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: 1561441
Sex: M
Age: 77
State: FL

Vax Date: 02/08/2021
Onset Date: 02/09/2021
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: Eats half of what he used to eat on the plate; Mouth gets very dry at night; Fever; Metallic taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Eats half of what he used to eat on the plate), DYSGEUSIA (Metallic taste in mouth), DRY MOUTH (Mouth gets very dry at night) and PYREXIA (Fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 08-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 09-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth) and PYREXIA (Fever). On an unknown date, the patient experienced DECREASED APPETITE (Eats half of what he used to eat on the plate) and DRY MOUTH (Mouth gets very dry at night). At the time of the report, DECREASED APPETITE (Eats half of what he used to eat on the plate), DRY MOUTH (Mouth gets very dry at night) and PYREXIA (Fever) outcome was unknown and DYSGEUSIA (Metallic taste in mouth) had not resolved. No concomitant medications were reported. No treatments were reported. This case was linked to MOD-2021-032335 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information provided:New events added and events outcome updated; Sender's Comments: MOD-2021-032335:Same reporter/Different patient

Other Meds:

Current Illness:

ID: 1561442
Sex: F
Age: 16
State: GA

Vax Date: 03/02/2021
Onset Date: 03/02/2021
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: Vaccinated a 16 year old; Off-Label use; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 16 year old) and OFF LABEL USE (Off-Label use) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 16 year old) and OFF LABEL USE (Off-Label use). On 02-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 16 year old) and OFF LABEL USE (Off-Label use) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No adverse events were reported after vaccine administration. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: The patient's race, ethnicity, pregnancy information updated and event off label use was added.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number 010A21A) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1561443
Sex: M
Age:
State:

Vax Date:
Onset Date:
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: mild discomfort; insomnia; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (mild discomfort), INSOMNIA (insomnia) and FATIGUE (fatigue) 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (mild discomfort), INSOMNIA (insomnia) and FATIGUE (fatigue). At the time of the report, DISCOMFORT (mild discomfort), INSOMNIA (insomnia) and FATIGUE (fatigue) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1561444
Sex: F
Age: 72
State:

Vax Date: 02/10/2021
Onset Date: 02/10/2021
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: Hand finger numbness and tingling; Hand finger numbness and tingling; Sore arm; Pain in neck; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Hand finger numbness and tingling ), PARAESTHESIA (Hand finger numbness and tingling), PAIN IN EXTREMITY (Sore arm ) and NECK PAIN (Pain in neck ) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination. The patient's past medical history included Numbness in hand (the past she has had left hand numbness, but it was associated with chest pain). 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 HYPOAESTHESIA (Hand finger numbness and tingling ), PARAESTHESIA (Hand finger numbness and tingling), PAIN IN EXTREMITY (Sore arm ) and NECK PAIN (Pain in neck ). At the time of the report, HYPOAESTHESIA (Hand finger numbness and tingling ), PARAESTHESIA (Hand finger numbness and tingling), PAIN IN EXTREMITY (Sore arm ) and NECK PAIN (Pain in neck ) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1561445
Sex: U
Age:
State: MA

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: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: shot administered from syringe at 8 hour mark; 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 WRONG TECHNIQUE IN DEVICE USAGE PROCESS (shot administered from syringe at 8 hour mark) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (shot administered from syringe at 8 hour mark). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (shot administered from syringe at 8 hour mark) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. No treatment details are provided.

Other Meds:

Current Illness:

ID: 1561446
Sex: F
Age: 33
State: CA

Vax Date: 03/02/2021
Onset Date: 03/02/2021
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: recieved Moderna COVID-19 Vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (recieved Moderna COVID-19 Vaccine while pregnant) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 13-Sep-2021. On 02-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (recieved Moderna COVID-19 Vaccine while pregnant). On 02-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (recieved Moderna COVID-19 Vaccine while pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1561447
Sex: M
Age: 47
State: MN

Vax Date: 03/02/2021
Onset Date: 03/02/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Left nostril is running like a faucet) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Seasonal allergy. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced RHINORRHOEA (Left nostril is running like a faucet). At the time of the report, RHINORRHOEA (Left nostril is running like a faucet) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported. Reporter did not allow further contact.

Other Meds: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Seasonal allergy

ID: 1561448
Sex: F
Age:
State: KY

Vax Date:
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: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: gave 17 year old vaccine; A sontaneous report was received from a health care professional concerning a 17-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event,was not provided. On unknown date , prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, was considered as recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1561449
Sex: M
Age: 75
State: VA

Vax Date: 01/21/2021
Onset Date: 03/01/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: Incorrect route of product administration; Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration ) and VACCINATION SITE PAIN (Vaccination site pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 032L20A) for COVID-19 vaccination. The patient's past medical history included Major depression on 01-Jan-1980. Concurrent medical conditions included Drug allergy (CA++ Channel Blockers), Asthma since 01-Jan-1950, Type 2 diabetes mellitus since 01-Jan-2000 and Arthritis (gradually worse with age) since 01-Jan-2006. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 01-Jan-2010 to an unknown date for Asthma, CITALOPRAM from 01-Jan-1987 to an unknown date for Depression, METFORMIN from 01-Jan-2010 to an unknown date, GLIMEPIRIDE from 01-Jan-2015 to an unknown date and INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) from 01-Jan-2010 to an unknown date for Diabetes. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration ) and VACCINATION SITE PAIN (Vaccination site pain). On 01-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration ) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments. No treatment medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-031651, US-MODERNATX, INC.-MOD-2021-032479 (E2B Linked Report). This case was linked to MOD-2021-031572 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Historical condition and concomitant products were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, vaccination site pain, a causal relationship cannot be excluded. This report also refers to a case of incorrect route of product administration for mRNA-1273, lot # 014M20A with no associated AEs. US-MODERNATX, INC.-MOD-2021-031651:Crosslinked case: Same reporter (Wife case 1st dose) US-MODERNATX, INC.-MOD-2021-032479:Crosslinked case: Same reporter (Wife case (2nd dose)

Other Meds: ADVAIR; METFORMIN; GLIMEPIRIDE; NOVOLIN N; CITALOPRAM

Current Illness: Arthritis (gradually worse with age); Asthma; Drug allergy (CA++ Channel Blockers); Type 2 diabetes mellitus

ID: 1561450
Sex: F
Age: 38
State: TX

Vax Date: 02/24/2021
Onset Date: 02/25/2021
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: Armpit is swollen; Armpit is hurting; Redness at the injection; Arm swell up the size of a silver dollar at the injection/swelling about 6 inches in diameter; Hotness,warmth at the injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Armpit is swollen), VACCINATION SITE WARMTH (Hotness,warmth at the injection), AXILLARY PAIN (Armpit is hurting), VACCINATION SITE ERYTHEMA (Redness at the injection) and VACCINATION SITE SWELLING (Arm swell up the size of a silver dollar at the injection/swelling about 6 inches in diameter) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hotness,warmth at the injection), VACCINATION SITE ERYTHEMA (Redness at the injection) and VACCINATION SITE SWELLING (Arm swell up the size of a silver dollar at the injection/swelling about 6 inches in diameter). On 01-Mar-2021, the patient experienced PERIPHERAL SWELLING (Armpit is swollen) and AXILLARY PAIN (Armpit is hurting). At the time of the report, PERIPHERAL SWELLING (Armpit is swollen), VACCINATION SITE WARMTH (Hotness,warmth at the injection), AXILLARY PAIN (Armpit is hurting) and VACCINATION SITE ERYTHEMA (Redness at the injection) outcome was unknown and VACCINATION SITE SWELLING (Arm swell up the size of a silver dollar at the injection/swelling about 6 inches in diameter) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1561451
Sex: F
Age: 68
State: TX

Vax Date: 01/02/2021
Onset Date: 02/08/2021
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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: bump the size of silver dollar; itching; arm was pink; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (arm was pink), SWELLING (bump the size of silver dollar) and PRURITUS (itching) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE and PRAMOXINE for an unknown indication. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced SKIN DISCOLOURATION (arm was pink). On 10-Feb-2021, the patient experienced SWELLING (bump the size of silver dollar) and PRURITUS (itching). At the time of the report, SKIN DISCOLOURATION (arm was pink), SWELLING (bump the size of silver dollar) and PRURITUS (itching) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient also took Allergy meds as concomitant medication The Treatment information was unknown.

Other Meds: LEVOTHYROXINE; PRAMOXINE

Current Illness:

ID: 1561452
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: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Arm was very painful and really puffed out; Arm was very painful and really puffed out; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (Arm was very painful and really puffed out) and PERIPHERAL SWELLING (Arm was very painful and really puffed out) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was very painful and really puffed out) and PERIPHERAL SWELLING (Arm was very painful and really puffed out). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was very painful and really puffed out) and PERIPHERAL SWELLING (Arm was very painful and really puffed out) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Information was obtained from a pharmaceutical company which was reported to them by a consumer. The consumer's son received the first dose of the Moderna vaccine. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1561453
Sex: F
Age: 72
State: NJ

Vax Date: 02/17/2021
Onset Date: 02/17/2021
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: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: sweating; night sweats; fever; chills/shivering at night; headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), NIGHT SWEATS (night sweats), PYREXIA (fever), CHILLS (chills/shivering at night) and HEADACHE (headaches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunization. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), SALBUTAMOL (VENTOLINE [SALBUTAMOL]), FLUTICASONE PROPIONATE (FLOVENT), LOVASTATIN, LOSARTAN, HCTZ and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), NIGHT SWEATS (night sweats), PYREXIA (fever), CHILLS (chills/shivering at night) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form every six hours. On 22-Feb-2021, HYPERHIDROSIS (sweating), NIGHT SWEATS (night sweats), PYREXIA (fever), CHILLS (chills/shivering at night) and HEADACHE (headaches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: SINGULAIR; VENTOLINE [SALBUTAMOL]; FLOVENT; LOVASTATIN; LOSARTAN; HCTZ; ASPIRIN 81

Current Illness:

ID: 1561454
Sex: F
Age: 73
State: MI

Vax Date: 02/19/2021
Onset Date: 02/19/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (So weak. could not get up), URINARY INCONTINENCE (pea in her pants), VACCINATION COMPLICATION (had a reaction), VACCINATION SITE INDURATION (it was hard to the touch) and HEADACHE (excruciating headache) in a 73-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 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced ASTHENIA (So weak. could not get up), URINARY INCONTINENCE (pea in her pants), VACCINATION COMPLICATION (had a reaction), VACCINATION SITE INDURATION (it was hard to the touch), HEADACHE (excruciating headache) and VACCINATION SITE PAIN (Injection Site hurt). The patient was treated with HYDROCODONE on 19-Feb-2021 for Adverse event following immunisation, at a dose of 1 dosage form. In February 2021, ASTHENIA (So weak. could not get up) had resolved. On 21-Feb-2021, URINARY INCONTINENCE (pea in her pants), VACCINATION COMPLICATION (had a reaction), VACCINATION SITE INDURATION (it was hard to the touch), HEADACHE (excruciating headache) and VACCINATION SITE PAIN (Injection Site hurt) had resolved. No relevant concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant follow-up Telephone Contact Report received and event outcomes updated to recovered since the patient stated she was fine.

Other Meds:

Current Illness:

ID: 1561455
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
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: Received the vaccine outside of temperature range; 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 EXPIRED PRODUCT ADMINISTERED (Received the vaccine outside of temperature range) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the vaccine outside of temperature range). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the vaccine outside of temperature range) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. It was reported that 10 people received the vaccine that were outside of the temperature range. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1561456
Sex: F
Age:
State: TX

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: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Pregnant while receiving the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant while receiving the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant while receiving the vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant while receiving the vaccine) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication information was provided.

Other Meds:

Current Illness:

ID: 1561457
Sex: F
Age: 49
State: WA

Vax Date: 02/20/2021
Onset Date: 02/21/2021
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: lymph nodes along the left neck swollen.; lymph nodes along the left side of back swollen/lymph nodes along the left ear swollen; lymph nodes along the left collarbone swollen; Covid arm; pinkish spot at the injection site; Mild itching at the injection site; mild swelling at the injection site; soreness at the injection site; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Covid arm), INJECTION SITE DISCOLOURATION (pinkish spot at the injection site), PRURITUS (Mild itching at the injection site), SWELLING (lymph nodes along the left neck swollen.) and SWELLING (lymph nodes along the left side of back swollen/lymph nodes along the left ear swollen) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 21-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (pinkish spot at the injection site), PRURITUS (Mild itching at the injection site), INJECTION SITE SWELLING (mild swelling at the injection site), INJECTION SITE PAIN (soreness at the injection site), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 27-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Covid arm), SWELLING (lymph nodes along the left neck swollen.), SWELLING (lymph nodes along the left side of back swollen/lymph nodes along the left ear swollen) and LYMPHADENOPATHY (lymph nodes along the left collarbone swollen). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Covid arm), INJECTION SITE DISCOLOURATION (pinkish spot at the injection site), PRURITUS (Mild itching at the injection site), SWELLING (lymph nodes along the left neck swollen.), SWELLING (lymph nodes along the left side of back swollen/lymph nodes along the left ear swollen), LYMPHADENOPATHY (lymph nodes along the left collarbone swollen), INJECTION SITE SWELLING (mild swelling at the injection site), INJECTION SITE PAIN (soreness at the injection site), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Treatment included Benadryl cream, oral Benadryl. Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Non-significant follow-up received on 20-jul-2021- Email details were updated.

Other Meds:

Current Illness:

ID: 1561458
Sex: F
Age:
State: AL

Vax Date: 02/25/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Head feels hot), PRURITUS (itching on hands, itching on rib cages), ASTHENIA (Overall weakness), PAIN IN EXTREMITY (left arm is sore) and LIMB MASS (little painful lumps all over forearm and tender spots - on forearm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Family history included Drug allergy (paradoxical drug). Concurrent medical conditions included Drug allergy (seasonal allergies). On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Head feels hot), PRURITUS (itching on hands, itching on rib cages), ASTHENIA (Overall weakness), PAIN IN EXTREMITY (left arm is sore), LIMB MASS (little painful lumps all over forearm and tender spots - on forearm), PAIN (little painful lumps all over forearm and tender spots - on forearm), SWELLING (swelling on cheeks, swelling a little bit on eyes and glands on throat are swollen), HEADACHE (Headache), ASTHENIA (Weak kneed), ARTHRALGIA (Pain in shoulders), PAIN (Achiness) and FEELING ABNORMAL (Fuzziness in my thing). At the time of the report, FEELING HOT (Head feels hot), PRURITUS (itching on hands, itching on rib cages), ASTHENIA (Overall weakness), PAIN IN EXTREMITY (left arm is sore), LIMB MASS (little painful lumps all over forearm and tender spots - on forearm), PAIN (little painful lumps all over forearm and tender spots - on forearm), SWELLING (swelling on cheeks, swelling a little bit on eyes and glands on throat are swollen), HEADACHE (Headache), ASTHENIA (Weak kneed), ARTHRALGIA (Pain in shoulders), PAIN (Achiness) and FEELING ABNORMAL (Fuzziness in my thing) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment included Tylenol, Claritin This case was linked to MOD-2021-032621 (Patient Link).

Other Meds:

Current Illness: Drug allergy (seasonal allergies)

ID: 1561459
Sex: F
Age: 73
State: PA

Vax Date: 02/17/2021
Onset Date: 02/21/2021
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: Pain in whole body in the same places she has arthritis after 1st dose/Patient had arthritis in her body everywhere; Bladder burn after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER PAIN (Bladder burn after 1st shot) and ARTHRITIS (Pain in whole body in the same places she has arthritis after 1st dose/Patient had arthritis in her body everywhere) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031mzua) for COVID-19 vaccination. Concurrent medical conditions included Arthritis. Concomitant products included RIVAROXABAN (XARELTO), DILTIAZEM, AMLODIPINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and BIOTIN for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced BLADDER PAIN (Bladder burn after 1st shot). On 24-Feb-2021, the patient experienced ARTHRITIS (Pain in whole body in the same places she has arthritis after 1st dose/Patient had arthritis in her body everywhere). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Feb-2021, BLADDER PAIN (Bladder burn after 1st shot) and ARTHRITIS (Pain in whole body in the same places she has arthritis after 1st dose/Patient had arthritis in her body everywhere) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient took Tylenol for the pain. Antibiotic was also used as treatment medication. Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up received on 06-APR-2021.Significant follow up appended.Event verbatim term was updated(Pain in whole body in the same places as she has arthritis after 1st dose was changed to Patient had arthritis in her body every where).An additional contact number is also included.

Other Meds: XARELTO; DILTIAZEM; AMLODIPINE; VITAMIN D 2000; BIOTIN

Current Illness:

ID: 1561460
Sex: M
Age: 69
State:

Vax Date: 02/06/2021
Onset Date: 02/20/2021
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: Severe reaction; pretty svere nerve pain; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reaction), HERPES ZOSTER (Shingles) and NEURALGIA (pretty svere nerve pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013D720A) for COVID-19 vaccination. The patient's past medical history included No adverse reaction. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe reaction) and NEURALGIA (pretty svere nerve pain). At the time of the report, VACCINATION COMPLICATION (Severe reaction), HERPES ZOSTER (Shingles) and NEURALGIA (pretty svere nerve pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. the concomitant product is not provided Treatment included Valacyclovir

Other Meds:

Current Illness:

ID: 1561461
Sex: F
Age: 49
State: VA

Vax Date: 02/28/2021
Onset Date: 03/01/2021
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: She started sweating; Chills; Started to shiver,; Very cold; Temperature of 101.7; Nausea; Sore muscles in her neck; fatigue; a little sneezing; Coughing; fast heart beat; Fever went down to 99.3degrees; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), CHILLS (Started to shiver,), FEELING COLD (Very cold), PYREXIA (Temperature of 101.7) and NAUSEA (Nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for an unknown indication. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included No adverse event. On 28-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 01-Mar-2021, the patient experienced CHILLS (Chills), CHILLS (Started to shiver,), FEELING COLD (Very cold), PYREXIA (Temperature of 101.7), NAUSEA (Nausea), NECK PAIN (Sore muscles in her neck), FATIGUE (fatigue), SNEEZING (a little sneezing), COUGH (Coughing), PALPITATIONS (fast heart beat) and PYREXIA (Fever went down to 99.3degrees). On 02-Mar-2021, the patient experienced HYPERHIDROSIS (She started sweating). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was unknown.

Other Meds:

Current Illness:

ID: 1561462
Sex: F
Age: 66
State: FL

Vax Date: 01/08/2021
Onset Date: 02/02/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu-like symptoms) and PRODUCT DOSE OMISSION ISSUE (2nd shot of vaccine not received >42 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 08-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 INFLUENZA (flu-like symptoms) and PRODUCT DOSE OMISSION ISSUE (2nd shot of vaccine not received >42 days). On 02-Feb-2021, PRODUCT DOSE OMISSION ISSUE (2nd shot of vaccine not received >42 days) had resolved. On 10-Feb-2021, INFLUENZA (flu-like symptoms) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Influenza virus test: negative (Negative) Negative. On 04-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was unknown.

Other Meds:

Current Illness:

ID: 1561463
Sex: F
Age: 71
State:

Vax Date: 02/06/2021
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: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Cold sore; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 06-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 ORAL HERPES (Cold sore). At the time of the report, ORAL HERPES (Cold sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication included eye drops for glaucoma and blood pressure medication Treatment information was unknown.

Other Meds:

Current Illness:

ID: 1561464
Sex: F
Age:
State: NJ

Vax Date: 02/13/2021
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: Intermittent asthma; Vaccine availability issue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Intermittent asthma) and PRODUCT AVAILABILITY ISSUE (Vaccine availability issue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced ASTHMA (Intermittent asthma) and PRODUCT AVAILABILITY ISSUE (Vaccine availability issue). At the time of the report, ASTHMA (Intermittent asthma) and PRODUCT AVAILABILITY ISSUE (Vaccine availability issue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications were not provided. The reporter stated that that she had intermittent asthma, did not clarified if it before or after receiving the vaccine. Treatment details were not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Very little information was received for this case. The patient declined follow-up so no new information is expected. Based on current available information it is unclear if the patient actually received the vaccine and if the event was an ongoing, pre-existing condition. Reporter did not allow further contact; Sender's Comments: Very little information was received for this case. The patient declined follow-up so no new information is expected. Based on current available information it is unclear if the patient actually received the vaccine and if the event was an ongoing, pre-existing condition.

Other Meds:

Current Illness:

ID: 1561465
Sex: F
Age:
State: OR

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: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: arm sensitivity; had some side effects that are on your package insert; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPERSENSITIVITY (arm sensitivity) and ADVERSE EVENT (had some side effects that are on your package insert) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HYPERSENSITIVITY (arm sensitivity) and ADVERSE EVENT (had some side effects that are on your package insert). At the time of the report, INJECTION SITE HYPERSENSITIVITY (arm sensitivity) and ADVERSE EVENT (had some side effects that are on your package insert) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was unknown.

Other Meds:

Current Illness:

ID: 1561466
Sex: M
Age: 72
State: MI

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: High blood pressure than normal; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure than normal) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event and Bypass surgery. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HYPERTENSION (High blood pressure than normal). At the time of the report, HYPERTENSION (High blood pressure than normal) 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. Treatment information was unknown. This case was linked to MOD21-043200 (E2B Linked Report).; Sender's Comments: MOD21-043200:same reporter, wife case

Other Meds:

Current Illness:

ID: 1561467
Sex: F
Age: 72
State: GA

Vax Date: 02/25/2021
Onset Date: 02/25/2021
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: Nausea, Pain in extremity, Pyrexia

Symptoms: little bit itching, little bit of rash on face, both arms and legs; Itching in face; Tingling in mouth and tounge and worked its way down to legs; Tingling down the legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in face), PARAESTHESIA ORAL (Tingling in mouth and tounge and worked its way down to legs), PARAESTHESIA (Tingling down the legs) and RASH PRURITIC (little bit itching, little bit of rash on face, both arms and legs) in a 72-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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (Itching in face), PARAESTHESIA ORAL (Tingling in mouth and tounge and worked its way down to legs) and PARAESTHESIA (Tingling down the legs). On 19-Mar-2021, the patient experienced RASH PRURITIC (little bit itching, little bit of rash on face, both arms and legs). At the time of the report, PRURITUS (Itching in face), PARAESTHESIA ORAL (Tingling in mouth and tounge and worked its way down to legs), PARAESTHESIA (Tingling down the legs) and RASH PRURITIC (little bit itching, little bit of rash on face, both arms and legs) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: New events were updated.

Other Meds:

Current Illness:

ID: 1561468
Sex: F
Age:
State: AL

Vax Date:
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: Left arm was sore after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm was sore after the first dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy. 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 PAIN IN EXTREMITY (Left arm was sore after the first dose). At the time of the report, PAIN IN EXTREMITY (Left arm was sore after the first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment included Tylenol and Claritin This case was linked to MOD-2021-032604.

Other Meds:

Current Illness: Seasonal allergy

ID: 1561469
Sex: M
Age: 83
State: IN

Vax Date: 01/23/2021
Onset Date: 02/28/2021
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: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Concurrent medical conditions included Blood pressure abnormal and Thyroid disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced MALAISE (Didn't feel good), HEADACHE (headache), VACCINATION SITE PAIN (pain in my arm of injection), FATIGUE (tiredness) and LYMPHADENOPATHY (Swelling of lymph nodes under arm of injection (left arm)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Didn't feel good), HEADACHE (headache), VACCINATION SITE PAIN (pain in my arm of injection), FATIGUE (tiredness) and LYMPHADENOPATHY (Swelling of lymph nodes under arm of injection (left arm)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications also reported were Blood pressure medicine, Thyroid medicine.

Other Meds: VITAMINS NOS

Current Illness: Blood pressure abnormal; Thyroid disorder NOS

ID: 1561470
Sex: F
Age:
State: IL

Vax Date: 01/24/2021
Onset Date: 01/24/2021
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: Patient is not tired but looks tired; Patient experienced severe squeezing headache after receiving 2nd dose and still not going away; Patient reported pain in injection site; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient reported pain in injection site), HEADACHE (Patient experienced severe squeezing headache after receiving 2nd dose and still not going away), FATIGUE (Patient is not tired but looks tired) and PAIN IN EXTREMITY (sore left arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 006M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Patient reported pain in injection site) and PAIN IN EXTREMITY (sore left arm). On 20-Feb-2021, the patient experienced HEADACHE (Patient experienced severe squeezing headache after receiving 2nd dose and still not going away). On 02-Mar-2021, the patient experienced FATIGUE (Patient is not tired but looks tired). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 26-Jan-2021, VACCINATION SITE PAIN (Patient reported pain in injection site) and PAIN IN EXTREMITY (sore left arm) had resolved. At the time of the report, HEADACHE (Patient experienced severe squeezing headache after receiving 2nd dose and still not going away) and FATIGUE (Patient is not tired but looks tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient is treated with Advil. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional information added.

Other Meds: ALENDRONATE

Current Illness:

ID: 1561471
Sex: F
Age:
State: IL

Vax Date: 02/11/2021
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: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: moderate sore arm; all hell broke loose; arm swollen; muscle that goes down the front of arm is also sore; hard to raise her arm; hurt too much to raise her arm; chills; shaking; threw up; stomch upset; freezing; could not get warm; teeth was shaking; became so disoriented that she was not capable figuring how to call her husband; running a feve; fever was 117; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (moderate sore arm), FEELING ABNORMAL (all hell broke loose), VACCINATION SITE SWELLING (arm swollen), MYALGIA (muscle that goes down the front of arm is also sore) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to raise her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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 METFORMIN, WARFARIN, PROPRANOLOL HYDROCHLORIDE (PROPANOLOL BOEHRINGER), BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), Nasacort as needed, Supplements and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication. On 11-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 MYALGIA (moderate sore arm), FEELING ABNORMAL (all hell broke loose), VACCINATION SITE SWELLING (arm swollen), MYALGIA (muscle that goes down the front of arm is also sore), VACCINATION SITE MOVEMENT IMPAIRMENT (hard to raise her arm), VACCINATION SITE PAIN (hurt too much to raise her arm), CHILLS (chills), TREMOR (shaking), VOMITING (threw up), ABDOMINAL DISCOMFORT (stomch upset), FEELING COLD (freezing), FEELING COLD (could not get warm), CHILLS (teeth was shaking), DISORIENTATION (became so disoriented that she was not capable figuring how to call her husband), PYREXIA (running a feve) and PYREXIA (fever was 117). At the time of the report, MYALGIA (moderate sore arm), FEELING ABNORMAL (all hell broke loose), VACCINATION SITE SWELLING (arm swollen), MYALGIA (muscle that goes down the front of arm is also sore), VACCINATION SITE MOVEMENT IMPAIRMENT (hard to raise her arm), VACCINATION SITE PAIN (hurt too much to raise her arm), CHILLS (chills), TREMOR (shaking), VOMITING (threw up), ABDOMINAL DISCOMFORT (stomch upset), FEELING COLD (freezing), FEELING COLD (could not get warm), CHILLS (teeth was shaking), DISORIENTATION (became so disoriented that she was not capable figuring how to call her husband), PYREXIA (running a feve) and PYREXIA (fever was 117) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was unknown.

Other Meds: METFORMIN; WARFARIN; PROPANOLOL BOEHRINGER; FIORICET; SINGULAIR; ZYRTEC ALLERGY; Nasacort as needed; Supplements; VITAMIN D 2000

Current Illness:

ID: 1561472
Sex: F
Age:
State: CA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
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: Fatigue; Headache; Fever; Chills; Body aches; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a female 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. 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 29-Jan-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and ARTHRALGIA (Joint pain). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and ARTHRALGIA (Joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitants and treatment were not reported. This case was linked to MOD-2021-032628 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1561473
Sex: M
Age: 80
State: CA

Vax Date: 02/28/2021
Onset Date: 02/28/2021
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: Couldn't sleep; in a lot of pain; whole body feels like pain from a serious back injury; Feels like hit on head with a baseball bat; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), HEADACHE (Feels like hit on head with a baseball bat), PAIN (in a lot of pain) and PAIN (whole body feels like pain from a serious back injury) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep), HEADACHE (Feels like hit on head with a baseball bat), PAIN (in a lot of pain) and PAIN (whole body feels like pain from a serious back injury). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Headache and Pain, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Couldn't sleep), HEADACHE (Feels like hit on head with a baseball bat), PAIN (in a lot of pain) and PAIN (whole body feels like pain from a serious back injury) outcome was unknown. No concomitant medications details were not reported.

Other Meds:

Current Illness:

ID: 1561474
Sex: M
Age: 39
State: FL

Vax Date: 01/27/2021
Onset Date: 01/27/2021
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: Chills; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Feb-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Antibody test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1561475
Sex: F
Age: 68
State: IL

Vax Date: 01/24/2021
Onset Date: 02/20/2021
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: Erythema, Pruritus

Symptoms: Not feeling herself; Patient is not tired but looks tired; Severe squeezing headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling herself), HEADACHE (Severe squeezing headache) and FATIGUE (Patient is not tired but looks tired) in a 68-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 Osteoporosis. Concomitant products included IBUPROFEN from 20-Feb-2021 to 20-Feb-2021 for Headache, ALENDRONATE SODIUM (ALENDRONATE) for Osteoporosis, MULTIVITAMIN [VITAMINS NOS], MAGNESIUM, VITAMIN D3, FISH OIL and BIOTIN for an unknown indication. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Severe squeezing headache). On 02-Mar-2021, the patient experienced FEELING ABNORMAL (Not feeling herself) and FATIGUE (Patient is not tired but looks tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Not feeling herself) and FATIGUE (Patient is not tired but looks tired) outcome was unknown and HEADACHE (Severe squeezing headache) had not resolved. This case was linked to MOD-2021-032624 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 3-5-2021, Patient demographics, medical history, concomitants updated

Other Meds: IBUPROFEN; ALENDRONATE; MULTIVITAMIN [VITAMINS NOS]; MAGNESIUM; VITAMIN D3; FISH OIL; BIOTIN

Current Illness:

ID: 1561476
Sex: F
Age: 82
State: TX

Vax Date: 12/30/2020
Onset Date: 12/30/2020
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: Arms were sore; Kind of itched; it was hot; shingles on left arm; another place of the exact kind of redness appeared; It turned red; Feverish; there was a knot there; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arms were sore), PRURITUS (Kind of itched), ERYTHEMA (another place of the exact kind of redness appeared), VACCINATION SITE WARMTH (it was hot) and HERPES ZOSTER (shingles on left arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037L20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chickenpox, Arthritis and Accident (whiplash from a car accident 40 years ago.). On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (It turned red) and PYREXIA (Feverish). On 03-Jan-2021, the patient experienced ERYTHEMA (another place of the exact kind of redness appeared). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arms were sore), PRURITUS (Kind of itched), VACCINATION SITE WARMTH (it was hot), HERPES ZOSTER (shingles on left arm) and VACCINATION SITE INDURATION (there was a knot there). On 02-Jan-2021, PYREXIA (Feverish) had resolved. On 07-Jan-2021, VACCINATION SITE ERYTHEMA (It turned red) had resolved. On 13-Jan-2021, ERYTHEMA (another place of the exact kind of redness appeared) had resolved. At the time of the report, PAIN IN EXTREMITY (Arms were sore), VACCINATION SITE WARMTH (it was hot) and VACCINATION SITE INDURATION (there was a knot there) had resolved, PRURITUS (Kind of itched) outcome was unknown and HERPES ZOSTER (shingles on left arm) had not resolved. No concomitant medications were reported. Treatment information included antivirals for shingles. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Reporter's contact details was added, updated the event, duration and outcome of event.

Other Meds:

Current Illness:

ID: 1561477
Sex: F
Age: 27
State: CA

Vax Date: 01/08/2021
Onset Date:
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: second dose in the series appointment was cancelled, rescheduled appointment is 60 days later after initial dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in the series appointment was cancelled, rescheduled appointment is 60 days later after initial dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis. Concomitant products included DIMETHYL FUMARATE (TECFIDERA) for Multiple sclerosis. On 08-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in the series appointment was cancelled, rescheduled appointment is 60 days later after initial dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in the series appointment was cancelled, rescheduled appointment is 60 days later after initial dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Second dose in the series appointment was cancelled, rescheduled appointment is 60 days later after initial dose. No treatment information was reported.

Other Meds: TECFIDERA

Current Illness: Multiple sclerosis

ID: 1561478
Sex: F
Age: 82
State: TX

Vax Date: 12/30/2020
Onset Date: 12/30/2020
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: This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye began to swell), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (It turned red, it was hot, and there was a knot there), PRURITUS (below the red area came another red area that was hot and kind of itched) and ARTHRITIS (woke up and had excruciating pain, not ache, in my left hand where I have a bit of arthritis, in) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037L20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced SKIN INDENTATION (two inch red place with a knot appeared) and PYREXIA (feverish). On 03-Jan-2021, the patient experienced ERYTHEMA (another place of the exact kind of redness appeared). On 30-Jan-2021, the patient experienced HERPES ZOSTER (still dealing with shingles after getting second shot). On 01-Feb-2021, the patient experienced ARTHRITIS (woke up and had excruciating pain, not ache, in my left hand where I have a bit of arthritis, in). On 08-Feb-2021, the patient experienced PARAESTHESIA (left forehead and scalp began tingling). On 09-Feb-2021, the patient experienced SENSITIVE SKIN (forehead and eyebrow were very sensitive to the slightest touch). On 10-Feb-2021, the patient experienced HERPES ZOSTER (shingles). On 13-Feb-2021, the patient experienced EYE SWELLING (Eye began to swell) and EYE PAIN (it was hurting behind my eye). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (It turned red, it was hot, and there was a knot there), PRURITUS (below the red area came another red area that was hot and kind of itched), PAIN (Every place was just excruciating pain), PAIN (hurting all on my left side), EYE PAIN (nerves behind my eye were red hot), RASH (A Rash beginning to form in forehead and going into scalp), HEADACHE (Dull headache) and VACCINATION SITE ERYTHEMA (below the red area came another red area that was hot and kind of itched). On 02-Jan-2021, PYREXIA (feverish) had resolved. On 07-Jan-2021, SKIN INDENTATION (two inch red place with a knot appeared) had resolved. On 13-Jan-2021, ERYTHEMA (another place of the exact kind of redness appeared) had resolved. On 08-Feb-2021, ARTHRITIS (woke up and had excruciating pain, not ache, in my left hand where I have a bit of arthritis, in) had resolved. On 10-Feb-2021, SENSITIVE SKIN (forehead and eyebrow were very sensitive to the slightest touch) had resolved. At the time of the report, EYE SWELLING (Eye began to swell), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (It turned red, it was hot, and there was a knot there), PRURITUS (below the red area came another red area that was hot and kind of itched), PAIN (Every place was just excruciating pain), PARAESTHESIA (left forehead and scalp began tingling), EYE PAIN (it was hurting behind my eye), PAIN (hurting all on my left side), EYE PAIN (nerves behind my eye were red hot), HERPES ZOSTER (shingles), RASH (A Rash beginning to form in forehead and going into scalp), HEADACHE (Dull headache) and VACCINATION SITE ERYTHEMA (below the red area came another red area that was hot and kind of itched) outcome was unknown and HERPES ZOSTER (still dealing with shingles after getting second shot) had not resolved. Treatment details included Patient received an antiviral medication for her shingles. This case was linked to MOD-2021-032642 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient still experiencing shingles

Other Meds:

Current Illness:

ID: 1561479
Sex: F
Age: 91
State: MI

Vax Date: 02/05/2021
Onset Date: 02/24/2021
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: UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The patient's past medical history included UTI (recently hospitalized for it on 12JAN2021.). On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1561480
Sex: M
Age: 82
State:

Vax Date: 02/25/2021
Onset Date: 02/26/2021
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: falling down; went to the ER were they were put on an IV; body chills; body aches; This spontaneous case was reported by a physician and describes the occurrence of FALL (falling down), EMERGENCY CARE (went to the ER were they were put on an IV), CHILLS (body chills) and MYALGIA (body aches) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The patient's past medical history included Cardiac disorder (con med: 4 different medication for a heart problem they had on 1990) in 1990 and COVID-19 in November 2020. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced FALL (falling down), EMERGENCY CARE (went to the ER were they were put on an IV), CHILLS (body chills) and MYALGIA (body aches). On 01-Mar-2021, FALL (falling down), EMERGENCY CARE (went to the ER were they were put on an IV), CHILLS (body chills) and MYALGIA (body aches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: 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 details included Tylenol, IV at the ER concomitant medicines include 4 different medication for a heart problem had on 1990 Action taken with mRNA-1273 in response to the event was unknown

Other Meds:

Current Illness:

ID: 1561481
Sex: U
Age:
State: WA

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: Pain in extremity

Symptoms: swollen arm; arm hurt; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (arm hurt) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Guillain-Barre syndrome. 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 arm) and PAIN IN EXTREMITY (arm hurt). At the time of the report, PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (arm hurt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment medications was not provided.

Other Meds:

Current Illness:

ID: 1561482
Sex: F
Age: 30
State: CA

Vax Date: 03/02/2021
Onset Date: 03/02/2021
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: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL UNDERDOSE (More than half of the dose was administered) and VACCINATION SITE DISCHARGE (Vaccination site discharge) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 02-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (More than half of the dose was administered). On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (Vaccination site discharge). At the time of the report, ACCIDENTAL UNDERDOSE (More than half of the dose was administered) had resolved and VACCINATION SITE DISCHARGE (Vaccination site discharge) 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.; Reporter's Comments: This report refers to a case of Accidental under-dose and Vaccination site discharge for mRNA-1273 (lot# 013A21A) with no associated adverse events.

Other Meds:

Current Illness:

ID: 1561483
Sex: F
Age: 95
State: TX

Vax Date: 02/03/2021
Onset Date: 03/03/2021
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: fever of 102.1; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102.1) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (fever of 102.1). At the time of the report, PYREXIA (fever of 102.1) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 102.1 degree Celsius High. No relevant concomitant medications were reported. Treatment details included Not provided.

Other Meds:

Current Illness:

ID: 1561484
Sex: F
Age: 72
State: PA

Vax Date: 01/31/2021
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: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Vaccine given halfway down her arm; she has a large red mark around the vaccine site; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history, as provided by the reporter, included autoimmune condition (Polymyalgia Rheumatica) and a pulmonary condition (Pulmonary Fibrosis). Concomitant medication included prednisone. On 31 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 039K2CA) intramuscularly for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 010A21A) subcutaneously for prophylaxis of COVID-19 infection. On an unspecified day in Mar-2021, after receiving the second dose the patient noticed a large red mark around the vaccine site and she believe the vaccine was given halfway down her arm. There was no treatment information provided. Action taken with mRNA-1273 in response to the events is not applicable. The outcome of the event vaccination site erythema was unknown. .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: PREDNISONE

Current Illness: Polymyalgia rheumatica (Medical history reported as the patient has an autoimmune condition (Polymyalgia Rheumatica).); Pulmonary fibrosis (Medical history reported as the patient has a pulmonary condition (Pulmonary Fibrosis).)

ID: 1561485
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: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: COVID arm - a big red area, size of palm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (COVID arm - a big red area, size of palm at injection site) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. 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 TYPE IV HYPERSENSITIVITY REACTION (COVID arm - a big red area, size of palm at injection site). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (COVID arm - a big red area, size of palm at injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1561486
Sex: F
Age: 61
State: MI

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: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Cramps; Severe lower stomach pain; Bloated; Didn't feel good; Pressure in lower abdomen; Injection site hurt to touch with pressure; Rash on chest; Headache; Nausea; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps), ABDOMINAL PAIN LOWER (Severe lower stomach pain), ABDOMINAL DISTENSION (Bloated), FEELING ABNORMAL (Didn't feel good) and ABDOMINAL DISCOMFORT (Pressure in lower abdomen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 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 MUSCLE SPASMS (Cramps), ABDOMINAL PAIN LOWER (Severe lower stomach pain), ABDOMINAL DISTENSION (Bloated), FEELING ABNORMAL (Didn't feel good), ABDOMINAL DISCOMFORT (Pressure in lower abdomen), VACCINATION SITE PAIN (Injection site hurt to touch with pressure), RASH (Rash on chest), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhaustion). At the time of the report, MUSCLE SPASMS (Cramps), ABDOMINAL PAIN LOWER (Severe lower stomach pain), ABDOMINAL DISTENSION (Bloated), FEELING ABNORMAL (Didn't feel good), ABDOMINAL DISCOMFORT (Pressure in lower abdomen), VACCINATION SITE PAIN (Injection site hurt to touch with pressure), RASH (Rash on chest), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhaustion) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received contains updated information on events outcome

Other Meds:

Current Illness:

ID: 1561487
Sex: F
Age:
State: FL

Vax Date: 02/04/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Headache; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (chills) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 04-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 HEADACHE (Headache), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, HEADACHE (Headache), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1561488
Sex: M
Age:
State: CT

Vax Date: 02/10/2021
Onset Date: 02/10/2021
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: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: stomach issues; Dizziness; weakness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues), DIZZINESS (Dizziness) and ASTHENIA (weakness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Stomach ache. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach issues), DIZZINESS (Dizziness) and ASTHENIA (weakness). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues), DIZZINESS (Dizziness) and ASTHENIA (weakness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness: Stomach ache

ID: 1561489
Sex: F
Age:
State: PA

Vax Date: 01/14/2021
Onset Date: 02/12/2021
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: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Developed COVID arm; Red area at injection site that grew bigger for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Developed COVID arm) and VACCINATION SITE ERYTHEMA (Red area at injection site that grew bigger for 3 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M2CA and 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (codeine). Concomitant products included MILK THISTLE [SILYBUM MARIANUM], SPIRONOLACTONE and IRON 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 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION (Developed COVID arm) and VACCINATION SITE ERYTHEMA (Red area at injection site that grew bigger for 3 days). On 20-Mar-2021, VACCINATION SITE ERYTHEMA (Red area at injection site that grew bigger for 3 days) had resolved. At the time of the report, VACCINATION SITE REACTION (Developed COVID arm) had not resolved. The patient reported there was still a shadow at the infection site. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Updated patient demographics, medical history, added concomitant medicines, added new event -vaccination site erythema.

Other Meds: MILK THISTLE [SILYBUM MARIANUM]; SPIRONOLACTONE; IRON

Current Illness: Drug allergy (codeine)

ID: 1561490
Sex: F
Age: 76
State: IA

Vax Date: 02/09/2021
Onset Date: 02/09/2021
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: nausea; vomiting; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea). At the time of the report, NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea) outcome was unknown. 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 24-Apr-2021: attached : Initiative

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm