VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1551835
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 08/13/2021
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: chills, blisters in my mouth; chills, blisters in my mouth; bright red face; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills, blisters in my mouth), GINGIVAL BLISTER (chills, blisters in my mouth) and ERYTHEMA (bright red face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills, blisters in my mouth), GINGIVAL BLISTER (chills, blisters in my mouth) and ERYTHEMA (bright red face). At the time of the report, CHILLS (chills, blisters in my mouth), GINGIVAL BLISTER (chills, blisters in my mouth) and ERYTHEMA (bright red face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1551836
Sex: F
Age: 69
State: TX

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
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: 2 inches of red circle around the injection site; it has been hot; around the injection site has been sore; around the injection site has been swollen; around the injection site has been itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (2 inches of red circle around the injection site), INJECTION SITE WARMTH (it has been hot), INJECTION SITE PAIN (around the injection site has been sore), INJECTION SITE SWELLING (around the injection site has been swollen) and INJECTION SITE PRURITUS (around the injection site has been itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (2 inches of red circle around the injection site), INJECTION SITE WARMTH (it has been hot), INJECTION SITE PAIN (around the injection site has been sore), INJECTION SITE SWELLING (around the injection site has been swollen) and INJECTION SITE PRURITUS (around the injection site has been itchy). The patient was treated with LORATADINE (CLARITINE) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, INJECTION SITE ERYTHEMA (2 inches of red circle around the injection site), INJECTION SITE WARMTH (it has been hot), INJECTION SITE PAIN (around the injection site has been sore), INJECTION SITE SWELLING (around the injection site has been swollen) and INJECTION SITE PRURITUS (around the injection site has been itchy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received

Other Meds:

Current Illness:

ID: 1551837
Sex: M
Age: 74
State: ME

Vax Date: 01/22/2021
Onset Date: 01/29/2021
Rec V Date: 08/13/2021
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: extreme itching on his lower legs,little itching on his ankles and feet; rash spread on most of his body,mild rash on his ankles and feet; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (extreme itching on his lower legs,little itching on his ankles and feet) and RASH (rash spread on most of his body,mild rash on his ankles and feet) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No medical history was updated by reporter. Concomitant products included CHOLESTEROL for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (extreme itching on his lower legs,little itching on his ankles and feet) and RASH (rash spread on most of his body,mild rash on his ankles and feet). At the time of the report, PRURITUS (extreme itching on his lower legs,little itching on his ankles and feet) and RASH (rash spread on most of his body,mild rash on his ankles and feet) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products included medicine for blood pressure. Treatment included antihistamines, a steroid cream and a Benadryl cream.

Other Meds: CHOLESTEROL

Current Illness:

ID: 1551838
Sex: F
Age: 56
State: NY

Vax Date: 01/12/2021
Onset Date: 01/20/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Tested positive for COVID-19 after first dose; Sore throat; Headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after first dose), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after first dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after first dose), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test positive: (Positive) COVID-antigen PCR-Positive. 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. Treatment medication include Acetaminophen. No concomitant medications were provided by reporter.

Other Meds:

Current Illness:

ID: 1551839
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: rosacea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ROSACEA (rosacea) 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 Rosacea. 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 ROSACEA (rosacea). The patient was treated with DOXYCYCLINE for Rosacea, at a dose of 1 dosage form. At the time of the report, ROSACEA (rosacea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1551840
Sex: F
Age: 73
State: NJ

Vax Date: 12/28/2020
Onset Date: 01/25/2021
Rec V Date: 08/13/2021
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: achy; local injection site reaction with itching; local injection site reaction with redness; local injection site reaction with swelling about walnut size; She felt fatigued; queasy; as soreness in her joints which was worse than her baseline; She has also felt feverish and chilled; chilled/shivering; pain in her injection arm; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (She felt fatigued), NAUSEA (queasy), ARTHRALGIA (as soreness in her joints which was worse than her baseline), PYREXIA (She has also felt feverish and chilled) and CHILLS (chilled/shivering) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Fatigue, Depressed state and Surgery on 07-Dec-2020. Concurrent medical conditions included UTI and Hypertension. Concomitant products included VALSARTAN for Hypertension, LEVOTHYROXINE for an unknown indication. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced FATIGUE (She felt fatigued), NAUSEA (queasy), ARTHRALGIA (as soreness in her joints which was worse than her baseline), PYREXIA (She has also felt feverish and chilled), CHILLS (chilled/shivering), VACCINATION SITE PAIN (pain in her injection arm), INJECTION SITE PRURITUS (local injection site reaction with itching), INJECTION SITE ERYTHEMA (local injection site reaction with redness) and INJECTION SITE SWELLING (local injection site reaction with swelling about walnut size). On an unknown date, the patient experienced MYALGIA (achy). The patient was treated with Bed rest (AND PUSHING LIQUIDS) for Fatigue; Bed rest (AND PUSHING LIQUIDS) for Nausea; Bed rest (AND PUSHING LIQUIDS) for Arthralgia; Bed rest (AND PUSHING LIQUIDS) for Pyrexia; Bed rest (AND PUSHING LIQUIDS) for Chills and Bed rest (AND PUSHING LIQUIDS) for Vaccination site pain. At the time of the report, FATIGUE (She felt fatigued), NAUSEA (queasy), ARTHRALGIA (as soreness in her joints which was worse than her baseline), PYREXIA (She has also felt feverish and chilled), CHILLS (chilled/shivering), VACCINATION SITE PAIN (pain in her injection arm), MYALGIA (achy), INJECTION SITE PRURITUS (local injection site reaction with itching), INJECTION SITE ERYTHEMA (local injection site reaction with redness) and INJECTION SITE SWELLING (local injection site reaction with swelling about walnut size) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications included Antibiotics. This case was linked to MOD-2021-072822 (Patient Link).

Other Meds: LEVOTHYROXINE; VALSARTAN

Current Illness: Hypertension; UTI

ID: 1551841
Sex: F
Age: 51
State: CA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 08/13/2021
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: white blood cells and plackets were low; white blood cells and plackets were low; Pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (white blood cells and plackets were low), PLATELET COUNT DECREASED (white blood cells and plackets were low) and PAIN IN EXTREMITY (Pain in her arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm). On 14-Jan-2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (white blood cells and plackets were low) and PLATELET COUNT DECREASED (white blood cells and plackets were low). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, WHITE BLOOD CELL COUNT DECREASED (white blood cells and plackets were low), PLATELET COUNT DECREASED (white blood cells and plackets were low) and PAIN IN EXTREMITY (Pain in her arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Platelet count: (Low) Low. On 14-Jan-2021, White blood cell count: (Low) Low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided.

Other Meds:

Current Illness:

ID: 1551842
Sex: U
Age: 76
State: CA

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Injection site Rash about 3"; Minor injection site Itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Injection site Rash about 3") and INJECTION SITE PRURITUS (Minor injection site Itching) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (Injection site Rash about 3") and INJECTION SITE PRURITUS (Minor injection site Itching). At the time of the report, INJECTION SITE RASH (Injection site Rash about 3") and INJECTION SITE PRURITUS (Minor injection site Itching) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Relevant concomitant medications were not reported. Treatment information was provided as diphenhydramine. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1551843
Sex: F
Age: 84
State: TX

Vax Date: 01/20/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
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: became anemic; had a urinary tract infection; became weaker; lost a lot of weight but has regained\ hasn't gained much weight; dehydration; lack of taste; never got her second vaccination/More than 35 days since the first shot was given; Sleepy; Wasn't eating and drinking; extreme fatigue/ extreme tiredness/very very tired/she was very tired; Feeling Lethargic; feeling cold; dark yellow urine; no bowel movement; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Feeling Lethargic), FEELING COLD (feeling cold), CHROMATURIA (dark yellow urine), CONSTIPATION (no bowel movement) and ANAEMIA (became anemic) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cardiovascular disease, unspecified and Blood pressure high. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), CLOPIDOGREL BISULFATE (PLAVIX), AMLODIPINE and SIMVASTATIN for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced LETHARGY (Feeling Lethargic), FEELING COLD (feeling cold), CHROMATURIA (dark yellow urine), CONSTIPATION (no bowel movement), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced ANAEMIA (became anemic), URINARY TRACT INFECTION (had a urinary tract infection), ASTHENIA (became weaker), WEIGHT DECREASED (lost a lot of weight but has regained\ hasn't gained much weight), DEHYDRATION (dehydration), AGEUSIA (lack of taste), PRODUCT DOSE OMISSION ISSUE (never got her second vaccination/More than 35 days since the first shot was given), FATIGUE (extreme fatigue/ extreme tiredness/very very tired/she was very tired), SOMNOLENCE (Sleepy) and EATING DISORDER (Wasn't eating and drinking). At the time of the report, LETHARGY (Feeling Lethargic), FEELING COLD (feeling cold), CHROMATURIA (dark yellow urine), CONSTIPATION (no bowel movement), ANAEMIA (became anemic), URINARY TRACT INFECTION (had a urinary tract infection), ASTHENIA (became weaker), WEIGHT DECREASED (lost a lot of weight but has regained\ hasn't gained much weight), DEHYDRATION (dehydration), AGEUSIA (lack of taste), PYREXIA (fever), CHILLS (chills), FATIGUE (extreme fatigue/ extreme tiredness/very very tired/she was very tired), SOMNOLENCE (Sleepy) and EATING DISORDER (Wasn't eating and drinking) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (never got her second vaccination/More than 35 days since the first shot was given) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 99.3 (Inconclusive) Temperature was 99.3 degree Fahrenheit. On 04-Feb-2021, SARS-CoV-2 test: negative (Negative) Tested negative with rapid test. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not reported. For mRNA-1273(Moderna COVID-19 Vaccine )(intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-101750 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: New events added.Reporter denied consent for further follow up. On 08-Jul-2021: Significant follow-up appended into AER MOD-2021-021003

Other Meds: LIPITOR; PLAVIX; AMLODIPINE; SIMVASTATIN

Current Illness: Blood pressure high; Cardiovascular disease, unspecified

ID: 1551844
Sex: F
Age:
State: TX

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 08/13/2021
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: tiredness x5 days; muscle tension in her neck/ muscle tension in her back/ muscle tension in her jaw; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (muscle tension in her neck/ muscle tension in her back/ muscle tension in her jaw) and FATIGUE (tiredness x5 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Lung cancer. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced MUSCLE TIGHTNESS (muscle tension in her neck/ muscle tension in her back/ muscle tension in her jaw). On 08-Jan-2021, the patient experienced FATIGUE (tiredness x5 days). At the time of the report, MUSCLE TIGHTNESS (muscle tension in her neck/ muscle tension in her back/ muscle tension in her jaw) and FATIGUE (tiredness x5 days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication and treatment information were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1551845
Sex: F
Age:
State: MD

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 08/13/2021
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: Sick; Psoriasis flare up; Joint pain; Fever; Fatigue; Extreme nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), PSORIASIS (Psoriasis flare up), ARTHRALGIA (Joint pain), PYREXIA (Fever) and FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Psoriasis. On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick), PSORIASIS (Psoriasis flare up), ARTHRALGIA (Joint pain), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Extreme nausea). At the time of the report, ILLNESS (Sick), PSORIASIS (Psoriasis flare up), ARTHRALGIA (Joint pain), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Extreme nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment and concomitant medications were not provided by reporter. This case was linked to US-MODERNATX, INC.-MOD-2021-021756, US-MODERNATX, INC.-MOD-2021-021756 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-021756: US-MODERNATX, INC.-MOD-2021-021756:Crosslinked (MOD21-021976)

Other Meds:

Current Illness: Psoriasis

ID: 1551846
Sex: F
Age:
State: NC

Vax Date: 01/22/2021
Onset Date: 01/29/2021
Rec V Date: 08/13/2021
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: Swollen lymph nodes in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in left arm). The patient was treated with Manual therapy (Cold compresses) for Vaccination site lymphadenopathy. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in left arm) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1551847
Sex: F
Age: 72
State: NY

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 08/13/2021
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: had little circle with small lymph on it at injection site on her left arm; approx 5-6 days later the following week the redness started to spread from topical side and past; hard to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (had little circle with small lymph on it at injection site on her left arm), VACCINATION SITE ERYTHEMA (approx 5-6 days later the following week the redness started to spread from topical side and past) and INDURATION (hard to touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 immunization. The patient's past medical history included Multiple sclerosis (from last 40 years). On 15-Jan-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 LYMPHADENOPATHY (had little circle with small lymph on it at injection site on her left arm), VACCINATION SITE ERYTHEMA (approx 5-6 days later the following week the redness started to spread from topical side and past) and INDURATION (hard to touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (had little circle with small lymph on it at injection site on her left arm), VACCINATION SITE ERYTHEMA (approx 5-6 days later the following week the redness started to spread from topical side and past) and INDURATION (hard to touch) 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. Concomitant medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1551848
Sex: F
Age: 75
State: NC

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/13/2021
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: brief moment in several parts of my body, (like a pin prick); very short term memory lapses, (may be age related.); sore arm; Raised blood pressure; hot flash from feet to head; Adrenaline rush; tingling in her feet / tingling in hands; Numbness in her fingers; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Raised blood pressure), HOT FLUSH (hot flash from feet to head), EPINEPHRINE INCREASED (Adrenaline rush), PARAESTHESIA (tingling in her feet / tingling in hands) and HYPOAESTHESIA (Numbness in her fingers) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 027K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anxiety disorder, Type 2 diabetes mellitus since 06-Apr-1999, Arthritis, Gluten free diet, Epinephrine and Penicillin allergy. Concomitant products included LEVOTHYROXINE and ALPRAZOLAM for Anxiety, METFORMIN, INSULIN DETEMIR (LEVEMIR) and INSULIN ASPART (NOVOLOG) for Diabetes, ZOLPIDEM for Insomnia, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced HYPERTENSION (Raised blood pressure), HOT FLUSH (hot flash from feet to head), EPINEPHRINE INCREASED (Adrenaline rush), PARAESTHESIA (tingling in her feet / tingling in hands) and HYPOAESTHESIA (Numbness in her fingers). On an unknown date, the patient experienced PAIN (brief moment in several parts of my body, (like a pin prick)), AMNESIA (very short term memory lapses, (may be age related.)) and PAIN IN EXTREMITY (sore arm). The patient was treated with ATENOLOL for Blood pressure high, at a dose of 25 mg. On 12-Jan-2021, HYPERTENSION (Raised blood pressure) had resolved. At the time of the report, HOT FLUSH (hot flash from feet to head), EPINEPHRINE INCREASED (Adrenaline rush), PARAESTHESIA (tingling in her feet / tingling in hands), HYPOAESTHESIA (Numbness in her fingers), PAIN (brief moment in several parts of my body, (like a pin prick)), AMNESIA (very short term memory lapses, (may be age related.)) and PAIN IN EXTREMITY (sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Blood pressure measurement: 190/110 (High) 190/110, 170/110 (High) 170/110 and 140/90 (High) 140/90. On 12-Jan-2021, Blood test: normal (normal) Normal. On 12-Jan-2021, Electrocardiogram: normal (normal) Normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERTENSION (Raised blood pressure) to be possibly related. No further causality assessments were provided for HOT FLUSH (hot flash from feet to head), EPINEPHRINE INCREASED (Adrenaline rush), PARAESTHESIA (tingling in her feet / tingling in hands), HYPOAESTHESIA (Numbness in her fingers), PAIN (brief moment in several parts of my body, (like a pin prick)), AMNESIA (very short term memory lapses, (may be age related.)) and PAIN IN EXTREMITY (sore arm). No treatment of events other then for raised blood pressure was reported. Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: ADR Form was received. Follow-up included address, height, weight, race, new events, and Dose 2 information

Other Meds: LEVOTHYROXINE; PRESERVISION; METFORMIN; LEVEMIR; NOVOLOG; ZOLPIDEM; ALPRAZOLAM

Current Illness: Anxiety disorder; Arthritis; Epinephrine; Penicillin allergy; Type 2 diabetes mellitus

ID: 1551849
Sex: M
Age: 59
State: WI

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 08/13/2021
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: Nerve pain in shoulder; Arm weakness; Soreness was getting worse daily; Having trouble raising arm; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain in shoulder), ASTHENIA (Arm weakness), PAIN (Soreness was getting worse daily) and LIMB DISCOMFORT (Having trouble raising arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (Nerve pain in shoulder), ASTHENIA (Arm weakness), PAIN (Soreness was getting worse daily) and LIMB DISCOMFORT (Having trouble raising arm). At the time of the report, NEURALGIA (Nerve pain in shoulder), ASTHENIA (Arm weakness), PAIN (Soreness was getting worse daily) and LIMB DISCOMFORT (Having trouble raising arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1551850
Sex: M
Age:
State: CA

Vax Date: 01/12/2021
Onset Date: 01/14/2020
Rec V Date: 08/13/2021
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: Shaking; Excruciating migraine; Whole body is freezing; felt Cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Shaking), FEELING COLD (felt Cold), MIGRAINE (Excruciating migraine) and CHILLS (Whole body is freezing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2020, the patient experienced FEELING COLD (felt Cold). On 14-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Shaking), MIGRAINE (Excruciating migraine) and CHILLS (Whole body is freezing). On 15-Jan-2021, MIGRAINE (Excruciating migraine) had resolved. At the time of the report, TREMOR (Shaking), FEELING COLD (felt Cold) and CHILLS (Whole body is freezing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information include patient Health Care Provider told her to take Benadryl. Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: NNI

Other Meds:

Current Illness:

ID: 1551851
Sex: F
Age: 83
State: IN

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 08/13/2021
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: rash over arms,The area has grown and now cover the upper arm and even down the elbow,it covers 3/4 of the arm and the only thing that doesn't cover is the inside of the arm.; tingly feeling; itchy; still has the tingly feeling, that called itchy before; the center is more pink and not so warm to the touch; feels like small bubbles under the skin; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash over arms,The area has grown and now cover the upper arm and even down the elbow,it covers 3/4 of the arm and the only thing that doesn't cover is the inside of the arm.), PARAESTHESIA (tingly feeling), PRURITUS (itchy), PARAESTHESIA (still has the tingly feeling, that called itchy before) and RASH ERYTHEMATOUS (the center is more pink and not so warm to the touch) in an 83-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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash over arms,The area has grown and now cover the upper arm and even down the elbow,it covers 3/4 of the arm and the only thing that doesn't cover is the inside of the arm.), PARAESTHESIA (tingly feeling), PRURITUS (itchy), PARAESTHESIA (still has the tingly feeling, that called itchy before), RASH ERYTHEMATOUS (the center is more pink and not so warm to the touch) and ECZEMA (feels like small bubbles under the skin). At the time of the report, RASH (rash over arms,The area has grown and now cover the upper arm and even down the elbow,it covers 3/4 of the arm and the only thing that doesn't cover is the inside of the arm.), PARAESTHESIA (tingly feeling), PRURITUS (itchy), PARAESTHESIA (still has the tingly feeling, that called itchy before), RASH ERYTHEMATOUS (the center is more pink and not so warm to the touch) and ECZEMA (feels like small bubbles under the skin) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1551852
Sex: F
Age: 72
State: WV

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
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: Very bad swelling around their neck/very severe/swelling came down a little but it is still swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Very bad swelling around their neck/very severe/swelling came down a little but it is still swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced SWELLING (Very bad swelling around their neck/very severe/swelling came down a little but it is still swollen). At the time of the report, SWELLING (Very bad swelling around their neck/very severe/swelling came down a little but it is still swollen) had not resolved. 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:

Current Illness:

ID: 1551853
Sex: F
Age: 48
State: AZ

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/13/2021
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: Feeling tired; t's hard to breath; Get's agitated a lot; Back pain when she lays down; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Feeling tired), DYSPNOEA (t's hard to breath), AGITATION (Get's agitated a lot) and BACK PAIN (Back pain when she lays down) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. no medical history is provided and concomitant drugs are provided. Concomitant products included PREGABALIN, LEVOTHYROXINE SODIUM (EUTHYROX), ASCORBIC ACID (VIT C), ZINC and FISH OIL for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced FATIGUE (Feeling tired), DYSPNOEA (t's hard to breath), AGITATION (Get's agitated a lot) and BACK PAIN (Back pain when she lays down). At the time of the report, FATIGUE (Feeling tired), DYSPNOEA (t's hard to breath), AGITATION (Get's agitated a lot) and BACK PAIN (Back pain when she lays down) 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.

Other Meds: PREGABALIN; EUTHYROX; VIT C; ZINC; FISH OIL.

Current Illness:

ID: 1551854
Sex: F
Age:
State:

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
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: Severe sciatic pain; Unable to move; Felt like her sciatic nerve was inflamed; This spontaneous case was reported by a nurse and describes the occurrence of SCIATICA (Severe sciatic pain), HYPOKINESIA (Unable to move) and PERIPHERAL NERVE LESION (Felt like her sciatic nerve was inflamed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced SCIATICA (Severe sciatic pain), HYPOKINESIA (Unable to move) and PERIPHERAL NERVE LESION (Felt like her sciatic nerve was inflamed). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, SCIATICA (Severe sciatic pain) had not resolved and HYPOKINESIA (Unable to move) and PERIPHERAL NERVE LESION (Felt like her sciatic nerve was inflamed) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. concomitant medications were not provided. Treatment for the event included kept putting ice, cold compress, heat.

Other Meds:

Current Illness:

ID: 1551855
Sex: F
Age: 78
State: AZ

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 08/13/2021
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: Diarrhoea; Hurts all over body; Temperature 100.4; Fatigue; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), PAIN (Hurts all over body), PYREXIA (Temperature 100.4), FATIGUE (Fatigue) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fibromyalgia. Concomitant products included MARIJUANA and FENTANYL (FENTANYL PATCH) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced DIARRHOEA (Diarrhoea), PAIN (Hurts all over body), PYREXIA (Temperature 100.4), FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint pain). On 24-Jan-2021, DIARRHOEA (Diarrhoea), PYREXIA (Temperature 100.4), FATIGUE (Fatigue) and CHILLS (Chills) had resolved. At the time of the report, PAIN (Hurts all over body) and ARTHRALGIA (Joint pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, COVID-19: (Negative) negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment of the events included, Imodium for diarrhea and marijuana for pain. This case was linked to MOD-2021-098719 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up information was received on 28 Apr 2021, contains NNI

Other Meds: MARIJUANA; FENTANYL PATCH

Current Illness: Fibromyalgia

ID: 1551856
Sex: F
Age: 79
State: FL

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
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: Patient started experiencing dizziness; Noticed her arm was swollen at the injection site; Noticed her arm was red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Patient started experiencing dizziness), VACCINATION SITE SWELLING (Noticed her arm was swollen at the injection site) and VACCINATION SITE ERYTHEMA (Noticed her arm was red at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LCHD) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included CELECOXIB (CELEBREX) for an unknown indication. On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Noticed her arm was swollen at the injection site) and VACCINATION SITE ERYTHEMA (Noticed her arm was red at the injection site). On 28-Jan-2021, the patient experienced DIZZINESS (Patient started experiencing dizziness). The patient was treated with PARACETAMOL (TYLENOL) on 27-Jan-2021 for Adverse event, at a dose of two tylenol. At the time of the report, DIZZINESS (Patient started experiencing dizziness), VACCINATION SITE SWELLING (Noticed her arm was swollen at the injection site) and VACCINATION SITE ERYTHEMA (Noticed her arm was red at the injection site) outcome was unknown. Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medication.

Other Meds: CELEBREX

Current Illness:

ID: 1551857
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: Patient had a very bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Patient had a very bad reaction) 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 (No medical history reported.). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Patient had a very bad reaction). At the time of the report, ADVERSE DRUG REACTION (Patient had a very bad reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1551858
Sex: M
Age: 57
State: AZ

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 08/13/2021
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: Upper body rash on neck shoulders, upper arms and parts of my back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Upper body rash on neck shoulders, upper arms and parts of my back) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Upper body rash on neck shoulders, upper arms and parts of my back). At the time of the report, RASH (Upper body rash on neck shoulders, upper arms and parts of my back) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: DOB was updated

Other Meds:

Current Illness:

ID: 1551859
Sex: F
Age: 74
State: NC

Vax Date: 01/17/2021
Onset Date: 01/25/2021
Rec V Date: 08/13/2021
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: soreness at injection site; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE PAIN (soreness at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at injection site). On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at injection site). At the time of the report, VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Follow up received on 18-Apr-2021 with no new information and patient not interested in Follow up.

Other Meds:

Current Illness:

ID: 1551860
Sex: F
Age: 73
State: GA

Vax Date: 01/11/2021
Onset Date: 01/21/2021
Rec V Date: 08/13/2021
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: left side of my face got numb; injection site arm developed a rsh; arm was flaming red from shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (left side of my face got numb), VACCINATION SITE RASH (injection site arm developed a rsh) and VACCINATION SITE ERYTHEMA (arm was flaming red from shoulder) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The patient's past medical history included Surgery (It was in that same arm.) in 2017. Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PARAESTHESIA (left side of my face got numb), VACCINATION SITE RASH (injection site arm developed a rsh) and VACCINATION SITE ERYTHEMA (arm was flaming red from shoulder). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK dosage form. At the time of the report, PARAESTHESIA (left side of my face got numb) had not resolved and VACCINATION SITE RASH (injection site arm developed a rsh) and VACCINATION SITE ERYTHEMA (arm was flaming red from shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other treatment medications include an ANTIBIOTIC, and a ANTIHISTAMINE prescribed by the doctor. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Updated outcome of event left side of my face got numb. Consent to FU denied.

Other Meds: EPIPEN

Current Illness:

ID: 1551861
Sex: F
Age: 70
State: TX

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
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: Facial flushing; Temperature of 99.9F; Discomfort at top of head; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Facial flushing), BODY TEMPERATURE INCREASED (Temperature of 99.9F), HEAD DISCOMFORT (Discomfort at top of head) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced FLUSHING (Facial flushing), BODY TEMPERATURE INCREASED (Temperature of 99.9F), HEAD DISCOMFORT (Discomfort at top of head) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 28-Jan-2021, FLUSHING (Facial flushing) and BODY TEMPERATURE INCREASED (Temperature of 99.9F) had resolved. At the time of the report, HEAD DISCOMFORT (Discomfort at top of head) and HEADACHE (Headache) 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. Concomitant medications were not provided. This case was linked to MOD-2021-090085 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received and contains :Outcome was updated for event Headache : the event was said to be resolved upon using Paracetamol. And patient was taken 2nd dose of Vaccine and still had sore arm

Other Meds:

Current Illness:

ID: 1551862
Sex: M
Age:
State: MS

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/13/2021
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: Fever; Body ache; chills; body ache; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (chills), MYALGIA (body ache), PYREXIA (Fever) and PAIN (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CHILLS (chills), MYALGIA (body ache) and PAIN (Body ache). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, CHILLS (chills), MYALGIA (body ache), PYREXIA (Fever) and PAIN (Body ache) outcome was unknown. Not Provided No treatment information provided.

Other Meds:

Current Illness:

ID: 1551863
Sex: F
Age: 70
State: MI

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/13/2021
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: Face started to flush; Sick to her stomach; Did not sleep or feel well; Did not sleep or feel well; Aches and pains throughout her body; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face started to flush), ABDOMINAL PAIN UPPER (Sick to her stomach), SLEEP DEFICIT (Did not sleep or feel well), FEELING ABNORMAL (Did not sleep or feel well) and MYALGIA (Aches and pains throughout her body) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FLUSHING (Face started to flush), ABDOMINAL PAIN UPPER (Sick to her stomach), SLEEP DEFICIT (Did not sleep or feel well), FEELING ABNORMAL (Did not sleep or feel well), MYALGIA (Aches and pains throughout her body) and HEADACHE (Bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 03-Feb-2021, FLUSHING (Face started to flush) had resolved. On 05-Feb-2021, ABDOMINAL PAIN UPPER (Sick to her stomach), SLEEP DEFICIT (Did not sleep or feel well), FEELING ABNORMAL (Did not sleep or feel well), MYALGIA (Aches and pains throughout her body) and HEADACHE (Bad headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1551864
Sex: M
Age: 42
State: NJ

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
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: Itching in the Waist Line; Hives around his waistline; Headache on the back of head; Elevated Blood Pressure; stressed out; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in the Waist Line), URTICARIA (Hives around his waistline), HEADACHE (Headache on the back of head), BLOOD PRESSURE INCREASED (Elevated Blood Pressure) and STRESS (stressed out) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PRURITUS (Itching in the Waist Line), URTICARIA (Hives around his waistline), HEADACHE (Headache on the back of head), BLOOD PRESSURE INCREASED (Elevated Blood Pressure) and STRESS (stressed out). At the time of the report, PRURITUS (Itching in the Waist Line), URTICARIA (Hives around his waistline), HEADACHE (Headache on the back of head), BLOOD PRESSURE INCREASED (Elevated Blood Pressure) and STRESS (stressed out) outcome was unknown. Not Provided No treatment information was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1551865
Sex: M
Age: 78
State: GA

Vax Date: 01/26/2021
Onset Date: 01/29/2021
Rec V Date: 08/13/2021
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: COVID-19; Sore throat; Runny nose; Diarrhea; Coughing; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021. The most recent information was received on 05-Feb-2021 and was forwarded to Moderna on an unknown date. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COVID-19 (COVID-19) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The patient's past medical history included Heart disorder on 01-Mar-2021. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose). On 03-Feb-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with AZITHROMYCIN at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: positive (Positive) positive. On 18-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. 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 were reported as Xarelto, Sotalol and OTC Vitamin in description. Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19 and mRNA-1273 use is assessed as not applicable. The other events are in consistence with COVID-19 infection. Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Upon internal review on 22-Jul-2021, dose 2 removed (not received, only scheduled), Vaccine derived SARS-CoV-2 infection removed, COVID-19 event added, updated action taken to unknown.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19 and mRNA-1273 use is assessed as not applicable. The other events are in consistence with COVID-19 infection.

Other Meds:

Current Illness:

ID: 1551866
Sex: F
Age: 72
State:

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
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: experienced significant reaction; fever; nausea; muscle aches; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (experienced significant reaction), PYREXIA (fever), NAUSEA (nausea), MYALGIA (muscle aches) and PAIN IN EXTREMITY (sore right arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 virus test positive and Asthma. Concurrent medical conditions included Adhesive tape allergy. Concomitant products included OMALIZUMAB (XOLAIR) for Asthma. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ADVERSE EVENT (experienced significant reaction), PYREXIA (fever), NAUSEA (nausea), MYALGIA (muscle aches) and PAIN IN EXTREMITY (sore right arm). At the time of the report, ADVERSE EVENT (experienced significant reaction), PYREXIA (fever), NAUSEA (nausea), MYALGIA (muscle aches) and PAIN IN EXTREMITY (sore right arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatments were reported. Reporter did not allow further contact

Other Meds: XOLAIR

Current Illness:

ID: 1551867
Sex: F
Age: 79
State: CO

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Swollen arm, like a big ball; swollen arm, like a big ball; arm was red and hot to the touch; arm was red and hot to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE MASS (Arm like a big ball), ERYTHEMA (Arm red) and FEELING HOT (Arm hot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (tetracycline) and Diabetes. Concomitant products included INSULIN for Diabetes. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE MASS (Arm like a big ball) and ERYTHEMA (Arm red). 23-Jan-2021, the patient experienced FEELING HOT (Arm hot). The patient was treated with Physical therapy (Put ice on arm) for Feeling hot. At the time of the report, PERIPHERAL SWELLING (Swollen arm) had resolved and VACCINATION SITE MASS (Arm like a big ball), ERYTHEMA (Arm red) and FEELING HOT (Arm hot) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that one hour after the vaccination the patient had a swollen arm, like a big ball, and the arm was red and hot to the touch. Symptoms were still ongoing. The physician advised to put ice on it. The concomitant medications were not provided. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-May-2021 contains information regarding outcome of the events.

Other Meds: INSULIN

Current Illness: Diabetes; Drug allergy (tetracycline)

ID: 1551868
Sex: F
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/13/2021
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: Migraine headache completely disappeared; Warm fairly short lived rush; A Spontaneous report was received from a consumer concerning an unknown year-old, (unknown gender) patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced therapeutic response unexpected and feeling hot/sensation of warmth. The patient's medical history was not provided .The concomitant medications were reported as multiple other prescribed medications. On 15 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route in an unknown location for prophylaxis of COVID-19 infection. It was reported that the patient had on and off migraine for about a week .On 15 Jan 2021, after seven minutes of vaccine administration patient developed a short lived rush of warmth. The patient was concerned that if it was a negative side effect from the vaccine. About 40 minutes later patient's headache completely disappeared. The patient took no other medications for treatment even though was consuming some other prescribed medications daily.Patient reported feeling better now with no side effects. No treatment medication was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events short lived warmth rush and migraine disappeared were considered as recovered.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1551869
Sex: F
Age: 72
State: NV

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: thickening of my tongue; itchy; lower intestines rumbled; arms felt heavy; Patient has not had second dose; Thowing up/Threw up that night; Felt like boiling water pouring down arm; Super tired; Felt dizzy; Arm and fingers felt sluggish for the day; Horrible migraine; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (thickening of my tongue), PRURITUS (itchy), GASTROINTESTINAL SOUNDS ABNORMAL (lower intestines rumbled), LIMB DISCOMFORT (arms felt heavy) and DIZZINESS (Felt dizzy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Allergy NOS (History of bad allergies (unspecified)). On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DIZZINESS (Felt dizzy), SLUGGISHNESS (Arm and fingers felt sluggish for the day), MIGRAINE (Horrible migraine), VOMITING (Thowing up/Threw up that night), VACCINATION SITE PAIN (Felt like boiling water pouring down arm) and FATIGUE (Super tired). On an unknown date, the patient experienced TONGUE DISORDER (thickening of my tongue), PRURITUS (itchy), GASTROINTESTINAL SOUNDS ABNORMAL (lower intestines rumbled), LIMB DISCOMFORT (arms felt heavy) and PRODUCT DOSE OMISSION ISSUE (Patient has not had second dose). On 26-Jan-2021, MIGRAINE (Horrible migraine) and FATIGUE (Super tired) had resolved. At the time of the report, TONGUE DISORDER (thickening of my tongue), PRURITUS (itchy), GASTROINTESTINAL SOUNDS ABNORMAL (lower intestines rumbled), LIMB DISCOMFORT (arms felt heavy), DIZZINESS (Felt dizzy), SLUGGISHNESS (Arm and fingers felt sluggish for the day), VOMITING (Thowing up/Threw up that night) and VACCINATION SITE PAIN (Felt like boiling water pouring down arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not had second dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Concomitant medications and treatment information was not provided. The patient has not gotten the second dose. She is afraid of having the second dose. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Based on the current available information and strong temporal association between the use of the product and the start date of the event, and excluding all other etiologies, a causal relationship cannot be excluded. Tiredness, vaccination site pain and vomiting are consistent with the known safety profile of the vaccine. Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Follow-up information received captured additional adverse events, medical history and reporter details.; Reporter's Comments: Based on the current available information and strong temporal association between the use of the product and the start date of the event, and excluding all other etiologies, a causal relationship cannot be excluded. Tiredness, vaccination site pain and vomiting are consistent with the known safety profile of the vaccine.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1551870
Sex: M
Age:
State: TX

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
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: soreness. He attributes this to his walking a lot; This spontaneous case was reported by a physician and describes the occurrence of PAIN (soreness. He attributes this to his walking a lot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History was provided by the reporter. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (soreness. He attributes this to his walking a lot). At the time of the report, PAIN (soreness. He attributes this to his walking a lot) outcome was unknown. Not Provided 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. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Updated reporter type to physician, Health care professional yes, email address added.

Other Meds:

Current Illness:

ID: 1551871
Sex: M
Age: 83
State: OH

Vax Date: 01/22/2021
Onset Date: 01/26/2021
Rec V Date: 08/13/2021
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: little bumps in skull both on the side and top of head were bleeding; upper left side of chest red spots; On upper left side of his chest he had red spots, they were itchy; little bumps up in skull both on the side and top of head; itchy rash left top of chest; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (little bumps in skull both on the side and top of head were bleeding), RASH ERYTHEMATOUS (upper left side of chest red spots), PRURITUS (On upper left side of his chest he had red spots, they were itchy), RASH (little bumps up in skull both on the side and top of head) and RASH PRURITIC (itchy rash left top of chest) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History was provided by the reporter. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), OCTREOTIDE ACETATE (SANDOSTATIN), LISINOPRIL, LEVOTHYROXINE and ACETAMINOPHEN for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SKIN HAEMORRHAGE (little bumps in skull both on the side and top of head were bleeding), RASH ERYTHEMATOUS (upper left side of chest red spots), PRURITUS (On upper left side of his chest he had red spots, they were itchy), RASH (little bumps up in skull both on the side and top of head) and RASH PRURITIC (itchy rash left top of chest). The patient was treated with TRIAMCINOLONE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, SKIN HAEMORRHAGE (little bumps in skull both on the side and top of head were bleeding), PRURITUS (On upper left side of his chest he had red spots, they were itchy) and RASH (little bumps up in skull both on the side and top of head) outcome was unknown and RASH ERYTHEMATOUS (upper left side of chest red spots) and RASH PRURITIC (itchy rash left top of chest) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: New event added and details updated, reporter information were added. Treatment drug information updated. On 22-Apr-2021: NNI updated. Patient declined to provide email address or provide any additional information.

Other Meds: BABY ASPIRIN; SANDOSTATIN; LISINOPRIL; LEVOTHYROXINE; ACETAMINOPHEN.

Current Illness:

ID: 1551872
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 01/22/2021
Rec V Date: 08/13/2021
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: Headache; Nausea; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History was provided by the reporter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (Tylenol) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) had not resolved and NAUSEA (Nausea) and MYALGIA (Muscle pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant information was reported.

Other Meds:

Current Illness:

ID: 1551873
Sex: U
Age: 44
State:

Vax Date: 01/02/2021
Onset Date:
Rec V Date: 08/13/2021
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: Facial swelling; Headache; This spontaneous case was reported by a dentist and describes the occurrence of SWELLING FACE (Facial swelling) and HEADACHE (Headache) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Facial swelling) and HEADACHE (Headache). At the time of the report, SWELLING FACE (Facial swelling) and HEADACHE (Headache) had not resolved. Not Provided 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. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Additional information added on 18JUN2021 contains no significant information

Other Meds:

Current Illness:

ID: 1551874
Sex: F
Age: 74
State: GA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/13/2021
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: rash size of an orange; blotchy place size of an orange; injection site redness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm), RASH MACULAR (blotchy place size of an orange), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE RASH (rash size of an orange) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History was provided by the reporter. Concomitant products included ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) for Eye discomfort, MULTIVITAMINS [VITAMINS NOS] and ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN, MALPIGHIA GLABRA, ROSA CANINA, RUTOSIDE (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced AXILLARY PAIN (sore arm). On 25-Jan-2021, the patient experienced RASH MACULAR (blotchy place size of an orange) and VACCINATION SITE ERYTHEMA (injection site redness). On an unknown date, the patient experienced VACCINATION SITE RASH (rash size of an orange). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) for Rash, at an unspecified dose and frequency. On 15-Jan-2021, AXILLARY PAIN (sore arm) outcome was unknown. At the time of the report, RASH MACULAR (blotchy place size of an orange), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE RASH (rash size of an orange) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's concomitant medication included Heart med and Betablockers.; 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: LUTEIN +; MULTIVITAMINS [VITAMINS NOS]; VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]

Current Illness:

ID: 1551875
Sex: F
Age: 70
State: AL

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/13/2021
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: Dry mouth; Metallic taste in my mouth; Blistery on her lips; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), DYSGEUSIA (Metallic taste in my mouth) and LIP BLISTER (Blistery on her lips) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. No Medical History was provided by the reporter. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DRY MOUTH (Dry mouth), DYSGEUSIA (Metallic taste in my mouth) and LIP BLISTER (Blistery on her lips). At the time of the report, DRY MOUTH (Dry mouth), DYSGEUSIA (Metallic taste in my mouth) and LIP BLISTER (Blistery on her lips) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1551876
Sex: F
Age:
State: KS

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/13/2021
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: SARS-CoV-2 test positive; COVID-19; Sore right arm; sinus problems; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUS DISORDER (sinus problems), COVID-19 (COVID-19), VACCINATION SITE PAIN (Sore right arm) and SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced SINUS DISORDER (sinus problems) and VACCINATION SITE PAIN (Sore right arm). On 11-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive). At the time of the report, SINUS DISORDER (sinus problems) and SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive) outcome was unknown and COVID-19 (COVID-19) and VACCINATION SITE PAIN (Sore right arm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. 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. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Additional information received: Patient had declined further follow-up.; 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: 1551877
Sex: M
Age: 80
State: SC

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
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: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant information not provided. Treatment included Aspirin

Other Meds:

Current Illness:

ID: 1551878
Sex: F
Age: 60
State: MN

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/13/2021
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: swollen lymph node; Swelling; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph node) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling) and HEADACHE (Headache). On 28-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node). At the time of the report, VACCINATION SITE SWELLING (Swelling), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: NNI

Other Meds:

Current Illness:

ID: 1551879
Sex: M
Age: 61
State: CA

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 08/13/2021
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: bedridden; Did not have good balance; Diarrhea; Loss of appetite; Nausea; headache migraine; Dizziness; Head heaviness; Feeling Uncomfortable; Uneasy feeling, Felt foggy; Heart Palpitations; can't even move; can't walk; Feeling stomach upset; Sore Arm; This spontaneous case was reported by a dentist and describes the occurrence of HYPOKINESIA (can't even move), GAIT INABILITY (can't walk), BALANCE DISORDER (Did not have good balance), PALPITATIONS (Heart Palpitations) and DIZZINESS (Dizziness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Enlarged prostate and GERD. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Enlarged prostate, OMEPRAZOLE for GERD. On 12-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PALPITATIONS (Heart Palpitations) and FEELING ABNORMAL (Uneasy feeling, Felt foggy). In January 2021, the patient experienced HYPOKINESIA (can't even move), GAIT INABILITY (can't walk), ABDOMINAL DISCOMFORT (Feeling stomach upset) and VACCINATION SITE PAIN (Sore Arm). On 20-Jan-2021, the patient experienced DIZZINESS (Dizziness), HEAD DISCOMFORT (Head heaviness), DISCOMFORT (Feeling Uncomfortable) and NAUSEA (Nausea). 20-Jan-2021, the patient experienced MIGRAINE (headache migraine). On 23-Jan-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and DIARRHOEA (Diarrhea). On 27-Jan-2021, the patient experienced BALANCE DISORDER (Did not have good balance). On an unknown date, the patient experienced BEDRIDDEN (bedridden). At the time of the report, HYPOKINESIA (can't even move), GAIT INABILITY (can't walk), BALANCE DISORDER (Did not have good balance), PALPITATIONS (Heart Palpitations), DIZZINESS (Dizziness), FEELING ABNORMAL (Uneasy feeling, Felt foggy), ABDOMINAL DISCOMFORT (Feeling stomach upset), DISCOMFORT (Feeling Uncomfortable), DECREASED APPETITE (Loss of appetite), BEDRIDDEN (bedridden), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Sore Arm) outcome was unknown and HEAD DISCOMFORT (Head heaviness), MIGRAINE (headache migraine) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HEAD DISCOMFORT (Head heaviness), MIGRAINE (headache migraine) and NAUSEA (Nausea) to have an unknown relationship. No further causality assessments were provided for HYPOKINESIA (can't even move), GAIT INABILITY (can't walk), BALANCE DISORDER (Did not have good balance), PALPITATIONS (Heart Palpitations), DIZZINESS (Dizziness), FEELING ABNORMAL (Uneasy feeling, Felt foggy), ABDOMINAL DISCOMFORT (Feeling stomach upset), DISCOMFORT (Feeling Uncomfortable), DECREASED APPETITE (Loss of appetite), BEDRIDDEN (bedridden), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Sore Arm). Patient received treatment of Tylenol, Advil for heavy head, Motrin/APAP, Meclizine for head problem and fogginess, unspecified medication for migraine. Patient was also prescribed Zoloft for unspecified condition. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient information, suspect product details,concomitant medications, outcome of the events, linking term for headache migraine updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.

Other Meds: FLOMAX [TAMSULOSIN HYDROCHLORIDE]; OMEPRAZOLE

Current Illness: Enlarged prostate; GERD

ID: 1551880
Sex: F
Age: 74
State: FL

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/13/2021
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: Body really ached; arm was sore; Migraine Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine Headache), PAIN (Body really ached) and VACCINATION SITE PAIN (arm was sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. No medical history information was reported. Concomitant products included ZOLMITRIPTAN for Migraine. On 21-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MIGRAINE (Migraine Headache) and VACCINATION SITE PAIN (arm was sore). On an unknown date, the patient experienced PAIN (Body really ached). On 24-Feb-2021, MIGRAINE (Migraine Headache) had resolved. At the time of the report, PAIN (Body really ached) and VACCINATION SITE PAIN (arm was sore) had resolved. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: updated event outcome , reporter address, patient demographics.

Other Meds: ZOLMITRIPTAN

Current Illness:

ID: 1551881
Sex: F
Age:
State: FL

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 08/13/2021
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: chills; fatigue; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and MYALGIA (muscle aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue) and MYALGIA (muscle aches). At the time of the report, CHILLS (chills), FATIGUE (fatigue) and MYALGIA (muscle aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Upon in internal review on 21 May 2021, the age was corrected to unknown age. Concomitant medications were not provided. No treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1551882
Sex: F
Age:
State: MD

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 08/13/2021
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: fever; extreme nausea; fatigue; joint pain; sick; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), NAUSEA (extreme nausea), FATIGUE (fatigue), ARTHRALGIA (joint pain) and ILLNESS (sick) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), NAUSEA (extreme nausea), FATIGUE (fatigue), ARTHRALGIA (joint pain) and ILLNESS (sick). At the time of the report, PYREXIA (fever), NAUSEA (extreme nausea), FATIGUE (fatigue), ARTHRALGIA (joint pain) and ILLNESS (sick) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1551883
Sex: M
Age: 71
State: OK

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/13/2021
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: Extremely dizzy; Can't walk without falling - he is on a wheelchair; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Extremely dizzy) and GAIT DISTURBANCE (Can't walk without falling - he is on a wheelchair) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included METFORMIN for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DIZZINESS (Extremely dizzy) and GAIT DISTURBANCE (Can't walk without falling - he is on a wheelchair). At the time of the report, DIZZINESS (Extremely dizzy) and GAIT DISTURBANCE (Can't walk without falling - he is on a wheelchair) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Computerised tomogram: clear (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was prescribed steroids (unspecified) after 5 days of dizziness and walking difficulty. The reporter states that the steroids helped a little, but the patient never recovered. The patient's HCP recommended the patient receive the second dose. Unknown if the patient received.

Other Meds: METFORMIN

Current Illness:

ID: 1551884
Sex: F
Age:
State:

Vax Date: 01/27/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
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: Reaction; Bright red; Lot of heat; Very itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction), ERYTHEMA (Bright red), FEELING HOT (Lot of heat) and PRURITUS (Very itchy) 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 (No medical history reported.). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION COMPLICATION (Reaction), ERYTHEMA (Bright red), FEELING HOT (Lot of heat) and PRURITUS (Very itchy). At the time of the report, VACCINATION COMPLICATION (Reaction), ERYTHEMA (Bright red), FEELING HOT (Lot of heat) and PRURITUS (Very itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm