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: 1548300
Sex: F
Age:
State: FL

Vax Date: 02/05/2021
Onset Date: 02/12/2021
Rec V Date: 08/12/2021
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: Red rash; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. NO medical history information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen). At the time of the report, RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen) 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. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. NO medical history information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen). At the time of the report, RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen) 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.

Other Meds:

Current Illness:

ID: 1548301
Sex: F
Age: 73
State: TN

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 08/12/2021
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: Lower right back pain; Sciatic nerve acting up; A spontaneous report was received from a consumer (patient), concerning herself, a 73 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lower right back pain (back pain) and sciatic nerve acting up (sciatica). The patient's medical history was not provided. Concomitant medications were not provided. On 12 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, the patient experienced lower right back pain and sciatic nerve was acting up. The symptoms were ongoing. Treatment for the events included ibuprofen. Action taken with second dose of mRNA-1273 in response to the events was unknown. The outcome of the events, lower right back pain and sciatic nerve acting up were considered as not recovered.

Other Meds:

Current Illness:

ID: 1548302
Sex: F
Age: 65
State: VA

Vax Date: 02/13/2021
Onset Date: 02/21/2021
Rec V Date: 08/12/2021
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: Redness and Rash on injection site; Redness and Rash on injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No medical history information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No medical history information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1548303
Sex: F
Age: 79
State: AK

Vax Date: 01/21/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
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: little pain; tiny rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little pain) and RASH (tiny rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Hypertension and Glaucoma. Concomitant products included INSULIN ASPART (NOVOLOG) for Diabetes, BIMATOPROST (LUMIGAN) for Glaucoma, EZETIMIBE for Hyperlipidemia, LISINOPRIL for Hypertension. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (little pain) and RASH (tiny rash). At the time of the report, PAIN (little pain) and RASH (tiny rash) had resolved. Treatment details included, pre-medication with - 100mg vitamin C, 2 diphenhydramine, 2 naproxen and cold zinc suckers. This case was linked to MOD-2021-040433 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Events for 2nd dose added, product details added, treatment details added. On 26-Apr-2021: Reporter's email address added. On 28-Apr-2021: Additional information recieved, contact details added, patient demographics added, history added, product details added, Concomitant medication added, event outcome updated.

Other Meds: LISINOPRIL; EZETIMIBE; NOVOLOG; LUMIGAN.

Current Illness: Diabetes; Glaucoma; Hypertension.

ID: 1548304
Sex: F
Age:
State: MA

Vax Date: 02/10/2021
Onset Date: 02/19/2021
Rec V Date: 08/12/2021
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: redness around the injection site; swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swollen) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swollen). At the time of the report, INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swollen) outcome was unknown. Unknown The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment details were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1548305
Sex: F
Age: 78
State: FL

Vax Date: 01/28/2021
Onset Date: 01/30/2021
Rec V Date: 08/12/2021
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: Fell onto floor and couldn't get up/No strength at all; couldn't get off the floor; couldn't stand up or get on knees to get into chair; still had infection after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Fell onto floor and couldn't get up/No strength at all; couldn't get off the floor), DYSSTASIA (couldn't stand up or get on knees to get into chair) and URINARY TRACT INFECTION (still had infection after vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Stroke (took cholesterol medicine.). Concurrent medical conditions included Urinary tract infection (Patient was on antibiotic for urinary tract infection prior to the shot. Still had infection after vaccine so took another antibiotic.) and Liver enzyme abnormal (Patient has stopped cholesterol medicine due to high liver enzyme). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Stroke. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced ASTHENIA (Fell onto floor and couldn't get up/No strength at all; couldn't get off the floor), DYSSTASIA (couldn't stand up or get on knees to get into chair) and URINARY TRACT INFECTION (still had infection after vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 01-Feb-2021, DYSSTASIA (couldn't stand up or get on knees to get into chair) and URINARY TRACT INFECTION (still had infection after vaccine) had resolved. At the time of the report, ASTHENIA (Fell onto floor and couldn't get up/No strength at all; couldn't get off the floor) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient stated that she fell on the floor and had two people help on the floor. It had happened twice. Patient was nervous about getting the shot again but nervous about not getting it. Antibiotic for urinary tract infection was 10 days course and then cleared up. This case was linked to MOD-2021-016905, MOD-2021-016843 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Patient mentioned she got the Pfizer vaccine and not Moderna.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Liver enzyme abnormal (Patient has stopped cholesterol medicine due to high liver enzyme); Urinary tract infection (Patient was on antibiotic for urinary tract infection prior to the shot. Still had infection after vaccine so took another antibiotic.)

ID: 1548306
Sex: M
Age: 44
State: WI

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 08/12/2021
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: Chest discomfort; Back ache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest discomfort), BACK PAIN (Back ache) and NAUSEA (Nausea) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The patient's past medical history included COVID-19. On 26-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 CHEST DISCOMFORT (Chest discomfort), BACK PAIN (Back ache) and NAUSEA (Nausea). At the time of the report, CHEST DISCOMFORT (Chest discomfort), BACK PAIN (Back ache) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. No treatment information was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up document was received. It contains no new information.

Other Meds:

Current Illness:

ID: 1548307
Sex: F
Age: 47
State: MA

Vax Date: 01/11/2021
Onset Date: 01/13/2021
Rec V Date: 08/12/2021
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: Shortness of breath; Allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath) and HYPERSENSITIVITY (Allergic reaction) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma, Drug allergy (Percocet), Bee sting (Bee sting) and Allergy to chemicals (Industrial floor cleaner). Concomitant products included TRETINOIN (ADINA), SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), DULOXETINE HYDROCHLORIDE (CYMBALTA), HYDROXYCHLOROQUINE, SULFASALAZINE and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) 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 13-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Shortness of breath) and HYPERSENSITIVITY (Allergic reaction) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: updated postal code,

Other Meds: ADINA; ALBUTEROL [SALBUTAMOL SULFATE]; CYMBALTA; HYDROXYCHLOROQUINE; SULFASALAZINE; SYMBICORT

Current Illness: Allergy to chemicals (Industrial floor cleaner); Asthma; Bee sting (Bee sting); Drug allergy (Percocet)

ID: 1548308
Sex: F
Age: 65
State: NY

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/12/2021
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: rash on her belly; rash on her breasts; rash on top of her back; rash on right foot; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (rash on her belly), RASH (rash on her breasts), RASH (rash on top of her back) and RASH (rash on right foot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date, Asthma since an unknown date and Diabetes since an unknown date. Concurrent medical conditions included Drug allergy (Sulfa) and Penicillin allergy. Concomitant products included MONTELUKAST, VERAPAMIL, LOSARTAN and FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) for an unknown indication. On 04-Feb-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 INFLUENZA LIKE ILLNESS (Flu like symptoms). On 11-Feb-2021, the patient experienced RASH (rash on her belly), RASH (rash on her breasts), RASH (rash on top of her back) and RASH (rash on right foot). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved and RASH (rash on her belly), RASH (rash on her breasts), RASH (rash on top of her back) and RASH (rash on right foot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (rash on her belly), RASH (rash on her breasts), RASH (rash on top of her back) and RASH (rash on right foot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date, Asthma since an unknown date and Diabetes since an unknown date. Concurrent medical conditions included Drug allergy (Sulfa) and Penicillin allergy. Concomitant products included MONTELUKAST, VERAPAMIL, LOSARTAN and FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) for an unknown indication. On 04-Feb-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 INFLUENZA LIKE ILLNESS (Flu like symptoms). On 11-Feb-2021, the patient experienced RASH (rash on her belly), RASH (rash on her breasts), RASH (rash on top of her back) and RASH (rash on right foot). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved and RASH (rash on her belly), RASH (rash on her breasts), RASH (rash on top of her back) and RASH (rash on right foot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. No treatment details were reported.

Other Meds: MONTELUKAST; VERAPAMIL; LOSARTAN; PROAIR [FLUTICASONE PROPIONATE]

Current Illness: Asthma; Diabetes; Drug allergy (Sulfa); Hypertension; Penicillin allergy

ID: 1548309
Sex: F
Age: 65
State: CO

Vax Date: 02/13/2021
Onset Date: 02/15/2021
Rec V Date: 08/12/2021
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: swollen throat; stinging in throat; Fast Heart Beat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Fast Heart Beat), PHARYNGEAL SWELLING (swollen throat) and OROPHARYNGEAL PAIN (stinging in throat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M00A) for COVID-19 vaccination. Concurrent medical conditions included Allergy (She hasdseasonal allergies and uses an inhaler, not using it now.). Concomitant products included LEVOTHYROXINE and PARACETAMOL (TYLENOL REGULAR) for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced TACHYCARDIA (Fast Heart Beat) and OROPHARYNGEAL PAIN (stinging in throat). On 15-Feb-2021 at 6:00 AM, the patient experienced PHARYNGEAL SWELLING (swollen throat). On 15-Feb-2021, TACHYCARDIA (Fast Heart Beat) and OROPHARYNGEAL PAIN (stinging in throat) had resolved. On 15-Feb-2021 at 11:00 AM, PHARYNGEAL SWELLING (swollen throat) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Heart rate: 120 (High) she had a fast heart beat at 120/BPM. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient also stated she uses sporadic while exercising but rare; she used the inhaler when she was exercising. Patient stated she had zero reaction to the 2nd vaccine and declined having any lingering effects. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR received- Dose-1 event outcome and dose-2 info updated.

Other Meds: LEVOTHYROXINE; TYLENOL REGULAR

Current Illness: Allergy (She hasdseasonal allergies and uses an inhaler, not using it now.)

ID: 1548310
Sex: U
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 08/12/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (more intense reactions) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (more intense reactions). At the time of the report, ADVERSE EVENT (more intense reactions) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD21-033420, MOD21-033319 (E2B Linked Report).; Sender's Comments: MOD21-033420:cross link; MOD21-033319:crosslink.

Other Meds:

Current Illness:

ID: 1548311
Sex: F
Age: 79
State: CA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/12/2021
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: nausea; sick to the stomach; bad diarrhea (wet the bed); high blood pressure (224/90mmHg); headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), HYPERTENSION (high blood pressure (224/90mmHg)), NAUSEA (nausea) and ABDOMINAL DISCOMFORT (sick to the stomach) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension since an unknown date. Concomitant products included CARVEDILOL (COREG) and LISINOPRIL for an unknown indication. On 05-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 HEADACHE (headache) and CHILLS (chills). On 08-Feb-2021, the patient experienced HYPERTENSION (high blood pressure (224/90mmHg)). On 17-Feb-2021, the patient experienced NAUSEA (nausea), ABDOMINAL DISCOMFORT (sick to the stomach) and DIARRHOEA (bad diarrhea (wet the bed)). On 08-Feb-2021, HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, HYPERTENSION (high blood pressure (224/90mmHg)), NAUSEA (nausea), ABDOMINAL DISCOMFORT (sick to the stomach) and DIARRHOEA (bad diarrhea (wet the bed)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Blood pressure measurement: (High) 224/90 mmHg. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), HYPERTENSION (high blood pressure (224/90mmHg)), NAUSEA (nausea) and ABDOMINAL DISCOMFORT (sick to the stomach) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension since an unknown date. Concomitant products included CARVEDILOL (COREG) and LISINOPRIL for an unknown indication. On 05-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 HEADACHE (headache) and CHILLS (chills). On 08-Feb-2021, the patient experienced HYPERTENSION (high blood pressure (224/90mmHg)). On 17-Feb-2021, the patient experienced NAUSEA (nausea), ABDOMINAL DISCOMFORT (sick to the stomach) and DIARRHOEA (bad diarrhea (wet the bed)). On 08-Feb-2021, HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, HYPERTENSION (high blood pressure (224/90mmHg)), NAUSEA (nausea), ABDOMINAL DISCOMFORT (sick to the stomach) and DIARRHOEA (bad diarrhea (wet the bed)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Blood pressure measurement: (High) 224/90 mmHg. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds: COREG; LISINOPRIL

Current Illness: Hypertension

ID: 1548312
Sex: F
Age: 67
State: IN

Vax Date: 02/09/2021
Onset Date: 02/16/2021
Rec V Date: 08/12/2021
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: Warm to the touch Injection Site; Red Rash on the Injection Site; swollen injection site; Red Rash on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE RASH (Red Rash on the Injection Site), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No medical history information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE RASH (Red Rash on the Injection Site), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site). At the time of the report, INJECTION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE RASH (Red Rash on the Injection Site), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information was received, events outcome was updated to recovered.

Other Meds:

Current Illness:

ID: 1548313
Sex: M
Age: 72
State: SC

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 08/12/2021
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: pain in the right artificial knee.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in the right artificial knee.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The patient's past medical history included Knee replacement since an unknown date. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced ARTHRALGIA (pain in the right artificial knee.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form, qd. At the time of the report, ARTHRALGIA (pain in the right artificial knee.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: On 03-MAY-2021 a follow up was received which contained no new information.

Other Meds:

Current Illness: Knee replacement

ID: 1548314
Sex: F
Age:
State: FL

Vax Date: 02/10/2021
Onset Date: 02/17/2021
Rec V Date: 08/12/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling around the injection site), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE PAIN (painful around the injection site) and VACCINATION SITE PRURITUS (itches around the injection site) 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 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling around the injection site), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE PAIN (painful around the injection site) and VACCINATION SITE PRURITUS (itches around the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling around the injection site), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE PAIN (painful around the injection site) and VACCINATION SITE PRURITUS (itches around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. NO treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021. No medical history information was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. NO treatment information was provided.

Other Meds:

Current Illness:

ID: 1548315
Sex: F
Age: 33
State: NY

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 08/12/2021
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: headache; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 33-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. On 28-Jan-2021 at 4:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. concomitant medications were not reported

Other Meds:

Current Illness:

ID: 1548316
Sex: F
Age: 47
State: MA

Vax Date: 01/11/2021
Onset Date: 02/11/2021
Rec V Date: 08/12/2021
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: Worse shortness of breath; Allergic reaction; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Worse shortness of breath) and HYPERSENSITIVITY (Allergic reaction) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Asthma since an unknown date. Concurrent medical conditions included Drug allergy (Percocet), Allergy to insect sting (Bee stings) and Allergy to chemicals (Industrial floor cleaner). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT RAPIHALER), TRETINOIN (ADINA), ALBUTEROL SULFATE, DULOXETINE HYDROCHLORIDE (CYMBALTA), HYDROXYCHLOROQUINE and SULFASALAZINE for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DYSPNOEA (Worse shortness of breath) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with PREDNISONE at an unspecified dose and frequency; ALBUTEROL SULFATE at an unspecified dose and frequency and FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Worse shortness of breath) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient has seen Pulmonologist for the reported events. This case was linked to MOD-2021-016875 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Worse shortness of breath) and HYPERSENSITIVITY (Allergic reaction) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Asthma since an unknown date. Concurrent medical conditions included Drug allergy (Percocet), Allergy to insect sting (Bee stings) and Allergy to chemicals (Industrial floor cleaner). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT RAPIHALER), TRETINOIN (ADINA), ALBUTEROL SULFATE, DULOXETINE HYDROCHLORIDE (CYMBALTA), HYDROXYCHLOROQUINE and SULFASALAZINE for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DYSPNOEA (Worse shortness of breath) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with PREDNISONE at an unspecified dose and frequency; ALBUTEROL SULFATE at an unspecified dose and frequency and FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Worse shortness of breath) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient has seen Pulmonologist for the reported events. This case was linked to MOD-2021-016875 (Patient Link).

Other Meds: SYMBICORT RAPIHALER; ADINA; ALBUTEROL SULFATE; CYMBALTA; HYDROXYCHLOROQUINE; SULFASALAZINE

Current Illness: Allergy to chemicals (Industrial floor cleaner); Allergy to insect sting (Bee stings); Asthma; Drug allergy (Percocet)

ID: 1548317
Sex: F
Age: 78
State: FL

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/12/2021
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: weakness; Dizziness; Chills; fever 102.4F; Nausea; Terrible Headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (fever 102.4F) and NAUSEA (Nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 PCR test positive on 29-Dec-2020. Concurrent medical conditions included Drug allergy (streptomycin) and Mycobacterium avium complex infection since 2018. Concomitant products included BUDESONIDE (BENACORT), MAGNESIUM, STEROIDS, Dulcosite sodium Stool softener, METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]), ROSUVASTATIN CALCIUM (CRESTOR), OLMESARTAN MEDOXOMIL (BENICAR), ESTRADIOL and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (fever 102.4F), NAUSEA (Nausea) and HEADACHE (Terrible Headache). On an unknown date, the patient experienced ASTHENIA (weakness). On 18-Feb-2021, DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (fever 102.4F), NAUSEA (Nausea) and HEADACHE (Terrible Headache) had resolved. At the time of the report, ASTHENIA (weakness) outcome was unknown. Concomitant medications taken included cholesterol medicines. Treatment details included Tylenol and Reglan. This case was linked to MOD-2021-101503 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Dose 2 related information was updated. Action taken was updated, new conmeds were added, patient details updated.

Other Meds: BENACORT; MAGNESIUM; STEROIDS; Dulcosite sodium Stool softener; REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]; CRESTOR; BENICAR; ESTRADIOL; DEXILANT

Current Illness: Mycobacterium avium complex infection

ID: 1548318
Sex: F
Age: 71
State: GA

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/12/2021
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: Headache; Mild Nausea; High level of fatigue; No energy; intestinal discomfort/cramp; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy) and ABDOMINAL PAIN (intestinal discomfort/cramp) in a 71-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 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy) and ABDOMINAL PAIN (intestinal discomfort/cramp) in a 71-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 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1548319
Sex: F
Age: 73
State: CA

Vax Date: 01/23/2021
Onset Date: 01/28/2021
Rec V Date: 08/12/2021
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: Golf ball sized lump protruding from arm/quarter sized lump; Pain/have been in terrible pain; Itch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Golf ball sized lump protruding from arm/quarter sized lump), VACCINATION SITE PRURITUS (Itch at the injection site) and VACCINATION SITE PAIN (Pain/have been in terrible pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No medical history information was reported. On 23-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 VACCINATION SITE PRURITUS (Itch at the injection site). On an unknown date, the patient experienced VACCINATION SITE MASS (Golf ball sized lump protruding from arm/quarter sized lump) and VACCINATION SITE PAIN (Pain/have been in terrible pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Golf ball sized lump protruding from arm/quarter sized lump), VACCINATION SITE PRURITUS (Itch at the injection site) and VACCINATION SITE PAIN (Pain/have been in terrible pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant product use was reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: No specific follow-up information recorded. This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021. The most recent information was received on 23-Feb-2021 and was forwarded to Moderna on 24-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Golf ball sized lump protruding from arm/quarter sized lump), VACCINATION SITE PRURITUS (Itch at the injection site) and VACCINATION SITE PAIN (Pain/have been in terrible pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No medical history information was reported. On 23-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 VACCINATION SITE PRURITUS (Itch at the injection site). On an unknown date, the patient experienced VACCINATION SITE MASS (Golf ball sized lump protruding from arm/quarter sized lump) and VACCINATION SITE PAIN (Pain/have been in terrible pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Golf ball sized lump protruding from arm/quarter sized lump), VACCINATION SITE PRURITUS (Itch at the injection site) and VACCINATION SITE PAIN (Pain/have been in terrible pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant product use was reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1548320
Sex: F
Age: 73
State:

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
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: After the vaccine she saw stars for a couple of minutes; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. NO medical history information was reported. On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes). On 18-Feb-2021, VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes) had resolved. Not Provided No relevant Concomitant medications were reported. No Treatment information for the event was provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. NO medical history information was reported. On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes). On 18-Feb-2021, VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes) had resolved. Not Provided No relevant Concomitant medications were reported. No Treatment information for the event was provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR

Other Meds:

Current Illness:

ID: 1548321
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/12/2021
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: Arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. NO medical history information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is sore). At the time of the report, VACCINATION SITE PAIN (Arm is sore) 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 for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. NO medical history information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is sore). At the time of the report, VACCINATION SITE PAIN (Arm is sore) 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 for the event was provided.

Other Meds:

Current Illness:

ID: 1548322
Sex: F
Age: 78
State: NH

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 08/12/2021
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: Hard, red 3x3 spot on arm.; Hard, red 3x3 spot on arm.; Itching on arm; Soreness at the time the shot was given.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE INDURATION (Hard, red 3x3 spot on arm.), VACCINATION SITE ERYTHEMA (Hard, red 3x3 spot on arm.), VACCINATION SITE PAIN (Soreness at the time the shot was given.) and VACCINATION SITE PRURITUS (Itching on arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No medical history information was reported. On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the time the shot was given.). On 20-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard, red 3x3 spot on arm.), VACCINATION SITE ERYTHEMA (Hard, red 3x3 spot on arm.) and VACCINATION SITE PRURITUS (Itching on arm). At the time of the report, VACCINATION SITE INDURATION (Hard, red 3x3 spot on arm.), VACCINATION SITE ERYTHEMA (Hard, red 3x3 spot on arm.), VACCINATION SITE PAIN (Soreness at the time the shot was given.) and VACCINATION SITE PRURITUS (Itching on arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Received Treatment including Benadryl cream. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE INDURATION (Hard, red 3x3 spot on arm.), VACCINATION SITE ERYTHEMA (Hard, red 3x3 spot on arm.), VACCINATION SITE PAIN (Soreness at the time the shot was given.) and VACCINATION SITE PRURITUS (Itching on arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No medical history information was reported. On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the time the shot was given.). On 20-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard, red 3x3 spot on arm.), VACCINATION SITE ERYTHEMA (Hard, red 3x3 spot on arm.) and VACCINATION SITE PRURITUS (Itching on arm). At the time of the report, VACCINATION SITE INDURATION (Hard, red 3x3 spot on arm.), VACCINATION SITE ERYTHEMA (Hard, red 3x3 spot on arm.), VACCINATION SITE PAIN (Soreness at the time the shot was given.) and VACCINATION SITE PRURITUS (Itching on arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Received Treatment including Benadryl cream.

Other Meds:

Current Illness:

ID: 1548323
Sex: M
Age: 72
State: CA

Vax Date: 01/24/2021
Onset Date: 01/29/2021
Rec V Date: 08/12/2021
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: stomach pain; Rash; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (stomach pain) and RASH (Rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The patient's past medical history included Stomach pain (history of stomach pain for 8 months) since an unknown date and Fatty liver since an unknown date. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HERPES ZOSTER (Shingles) and RASH (Rash). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (stomach pain) and RASH (Rash) 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. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 19-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (stomach pain) and RASH (Rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The patient's past medical history included Stomach pain (history of stomach pain for 8 months) since an unknown date and Fatty liver since an unknown date. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HERPES ZOSTER (Shingles) and RASH (Rash). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (stomach pain) and RASH (Rash) 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.

Other Meds:

Current Illness: Fatty liver; Stomach pain (history of stomach pain for 8 months)

ID: 1548324
Sex: F
Age:
State: NC

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 08/12/2021
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: chills; shaking; joint aching; soreness; her left arm is extremely sore and hurts; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. NO medical history information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts). At the time of the report, CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. NO medical history information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts). At the time of the report, CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1548325
Sex: M
Age: 77
State: CA

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 08/12/2021
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: mild headache/I felt a little headache; tiredness; I had injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (I had injection site pain), HEADACHE (mild headache/I felt a little headache) and FATIGUE (tiredness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 062G20A) for COVID-19 vaccination. Concurrent medical conditions included Stroke. Concomitant products included EZETIMIBE (ZETIA) for Cholesterol. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (I had injection site pain). On an unknown date, the patient experienced HEADACHE (mild headache/I felt a little headache) and FATIGUE (tiredness). At the time of the report, INJECTION SITE PAIN (I had injection site pain), HEADACHE (mild headache/I felt a little headache) and FATIGUE (tiredness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medications were not provided by reporter.

Other Meds: ZETIA

Current Illness:

ID: 1548326
Sex: M
Age: 88
State: WI

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
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: Fever; Chills; Flu like symptoms; weakness; I fell on the floor and could not get up for 15 minutes today.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (weakness) and FALL (I fell on the floor and could not get up for 15 minutes today.) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FALL (I fell on the floor and could not get up for 15 minutes today.). On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ASTHENIA (weakness). At the time of the report, PYREXIA (Fever), CHILLS (Chills), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (weakness) and FALL (I fell on the floor and could not get up for 15 minutes today.) 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: 1548327
Sex: F
Age: 59
State: TX

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/12/2021
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: slept 3/4 of the day; exhausted; lower back, shoulder and neck hurt; lower back, shoulder and neck hurt; had a hard time with it; hurt all over; lower back, shoulder and neck hurt; tried to turn and I couldn't; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (had a hard time with it), PAIN (hurt all over), BACK PAIN (lower back, shoulder and neck hurt), ASTHENIA (tried to turn and I couldn't) and HYPERSOMNIA (slept 3/4 of the day) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis and Degenerative disc disease (In her lower back). On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ILLNESS (had a hard time with it), PAIN (hurt all over), BACK PAIN (lower back, shoulder and neck hurt), ASTHENIA (tried to turn and I couldn't), NECK PAIN (lower back, shoulder and neck hurt) and ARTHRALGIA (lower back, shoulder and neck hurt). On 08-Feb-2021, the patient experienced HYPERSOMNIA (slept 3/4 of the day) and FATIGUE (exhausted). On 08-Feb-2021, ILLNESS (had a hard time with it), PAIN (hurt all over), BACK PAIN (lower back, shoulder and neck hurt), ASTHENIA (tried to turn and I couldn't), NECK PAIN (lower back, shoulder and neck hurt) and ARTHRALGIA (lower back, shoulder and neck hurt) had resolved. At the time of the report, HYPERSOMNIA (slept 3/4 of the day) and FATIGUE (exhausted) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment medication was not given.

Other Meds:

Current Illness: Arthritis; Degenerative disc disease (In her lower back)

ID: 1548328
Sex: F
Age: 33
State: CO

Vax Date: 01/20/2021
Onset Date: 02/17/2021
Rec V Date: 08/12/2021
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: tested positive for COVID she is asymptomatic.; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (tested positive for COVID she is asymptomatic.) and DRUG INEFFECTIVE (Lack of drug effect) in a 33-year-old female patient 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced ASYMPTOMATIC COVID-19 (tested positive for COVID she is asymptomatic.) and DRUG INEFFECTIVE (Lack of drug effect). On 17-Feb-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, ASYMPTOMATIC COVID-19 (tested positive for COVID she is asymptomatic.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, SARS-CoV-1 test: positive (Positive) Positive. Treatment and concomitant medications were not provided by reporter. This is a case of lack of efficacy of the vaccine. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Asymptomatic COVID-19 is assessed as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: Upon internal review on 06-Aug-2021, event of Lack of drug effect was added. Lab data and dose 1 information were also updated.; Sender's Comments: This is a case of lack of efficacy of the vaccine. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Asymptomatic COVID-19 is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1548329
Sex: M
Age:
State: OH

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 08/12/2021
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: chills; high fever of 100.3.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (high fever of 100.3.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Leukemia lymphocytic chronic and COVID-19 in December 2020. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (high fever of 100.3.). At the time of the report, CHILLS (chills) and PYREXIA (high fever of 100.3.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment and concomitant medications were not provided by reporter. This case was linked to MOD-2021-017163 (Patient Link).

Other Meds:

Current Illness:

ID: 1548330
Sex: M
Age: 81
State:

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 08/12/2021
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: Swelling at injection site; Rash at injection site; warmness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE RASH (Rash at injection site) and INJECTION SITE WARMTH (warmness at injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13m20a) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE RASH (Rash at injection site) and INJECTION SITE WARMTH (warmness at injection site). At the time of the report, INJECTION SITE SWELLING (Swelling at injection site) had resolved and INJECTION SITE RASH (Rash at injection site) and INJECTION SITE WARMTH (warmness at injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment and concomitant medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1548331
Sex: U
Age: 54
State: IL

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little sore arm) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unk) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Little sore arm). At the time of the report, PAIN IN EXTREMITY (Little sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment details included 2 Advil before the shot, 2 Tylenol.

Other Meds:

Current Illness:

ID: 1548332
Sex: F
Age: 75
State: NC

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 08/12/2021
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: Back ache; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back ache), CHILLS (Chills) and VOMITING (Vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011320A) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back ache), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, BACK PAIN (Back ache), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided but mentions being on a blood thinner, of unspecified type. Treatment medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1548333
Sex: M
Age:
State: MD

Vax Date: 01/25/2021
Onset Date: 02/04/2021
Rec V Date: 08/12/2021
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: Bone and muscle ache; muscle pain; joint pain; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Bone and muscle ache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. Concurrent medical conditions included Cancer (treated for cancer and is on immunotherapy). On 25-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 MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced BONE PAIN (Bone and muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, BONE PAIN (Bone and muscle ache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. This case was linked to US-MODERNATX, INC.-MOD-2021-090440, US-MODERNATX, INC.-MOD-2021-090431 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-Apr-2021. AE contact information Updated and additional event added.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-090431: US-MODERNATX, INC.-MOD-2021-090440:

Other Meds:

Current Illness: Cancer (treated for cancer and is on immunotherapy)

ID: 1548334
Sex: M
Age: 79
State: NY

Vax Date: 02/09/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
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: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Severe itching), ERYTHEMA (red mark appeared in the wound area, redness mostly in his upper body, the trunk and his scalp) and SLEEP DEFICIT (Impossible to sleep) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20a) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history.). On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PRURITUS (Severe itching), ERYTHEMA (red mark appeared in the wound area, redness mostly in his upper body, the trunk and his scalp) and SLEEP DEFICIT (Impossible to sleep). At the time of the report, PRURITUS (Severe itching), ERYTHEMA (red mark appeared in the wound area, redness mostly in his upper body, the trunk and his scalp) and SLEEP DEFICIT (Impossible to sleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment: Benadryl (diphenhydramine HCL). Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient's address added.

Other Meds:

Current Illness:

ID: 1548335
Sex: F
Age: 76
State: CA

Vax Date: 01/16/2021
Onset Date: 01/21/2021
Rec V Date: 08/12/2021
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: Extreme burning sensation in my extremities, elbow to fingertips and knees to toes / terrible burning in her limbs; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Extreme burning sensation in my extremities, elbow to fingertips and knees to toes / terrible burning in her limbs) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037J20A) for COVID-19 vaccination. Concomitant products included PROPAFENONE, EZETIMIBE, PRAVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), PANTOPRAZOLE, ALPRAZOLAM, LATANOPROST, CICLOSPORIN (RESTASIS), ACETYLSALICYLIC ACID (BABY ASPIRIN), MULTIVITAMINS [VITAMINS NOS], FISH OIL and UBIDECARENONE (CO ENZYME Q10 [UBIDECARENONE]) for an unknown indication. On 16-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 BURNING SENSATION (Extreme burning sensation in my extremities, elbow to fingertips and knees to toes / terrible burning in her limbs). The patient was treated with GABAPENTIN for Burning sensation, at an unspecified dose and frequency. On 22-Jan-2021, BURNING SENSATION (Extreme burning sensation in my extremities, elbow to fingertips and knees to toes / terrible burning in her limbs) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-214641 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Significant Follow up received on 01-FEB-2021 and includes treatment, address, second dose details and additional events after second dose.

Other Meds: PROPAFENONE; EZETIMIBE; PRAVASTATIN; SYNTHROID; PANTOPRAZOLE; ALPRAZOLAM; LATANOPROST; RESTASIS; BABY ASPIRIN; MULTIVITAMINS [VITAMINS NOS]; FISH OIL; CO ENZYME Q10 [UBIDECARENONE]

Current Illness:

ID: 1548336
Sex: F
Age: 76
State: FL

Vax Date: 02/16/2021
Onset Date: 02/01/2021
Rec V Date: 08/12/2021
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: exhaustion; Fever; Chills; Headache; Badly swollen arms; Aches and pains; Were feeling awful; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and PERIPHERAL SWELLING (Badly swollen arms) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced FATIGUE (exhaustion), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Badly swollen arms), PAIN (Aches and pains) and VACCINATION COMPLICATION (Were feeling awful). At the time of the report, FATIGUE (exhaustion), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Badly swollen arms), PAIN (Aches and pains) and VACCINATION COMPLICATION (Were feeling awful) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1548337
Sex: F
Age: 58
State: MA

Vax Date: 02/19/2021
Onset Date: 02/18/2021
Rec V Date: 08/12/2021
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: significant allergic reaction; eyes swelled up; nose was congested; throat was swollen; throat was sore; itching throughout her body,ears, butt, on back; itching on eyes; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (significant allergic reaction), EYE SWELLING (eyes swelled up), NASAL CONGESTION (nose was congested), PHARYNGEAL SWELLING (throat was swollen) and OROPHARYNGEAL PAIN (throat was sore) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced HYPERSENSITIVITY (significant allergic reaction), EYE SWELLING (eyes swelled up), NASAL CONGESTION (nose was congested), PHARYNGEAL SWELLING (throat was swollen), OROPHARYNGEAL PAIN (throat was sore), PRURITUS (itching throughout her body,ears, butt, on back) and EYE PRURITUS (itching on eyes). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and FAMOTIDINE (PEPCID AC) at a dose of 1 dosage form. At the time of the report, HYPERSENSITIVITY (significant allergic reaction), EYE SWELLING (eyes swelled up), NASAL CONGESTION (nose was congested), PHARYNGEAL SWELLING (throat was swollen), OROPHARYNGEAL PAIN (throat was sore), PRURITUS (itching throughout her body,ears, butt, on back) and EYE PRURITUS (itching on eyes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1548338
Sex: F
Age: 63
State: GA

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/12/2021
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: disorientated; brain was foggy; totally crashed and had to go to sleep; severe diarrhea,like never before. Still not having normal bowel movements; sore arm; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientated), FEELING ABNORMAL (brain was foggy), SOMNOLENCE (totally crashed and had to go to sleep), DIARRHOEA (severe diarrhea,like never before. Still not having normal bowel movements) and PAIN IN EXTREMITY (sore arm) in a 63-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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced DISORIENTATION (disorientated), FEELING ABNORMAL (brain was foggy), SOMNOLENCE (totally crashed and had to go to sleep), DIARRHOEA (severe diarrhea,like never before. Still not having normal bowel movements), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and CHILLS (chills). On 10-Feb-2021, DISORIENTATION (disorientated), FEELING ABNORMAL (brain was foggy), SOMNOLENCE (totally crashed and had to go to sleep), FATIGUE (fatigue) and CHILLS (chills) had resolved. On 12-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, DIARRHOEA (severe diarrhea,like never before. Still not having normal bowel movements) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication included Imodium. No concomitant medications were provided by reporter.

Other Meds:

Current Illness:

ID: 1548339
Sex: F
Age: 71
State: WI

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/12/2021
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: Arm is very hot, like you can fry an egg on it; Chills for 15-20 minutes and then go supper hot; Sore arm went down to elbowand into my shoulder; Arm is really sore, started to boom boom; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Arm is very hot, like you can fry an egg on it), FEELING OF BODY TEMPERATURE CHANGE (Chills for 15-20 minutes and then go supper hot), ARTHRALGIA (Sore arm went down to elbowand into my shoulder) and PAIN (Arm is really sore, started to boom boom) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure and Thyroid disorder NOS. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FEELING HOT (Arm is very hot, like you can fry an egg on it), FEELING OF BODY TEMPERATURE CHANGE (Chills for 15-20 minutes and then go supper hot), ARTHRALGIA (Sore arm went down to elbowand into my shoulder) and PAIN (Arm is really sore, started to boom boom). At the time of the report, FEELING HOT (Arm is very hot, like you can fry an egg on it), FEELING OF BODY TEMPERATURE CHANGE (Chills for 15-20 minutes and then go supper hot), ARTHRALGIA (Sore arm went down to elbowand into my shoulder) and PAIN (Arm is really sore, started to boom boom) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Blood pressure; Thyroid disorder NOS

ID: 1548340
Sex: F
Age: 72
State: MI

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/12/2021
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: nightmares; foggy head; headaches; chills on and off; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (nightmares), FEELING ABNORMAL (foggy head), HEADACHE (headaches) and CHILLS (chills on and off) in a 72-year-old female 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced NIGHTMARE (nightmares), FEELING ABNORMAL (foggy head), HEADACHE (headaches) and CHILLS (chills on and off). On 15-Feb-2021, NIGHTMARE (nightmares) and FEELING ABNORMAL (foggy head) had resolved. At the time of the report, HEADACHE (headaches) and CHILLS (chills on and off) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1548341
Sex: F
Age:
State:

Vax Date: 01/25/2021
Onset Date: 02/17/2021
Rec V Date: 08/12/2021
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: Red spots on her right arm where she got the the injection; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red spots on her right arm where she got the injection. The patient's medical history was not provided. No relevant concomitant medications were reported. On 25 Jan 2021, prior to the onset of the events the patient received the first planned dose of mRNA-1273 (lot/batch: unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced the event red spots on her right arm where she got the injection. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event red spots was unknown.; Reporter'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.

Other Meds:

Current Illness:

ID: 1548342
Sex: M
Age: 60
State: FL

Vax Date: 02/05/2021
Onset Date: 02/01/2021
Rec V Date: 08/12/2021
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: the rash has return to the same area, to the area of the injection, it's a bit larger, it's a little bitsensitive, not itchy; woke up with the rash today /It's not as severe but it's larger, it covers a bigger area; a little bit sore; got what people are calling a COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit sore), HYPERSENSITIVITY (got what people are calling a COVID arm), INJECTION SITE RASH (the rash has return to the same area, to the area of the injection, it's a bit larger, it's a little bitsensitive, not itchy) and RASH (woke up with the rash today /It's not as severe but it's larger, it covers a bigger area) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DOMZOA) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included METFORMIN, ATORVASTATIN and METHAQUALONE (TOQUILONE) for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (a little bit sore) and HYPERSENSITIVITY (got what people are calling a COVID arm). On 19-Feb-2021, the patient experienced INJECTION SITE RASH (the rash has return to the same area, to the area of the injection, it's a bit larger, it's a little bitsensitive, not itchy) and RASH (woke up with the rash today /It's not as severe but it's larger, it covers a bigger area). At the time of the report, PAIN IN EXTREMITY (a little bit sore), HYPERSENSITIVITY (got what people are calling a COVID arm), INJECTION SITE RASH (the rash has return to the same area, to the area of the injection, it's a bit larger, it's a little bitsensitive, not itchy) and RASH (woke up with the rash today /It's not as severe but it's larger, it covers a bigger area) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds: METFORMIN; ATORVASTATIN; TOQUILONE

Current Illness:

ID: 1548343
Sex: M
Age: 77
State: NY

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/12/2021
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: High blood sugar 279 and 197; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (High blood sugar 279 and 197) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 016M20A) for COVID-19 immunisation. Concurrent medical conditions included Type 2 diabetes mellitus, Diverticulitis since 1988, Hypertension, Obesity and Mercury sensitivity. On 17-Feb-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (High blood sugar 279 and 197). At the time of the report, BLOOD GLUCOSE INCREASED (High blood sugar 279 and 197) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Blood glucose: 279 (High) complete. On 18-Feb-2021, Blood glucose: 197 (High) complete. Treatment medication included glimepiride. Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: 2nd dose vaccination date and batch number added, race,height, weight, medical condition of hypertension and obese, diverticulitus since 1988 as chronic condition added, allergy to mercury added; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Diverticulitis; Hypertension; Mercury sensitivity; Obesity; Type 2 diabetes mellitus

ID: 1548344
Sex: M
Age:
State: GA

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/12/2021
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: Swollen gland on opposite arm after the 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen gland on opposite arm after the 1st vaccine) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0266208 and 01SM20A) 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 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen gland on opposite arm after the 1st vaccine). At the time of the report, LYMPHADENOPATHY (Swollen gland on opposite arm after the 1st vaccine) outcome was unknown. No treatment information was provided by Reporter. Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: TCR received.Nobody received the call. Left voicemail with call back number and Argus case number.; Reporter's Comments: Based on the current available information which includes a g temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded.

Other Meds:

Current Illness:

ID: 1548345
Sex: F
Age: 79
State: NJ

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/12/2021
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: Arm became numb; Tingling; Achy sensation; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Arm became numb), PARAESTHESIA (Tingling) and PAIN (Achy sensation) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023H0A) for an unknown indication. The patient's past medical history included No adverse event (The patient's medical history was not provided. ). Concomitant products included PITAVASTATIN CALCIUM (LIVALO) for Cholesterol, WARFARIN. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HYPOAESTHESIA (Arm became numb), PARAESTHESIA (Tingling) and PAIN (Achy sensation). On 17-Feb-2021, HYPOAESTHESIA (Arm became numb), PARAESTHESIA (Tingling) and PAIN (Achy sensation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds: WARFARIN; LIVALO

Current Illness:

ID: 1548346
Sex: F
Age: 64
State: PA

Vax Date: 12/31/2020
Onset Date: 01/27/1900
Rec V Date: 08/12/2021
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: Clammy; Hot; In pain; Feverish; Fatigue; Red/Erythema at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Clammy), FEELING HOT (Hot), PAIN (In pain), PYREXIA (Feverish) and FATIGUE (Fatigue) in a 64-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 was provided by the reporter. Concomitant products included METFORMIN for an unknown indication. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-1900, the patient experienced VACCINATION SITE ERYTHEMA (Red/Erythema at injection site). On 27-Jan-2021, the patient experienced COLD SWEAT (Clammy), FEELING HOT (Hot), PAIN (In pain), PYREXIA (Feverish) and FATIGUE (Fatigue). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, COLD SWEAT (Clammy), FEELING HOT (Hot), PAIN (In pain), PYREXIA (Feverish), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red/Erythema at injection site) outcome was unknown.; 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: METFORMIN

Current Illness:

ID: 1548347
Sex: F
Age:
State:

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/12/2021
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: A spontaneous report was received from a consumer concerning an 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events woke up on the middle of the night extremely dizzy/dizziness, interrupted her sleep/insomnia and sore arm/vaccination site pain. The patient's medical history was not provided. No relevant concomitant medications on use were reported. On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025120A) intramuscularly for prophylaxis of COVID-19 infection. On 9 Feb 2021, the patient experienced the event sore arm. On 16 Feb 2021, the patient experienced the events woke up on the middle of the night extremely dizzy and this interrupted her sleep. No laboratory data was provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event sore arm was resolved on 11 Feb 2021. The events woke up on the middle of the night extremely dizzy and this interrupted her sleep were recovered on 17 Feb. 2021.

Other Meds:

Current Illness:

ID: 1548348
Sex: F
Age: 73
State: FL

Vax Date: 01/13/2021
Onset Date: 02/09/2021
Rec V Date: 08/12/2021
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: Vomiting; Sore arm; Bad headache; Fatigued/Tired; A spontaneous report was received from a consumer (patient) concerning a 73 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like a sore arm, a bad headache, fatigued/tired, and vomiting. The patient's medical history was not provided. Relevant concomitant medications were reported. The patient is taking blood pressure medicines. On 13-JAN-2021, the patient received their first of two planned doses of mRNA-1273(Batch number 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On 09-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273( Batch Number 010M20A ) intramuscularly for prophylaxis of COVID-19 infection. On 09-FEB-2021, the patient experienced a sore arm, a bad headache and was fatigued/tired. On 18-FEB-2021, the patient experienced the event vomiting. Treatment details were not reported. Action taken with mRNA-1273 in response to the events was not applicable. The outcomes of the events, a sore arm, a bad headache and was fatigued/tired were considered resolved on 12 Feb 2021. The outcome of the event, vomiting was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1548349
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/12/2021
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: Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Company comment: Although temporality cannot be established due to the known safety profile of the vaccine, a causal relationship with the event cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow up information was received on 31 Mar 2021: added reporter E mail ID

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm