VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1631818
Sex: M
Age: 78
State: OH

Vax Date: 03/12/2021
Onset Date: 03/19/2021
Rec V Date: 08/25/2021
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: Dizziness; headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (headaches) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (headaches). At the time of the report, DIZZINESS (Dizziness) outcome was unknown and HEADACHE (headaches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1631819
Sex: M
Age:
State:

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: light tiredness; tiredness in the legs only after his second dose; heaviness in the legs; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (light tiredness), FATIGUE (tiredness in the legs only after his second dose) and LIMB DISCOMFORT (heaviness in the legs) in a male patient of an unknown age who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) .5 dosage form. On an unknown date, the patient experienced FATIGUE (light tiredness), FATIGUE (tiredness in the legs only after his second dose) and LIMB DISCOMFORT (heaviness in the legs). At the time of the report, FATIGUE (light tiredness), FATIGUE (tiredness in the legs only after his second dose) and LIMB DISCOMFORT (heaviness in the legs) outcome was unknown. Not Provided The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. No concomitant and treatment medications were reported. This case was linked to MOD-2021-064063.

Other Meds:

Current Illness:

ID: 1631820
Sex: F
Age: 64
State: CA

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 08/25/2021
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: fatigue; her arm was very sore; get a little flash of white light on left eye of peripheral vision; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (her arm was very sore) and VISUAL IMPAIRMENT (get a little flash of white light on left eye of peripheral vision) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUPROPION, MULTIVITAMINS [VITAMINS NOS], ESTRADIOL and PROGESTERONE for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), MYALGIA (her arm was very sore) and VISUAL IMPAIRMENT (get a little flash of white light on left eye of peripheral vision). At the time of the report, FATIGUE (fatigue), MYALGIA (her arm was very sore) and VISUAL IMPAIRMENT (get a little flash of white light on left eye of peripheral vision) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment details were reported.

Other Meds: ASPIRIN (E.C.); BUPROPION; MULTIVITAMINS [VITAMINS NOS]; ESTRADIOL; PROGESTERONE

Current Illness:

ID: 1631821
Sex: F
Age:
State:

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Name: Ultrasound; Result Unstructured Data: normal

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 44-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The patient's past medical history included Alcoholism (1 glass of wine a day) in 1995. Concurrent medical conditions included Mental disorder (It is improving) since 1998. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, LEVOTHYROXINE for Thyroid disorder. On 08-Mar-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Dec-2020 and the estimated date of delivery was 12-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the thirteenth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds: LEVOTHYROXINE; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS

Current Illness: Mental disorder (It is improving)

ID: 1631822
Sex: F
Age: 64
State: OH

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/25/2021
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: felt like there was something stuck in my throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (felt like there was something stuck in my throat) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced THROAT IRRITATION (felt like there was something stuck in my throat). On 04-Mar-2021, THROAT IRRITATION (felt like there was something stuck in my throat) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication was unknown

Other Meds:

Current Illness:

ID: 1631823
Sex: F
Age:
State:

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 08/25/2021
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: rash on middle section of her body like hives; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (rash on middle section of her body like hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (rash on middle section of her body like hives). At the time of the report, URTICARIA (rash on middle section of her body like hives) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1631824
Sex: M
Age: 51
State: TX

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 08/25/2021
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: body aches; coughing; loss of tatse and smell; Loss of taste and smell; nauseated; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), COUGH (coughing), AGEUSIA (loss of tatse and smell), ANOSMIA (Loss of taste and smell) and NAUSEA (nauseated) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), COUGH (coughing), AGEUSIA (loss of tatse and smell), ANOSMIA (Loss of taste and smell), NAUSEA (nauseated) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;SALICYLAMIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (body aches), COUGH (coughing), AGEUSIA (loss of tatse and smell), ANOSMIA (Loss of taste and smell), NAUSEA (nauseated) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1631825
Sex: M
Age: 61
State: CA

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Name: blood test; Result Unstructured Data: had IgM and IgG antibodies

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: COVID-19 like symptoms; Chills; Body aches; Heavy Perspiration; Extremely thirsty; Cannot sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), HYPERHIDROSIS (Heavy Perspiration), INSOMNIA (Cannot sleep), THIRST (Extremely thirsty) and COVID-19 (COVID-19 like symptoms) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (COVID-19 positive). Concomitant products included TESTOSTERONE (ANDROGEL) for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced INSOMNIA (Cannot sleep). On 27-Mar-2021, the patient experienced PAIN (Body aches), HYPERHIDROSIS (Heavy Perspiration), THIRST (Extremely thirsty) and CHILLS (Chills). On an unknown date, the patient experienced COVID-19 (COVID-19 like symptoms). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 27-Mar-2021, INSOMNIA (Cannot sleep) had resolved. On 29-Mar-2021, PAIN (Body aches), HYPERHIDROSIS (Heavy Perspiration), THIRST (Extremely thirsty) and CHILLS (Chills) had resolved. At the time of the report, COVID-19 (COVID-19 like symptoms) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test (other-Unknown): had IgM and IgG antibodies. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information include androgen Treatment information included Tylenol .

Other Meds: ANDROGEL

Current Illness:

ID: 1631826
Sex: F
Age: 32
State: OK

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 08/25/2021
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: nose bleed; coughing up blood; Bad headache; vaccination site pain; pyrexia; Pain traveled to neck and head; body pain; migraine; Could hardly walk for three days; Felt sick; Burning felt throughout body; Burning arm traveling to neck and face; Sore arm after first dose; Fever of 102 degrees fahrenheit; Muscle soreness; Muscle and joint pain; Muscle and joint pain; Tingling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (coughing up blood), PARAESTHESIA (Tingling), MIGRAINE (migraine), GAIT DISTURBANCE (Could hardly walk for three days) and ILLNESS (Felt sick) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anemia, Red blood cell count decreased and White blood cell count increased. Concurrent medical conditions included Drug allergy and Bee sting hypersensitivity. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PARAESTHESIA (Tingling), GAIT DISTURBANCE (Could hardly walk for three days), ILLNESS (Felt sick), BURNING SENSATION (Burning felt throughout body), PAIN IN EXTREMITY (Burning arm traveling to neck and face), PAIN IN EXTREMITY (Sore arm after first dose), PYREXIA (Fever of 102 degrees fahrenheit), MYALGIA (Muscle soreness), ARTHRALGIA (Muscle and joint pain) and MYALGIA (Muscle and joint pain). On 30-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (migraine), PAIN (Pain traveled to neck and head), PAIN (body pain), PYREXIA (pyrexia), HEADACHE (Bad headache) and VACCINATION SITE PAIN (vaccination site pain). On 31-Mar-2021, the patient experienced HAEMOPTYSIS (coughing up blood) and EPISTAXIS (nose bleed). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, HAEMOPTYSIS (coughing up blood), PARAESTHESIA (Tingling), MIGRAINE (migraine), GAIT DISTURBANCE (Could hardly walk for three days), ILLNESS (Felt sick), BURNING SENSATION (Burning felt throughout body), PAIN IN EXTREMITY (Burning arm traveling to neck and face), PAIN IN EXTREMITY (Sore arm after first dose), EPISTAXIS (nose bleed), PAIN (Pain traveled to neck and head), PAIN (body pain), PYREXIA (Fever of 102 degrees fahrenheit), PYREXIA (pyrexia), MYALGIA (Muscle soreness), ARTHRALGIA (Muscle and joint pain), MYALGIA (Muscle and joint pain), HEADACHE (Bad headache) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. elevated white blood cell, low red blood cell, and anemic. Concomitant medications were not provided.

Other Meds:

Current Illness: Bee sting hypersensitivity; Drug allergy

ID: 1631827
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: blood blisters in my mouth; swollen white tongue; swollen white tongue; difficult to eat; there is pain; This spontaneous case was reported by a consumer and describes the occurrence of ORAL BLOOD BLISTER (blood blisters in my mouth), SWOLLEN TONGUE (swollen white tongue), TONGUE DISCOLOURATION (swollen white tongue), EATING DISORDER (difficult to eat) and PAIN (there is pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ORAL BLOOD BLISTER (blood blisters in my mouth), SWOLLEN TONGUE (swollen white tongue), TONGUE DISCOLOURATION (swollen white tongue), EATING DISORDER (difficult to eat) and PAIN (there is pain). This case was linked to MOD-2021-024310 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: NNI.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1631828
Sex: M
Age:
State: FL

Vax Date: 03/16/2021
Onset Date: 03/17/2021
Rec V Date: 08/25/2021
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: Couldn't eat nor drink anything; Nauseous for a period of 8-10 hours; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (Couldn't eat nor drink anything) and NAUSEA (Nauseous for a period of 8-10 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced EATING DISORDER (Couldn't eat nor drink anything) and NAUSEA (Nauseous for a period of 8-10 hours). On 17-Mar-2021, EATING DISORDER (Couldn't eat nor drink anything) and NAUSEA (Nauseous for a period of 8-10 hours) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1631829
Sex: F
Age: 44
State:

Vax Date: 03/06/2021
Onset Date: 03/14/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: rash on the arm where she received the vaccine; This spontaneous case was reported by a physician and describes the occurrence of RASH (rash on the arm where she received the vaccine) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced RASH (rash on the arm where she received the vaccine). On 16-Mar-2021, RASH (rash on the arm where she received the vaccine) had resolved. Not Provided 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.

Other Meds:

Current Illness:

ID: 1631830
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. 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 RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1631831
Sex: M
Age: 54
State: NJ

Vax Date: 03/12/2021
Onset Date: 04/01/2021
Rec V Date: 08/25/2021
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: similar symptoms (of COVID); I have a Covid, result came yesterday; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I have a Covid, result came yesterday) and COVID-19 (similar symptoms (of COVID)) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced COVID-19 (I have a Covid, result came yesterday). On an unknown date, the patient experienced COVID-19 (similar symptoms (of COVID)). At the time of the report, COVID-19 (I have a Covid, result came yesterday) and COVID-19 (similar symptoms (of COVID)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications medication were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1631832
Sex: F
Age: 78
State:

Vax Date: 03/29/2021
Onset Date: 04/02/2021
Rec V Date: 08/25/2021
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: Pain at the injection site/Tenderness at the injection site (left arm); muscle pain; joint pain; headaches; migraine; neck pain "like snapping a rubber band"; a pain in the face nerve like "bell palsy" which caused a brief 20 second paralysis but was not a bell palsy; a redness on the muscle area/a red line around the arm; Swelling; fatigue; chills; Feels a very nasty taste when is gargling and brushing the teeth.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site/Tenderness at the injection site (left arm)), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headaches) and MIGRAINE (migraine) 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. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site/Tenderness at the injection site (left arm)), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headaches), MIGRAINE (migraine), NECK PAIN (neck pain "like snapping a rubber band"), FACIAL PAIN (a pain in the face nerve like "bell palsy" which caused a brief 20 second paralysis but was not a bell palsy), ERYTHEMA (a redness on the muscle area/a red line around the arm), SWELLING (Swelling), FATIGUE (fatigue), CHILLS (chills) and TASTE DISORDER (Feels a very nasty taste when is gargling and brushing the teeth.). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site/Tenderness at the injection site (left arm)), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headaches), MIGRAINE (migraine), NECK PAIN (neck pain "like snapping a rubber band"), FACIAL PAIN (a pain in the face nerve like "bell palsy" which caused a brief 20 second paralysis but was not a bell palsy), ERYTHEMA (a redness on the muscle area/a red line around the arm), SWELLING (Swelling), FATIGUE (fatigue), CHILLS (chills) and TASTE DISORDER (Feels a very nasty taste when is gargling and brushing the teeth.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant and Treatment medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1631833
Sex: F
Age: 63
State: GA

Vax Date: 03/24/2021
Onset Date: 03/30/2021
Rec V Date: 08/25/2021
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: Soreness around the injection site; Itchiness around the injection site; Swelling around the injection site; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039a21a) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Cholesterol. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Soreness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication includes blood pressure medication, cholesterol medication, and supplements.

Other Meds:

Current Illness: Cholesterol; Hypertension

ID: 1631834
Sex: M
Age:
State: OH

Vax Date: 03/07/2021
Onset Date: 03/14/2021
Rec V Date: 08/25/2021
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: Tested positive for Covid 7 days after the 1st dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid 7 days after the 1st dose of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid 7 days after the 1st dose of the Moderna vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid 7 days after the 1st dose of the Moderna vaccine) 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. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1631835
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 08/25/2021
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: Headache; Fatigue; Pain in armpit; Sore throat; This spontaneous case was reported by a physician and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), FATIGUE (Fatigue) and AXILLARY PAIN (Pain in armpit) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (allergic to Topamax.). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and AXILLARY PAIN (Pain in armpit). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), FATIGUE (Fatigue) and AXILLARY PAIN (Pain in armpit) 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. Concomitant medications includes Water pill for blood pressure. treatment information includes Cough drops, Lozenges, Took lots of water.

Other Meds:

Current Illness: Drug allergy (allergic to Topamax.)

ID: 1631836
Sex: M
Age:
State: GA

Vax Date: 03/16/2021
Onset Date: 03/30/2021
Rec V Date: 08/25/2021
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: Indigestion; tired easily; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Indigestion), FATIGUE (tired easily) and DYSPNOEA (difficulty breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DYSPEPSIA (Indigestion), FATIGUE (tired easily) and DYSPNOEA (difficulty breathing). The patient was treated with CITRIC ACID, SODIUM BICARBONATE (ALKA-SELTZER HEARTBURN RELIEF) from 30-Mar-2021 to 03-Apr-2021 for Indigestion, at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (Indigestion), FATIGUE (tired easily) and DYSPNOEA (difficulty breathing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment: Alka-Seltzer or Alka-Seltzer plus Concomitants were not provided.

Other Meds:

Current Illness:

ID: 1631837
Sex: F
Age: 79
State: AR

Vax Date: 03/10/2021
Onset Date: 03/21/2021
Rec V Date: 08/25/2021
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: sore arm; Fever 100.6 degree temperature; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (Shivers) and PYREXIA (Fever 100.6 degree temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced CHILLS (Shivers). On 01-Apr-2021, the patient experienced PYREXIA (Fever 100.6 degree temperature). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (Shivers) and PYREXIA (Fever 100.6 degree temperature) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment details were not reported by the reporter. This case was linked to MOD-2021-066171 (Patient Link).

Other Meds:

Current Illness:

ID: 1631838
Sex: F
Age: 24
State: CA

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 08/25/2021
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: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). On 02-Apr-2021, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment products information was provided.

Other Meds:

Current Illness:

ID: 1631839
Sex: F
Age:
State: AR

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 08/25/2021
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: sore arm; feeling sick; very nauseous/queasy feeling; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (feeling sick), NAUSEA (very nauseous/queasy feeling) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (feeling sick), NAUSEA (very nauseous/queasy feeling) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (feeling sick), NAUSEA (very nauseous/queasy feeling) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1631840
Sex: F
Age: 31
State: GA

Vax Date: 03/26/2021
Onset Date: 03/27/2021
Rec V Date: 08/25/2021
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: injection site area was itching really bad; red splotchiness; injection site red splotchiness; feverish; injection site was firm; injection site pain; headache; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PRURITUS (injection site area was itching really bad) and VACCINATION SITE RASH (red splotchiness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included ETODOLAC and CANNABIDIOL, CANNABIS SATIVA SEED OIL, MEDIUM-CHAIN TRIGLYCERIDES (CBD CANNABIDIOL HANFOEL EXTRAKT) for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site pain), HEADACHE (headache) and FATIGUE (fatigue). On 02-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (injection site area was itching really bad), VACCINATION SITE RASH (red splotchiness), VACCINATION SITE ERYTHEMA (injection site red splotchiness), PYREXIA (feverish) and VACCINATION SITE SWELLING (injection site was firm). At the time of the report, VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PRURITUS (injection site area was itching really bad), VACCINATION SITE RASH (red splotchiness), VACCINATION SITE ERYTHEMA (injection site red splotchiness), PYREXIA (feverish) and VACCINATION SITE SWELLING (injection site was firm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.

Other Meds: ETODOLAC; CBD CANNABIDIOL HANFOEL EXTRAKT

Current Illness:

ID: 1631841
Sex: F
Age: 78
State: IL

Vax Date: 02/27/2021
Onset Date: 03/27/2021
Rec V Date: 08/25/2021
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: Difficulty breathing; multiple red, hot, itchy lumps at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) and VACCINATION SITE ERYTHEMA (multiple red, hot, itchy lumps at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 038K20A) for COVID-19 vaccination. Concurrent medical conditions included COPD. Concomitant products included WARFARIN, ATORVASTATIN, METOPROLOL and PARACETAMOL (TYLENOL) for an unknown indication. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing) and VACCINATION SITE ERYTHEMA (multiple red, hot, itchy lumps at the injection site). At the time of the report, DYSPNOEA (Difficulty breathing) and VACCINATION SITE ERYTHEMA (multiple red, hot, itchy lumps at the injection site) was resolving. Concomitant medications taken were Heart medication No treatment medications were reported Action taken with mRNA-1273 in response to the events were Not Applicable

Other Meds: WARFARIN; ATORVASTATIN; METOPROLOL; TYLENOL

Current Illness:

ID: 1631842
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Warm Transferred from Moderna Customer Care Case No.00135704. HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to : Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses Lot no 027B21A 100 doses Lot no 030B21A 100 doses Lot No 02B21A 140 doses HCP said that 63 doses were administered to 63 Patients. She provided all requested information of patients who received the effected Vaccine. This case was linked to MOD21-068792, MOD21-068791, MOD21-068620, MOD21-068645, MOD21-068696, MOD21-068788, MOD21-068703, MOD21-068705, MOD21-068707, MOD21-068709, MOD21-068711, MOD21-068713, MOD21-068716, MOD21-068786, MOD21-068717, MOD21-068718, MOD21-068718, MOD21-068721, MOD21-068722, MOD21-068723, MOD21-068724, MOD21-068727, MOD21-068729, MOD21-068731, MOD21-068732, MOD21-068733, MOD21-068734, MOD21-068735, MOD21-068736, MOD21-068738, MOD21-068785, MOD21-068739, MOD21-068768, MOD21-068769, MOD21-068770, MOD21-068771, MOD21-068772, MOD21-068773, MOD21-068774, MOD21-068775, MOD21-068776, MOD21-068778, MOD21-068780, MOD21-068781, MOD21-068782, MOD21-068783, MOD21-068784 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: MOD21-068792: MOD21-068791: MOD21-068620: MOD21-068645: MOD21-068696: MOD21-068788: MOD21-068703: MOD21-068705: MOD21-068707: MOD21-068709: MOD21-068711: MOD21-068713: MOD21-068716: MOD21-068786: MOD21-068717: MOD21-068718: MOD21-068718: MOD21-068721: MOD21-068722: MOD21-068723: MOD21-068724: MOD21-068727: MOD21-068729: MOD21-068731: MOD21-068732: MOD21-068733: MOD21-068734: MOD21-068735: MOD21-068736: MOD21-068738: MOD21-068785: MOD21-068739: MOD21-068768: MOD21-068769: MOD21-068770: MOD21-068771: MOD21-068772: MOD21-068773: MOD21-068774: MOD21-068775: MOD21-068776: MOD21-068778: MOD21-068780: MOD21-068781: MOD21-068782: MOD21-068783: MOD21-068784:

Other Meds:

Current Illness:

ID: 1631843
Sex: F
Age: 80
State: NY

Vax Date: 02/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: burning sensation over the skin in lower extremities on both sides; pain in extremity; Vaccination site pain; burning sensation over the skin underneath both arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain in extremity), VACCINATION SITE PAIN (Vaccination site pain), SKIN BURNING SENSATION (burning sensation over the skin underneath both arms) and BURNING SENSATION (burning sensation over the skin in lower extremities on both sides) in an 80-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 No adverse event. On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in extremity), VACCINATION SITE PAIN (Vaccination site pain) and SKIN BURNING SENSATION (burning sensation over the skin underneath both arms). On an unknown date, the patient experienced BURNING SENSATION (burning sensation over the skin in lower extremities on both sides). On 08-Mar-2021, PAIN IN EXTREMITY (pain in extremity) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. At the time of the report, SKIN BURNING SENSATION (burning sensation over the skin underneath both arms) and BURNING SENSATION (burning sensation over the skin in lower extremities on both sides) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. concomitant medications provided was Atorvastatin,blood pressure medication Treatment information provided was Tylenol.

Other Meds: ATORVASTATIN

Current Illness:

ID: 1631844
Sex: F
Age: 66
State:

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 08/25/2021
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: diarrhea; little energy, very tired; wants to lie down all the time; can't get a meal down; little energy, very tired; annoying headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ASTHENIA (little energy, very tired), HYPOKINESIA (wants to lie down all the time), EATING DISORDER (can't get a meal down) and FATIGUE (little energy, very tired) in a 66-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 Cancer since 2014, Chronic obstructive pulmonary disease and Heart disease, unspecified. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced DIARRHOEA (diarrhea), ASTHENIA (little energy, very tired), HYPOKINESIA (wants to lie down all the time), EATING DISORDER (can't get a meal down), FATIGUE (little energy, very tired) and HEADACHE (annoying headache). At the time of the report, DIARRHOEA (diarrhea), ASTHENIA (little energy, very tired), HYPOKINESIA (wants to lie down all the time), EATING DISORDER (can't get a meal down), FATIGUE (little energy, very tired) and HEADACHE (annoying headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No relevant concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness: Cancer; Chronic obstructive pulmonary disease; Heart disease, unspecified

ID: 1631845
Sex: F
Age: 59
State: TX

Vax Date: 03/26/2021
Onset Date: 03/27/2021
Rec V Date: 08/25/2021
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: achy; just did not feel good; redness and puffiness are still present; It looks like a knot; soreness; redness and puffiness are still present; Swollen, red, and itchy; very itchy; Swollen, red, and itchy; Swollen, red, and itchy; headache; body chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), MALAISE (just did not feel good), SKIN SWELLING (redness and puffiness are still present), MASS (It looks like a knot) and PAIN (soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Egg allergy and Drug allergy (codeine). On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (achy), MALAISE (just did not feel good), SKIN SWELLING (redness and puffiness are still present), MASS (It looks like a knot), PAIN (soreness), ERYTHEMA (redness and puffiness are still present), ERYTHEMA (Swollen, red, and itchy), PRURITUS (very itchy), PRURITUS (Swollen, red, and itchy), SWELLING (Swollen, red, and itchy), HEADACHE (headache) and CHILLS (body chills). On 28-Mar-2021, PAIN (achy), MALAISE (just did not feel good), HEADACHE (headache) and CHILLS (body chills) had resolved. At the time of the report, SKIN SWELLING (redness and puffiness are still present), MASS (It looks like a knot), PAIN (soreness), ERYTHEMA (redness and puffiness are still present), ERYTHEMA (Swollen, red, and itchy), PRURITUS (very itchy), PRURITUS (Swollen, red, and itchy) and SWELLING (Swollen, red, and itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness: Drug allergy (codeine); Egg allergy

ID: 1631846
Sex: F
Age: 49
State: CA

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication information was provided This case was linked to MOD21-068791, MOD21-068788, MOD21-068620, MOD21-068645, MOD21-068696, MOD21-068786, MOD21-068703, MOD21-068705, MOD21-068707, MOD21-068709, MOD21-068711, MOD21-068713, MOD21-068716, MOD21-068785, MOD21-068717, MOD21-068718, MOD21-068721, MOD21-068722, MOD21-068723, MOD21-068724, MOD21-068727, MOD21-068729, MOD21-068731, MOD21-068732, MOD21-068733, MOD21-068734, MOD21-068735, MOD21-068736, MOD21-068738, MOD21-068784, MOD21-068739, MOD21-068768, MOD21-068769, MOD21-068770, MOD21-068771, MOD21-068772, MOD21-068774, MOD21-068775, MOD21-068776, MOD21-068778, MOD21-068780, MOD21-068781, MOD21-068782, MOD21-068783 (E2B Linked Report).; Sender's Comments: MOD21-068791: MOD21-068788: MOD21-068620: MOD21-068645: MOD21-068696: MOD21-068786: MOD21-068703: MOD21-068705: MOD21-068707: MOD21-068709: MOD21-068711: MOD21-068713: MOD21-068716: MOD21-068785: MOD21-068717: MOD21-068718: MOD21-068721: MOD21-068722: MOD21-068723: MOD21-068724: MOD21-068727: MOD21-068729: MOD21-068731: MOD21-068732: MOD21-068733: MOD21-068734: MOD21-068735: MOD21-068736: MOD21-068738: MOD21-068784: MOD21-068739: MOD21-068768: MOD21-068769: MOD21-068770: MOD21-068771: MOD21-068772: MOD21-068774: MOD21-068775: MOD21-068776: MOD21-068778: MOD21-068780: MOD21-068781: MOD21-068782: MOD21-068783:

Other Meds:

Current Illness:

ID: 1631847
Sex: F
Age: 63
State: LA

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/25/2021
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: FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (FEVER). At the time of the report, PYREXIA (FEVER) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. Relevant concomitant medications included, Blood pressure medications were reported. Treatment information was not provided.

Other Meds:

Current Illness: Hypertension

ID: 1631848
Sex: F
Age: 20
State: CA

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 08/25/2021
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: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. Not Provided 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. On 02 Apr 2021 that they had power outage and vials were in Freezer and Refrigerator where temperature dropped to : Frozen Vaccine 47Minutes minus 13.79 C Refrigerator 59 Minutes 12 C No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments: MOD21-068620:crosslinked

Other Meds:

Current Illness:

ID: 1631849
Sex: M
Age: 49
State: FL

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/25/2021
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: "little stabbing pain" in his heart; Swelling in the armpit up to his nipple area; Sore Injection Site; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN ("little stabbing pain" in his heart), PYREXIA (Fever), HEADACHE (Headache), AXILLARY PAIN (Swelling in the armpit up to his nipple area) and VACCINATION SITE PAIN (Sore Injection Site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore Injection Site). On 03-Apr-2021, the patient experienced CHEST PAIN ("little stabbing pain" in his heart) and AXILLARY PAIN (Swelling in the armpit up to his nipple area). At the time of the report, CHEST PAIN ("little stabbing pain" in his heart), PYREXIA (Fever), HEADACHE (Headache), AXILLARY PAIN (Swelling in the armpit up to his nipple area) and VACCINATION SITE PAIN (Sore Injection Site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1631850
Sex: F
Age: 59
State: FL

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 20210402; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: fever of 101.7F

Allergies:

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

Symptoms: patient cannot move; flu like symptoms; chest pain; scratchy throat; nausea; fever; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (patient cannot move), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST PAIN (chest pain), THROAT IRRITATION (scratchy throat) and NAUSEA (nausea) in a 59-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 Lupus syndrome (the patient has lupus.). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced MOVEMENT DISORDER (patient cannot move), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST PAIN (chest pain), THROAT IRRITATION (scratchy throat), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle ache). At the time of the report, MOVEMENT DISORDER (patient cannot move), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST PAIN (chest pain), THROAT IRRITATION (scratchy throat), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle ache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101.7 (Inconclusive) fever of 101.7F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information provided. List of concomitant medication were not given. This case was linked to MOD-2021-118963 (Patient Link).

Other Meds:

Current Illness:

ID: 1631851
Sex: F
Age: 74
State: PA

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 08/25/2021
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: Rash at injection site rash; Injection site redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash at injection site rash) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at injection site rash) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE RASH (Rash at injection site rash) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information included Ibuprofen, aspirin and applied cool packs on the injections site.

Other Meds:

Current Illness:

ID: 1631852
Sex: M
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
Hospital: Y

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

Lab Data: Test Name: Coronary Angiogram; Result Unstructured Data: revealed complete occlusion of the LC artery; Test Name: Coronary angiography; Result Unstructured Data: CT coronary angiography showed a large amount of noncalcified plaque in the proximal LC artery, resulting in complete focal occlusion just proximal to the origin of first obtuse marginal artery. Coronary angiography in the catheterization laboratory revealed a 90% stenosis in the proximal LC artery with TIMI 1 flow.; Test Name: Angiogram; Test Result: Inconclusive; Result Unstructured Data: angiogram showed an excellent result with TIMI III flow; Test Name: BMI; Test Result: Inconclusive; Result Unstructured Data: 42.8 kg/m2; Test Name: LVEF; Test Result: Inconclusive; Result Unstructured Data: 50%; Test Name: Cardiac ultrasound; Result Unstructured Data: Cardiac ultrasound showed left ventricular ejection fraction of 60%, with hypokinetic inferior and inferolateral walls.; Test Name: PCI Vessel; Test Result: Inconclusive; Result Unstructured Data: LC; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: Peak Troponin; Test Result: Inconclusive; Result Unstructured Data: 1763 ng/L; Test Name: Troponin; Test Result: Inconclusive; Result Unstructured Data: elevated Troponin with no significant ECG change; Test Name: Ultrasensitive troponin-I; Result Unstructured Data: 9,200 ng/L; Test Name: Troponin-T; Result Unstructured Data: high-sensitivity troponin-T rose was from 723 ng/L to 1763 ng/L.

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Acute Myocardial Infarction; Injection site pain from the vaccination but was otherwise asymptomatic; Chest pain; Shoulder pain; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Acute Myocardial Infarction), VACCINATION SITE PAIN (Injection site pain from the vaccination but was otherwise asymptomatic), CHEST PAIN (Chest pain) and ARTHRALGIA (Shoulder pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Acute myocardial infarction within 24 hours after COVID-19 vaccination. 2021;S0002-9149(21):00631-7 The patient's past medical history included Percutaneous coronary intervention (The patient had no more chest pain after PCI and remained hemodynamically stable) and Catheterization arterial. Family history included Coronary artery disease since an unknown date. Concurrent medical conditions included Hyperlipidemia. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACUTE MYOCARDIAL INFARCTION (Acute Myocardial Infarction) (seriousness criteria hospitalization and medically significant), VACCINATION SITE PAIN (Injection site pain from the vaccination but was otherwise asymptomatic) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and ARTHRALGIA (Shoulder pain) (seriousness criterion hospitalization). At the time of the report, ACUTE MYOCARDIAL INFARCTION (Acute Myocardial Infarction) and VACCINATION SITE PAIN (Injection site pain from the vaccination but was otherwise asymptomatic) outcome was unknown and CHEST PAIN (Chest pain) and ARTHRALGIA (Shoulder pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiocardiogram: abnormal (abnormal) revealed complete occlusion of the LC artery and LC 90% (abnormal) CT coronary angiography showed a large amount of noncalcified plaque in the proximal LC artery, resulting in complete focal occlusion just proximal to the origin of first obtuse marginal artery. Coronary angiography in the catheterization laboratory revealed a 90% stenosis in the proximal LC artery with TIMI 1 flow.. On an unknown date, Angiogram: final (Inconclusive) angiogram showed an excellent result with TIMI III flow. On an unknown date, Body mass index: 42.8 (Inconclusive) 42.8 kg/m2. On an unknown date, Ejection fraction: 50 (Inconclusive) 50%. On an unknown date, Electrocardiogram: cardiac ultrasound showed (abnormal) Cardiac ultrasound showed left ventricular ejection fraction of 60%, with hypokinetic inferior and inferolateral walls.. On an unknown date, Percutaneous coronary intervention: LC (Inconclusive) LC. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Troponin: 1763 ng/l (Inconclusive) 1763 ng/L and elevated (Inconclusive) elevated Troponin with no significant ECG change. On an unknown date, Troponin I (0-47): 9,200 ng/l (abnormal) 9,200 ng/L. On an unknown date, Troponin T (0-14): 723 ng/l (High) high-sensitivity troponin-T rose was from 723 ng/L to 1763 ng/L. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ACUTE MYOCARDIAL INFARCTION (Acute Myocardial Infarction), VACCINATION SITE PAIN (Injection site pain from the vaccination but was otherwise asymptomatic), CHEST PAIN (Chest pain) and ARTHRALGIA (Shoulder pain) to be possibly related. Concomitant medications were not provided by the reporter. The patient presented with 4 days of chest and shoulder pain. Symptoms started the night after he had his first dose of COVID-19 vaccine (mRNA-1273). He woke up from sleep with sharp, intense chest pain that radiated to the jaw. Symptoms slightly improved but remained for 4 more days, and he finally presented to an outside hospital. Interval (hours) between vaccine injection and Chest pain was less than 12 hours. Emergency PCI of the LC artery was performed. A workhorse wire was used to cross the lesion. The lesion was dilated with a 2.5 mm x 12 mm semi compliant balloon. A 3.0 mm x 18 mm zotarolimus eluting stent was deployed to treat the lesion and was optimized with a 3.5 mm x 12 mm noncompliant balloon. He was initiated on guideline-directed medical therapy and discharged home 2 days later. Company Comment: Based on the current available information and temporal association between the use of the product and the start of events (according to information in the article), a causal relationship cannot be excluded. Patient's age and previous history of hyperlipidemia and prior coronary artery disease can be confounders. This case was linked to MOD-2021-290625 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start of events (according to information in the article), a causal relationship cannot be excluded. Patient's age and previous history of hyperlipidemia and prior coronary artery disease can be confounders.

Other Meds:

Current Illness: Coronary artery disease; Hyperlipidemia

ID: 1631916
Sex: F
Age: 24
State:

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 08/25/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

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

Symptoms: Tingling lips; Burning lips; Swelling of injection site; Tenderness of injection site; Burning sensation; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (Burning sensation), PARAESTHESIA ORAL (Tingling lips), ORAL DISCOMFORT (Burning lips), INJECTION SITE SWELLING (Swelling of injection site) and INJECTION SITE PAIN (Tenderness of injection site) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. Concurrent medical conditions included Premature atrial contraction, Post concussion syndrome, Chronic migraine, Tendinitis (around right ankle), Drug allergy (codeine (suicidal ideation)), Topical adhesive allergy (rash) and Contrast media allergy (generalized delayed rash). On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced BURNING SENSATION (Burning sensation), ORAL DISCOMFORT (Burning lips), INJECTION SITE SWELLING (Swelling of injection site) and INJECTION SITE PAIN (Tenderness of injection site). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling lips). At the time of the report, BURNING SENSATION (Burning sensation), PARAESTHESIA ORAL (Tingling lips) and ORAL DISCOMFORT (Burning lips) was resolving and INJECTION SITE SWELLING (Swelling of injection site) and INJECTION SITE PAIN (Tenderness of injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness: Chronic migraine; Contrast media allergy (generalized delayed rash); Drug allergy (codeine (suicidal ideation)); Post concussion syndrome; Premature atrial contraction; Tendinitis (around right ankle)

ID: 1631920
Sex: F
Age:
State: FL

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional AEs; a 7-year-old female patient was mistakenly mixed up with an older female patient that had similar names and was administered GARDASIL 9 in error; a 7-year-old female patient was mistakenly mixed up with an older female patient that had similar names and was administered GARDASIL 9 in error; This spontaneous report was received from a healthcare business professional (described also as an administrator) via a Company representative and refers to a 7-year-old female patient. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided. On 19-AUG-2021, the patient was mistakenly mixed up with an older female patient that had similar names and was inadvertently vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 time dose (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration, wrong patient received product). No adverse event was reported.

Other Meds:

Current Illness:

ID: 1631921
Sex: U
Age:
State: KY

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 08/25/2021
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: No additional AE/PQC's reported; excursions vaccine was administered to patients; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided. On 20-AUG-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot # T002847, expiration date23-JAN-2022 (dose number, dose and route of administration were not reported) for prophylaxis. The vaccine was stored improperly in the temperature between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (13.5 F) for the time frame of 57 minutes, and between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (7.3 F) for the time frame of 15 minutes. There was no previous temperature excursion. No adverse event was reported. This is one of two reports from the same source.; Sender's Comments: US-009507513-2108USA006421:

Other Meds:

Current Illness:

ID: 1631922
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: had the 2 shot vaccine / shingles/suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient had the shingles vaccine and got the shingles. The patient stated it did not do him/her any good to get vaccinated and he/she got shingles anyway. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1631923
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: I had both shingles shots. I still get shingles/ suspected Vaccination Failure; I still get shingles, not bad, but I do break out in the same place every time.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported. The patient had both shingles shots and still got shingles, not bad, but it broke out in the same place every time. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1631924
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: HAD THE SHOT AND STILL GOT THEM/Suspected Vaccination Failure; HAD THE SHOT AND STILL GOT THEM; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported. The patient had the shot and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1631925
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I had the shot and still had the shingles/ Suspected Vaccination Failure; I had the shot and still had the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported. The reported had the shot and still had the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1631926
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Suspected Vaccination Failure; had the shots and I still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The case was reported by patient himself or herself. The age at vaccination was not reported. The patient had the shots and still got shingles. The patient's doctor said it was mild case because the patient had the shots. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1631927
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: so sick; was that awful; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of illness (received 1st dose on an unknown date and experienced illness and felt awful, refer case US2021AMR176096). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and feeling bad. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness and feeling bad were unknown. It was unknown if the reporter considered the sickness and feeling bad to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2nd shot and was so sick and experienced severe side effects. The patient said he/she would not do that again. The patient said he/she would never had taken the shots if his/her body would react, it was awful.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176096:Same reporter

Other Meds:

Current Illness:

ID: 1631928
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Genital herpes outbreaks; Increased genital herpes outbreaks after both doses; This case was reported by a nurse via call center representative and described the occurrence of genital herpes in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included genital herpes. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced genital herpes and condition aggravated. On an unknown date, the outcome of the genital herpes and condition aggravated were recovered/resolved. It was unknown if the reporter considered the genital herpes and condition aggravated to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient felt increased genital herpes outbreaks after receiving the dose of Shingrix vaccine. The reporter was unable to provide. Adverse event information other than gender. The reporter consented to follow up. For the tolerance of 2nd dose, refer case US2021AMR176145, reported by the same reporter. The case is linked to the case US2021AMR177309 and US2021AMR177313 reported by the same reporter for different patients.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176145:Same reporter. US-GLAXOSMITHKLINE-US2021AMR177309:Same reporter. Pt2 - 1st dose. US-GLAXOSMITHKLINE-US2021AMR177313:Same reporter. Pt2 - 2nd dose.

Other Meds:

Current Illness: Genital herpes

ID: 1631929
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Genital herpes outbreaks; Increased genital herpes outbreaks after both doses; This case was reported by a nurse via call center representative and described the occurrence of genital herpes in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of genital herpes (1st dose received on an unknown date and experienced increased genital herpes outbreaks). Concurrent medical conditions included genital herpes. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced genital herpes and condition aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the genital herpes and condition aggravated were unknown. It was unknown if the reporter considered the genital herpes and condition aggravated to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient experienced increased genital herpes outbreaks after receiving the dose of Shingrix vaccine. The reporter did not have any other information except patient's gender. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176130:Same reporter. US-GLAXOSMITHKLINE-US2021AMR177309:Same reporter. Pt2 - 1st dose. US-GLAXOSMITHKLINE-US2021AMR177313:Same reporter. Pt2 - 2nd dose.

Other Meds:

Current Illness: Genital herpes

ID: 1631930
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient himself or herself. The age at vaccination was not reported. The patient stated that the he/she received shingles shot and experienced shingles 2 times. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1631931
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shot and 3 years later now had shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1631932
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: suspected vaccination failure; still got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1631933
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Suspected Vaccination failure; shingles on my forehead / shingles over my eye visits to eye Dr, to make sure it did not get into eye/ Shingles shot gave me shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shot and then a little small amount of the shingles on the forehead over the eye. The patient visited the eye doctor to make sure it did not get into eye. The patient stated that shingles shot gave him/ her shingles, and to not listen to this add. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am