VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1817298
Sex: M
Age:
State:

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/26/2021
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: administered the Moderna COVID-19 Vaccine to a patient more than 12 hours after the vial was punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 Vaccine to a patient more than 12 hours after the vial was punctured) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 Vaccine to a patient more than 12 hours after the vial was punctured). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 Vaccine to a patient more than 12 hours after the vial was punctured) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1817299
Sex: F
Age: 67
State: NY

Vax Date: 01/11/2021
Onset Date: 09/01/2021
Rec V Date: 10/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 20211001; Test Name: Hearing test; Result Unstructured Data: First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Feeling deaf in the left ear/First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.; Tinnitus; Wind in the ear; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOACUSIS (Feeling deaf in the left ear/First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.), TINNITUS (Tinnitus) and EAR DISCOMFORT (Wind in the ear) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 011L20A and 004M20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Hypothyroidism and Hypertension. Concomitant products included RAMIPRIL, HYDROCHLOROTHIAZIDE, AMLODIPINE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) and LEVOTHYROXINE for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced HYPOACUSIS (Feeling deaf in the left ear/First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.), TINNITUS (Tinnitus) and EAR DISCOMFORT (Wind in the ear). At the time of the report, HYPOACUSIS (Feeling deaf in the left ear/First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.), TINNITUS (Tinnitus) and EAR DISCOMFORT (Wind in the ear) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Acoustic stimulation tests: abnormal (abnormal) First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient received 4 doses of steroids in the ear and it had no significant improvement. ENT suggested taking steroids by mouth. On 18OCT2021 the ringing in the ear has improved a little and she can hear a little better but the problem hearing still exists.

Other Meds: RAMIPRIL; HYDROCHLOROTHIAZIDE; AMLODIPINE; JANUMET; LEVOTHYROXINE

Current Illness: Diabetes; Hypertension; Hypothyroidism

ID: 1817300
Sex: F
Age: 65
State: FL

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 10/26/2021
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: patient had fatigue and a red hot injection site few hours after first dose; patient had fatigue and a red hot injection site few hours after first dose; patient had fatigue and a red hot injection site few hours after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE WARMTH (patient had fatigue and a red hot injection site few hours after first dose), FATIGUE (patient had fatigue and a red hot injection site few hours after first dose) and INJECTION SITE ERYTHEMA (patient had fatigue and a red hot injection site few hours after first dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included PRAVASTATIN and LAMOTRIGINE (LAMICTAL) for an unknown indication. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE WARMTH (patient had fatigue and a red hot injection site few hours after first dose), FATIGUE (patient had fatigue and a red hot injection site few hours after first dose) and INJECTION SITE ERYTHEMA (patient had fatigue and a red hot injection site few hours after first dose). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (patient had fatigue and a red hot injection site few hours after first dose), FATIGUE (patient had fatigue and a red hot injection site few hours after first dose) and INJECTION SITE ERYTHEMA (patient had fatigue and a red hot injection site few hours after first dose) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-356141, MOD-2021-356002 (Patient Link).

Other Meds: PRAVASTATIN; LAMICTAL

Current Illness:

ID: 1817301
Sex: M
Age:
State: UT

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/26/2021
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: received a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No medical history was provided by the reporter. No treatment information was provided by the reporter. No Concomitant medicines were reported.

Other Meds:

Current Illness:

ID: 1817302
Sex: F
Age:
State:

Vax Date: 10/06/2021
Onset Date: 10/06/2021
Rec V Date: 10/26/2021
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: Patient states she received the Johnson and Johnson COVID19 vaccine 6Mar2021 and then she stated she "chose to get" the Moderna vaccine 6Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient states she received the Johnson and Johnson COVID19 vaccine 6Mar2021 and then she stated she "chose to get" the Moderna vaccine 6Oct2021) 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 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient states she received the Johnson and Johnson COVID19 vaccine 6Mar2021 and then she stated she "chose to get" the Moderna vaccine 6Oct2021). On 06-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient states she received the Johnson and Johnson COVID19 vaccine 6Mar2021 and then she stated she "chose to get" the Moderna vaccine 6Oct2021) had resolved. On 06-Mar-2021, patient had received the Johnson and Johnson COVID19 vaccine. In addition it was stated that the patient chose to get Moderna vaccine. No relevant concomitant and treatment medications were reported.

Other Meds:

Current Illness:

ID: 1817303
Sex: F
Age: 86
State: CA

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Patient who received a dose past 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received a dose past 30-day use by date) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received a dose past 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient who received a dose past 30-day use by date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported. No Treatment information was reported. This case was linked to MOD-2021-355908 (Patient Link).

Other Meds:

Current Illness:

ID: 1817304
Sex: M
Age:
State: NM

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Fever; Pretty pronounced fatigue; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) and FATIGUE (Pretty pronounced fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Pretty pronounced fatigue). At the time of the report, PYREXIA (Fever) outcome was unknown and FATIGUE (Pretty pronounced fatigue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1817305
Sex: F
Age: 81
State: WI

Vax Date: 02/24/2021
Onset Date: 03/17/2021
Rec V Date: 10/26/2021
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: Patient got first dose of the Moderna vaccine and second dose of the Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient got first dose of the Moderna vaccine and second dose of the Pfizer vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high, Acid reflux (esophageal) and MS. Concomitant products included COLECALCIFEROL (VITAMIN D3) and ASCORBIC ACID (VIT C) for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient got first dose of the Moderna vaccine and second dose of the Pfizer vaccine). On 17-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient got first dose of the Moderna vaccine and second dose of the Pfizer vaccine) had resolved. Concomitant medications taken by the patient also included unspecified high blood pressure medication and acid reflux medication. No treatment medications were reported.

Other Meds: VITAMIN D3; VIT C

Current Illness: Acid reflux (esophageal); Blood pressure high; MS

ID: 1817306
Sex: F
Age: 75
State: PA

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 10/26/2021
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: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore left arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Sore left arm). At the time of the report, MYALGIA (Sore left arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication was reported. No treatment medications were reported. This case was linked to MOD-2021-356258, MOD-2021-356046 (Patient Link).

Other Meds:

Current Illness:

ID: 1817307
Sex: M
Age: 57
State: WI

Vax Date: 04/09/2021
Onset Date: 09/01/2021
Rec V Date: 10/26/2021
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: every time when sweats or when rubs, skin broke out in hives everything but his neck and head, getting hives; itching; Rash in his armpit for a couple of months; Got COVID already after vaccination; Lack of drug effect/got COVID already after vaccination 3 weeks ago; coming out of a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (coming out of a cold), URTICARIA (every time when sweats or when rubs, skin broke out in hives everything but his neck and head, getting hives), PRURITUS (itching), DRUG INEFFECTIVE (Lack of drug effect/got COVID already after vaccination 3 weeks ago) and RASH (Rash in his armpit for a couple of months) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Food allergy (allergic to honey and that it was not an allergy, started when got the vaccine) and Allergy NOS (Patient had allergies). On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced NASOPHARYNGITIS (coming out of a cold), DRUG INEFFECTIVE (Lack of drug effect/got COVID already after vaccination 3 weeks ago) and COVID-19 (Got COVID already after vaccination). On an unknown date, the patient experienced URTICARIA (every time when sweats or when rubs, skin broke out in hives everything but his neck and head, getting hives), PRURITUS (itching) and RASH (Rash in his armpit for a couple of months). The patient was treated with PREDNISONE for Rash and Hives, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (coming out of a cold), URTICARIA (every time when sweats or when rubs, skin broke out in hives everything but his neck and head, getting hives), PRURITUS (itching), RASH (Rash in his armpit for a couple of months) and COVID-19 (Got COVID already after vaccination) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect/got COVID already after vaccination 3 weeks ago) had resolved. Concomitant drugs included decongestant every now and then for his allergies. Patient had allergies so took prednisone when the hives got really bad HCP prescribed prednisone and got rid of the rash after a few hours but it came again when patient sweats. This report concerns a 57-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID 19. Additionally, Drug ineffective was considered as an event. The events occurred approximately 5 months after receiving the second dose of Spikevax. Rechallenge is not applicable since it is a COVID 19 case. The benefit-risk relation of Spikevax is not affected by this report. This case was linked to MOD-2021-356174 (Patient Link).; Sender's Comments: This report concerns a 57-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID 19. Additionally, Drug ineffective was considered as an event. The events occurred approximately 5 months after receiving the second dose of Spikevax. Rechallenge is not applicable since it is a COVID 19 case. The benefit-risk relation of Spikevax is not affected by this report.

Other Meds:

Current Illness: Allergy NOS (Patient had allergies)

ID: 1817308
Sex: M
Age: 90
State: CA

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 10/26/2021
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: received a dose past 30-day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.) 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-2021-355908 (Patient Link).

Other Meds:

Current Illness:

ID: 1817309
Sex: F
Age: 64
State: CT

Vax Date: 03/17/2021
Onset Date: 04/14/2021
Rec V Date: 10/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data: Test Date: 202109; Test Name: ULTRASOUND; Result Unstructured Data: ultrasound shows that I have eggs

Allergies:

Symptom List: Rash, Urticaria

Symptoms: In August I had a full fledged period. I have been Menopausal for several years; achy; fever for 24 hours; felt like I got kicked by a bus; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like I got kicked by a bus), POSTMENOPAUSAL HAEMORRHAGE (In August I had a full fledged period. I have been Menopausal for several years), MYALGIA (achy) and PYREXIA (fever for 24 hours) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21o and 002B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING ABNORMAL (felt like I got kicked by a bus), MYALGIA (achy) and PYREXIA (fever for 24 hours). In August 2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (In August I had a full fledged period. I have been Menopausal for several years). At the time of the report, FEELING ABNORMAL (felt like I got kicked by a bus), POSTMENOPAUSAL HAEMORRHAGE (In August I had a full fledged period. I have been Menopausal for several years) and MYALGIA (achy) outcome was unknown and PYREXIA (fever for 24 hours) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Ultrasound scan: abnormal (abnormal) ultrasound shows that I have eggs. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug details were reported. No treatment details were reported. Patient had been Menopausal for several years Patient next ultrasound scheduled for 01- Nov-2021. This case was linked to MOD-2021-355962 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 64-year-old female patient with no relevant medical history reported, who experienced non-serious unexpected event of Postmenopausal Haemorrhage. The event occurred approximately 4 months after the second dose of mRNA-1273 (in August, exact onset date not provided). The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.. The event postmenopausal haemorrhage is marked serious by the auto-seriousness tool. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint, and reporter assessed the case as non-serious.

Other Meds:

Current Illness:

ID: 1817310
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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 a dose past 30-day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not provided.

Other Meds:

Current Illness:

ID: 1817311
Sex: U
Age:
State:

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: expired dose administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1817312
Sex: F
Age: 71
State:

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 10/26/2021
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: sleep after second dose; feeling of wanting to go back into bed; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleep after second dose) and FATIGUE (feeling of wanting to go back into bed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleep after second dose) and FATIGUE (feeling of wanting to go back into bed). At the time of the report, SOMNOLENCE (sleep after second dose) and FATIGUE (feeling of wanting to go back into bed) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided by the reporter. No Treatment information was reported. This case was linked to MOD-2021-355704 (Patient Link).

Other Meds:

Current Illness:

ID: 1817313
Sex: F
Age:
State: AL

Vax Date: 09/21/2021
Onset Date: 09/21/2021
Rec V Date: 10/26/2021
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: Pruritus; Severe Edema; Erythema at injection site extending to elbow; Fatigue; Temp; Generalized myalgia; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Pruritus), OEDEMA (Severe Edema), INJECTION SITE ERYTHEMA (Erythema at injection site extending to elbow), FATIGUE (Fatigue) and PYREXIA (Temp) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension (Mild hypertension-Treated). Concomitant products included SIMVASTATIN (ZOCOR), LANSOPRAZOLE (PREVACID), MELOXICAM and METOPROLOL for an unknown indication. On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PRURITUS (Pruritus), OEDEMA (Severe Edema), INJECTION SITE ERYTHEMA (Erythema at injection site extending to elbow), FATIGUE (Fatigue), PYREXIA (Temp) and MYALGIA (Generalized myalgia). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 28-Sep-2021, PRURITUS (Pruritus), OEDEMA (Severe Edema), INJECTION SITE ERYTHEMA (Erythema at injection site extending to elbow), FATIGUE (Fatigue), PYREXIA (Temp) and MYALGIA (Generalized myalgia) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient took bed rest and was observed and treated at home. The vaccine was taken on 21-Sep-2021 at 08:45 a.m. Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow-up received on 18-oct-2021, case contains No new information.

Other Meds: ZOCOR; PREVACID; MELOXICAM; METOPROLOL

Current Illness: Hypertension (Mild hypertension-Treated)

ID: 1817314
Sex: M
Age:
State: PA

Vax Date: 03/28/2021
Onset Date: 03/28/2021
Rec V Date: 10/26/2021
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: arm hurt a little bit; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little bit) and FATIGUE (felt tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt a little bit) and FATIGUE (felt tired). On 28-Mar-2021, PAIN IN EXTREMITY (arm hurt a little bit) and FATIGUE (felt tired) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information was unknown. This case was linked to MOD-2021-356505, MOD-2021-356638 (Patient Link).

Other Meds:

Current Illness:

ID: 1817315
Sex: M
Age:
State: PA

Vax Date: 03/28/2021
Onset Date: 04/25/2021
Rec V Date: 10/26/2021
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: Euphoria; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (Euphoria) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced EUPHORIC MOOD (Euphoria). On 25-Apr-2021, EUPHORIC MOOD (Euphoria) had resolved. No concomitant medication was reported. No treatment medication use was reported. This case was linked to MOD-2021-356492, MOD-2021-356638 (Patient Link).

Other Meds:

Current Illness:

ID: 1817316
Sex: U
Age:
State: PA

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/26/2021
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: Receiving a dose from an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving a dose from an expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving a dose from an expired vaccine). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Receiving a dose from an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not provided. It was reported that 10 or 11 patients received a third dose of Moderna COVID-19 vaccine. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1817317
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: Blood clot in his leg; really bad side effects; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in his leg) in a 5-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot in his leg) (seriousness criterion medically significant) and VACCINATION COMPLICATION (really bad side effects). At the time of the report, THROMBOSIS (Blood clot in his leg) and VACCINATION COMPLICATION (really bad side effects) had resolved. No relevant concomitant medication information provided. Caller said that friend got really bad side effects from the Moderna vaccine. It was after the second shot. He was over 50. Within a very short time (days to a week), friend got a blood clot in his leg. He went to the hospital and doctors believed it was due to the Moderna vaccine. Doctors gave him blood thinners for three months and nowhe was doing fine. Caller did not want to provide any additional personal information. Caller said that friend probably got the first shot in February/March. Treatment medication include blood thinners for blood clot provided. Company Comment: This case concerns an unknown age male patient with no relevant medical history, who experienced the unexpected serious event of thrombosis. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event occurred after the second dose and no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an unknown age male patient with no relevant medical history, who experienced the unexpected serious event of thrombosis. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event occurred after the second dose and no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1817318
Sex: M
Age: 61
State: NC

Vax Date: 10/15/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm was sore; A little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and FATIGUE (A little tired) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore) and FATIGUE (A little tired). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and FATIGUE (A little tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment drug details was reported.

Other Meds:

Current Illness:

ID: 1817319
Sex: F
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: Having COVID19 following vaccination; Congestion in her chest; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Having COVID19 following vaccination) and NASAL CONGESTION (Congestion in her chest) 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 COVID-19 (Having COVID19 following vaccination) and NASAL CONGESTION (Congestion in her chest). At the time of the report, COVID-19 (Having COVID19 following vaccination) and NASAL CONGESTION (Congestion in her chest) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This case concerns a female patient of unknown age, with no medical history disclosed, who experienced the unexpected non-serious adverse event of special interest of COVID-19 with other non-serious unexpected event. The event of COVID-19 occurred on unknown date, after the most recent dose of Spikevax (Moderna COVID-19 vaccine). No information is provided regarding dates of events and vaccination, so assessment is very limited. The rechallenge was not applicable as dose number is not informed in the source document. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.

Other Meds:

Current Illness:

ID: 1817320
Sex: F
Age:
State: PA

Vax Date: 03/28/2021
Onset Date: 03/28/2021
Rec V Date: 10/26/2021
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: fever; headache; achy arm/sore arm; felt tired /felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm/sore arm), FATIGUE (felt tired /felt really tired), PYREXIA (fever) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (achy arm/sore arm) and FATIGUE (felt tired /felt really tired). On 29-Mar-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (achy arm/sore arm), FATIGUE (felt tired /felt really tired), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD-2021-356645, MOD-2021-356492, MOD-2021-356505 (Patient Link).

Other Meds:

Current Illness:

ID: 1817321
Sex: M
Age: 72
State: AZ

Vax Date: 08/14/2021
Onset Date: 09/12/2021
Rec V Date: 10/26/2021
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: shortness of breath/difficulty breathing; loss of energy; next day experienced redness; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (shortness of breath/difficulty breathing), ASTHENIA (loss of energy) and ERYTHEMA (next day experienced redness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 053E21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Sep-2021, the patient experienced DYSPNOEA (shortness of breath/difficulty breathing), ASTHENIA (loss of energy) and ERYTHEMA (next day experienced redness). At the time of the report, DYSPNOEA (shortness of breath/difficulty breathing), ASTHENIA (loss of energy) and ERYTHEMA (next day experienced redness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter. Patient had no reactions after receiving first dose and after the second shot had no reactions in the beginning. Patient experienced the symptoms the next day after the second dose.

Other Meds:

Current Illness:

ID: 1817322
Sex: F
Age:
State: PA

Vax Date: 04/25/2021
Onset Date: 04/25/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20210426; Test Name: Body temperature; Result Unstructured Data: 100?

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Fever blisters in the lip; "I thought my head was going to blow up"; "Couldn't even walk a mile"; Diarrhea; Face were really swollen/swell up so bad; Hands were really swollen/swell up so bad; Spasms in the stomach; Back of my head neck were so sore; Itchy small rash; Upper part was so sore; Every joint hurt; Headache was so bad/really bad headache/ headache got worse in the back of my head; Fever was up and down all day/100? fever/slight fever; Bad chills; Exhaustion/ totally exhausted/ was very tired; Achy all over; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face were really swollen/swell up so bad), PERIPHERAL SWELLING (Hands were really swollen/swell up so bad), ABDOMINAL PAIN UPPER (Spasms in the stomach), NECK PAIN (Back of my head neck were so sore) and PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Apr-2021, the patient experienced SWELLING FACE (Face were really swollen/swell up so bad), PERIPHERAL SWELLING (Hands were really swollen/swell up so bad), ABDOMINAL PAIN UPPER (Spasms in the stomach), NECK PAIN (Back of my head neck were so sore), DIARRHOEA (Diarrhea), RASH PRURITIC (Itchy small rash), PAIN (Upper part was so sore), ARTHRALGIA (Every joint hurt), HEADACHE (Headache was so bad/really bad headache/ headache got worse in the back of my head), PYREXIA (Fever was up and down all day/100? fever/slight fever), CHILLS (Bad chills), FATIGUE (Exhaustion/ totally exhausted/ was very tired) and MYALGIA (Achy all over). On 01-May-2021, the patient experienced GAIT DISTURBANCE ("Couldn't even walk a mile"), LIP BLISTER (Fever blisters in the lip) and FEELING ABNORMAL ("I thought my head was going to blow up"). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Face were really swollen/swell up so bad), PERIPHERAL SWELLING (Hands were really swollen/swell up so bad), ABDOMINAL PAIN UPPER (Spasms in the stomach), NECK PAIN (Back of my head neck were so sore), PAIN IN EXTREMITY (Sore arm), GAIT DISTURBANCE ("Couldn't even walk a mile"), DIARRHOEA (Diarrhea), LIP BLISTER (Fever blisters in the lip), FEELING ABNORMAL ("I thought my head was going to blow up"), RASH PRURITIC (Itchy small rash), PAIN (Upper part was so sore), ARTHRALGIA (Every joint hurt), HEADACHE (Headache was so bad/really bad headache/ headache got worse in the back of my head), PYREXIA (Fever was up and down all day/100? fever/slight fever), CHILLS (Bad chills), FATIGUE (Exhaustion/ totally exhausted/ was very tired) and MYALGIA (Achy all over) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Body temperature: 100 (High) 100?. No relevant concomitant medications was reported. This case was linked to MOD-2021-356638 (Patient Link).

Other Meds:

Current Illness:

ID: 1817323
Sex: M
Age: 49
State: CA

Vax Date: 02/04/2021
Onset Date: 03/03/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20210304; Test Name: Body temperature; Result Unstructured Data: 104; Test Date: 20210305; Test Name: Body temperature; Result Unstructured Data: low grade fever

Allergies:

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

Symptoms: [after second dose] pain in my arm at the injection site; felt really really, super sick; couldn't even walk from my room to the bathroom; almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever; Fifteen minutes after the second shot, the lump appeared even bigger; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (Fifteen minutes after the second shot, the lump appeared even bigger), ILLNESS (felt really really, super sick), GAIT DISTURBANCE (couldn't even walk from my room to the bathroom), PYREXIA (almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever) and VACCINATION SITE PAIN ([after second dose] pain in my arm at the injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20H and 013M20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 03-Mar-2021, the patient experienced NECK MASS (Fifteen minutes after the second shot, the lump appeared even bigger). On 04-Mar-2021, the patient experienced ILLNESS (felt really really, super sick), GAIT DISTURBANCE (couldn't even walk from my room to the bathroom) and PYREXIA (almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever). On an unknown date, the patient experienced VACCINATION SITE PAIN ([after second dose] pain in my arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK MASS (Fifteen minutes after the second shot, the lump appeared even bigger), ILLNESS (felt really really, super sick), GAIT DISTURBANCE (couldn't even walk from my room to the bathroom), PYREXIA (almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever) and VACCINATION SITE PAIN ([after second dose] pain in my arm at the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 104 (High) 104. On 05-Mar-2021, Body temperature: low (Low) low grade fever. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. This case was linked to MOD-2021-356190, MOD-2021-356658 (Patient Link).

Other Meds:

Current Illness: Asthma

ID: 1817324
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: administered with an expired vaccine; 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 (administered with an expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) 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 (administered with an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The HCP had reported that the vaccine was administered to an unknown number of patients and it was not known whether that were the patients 1st or 2nd doses. It was unknown to him if the vaccines were stored in the freezer or refrigerator prior its use. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1817325
Sex: M
Age:
State: NY

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 10/26/2021
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: Chronic diarrhea/Diarrhea since 1st dose/He stated that 7 months later they are still taking medications (anti-diarrheal treatment); This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Chronic diarrhea/Diarrhea since 1st dose/He stated that 7 months later they are still taking medications (anti-diarrheal treatment)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIARRHOEA (Chronic diarrhea/Diarrhea since 1st dose/He stated that 7 months later they are still taking medications (anti-diarrheal treatment)). The patient was treated with LOPERAMIDE HYDROCHLORIDE (ANTI-DIARRHEAL) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Chronic diarrhea/Diarrhea since 1st dose/He stated that 7 months later they are still taking medications (anti-diarrheal treatment)) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Reporter stated that 7 months later they are still taking medications (anti-diarrheal treatment). Before they had diarrheal episodes 6-7 times a day but now it is 2-3 times a day.

Other Meds:

Current Illness:

ID: 1817326
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital: Y

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 Name: Body temperature; Result Unstructured Data: fever 102F; Test Name: Contrast enhanced computed tomography; Result Unstructured Data: Contrast enhanced computed tomography (CT) of chest/abdomen/pelvis revealed known left lower lobe lesion which is decreased in size, without signs of pulmonary or abdominal infection.; Test Name: Echocardiogram; Result Unstructured Data: Echocardiogram was without signs of vegetation, with preserved ejection fraction.; Test Name: WBC; Result Unstructured Data: Infectious workup was negative, which included normal WBC without left shift

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Acute COPD exacerbation; This literature-non-study case was reported in a literature article and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Acute COPD exacerbation) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Lung adenocarcinoma stage II (lung adenocarcinoma stage IIB on chemotherapy), Chronic obstructive pulmonary disease (underlying oxygen dependent severe COPD.), Hypoxic respiratory failure (chronic hypoxic respiratory failure), Non-Hodgkin's lymphoma (low grade non Hodgkin's lymphoma in remission), Hypertension, Gout and Hearing loss (hear failure). 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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Acute COPD exacerbation) (seriousness criterion hospitalization prolonged). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Acute COPD exacerbation) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102f (High) fever 102F. On an unknown date, Computerised tomogram: abnormal (abnormal) Contrast enhanced computed tomography (CT) of chest/abdomen/pelvis revealed known left lower lobe lesion which is decreased in size, without signs of pulmonary or abdominal infection.. On an unknown date, Echocardiogram: abnormal (abnormal) Echocardiogram was without signs of vegetation, with preserved ejection fraction.. On an unknown date, White blood cell count: normal (normal) Infectious workup was negative, which included normal WBC without left shift. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Acute COPD exacerbation) to be possibly related. Patient presented with fever 102F and shortness of breath. Patient was in his usual state of health, undergoing last chemotherapy 3 weeks ago which he tolerated well. A day prior the admission patient received his 2nd dose of mRNA-1273 (Moderna COVID-19 vaccine). Within the next 24h patient developed fever and shortness of breath which brought him to the emergency department. On admission patient with obvious respiratory wheezing, for which he was treated with systemic steroids. Patient was monitored off antibiotics. Fever and shortness of breath quickly improved with systemic steroids. Patient remained stable on his home dose of oxygen supplementation while inpatient, and was successfully discharged to home with prednisone taper. Author concluded that the inflammatory response from receiving COVID-19 vaccine, can lead to acute exacerbation of COPD in certain high risk patients. Additional safety data is needed in post vaccine surveillance in this sub group of patients. Company Comment: This is a literature case concerning a 78 year-old male patient with medical history of Lung adenocarcinoma stage II, Chronic obstructive pulmonary disease, Hypoxic respiratory failure and Non-Hodgkin's lymphoma who experienced the serious unexpected event of CHRONIC OBSTRUCTIVE PULMONARY DISEASE one dat after receiving the second dose of spikevax. Rechallenge was not applicable. Patient?s medical history mentioned above remains as confounders/co suspect for these events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow up received by safety on 21-Oct-2021 included an Email with FTA received from SARA team and does not contain any new information.; Sender's Comments: This is a literature case concerning a 78 year-old male patient with medical history of Lung adenocarcinoma stage II, Chronic obstructive pulmonary disease, Hypoxic respiratory failure and Non-Hodgkin's lymphoma who experienced the serious unexpected event of CHRONIC OBSTRUCTIVE PULMONARY DISEASE one dat after receiving the second dose of spikevax. Rechallenge was not applicable. Patient?s medical history mentioned above remains as confounders/co suspect for these events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness: Chronic obstructive pulmonary disease (underlying oxygen dependent severe COPD.); Gout; Hearing loss (hear failure); Hypertension; Hypoxic respiratory failure (chronic hypoxic respiratory failure); Lung adenocarcinoma stage II (lung adenocarcinoma stage IIB on chemotherapy); Non-Hodgkin's lymphoma (low grade non Hodgkin's lymphoma in remission)

ID: 1817327
Sex: U
Age:
State: NC

Vax Date:
Onset Date: 10/14/2021
Rec V Date: 10/26/2021
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: Patient received expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) 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 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 07Oct2021: Removed from freezer & placed in the refrigerator. 14Oct2021: Administered to 21 patients/soldiers. Concomitant medications was not provided by the reporter Treatment information was not provided

Other Meds:

Current Illness:

ID: 1817328
Sex: F
Age: 72
State: TX

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: arm pain that really hurt after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain that really hurt after first dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The patient's past medical history included Breast cancer, Benign renal neoplasm (a benign mass on her left kidney), Stevens Johnson syndrome (after getting a facial after being in sun and also receiving radiation for breast cancer.), Radiation therapy and Chemotherapy (radiation and chemotherapy treatments for breast cancer 14 years ago.). Concurrent medical conditions included Immunocompromised (underlying autoimmune conditions and is considered immunocompromised due to a past medical history). Concomitant products included COLECALCIFEROL (VITAMIN D3) for Osteoporosis, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ALPRAZOLAM, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), CLONAZEPAM (KLONOPIN), PITAVASTATIN CALCIUM (LIVALO), ZOLPIDEM TARTRATE (ZOLPIDEM [ZOLPIDEM TARTRATE]), DENOSUMAB (PROLIA), LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS PROBIOTIC), AIRBORNE, FLUTICASONE PROPIONATE (ALLER FLO), DOXEPIN, CHONDROITIN SULFATE, GLUCOSAMINE (MOVE FREE [CHONDROITIN SULFATE; GLUCOSAMINE]), MULTIVITAMIN [VITAMINS NOS] and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain that really hurt after first dose). On 02-Feb-2021, PAIN IN EXTREMITY (arm pain that really hurt after first dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications provided by the reporter. Patient experienced arm pain that really hurt after receiving the vaccine; however, patient states she had "nothing" the next day. Doses were administered in the patient's right upper arm, which is her dominant arm, due to lymphadenopathy in her left arm as a result of radiation and chemotherapy treatments for breast cancer 14 years ago. This case was linked to MOD-2021-356901, MOD-2021-356902 (Patient Link).

Other Meds: Allegra; Alprazolam; Areds; Klonopin; Livalo; Vitamin D3; Zolpidem [Zolpidem Tartrate]; Prolia; Acidophilus Probiotic; Airborne; Aller Flo; Doxepin; Move Free [Chondroitin Sulfate; Glucosamine]; Multivitamin [Vitamins Nos]; Premarin

Current Illness: Immunocompromised (underlying autoimmune conditions and is considered immunocompromised due to a past medical history).

ID: 1817329
Sex: F
Age: 72
State: TX

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: one day of feeling crummy after second dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (one day of feeling crummy after second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The patient's past medical history included Breast cancer, Benign renal neoplasm (a benign mass on her left kidney), Stevens Johnson syndrome (after getting a facial after being in sun and also receiving radiation for breast cancer.), Radiation therapy and Chemotherapy (radiation and chemotherapy treatments for breast cancer 14 years ago.). Concurrent medical conditions included Immunocompromised (underlying autoimmune conditions and is considered immunocompromised due to a past medical history). Concomitant products included COLECALCIFEROL (VITAMIN D3) for Osteoporosis, LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS PROBIOTIC), AIRBORNE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE (ALLER FLO), ALPRAZOLAM, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), DOXEPIN, CLONAZEPAM (KLONOPIN), PITAVASTATIN CALCIUM (LIVALO), MULTIVITAMIN [VITAMINS NOS], ESTROGENS CONJUGATED (PREMARIN), ZOLPIDEM, DENOSUMAB (PROLIA) and CHONDROITIN SULFATE, GLUCOSAMINE (MOVE FREE [CHONDROITIN SULFATE;GLUCOSAMINE]) for an unknown indication. On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced FEELING ABNORMAL (one day of feeling crummy after second dose). On 02-Mar-2021, FEELING ABNORMAL (one day of feeling crummy after second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication details was provided. Patient reports experiencing one day of "feeling crummy", but felt better the next day. Doses were administered in the patient's right upper arm, which was her dominant arm, due to lymphadenopathy in her left arm as a result of radiation and chemotherapy treatments for breast cancer 14 years ago. This case was linked to MOD-2021-356856, MOD-2021-356902.

Other Meds: ACIDOPHILUS PROBIOTIC; AIRBORNE; ALLEGRA; ALLER FLO; ALPRAZOLAM; AREDS; DOXEPIN; KLONOPIN; LIVALO; MULTIVITAMIN [VITAMINS NOS]; PREMARIN; VITAMIN D3; ZOLPIDEM; PROLIA; MOVE FREE [CHONDROITIN SULFATE;GLUCOSAMINE]

Current Illness: Immunocompromised (underlying autoimmune conditions and is considered immunocompromised due to a past medical history)

ID: 1817330
Sex: F
Age: 24
State: AK

Vax Date: 10/04/2021
Onset Date: 10/01/2021
Rec V Date: 10/26/2021
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: a couple of days later "hot"; red on the arm she got the shot; 10 days after she got a reaction on the arm she got the shot:sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a couple of days later "hot"), VACCINATION SITE ERYTHEMA (red on the arm she got the shot) and VACCINATION SITE PAIN (10 days after she got a reaction on the arm she got the shot:sore) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication. On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE WARMTH (a couple of days later "hot"), VACCINATION SITE ERYTHEMA (red on the arm she got the shot) and VACCINATION SITE PAIN (10 days after she got a reaction on the arm she got the shot:sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (a couple of days later "hot"), VACCINATION SITE ERYTHEMA (red on the arm she got the shot) and VACCINATION SITE PAIN (10 days after she got a reaction on the arm she got the shot:sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported that she got a reaction 'red and sore' 10 days after getting the shot and a couple of days later, she reported it being 'hot'. Patient was also treated with an unspecified antihistamine.

Other Meds: ORAL CONTRACEPTIVE NOS

Current Illness:

ID: 1817331
Sex: U
Age: 39
State: PA

Vax Date: 04/01/2021
Onset Date: 10/18/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1817332
Sex: M
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: weakness in legs and upper body; Leg pain; Allergic reaction to vaccine; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in legs and upper body), PAIN IN EXTREMITY (Leg pain), ALLERGY TO VACCINE (Allergic reaction to vaccine) and ARTHRALGIA (Knee pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (weakness in legs and upper body), PAIN IN EXTREMITY (Leg pain), ALLERGY TO VACCINE (Allergic reaction to vaccine) and ARTHRALGIA (Knee pain). At the time of the report, MUSCULAR WEAKNESS (weakness in legs and upper body), PAIN IN EXTREMITY (Leg pain), ALLERGY TO VACCINE (Allergic reaction to vaccine) and ARTHRALGIA (Knee pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment information was provided

Other Meds:

Current Illness:

ID: 1817333
Sex: M
Age:
State: PA

Vax Date: 01/09/2021
Onset Date: 01/10/2021
Rec V Date: 10/26/2021
Hospital: Y

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: Test Name: CT angiogram; Test Result: Negative ; Result Unstructured Data: The CT angiogram of the chest was negative for pulmonary embolism.; Test Name: Aspartate aminotransferase; Result Unstructured Data: 44 U/L; Test Name: Alkaline phosphatase; Result Unstructured Data: 272 U/L; Test Name: bilirubin; Result Unstructured Data: 1.8 mg/dL; Test Name: fibrinogen; Result Unstructured Data: 730 mg/dL; Test Name: Lactate dehydrogenase; Result Unstructured Data: 220 U/L; Test Name: ct scan; Result Unstructured Data: The CT scan of the chest in the emergency room showed ground-glass infiltrates in both lungs and associated interstitial infiltrates, consistent with COVID-19 multifocal pneumonia; Test Name: d-dimer test; Result Unstructured Data: 2.45 ug/mL.Rreference range lesser than0.44 ug/mL; Test Name: imaging; Result Unstructured Data: The imaging showed a new pneumo- mediastinum; Test Name: imaging; Result Unstructured Data: Repeated imaging confirmed a pneumo-mediastinum with no pneumothorax; Test Name: oxygen saturation; Result Unstructured Data: His oxygen saturation on the pulse oximetry at home was 90% initially but later dropped to 85% over the next three days.; Test Name: pcr test; Result Unstructured Data: tested positive for COVID-19 by PCR; Test Name: pcr test; Result Unstructured Data: In the emergency room, he was hypoxic, re-tested for COVID-19 infection, which was positive.; Test Name: SARS-CoV-2 IgG; Test Result: Positive ; Result Unstructured Data: Positive; Test Name: lower extremity doppler study; Result Unstructured Data: The lower extremity doppler study was negative for DVT;

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: COVID-19; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 PNEUMONIA (COVID-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Liver cirrhosis since an unknown date and Cessation of smoking (He had a history of 10-year pack per day (PPD), quit smoking over 30 years ago). Concurrent medical conditions included Essential hypertension, Type 2 diabetes mellitus, Obstructive sleep apnea hypopnea syndrome and Hypothyroidism. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19) (seriousness criterion hospitalization prolonged). The patient was treated with REMDESIVIR (intravenous) for COVID-19, at an unspecified dose and frequency; REMDESIVIR (oral) for COVID-19, at an unspecified dose and frequency; BARICITINIB (oral) for COVID-19, at an unspecified dose and frequency; TOCILIZUMAB for COVID-19, at a dose of 3 dosage form; PREDNISONE (oral) for COVID-19, at a dose of 20 milligram and CONVALESCENT PLASMA COVID-19 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 PNEUMONIA (COVID-19) was resolving. Possible DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: negative (Negative) The CT angiogram of the chest was negative for pulmonary embolism.. On an unknown date, Aspartate aminotransferase (6-29 u/l): 44 u/l (High) 44 U/L. On an unknown date, Blood alkaline phosphatase (37 u/l-153 u/l): 272 u/l (High) 272 U/L. On an unknown date, Blood bilirubin (0.2 mg/dl-1.2 mg/dl): 1.8 mg/dl (High) 1.8 mg/dL. On an unknown date, Blood fibrinogen (190 mg/dl-480 mg/dl): 730 mg/dl (High) 730 mg/dL. On an unknown date, Blood lactate dehydrogenase (98 u/l-192 u/l): 220 u/l (High) 220 U/L. On an unknown date, Computerised tomogram: pneumonia The CT scan of the chest in the emergency room showed ground-glass infiltrates in both lungs and associated interstitial infiltrates, consistent with COVID-19 multifocal pneumonia. On an unknown date, Fibrin D dimer: 2.45 ug/ml 2.45 ug/mL.Rreference range lesser than0.44 ug/mL. On an unknown date, Imaging procedure: the imaging showed a new pneumo- mediastinum The imaging showed a new pneumo- mediastinum and repeated imaging confirmed a pneumo-mediastinum wi Repeated imaging confirmed a pneumo-mediastinum with no pneumothorax. On an unknown date, Oxygen saturation: decreased His oxygen saturation on the pulse oximetry at home was 90% initially but later dropped to 85% over the next three days.. On an unknown date, Polymerase chain reaction: positive tested positive for COVID-19 by PCR and positive In the emergency room, he was hypoxic, re-tested for COVID-19 infection, which was positive.. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive. On an unknown date, Ultrasound Doppler: negative The lower extremity doppler study was negative for DVT;. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 PNEUMONIA (COVID-19) to be possibly related. He regularly uses continuous positive airway pressure. A day after receiving the vaccine, he started having body aches and headaches. Later, his headache improved, but he progressively developed shortness of breath. He presented to the emergency room with worsening shortness of breath and denied cough, fever, chest pain or palpitations, trouble with urination, and bowel movements. His hepatic function panel and renal function panel were within normal limits. At the time of admission, laboratory parameters were normal for the most part. He was initially treated with intravenous steroids, oxygen supplements, and intravenous remdesivir. When there was no clinical improvement over the next 48 hours, he was started on combination of oral baricitinib and remdesivir as this combination was proven superior to remdesivir alone in the length of stay of hospitalized patients from COVID-19. There was still no improvement after 72 hours, and two doses of tocilizumab were administered. However, he continued to deteriorate with progressive hypoxia, requiring up to 15 L oxygen through a high-flow nasal cannula. Convalescent plasma was routinely administered to COVID-19 patients during that period. After much debate, it was decided not to administer convalescent plasma. Over the next 2 days, his hypoxia worsened, and the imaging showed a new pneumo- mediastinum. He was then transferred to the intensive care unit for further management and completed the ten-day course of IV remdesivir therapy. He was also given intermittent diuretics, high-dose IV steroids. His liver enzymes, renal function panel, and inflammatory markers were within normal limits. He was eventually transferred back to the medical floor and discharged home with one-liter supplemental oxygen. He was advised to wait for three months before receiving the second dose of the vaccine. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Followup received by safety on 21-Oct-2021 doesnot contain any new information.; Sender's Comments: This literature review case concerns a 69 year old male with a history of obstructive sleep apnea and a 10 pack year history of smoking who experienced the serious, unlisted medical event of COVID-19 pneumonia the day after the first dose of mRNA-1273. Re-challenge is unknown as no information about further dosing is reported. The history of obstructive sleep apnea and 10 pack years of smoking remains a confounder as these can exacerbate the symptoms. Benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness: Essential hypertension; Hypothyroidism; Liver cirrhosis; Obstructive sleep apnea hypopnea syndrome; Type 2 diabetes mellitus

ID: 1817334
Sex: F
Age: 68
State: NY

Vax Date: 03/02/2021
Onset Date: 10/06/2021
Rec V Date: 10/26/2021
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 Date: 20211008; Test Name: SARS CoV-2 Test; Test Result: Negative ; Result Unstructured Data: Tested Negative for COVID-19; Test Date: 202110; Test Name: SARS CoV-2 Test; Test Result: Positive ; Result Unstructured Data: Tested Positive for COVID-19

Allergies:

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

Symptoms: Second covid-19 test which resulted as positive; Not feel well; Lack of effect; Post-acute COVID-19 syndrome; She started to "feel the effects" of what she thought was allergies; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (She started to "feel the effects" of what she thought was allergies), COVID-19 (Second covid-19 test which resulted as positive), MALAISE (Not feel well), DRUG INEFFECTIVE (Lack of effect) and POST-ACUTE COVID-19 SYNDROME (Post-acute COVID-19 syndrome) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced HYPERSENSITIVITY (She started to "feel the effects" of what she thought was allergies) and POST-ACUTE COVID-19 SYNDROME (Post-acute COVID-19 syndrome). On 10-Oct-2021, the patient experienced COVID-19 (Second covid-19 test which resulted as positive), MALAISE (Not feel well) and DRUG INEFFECTIVE (Lack of effect). At the time of the report, HYPERSENSITIVITY (She started to "feel the effects" of what she thought was allergies), COVID-19 (Second covid-19 test which resulted as positive), MALAISE (Not feel well) and DRUG INEFFECTIVE (Lack of effect) outcome was unknown and POST-ACUTE COVID-19 SYNDROME (Post-acute COVID-19 syndrome) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2021, SARS-CoV-2 test: negative (Negative) Tested Negative for COVID-19. In October 2021, SARS-CoV-2 test: positive (Positive) Tested Positive for COVID-19. The concomitant history was not reported. The patient had given prescription for prednisone, but patient not consumed it, on 10-OCT-2021 patient not felt well and went to different urgent care, at that appointment patient had second COVID-19 test resulted in positive, also received a monoclonal antibody IV on 12-0CT-2021, patient continued to have symptoms and post COVID syndrome.; Sender's Comments: This spontaneous report concerns a 68 year old female patient with no relevant medical history who experienced the non-serious events of allergies (coded as hypersensitivity) (expected event) and malaise (unexpected). Later, the patient tested positive for SARS-Cov-2 (coded as COVID-19, an unexpected AESI) after being exposed to a COVID 19 positive patient at work. The events occurred approximately 6 months after the second dose and nearly 7 months after the first dose of mRNA-1273. Based on the current available information, lack of effect was considered as an additional event. The patient was treated with intravenous monoclonal antibody and continues to have post-COVID syndrome (a non-serious, unexpected event). Rechallenge was not applicable as the events happened after the administration of the second dose of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1817335
Sex: F
Age:
State: OH

Vax Date: 07/07/2021
Onset Date: 07/19/2021
Rec V Date: 10/26/2021
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: felt like her face was tight and swollen" at her jaw and underneath her eye; a rash in the back of her ear; This is a spontaneous report from a contactable consumer. A 91-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 07Jul2021 (Batch/Lot number was not reported) (age at vaccination 91-year-old) as dose 2, single for covid-19 immunisation. The patient medical history included high blood pressure, heart attack and allergic to penicillin from an unknown date and unknown if ongoing. The patient is taking medications for heart attack. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unknown date as dose 1, single for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. The adverse events following prior vaccinations was reported as none. No family Medical History Relevant to adverse events and relevant tests was reported as none. On 19Jul2021 morning, the patient experienced felt like her face was tight and swollen" at her jaw and underneath her eye and a rash in the back of her ear. She has been putting ice on it. Treatment medications were reported as none. The adverse events did not resulted to visit emergency room or physician office. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1817336
Sex: U
Age:
State: FL

Vax Date:
Onset Date: 07/21/2021
Rec V Date: 10/26/2021
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: Confused; Kind of dizzy; I dont have my balance; Really dont feel well enough to walk in to another room; Felt super super tired/Tired/really really tired; I got really sick/Feeling very very sick/I feel sick; Running a fever/still feel like I might have a low grade fever; Aching; Chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. On 21Jul2021, yesterday, patient got really sick/feeling very sick/i feel sick and had a running a fever/still feel like might have a low-grade fever, patient don't know exactly how high it was because the battery was dead in thermometer. But aching, chills, just really feeling very sick, so patient live alone and just basically felt super tired and went to bed, patient just got up a little while ago and patient still feel like patient might had a low-grade fever but like patient said the battery was dead, so patient cant check it to give you a number, so that part patient guess it's better. Okay the fever did go down, but patient still felt just out of it like super just confused and tired, really tired, kind of dizzy like patient didn't have balance and just felt sick. When patient was asked about immunisation card, patient stated don't feel well enough to walk into another room. Patient reported that the first vaccination didn't do this. At the time of this report, the outcome of event running a fever/still feel like i might have a low-grade fever was recovering and other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1817337
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: Bad allergic reaction through the Pfizer COVID-19 Vaccine; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization; acetylsalicylic acid (ASPIRIN (E.C.)), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included hypersensitivity- have allergies but haven't been tested in years. The patient's concomitant medications were not reported. The patient experienced bad allergic reaction through the pfizer covid-19 vaccine (hypersensitivity) on an unspecified date. She mentioned that she knows someone who have bad allergic reaction to Pfizer COVID-19 Vaccine. Limited information was available over the call. The action taken in response to the event(s) for acetylsalicylic acid was unknown. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1817338
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 06/21/2021
Rec V Date: 10/26/2021
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: 20210721; Test Name: Blood work; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Pain in extremity

Symptoms: rashes/blotches on skin; Hair loss; This is a spontaneous report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # (21K-163-4022416-00) via a contactable consumer (patient). A 14-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), via intramuscular route, administered on 08Jun2021 (age at vaccination 14-year-old) as DOSE 2, SINGLE for COVID-19 immunization and adalimumab (HUMIRA 40mg/0.4ml (40 Milligram, Solution for injection in pre-filled pen) (ADALIMUMAB)) via subcutaneous route for Crohn's disease from 01Apr2021 and ongoing. The patient medical history included non-smoker and abstains from alcohol. The patient had no known allergies. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161, expiration date: Jul2021) via intramuscular route, administered on 15May2021 (age at vaccination 14-year-old), as single dose for COVID-19 immunization. On 21Jun2021, the patient experienced rashes/blotches on skin and hair loss. The patient underwent lab tests and procedures which included blood work on 21Jul2021: normal. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds: HUMIRA 40 mg

Current Illness:

ID: 1817339
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/18/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20210318; Test Name: sars-cov-2 test; Result Unstructured Data: Test Result:low covid -19 antibody after receiving covid-19 va

Allergies:

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

Symptoms: fever and chills; Body aches; Forgetting stuff worsening; Forgetting stuff worsening; low Covid -19 antibody after receiving Covid-19 Vaccine; headache; fever and chills; This is a spontaneous report from a contactable consumer or other non hcp (patient) and Other HCP. A 48-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation; teriflunomide (AUBAGIO), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for multiple sclerosis. Medical history included ongoing allergies (hypersensitivity), ongoing GERD (Gastro oesophageal reflux disease), ongoing covid-19 pneumonia, ongoing jc virus infection, ongoing multiple sclerosis, ongoing migraine, ongoing nerve pain. Concomitant medications included gabapentin (GABAPENTIN); omeprazole (PROTONIX [OMEPRAZOLE]); azelastine (AZELASTINE); mometasone furoate (FLONASE [MOMETASONE FUROATE]); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported. On 18Mar2021 the patient experienced fever and chills, body aches, forgetting stuff worsening, condition aggravated, low covid -19 antibody after receiving covid-19 vaccine, headache. Following the first dose intake of Teriflunomide and bnt162b2. It was not reported if the patient received a corrective treatment for the adverse events. The action taken in response to the events for teriflunomide was unknown. At time of reporting, the outcome of all the events was resolved on an unspecified date in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: GABAPENTIN; PROTONIX [OMEPRAZOLE]; AZELASTINE; FLONASE [MOMETASONE FUROATE]; ADDERALL; SINGULAIR

Current Illness: Allergy; COVID-19 pneumonia; GERD; JC virus infection; Migraine; Multiple sclerosis; Nerve pain

ID: 1817340
Sex: F
Age:
State: NJ

Vax Date: 08/12/2021
Onset Date: 08/15/2021
Rec V Date: 10/26/2021
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: Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; This is a spontaneous report from contactable consumer. This consumer reported similar events for self and her daughter. This report is for daughter. This consumer (patient's mother) reported for a female patient (daughter) that. A non-pregnant female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number Batch/Lot Number: FC3180) via an unspecified route of administration, administered in Arm Left on 12Aug2021 18:30 pm as dose 1, single for COVID-19 immunisation. The patient medical history included lichen planus on an unspecified date. The concomitant medications were not reported. Other medications she took in two weeks was Prilosec. She did not receive any other vaccines in 4 weeks. She had no known allergies. Prior to vaccination she was not tested for COVID. She was not tested for COVID post vaccination. The patient experienced me and my daughter has vaccine same day and time. we both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness on 15Aug2021 16:00 pm. She did not receive treatment for the adverse events. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101057825 same event/drug, different patient

Other Meds:

Current Illness:

ID: 1817341
Sex: F
Age:
State: NY

Vax Date: 06/03/2021
Onset Date: 06/03/2021
Rec V Date: 10/26/2021
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: joint pain; Headache; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female consumer reported in response to Non-HCP follow up letter sent in cross reference case which included that: A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0186; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 03Jun2021 16:43 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included hypersensitivity, anaemia and oral herpes from an unknown date and unknown if ongoing. Concomitant medications included levocetirizine (LEVOCETIRIZINE) taken for hypersensitivity from 25May2021 to 01Jun2021; famciclovir (FAMCICLOVIR) taken for oral herpes from 11Jun2021 to an unspecified stop date and ferrous gluconate (POLY-IRON [FERROUS GLUCONATE]) from 2021 to an unspecified date [Been taking this or a long time- on and off. I was taking the iron pill days before the 03Jun2021 1st dose] for anaemia. On 03Jun2021 patient experienced joint pain and headache. The outcome of both the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: LEVOCETIRIZINE; POLY-IRON [FERROUS GLUCONATE]; FAMCICLOVIR

Current Illness:

ID: 1817342
Sex: F
Age:
State: NC

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 10/26/2021
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: Severe Headache; LT arm numbness and shaking; LT arm numbness and shaking/Involuntary muscle jerks in LT arm and shoulder; Nausea; Vomitting; Fatigue; Insomnia; This is a spontaneous report from a contactable other health care professional (patient). A 31-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0183) via an unspecified route of administration, administered in left arm on 27Aug2021 at 01:45 (at the age of 31-year-old) as single dose for COVID-19 immunization. Patient had known allergies to penicillins, Ibuprofen. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. The patient received within 2 weeks of vaccination naproxen sodium (ALEVE, batch/lot number not reported), route of administration, start and stop date, dose not reported. The patient previously took ibuprofen and experienced drug hypersensitivity. On 27Aug2021 at 14:00 the patient experienced severe headache, arm numbness and shaking, involuntary muscle jerks in lt arm and shoulder, nausea, vomiting, fatigue, insomnia. Treatment received with OTC medications for the event headache. No treatment received for other events. Device Date: 29Aug2021. Outcome of the events were not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds: ALEVE

Current Illness:

ID: 1817343
Sex: M
Age:
State:

Vax Date: 02/01/2021
Onset Date: 08/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result:No antibodies for the Covid vaccine; Test Date: 20210815; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result:unknown result; Comments: No antibodies for the Covid vaccine; Test Date: 202108; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:negative

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: was at an even where someone was infected with covid; have no antibodies for the Covid vaccine; SARS-CoV-2 test, Negative; tingling in fingers and toes; rash came back; using dupixent every 20 or 21 days, went out to 30 (every 30 days); This is a spontaneous report from a contactable consumer or other non hcp (patient) and Other HCP. An 80-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EK9231) on 11Jan2021 (at the age of 80-year-old) at dose 1, 0.3 ml single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9265 or EK9265) on 01Feb2021 (at the age of 80-year-old) at dose 2, 0.3 ml single, both the doses via an unspecified route of administration for covid-19 immunisation; dupilumab (DUPIXENT), via an unspecified route of administration from 2017 (Batch/Lot number was not reported) and ongoing, at 300 mg for dermatitis atopic. Medical history included ongoing asthma and atopic dermatitis from an unknown date and unknown if ongoing. Concomitant medications were not reported. Event description: Experienced tingling in fingers and toes, have no antibodies for the covid vaccine, was at an even where some-one was infected with covid, rash came back and using dupixent every 20 or 21 days, went out to 30 (every 30 days) while being treated with DUPILUMAB (DUPIXENT) with the use of medical device not reported and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE). In 2017, the patient started taking DUPIXENT (DUPILUMAB) (strength: 300 mg) injection at a dose of 600 mg then was prescribed to take 300 mg for every 14 days but patient was taking dose of 300 mg every 30 days or every 20 or 21 days (with an unknown batch number and expiry date) for Atopic dermatitis delivered via unknown device. In the context of COVID19 crisis, the batch number and expiration date were not requested. Therapy date: 2017 to 2017. Dupilumab was not used for the first time. In 2019 the patient developed a non-serious event tingling in fingers and toes (paraesthesla) (un-known latency) following the first dose intake of DUPILUMAB. On 11Jan2021, the patient started taking first dose of PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) at a dose of 0.3 mL (lot EK9231; strength, form, frequency, route, expiry date: unknown) for COVID-19 vaccination and received second dose on 01Feb2021 (batch number. E then L or K then 9265 (EL9265 or EK9265). In Aug2021 the patient developed a non-serious event have no antibodies for the covid vaccine (sars-cov-2 antibody test negative) (unknown latency) following the first dose intake or DUPILUMAB and (unknown latency) following the first dose Intake and (unknown latency) following the last dose intake of TOZINAMERAN. On 01Aug2021 the patient developed a non-serious event was at an even where someone was infected with covid (exposure to sars-cov-2) (unknown latency) following the first dose intake of DUPILUMAB and 6 months 21 days following the first dose intake and 6 months following the last dose intake of TOZINAMERAN. On an unknown date the patient developed a non-serious event rash came back (rash) using dupixent every 20 or 21 days, went out to 30 (every 30 days) (product use issue) (unknown latency) following the first dose intake of DUPI-LUMAB and (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of TOZINAMERAN. It was reported Consumer states that he has been on Dupixent almost 4 years. I had my first Pfizer Covid-19 vaccine on 11Jan2021. I had my second Pfizer Covid-19 vaccine dose on 01Feb2021. My wife had it (Covld-19 vaccines) done the same time. Sunday we were at a wedding. Then we were notified that there was a Covid outbreak, and my wife and I got tested for Covid. I was negative and my wife was negative. Then we got instructions from our doc-tor to get the antibody test. My wife's antibody test was 18 and I have no antibodies for the Covid vaccine. So, I am wondering if I should be getting a booster shot or does DUPIXENT kill the effects of the vaccine because it stops the inflammation. I am taking DUPIXENT for dermatitis, but I think it also works for asthma because I have not had one asthma attack in this period of almost four years that I have been taking DUPIXENT. And I no longer take any asthma medication and it has cleared up my skin. So, it is working for both. So, I am wondering if DUPIXENT caused me not to have anti-bodies to the vaccine and if I am protected against Covid. My job Is that I am an x-ray technician and I take care of patients every day. I think the starter dose was 600 mg and I take 300 mg. I am using it (DUPIXENT) every 20 days. I think it was prescribed for every 14 days. I went out to 30 (every 30 days) but then my rash came back. So, now I am using it (DUPIXENT) every 20 or 21 days and It is controlling my dermatitis. That is how I am using it now. No, I do not have the lot number and expiration date. I am at work now. My doctor is with the Hospital. The lot number for my first Pfizer Covld-19 vaccine of 0.3 mL on 11Jan2021 was EK9231. The lot number for my second Pfizer Covid-19 vaccine of 0.3 mL on 01Feb2021 was E then L or K then 9265 (EL9265 or EK9265). I had called Sandi before because I was having tingling in my fingers and toes and my doctor told me to do that. So, there is correspondence back and forth on that. That was back in Apr2019. I still have that tingling in my fingers and toes but that may be from my age or It may be from this (DUPIXENT). I am slit taking the drug (DUPIXENT). Consumer wants to know is this because of DUPIXENT that stops inflammation could killed the effect of the Covid-19 vaccine. Also wants to know should he get a booster vaccine. Is It possible that he has zero antibodies because his is on DUPIXENT. No further information was provided. Relevant laboratory test results included: SARS-COV-2 antibody test- In Aug2021, 15Aug2021: unknown result no antibodies for the Covid vaccine and SARS-CoV-2 test - In Aug2021: Negative. It was not reported if the patient received a corrective treatment for the events (have no antibodies for the Covid vaccine, using dupixent every 20 or 21 days, went out to 30 (every 30 days), tingling in fingers and toes, was at an even where someone was infected with Covid, rash came back). The action taken in response to the events for dupilumab was dose not changed. At time of reporting, the outcome was not recovered / not resolved for the event have no antibodies for the covid vaccine, unknown for the event using dupixent every 20 or 21 days, went out to 30 (every 30 days), not recovered/, not resolved for the event tingling in fingers and toes, recovered / resolved in aug2021 for the event was at an even where someone was infected with covid and was unknown for the event rash came back, unknown for sars-cov-2 test, negative. Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Asthma

ID: 1817344
Sex: M
Age:
State: NV

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headache; fever; tired; This is a Spontaneous report based on the information received by Pfizer. (Manufacturer Control No: 2021SA257190). A contactable consumer (mother) reported for a 14-year-old male patient who received the first dose of BNT162B2 (Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date in Jul2021 as dose 1, single for COVID-19 immunization and dupilumab (Dupixent) at an unknown dose for an unknown indication. The patient's medical history, concomitant medications and family history were not reported. On an unknown date in Jul2021 following the first dose intake, the patient developed headache, pyrexia and fatigue. In the context of Covid-19 crisis, the batch number and expiration date were not requested. It was reported that patient's mother mentioned that her son got the Pfizer Covid vaccine and his dupilumab shot was due today but he felt tired, had a headache and a very mild fever and was out of it. It was not reported if the patient received a corrective treatment for the events (headache, fever, tired). On an unknown date in 2021 the patient recovered. No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected.

Other Meds:

Current Illness:

ID: 1817345
Sex: M
Age:
State: GA

Vax Date: 04/07/2021
Onset Date: 04/22/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20210422; Test Name: cholesterol; Result Unstructured Data: Test Result:High; Comments: cholesterol is high

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: cholesterol is high; acid indigestion; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: Unknown) via an unspecified route of administration on 07Apr2021 (age at vaccination 58 years) as DOSE 1, SINGLE for COVID-19 immunization. Patient had no known drug allergies. The patient medical history and concurrent conditions was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks was reported. Prior vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID- 19. Relevant past drug history was reported as no. The patient previously received other vaccine via an unspecified route of administration administered in arm right on 07Apr2021 (Lot number: Unknown) (age at vaccination 58 years) as dose 2, single. On 22Apr2021, patient experienced cholesterol is high and acid indigestion. It was reported that he has had acid indigestion since the vaccine and have not before. The patient never had cholesterol high before. The events were reported as non-serious. The patient underwent lab tests and procedures which included cholesterol : high on 22Apr2021 (cholesterol is high). It was unknown whether patient received any treatment for adverse events. The outcome of the events was unknown. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further in-formation is expected.

Other Meds:

Current Illness:

ID: 1817346
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: prepared syringe was administered to a patient between 20-25 minutes past the beyond use time for the dose; prepared syringe was administered to a patient between 20-25 minutes past the beyond use time for the dose; This is a spontaneous report from a contactable other healthcare professional (Nurse). A 12-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date caller explained that prepared syringe was administered to patient between 20-25 minutes past the beyond use time for the dose. Caller also explained that vaccine dose in question was diluted, drawn into a syringe, with the prepared syringe was labeled with expiration and dose and stored in the fridge. The undiluted vial was placed at room temperature, then reconstituted with diluent, drawn into syringes, then placed in the fridge after being labeled with expiration time. outcome of events was unknown. Information about batch/lot number is not available. Follow-up attempts completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1817347
Sex: F
Age:
State: VA

Vax Date: 08/21/2021
Onset Date: 08/21/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: back twitching/ her fingers and feet twitching at night when lays in bed and also her butt twitching sometimes/ her eyes will twitch on and off too/ arms, legs, hands, calves twitching; arms, legs, hands, calves twitching was reported as worsened; The twitching is interrupting her sleep at night; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Aug2021 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 57-year-old) for covid-19 immunisation. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) taken for blood pressure abnormal from an unspecified start date and ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced back twitching/ her fingers and feet twitching at night when lays in bed and also her butt twitching sometimes/ her eyes will twitch on and off too/ arms, legs, hands, calves twitching on 21Aug2021, arms, legs, hands, calves twitching was reported as worsened (condition aggravated) on an unknown date in 2021 and the twitching is interrupting her sleep at night on an unknown date in 2021. Caller states she had a question, states she got her first dose of the Pfizer Covid vaccine on 21Aug2021, when she got home her leg started twitching, caller states when she lays down at night arms and legs will twitch, states her calves will twitch and her eyes will twitch on and off too, states her eye is not that bad, its mostly her legs and arms and even her butt sometimes. Caller wants to know if this is a side effect or if it has been reported. Caller states she was supposed to get the second dose on Saturday but has not because she is scared to due to this side effect. Also noted caller stated that the twitching doesn't happen while she is up walking, only when she is laying down. The outcome for event The twitching is interrupting her sleep at night was unknown while rest were not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: LOSARTAN

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am