittent pain in my head that goes from one ear to the other, like a string is inside my head and it connects to my ears or the place above your jaw.; pain in left arm for about a day 1/2,; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol, osteoporosis, migraines, allergies and known allergy to latex and a long list of foods. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included rosuvastatin calcium (CRESTOR), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), vitamin d nos (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received ibuprofen (ADVIL) and cefaclor (CECLOR); both for unspecified indication from unknown date and experienced drug allergy. On an unknown date in 2021, originally after shot, the patient had pain in left arm for about a day and half and a slight headache. On 05May2021 at 23:00, two weeks after shot, the patient experienced migraine but for the last 2 days, the patient had this intermittent pain in head that went from one ear to the other, like a string was inside head and it connected to ears or the place above your jaw. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in left arm was resolved on unknown date in 2021, after a day and half. The clinical outcome of the events slight headache, migraine and intermittent pain in head that went from one ear to the other, like a string was inside head and it connected to ears or the place above your jaw was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: CRESTOR; SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D NOS; TYLENOL

Current Illness:

ID: 1824194
Sex: F
Age:
State: NY

Vax Date: 04/06/2021
Onset Date: 05/02/2021
Rec V Date: 10/28/2021
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: This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included malignant melanoma, diverticulitis, high blood pressure and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medicines (unspecified) and medicines for high blood pressure (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6205) via an unspecified route of administration in the right arm on 17Mar2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 09:00, three weeks after the second dose of the vaccine the patient's tongue started to hurt/burn and there were little red bumps on it and a yellowish/whitish coating. It was very painful and sore; the patient was not able to brush it off or remove the coating. It was bad for 2 days and then started to slowly resolve. On the day of reporting, it was day 6 and the coating had finally gone but it still felt as if the patient had burned the tongue on hot food. It was noted that, the patient had recently been to the dentist for a full check-up so aware that oral health was totally fine. The patient had not eaten or drank anything that would have contributed to this. Hence, the patient, was convinced it was reaction to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tongue started to hurt/burn, was very painful and sore, there were little red bumps on it and a yellowish/whitish coating were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1824195
Sex: F
Age:
State: FL

Vax Date: 05/05/2021
Onset Date: 05/07/2021
Rec V Date: 10/28/2021
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: Arthritis flare in upper mid back and neck; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0173) via an unspecified route of administration in the left arm on 05May2021 at 08:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, polycystic ovarian syndrome (PCOS) and allergy to sulfa. The patient previously received fluconazole (MANUFACTURER UNKNOWN) and ciprofloxacin (CIPRO) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included too many supplements (unspecified) for unknown indications, from unknown start dates and unknown if on going. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153) via an unspecified route of administration in the left arm on 07Apr2021 at 08:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. On 07May2021 at 10:00, on the third day after COVID shot, the patient experienced arthritis flare in upper mid back and neck. The patient was not on any immunosuppressive therapy or particular treatment plan for arthritis, but she suffered from flares for nearly 10 years for unknown reasons despite thorough testing. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event arthritis flare in upper mid back and neck was unknown at the time of report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1824196
Sex: F
Age:
State: WI

Vax Date: 05/05/2021
Onset Date: 05/06/2021
Rec V Date: 10/28/2021
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: Headache; Nausea; Severe pain in arms/legs (feels like arm was being broken in half); Severe pain in arms & legs (feels like my arm was being broken in half, could not walk on legs without shooting pain going up & down my legs),; Tiredness; Injection sight was burning; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05May2021 at 19:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome (POTS), asthma, penicillin allergy and adhesive allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included norethisterone acetate (NORETHINDRONE) and metoprolol (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN); amoxicillin, clavulanic acid (AUGMENTIN) and morphine (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 16Apr2021 at 20:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 10:00, the patient experienced headache, nausea, severe pain in arms and legs (felt like her arm was being broken in half, could not walk on legs without shooting pain going up and down legs), tiredness and injection site was burning. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, severe pain in arms and legs (felt like arm was being broken in half, could not walk on legs without shooting pain going up and down legs), tiredness and injection site was burning was unknown at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: NORETHINDRONE [NORETHISTERONE ACETATE]; METOPROLOL

Current Illness:

ID: 1824197
Sex: F
Age:
State: PA

Vax Date: 05/05/2021
Onset Date: 05/06/2021
Rec V Date: 10/28/2021
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: Insomnia; Body aches; Fever; Chills; Headache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW976) via an unspecified route of administration in the left arm on 05May2021 at 10:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 10:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 06May2021 at 03:30, the patient experienced insomnia, body aches, fever, chills, headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events insomnia, body aches, fever, chills, headache and nausea were recovered on an unknown date in May2021. No follow-up attempts are possible. No further information is expected.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1824198
Sex: M
Age:
State: CT

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 10/28/2021
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: After second dose, pain at site injection administration; Muscle and joint aches; Muscle and joint aches; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05May2021 at 12:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history included allergy to lysol and bleach. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included loratadine (MANUFACTURER UNKNOWN), mometasone (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), clonazepam (MANUFACTURER UNKNOWN) and an unspecified medication; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 14Apr2021 at 12:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 18:30, after second dose, the patient experienced pain at site injection administration, muscle and joint aches, chills and headache. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at site injection administration, muscle and joint aches, chills and headache were resolved on an unknown date in May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: LORATADINE; MOMETASONE; MELATONIN; CLONAZEPAM

Current Illness:

ID: 1824199
Sex: F
Age:
State: IN

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 10/28/2021
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: Within an hour and a half develop pruritic, hive-like lesions that then morphed into more of a pustule appearance; Eyes were burning; With in an hour got hives/ Hives on legs, arms, neck, thighs and trunk; Headache; Body aches/ severe body aches the night of the shot.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 21Apr2021 at 14:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included furosemide (MANUFACTURER UNKNOWN), potassium chloride (KLOR-CON) and loratadine (CLARITIN); all for an unknown indication from an unknown start date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 21Apr2021 at 15:15, within an hour of vaccination, the patient experienced hives, headache and eyes were burning and body aches. At 15:45, within an hour and a half, the patient developed pruritic, hive-like lesions that then morphed into more of a pustule appearance. It was on legs, arms, neck, thighs, and trunk. Also, the patient had severe body aches the night of the shot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of events which included treatment with fluocinonide (MANUFACTURER UNKNOWN) 0.05 % cream 2 times a day from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events within an hour got hives/ hives on legs, arms, neck, thighs and trunk, headache, body aches, pruritic hive-like lesions that then morphed into more of a pustule appearance and eyes were burning was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: FUROSEMIDE; KLOR-CON; CLARITIN [LORATADINE]

Current Illness:

ID: 1824200
Sex: F
Age:
State: FL

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Had a very bad headache mostly front of head (eyes and forehead area); Slight discomfort in the abdominal area; Slight discomfort in the abdominal area and lower back; Had a mild fever; Had a mild fever with chills / chills again / continued having chills; Would feel very hot and start sweating / feeling hot seconds after; Would feel very hot and start sweating; Felt pain in the injection site (left arm); Felt pain in the injection site (left arm) with limited mobility in the arm; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 06May2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 23:00, after the second dose of Pfizer, on the same night after vaccination, the patient experienced mild fever with chills all over and seconds later she felt very hot, started sweating and then got the chills again. She also felt pain in the injection site (left arm) with limited mobility in the arm. On 07May2021, in the morning, she had a very bad headache, mostly front of her head (eyes and forehead area) and continued having chills and felt hot seconds after. She also felt slight discomfort in the abdominal area and lower back. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild fever with chills all over / chills again / continued having chills, would feel very hot and started sweating / feeling hot, felt pain in the injection site (left arm) with limited mobility in the arm, very bad headache mostly front of head (eyes and forehead area) and slight discomfort in the abdominal area and lower back was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1824201
Sex: F
Age:
State: FL

Vax Date: 05/06/2021
Onset Date: 05/07/2021
Rec V Date: 10/28/2021
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: Muscle aches; Joint aches; Malaise; Headache and earache on left side of head; Headache and earache on left side of head; Nausea; Lightheadedness; Fatigue; Alternating between the chills and feeling feverish; Feverish; Chest pain; Dry mouth; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO179) via an unspecified route of administration in the left arm on 06May2021 at 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included raynaud's phenomenon and polycystic ovarian syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3), amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) and bupropion hydrochloride (WELLBUTRIN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 03:00, the patient experienced muscle/joint aches, malaise, headache and earache on left side of head, nausea, lightheadedness, fatigue, alternating between the chills and feeling feverish, chest pain, dry mouth and brain fog. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle/joint aches, malaise, headache and earache on left side of head, nausea, lightheadedness, fatigue, alternating between the chills and feeling feverish, chest pain, dry mouth and brain fog was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: IBUPROFEN; VITAMIN D3; ADDERALL; WELLBUTRIN

Current Illness:

ID: 1824202
Sex: F
Age:
State: NY

Vax Date: 05/02/2021
Onset Date: 05/03/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: ''My'' left arm has been tingling/pins and needles from ''my'' shoulder down to ''my'' fingers for the past few days. It has been almost a week since ''my'' second injection; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02May2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on unknown date as a single dose for COVID-19 immunisation. On 03May2021 at 11:00, the patient experienced her left arm had been tingling/pins and needles from her shoulder down to her fingers for the past few days. It had been almost a week since her second injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of event. The clinical outcome of the event left arm had been tingling/pins and needles from her shoulder down to her fingers for the past few days was not recovered at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1824203
Sex: F
Age:
State: TX

Vax Date: 05/03/2021
Onset Date: 05/04/2021
Rec V Date: 10/28/2021
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: Chills; migraine; inflammation throughout entire body; tingling and numbness in hands and feet.; tingling and numbness in hands and feet.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8736) via an unspecified route of administration in the right arm on 03May2021 at 13:15 at the age of 37-years-old as a single dose for COVID-19 immunisation. The medical history included fibromyalgia, lupus, and allergic to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included IBUPROFEN for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8731) via an unspecified route of administration in the right arm on 12Apr2021 at 13:15 at the age of 37-years-old as a single dose for COVID-19 immunisation. On 04May2021 at 01:00, the patient experienced chills, migraine, inflammation throughout entire body, and tingling and numbness in hands and feet. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events which included treatment with unspecified pain medication and anti-depressant. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, migraine, inflammation throughout entire body, and tingling and numbness in hands and feet were resolved with sequelae on an unknown date in May2021. No follow-up attempts are needed. No further information is expected.

Other Meds: IBUPROFEN

Current Illness:

ID: 1824204
Sex: F
Age:
State: CA

Vax Date: 03/21/2021
Onset Date: 03/22/2021
Rec V Date: 10/28/2021
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: Test Date: 20210406; Test Name: RT-PCR; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: "I" had a significant increase in tinnitus after the first vaccine dose primarily in what seems like "my" right ear.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6208) via an unspecified route of administration in the arm left on 21Mar2021 at 12:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The medical history included osteoporosis, minor tinnitus and allergies to penicillin and sulphates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included multi vitamin (unspecified), calcium/vitamin d nos (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 22Mar2021 at 21:00, after the first vaccine dose, the patient had significant increase in tinnitus primarily in what seemed like the right ear. The patient had slight tinnitus prior to vaccine, but had experienced a significant increase that was impacted the patient's ability to sleep. On 06Apr2021, the patient underwent RT-PCR test via nasal swab and the result was negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event significant increase in tinnitus was not resolved at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm right on 11Apr2021 at 10:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. No follow-up attempts are needed. No further information is expected.

Other Meds: CALCIUM;VITAMIN D NOS; FISH OIL

Current Illness:

ID: 1824205
Sex: F
Age:
State: IA

Vax Date: 04/27/2021
Onset Date: 04/30/2021
Rec V Date: 10/28/2021
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:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Several body aches; Ears plugged; Runny nose; Loss of taste; Loss of smell; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 27Apr2021 at 08:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, anxiety, depression and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included piroxicam (PAXIL), losartan (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and mirabegron (MIRANIX); all for an unknown indication from an unknown date and an unknown if ongoing. The patient previously took fluticasone propionate (FLONASE) for an unknown indication on an unknown date and experienced drug allergy. On 30Apr2021, the patient experienced several body aches, ears plugged, runny nose, loss of taste and smell. At the time of the report the patient had not gained back taste or smell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events several body aches, ears plugged, runny nose, loss of taste and loss of smell were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: PAXIL [PIROXICAM]; LOSARTAN; VITAMIN D [VITAMIN D NOS]; MIRANIX

Current Illness:

ID: 1824206
Sex: F
Age:
State: WI

Vax Date: 04/09/2021
Onset Date: 04/21/2021
Rec V Date: 10/28/2021
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: "I" woke up with dizziness/vertigo, and continued to feel it like motion sickness especially when going up/down stairs or bending over.; "I" woke up with dizziness/vertigo, and continued to feel it like motion sickness especially when going up/down stairs or bending over; "I" woke up with dizziness/vertigo, and continued to feel it like motion sickness especially when going up/down stairs or bending over; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on 09Apr2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The medical history included endometriosis when the patient was young, environmental allergies(pets, dust, pollen, etc.). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included multivitamin(unspecified), iron (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D) and zinc (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. On 21Apr2021 at 08:00, 12th day after 1st COVID shot, the patient woke up with dizziness/vertigo, and continued to feel it like motion sickness especially when went up/down stairs or bending over. The patient never experienced this before. That was day 2 of menstrual cycle at the time of report and the patient originally thought perhaps due to that, but not a heavy period. The patient reported that it was severe the first half day and had persisted several days, though gradually got a bit better. The patient treated it with BENADRYL, iron, vitamin C/D/zinc, rest, etc. The therapeutic measures were taken as a result of the reported events and included treatment with diphenhydramine hydrochloride (BENADRYL), iron(MANUFACUTURER UNKNOWN), vitamin C (MANUFACUTURER UNKNOWN), vitamin D(MANUFACUTURER UNKNOWN), zinc (MANUFACUTURER UNKNOWN) and rest. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness/vertigo, motion sickness was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: IRON; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; ZINC

Current Illness:

ID: 1824207
Sex: M
Age:
State: MA

Vax Date: 04/02/2021
Onset Date: 04/16/2021
Rec V Date: 10/28/2021
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: Sulfonamide allergy (Sulfa drugs)

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8737), at the age of 57, via an unspecified route of administration, in left arm, on Apr 2, 2021, at 12:45, single dose, for COVID-19 immunisation. Medical history included known allergies to sulfa drugs. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On Apr 16, 2021, patient experienced bursitis in the right elbow. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the events. The outcome of bursitis in the right elbow: unknown (at the time of this report). No follow-up attempts needed. No further information expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am