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: 1570622
Sex: M
Age:
State:

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
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: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not 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 26-Mar-2021: Significant Follow up Appended

Other Meds:

Current Illness:

ID: 1570623
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: Swollen feet; fast heart beat; rush in her risk to her elbow; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen feet), HEART RATE INCREASED (fast heart beat) and FEELING ABNORMAL (rush in her risk to her elbow) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen feet), HEART RATE INCREASED (fast heart beat) and FEELING ABNORMAL (rush in her risk to her elbow). At the time of the report, PERIPHERAL SWELLING (Swollen feet), HEART RATE INCREASED (fast heart beat) and FEELING ABNORMAL (rush in her risk to her elbow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1570624
Sex: F
Age: 97
State: FL

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
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: size of the palm of your hand; hot to touch; itching at injection site; left arm swelling at vaccination site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (size of the palm of your hand), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (left arm swelling at vaccination site) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Asymptomatic COVID-19 in 2021. Concurrent medical conditions included Sulfonamide allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PARACETAMOL (TYLENOL), GABAPENTIN and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ADVERSE EVENT (size of the palm of your hand), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (left arm swelling at vaccination site) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, ADVERSE EVENT (size of the palm of your hand), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (left arm swelling at vaccination site) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included blood pressure medication and antibiotic. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: information regarding second dose updated NNI FOR DOSE ONE

Other Meds: SYNTHROID; TYLENOL; GABAPENTIN; PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]

Current Illness: Sulfonamide allergy

ID: 1570625
Sex: F
Age: 76
State: SC

Vax Date: 02/12/2021
Onset Date: 02/14/2021
Rec V Date: 08/15/2021
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: 1st dose of the Moderna vaccine and by day number 39 she has not received the 2nd dose yet.; Really Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna vaccine and by day number 39 she has not received the 2nd dose yet.) and PAIN IN EXTREMITY (Really Sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029AOL) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medial history reported). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna vaccine and by day number 39 she has not received the 2nd dose yet.) and PAIN IN EXTREMITY (Really Sore arm). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna vaccine and by day number 39 she has not received the 2nd dose yet.) outcome was unknown and PAIN IN EXTREMITY (Really Sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Medication regularly taken: Blood pressure medication, Lipitor, fluid pill, thyroid medication. No Treatment information provided

Other Meds: LIPITOR

Current Illness:

ID: 1570626
Sex: F
Age: 82
State: MA

Vax Date: 02/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
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: itching; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching) and PAIN IN EXTREMITY (sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032L20A) 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) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 13-Mar-2021, the patient experienced PRURITUS (itching) and PAIN IN EXTREMITY (sore arm). At the time of the report, PRURITUS (itching) and PAIN IN EXTREMITY (sore arm) outcome was unknown. No concomitant medications and treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-017475 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-017475:crosslink

Other Meds:

Current Illness:

ID: 1570627
Sex: F
Age: 68
State: AL

Vax Date: 03/12/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
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: This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of diarrhea in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 17, 2021, patient experienced diarrhea. At the time of the report, diarrhea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use, treatment information and lab details not provided. Patient stated she went to her doctor and after a test, he determined the diarrhea was caused by antibiotics she had taken after oral surgery. Most recent follow-up information incorporated above includes: On May 11, 2021: Reporter comment added.

Other Meds:

Current Illness:

ID: 1570628
Sex: M
Age: 36
State: CA

Vax Date: 03/12/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
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: pain in his foot; it's hard to walk and bend himself; he's lame; he started having chills for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his foot), GAIT INABILITY (it's hard to walk and bend himself), GAIT INABILITY (he's lame) and CHILLS (he started having chills for 3 days) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in his foot), GAIT INABILITY (it's hard to walk and bend himself), GAIT INABILITY (he's lame) and CHILLS (he started having chills for 3 days). The patient was treated with IBUPROFEN (ADVEL) for Prophylaxis, at an unspecified dose and frequency. On 20-Mar-2021, CHILLS (he started having chills for 3 days) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in his foot), GAIT INABILITY (it's hard to walk and bend himself) and GAIT INABILITY (he's lame) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information included advel.

Other Meds:

Current Illness:

ID: 1570629
Sex: M
Age: 34
State: MD

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
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: diarrhea; began having fever; chills; body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Mar-2021 and was forwarded to Moderna on 23-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (began having fever), CHILLS (chills) and MYALGIA (body aches) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PYREXIA (began having fever), CHILLS (chills) and MYALGIA (body aches). On 22-Mar-2021, the patient experienced DIARRHOEA (diarrhea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), PYREXIA (began having fever), CHILLS (chills) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1570630
Sex: M
Age: 67
State: SC

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 08/15/2021
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: aches/pain/soreness; low-grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches/pain/soreness), PYREXIA (low-grade fever) and CHILLS (chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017A21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. Concomitant products included POTASSIUM for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches/pain/soreness), PYREXIA (low-grade fever) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (aches/pain/soreness), PYREXIA (low-grade fever) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. concomitant medication including high blood pressure pill and sugar pill.

Other Meds: POTASSIUM

Current Illness: Blood pressure high

ID: 1570631
Sex: F
Age:
State: CA

Vax Date: 03/09/2021
Onset Date:
Rec V Date: 08/15/2021
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: diarrhea; a little weakness; muscle pain; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 23-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ASTHENIA (a little weakness), MYALGIA (muscle pain) and HEADACHE (headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-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 an unknown date, the patient experienced DIARRHOEA (diarrhea), ASTHENIA (a little weakness), MYALGIA (muscle pain) and HEADACHE (headache). At the time of the report, DIARRHOEA (diarrhea), ASTHENIA (a little weakness), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: NNI, FU call with patient's granddaughter, granddaughter states patient has no email and no one to speak on patient's behalf

Other Meds:

Current Illness:

ID: 1570632
Sex: F
Age: 59
State: DE

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 08/15/2021
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: Twinging; pain is in her shoulder and left side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Twinging) and PAIN (pain is in her shoulder and left side) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B121A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, High cholesterol and Overweight. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Twinging) and PAIN (pain is in her shoulder and left side). At the time of the report, PAIN (Twinging) and PAIN (pain is in her shoulder and left side) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication not reported. Treatment medication not reported.

Other Meds:

Current Illness: Diabetes; High cholesterol; Overweight

ID: 1570633
Sex: F
Age:
State: NJ

Vax Date: 01/28/2021
Onset Date: 02/04/2021
Rec V Date: 08/15/2021
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: Tired; Rash around the site of injection; Redness around the site of injection; Mild swelling around the site of injection; Redness, swelling and itching; Red scar, teeny bit of swelling around red site for 48 hours; Hypersensitivity reaction; Itching for first 18 hours; Itching around the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness, swelling and itching), SWELLING (Red scar, teeny bit of swelling around red site for 48 hours), HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itching for first 18 hours) and VACCINATION SITE PRURITUS (Itching around the site of injection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LOSARTAN from 01-Nov-2018 to an unknown date for Blood pressure high, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM D3) for Bone disorder, MULTIVITAMINS WITH IRON [ASCORBIC ACID;CYANOCOBALAMIN;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHEROL] and FISH OIL for Vitamin supplementation, VITAMIN D3 for an unknown indication. On 28-Jan-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 2:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021 at 4:00 AM, the patient experienced ERYTHEMA (Redness, swelling and itching), SWELLING (Red scar, teeny bit of swelling around red site for 48 hours), HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itching for first 18 hours), VACCINATION SITE PRURITUS (Itching around the site of injection), VACCINATION SITE RASH (Rash around the site of injection), VACCINATION SITE ERYTHEMA (Redness around the site of injection) and VACCINATION SITE SWELLING (Mild swelling around the site of injection). On an unknown date, the patient experienced FATIGUE (Tired). The patient was treated with HYDROCORTISONE (topical) ongoing since an unknown date for Itching, Redness and Rash, at an unspecified dose and frequency. On 08-Feb-2021 at 10:00 AM, ERYTHEMA (Redness, swelling and itching), SWELLING (Red scar, teeny bit of swelling around red site for 48 hours), HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itching for first 18 hours), VACCINATION SITE PRURITUS (Itching around the site of injection), VACCINATION SITE RASH (Rash around the site of injection), VACCINATION SITE ERYTHEMA (Redness around the site of injection) and VACCINATION SITE SWELLING (Mild swelling around the site of injection) had resolved. At the time of the report, FATIGUE (Tired) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. patient started experiencing the events 'eight days after getting the first dose of the Moderna vaccine" and that the event fatigue was experienced on the second dose only. Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up updated on 26-Jun-2021:Patients demographic details, lab data, concomitant product details , event start date and end date, event outcome updated.

Other Meds: LOSARTAN; CALCIUM D3; MULTIVITAMINS WITH IRON [ASCORBIC ACID;CYANOCOBALAMIN;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PYRIDOX; FISH OIL; VITAMIN D3

Current Illness:

ID: 1570634
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on the injection site). At the time of the report, VACCINATION SITE RASH (Rash on the injection site) outcome was unknown. No relevant concomitant medications were reported. Treatment information provided as none. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1570635
Sex: F
Age: 68
State: TX

Vax Date: 01/21/2021
Onset Date: 05/03/2021
Rec V Date: 08/15/2021
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: getting hot flashes; Aches in lower back/pain in lower back; Pain in back of legs; headache everyday; Had a fall; Hurt elbow; Pounding in ears; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (getting hot flashes), BACK PAIN (Aches in lower back/pain in lower back), TINNITUS (Pounding in ears), PAIN IN EXTREMITY (Pain in back of legs) and FALL (Had a fall) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M0A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bronchitis (January 2021). Concurrent medical conditions included Arthritis and Diabetes (2020). Concomitant products included GLIMEPIRIDE and METFORMIN for Diabetes, VITAMIN B12 NOS, MULTIVITAMIN FOR WOMEN and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced FALL (Had a fall) and JOINT INJURY (Hurt elbow). On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HOT FLUSH (getting hot flashes), BACK PAIN (Aches in lower back/pain in lower back), TINNITUS (Pounding in ears), PAIN IN EXTREMITY (Pain in back of legs) and HEADACHE (headache everyday). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (getting hot flashes) and BACK PAIN (Aches in lower back/pain in lower back) had not resolved, TINNITUS (Pounding in ears) and HEADACHE (headache everyday) had resolved and PAIN IN EXTREMITY (Pain in back of legs), FALL (Had a fall) and JOINT INJURY (Hurt elbow) outcome was unknown. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: follow up was received on 18 may 2021 patient demographics, date of the events, other events ,events outcome, concomitant medication was updated.

Other Meds: GLIMEPIRIDE; METFORMIN; VITAMIN B12 NOS; MULTIVITAMIN FOR WOMEN; VITAMIN C [ASCORBIC ACID]

Current Illness: Diabetes (2020)

ID: 1570636
Sex: F
Age: 86
State: AZ

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
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 TREMOR (she was shaking like a druggy), HEART RATE DECREASED (heart rate at 44), FATIGUE (wiped out) and HEADACHE (headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced TREMOR (she was shaking like a druggy), FATIGUE (wiped out) and HEADACHE (headache). On 21-Mar-2021, the patient experienced HEART RATE DECREASED (heart rate at 44). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 19-Mar-2021, TREMOR (she was shaking like a druggy) and FATIGUE (wiped out) had resolved. On 21-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, HEART RATE DECREASED (heart rate at 44) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1570637
Sex: F
Age: 35
State: IL

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
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: Pregnant patient received the 1st Moderna covid-19 vaccination; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st Moderna covid-19 vaccination) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 039A21A) for COVID-19 vaccination. The patient's past medical history included Pregnancy (complication of shoulder dystocia upon delivery and live, full-term birth.) on 02-Jun-2016 and Pregnancy on 24-Nov-2017. Concurrent medical conditions included Drug allergy (Sulfa), Rash lupus-like (Lupus- NOS) since 01-Feb-2020, Drug allergy (Ceclor), Drug allergy (Bactrim) and Drug allergy (cephalosporins - rash). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ASPIRIN [ACETYLSALICYLIC ACID] for Pregnancy, HYDROXYCHLOROQUINE for Rash lupus-like, VITAMIN D NOS for Vitamin D deficiency. On 12-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Nov-2020 and the estimated date of delivery was 24-Aug-2021. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st Moderna covid-19 vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the sixteenth week of the pregnancy. On 12-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st Moderna covid-19 vaccination) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Ultrasound foetal: normal (normal) 12 week US. On 03-Mar-2021, Ultrasound foetal: normal (normal) 20 Week Ultrasound. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The date of positive pregnancy test was 24-Dec-2020. The patient has an established prenatal care. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received contains non-significant information.

Other Meds: HYDROXYCHLOROQUINE; VITAMIN D NOS; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Drug allergy (Sulfa); Drug allergy (cephalosporins - rash); Drug allergy (Ceclor); Drug allergy (Bactrim); Rash lupus-like (Lupus- NOS)

ID: 1570638
Sex: F
Age: 89
State:

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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: Aches; Sore Throat; Was in Bed 3 days; Arm was really sore; Bad cough; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), OROPHARYNGEAL PAIN (Sore Throat), BED REST (Was in Bed 3 days), PAIN IN EXTREMITY (Arm was really sore) and COUGH (Bad cough) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, the patient experienced PAIN (Aches), OROPHARYNGEAL PAIN (Sore Throat), BED REST (Was in Bed 3 days), PAIN IN EXTREMITY (Arm was really sore) and COUGH (Bad cough). At the time of the report, PAIN (Aches), OROPHARYNGEAL PAIN (Sore Throat), BED REST (Was in Bed 3 days), PAIN IN EXTREMITY (Arm was really sore) and COUGH (Bad cough) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 102f (Inconclusive) Inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Event outcome updated.

Other Meds:

Current Illness:

ID: 1570639
Sex: F
Age:
State: NV

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: severe pain from her neck to the top of her arm; severe pain from her neck to the top of her arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe pain from her neck to the top of her arm) and PAIN IN EXTREMITY (severe pain from her neck to the top of her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (severe pain from her neck to the top of her arm) and PAIN IN EXTREMITY (severe pain from her neck to the top of her arm). At the time of the report, NECK PAIN (severe pain from her neck to the top of her arm) and PAIN IN EXTREMITY (severe pain from her neck to the top of her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1570640
Sex: F
Age:
State: LA

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
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: 9 cm area erythema; hot to the touch at the injection site; itching at the injection site; red at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (9 cm area erythema), VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ERYTHEMA (9 cm area erythema), VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) (oral) at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE (topical) at a dose of 0.1 percent. At the time of the report, ERYTHEMA (9 cm area erythema), VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) 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. No concomitant medication were provided. Treatment medication included Bactrom and triamcinolone acetonide 0.1 % topical cream.

Other Meds:

Current Illness:

ID: 1570641
Sex: F
Age:
State: LA

Vax Date: 03/22/2021
Onset Date: 03/23/2021
Rec V Date: 08/15/2021
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: having shortness of breath; Doing a great deal of coughing; Really panicking; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having shortness of breath), COUGH (Doing a great deal of coughing) and PANIC REACTION (Really panicking) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DYSPNOEA (having shortness of breath), COUGH (Doing a great deal of coughing) and PANIC REACTION (Really panicking). At the time of the report, DYSPNOEA (having shortness of breath), COUGH (Doing a great deal of coughing) and PANIC REACTION (Really panicking) had resolved. Not Provided 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 28-Jun-2021: Follow up received on 28-Jun-2021 contains significant information. Changed outcome of the event from unknown to recovered/resolved.

Other Meds:

Current Illness:

ID: 1570642
Sex: F
Age: 66
State: OH

Vax Date: 02/20/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
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: Hard time sleeping; Didnt feel good; Feeling sick; Arm started hurting, right arm also started hurting; Feeling very tired; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Hard time sleeping), FEELING ABNORMAL (Didnt feel good), MALAISE (Feeling sick), PAIN IN EXTREMITY (Arm started hurting, right arm also started hurting) and FATIGUE (Feeling very tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A 028L20A and 038A21A) 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 GABAPENTIN, SPIRONOLACTONE, FUROSEMIDE, OMEPRAZOLE, FOLIC ACID, VITAMIN B12 NOS, POTASSIUM, ELDERBERRY [SAMBUCUS NIGRA], GARLIC [ALLIUM SATIVUM], TURMERIC [CURCUMA LONGA RHIZOME], CALCIUM, MAGNESIUM, LACTULOSE and UBIDECARENONE (COQ 10) for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INSOMNIA (Hard time sleeping), FEELING ABNORMAL (Didnt feel good), MALAISE (Feeling sick), PAIN IN EXTREMITY (Arm started hurting, right arm also started hurting), HEADACHE (Headache) and CHILLS (Chills). 20-Mar-2021, the patient experienced FATIGUE (Feeling very tired). The patient was treated with TRAMADOL at an unspecified dose and frequency and Manual therapy (cold packs on arm) for Pain in extremity. At the time of the report, INSOMNIA (Hard time sleeping), FEELING ABNORMAL (Didnt feel good), MALAISE (Feeling sick), PAIN IN EXTREMITY (Arm started hurting, right arm also started hurting), FATIGUE (Feeling very tired), HEADACHE (Headache) and CHILLS (Chills) was resolving. This case was linked to US-MODERNATX, INC.-MOD-2021-054246 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-054246:patient link, 1st dose case

Other Meds: GABAPENTIN; SPIRONOLACTONE; FUROSEMIDE; OMEPRAZOLE; FOLIC ACID; VITAMIN B12 NOS; POTASSIUM; ELDERBERRY [SAMBUCUS NIGRA]; GARLIC [ALLIUM SATIVUM]; TURMERIC [CURCUMA LONGA RHIZOME]; CALCIUM; MAGNESIUM; LACTULOSE; COQ 10

Current Illness:

ID: 1570643
Sex: M
Age:
State: CA

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
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: Affected heartbeat (the next morning).; Swollen throat--not too much; Difficulty breathing--not gasping for air,; Unable to sleep; Headache; Joint pain; Nausea; Muscle pain; Fever of 101.3; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Affected heartbeat (the next morning).), PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep) and HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (December 2020). Concurrent medical conditions included Lung scarring (Due to COVID-19 in December2020). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), LATANOPROST, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & COLD) and DORZOLAMIDE for an unknown indication. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle pain), PYREXIA (Fever of 101.3) and CHILLS (Chills). On 28-Feb-2021, the patient experienced HEART RATE IRREGULAR (Affected heartbeat (the next morning).). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, HEART RATE IRREGULAR (Affected heartbeat (the next morning).), PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle pain), PYREXIA (Fever of 101.3) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) Units not reported, Fever confirmed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: PRILOSEC [OMEPRAZOLE MAGNESIUM]; LATANOPROST; BENADRYL ALLERGY & COLD; DORZOLAMIDE

Current Illness: Lung scarring (Due to COVID-19 in December2020)

ID: 1570644
Sex: F
Age: 53
State: WI

Vax Date: 03/21/2021
Onset Date: 03/21/2021
Rec V Date: 08/15/2021
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: skin infection; Itchiness; Hotness; Stiff shoulders; Swelling; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), FEELING HOT (Hotness), MUSCULOSKELETAL STIFFNESS (Stiff shoulders), SWELLING (Swelling) and HEADACHE (Headache) in a 53-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. The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL), METFORMIN, LISDEXAMFETAMINE MESILATE (VYVANSE), COLECALCIFEROL (VIT D [COLECALCIFEROL]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), TIOTROPIUM BROMIDE (SPIRIVA) and ALBUTEROL [SALBUTAMOL] for an unknown indication. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PRURITUS (Itchiness), FEELING HOT (Hotness), MUSCULOSKELETAL STIFFNESS (Stiff shoulders), SWELLING (Swelling), HEADACHE (Headache) and NAUSEA (Nausea). On 02-Apr-2021, the patient experienced SKIN INFECTION (skin infection). The patient was treated with DICLOFENAC at a dose of UNK dosage form. At the time of the report, PRURITUS (Itchiness), FEELING HOT (Hotness), MUSCULOSKELETAL STIFFNESS (Stiff shoulders), SWELLING (Swelling), HEADACHE (Headache), NAUSEA (Nausea) and SKIN INFECTION (skin infection) 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. The patient's medical history was not provided. Treatment details included Diclofenac, Tylenol. Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: fallow up information received on 05-apr-2021 updated the outcome of the event skin infection from( unknown to unknown)

Other Meds: TYLENOL; METFORMIN; VYVANSE; VIT D [COLECALCIFEROL]; ADVAIR; SPIRIVA; ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1570645
Sex: F
Age:
State: PA

Vax Date: 03/21/2021
Onset Date:
Rec V Date: 08/15/2021
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: Allergic reaction to her face cream; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to her face cream) 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 21-Mar-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 HYPERSENSITIVITY (Allergic reaction to her face cream). At the time of the report, HYPERSENSITIVITY (Allergic reaction to her face cream) 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: 1570646
Sex: F
Age: 71
State: OR

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), VACCINATION SITE WARMTH (hot to touch), ORAL HERPES (fever blister(cold sore)), VACCINATION SITE INDURATION (hard to touch) and VACCINATION SITE ERYTHEMA (red swatch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). On 14-Apr-2021, the patient experienced ORAL HERPES (fever blister(cold sore)). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (hard to touch), VACCINATION SITE ERYTHEMA (red swatch) and VACCINATION SITE SWELLING (size of peach in diameter). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, PAIN IN EXTREMITY (very sore arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot to touch), ORAL HERPES (fever blister(cold sore)), VACCINATION SITE INDURATION (hard to touch), VACCINATION SITE ERYTHEMA (red swatch) and VACCINATION SITE SWELLING (size of peach in diameter) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant Product was none. Treatment included as tylenol and ice pack

Other Meds:

Current Illness:

ID: 1570647
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: Bone pain; Vivid dreams; vaccination related malaise; Night sweat; Vaccination site erythema; Vaccination site swelling; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), ABNORMAL DREAMS (Vivid dreams), VACCINATION COMPLICATION (vaccination related malaise), NIGHT SWEATS (Night sweat) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 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 BONE PAIN (Bone pain), ABNORMAL DREAMS (Vivid dreams), VACCINATION COMPLICATION (vaccination related malaise), NIGHT SWEATS (Night sweat), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and MYALGIA (Myalgia). At the time of the report, BONE PAIN (Bone pain), ABNORMAL DREAMS (Vivid dreams), VACCINATION COMPLICATION (vaccination related malaise), NIGHT SWEATS (Night sweat), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and MYALGIA (Myalgia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information received

Other Meds:

Current Illness:

ID: 1570648
Sex: M
Age:
State: AR

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 08/15/2021
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: Second Dose administered at day 20; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose administered at day 20) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported. ). On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose administered at day 20). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose administered at day 20) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown with no associated AEs. Reporter did not allow further contact; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown with no associated AEs.

Other Meds:

Current Illness:

ID: 1570649
Sex: F
Age:
State: IL

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/15/2021
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: serious joint pain in shoulder in the same arm as injection, left non-dominant arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (serious joint pain in shoulder in the same arm as injection, left non-dominant arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 026L20A) for COVID-19 vaccination. The patient's past medical history included Blood pressure (high). On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (serious joint pain in shoulder in the same arm as injection, left non-dominant arm). At the time of the report, ARTHRALGIA (serious joint pain in shoulder in the same arm as injection, left non-dominant arm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. It was not reported if the patient was received any corrective treatment for the event.

Other Meds:

Current Illness:

ID: 1570650
Sex: F
Age:
State: FL

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/15/2021
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: Have not received second dose within 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Have not received second dose within 36 days) 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. In January 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Have not received second dose within 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Have not received second dose within 36 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.

Other Meds:

Current Illness:

ID: 1570651
Sex: F
Age:
State: NJ

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
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: Dizziness; Near fainting; Couldn't use arm to get off floor; arm was very painful/arm was achy; General body pain; Nauseated; Pain in arm; Swollen lymph node / lymph node under arm where received shot is swollen; Fever; Vomiting; Fatigue; Missed dose; Dehydration; Movement disorder; Vertigo; Brain fog; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), MOVEMENT DISORDER (Movement disorder), PAIN IN EXTREMITY (Pain in arm), VERTIGO (Vertigo) and FEELING ABNORMAL (Brain fog) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Multiple sclerosis since 11-Jan-2004, Sturge-Weber syndrome since 02-Jun-1980, Asthma since 1981, COVID-19 on 02-Feb-2021 and Abdominal pain since 31-Oct-2020. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (TRI-LO-SPRINTEC) for Birth control, PARACETAMOL (TYLENOL) for Fever, VITAMIN B12 NOS and VITAMIN D3 for MS, INTERFERON BETA-1A (REBIF) for Multiple sclerosis, VITAMIN B NOS and VITAMIN D NOS for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). On 13-Mar-2021, the patient experienced DEHYDRATION (Dehydration), MOVEMENT DISORDER (Movement disorder), PAIN IN EXTREMITY (Pain in arm), VERTIGO (Vertigo), FEELING ABNORMAL (Brain fog), PRODUCT DOSE OMISSION ISSUE (Missed dose), LYMPHADENOPATHY (Swollen lymph node / lymph node under arm where received shot is swollen), PYREXIA (Fever), VOMITING (Vomiting) and FATIGUE (Fatigue). On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (General body pain), PRESYNCOPE (Near fainting), MOBILITY DECREASED (Couldn't use arm to get off floor), PAIN IN EXTREMITY (arm was very painful/arm was achy) and NAUSEA (Nauseated). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Vomiting, at a dose of 1 dosage form. On 14-Mar-2021, VERTIGO (Vertigo) and VOMITING (Vomiting) had resolved. On 15-Mar-2021, DEHYDRATION (Dehydration) had resolved. At the time of the report, MOVEMENT DISORDER (Movement disorder), FEELING ABNORMAL (Brain fog), DIZZINESS (Dizziness), PAIN (General body pain), PRESYNCOPE (Near fainting), VACCINATION COMPLICATION (Vaccination adverse reaction), MOBILITY DECREASED (Couldn't use arm to get off floor), PAIN IN EXTREMITY (arm was very painful/arm was achy), LYMPHADENOPATHY (Swollen lymph node / lymph node under arm where received shot is swollen), FATIGUE (Fatigue) and NAUSEA (Nauseated) outcome was unknown, PAIN IN EXTREMITY (Pain in arm) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: unknown (abnormal) unknown. On 11-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information included fluids for dehydration and nausea medicine that did not relief the nausea and stopped taking it. Patient canceled the second appointment and planning on getting Pfizer when we need boosters. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant followup received on 19-JUL-2021 and events outcome ,new events, concomitant medications, relevant medical history were updated

Other Meds: REBIF; VITAMIN B NOS; VITAMIN D NOS; TRI-LO-SPRINTEC; VITAMIN B12 NOS; VITAMIN D3; TYLENOL

Current Illness: Abdominal pain; Asthma; Multiple sclerosis; Sturge-Weber syndrome

ID: 1570652
Sex: F
Age: 39
State: NY

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 08/15/2021
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: Increased bleeding during period; Itching; Vaginal dryness; Vaginal pain; Difficulty sleeping; Circular pattern; Sharp pain; Tendon pain; Bump on underarm; Arm pain; Tirdness; Headache; Nausea; Throwing up; Arm swelling; Not being able to lift up arm; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), MASS (Bump on underarm), PAIN IN EXTREMITY (Arm pain), PAIN (Sharp pain) and TENDON PAIN (Tendon pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), LIMB DISCOMFORT (Not being able to lift up arm) and VOMITING (Throwing up). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), FATIGUE (Tirdness), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Mar-2021, the patient experienced MASS (Bump on underarm). On 16-Mar-2021, the patient experienced PAIN (Sharp pain), TENDON PAIN (Tendon pain) and RASH (Circular pattern). On 17-Mar-2021, the patient experienced INSOMNIA (Difficulty sleeping). On 22-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Increased bleeding during period), PRURITUS (Itching), VULVOVAGINAL DRYNESS (Vaginal dryness) and VULVOVAGINAL PAIN (Vaginal pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm swelling), MASS (Bump on underarm), PAIN IN EXTREMITY (Arm pain), PAIN (Sharp pain), TENDON PAIN (Tendon pain), INSOMNIA (Difficulty sleeping), HEAVY MENSTRUAL BLEEDING (Increased bleeding during period), PRURITUS (Itching), VULVOVAGINAL DRYNESS (Vaginal dryness), VULVOVAGINAL PAIN (Vaginal pain), LIMB DISCOMFORT (Not being able to lift up arm), RASH (Circular pattern), FATIGUE (Tirdness), VOMITING (Throwing up), HEADACHE (Headache) and NAUSEA (Nausea) 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 reported

Other Meds:

Current Illness:

ID: 1570653
Sex: F
Age: 58
State: IN

Vax Date: 03/21/2021
Onset Date: 03/21/2021
Rec V Date: 08/15/2021
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 hive like rash on middle of both arms; dizziness; dry mouth; left ear red/swollen; right ear is red; didn't sleep well; back of neck felt like sunburn; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DRY MOUTH (dry mouth), EAR SWELLING (left ear red/swollen), ERYTHEMA (right ear is red) and INSOMNIA (didn't sleep well) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. No Medical History information was reported. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 21-Mar-2021, the patient experienced DIZZINESS (dizziness), DRY MOUTH (dry mouth), EAR SWELLING (left ear red/swollen), ERYTHEMA (right ear is red), INSOMNIA (didn't sleep well) and SUNBURN (back of neck felt like sunburn). On 22-Mar-2021, the patient experienced RASH PRURITIC (itchy hive like rash on middle of both arms). On 23-Mar-2021, DIZZINESS (dizziness) had resolved. At the time of the report, DRY MOUTH (dry mouth), EAR SWELLING (left ear red/swollen), ERYTHEMA (right ear is red), INSOMNIA (didn't sleep well), SUNBURN (back of neck felt like sunburn) and RASH PRURITIC (itchy hive like rash on middle of both arms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1570654
Sex: F
Age: 35
State:

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 08/15/2021
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: lost sense of taste; lost sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell). At the time of the report, AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication was not provided.

Other Meds: CLARITIN [LORATADINE]

Current Illness:

ID: 1570655
Sex: F
Age: 53
State: TX

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
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: Cant move her arm; Pain increased; Left arm felt numb; Dizzy; Joint swollen; Fever 103; Needle pain where joint is; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), JOINT SWELLING (Joint swollen), HYPOAESTHESIA (Left arm felt numb), HYPOKINESIA (Cant move her arm) and PAIN (Pain increased) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizzy), JOINT SWELLING (Joint swollen), PYREXIA (Fever 103), ARTHRALGIA (Needle pain where joint is) and CHILLS (Chills). On 20-Mar-2021, the patient experienced HYPOAESTHESIA (Left arm felt numb). On 22-Mar-2021, the patient experienced HYPOKINESIA (Cant move her arm) and PAIN (Pain increased). The patient was treated with PARACETAMOL (TYLENOL) for Numbness, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Joint pain, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), JOINT SWELLING (Joint swollen), HYPOAESTHESIA (Left arm felt numb), PAIN (Pain increased), PYREXIA (Fever 103), ARTHRALGIA (Needle pain where joint is) and CHILLS (Chills) outcome was unknown and HYPOKINESIA (Cant move her arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 103 High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1570656
Sex: F
Age: 30
State: IL

Vax Date: 01/06/2021
Onset Date: 10/31/2020
Rec V Date: 08/15/2021
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: Pregnant patient reported she has received both doses of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient reported she has received both doses of the Moderna vaccine) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-Jul-2021. On 31-Oct-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient reported she has received both doses of the Moderna vaccine). The delivery occurred on 11-Jul-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient reported she has received both doses of the Moderna vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1570657
Sex: F
Age:
State:

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
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: Hurt her knee; Headache; Sore left armpit; Sore left breast; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Sore left armpit), BREAST PAIN (Sore left breast), PAIN IN EXTREMITY (Sore left arm), JOINT INJURY (Hurt her knee) 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 10-Mar-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 10-Mar-2021, the patient experienced AXILLARY PAIN (Sore left armpit), BREAST PAIN (Sore left breast) and PAIN IN EXTREMITY (Sore left arm). On 23-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced JOINT INJURY (Hurt her knee). On 13-Mar-2021, AXILLARY PAIN (Sore left armpit), BREAST PAIN (Sore left breast) and PAIN IN EXTREMITY (Sore left arm) had resolved. At the time of the report, JOINT INJURY (Hurt her knee) and HEADACHE (Headache) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.

Other Meds:

Current Illness:

ID: 1570658
Sex: F
Age: 91
State: CA

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 08/15/2021
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: a little tired and achy in the arm; a little tired and achy in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little tired and achy in the arm) and FATIGUE (a little tired and achy in the arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. Concurrent medical conditions included Alzheimer's disease. On 17-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 PAIN IN EXTREMITY (a little tired and achy in the arm) and FATIGUE (a little tired and achy in the arm). On 20-Feb-2021, PAIN IN EXTREMITY (a little tired and achy in the arm) and FATIGUE (a little tired and achy in the arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication was not reported.

Other Meds:

Current Illness: Alzheimer's disease

ID: 1570659
Sex: F
Age: 80
State: AL

Vax Date: 02/04/2021
Onset Date: 02/10/2021
Rec V Date: 08/15/2021
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: Affected area was red; Itchy around her eyes; Rash on face; Rash on neck/Rash on chin/Rash around her eyes/Rash on trunk (lower stomach); Itchy face; Itchy neck/Itchy chin/Itchy around her eyes/Itchy arms (from her elbow down to the wrist)/Itchy trunk (lower stomach); This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on face), RASH (Rash on neck/Rash on chin/Rash around her eyes/Rash on trunk (lower stomach)), PRURITUS (Itchy face), PRURITUS (Itchy neck/Itchy chin/Itchy around her eyes/Itchy arms (from her elbow down to the wrist)/Itchy trunk (lower stomach)) and ERYTHEMA (Affected area was red) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH (Rash on face), RASH (Rash on neck/Rash on chin/Rash around her eyes/Rash on trunk (lower stomach)), PRURITUS (Itchy face), PRURITUS (Itchy neck/Itchy chin/Itchy around her eyes/Itchy arms (from her elbow down to the wrist)/Itchy trunk (lower stomach)) and EYE PRURITUS (Itchy around her eyes). On 12-Feb-2021, the patient experienced ERYTHEMA (Affected area was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency and HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (Rash on face), RASH (Rash on neck/Rash on chin/Rash around her eyes/Rash on trunk (lower stomach)), PRURITUS (Itchy face), PRURITUS (Itchy neck/Itchy chin/Itchy around her eyes/Itchy arms (from her elbow down to the wrist)/Itchy trunk (lower stomach)), ERYTHEMA (Affected area was red) and EYE PRURITUS (Itchy around her eyes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1570660
Sex: M
Age:
State: CA

Vax Date: 02/20/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
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: Increase blood pressure; Palpitation; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Increase blood pressure) and PALPITATIONS (Palpitation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced HYPERTENSION (Increase blood pressure) and PALPITATIONS (Palpitation). At the time of the report, HYPERTENSION (Increase blood pressure) had resolved and PALPITATIONS (Palpitation) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Blood pressure measurement: unknown (High) increased. On 20-Mar-2021, Electrocardiogram: unknown (Inconclusive) Unknown. On 20-Mar-2021, Heart rate: unknown (High) increased. On 20-Mar-2021, Laboratory test: unknown (Inconclusive) Unknown. Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator Intravenous fluid and some medicine was given as treatment medication Patient experienced palpitation, increased heart rate and increased blood pressure in evening for that he visited Emergency room where he kept for observation for 5 hours and Lab investigations and EKG done to rule out heart problem. Intravenous fluid and some medicine was given. No information of concomitant medication. His blood pressure never high. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1570661
Sex: M
Age: 82
State: SC

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 08/15/2021
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: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant and treatment medications were reported. This case was linked to MOD-2021-225724 (Patient Link).

Other Meds:

Current Illness: Arthritis

ID: 1570662
Sex: F
Age: 43
State: CO

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
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: Burning Sensation Hip Replacement; Fatigue; Achy Joints; Headache; Muscle pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning Sensation Hip Replacement), FATIGUE (Fatigue), ARTHRALGIA (Achy Joints), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hip replacement (In 2019. Made of Titanium and Ceramic material.). Concurrent medical conditions included Allergy (Allergic to PCN). Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and LOSARTAN for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BURNING SENSATION (Burning Sensation Hip Replacement), FATIGUE (Fatigue), ARTHRALGIA (Achy Joints), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Nausea). On 18-Mar-2021, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Nausea) had resolved. At the time of the report, BURNING SENSATION (Burning Sensation Hip Replacement) and ARTHRALGIA (Achy Joints) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication not reported.

Other Meds: CLARITIN ALLERGIC; LOSARTAN

Current Illness: Penicillin allergy (Allergic to PCN)

ID: 1570663
Sex: F
Age: 57
State: OR

Vax Date: 03/11/2021
Onset Date: 03/21/2021
Rec V Date: 08/15/2021
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: delayed reaction known as "covid arm"; itchy big red warm spot on the injection site; itchy big red warm spot on the injection site; itchy big red warm spot on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (delayed reaction known as "covid arm"), VACCINATION SITE WARMTH (itchy big red warm spot on the injection site), VACCINATION SITE PRURITUS (itchy big red warm spot on the injection site) and VACCINATION SITE ERYTHEMA (itchy big red warm spot on the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Eczema and Allergy (skin allergy). On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HYPERSENSITIVITY (delayed reaction known as "covid arm"), VACCINATION SITE WARMTH (itchy big red warm spot on the injection site), VACCINATION SITE PRURITUS (itchy big red warm spot on the injection site) and VACCINATION SITE ERYTHEMA (itchy big red warm spot on the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (delayed reaction known as "covid arm"), VACCINATION SITE WARMTH (itchy big red warm spot on the injection site), VACCINATION SITE PRURITUS (itchy big red warm spot on the injection site) and VACCINATION SITE ERYTHEMA (itchy big red warm spot on 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. Patient reported that she took Benadryl daily for allergies.

Other Meds:

Current Illness: Allergy (skin allergy); Eczema

ID: 1570664
Sex: F
Age: 91
State: CA

Vax Date: 02/17/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
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: Severe muscle weakness; Very weak couldnot really walk; She hasn't had clear thoughts for several years. It fired up her brain, she said "I have so much to think about ..i gotta think about some stuff; She was so weak she couldn't sit up.; Sharp pains in her side. She keeps saying her breast hurt off to side under her armpit; She is still very tired and kind of lethargic. She wants to stay in bed.; increase in brain activity; elevated temperature 102; All of a sudden, she starting vomiting. She hurled. It flew out of her body without any warning.; She is still very tired and kind of lethargic. She wants to stay in bed.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Severe muscle weakness), GAIT INABILITY (Very weak couldnot really walk), THINKING ABNORMAL (She hasn't had clear thoughts for several years. It fired up her brain, she said "I have so much to think about ..i gotta think about some stuff), ASTHENIA (She was so weak she couldn't sit up.) and PAIN (Sharp pains in her side. She keeps saying her breast hurt off to side under her armpit) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Alzheimer's disease. On 17-Feb-2021, 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 18-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Severe muscle weakness), GAIT INABILITY (Very weak couldnot really walk), THINKING ABNORMAL (She hasn't had clear thoughts for several years. It fired up her brain, she said "I have so much to think about ..i gotta think about some stuff), ASTHENIA (She was so weak she couldn't sit up.), LETHARGY (She is still very tired and kind of lethargic. She wants to stay in bed.), THERAPEUTIC RESPONSE UNEXPECTED (increase in brain activity), PYREXIA (elevated temperature 102), VOMITING (All of a sudden, she starting vomiting. She hurled. It flew out of her body without any warning.) and FATIGUE (She is still very tired and kind of lethargic. She wants to stay in bed.). 18-Mar-2021, the patient experienced PAIN (Sharp pains in her side. She keeps saying her breast hurt off to side under her armpit). On 18-Mar-2021, PYREXIA (elevated temperature 102) and VOMITING (All of a sudden, she starting vomiting. She hurled. It flew out of her body without any warning.) had resolved. At the time of the report, MUSCULAR WEAKNESS (Severe muscle weakness), GAIT INABILITY (Very weak couldnot really walk), THINKING ABNORMAL (She hasn't had clear thoughts for several years. It fired up her brain, she said "I have so much to think about .i gotta think about some stuff), ASTHENIA (She was so weak she couldn't sit up.), PAIN (Sharp pains in her side. She keeps saying her breast hurt off to side under her armpit), LETHARGY (She is still very tired and kind of lethargic. She wants to stay in bed.), THERAPEUTIC RESPONSE UNEXPECTED (increase in brain activity) and FATIGUE (She is still very tired and kind of lethargic. She wants to stay in bed.) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: high (High) 102. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-054304 (Patient Link).

Other Meds:

Current Illness: Alzheimer's disease

ID: 1570665
Sex: F
Age: 69
State: AL

Vax Date: 03/22/2021
Onset Date: 03/23/2021
Rec V Date: 08/15/2021
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: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030220A) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included INSULIN for an unknown indication. On 22-Mar-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 23-Mar-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided Patient was taking blood pressure pills,cholesterol pills,type 2 diabetes pills as concomitant medication. Action taken for Moderna COVID-19 Vaccine was not applicable.

Other Meds: INSULIN

Current Illness: Type 2 diabetes mellitus

ID: 1570666
Sex: F
Age: 80
State: FL

Vax Date: 03/20/2021
Onset Date: 03/21/2021
Rec V Date: 08/15/2021
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: Stayed in Bed all day; Shaky (Not sure if she had a fever); Achy Body; Joint Pain; Itching below and to the right of injection site; Big Red Spot (as big as her hand) below and to the right of injection site; Swollen below and to the right of injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Stayed in Bed all day), NERVOUSNESS (Shaky (Not sure if she had a fever)), PAIN (Achy Body), ARTHRALGIA (Joint Pain) and INJECTION SITE PRURITUS (Itching below and to the right of injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ASTHENIA (Stayed in Bed all day), NERVOUSNESS (Shaky (Not sure if she had a fever)), PAIN (Achy Body), ARTHRALGIA (Joint Pain), INJECTION SITE PRURITUS (Itching below and to the right of injection site), VACCINATION SITE ERYTHEMA (Big Red Spot (as big as her hand) below and to the right of injection site) and VACCINATION SITE SWELLING (Swollen below and to the right of injection site). At the time of the report, ASTHENIA (Stayed in Bed all day), NERVOUSNESS (Shaky (Not sure if she had a fever)), PAIN (Achy Body), ARTHRALGIA (Joint Pain), INJECTION SITE PRURITUS (Itching below and to the right of injection site), VACCINATION SITE ERYTHEMA (Big Red Spot (as big as her hand) below and to the right of injection site) and VACCINATION SITE SWELLING (Swollen below and to the right of injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information not provided. Concomitant medications were not provided.

Other Meds:

Current Illness:

ID: 1570667
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
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: Tinnitus in her right ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus in her right ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 032L20A) for COVID-19 vaccination. No medical history reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced TINNITUS (Tinnitus in her right ear). At the time of the report, TINNITUS (Tinnitus in her right ear) outcome was unknown. Not Provided Concomitant medications were not reported. No treatment information was reported. Per reporter, the patient's was being getting an ENT referral from her primary care doctor. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Reporter has no further information about the event.

Other Meds:

Current Illness:

ID: 1570668
Sex: M
Age: 52
State: MI

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 08/15/2021
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: rapid test and it was COVID positive; basic flu symptoms; Soreness; Fever; Fatigue; second dose might be over 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose might be over 42 days), COVID-19 (rapid test and it was COVID positive), INFLUENZA (basic flu symptoms), PAIN (Soreness) and PYREXIA (Fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Allergy (Allergy NOS). Concomitant products included FLUTICASONE for Allergy, METOPROLOL for Blood pressure, VITAMIN C [ASCORBIC ACID] for Vitamin C supplementation, VITAMIN D NOS for Vitamin D supplementation, ZINC for Zinc supplementation. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose might be over 42 days), PAIN (Soreness), PYREXIA (Fever) and FATIGUE (Fatigue). On 23-Mar-2021, the patient experienced INFLUENZA (basic flu symptoms). On 24-Mar-2021, the patient experienced COVID-19 (rapid test and it was COVID positive). The patient was treated with IBUPROFEN for Fever and Headache, at a dose of 200 mg, 3 tablets; PREDNISONE at a dose of 10 mg and AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN BAMBINI) at a dose of 875 mg. On 22-Mar-2021, PRODUCT DOSE OMISSION ISSUE (second dose might be over 42 days) had resolved. At the time of the report, COVID-19 (rapid test and it was COVID positive), INFLUENZA (basic flu symptoms), PAIN (Soreness), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 101f (High) 101F. On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. On 10-May-2021, Body temperature: 100.7f (High) 100.7F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021,contains significant information, added new event. On 10-May-2021: Follow-up information received on 11-May-2021,contains significant information. Added Medical History, Lab data, Suspect drug details, Concomitant medications

Other Meds: METOPROLOL; VITAMIN D NOS; VITAMIN C [ASCORBIC ACID]; ZINC; FLUTICASONE

Current Illness: Allergy (Allergy NOS); Hypertension

ID: 1570669
Sex: F
Age: 75
State: DE

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 08/15/2021
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: Up all night long; Heart racing; Shortness of breath; Bed ridden; Delayed the second shot; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Up all night long), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath), BEDRIDDEN (Bed ridden) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second shot) in a 75-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 included No adverse event (No medical history reported) and COVID-19. On 10-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 INSOMNIA (Up all night long), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath), BEDRIDDEN (Bed ridden), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second shot) and FATIGUE (Extreme fatigue). At the time of the report, INSOMNIA (Up all night long), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath) and FATIGUE (Extreme fatigue) outcome was unknown and BEDRIDDEN (Bed ridden) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second shot) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1570670
Sex: F
Age:
State: TX

Vax Date: 02/27/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
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: Diarrhea; Disoriented; Chills; Being tired; Headache; Muscle ache; Vomiting; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DISORIENTATION (Disoriented), CHILLS (Chills) and FATIGUE (Being tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No reported medical history. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DISORIENTATION (Disoriented), CHILLS (Chills), FATIGUE (Being tired), HEADACHE (Headache), MYALGIA (Muscle ache) and VOMITING (Vomiting). The patient was treated with HYDROXYCHLOROQUINE at an unspecified dose and frequency and AZITHROMYCIN (ZITHROMAX) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DISORIENTATION (Disoriented), CHILLS (Chills), FATIGUE (Being tired), HEADACHE (Headache), MYALGIA (Muscle ache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment also included nausea medicine.

Other Meds:

Current Illness:

ID: 1570671
Sex: F
Age:
State: CA

Vax Date: 02/26/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
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: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test: positive Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm