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: 1581579
Sex: M
Age: 65
State: IL

Vax Date: 01/29/2021
Onset Date: 01/05/2021
Rec V Date: 08/18/2021
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: Reports having a localized rash in lower torso/belly that is stretching to sides a bit. Patient describes appearance as "little red dots". Is there anything about rashes?; little red pimples; little red pimples; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Reports having a localized rash in lower torso/belly that is stretching to sides a bit. Patient describes appearance as "little red dots". Is there anything about rashes?), ACNE (little red pimples) and ERYTHEMA (little red pimples) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced ACNE (little red pimples) and ERYTHEMA (little red pimples). On 05-Feb-2021, the patient experienced RASH (Reports having a localized rash in lower torso/belly that is stretching to sides a bit. Patient describes appearance as "little red dots". Is there anything about rashes?). At the time of the report, RASH (Reports having a localized rash in lower torso/belly that is stretching to sides a bit. Patient describes appearance as "little red dots". Is there anything about rashes?), ACNE (little red pimples) and ERYTHEMA (little red pimples) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1581580
Sex: M
Age: 88
State: OR

Vax Date: 02/20/2021
Onset Date:
Rec V Date: 08/18/2021
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: nose bleeds; diarrhea; muscle ache; body aches; sore throat; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleeds), DIARRHOEA (diarrhea), MYALGIA (muscle ache), MYALGIA (body aches) and OROPHARYNGEAL PAIN (sore throat) in a male patient of an unknown age 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. On 20-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 EPISTAXIS (nose bleeds), DIARRHOEA (diarrhea), MYALGIA (muscle ache), MYALGIA (body aches), OROPHARYNGEAL PAIN (sore throat) and VOMITING (vomiting). At the time of the report, EPISTAXIS (nose bleeds), DIARRHOEA (diarrhea), MYALGIA (muscle ache), MYALGIA (body aches), OROPHARYNGEAL PAIN (sore throat) and VOMITING (vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1581581
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date: 02/03/2021
Rec V Date: 08/18/2021
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: Her arm is itchy; Her arm is red, there is a red spot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Her arm is itchy) and ERYTHEMA (Her arm is red, there is a red spot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (Her arm is itchy) and ERYTHEMA (Her arm is red, there is a red spot). At the time of the report, PRURITUS (Her arm is itchy) and ERYTHEMA (Her arm is red, there is a red spot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. The patient did not take any treatment medication.

Other Meds:

Current Illness:

ID: 1581582
Sex: F
Age: 74
State:

Vax Date: 02/10/2021
Onset Date: 02/19/2021
Rec V Date: 08/18/2021
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: Chills; Eye pain; sore lymph nodes on right neck; Fatigue; pain of lymph node on both arms; pain of lymph node on the neck; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), LYMPH NODE PAIN (pain of lymph node on both arms), LYMPH NODE PAIN (pain of lymph node on the neck), LYMPH NODE PAIN (sore lymph nodes on right neck) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced FATIGUE (Fatigue), LYMPH NODE PAIN (pain of lymph node on both arms) and LYMPH NODE PAIN (pain of lymph node on the neck). On 22-Feb-2021, the patient experienced LYMPH NODE PAIN (sore lymph nodes on right neck) and EYE PAIN (Eye pain). On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, FATIGUE (Fatigue), LYMPH NODE PAIN (pain of lymph node on both arms), LYMPH NODE PAIN (pain of lymph node on the neck), LYMPH NODE PAIN (sore lymph nodes on right neck), CHILLS (Chills) and EYE PAIN (Eye pain) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1581583
Sex: F
Age:
State: PA

Vax Date: 01/20/2021
Onset Date: 02/17/2021
Rec V Date: 08/18/2021
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: Arm soreness; Dizziness; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), FATIGUE (Fatigue) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 039K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. No concomitant medication was provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1581584
Sex: F
Age: 73
State: AR

Vax Date: 01/18/2021
Onset Date: 02/24/2021
Rec V Date: 08/18/2021
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: Slight Fever; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight Fever), HEADACHE (Headache) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Slight Fever), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Slight Fever), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. No concomitant medication was provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1581585
Sex: F
Age: 38
State: PA

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/18/2021
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: Red face; Red neck; Tingling tongue; Tingling lips; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red face), ERYTHEMA (Red neck), PARAESTHESIA ORAL (Tingling tongue) and PARAESTHESIA ORAL (Tingling lips) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ERYTHEMA (Red face), ERYTHEMA (Red neck), PARAESTHESIA ORAL (Tingling tongue) and PARAESTHESIA ORAL (Tingling lips). At the time of the report, ERYTHEMA (Red face), ERYTHEMA (Red neck), PARAESTHESIA ORAL (Tingling tongue) and PARAESTHESIA ORAL (Tingling lips) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1581586
Sex: F
Age: 70
State: NC

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 08/18/2021
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: sore neck; chills; sore shoulder where she received the injection; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (sore neck), CHILLS (chills) and VACCINATION SITE PAIN (sore shoulder where she received the injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. Concomitant products included ATENOLOL for an unknown indication. On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced NECK PAIN (sore neck), CHILLS (chills) and VACCINATION SITE PAIN (sore shoulder where she received the injection). At the time of the report, NECK PAIN (sore neck), CHILLS (chills) and VACCINATION SITE PAIN (sore shoulder where she received the injection) outcome was unknown. The patient received unspecified concomitant medications. The patient did not take any treatment medication.

Other Meds: ATENOLOL

Current Illness:

ID: 1581587
Sex: F
Age: 78
State: MI

Vax Date: 02/20/2021
Onset Date: 02/23/2021
Rec V Date: 08/18/2021
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: Nagging headache; Body aches; Backache; Feels extremely tired; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), HEADACHE (Nagging headache), PAIN (Body aches), BACK PAIN (Backache) and FATIGUE (Feels extremely tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included High Blood Pressure Medication, Antihyperlipidemic, LEVOTHYROXINE, ESCITALOPRAM OXALATE (LEXAPRO), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), COLECALCIFEROL, UBIDECARENONE (CO-Q10+VITAMIN D3) and VITAMIN B COMPLEX 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 23-Feb-2021, the patient experienced FATIGUE (Tiredness). On 24-Feb-2021, the patient experienced HEADACHE (Nagging headache), PAIN (Body aches), BACK PAIN (Backache) and FATIGUE (Feels extremely tired). At the time of the report, FATIGUE (Tiredness), HEADACHE (Nagging headache), PAIN (Body aches), BACK PAIN (Backache) and FATIGUE (Feels extremely tired) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment details were provided.

Other Meds: High Blood Pressure Medication; Antihyperlipidemic; LEVOTHYROXINE; LEXAPRO; VITAMIN D 2000; CO-Q10+VITAMIN D3; VITAMIN B COMPLEX

Current Illness:

ID: 1581588
Sex: F
Age: 69
State: OH

Vax Date: 02/11/2021
Onset Date: 02/17/2021
Rec V Date: 08/18/2021
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: itchiness at the area of the injection; swelling at the area of the injection; redness at the area of the injection; burning at the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the area of the injection), VACCINATION SITE SWELLING (swelling at the area of the injection), VACCINATION SITE ERYTHEMA (redness at the area of the injection) and VACCINATION SITE PAIN (burning at the area of the injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the area of the injection), VACCINATION SITE SWELLING (swelling at the area of the injection), VACCINATION SITE ERYTHEMA (redness at the area of the injection) and VACCINATION SITE PAIN (burning at the area of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Vaccination site swelling, Vaccination site erythema, Vaccination site pruritus and Vaccination site burning, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Vaccination site swelling, Vaccination site erythema, Vaccination site pruritus and Vaccination site burning, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (itchiness at the area of the injection), VACCINATION SITE SWELLING (swelling at the area of the injection) and VACCINATION SITE PAIN (burning at the area of the injection) outcome was unknown and VACCINATION SITE ERYTHEMA (redness at the area of the injection) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. The redness extended up to her shoulder and down to her elbow. The patient consulted her primary care physician who prescribed her with Benadryl Cream, Tylenol and advised her to apply cold compress on the area. The area of redness had decreased in size.

Other Meds:

Current Illness:

ID: 1581589
Sex: F
Age: 78
State: CO

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/18/2021
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: 24Feb2021 the injection site is pale; Fatigue; injection site was warm; injection site was bright red; area swelled to the size of a Tennis Ball; soreness; hardness the size of a quarter at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (24Feb2021 the injection site is pale), VACCINATION SITE INDURATION (hardness the size of a quarter at the injection site), VACCINATION SITE WARMTH (injection site was warm), VACCINATION SITE ERYTHEMA (injection site was bright red) and VACCINATION SITE SWELLING (area swelled to the size of a Tennis Ball) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0161M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hardness the size of a quarter at the injection site) and VACCINATION SITE PAIN (soreness). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site was warm), VACCINATION SITE ERYTHEMA (injection site was bright red) and VACCINATION SITE SWELLING (area swelled to the size of a Tennis Ball). On 24-Feb-2021, the patient experienced PALLOR (24Feb2021 the injection site is pale) and FATIGUE (Fatigue). At the time of the report, PALLOR (24Feb2021 the injection site is pale), VACCINATION SITE INDURATION (hardness the size of a quarter at the injection site), VACCINATION SITE WARMTH (injection site was warm), VACCINATION SITE ERYTHEMA (injection site was bright red), VACCINATION SITE SWELLING (area swelled to the size of a Tennis Ball), VACCINATION SITE PAIN (soreness) and FATIGUE (Fatigue) 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. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1581590
Sex: F
Age: 65
State: TX

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/18/2021
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: This spontaneous case reported by a consumer, describes the occurrence of vaccination site warmth (injection site feels warm), rash macular (bright red spot at injection site and it's spreading), vaccination site pain (soreness in arm) and vaccination site swelling (swelling at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 004M20A) for COVID-19 immunization. Concomitant products included temazepam and omeprazole for an unknown indication. On Jan 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 27, 2021, patient experienced vaccination site pain (soreness in arm). On Feb 3, 2021, patient experienced vaccination site warmth (injection site feels warm), rash macular (bright red spot at injection site and it's spreading) and vaccination site swelling (swelling at injection site). On Jan 28, 2021, vaccination site pain (soreness in arm) resolved. At the time of the report, vaccination site warmth (injection site feels warm), rash macular (bright red spot at injection site and it's spreading) and vaccination site swelling (swelling at injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment information provided.

Other Meds: Temazepam; Omeprazole

Current Illness:

ID: 1581591
Sex: M
Age: 54
State: LA

Vax Date: 01/27/2021
Onset Date: 02/01/2021
Rec V Date: 08/18/2021
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: shingles on face; Rash on his face; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles on face) and RASH (Rash on his face) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced HERPES ZOSTER (shingles on face) and RASH (Rash on his face). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles on face) and RASH (Rash on his face) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1581592
Sex: F
Age: 67
State: MI

Vax Date: 02/20/2021
Onset Date:
Rec V Date: 08/18/2021
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: Arms are getting sore, and pain has gone down to her legs.; feels tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Arms are getting sore, and pain has gone down to her legs.) and FATIGUE (feels tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Arms are getting sore, and pain has gone down to her legs.) and FATIGUE (feels tired). At the time of the report, PAIN (Arms are getting sore, and pain has gone down to her legs.) and FATIGUE (feels tired) outcome was unknown. No concomitant medications reported. No treatment medications provided by the reporter. Action taken with mRNA-1273 in response to events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Non significant follow up - AE contact details updated. Reported getting second dose on 16 MAR 2021.

Other Meds:

Current Illness:

ID: 1581593
Sex: F
Age: 41
State: WA

Vax Date: 01/03/2021
Onset Date: 01/03/2021
Rec V Date: 08/18/2021
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: 2nd dose was this past Sunday, but she did not want to receive it because of the cetirizine; Hives on abdomen and both arms; itching; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), URTICARIA (Hives on abdomen and both arms), PRURITUS (itching) and PRODUCT DOSE OMISSION ISSUE (2nd dose was this past Sunday, but she did not want to receive it because of the cetirizine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE for an unknown indication. On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 05-Jan-2021, the patient experienced URTICARIA (Hives on abdomen and both arms) and PRURITUS (itching). On 31-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose was this past Sunday, but she did not want to receive it because of the cetirizine). The patient was treated with CETIRIZINE for Pain in arm, Hives and Itching, at a dose of UNK dosage form. On 31-Jan-2021, PRODUCT DOSE OMISSION ISSUE (2nd dose was this past Sunday, but she did not want to receive it because of the cetirizine) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm pain) and PRURITUS (itching) outcome was unknown and URTICARIA (Hives on abdomen and both arms) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1581594
Sex: M
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 08/18/2021
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: experiencing symptoms exactly like covid symptoms; slept the day away; never ate or drank; lips was looking dehydrated; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (experiencing symptoms exactly like covid symptoms), HYPERSOMNIA (slept the day away), DECREASED APPETITE (never ate or drank), DEHYDRATION (lips was looking dehydrated) and FATIGUE (Tired) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination. The patient's past medical history included COVID-19 in October 2020. Concomitant products included ATORVASTATIN, CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), FINASTERIDE, LISINOPRIL, TAMSULOSIN and VALACYCLOVIR [VALACICLOVIR] for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced SUSPECTED COVID-19 (experiencing symptoms exactly like covid symptoms), HYPERSOMNIA (slept the day away), DECREASED APPETITE (never ate or drank), DEHYDRATION (lips was looking dehydrated) and FATIGUE (Tired). At the time of the report, SUSPECTED COVID-19 (experiencing symptoms exactly like covid symptoms), HYPERSOMNIA (slept the day away), DECREASED APPETITE (never ate or drank), DEHYDRATION (lips was looking dehydrated) and FATIGUE (Tired) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 100.2 (High) 100.2. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient did not take any treatment. The patient had COVID-19 in Oct-2020. It was 8 days prior to fulfilling the 3 month waiting period when he received the vaccine. He was very ill with the covid symptoms for about 12 hours the next day. This happened for just one day. The patient did not take anything for his symptoms.

Other Meds: ATORVASTATIN; CALTRATE [CALCIUM CARBONATE]; FINASTERIDE; LISINOPRIL; TAMSULOSIN; VALACYCLOVIR [VALACICLOVIR]

Current Illness:

ID: 1581595
Sex: F
Age: 68
State: LA

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 08/18/2021
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: Arm swollen; Arm is hurting; Arm is warm to the touch; Arm is red down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm is hurting), FEELING HOT (Arm is warm to the touch) and ERYTHEMA (Arm is red down to the elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. 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 PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm is hurting), FEELING HOT (Arm is warm to the touch) and ERYTHEMA (Arm is red down to the elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm is hurting), FEELING HOT (Arm is warm to the touch) and ERYTHEMA (Arm is red down to the elbow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1581596
Sex: M
Age:
State: NJ

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 08/18/2021
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: diarrhea/possible food poisoning; diarrhea/possible food poisoning; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea/possible food poisoning) and FOOD POISONING (diarrhea/possible food poisoning) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea/possible food poisoning) and FOOD POISONING (diarrhea/possible food poisoning). At the time of the report, DIARRHOEA (diarrhea/possible food poisoning) and FOOD POISONING (diarrhea/possible food poisoning) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Treatment medication was not reported.

Other Meds:

Current Illness:

ID: 1581597
Sex: F
Age:
State: TX

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 08/18/2021
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: Thinks she has start of a sinus infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Thinks she has start of a sinus infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The patient's past medical history included No adverse reaction. On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SINUSITIS (Thinks she has start of a sinus infection). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, SINUSITIS (Thinks she has start of a sinus infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. concomitant medication was not provided.

Other Meds:

Current Illness:

ID: 1581598
Sex: F
Age: 65
State: UT

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/18/2021
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: fever; terrible aching; headache; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (terrible aching), HEADACHE (headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 23-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 PYREXIA (fever), MYALGIA (terrible aching), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), MYALGIA (terrible aching), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. concomitant medication was not provided.

Other Meds:

Current Illness:

ID: 1581599
Sex: F
Age: 63
State: CA

Vax Date: 02/03/2021
Onset Date: 02/22/2021
Rec V Date: 08/18/2021
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: fever; chills; vomiting; Rash is itchy; developed rash all over body, started on thighs and then lip was swelling; developed rash all over body, started on thighs and then lip was swelling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), CHILLS (chills), VOMITING (vomiting), RASH (developed rash all over body, started on thighs and then lip was swelling) and LIP SWELLING (developed rash all over body, started on thighs and then lip was swelling) in a 63-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. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VITAMINS NOS. On 03-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 RASH (developed rash all over body, started on thighs and then lip was swelling) and LIP SWELLING (developed rash all over body, started on thighs and then lip was swelling). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), VOMITING (vomiting) and RASH PRURITIC (Rash is itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chills), VOMITING (vomiting), RASH (developed rash all over body, started on thighs and then lip was swelling), LIP SWELLING (developed rash all over body, started on thighs and then lip was swelling) and RASH PRURITIC (Rash is itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1581600
Sex: U
Age:
State: IL

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 08/18/2021
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: Positive SARS-CoV-2; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive SARS-CoV-2) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Positive SARS-CoV-2). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive SARS-CoV-2) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test positive: 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. No concomitant and treatment medications were reported.

Other Meds:

Current Illness:

ID: 1581601
Sex: F
Age:
State: ME

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 08/18/2021
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: arm soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm soreness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event and No adverse event. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PAIN (arm soreness). At the time of the report, INJECTION SITE PAIN (arm soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Concomitant information was not provided.

Other Meds:

Current Illness:

ID: 1581602
Sex: F
Age:
State: GA

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 08/18/2021
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: Fever 101.0 and 100.0; Very bad headache; A spontaneous report was received from a consumer concerning who received Modern's COVID-19 vaccine (mRNA-1273) patient who developed very bad headache and fever of 101 ,100.0. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) ON 22-FEB-2021, same day prior to the onset of the events intramuscularly for prophylaxis of COVID-19 infection. Treatment information was not provided. Therefore, action taken with the drug in response to the event is not applicable. The outcome of the events were unknown.

Other Meds:

Current Illness: No adverse event

ID: 1581603
Sex: F
Age: 67
State: TX

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 08/18/2021
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: patient's arm has been a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (patient's arm has been a little sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included Hodgkin's disease ((Hodgkins Lymphoma)). On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (patient's arm has been a little sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (patient's arm has been a little sore) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1581604
Sex: F
Age: 72
State: IL

Vax Date: 01/25/2021
Onset Date: 02/23/2021
Rec V Date: 08/18/2021
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: first shot that got inflamed and itchy; little swelling, redness, itching, and the usual pain; little swelling, redness, itching, and the usual pain; little swelling, redness, itching, and the usual pain; little swelling, redness, itching, and the usual pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (first shot that got inflamed and itchy), VACCINATION SITE PRURITUS (little swelling, redness, itching, and the usual pain), VACCINATION SITE SWELLING (little swelling, redness, itching, and the usual pain), VACCINATION SITE ERYTHEMA (little swelling, redness, itching, and the usual pain) and VACCINATION SITE PAIN (little swelling, redness, itching, and the usual pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 012M20A) for COVID-19 vaccination. The patient's past medical history included Iliotibial band syndrome (left side) in 2019, Bronchiectasis in 2019 and Rosacea in 2000. Concurrent medical conditions included Sulfonamide allergy (sulfa), Drug allergy (Demerol), Drug allergy (altaryl), Drug allergy (hydrocodone-acetaminophen), Drug allergy (Sudafed), Myofascitis (Worst flare-up ever) since 2010, Hip arthritis since 2019 and Osteopenia. Concomitant products included ALBUTEROL [SALBUTAMOL] for Cough, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Multiple allergies, BACLOFEN for Myofascitis, VITAMIN K [VITAMIN K NOS] and CALCIUM CARBONATE, COLECALCIFEROL (CAL-D) for Osteopenia. On 25-Jan-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 1:35 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021 at 2:30 PM, the patient experienced VACCINATION SITE INFLAMMATION (first shot that got inflamed and itchy). 23-Feb-2021 at 2:30 PM, the patient experienced VACCINATION SITE PRURITUS (little swelling, redness, itching, and the usual pain), VACCINATION SITE SWELLING (little swelling, redness, itching, and the usual pain), VACCINATION SITE ERYTHEMA (little swelling, redness, itching, and the usual pain) and VACCINATION SITE PAIN (little swelling, redness, itching, and the usual pain). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. On 27-Feb-2021, VACCINATION SITE INFLAMMATION (first shot that got inflamed and itchy), VACCINATION SITE PRURITUS (little swelling, redness, itching, and the usual pain), VACCINATION SITE SWELLING (little swelling, redness, itching, and the usual pain), VACCINATION SITE ERYTHEMA (little swelling, redness, itching, and the usual pain) and VACCINATION SITE PAIN (little swelling, redness, itching, and the usual pain) had resolved. The patient felt strange that the sight of second shot did not react at all. It was first shot site that had all the reactions. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received reporter contact details, patient demographics, medical history, event and dosage details updated. On 03-Aug-2021: Significant follow-up received. Updated patient height, medical history and event outcome. Start date of concomitant medication for calcium-d and vitamin K was added.

Other Meds: BACLOFEN; VITAMIN K [VITAMIN K NOS]; ALBUTEROL [SALBUTAMOL]; FLONASE [FLUTICASONE PROPIONATE]; CAL-D

Current Illness: Drug allergy (Sudafed); Drug allergy (hydrocodone-acetaminophen); Drug allergy (Demerol); Drug allergy (altaryl); Hip arthritis; Myofascitis (Worst flare-up ever); Osteopenia; Sulfonamide allergy (sulfa)

ID: 1581605
Sex: F
Age:
State:

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/18/2021
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: Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and NAUSEA (Nausea) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported.

Other Meds:

Current Illness:

ID: 1581606
Sex: M
Age: 38
State: IL

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Fever; chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever) and CHILLS (chills) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). At the time of the report, PYREXIA (Fever) and CHILLS (chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment information not provided.

Other Meds:

Current Illness:

ID: 1581607
Sex: F
Age: 66
State: MI

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/18/2021
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: headache; chills; vomiting; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (injection arm soreness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination. No medical history was provided by the reporter. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (headache), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (injection arm soreness). At the time of the report, HEADACHE (headache), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (injection arm soreness) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: POTASSIUM 99; HYDROCODONE; MULTIVITAMINS [VITAMINS NOS]; VITAMIN D [VITAMIN D NOS]; LYRICA

Current Illness:

ID: 1581608
Sex: F
Age: 55
State: CA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/18/2021
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: weakness in legs; pain at injection; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in legs), VACCINATION SITE PAIN (pain at injection) and FATIGUE (fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs), VACCINATION SITE PAIN (pain at injection) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK. On 29-Jan-2021, MUSCULAR WEAKNESS (weakness in legs), VACCINATION SITE PAIN (pain at injection) and FATIGUE (fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1581609
Sex: F
Age: 81
State: AL

Vax Date: 01/28/2021
Onset Date: 02/02/2021
Rec V Date: 08/18/2021
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: Itchy red bumps on her torso (front and back); bumps on her torso (front and back); red bumps on her torso (front and back); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy red bumps on her torso (front and back)), PAPULE (bumps on her torso (front and back)) and ERYTHEMA (red bumps on her torso (front and back)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRURITUS (Itchy red bumps on her torso (front and back)), PAPULE (bumps on her torso (front and back)) and ERYTHEMA (red bumps on her torso (front and back)). At the time of the report, PRURITUS (Itchy red bumps on her torso (front and back)), PAPULE (bumps on her torso (front and back)) and ERYTHEMA (red bumps on her torso (front and back)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1581610
Sex: F
Age: 76
State: MI

Vax Date: 02/16/2021
Onset Date: 02/24/2020
Rec V Date: 08/18/2021
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: firmness at the site of injection; itching at injection site; redness/pinkness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (firmness at the site of injection), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (redness/pinkness at the site of injection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031420A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included METFORMIN, GLIPIZIDE, METOPROLOL, LISINOPRIL and WARFARIN for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2020, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (redness/pinkness at the site of injection). On 24-Feb-2021, the patient experienced VACCINATION SITE INDURATION (firmness at the site of injection) and VACCINATION SITE PRURITUS (itching at injection site). At the time of the report, VACCINATION SITE INDURATION (firmness at the site of injection), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (redness/pinkness at the site of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: METFORMIN; GLIPIZIDE; METOPROLOL; LISINOPRIL; WARFARIN

Current Illness:

ID: 1581611
Sex: F
Age:
State:

Vax Date: 01/26/2021
Onset Date: 02/03/2021
Rec V Date: 08/18/2021
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: stressed out and have hives; stressed out and have hives; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (stressed out and have hives) and URTICARIA CHOLINERGIC (stressed out and have hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Hives. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced URTICARIA CHOLINERGIC (stressed out and have hives). On an unknown date, the patient experienced STRESS (stressed out and have hives). At the time of the report, STRESS (stressed out and have hives) and URTICARIA CHOLINERGIC (stressed out and have hives) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1581612
Sex: F
Age: 60
State: OR

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 08/18/2021
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: diarrhea lasted several days; fatigue; headaches; nausea lasted several days; terrible congestion, upper respiratory related; lost of appetite; lost of taste; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT CONGESTION (terrible congestion, upper respiratory related), DECREASED APPETITE (lost of appetite), AGEUSIA (lost of taste), DIARRHOEA (diarrhea lasted several days) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced UPPER RESPIRATORY TRACT CONGESTION (terrible congestion, upper respiratory related), DECREASED APPETITE (lost of appetite), DIARRHOEA (diarrhea lasted several days), FATIGUE (fatigue), HEADACHE (headaches) and NAUSEA (nausea lasted several days). In January 2021, the patient experienced AGEUSIA (lost of taste). At the time of the report, UPPER RESPIRATORY TRACT CONGESTION (terrible congestion, upper respiratory related), DECREASED APPETITE (lost of appetite), AGEUSIA (lost of taste), DIARRHOEA (diarrhea lasted several days), FATIGUE (fatigue), HEADACHE (headaches) and NAUSEA (nausea lasted several days) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative twice. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1581613
Sex: F
Age: 66
State: OH

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 08/18/2021
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: cant keep down fluids, and diarrhea; Nausea; Vomiting; Abdominal Cramps; Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal Cramps), FEELING ABNORMAL (Felt terrible), DIARRHOEA (cant keep down fluids, and diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced ABDOMINAL PAIN (Abdominal Cramps), FEELING ABNORMAL (Felt terrible), NAUSEA (Nausea) and VOMITING (Vomiting). On 04-Feb-2021, the patient experienced DIARRHOEA (cant keep down fluids, and diarrhea). At the time of the report, ABDOMINAL PAIN (Abdominal Cramps), FEELING ABNORMAL (Felt terrible), DIARRHOEA (cant keep down fluids, and diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient took no treatment.

Other Meds:

Current Illness:

ID: 1581614
Sex: M
Age:
State: MA

Vax Date: 01/17/2021
Onset Date: 02/14/2021
Rec V Date: 08/18/2021
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: Arm pain; fatigue; Fever (100.4F); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm pain), FATIGUE (fatigue) and PYREXIA (Fever (100.4F)) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE PAIN (Arm pain), FATIGUE (fatigue) and PYREXIA (Fever (100.4F)). On 16-Feb-2021, INJECTION SITE PAIN (Arm pain), FATIGUE (fatigue) and PYREXIA (Fever (100.4F)) had resolved. Not Provided No concomitant medications reported by investigator o No treatment medications provided by the reporter. This case was linked to MOD-2021-024269 (Patient Link).

Other Meds:

Current Illness:

ID: 1581615
Sex: M
Age: 76
State: PA

Vax Date: 01/14/2021
Onset Date: 02/09/2021
Rec V Date: 08/18/2021
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: dizziness; Body ache; Nausea; Chills; Sore arm; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Body aches), DIZZINESS (dizziness), PAIN (Body ache) and NAUSEA (Nausea) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), HCTZ, LISINOPRIL, SERTRALINE, SIMVASTATIN, BIMATOPROST (LUMIGAN) and DORZOLAMIDE for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PAIN (Body aches). On 23-Feb-2021, the patient experienced DIZZINESS (dizziness), PAIN (Body ache), NAUSEA (Nausea) and CHILLS (Chills). On 10-Feb-2021, PAIN (Body aches) had resolved. On 11-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, DIZZINESS (dizziness), PAIN (Body ache), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown. 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. Treatment information was not provided. This case was linked to MOD-2021-024355 (Patient Link).

Other Meds: BABY ASPIRIN; HCTZ; LISINOPRIL; SERTRALINE; SIMVASTATIN; LUMIGAN; DORZOLAMIDE

Current Illness:

ID: 1581616
Sex: F
Age:
State: NC

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/18/2021
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: looks like an allergic reaction; still does not feel real good; her cheeks gets red; Stomach has a bunch of growling and gassy like; 3 to 4 hours of vomiting; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (looks like an allergic reaction), FEELING ABNORMAL (still does not feel real good), RASH ERYTHEMATOUS (her cheeks gets red), FLATULENCE (Stomach has a bunch of growling and gassy like) and INJECTION SITE PAIN (very sore arm) in an 85-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. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and METOPROLOL for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE PAIN (very sore arm). On 29-Jan-2021, the patient experienced VACCINATION COMPLICATION (looks like an allergic reaction), FEELING ABNORMAL (still does not feel real good), RASH ERYTHEMATOUS (her cheeks gets red), FLATULENCE (Stomach has a bunch of growling and gassy like) and VOMITING (3 to 4 hours of vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Feb-2021, VOMITING (3 to 4 hours of vomiting) had resolved. At the time of the report, VACCINATION COMPLICATION (looks like an allergic reaction), FEELING ABNORMAL (still does not feel real good), RASH ERYTHEMATOUS (her cheeks gets red), FLATULENCE (Stomach has a bunch of growling and gassy like) and INJECTION SITE PAIN (very sore arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Tylenol and Ibuprofen used as a Treatment medication

Other Meds: SYNTHROID; METOPROLOL

Current Illness:

ID: 1581617
Sex: F
Age: 30
State: MN

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 08/18/2021
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: Sore throat; Swollen tonsils; Multiple cycles each month; cold like symptoms; minor headach/Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), TONSILLAR HYPERTROPHY (Swollen tonsils), MENSTRUATION IRREGULAR (Multiple cycles each month), NASOPHARYNGITIS (cold like symptoms) and HEADACHE (minor headach/Headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Migraine in 2004. Concurrent medical conditions included Anxiety since 2012. Concomitant products included SERTRALINE for Anxiety. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (minor headach/Headache) and FATIGUE (Fatigue). On 02-Feb-2021, the patient experienced NASOPHARYNGITIS (cold like symptoms). On 03-Feb-2021, the patient experienced MENSTRUATION IRREGULAR (Multiple cycles each month). On 23-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and TONSILLAR HYPERTROPHY (Swollen tonsils). On 30-Jan-2021, HEADACHE (minor headach/Headache) and FATIGUE (Fatigue) had resolved. On 27-Feb-2021, NASOPHARYNGITIS (cold like symptoms) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and TONSILLAR HYPERTROPHY (Swollen tonsils) outcome was unknown and MENSTRUATION IRREGULAR (Multiple cycles each month) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No treatment information was reported. The patient not had any actute illness at the time of vaccination and up to 1 month before.The patient had not experienced similar adverse event in the past and not had other potential causes for the event.Beginning in February 2021, The patient began to had her period twice a month. She had that each month to date (August 2021). In April, she had her intrauterine device (IUD) checked to make sure that had not become misplaced. The ultra sound showed that her IUD was still in place. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional information received: Suspect product information and reporter contact details updated. On 03-Aug-2021: Follow-up received: Patient details, relevant medical history added, Dosing regimen added, concomitant medication information added, new events added as a fatigue, Irregular menstrual cycle and cold and narrative updated.

Other Meds: SERTRALINE

Current Illness: Anxiety

ID: 1581618
Sex: F
Age: 83
State: FL

Vax Date: 02/02/2021
Onset Date: 02/05/2021
Rec V Date: 08/18/2021
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: large red area on the arm; area was bumpy like a rash; A spontaneous report was received from a Consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events large red area on the arm(erythema), area was bumpy like a rash(rash). The patient's medical history was not provided. No relevant concomitant medications were reported. On 2 Feb 2021,approximately 4 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly in arm for prophylaxis of COVID-19 infection. On 5 Feb 2021, the patient experienced the event(s) large red area on the arm and area was bumpy like a rash. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s) large red area on the arm and area was bumpy like a rash was considered resolved on 15 Feb 2021. .

Other Meds:

Current Illness:

ID: 1581619
Sex: M
Age: 81
State: CA

Vax Date: 01/28/2021
Onset Date: 02/01/2021
Rec V Date: 08/18/2021
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: PAIN AT THE INJECTION SITE; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (PAIN AT THE INJECTION SITE) and CHILLS (CHILLS) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNKNOWN and UNKNOWN) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INJECTION SITE PAIN (PAIN AT THE INJECTION SITE) and CHILLS (CHILLS). At the time of the report, INJECTION SITE PAIN (PAIN AT THE INJECTION SITE) and CHILLS (CHILLS) had not resolved. Not Provided No concomitant medications reported by investigator TYLENOL AND ORANGE JUICE used as Treatment medication.

Other Meds:

Current Illness:

ID: 1581620
Sex: U
Age:
State: TX

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/18/2021
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: shoulder was sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder was sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-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 ARTHRALGIA (shoulder was sore). At the time of the report, ARTHRALGIA (shoulder was sore) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were reported.

Other Meds:

Current Illness:

ID: 1581621
Sex: F
Age: 24
State: MD

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 08/18/2021
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: body aches; chills; chest pains; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (chills), CHEST PAIN (chest pains) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for an unknown indication. The patient's past medical history included No adverse event. On 03-Feb-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 (body aches), CHILLS (chills), CHEST PAIN (chest pains) and HEADACHE (headache). At the time of the report, PAIN (body aches), CHILLS (chills), CHEST PAIN (chest pains) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Treatment includes Tylenol and Advil. Patient was taking Centamin previously but stopped a few month ago.

Other Meds:

Current Illness:

ID: 1581622
Sex: U
Age:
State: AL

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/18/2021
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: enlarged lymph node (in armpit) on the opposite arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node (in armpit) on the opposite arm) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-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 LYMPHADENOPATHY (enlarged lymph node (in armpit) on the opposite arm). At the time of the report, LYMPHADENOPATHY (enlarged lymph node (in armpit) on the opposite arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications and treatment information were reported.

Other Meds:

Current Illness:

ID: 1581623
Sex: F
Age:
State:

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/18/2021
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: Chills; Temperature; Diarrhea; Pain in the chest; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), BODY TEMPERATURE INCREASED (Temperature), DIARRHOEA (Diarrhea), CHEST PAIN (Pain in the chest) and FATIGUE (Very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced CHILLS (Chills), BODY TEMPERATURE INCREASED (Temperature), DIARRHOEA (Diarrhea), CHEST PAIN (Pain in the chest) and FATIGUE (Very tired). At the time of the report, CHILLS (Chills), BODY TEMPERATURE INCREASED (Temperature), DIARRHOEA (Diarrhea), CHEST PAIN (Pain in the chest) and FATIGUE (Very tired) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1581624
Sex: F
Age: 87
State: NY

Vax Date: 02/15/2021
Onset Date: 02/23/2021
Rec V Date: 08/18/2021
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: Itchy knot; Red knot; Warm to the touch at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy knot), ERYTHEMA (Red knot) and INJECTION SITE WARMTH (Warm to the touch at the site of injection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PRURITUS (Itchy knot), ERYTHEMA (Red knot) and INJECTION SITE WARMTH (Warm to the touch at the site of injection). At the time of the report, PRURITUS (Itchy knot), ERYTHEMA (Red knot) and INJECTION SITE WARMTH (Warm to the touch at the site of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information and concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1581625
Sex: F
Age: 67
State: MD

Vax Date: 02/22/2021
Onset Date:
Rec V Date: 08/18/2021
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: Arthritis Pain; Neuropathic Pain; I still have enlarged underarm lymph nodes.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis Pain), NEURALGIA (Neuropathic Pain) and LYMPHADENOPATHY (I still have enlarged underarm lymph nodes.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis since 01-Dec-2020 and Neuropathic pain since 01-Dec-2020. On 22-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 ARTHRITIS (Arthritis Pain), NEURALGIA (Neuropathic Pain) and LYMPHADENOPATHY (I still have enlarged underarm lymph nodes.). At the time of the report, ARTHRITIS (Arthritis Pain) and NEURALGIA (Neuropathic Pain) was resolving and LYMPHADENOPATHY (I still have enlarged underarm lymph nodes.) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received contains added event - Lymphadenopathy and updated outcome from not recovered to recovering

Other Meds:

Current Illness: Arthritis; Neuropathic pain

ID: 1581626
Sex: U
Age:
State: AL

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/18/2021
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: doesn't feel well at all today; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (doesn't feel well at all today), HEADACHE (headache) and CHILLS (chills) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-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 an unknown date, the patient experienced MALAISE (doesn't feel well at all today), HEADACHE (headache) and CHILLS (chills). At the time of the report, MALAISE (doesn't feel well at all today), HEADACHE (headache) and CHILLS (chills) outcome was unknown. No concomitant medications and treatment information were reported. This case was linked to MOD-2021-024388 (Patient Link).

Other Meds:

Current Illness:

ID: 1581627
Sex: F
Age: 76
State: FL

Vax Date: 01/22/2021
Onset Date: 01/30/2021
Rec V Date: 08/18/2021
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: arm was red size of my palm; hot arm; itchy arm; hard arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was red size of my palm), FEELING HOT (hot arm), PRURITUS (itchy arm) and INDURATION (hard arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included METFORMIN, PRAVASTATIN, POTASSIUM (POTASIUM M), ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN, METOPROLOL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 22-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ERYTHEMA (arm was red size of my palm), FEELING HOT (hot arm), PRURITUS (itchy arm) and INDURATION (hard arm). On 03-Feb-2021, FEELING HOT (hot arm), PRURITUS (itchy arm) and INDURATION (hard arm) had resolved. At the time of the report, ERYTHEMA (arm was red size of my palm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Benadryl when itching badly.

Other Meds: METFORMIN; PRAVASTATIN; POTASIUM M; BABY ASPIRIN; LOSARTAN; METOPROLOL; SYNTHROID

Current Illness:

ID: 1581628
Sex: F
Age: 70
State:

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/18/2021
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: Delayed Swelling bruise; Delayed itchy brusie; Delayed red bruise; Tiny bruise the size of a penny; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Tiny bruise the size of a penny), VACCINATION SITE SWELLING (Delayed Swelling bruise), INJECTION SITE PRURITUS (Delayed itchy brusie) and INJECTION SITE ERYTHEMA (Delayed red bruise) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy. On 10-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 INJECTION SITE BRUISING (Tiny bruise the size of a penny). On 19-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Delayed Swelling bruise), INJECTION SITE PRURITUS (Delayed itchy brusie) and INJECTION SITE ERYTHEMA (Delayed red bruise). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE BRUISING (Tiny bruise the size of a penny), VACCINATION SITE SWELLING (Delayed Swelling bruise), INJECTION SITE PRURITUS (Delayed itchy brusie) and INJECTION SITE ERYTHEMA (Delayed red bruise) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. treatment information includes ice. No concomitant medications were reported Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: ADR Form received on 11-MAY-2021 Contains patient details updated , medical history was updated.

Other Meds:

Current Illness: Sulfonamide allergy

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm