VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1595037
Sex: F
Age: 76
State: GA

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 08/21/2021
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: Severe explosive diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe explosive diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Severe explosive diarrhea). At the time of the report, DIARRHOEA (Severe explosive diarrhea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment of events was reported. The reporter mentioned the patient withheld her doses of Xeljanz for 5 days prior to her second dose of Moderna vaccine and did not experience the event of explosive diarrhea again. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up received: Medical history, vaccine information, concomitant medication information and event information were updated.

Other Meds: XELJANZ XR

Current Illness: Rheumatoid arthritis

ID: 1595038
Sex: F
Age:
State: FL

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 08/21/2021
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: Redness spreads like it was a mess like 6; Hot to touch; Redness around the injection site; Painful like when you get a shot; little swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness spreads like it was a mess like 6), SWELLING (little swelling), INJECTION SITE WARMTH (Hot to touch), INJECTION SITE ERYTHEMA (Redness around the injection site) and INJECTION SITE PAIN (Painful like when you get a shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) 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) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced SWELLING (little swelling). On 26-Feb-2021, the patient experienced ERYTHEMA (Redness spreads like it was a mess like 6), INJECTION SITE WARMTH (Hot to touch), INJECTION SITE ERYTHEMA (Redness around the injection site) and INJECTION SITE PAIN (Painful like when you get a shot). At the time of the report, ERYTHEMA (Redness spreads like it was a mess like 6), SWELLING (little swelling), INJECTION SITE WARMTH (Hot to touch), INJECTION SITE ERYTHEMA (Redness around the injection site) and INJECTION SITE PAIN (Painful like when you get a shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1595039
Sex: F
Age: 78
State: FL

Vax Date: 01/24/2021
Onset Date: 02/19/2021
Rec V Date: 08/21/2021
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: Runny nose; Coughing; Sweating; Cold; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), COUGH (Coughing), HYPERHIDROSIS (Sweating) and NASOPHARYNGITIS (Cold) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. no medical history is provided and concomitant drugs are provided. Concomitant products included CARVEDILOL for an unknown indication. On 24-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced RHINORRHOEA (Runny nose), COUGH (Coughing), HYPERHIDROSIS (Sweating) and NASOPHARYNGITIS (Cold). At the time of the report, RHINORRHOEA (Runny nose), COUGH (Coughing), HYPERHIDROSIS (Sweating) and NASOPHARYNGITIS (Cold) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: CARVEDILOL

Current Illness:

ID: 1595040
Sex: F
Age: 56
State: CA

Vax Date: 02/12/2021
Onset Date: 02/15/2021
Rec V Date: 08/21/2021
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: Eosinophil count was high; granulocyte is low; This spontaneous case was reported by a consumer and describes the occurrence of EOSINOPHIL COUNT INCREASED (Eosinophil count was high) and GRANULOCYTE COUNT DECREASED (granulocyte is low) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced EOSINOPHIL COUNT INCREASED (Eosinophil count was high) and GRANULOCYTE COUNT DECREASED (granulocyte is low). At the time of the report, EOSINOPHIL COUNT INCREASED (Eosinophil count was high) and GRANULOCYTE COUNT DECREASED (granulocyte is low) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitants were reported. No treatment was reported.

Other Meds:

Current Illness:

ID: 1595041
Sex: M
Age: 72
State: TX

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 08/21/2021
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: Hardness Near the Injection Site; Itchy Sensation - Near Injection Site; Hot to Touch - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE INDURATION (Hardness Near the Injection Site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. Concurrent medical conditions included Claritin. Concomitant products included Allergy Shot Allergies and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hardness Near the Injection Site). At the time of the report, VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: Allergy Shot Allergies; CLARITIN ALLERGIC

Current Illness:

ID: 1595042
Sex: M
Age: 70
State: IL

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 08/21/2021
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: some of the dose dripped down the patients arm; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEVICE CONNECTION ISSUE (some of the dose dripped down the patients arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. No Medical History information was reported. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Jan-2021, the patient experienced DEVICE CONNECTION ISSUE (some of the dose dripped down the patients arm). At the time of the report, DEVICE CONNECTION ISSUE (some of the dose dripped down the patients arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1595043
Sex: U
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: Side effects show up 10 to 14 days after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Side effects show up 10 to 14 days after vaccination) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Side effects show up 10 to 14 days after vaccination). At the time of the report, VACCINATION SITE REACTION (Side effects show up 10 to 14 days after vaccination) 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.

Other Meds:

Current Illness:

ID: 1595044
Sex: F
Age: 73
State: IN

Vax Date: 01/27/2021
Onset Date: 01/22/2021
Rec V Date: 08/21/2021
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: skin rash; Swollen lymph nodes behind neck, ear and jaw; facial rash; facial redness; A spontaneous report was received from a Healthcare Professional concerning a 73-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events skin rash, swollen lymph nodes behind neck, swollen lymph nodes behind ear, swollen lymph nodes behind jaw, facial redness, facial rash. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029k20A) intramuscularly for prophylaxis of COVID-19 infection. The patient experienced skin rash. On 29 Jan 2021, the patient experienced the events swollen lymph nodes behind neck.,swollen lymph nodes behind ear, swollen lymph nodes behind jaw. On 22 Jan 2021, the patient experienced the events facial redness. facial rash. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The Outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1595045
Sex: F
Age:
State:

Vax Date: 01/29/2020
Onset Date: 01/30/2020
Rec V Date: 08/21/2021
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: Arm subsequently hurt; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (Arm subsequently hurt) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Jan-2020, the patient experienced PAIN IN EXTREMITY (Arm subsequently hurt). At the time of the report, PAIN IN EXTREMITY (Arm subsequently hurt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1595046
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. 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 INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1595047
Sex: M
Age: 86
State:

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/21/2021
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: Fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20a) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PYREXIA (Fever of 101). At the time of the report, PYREXIA (Fever of 101) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 101 degree (plane angle). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1595048
Sex: F
Age: 66
State: NH

Vax Date: 02/09/2021
Onset Date:
Rec V Date: 08/21/2021
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: Severe headache; Chills; Fatigue; Fever; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache), CHILLS (Chills), FATIGUE (Fatigue), PYREXIA (Fever) and PAIN IN EXTREMITY (Arm pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 an unknown date, the patient experienced HEADACHE (Severe headache), CHILLS (Chills), FATIGUE (Fatigue), PYREXIA (Fever) and PAIN IN EXTREMITY (Arm pain). At the time of the report, HEADACHE (Severe headache), CHILLS (Chills), FATIGUE (Fatigue), PYREXIA (Fever) and PAIN IN EXTREMITY (Arm pain) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1595049
Sex: U
Age:
State: TX

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 08/21/2021
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: tested positive COVID19 after vaccination; diarrhea; congestion; nausea; tiredness; A spontaneous report was received from a Healthcare Professional concerning a patient aged between 30-50 years who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced covid19, nausea, diarhoea , fatigue and congestion . The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number not provided ) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date patient experienced covid19, nausea, diarrhea , fatigue and congestion. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of covid19, nausea, diarrhea , fatigue and congestion was not reported.

Other Meds:

Current Illness:

ID: 1595050
Sex: F
Age: 85
State: NJ

Vax Date: 01/28/2021
Onset Date: 02/06/2021
Rec V Date: 08/21/2021
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: runny nose; achy; cough; fever; tired over the weekend; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), COUGH (cough), MYALGIA (achy), FATIGUE (tired over the weekend) and PYREXIA (fever) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 038K20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021 at 12:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (tired over the weekend). On 08-Feb-2021, the patient experienced COUGH (cough) and PYREXIA (fever). On 09-Feb-2021, the patient experienced RHINORRHOEA (runny nose) and MYALGIA (achy). The patient was treated with PARACETAMOL (TYLENOL) on 09-Feb-2021 for Pain and Fever, at an unspecified dose and frequency. On 07-Feb-2021, FATIGUE (tired over the weekend) had resolved. On 12-Feb-2021, COUGH (cough) and PYREXIA (fever) had resolved. At the time of the report, RHINORRHOEA (runny nose) and MYALGIA (achy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, after first dose. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported concomitant medications as none but she usually took Vitamin D. This case was linked to MOD-2021-068364, MOD-2021-068364. Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up received: Updated patient demographics and cough event outcome to recovered/resolved. Added new event fever and lab data.

Other Meds:

Current Illness:

ID: 1595051
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: Mild swelling in lips; Mild swelling in cheeks; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Mild swelling in lips) and SWELLING FACE (Mild swelling in cheeks) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The patient's past medical history included Lip cosmetic procedure (patient was injected with 1 ml of volume 0.6 volbella in the lip) on 30-Oct-2020 and Dermal filler injection (patient was injected with 1 ml of volume 0.5 per side in the cheek) on 30-Oct-2020. 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 LIP SWELLING (Mild swelling in lips) and SWELLING FACE (Mild swelling in cheeks). At the time of the report, LIP SWELLING (Mild swelling in lips) and SWELLING FACE (Mild swelling in cheeks) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1595052
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 02/06/2021
Rec V Date: 08/21/2021
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: This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (felt tired), ERYTHEMA (arm was red and swollen), PERIPHERAL SWELLING (arm was red and swollen), DYSPNOEA (shortness of breath) and HYPERSENSITIVITY (allergic reaction) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy, Hypothyroidism, Emphysema and Lung cancer. Concomitant products included ROPINIROLE, PRAVASTATIN and TIOTROPIUM BROMIDE (SPIRIVA) for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Feb-2021, the patient experienced ERYTHEMA (arm was red and swollen), PERIPHERAL SWELLING (arm was red and swollen) and DYSPNOEA (shortness of breath). On an unknown date, the patient experienced FATIGUE (felt tired) and HYPERSENSITIVITY (allergic reaction). At the time of the report, FATIGUE (felt tired), ERYTHEMA (arm was red and swollen), PERIPHERAL SWELLING (arm was red and swollen), DYSPNOEA (shortness of breath) and HYPERSENSITIVITY (allergic reaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided.

Other Meds: ROPINIROLE; PRAVASTATIN; SPIRIVA

Current Illness: Emphysema; Hypothyroidism; Lung cancer; Sulfonamide allergy

ID: 1595053
Sex: M
Age: 68
State:

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/21/2021
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: on his arm he is seeing 3-4 inch raised rash; Developed hives around belt line; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives around belt line) and RASH (on his arm he is seeing 3-4 inch raised rash) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included EPINEPHRINE (EPIPEN) for Insect sting allergy. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced URTICARIA (Developed hives around belt line). On 16-Feb-2021, the patient experienced RASH (on his arm he is seeing 3-4 inch raised rash). At the time of the report, URTICARIA (Developed hives around belt line) and RASH (on his arm he is seeing 3-4 inch raised rash) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds: EPIPEN

Current Illness:

ID: 1595054
Sex: F
Age: 69
State: PA

Vax Date: 01/24/2021
Onset Date: 01/25/2021
Rec V Date: 08/21/2021
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: Fever of 100.3F; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and PYREXIA (Fever of 100.3F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concomitant products included MONTELUKAST, ATORVASTATIN, ACETYLSALICYLIC ACID, DIPYRIDAMOLE (AGRENOX), METFORMIN, ALENDRONATE SODIUM, VITAMIN D3, CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL (ACETAMINOPHEN WITH CODEINE), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), CALCIUM CARBONATE (OSCAL [CALCIUM CARBONATE]) and OLMESARTAN for an unknown indication. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced CHILLS (chills) and FATIGUE (fatigue). On 26-Jan-2021, the patient experienced PYREXIA (Fever of 100.3F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, CHILLS (chills), FATIGUE (fatigue) and PYREXIA (Fever of 100.3F) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature increased: high (High) 100.3 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication also included allergy shot every 3 weeks.

Other Meds: MONTELUKAST; ATORVASTATIN; AGRENOX; METFORMIN; ALENDRONATE SODIUM; VITAMIN D3; ACETAMINOPHEN WITH CODEINE; VITAMIN B12 [CYANOCOBALAMIN]; OSCAL [CALCIUM CARBONATE]; OLMESARTAN

Current Illness:

ID: 1595055
Sex: M
Age: 65
State: TN

Vax Date: 02/05/2021
Onset Date: 02/13/2021
Rec V Date: 08/21/2021
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: big red spots; rash all over his back and his sides and front, from back to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over his back and his sides and front, from back to shoulder) and RASH (big red spots) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced RASH (rash all over his back and his sides and front, from back to shoulder). On an unknown date, the patient experienced RASH (big red spots). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (rash all over his back and his sides and front, from back to shoulder) and RASH (big red spots) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1595056
Sex: F
Age: 80
State: AZ

Vax Date: 02/08/2021
Onset Date: 02/10/2021
Rec V Date: 08/21/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: blood shot eye; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (blood shot eye) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced OCULAR HYPERAEMIA (blood shot eye). At the time of the report, OCULAR HYPERAEMIA (blood shot eye) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1595057
Sex: M
Age: 57
State: MI

Vax Date: 02/15/2021
Onset Date:
Rec V Date: 08/21/2021
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: sore throat; plugged up nos; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (plugged up nos) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No medical history was provided by the reporter. On 15-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 OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (plugged up nos). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (plugged up nos) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1595058
Sex: M
Age: 82
State: NY

Vax Date: 02/13/2021
Onset Date: 02/14/2021
Rec V Date: 08/21/2021
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: blood appeared in the urination as well; burning pain while they urinated; loss their appetite; FATIGUE; Chills; Muscle pain; Joint pain; Headache; nausea; vomiting; fever up to 101 degrees; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (blood appeared in the urination as well), DYSURIA (burning pain while they urinated), DECREASED APPETITE (loss their appetite), FATIGUE (FATIGUE) and CHILLS (Chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HAEMATURIA (blood appeared in the urination as well), DYSURIA (burning pain while they urinated), DECREASED APPETITE (loss their appetite), FATIGUE (FATIGUE), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever up to 101 degrees). At the time of the report, HAEMATURIA (blood appeared in the urination as well), DYSURIA (burning pain while they urinated), DECREASED APPETITE (loss their appetite), FATIGUE (FATIGUE), CHILLS (Chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever up to 101 degrees) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: high (High) 101 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1595059
Sex: U
Age: 66
State: SC

Vax Date: 02/14/2021
Onset Date:
Rec V Date: 08/21/2021
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: Sore arm; chills could not get warm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (chills could not get warm) and PYREXIA (Fever) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (chills could not get warm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (chills could not get warm) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1595060
Sex: F
Age: 68
State: PA

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/21/2021
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: Feels like an earache with pain scale of 3; Headache comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Feels like an earache with pain scale of 3) and HEADACHE (Headache comes and goes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included GABAPENTIN, AMLODIPINE, METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), APOAEQUORIN (PREVAGEN [APOAEQUORIN]) and PARACETAMOL (TYLENOL ARTHRITIS) for an unknown indication. 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 EAR PAIN (Feels like an earache with pain scale of 3) and HEADACHE (Headache comes and goes). At the time of the report, EAR PAIN (Feels like an earache with pain scale of 3) and HEADACHE (Headache comes and goes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds: GABAPENTIN; AMLODIPINE; METFORMIN; LIPITOR; PROTONIX [OMEPRAZOLE]; PREVAGEN [APOAEQUORIN]; TYLENOL ARTHRITIS

Current Illness:

ID: 1595061
Sex: F
Age: 81
State: AL

Vax Date: 02/01/2021
Onset Date: 02/08/2021
Rec V Date: 08/21/2021
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: Itchy red rash with some swelling on her right arm and right leg above the knee.; Itchy red rash with some swelling on her right arm and right leg above the knee.; Itchy red rash with some swelling on her right arm and right leg above the knee.; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy red rash with some swelling on her right arm and right leg above the knee.), ERYTHEMA (Itchy red rash with some swelling on her right arm and right leg above the knee.) and SWELLING (Itchy red rash with some swelling on her right arm and right leg above the knee.) in an 81-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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH PRURITIC (Itchy red rash with some swelling on her right arm and right leg above the knee.), ERYTHEMA (Itchy red rash with some swelling on her right arm and right leg above the knee.) and SWELLING (Itchy red rash with some swelling on her right arm and right leg above the knee.). At the time of the report, RASH PRURITIC (Itchy red rash with some swelling on her right arm and right leg above the knee.), ERYTHEMA (Itchy red rash with some swelling on her right arm and right leg above the knee.) and SWELLING (Itchy red rash with some swelling on her right arm and right leg above the knee.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment details were not provided.

Other Meds:

Current Illness:

ID: 1595062
Sex: M
Age: 72
State: PA

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/21/2021
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: worse tinnitus, both their ears are ringing and fizzing.; little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (worse tinnitus, both their ears are ringing and fizzing.) and PAIN IN EXTREMITY (little sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included Tinnitus. Previously administered products included for an unreported indication: SHINGRIX. Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced TINNITUS (worse tinnitus, both their ears are ringing and fizzing.) and PAIN IN EXTREMITY (little sore arm). On 10-Feb-2021, TINNITUS (worse tinnitus, both their ears are ringing and fizzing.) outcome was unknown and PAIN IN EXTREMITY (little sore arm) had resolved. Not Provided The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications cholesterol medication, vitamin C Treatment details were not provided.

Other Meds: VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1595063
Sex: F
Age: 28
State: NY

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 08/21/2021
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: 2 hives that are red and warm to touch; Fatigue; Hives near throat; Swollen throat; Itchy Legs; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), FATIGUE (Fatigue), URTICARIA (Hives near throat), OROPHARYNGEAL PAIN (Swollen throat) and PRURITUS (Itchy Legs) in a 28-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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm). On 16-Feb-2021, the patient experienced FATIGUE (Fatigue), URTICARIA (Hives near throat), OROPHARYNGEAL PAIN (Swollen throat) and PRURITUS (Itchy Legs). On 17-Feb-2021, the patient experienced URTICARIA (2 hives that are red and warm to touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 16-Feb-2021, PAIN IN EXTREMITY (Soreness in arm), FATIGUE (Fatigue), URTICARIA (Hives near throat), OROPHARYNGEAL PAIN (Swollen throat) and PRURITUS (Itchy Legs) had resolved. At the time of the report, URTICARIA (2 hives that are red and warm to touch) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided.

Other Meds:

Current Illness:

ID: 1595064
Sex: U
Age:
State:

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/21/2021
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: rapid Heart beat; difficulty breathing; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid Heart beat), DYSPNOEA (difficulty breathing) and DIZZINESS (dizziness) 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 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced HEART RATE INCREASED (rapid Heart beat), DYSPNOEA (difficulty breathing) and DIZZINESS (dizziness). At the time of the report, HEART RATE INCREASED (rapid Heart beat), DYSPNOEA (difficulty breathing) and DIZZINESS (dizziness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment details were not provided.

Other Meds:

Current Illness:

ID: 1595065
Sex: F
Age: 85
State: NC

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/21/2021
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: lethargic; arm is still sore and itchy; arm is still sore and itchy; Felt sick; still feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PAIN IN EXTREMITY (arm is still sore and itchy), PRURITUS (arm is still sore and itchy), MALAISE (Felt sick) and FATIGUE (still feeling tired) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 11-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 LETHARGY (lethargic), PAIN IN EXTREMITY (arm is still sore and itchy), PRURITUS (arm is still sore and itchy), MALAISE (Felt sick) and FATIGUE (still feeling tired). At the time of the report, LETHARGY (lethargic), PAIN IN EXTREMITY (arm is still sore and itchy), PRURITUS (arm is still sore and itchy), MALAISE (Felt sick) and FATIGUE (still feeling tired) had not resolved. Not Provided Concomitant medications were not provided. Treatment details were not provided.

Other Meds:

Current Illness:

ID: 1595066
Sex: F
Age:
State:

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 08/21/2021
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: Injection site Soreness; tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site Soreness) and VACCINATION SITE PAIN (tender) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. 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. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site Soreness) and VACCINATION SITE PAIN (tender). At the time of the report, VACCINATION SITE PAIN (Injection site Soreness) and VACCINATION SITE PAIN (tender) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment details were not provided.

Other Meds:

Current Illness:

ID: 1595067
Sex: F
Age:
State: PA

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/21/2021
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: tingling lips; numb lips; continual clearing of throat; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling lips), HYPOAESTHESIA ORAL (numb lips) and OROPHARYNGEAL DISCOMFORT (continual clearing of throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. Concurrent medical conditions included Fish allergy. On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling lips), HYPOAESTHESIA ORAL (numb lips) and OROPHARYNGEAL DISCOMFORT (continual clearing of throat). At the time of the report, PARAESTHESIA ORAL (tingling lips) and HYPOAESTHESIA ORAL (numb lips) had resolved and OROPHARYNGEAL DISCOMFORT (continual clearing of throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment details were not provided.

Other Meds:

Current Illness: Fish allergy.

ID: 1595068
Sex: F
Age: 81
State: TX

Vax Date: 01/21/2021
Onset Date: 02/01/2021
Rec V Date: 08/21/2021
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: itchy bumps in left arm; Red round circle in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (itchy bumps in left arm) and VACCINATION SITE ERYTHEMA (Red round circle in the left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 941L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (itchy bumps in left arm) and VACCINATION SITE ERYTHEMA (Red round circle in the left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE URTICARIA (itchy bumps in left arm) and VACCINATION SITE ERYTHEMA (Red round circle in the left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided.

Other Meds:

Current Illness:

ID: 1595069
Sex: M
Age: 60
State: PA

Vax Date: 02/08/2021
Onset Date: 02/09/2021
Rec V Date: 08/21/2021
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: Small fever; A spontaneous report was received from a Consumer concerning a 60-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced small fever. The patient's medical history was not provided. Concomitant medications reported were Plavix, Baby Aspirin for drug use for unknown indication. On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the right arm for prophylaxis of COVID-19 infection. On 9 Feb 2021, the patient experienced the events small fever. Treatment details included Tylenol Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of events, small fever was resolved.

Other Meds: PLAVIX; BABY ASPIRIN

Current Illness:

ID: 1595070
Sex: F
Age: 77
State: SC

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/21/2021
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: A spontaneous report was received from a Consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe abdominal pain, worsen by walking and relieved by sitting.. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 12 Feb 2021, the patient experienced the events severe abdominal pain. worsen by walking and relieved by sitting.. Treatment details included Tylenol Action taken with mRNA-1273 in response to the events was not reported. On 15 Feb 2021 the outcome of events severe abdominal pain was resolved.On 15 Feb 2021 the outcome of events worsen by walking and relieved by sitting. was resolved. .

Other Meds:

Current Illness:

ID: 1595071
Sex: F
Age:
State: VA

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 08/21/2021
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: COVID-19 Diagnosis; WEAKNESS; COUGH; FEELING TIRED; FEVER; CHILLS; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 Diagnosis), ASTHENIA (WEAKNESS), COUGH (COUGH), FATIGUE (FEELING TIRED) and PYREXIA (FEVER) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 Diagnosis), ASTHENIA (WEAKNESS), COUGH (COUGH), FATIGUE (FEELING TIRED), PYREXIA (FEVER) and CHILLS (CHILLS). At the time of the report, COVID-19 (COVID-19 Diagnosis), ASTHENIA (WEAKNESS), COUGH (COUGH), FATIGUE (FEELING TIRED), PYREXIA (FEVER) and CHILLS (CHILLS) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Medications were provided. No Treatment Medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Non-significant follow-up received.

Other Meds:

Current Illness:

ID: 1595072
Sex: F
Age: 81
State: FL

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 08/21/2021
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: dizziness; stomach hurts not consistent but comes and goes and when it comes it hurts; feeling weak; muscle achness; joint pain; chills; Headache; started feeling sick; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (started feeling sick), INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach hurts not consistent but comes and goes and when it comes it hurts) and ASTHENIA (feeling weak) in an 82-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 08-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 ILLNESS (started feeling sick), INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach hurts not consistent but comes and goes and when it comes it hurts), ASTHENIA (feeling weak), MYALGIA (muscle achness), ARTHRALGIA (joint pain), CHILLS (chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Muscle pain, at an unspecified dose and frequency. At the time of the report, ILLNESS (started feeling sick), INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach hurts not consistent but comes and goes and when it comes it hurts), ASTHENIA (feeling weak), MYALGIA (muscle achness), ARTHRALGIA (joint pain), CHILLS (chills) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided

Other Meds:

Current Illness:

ID: 1595073
Sex: M
Age: 74
State: WI

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/21/2021
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: Right arm is sore and soreness in both legs; stiffness in back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm is sore and soreness in both legs) and MUSCULOSKELETAL STIFFNESS (stiffness in back) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included WARFARIN, LOSARTAN, MULTIVITAMIN [VITAMINS NOS], UBIDECARENONE (COQ 10) and HYDROCHLOROTHIAZIDE 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-Feb-2021, the patient experienced PAIN IN EXTREMITY (Right arm is sore and soreness in both legs) and MUSCULOSKELETAL STIFFNESS (stiffness in back). At the time of the report, PAIN IN EXTREMITY (Right arm is sore and soreness in both legs) and MUSCULOSKELETAL STIFFNESS (stiffness in back) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided No Treatment information provided

Other Meds: WARFARIN; LOSARTAN; MULTIVITAMIN [VITAMINS NOS]; COQ 10; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1595074
Sex: F
Age: 85
State: OH

Vax Date: 01/16/2021
Onset Date: 02/14/2021
Rec V Date: 08/21/2021
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: Itchy; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and ERYTHEMA (Redness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PRURITUS (Itchy) and ERYTHEMA (Redness). At the time of the report, PRURITUS (Itchy) and ERYTHEMA (Redness) outcome was unknown. Not Provided No Concomitant medications were provided No Treatment information provided

Other Meds:

Current Illness:

ID: 1595075
Sex: M
Age: 72
State: TX

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 08/21/2021
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: Chills; nausea,; pain in the injection site/ it is real sore; headache; couldn't get comfortable; feels unstable; feels dizzy; did not get enough sleep; achy; violently shaking; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (couldn't get comfortable), FEELING ABNORMAL (feels unstable), DIZZINESS (feels dizzy), INSOMNIA (did not get enough sleep) and PAIN (achy) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Patient had COVID-19 back in November.). Concurrent medical conditions included Stomach upset (patient has stomach problem), Diverticulitis, Heart disorder and Allergy. Concomitant products included TRAMADOL and CYANOCOBALAMIN (B12-VITAMIIN) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DISCOMFORT (couldn't get comfortable), FEELING ABNORMAL (feels unstable), DIZZINESS (feels dizzy), INSOMNIA (did not get enough sleep), PAIN (achy), TREMOR (violently shaking), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the injection site/ it is real sore). On an unknown date, the patient experienced CHILLS (Chills) and NAUSEA (nausea,). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, DISCOMFORT (couldn't get comfortable), FEELING ABNORMAL (feels unstable), DIZZINESS (feels dizzy), INSOMNIA (did not get enough sleep), PAIN (achy), TREMOR (violently shaking), CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea,) and VACCINATION SITE PAIN (pain in the injection site/ it is real sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: TRAMADOL; B12-VITAMIIN

Current Illness:

ID: 1595076
Sex: F
Age:
State: FL

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 08/21/2021
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: flu like symptoms; sick; feels pretty bad today; red blotches on face; extreme fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), ILLNESS (sick), MOOD ALTERED (feels pretty bad today) and RASH MACULAR (red blotches on face) in an 80-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. The patient's past medical history was not reported . Concomitant products included LEVOTHYROXINE, CALCIUM, MAGNESIUM, VITAMIN D3, FAMOTIDINE, MONTELUKAST and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 15-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), ILLNESS (sick), MOOD ALTERED (feels pretty bad today), RASH MACULAR (red blotches on face) and FATIGUE (extreme fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), ILLNESS (sick), MOOD ALTERED (feels pretty bad today), RASH MACULAR (red blotches on face) and FATIGUE (extreme fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products also included b12 complex, ginko boiloba, . No treatment information was provided.

Other Meds: LEVOTHYROXINE; CALCIUM; MAGNESIUM; VITAMIN D3; FAMOTIDINE; MONTELUKAST; ZYRTEC ALLERGY

Current Illness:

ID: 1595077
Sex: F
Age:
State: MO

Vax Date: 02/04/2021
Onset Date: 02/01/2021
Rec V Date: 08/21/2021
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: a few aches; bruise; itching; tenderness; redness; slight fatigue "draggy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a few aches), VACCINATION SITE BRUISING (bruise), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (tenderness) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown by patient) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: PREVNAR 13. On 04-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 (a few aches), VACCINATION SITE BRUISING (bruise), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (tenderness), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (slight fatigue "draggy). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PAIN (a few aches), VACCINATION SITE BRUISING (bruise), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (tenderness), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (slight fatigue "draggy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1595078
Sex: F
Age: 74
State: CA

Vax Date: 02/08/2021
Onset Date: 02/15/2021
Rec V Date: 08/21/2021
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 rash; Soreness; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red rash(rash erythematous), soreness(pain). The patient's medical history was not provided. No relevant concomitant medications were reported. On 8 Feb 2021, approximately 8 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 15 Feb 2021, the patient experienced the event(s) red rash and soreness. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), red rash and soreness was unknown..

Other Meds:

Current Illness:

ID: 1595079
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction). At the time of the report, VACCINATION COMPLICATION (Adverse reaction) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1595080
Sex: M
Age: 68
State: NC

Vax Date: 02/03/2021
Onset Date: 02/17/2021
Rec V Date: 08/21/2021
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: Fever of 99.1F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 99.1F) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (Fever of 99.1F). At the time of the report, PYREXIA (Fever of 99.1F) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1595081
Sex: F
Age: 76
State: TN

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/21/2021
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: Very srtong urine odor; Muscle aches; Threw up; rash is very red/rash all over her face; this rash started being itchy; Rash on her forehead/rash appeared on the side of her face as well; Shaky; Loss of appetite; Felt faint/Lightheaded; Headache; Nausea; Fatigue; Chills really badly; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), RASH ERYTHEMATOUS (rash is very red/rash all over her face), URINE ODOUR ABNORMAL (Very srtong urine odor), RASH PRURITIC (this rash started being itchy) and DECREASED APPETITE (Loss of appetite) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (Chills really badly). On 06-Feb-2021, the patient experienced TREMOR (Shaky), DECREASED APPETITE (Loss of appetite), DIZZINESS (Felt faint/Lightheaded), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 23-Feb-2021, the patient experienced RASH (Rash on her forehead/rash appeared on the side of her face as well). On 28-Feb-2021, the patient experienced RASH PRURITIC (this rash started being itchy). On 01-Mar-2021, the patient experienced RASH ERYTHEMATOUS (rash is very red/rash all over her face). On an unknown date, the patient experienced URINE ODOUR ABNORMAL (Very srtong urine odor), MYALGIA (Muscle aches) and VOMITING (Threw up). At the time of the report, TREMOR (Shaky), RASH ERYTHEMATOUS (rash is very red/rash all over her face), URINE ODOUR ABNORMAL (Very srtong urine odor), RASH PRURITIC (this rash started being itchy), DECREASED APPETITE (Loss of appetite), DIZZINESS (Felt faint/Lightheaded), RASH (Rash on her forehead/rash appeared on the side of her face as well), CHILLS (Chills really badly), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), MYALGIA (Muscle aches) and VOMITING (Threw up) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: significant followup received on 28-jul-2021 in which AE were added and contact details were updated

Other Meds:

Current Illness:

ID: 1595082
Sex: F
Age: 59
State: MT

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 08/21/2021
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: Itching all over her head, neck and arms/Extreme itchiness; Runny nose; Felt like she had a mild cold; Muscle pain; Underarm swelling of her lymph nodes; Raised red spot on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over her head, neck and arms/Extreme itchiness), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Felt like she had a mild cold), MYALGIA (Muscle pain) and PERIPHERAL SWELLING (Underarm swelling of her lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 05-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 PRURITUS (Itching all over her head, neck and arms/Extreme itchiness), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Felt like she had a mild cold), MYALGIA (Muscle pain), PERIPHERAL SWELLING (Underarm swelling of her lymph nodes) and VACCINATION SITE ERYTHEMA (Raised red spot on her arm). The patient was treated with PARACETAMOL (TYLENOL) for Muscle pain, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching all over her head, neck and arms/Extreme itchiness), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Felt like she had a mild cold), MYALGIA (Muscle pain), PERIPHERAL SWELLING (Underarm swelling of her lymph nodes) and VACCINATION SITE ERYTHEMA (Raised red spot on her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1595083
Sex: U
Age:
State: CA

Vax Date: 02/09/2021
Onset Date: 02/13/2021
Rec V Date: 08/21/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Delayed reaction red spot), INFECTION (infection), SWELLING (Delayed reaction swelling), PRURITUS (Delayed reaction itching) and PAIN (Delayed reaction pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced RASH MACULAR (Delayed reaction red spot), SWELLING (Delayed reaction swelling), PRURITUS (Delayed reaction itching) and PAIN (Delayed reaction pain). On 14-Feb-2021, the patient experienced INFECTION (infection). The patient was treated with CEFALEXIN (CEPHALEXINE) (oral) at a dose of 500 mg. At the time of the report, RASH MACULAR (Delayed reaction red spot), INFECTION (infection), SWELLING (Delayed reaction swelling), PRURITUS (Delayed reaction itching) and PAIN (Delayed reaction pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1595084
Sex: F
Age: 81
State: FL

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/21/2021
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: headache; fever; can't move her arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever) and LIMB DISCOMFORT (can't move her arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included normal medications 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-Feb-2021, the patient experienced HEADACHE (headache), PYREXIA (fever) and LIMB DISCOMFORT (can't move her arm). At the time of the report, HEADACHE (headache), PYREXIA (fever) and LIMB DISCOMFORT (can't move her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Tylenol

Other Meds: normal medications

Current Illness:

ID: 1595085
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: strange side effect 8 days later; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strange side effect 8 days later) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (strange side effect 8 days later). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (strange side effect 8 days later) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to US-MODERNATX, INC.-MOD-2021-092609, US-MODERNATX, INC.-MOD-2021-091728 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2021-091728: Phone number is matching in this case with mothers case US-MODERNATX, INC.-MOD-2021-092609: Phone number is same in mother case and this case

Other Meds:

Current Illness:

ID: 1595086
Sex: F
Age: 85
State: OH

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 08/21/2021
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: Patient developed blisters and sores in her mouth; Patient developed blisters and sores in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Patient developed blisters and sores in her mouth) and ORAL PAIN (Patient developed blisters and sores in her mouth) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03HK20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced BLISTER (Patient developed blisters and sores in her mouth) and ORAL PAIN (Patient developed blisters and sores in her mouth). At the time of the report, BLISTER (Patient developed blisters and sores in her mouth) and ORAL PAIN (Patient developed blisters and sores in her mouth) outcome was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm