VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1569772
Sex: F
Age: 82
State:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: migraine headache; some flashes; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine headache) and FLUSHING (some flashes) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included Lymphadenectomy. 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 FLUSHING (some flashes). On 18-Feb-2021, the patient experienced MIGRAINE (migraine headache). The patient was treated with PARACETAMOL (TYLENOL) for Migraine headache, at an unspecified dose and frequency. On 17-Feb-2021, FLUSHING (some flashes) had resolved. At the time of the report, MIGRAINE (migraine headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products reported. It was reported that she was not going to take the second dose.

Other Meds:

Current Illness:

ID: 1569773
Sex: F
Age: 77
State: NY

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Warm/hot rash; Itchy rash; pink/red rash; Triangular 5.5x5" rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm/hot rash), VACCINATION SITE PRURITUS (Itchy rash), VACCINATION SITE ERYTHEMA (pink/red rash) and VACCINATION SITE RASH (Triangular 5.5x5" rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Immunization: Shingrix. Past adverse reactions to the above products included Local reaction with Shingrix. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm/hot rash), VACCINATION SITE PRURITUS (Itchy rash), VACCINATION SITE ERYTHEMA (pink/red rash) and VACCINATION SITE RASH (Triangular 5.5x5" rash). At the time of the report, VACCINATION SITE WARMTH (Warm/hot rash), VACCINATION SITE PRURITUS (Itchy rash) and VACCINATION SITE ERYTHEMA (pink/red rash) outcome was unknown and VACCINATION SITE RASH (Triangular 5.5x5" rash) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1569774
Sex: F
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: Itchy on injection site; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy on injection site) and VACCINATION SITE ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 VACCINATION SITE PRURITUS (Itchy on injection site) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE PRURITUS (Itchy on injection site) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable Treatment medicines were not reported Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1569775
Sex: M
Age: 60
State: TX

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant and treatment products reported. This case was linked to MOD-2021-051866 (Patient Link).

Other Meds:

Current Illness:

ID: 1569776
Sex: F
Age: 63
State:

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Itching as crazy; Swelling; Very hot to the touch; Sort of redness; Warm to the touch injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch injection site), PRURITUS (Itching as crazy), SWELLING (Swelling), FEELING HOT (Very hot to the touch) and ERYTHEMA (Sort of redness ) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013K21A) for COVID-19 vaccination. The patient's past medical history included Diverticulitis (Mild). Concurrent medical conditions included Drug allergy (Amoxicillin), Diabetes and Bronchiectasis (Mild). Concomitant products included METFORMIN for Diabetes. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch injection site) and ERYTHEMA (Sort of redness ). On 11-Mar-2021, the patient experienced PRURITUS (Itching as crazy), SWELLING (Swelling) and FEELING HOT (Very hot to the touch). At the time of the report, INJECTION SITE WARMTH (Warm to the touch injection site), PRURITUS (Itching as crazy), SWELLING (Swelling), FEELING HOT (Very hot to the touch) and ERYTHEMA (Sort of redness ) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications also included several medications for an unknown indication. Treatment information was not provided.

Other Meds: METFORMIN

Current Illness: Bronchiectasis (Mild); Diabetes; Drug allergy (Amoxicillin)

ID: 1569777
Sex: F
Age: 67
State: NJ

Vax Date: 03/18/2021
Onset Date: 03/18/2021
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: Hard lump; Pain; Swelling; This spontaneous case was reported by a patient and describes the occurrence of MASS (Hard lump), PAIN (Pain) and SWELLING (Swelling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MASS (Hard lump), PAIN (Pain) and SWELLING (Swelling). At the time of the report, MASS (Hard lump), PAIN (Pain) and SWELLING (Swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and treatment information were not provided.

Other Meds:

Current Illness:

ID: 1569778
Sex: M
Age: 60
State: PA

Vax Date: 02/06/2021
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: Pyrexia, White blood cell count decreased

Symptoms: body aches; At times it has been debilitating; general exhaustion; joint pain especially in the knees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), ASTHENIA (At times it has been debilitating), FATIGUE (general exhaustion) and ARTHRALGIA (joint pain especially in the knees) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Demyelinating polyneuropathy. Concomitant products included IMMUNOGLOBULIN HUMAN NORMAL (GAMMAGARD) for Demyelinating polyneuropathy. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), ASTHENIA (At times it has been debilitating), FATIGUE (general exhaustion) and ARTHRALGIA (joint pain especially in the knees). At the time of the report, PAIN (body aches), ASTHENIA (At times it has been debilitating), FATIGUE (general exhaustion) and ARTHRALGIA (joint pain especially in the knees) outcome was unknown. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Followup received on 14-JUL-2021 & added a new event as At times it has been debilitating

Other Meds: GAMMAGARD

Current Illness: Demyelinating polyneuropathy

ID: 1569779
Sex: F
Age:
State:

Vax Date: 02/19/2021
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: Pharyngeal swelling

Symptoms: A spontaneous report was received from a consumer, a female patient (age not provided), who received Moderna's COVID-19 vaccine (mRNA-1273) and reported second dose of vaccine was 20 March, but it was cancelled and would be rescheduled on 31 March 2021 (inappropriate schedule of vaccine administration). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the events was not provided. On 19 Feb 2021, the patient received her first of the two planned vaccine doses of mRNA-1273 (Lot number: 029L20A) intramuscularly (unknown site) for prophylaxis of COVID-19 infection. The patient was supposed to get the second dose of vaccine, but it was cancelled and rescheduled on 31 Mar 2021. Treatment was not reported. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event was recovered.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administration, for mRNA-1273, lot #: 029L20A, with no associated AEs.

Other Meds:

Current Illness:

ID: 1569780
Sex: F
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: Abdominal pain, Chills, Sleep disorder

Symptoms: mild symptoms; COVID arm; This spontaneous case was reported by a nurse and describes the occurrence of ADVERSE EVENT (mild symptoms) and PAIN IN EXTREMITY (COVID arm) 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. On an unknown date, the patient experienced ADVERSE EVENT (mild symptoms) and PAIN IN EXTREMITY (COVID arm). At the time of the report, ADVERSE EVENT (mild symptoms) and PAIN IN EXTREMITY (COVID arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided treatment was not provided

Other Meds:

Current Illness:

ID: 1569781
Sex: F
Age: 71
State: NY

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: second dose is scheduled 18 days post first dose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is scheduled 18 days post first dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypercholesterolemia (On cholesterol medicine.) and Blood pressure (Currently evaluated to see if she needs BP medication.). On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is scheduled 18 days post first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is scheduled 18 days post first dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication included: Cholesterol medication, Potential BP medication. Reporter did not allow further contact; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 014M20A) with no associated AEs.

Other Meds:

Current Illness: Blood pressure (Currently evaluated to see if she needs BP medication.); Hypercholesterolemia (On cholesterol medicine.)

ID: 1569782
Sex: U
Age: 92
State: CA

Vax Date: 03/11/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: started itching very bad from shoulder to elbow; arm got a little bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (started itching very bad from shoulder to elbow) and VACCINATION SITE SWELLING (arm got a little bit swollen) in a 92-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0015214) for COVID-19 vaccination. No medical history information was provided. Concomitant products included LYSINE, FLUOROMETHOLONE, LATANOPROST, BROMOCRIPTINE MESILATE (BROMIDINE), LISINOPRIL, COLECALCIFEROL (VITAMIN D), BIOTIN and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication. On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (started itching very bad from shoulder to elbow) and VACCINATION SITE SWELLING (arm got a little bit swollen). At the time of the report, VACCINATION SITE PRURITUS (started itching very bad from shoulder to elbow) and VACCINATION SITE SWELLING (arm got a little bit swollen) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable. Other Concomitant mediation included: Samciclovir, Timnol, amoidaodine and Water pill. Treatment: Alcohol.

Other Meds: LYSINE; FLUOROMETHOLONE; LATANOPROST; BROMIDINE; LISINOPRIL; VITAMIN D; BIOTIN; ASPIRIN

Current Illness:

ID: 1569783
Sex: F
Age: 36
State: IL

Vax Date: 03/03/2021
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: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 36-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included Alcohol addiction (1-2 drinks, 3 times per week) on 22-Jun-2020. Concurrent medical conditions included Hypothyroidism and Penicillin allergy. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for GERD, LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation. On 03-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 in June 2020 and the estimated date of delivery was 12-Apr-2021. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The cesarean delivery occurred on 02-Apr-2021, which was reported as Premature. For neonate 1, the birth weight was 2268 grams (5lbs). The outcome was reported as Pre-Term Birth NOS. Baby was conceived through IVF, Low AMH is culprit of infertility. Water broke and chose to do a C-section. Live, pre-term birth. Length - 18 inches. Pregnancy related complication was Baby was measuring small- labeled as IUGR. On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound Doppler: normal (normal) Good chances for having early delivery. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. LMP was reported as JUN-2020, Date of positive pregnancy test was 06-JUN-2020. Relevant Lab test included: weekly NST and result was normal. Patient reported there is no adverse event for first dose. This case was linked to MOD-2021-256756, MOD-2021-269190, MOD-2021-269190 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant follow up received on 14-JUL-2021: Patient demographics, ethnic group, Race , pregnancy details were added. Historical condition was added. Concomitant medication, new event were added. On 28-Jul-2021: Significant FU - Narrative updated.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; LEVOTHYROXINE; PROTONIX [OMEPRAZOLE]

Current Illness: Hypothyroidism; Penicillin allergy

ID: 1569784
Sex: F
Age: 56
State: MS

Vax Date: 02/03/2021
Onset Date: 02/03/2021
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: Red Rash on Bilateral Legs and Forearm; This spontaneous case was reported by a health care professional and describes the occurrence of RASH ERYTHEMATOUS (Red Rash on Bilateral Legs and Forearm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash on Bilateral Legs and Forearm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red Rash on Bilateral Legs and Forearm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided.

Other Meds:

Current Illness:

ID: 1569785
Sex: M
Age:
State: FL

Vax Date: 02/11/2021
Onset Date: 02/23/2021
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: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) 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 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. Concomitant medication was not reported. Treatment medication was not reported.

Other Meds:

Current Illness:

ID: 1569786
Sex: U
Age: 70
State: NY

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Outside dosing interval invalid dose; COVID positive; Sinitus; Loss of efficacy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside dosing interval invalid dose), SARS-COV-2 TEST POSITIVE (COVID positive), SINUSITIS (Sinitus), DRUG INEFFECTIVE (Loss of efficacy) and PYREXIA (Fever) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ERYTHROMYCIN and AZELASTINE for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (Fever). On 09-Feb-2021, the patient experienced DRUG INEFFECTIVE (Loss of efficacy). On 27-Feb-2021, the patient experienced SINUSITIS (Sinitus). On 01-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID positive). On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside dosing interval invalid dose). On 07-Feb-2021, PYREXIA (Fever) had resolved. On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside dosing interval invalid dose) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (COVID positive), SINUSITIS (Sinitus) and DRUG INEFFECTIVE (Loss of efficacy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, SARS-CoV-2 test: positive Positive. On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) Doctor prescribed antibodies and performed PCR test (second test). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. prescribed antibodies and performed PCR test Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ERYTHROMYCIN; AZELASTINE

Current Illness:

ID: 1569787
Sex: F
Age: 55
State: CT

Vax Date: 03/14/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy, ACETAMINOPHEN for Symptomatic treatment. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced MYALGIA (muscle pain). At the time of the report, MYALGIA (muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. NO treatment information was provided.

Other Meds: ALLEGRA; ACETAMINOPHEN

Current Illness:

ID: 1569788
Sex: F
Age: 63
State: TX

Vax Date: 03/17/2021
Onset Date: 03/18/2021
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: Diarrhea; Fever(101.00F to 102.5F); This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA and PYREXIA (Fever(101.00F to 102.5F)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (Fever(101.00F to 102.5F)). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Fever and Diarrhea, at an unspecified dose and frequency. On 19-Mar-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, PYREXIA (Fever(101.00F to 102.5F)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101 f (High) 101.00 F to 102.5 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication were not provided.

Other Meds:

Current Illness:

ID: 1569789
Sex: F
Age: 82
State: IL

Vax Date: 03/09/2021
Onset Date: 03/10/2021
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: Headache which come and go on regular basis; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache which come and go on regular basis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headache which come and go on regular basis). At the time of the report, HEADACHE (Headache which come and go on regular basis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication was not provided.

Other Meds:

Current Illness:

ID: 1569790
Sex: F
Age:
State: OH

Vax Date: 02/26/2021
Onset Date: 02/26/2021
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: Tightness in her chest; Sensation of her heart pounding; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in her chest) and CARDIAC DISCOMFORT (Sensation of her heart pounding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHEST DISCOMFORT (Tightness in her chest) and CARDIAC DISCOMFORT (Sensation of her heart pounding). On 26-Feb-2021, CHEST DISCOMFORT (Tightness in her chest) and CARDIAC DISCOMFORT (Sensation of her heart pounding) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1569791
Sex: F
Age: 60
State: KY

Vax Date: 03/06/2021
Onset Date: 03/07/2021
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: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INFECTION (infection), VACCINATION SITE WARMTH (warm at injection site), RASH (rash), VACCINATION SITE PRURITUS (itching, itching, itching at injection site) and VACCINATION SITE SWELLING (swollen at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) 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 GABAPENTIN, ROSUVASTATIN, METOPROLOL, VENLAFAXINE, LOSARTAN, DICLOFENAC SODIUM and RANOLAZINE for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced INFECTION (infection), VACCINATION SITE WARMTH (warm at injection site), RASH (rash), VACCINATION SITE PRURITUS (itching, itching, itching at injection site), VACCINATION SITE SWELLING (swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). On 07-Mar-2021, RASH (rash) outcome was unknown. At the time of the report, INFECTION (infection), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itching, itching, itching at injection site), VACCINATION SITE SWELLING (swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment given for infection at the site of injection was antibiotics which the patient ahs not started taking yet.

Other Meds: GABAPENTIN; ROSUVASTATIN; METOPROLOL; VENLAFAXINE; LOSARTAN; DICLOFENAC SODIUM; RANOLAZINE

Current Illness:

ID: 1569792
Sex: F
Age: 70
State: OR

Vax Date: 03/17/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: 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: Wide range of fluctuations in oxygen; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OXYGEN SATURATION ABNORMAL (Wide range of fluctuations in oxygen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. Concurrent medical conditions included COPD. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced OXYGEN SATURATION ABNORMAL (Wide range of fluctuations in oxygen). At the time of the report, OXYGEN SATURATION ABNORMAL (Wide range of fluctuations in oxygen) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness: COPD

ID: 1569793
Sex: F
Age: 54
State: IL

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Severe migraine; Like cluster headaches; Severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Severe migraine), CLUSTER HEADACHE (Like cluster headaches) and HEADACHE (Severe headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The patient's past medical history included Cluster headache (Patient mentioned that she had cluster headaches when she was younger wherein it was debilitating and she couldn't look through light,she has not experienced this for 20 years until she received the vaccine). Concurrent medical conditions included Seasonal allergy and Blood pressure. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Blood pressure management, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, MOMETASONE FUROATE (NASONEX) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MIGRAINE (Severe migraine), CLUSTER HEADACHE (Like cluster headaches) and HEADACHE (Severe headache). The patient was treated with SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Pain, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Severe migraine), CLUSTER HEADACHE (Like cluster headaches) and HEADACHE (Severe headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported that as a treatment she had an ice pack on head

Other Meds: NASONEX; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BYSTOLIC

Current Illness: Blood pressure; Seasonal allergy

ID: 1569794
Sex: F
Age: 60
State: AZ

Vax Date: 01/25/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 25-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 145/101 (High) 145/101 and 113/89 (Inconclusive) 113/89. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication details included pill for hypertension. Treatment details was not reported by the reporter. This case was linked to MOD-2021-051827 (Patient Link).

Other Meds:

Current Illness: Hypertension

ID: 1569795
Sex: M
Age: 63
State: GA

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Soreness of his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of his arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131921a) for COVID-19 vaccination. Concomitant products included LORATADINE (DESOLIN), ATORVASTATIN and PROBIOTICS NOS for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of his arm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 2 tylenol. At the time of the report, PAIN IN EXTREMITY (Soreness of his arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: DESOLIN; ATORVASTATIN; PROBIOTICS NOS

Current Illness:

ID: 1569796
Sex: M
Age:
State: FL

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Scheduled for his 2nd dose on 22Mar2021, only 20 days from his 1st dose.; This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Scheduled for his 2nd dose on 22Mar2021, only 20 days from his 1st dose.) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Scheduled for his 2nd dose on 22Mar2021, only 20 days from his 1st dose.). On 19-Mar-2021, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Scheduled for his 2nd dose on 22Mar2021, only 20 days from his 1st dose.) had resolved. Unknown The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1569797
Sex: F
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: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Headache after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after the first dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after the first dose). At the time of the report, HEADACHE (Headache after the first dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-063828 (Patient Link).

Other Meds:

Current Illness:

ID: 1569798
Sex: F
Age: 27
State: MA

Vax Date: 03/07/2021
Onset Date: 03/17/2021
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: feeling achy; (rash) swollen; (rash) raised; (rash) itchy; developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (feeling achy), SWELLING ((rash) swollen), RASH PAPULAR ((rash) raised), RASH PRURITIC ((rash) itchy) and RASH (developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (feeling achy), SWELLING ((rash) swollen), RASH PAPULAR ((rash) raised), RASH PRURITIC ((rash) itchy) and RASH (developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN (feeling achy), SWELLING ((rash) swollen), RASH PAPULAR ((rash) raised), RASH PRURITIC ((rash) itchy) and RASH (developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1569799
Sex: M
Age: 12
State: OH

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: 12 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. Concurrent medical conditions included Type 1 diabetes mellitus. On 18-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021 at 10:00 AM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Initial additional. Added race, ethnicity, relevant history, route of administration of vaccine, event start time. Reporter, Nursing Director stated that Parent were aware and verbalized that there have been no side effects or reactions. Parent requests client be put in pediatric trial and wants client to have the second dose to be administered when due. Nursing Director declined and referred them to Moderna. On 16-Jul-2021: Follow up received on 16 Jul 2021 included no new information.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (12 year old male) for mRNA-1273 (lot number 048A21A) with no associated AEs reported. FU1 does not change company comment or causality.

Other Meds:

Current Illness: Type 1 diabetes mellitus

ID: 1569800
Sex: M
Age: 67
State: SC

Vax Date: 02/19/2021
Onset Date: 02/23/2021
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: Both of his hands itched like crazy; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Both of his hands itched like crazy) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. No Medical History information was reported. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PRURITUS (Both of his hands itched like crazy). At the time of the report, PRURITUS (Both of his hands itched like crazy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. Treatment for the events included a steroid shot, steroid dose pack, steroid cream, and antihistamine. Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up received contains non-significant information of updated Email.

Other Meds:

Current Illness:

ID: 1569801
Sex: F
Age: 67
State: WI

Vax Date: 03/05/2021
Onset Date: 03/05/2021
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: Began to sweat profusely; Fever of 99.8F; Blistery rash on stomach, upper thigh which ran out towards hip area; Redness from rash took a few days to go away; Mucus came out of the stye; Developed a stye on right lower eyelid; This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (Mucus came out of the stye), HORDEOLUM (Developed a stye on right lower eyelid), RASH VESICULAR (Blistery rash on stomach, upper thigh which ran out towards hip area), HYPERHIDROSIS (Began to sweat profusely) and RASH ERYTHEMATOUS (Redness from rash took a few days to go away) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ATORVASTATIN, OMEPRAZOLE, METFORMIN, CELECOXIB (CELEBREX), ASCORBIC ACID (VITAMIN C FLAVOUR), CALTRATE + D PLUS, VITAMIN B1 NOS;VITAMIN B12 NOS and SENNA ALEXANDRINA (SENNA-GEN) for an unknown indication. On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HORDEOLUM (Mucus came out of the stye) and HORDEOLUM (Developed a stye on right lower eyelid). On 08-Mar-2021, the patient experienced RASH VESICULAR (Blistery rash on stomach, upper thigh which ran out towards hip area) and RASH ERYTHEMATOUS (Redness from rash took a few days to go away). On 10-Mar-2021, the patient experienced HYPERHIDROSIS (Began to sweat profusely) and PYREXIA (Fever of 99.8F). On 05-Mar-2021, HORDEOLUM (Mucus came out of the stye) had resolved. On 08-Mar-2021, HORDEOLUM (Developed a stye on right lower eyelid) had resolved. On 10-Mar-2021, HYPERHIDROSIS (Began to sweat profusely) and PYREXIA (Fever of 99.8F) had resolved. At the time of the report, RASH VESICULAR (Blistery rash on stomach, upper thigh which ran out towards hip area) and RASH ERYTHEMATOUS (Redness from rash took a few days to go away) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment included Triamcinolone.

Other Meds: ATORVASTATIN; OMEPRAZOLE; METFORMIN; CELEBREX; VITAMIN C FLAVOUR; CALTRATE + D PLUS; VITAMIN B1 NOS;VITAMIN B12 NOS; SENNA-GEN

Current Illness:

ID: 1569802
Sex: F
Age: 72
State: NC

Vax Date: 02/10/2021
Onset Date: 02/14/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Patient developed COVID-19 four days after the 1st Dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient developed COVID-19 four days after the 1st Dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced COVID-19 (Patient developed COVID-19 four days after the 1st Dose). At the time of the report, COVID-19 (Patient developed COVID-19 four days after the 1st Dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. On 02-Mar-2021, SARS-CoV-2 test: positive (Positive) Still tested positive on 04-Mar-2021. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. No treatment information was provided. . Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR document was attached. No new information was reported.

Other Meds:

Current Illness:

ID: 1569803
Sex: F
Age: 74
State:

Vax Date: 03/15/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore arm; could not walk and developed extreme muscle pain, joint pain, fever, chills, fever, headache, and; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore arm) and GAIT DISTURBANCE (could not walk and developed extreme muscle pain, joint pain, fever, chills, fever, headache, and) in a 74-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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (sore arm) and GAIT DISTURBANCE (could not walk and developed extreme muscle pain, joint pain, fever, chills, fever, headache, and). The patient was treated with PARACETAMOL (TYLENOL) for Paracetamol, at an unspecified dose and frequency and SIMETICONE (ALKA SELTZER ANTI GAS) at an unspecified dose and frequency. At the time of the report, PAIN (sore arm) and GAIT DISTURBANCE (could not walk and developed extreme muscle pain, joint pain, fever, chills, fever, headache, and) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-052653 (E2B Linked Report).; Sender's Comments: MOD-2021-052653:2nd dose

Other Meds:

Current Illness:

ID: 1569804
Sex: M
Age:
State: NE

Vax Date: 02/26/2021
Onset Date: 02/27/2021
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: COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 immunisation. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. 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 details were provided The patient received monoclonal antibodies for the treatment of COVID-19.

Other Meds:

Current Illness:

ID: 1569805
Sex: F
Age: 93
State: FL

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Ongoing severe cognitive impairment; Heart rate > 100; Lethargic; Not functioning, Patient does not know how to wash soap off of hands; weak; Extreme exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of COGNITIVE DISORDER (Ongoing severe cognitive impairment), HEART RATE INCREASED (Heart rate > 100), LETHARGY (Lethargic), FEELING ABNORMAL (Not functioning, Patient does not know how to wash soap off of hands) and ASTHENIA (weak) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Atrial fibrillation and Vaccination site reaction (had a strong reaction to a flu vaccine 30 years ago and hasn't gotten one since was reported.). Concurrent medical conditions included Heart failure. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]), PROBIOTICS NOS, FISH OIL and VITAMIN D NOS for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced COGNITIVE DISORDER (Ongoing severe cognitive impairment), HEART RATE INCREASED (Heart rate > 100), LETHARGY (Lethargic), FEELING ABNORMAL (Not functioning, Patient does not know how to wash soap off of hands), ASTHENIA (weak) and FATIGUE (Extreme exhaustion). At the time of the report, COGNITIVE DISORDER (Ongoing severe cognitive impairment), HEART RATE INCREASED (Heart rate > 100), LETHARGY (Lethargic), FEELING ABNORMAL (Not functioning, Patient does not know how to wash soap off of hands), ASTHENIA (weak) and FATIGUE (Extreme exhaustion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Heart rate: 100 (High) heart rate greater than 100. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: LASIX [FUROSEMIDE]; PROBIOTICS NOS; FISH OIL; VITAMIN D NOS

Current Illness:

ID: 1569806
Sex: M
Age: 56
State: TX

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking ), PYREXIA (Fever), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty ) and NASOPHARYNGITIS (Cold) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced TREMOR (Shaking ), PYREXIA (Fever) and GAIT DISTURBANCE (Walking difficulty ). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm), NASOPHARYNGITIS (Cold), SWELLING (Swelling ), CHILLS (Chills) and CHILLS (Teeth chattering). At the time of the report, TREMOR (Shaking ), PYREXIA (Fever), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty ), NASOPHARYNGITIS (Cold), SWELLING (Swelling ), CHILLS (Chills) and CHILLS (Teeth chattering) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive. 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 medication use was not provided. Treatment information included Tylenol.

Other Meds:

Current Illness:

ID: 1569807
Sex: F
Age:
State: KS

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: incoherent; Brain Fog; Palpitation; Arm Sore; headache; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of INCOHERENT (incoherent), FEELING ABNORMAL (Brain Fog), PALPITATIONS (Palpitation), MYALGIA (Arm Sore) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. . Concomitant products included MELOXICAM for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PALPITATIONS (Palpitation), MYALGIA (Arm Sore), HEADACHE (headache) and NAUSEA (Nauseas). On 19-Mar-2021, the patient experienced INCOHERENT (incoherent) and FEELING ABNORMAL (Brain Fog). At the time of the report, INCOHERENT (incoherent), FEELING ABNORMAL (Brain Fog), PALPITATIONS (Palpitation), MYALGIA (Arm Sore), HEADACHE (headache) and NAUSEA (Nauseas) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. concomitant medications are Put ice on sore arm. No treatment medications were reported.

Other Meds: MELOXICAM

Current Illness:

ID: 1569808
Sex: F
Age:
State: FL

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: shaking from the chills; fever of 101.0; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (shaking from the chills) and PYREXIA (fever of 101.0) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CHILLS (shaking from the chills) and PYREXIA (fever of 101.0). At the time of the report, CHILLS (shaking from the chills) and PYREXIA (fever of 101.0) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, COVID-19: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included Tylenol Quarantine ended 11-Mar-2021.

Other Meds:

Current Illness:

ID: 1569809
Sex: F
Age: 62
State: CA

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Dry throat; Coughing (5minutes); Flushed; Face and cheeks were getting puffy; Metallic taste in her mouth; Her head started feeling like she was developing a head cold; Ears felt like they were blocked up/congested; Felt dizzy; Face, cheeks, and forehead was red; felt droopy; Felt a little weak; Her arm now started feeling sore; Arm has a little lump on it; Felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (Dry throat), COUGH (Coughing (5minutes)), FLUSHING (Flushed), SKIN SWELLING (Face and cheeks were getting puffy) and DYSGEUSIA (Metallic taste in her mouth) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was reported by reporter. Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT), LORATADINE, FAMOTIDINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DRY THROAT (Dry throat), COUGH (Coughing (5minutes)), FLUSHING (Flushed), SKIN SWELLING (Face and cheeks were getting puffy), DYSGEUSIA (Metallic taste in her mouth), NASOPHARYNGITIS (Her head started feeling like she was developing a head cold), EAR CONGESTION (Ears felt like they were blocked up/congested), DIZZINESS (Felt dizzy), ERYTHEMA (Face, cheeks, and forehead was red), FEELING ABNORMAL (felt droopy), ASTHENIA (Felt a little weak), PAIN IN EXTREMITY (Her arm now started feeling sore), VACCINATION SITE MASS (Arm has a little lump on it) and FATIGUE (Felt fatigue). On 19-Mar-2021, DRY THROAT (Dry throat), COUGH (Coughing (5minutes)), FLUSHING (Flushed), SKIN SWELLING (Face and cheeks were getting puffy), DYSGEUSIA (Metallic taste in her mouth), NASOPHARYNGITIS (Her head started feeling like she was developing a head cold), EAR CONGESTION (Ears felt like they were blocked up/congested), DIZZINESS (Felt dizzy), ERYTHEMA (Face, cheeks, and forehead was red), FEELING ABNORMAL (felt droopy), ASTHENIA (Felt a little weak), PAIN IN EXTREMITY (Her arm now started feeling sore) and FATIGUE (Felt fatigue) had resolved. At the time of the report, VACCINATION SITE MASS (Arm has a little lump on it) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments

Other Meds: NASACORT; LORATADINE; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1569810
Sex: F
Age: 78
State: MD

Vax Date: 02/01/2021
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: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Bladder infection for about a week; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CYSTITIS (Bladder infection for about a week) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Handicap and Incontinence (wearing Depends makes it hard not to get an infection). In February 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 CYSTITIS (Bladder infection for about a week). At the time of the report, CYSTITIS (Bladder infection for about a week) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were provided. The patient was prescribed antibiotic (unspecified) for bladder infection. She did not take the antibiotics at the time of reporting (she wanted to know if it would be ok to take the antibiotics before getting second dose). The patient had her second dose scheduled on 12-Mar-2021.

Other Meds:

Current Illness: Handicap; Incontinence (wearing Depends makes it hard not to get an infection).

ID: 1569811
Sex: M
Age: 23
State: NY

Vax Date: 03/17/2021
Onset Date: 03/17/2021
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: Hot feeling arm; unbalanced; brain fog; headache; body ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot feeling arm), BALANCE DISORDER (unbalanced), CONFUSIONAL STATE (brain fog), HEADACHE (headache) and MYALGIA (body ache) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING HOT (Hot feeling arm), BALANCE DISORDER (unbalanced), CONFUSIONAL STATE (brain fog), HEADACHE (headache), MYALGIA (body ache) and CHILLS (chills). At the time of the report, FEELING HOT (Hot feeling arm), BALANCE DISORDER (unbalanced), CONFUSIONAL STATE (brain fog), HEADACHE (headache), MYALGIA (body ache) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1569812
Sex: F
Age: 78
State: NJ

Vax Date: 03/10/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and LIP SWELLING (upper lip swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRURITUS (itchiness) and LIP SWELLING (upper lip swelling). On 18-Mar-2021, PRURITUS (itchiness) and LIP SWELLING (upper lip swelling) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medication provided. No treatment drugs were provided.

Other Meds:

Current Illness:

ID: 1569813
Sex: F
Age:
State:

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication not reported. Treatment medication not reported.

Other Meds:

Current Illness:

ID: 1569814
Sex: F
Age: 59
State: MS

Vax Date: 02/03/2021
Onset Date: 02/03/2021
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: Chills; Fever; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue). In February 2021, CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment medications was not reported.

Other Meds:

Current Illness:

ID: 1569815
Sex: F
Age: 46
State: OK

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: boil is coming up under her arm; can not raise my arm up and down/hard to move it around; throbbing pain; severe pain; She has swollen under her armpit; sore arm/whole shoulder is sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/whole shoulder is sore), SWELLING (boil is coming up under her arm), MOVEMENT DISORDER (can not raise my arm up and down/hard to move it around), PAIN (throbbing pain) and INJECTION SITE PAIN (severe pain) in a 46-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. Concurrent medical conditions included Fibromyalgia and Rheumatoid arthritis. Concomitant products included METOPROLOL for Blood pressure, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Pain, ONDANSETRON (ZOFRAN [ONDANSETRON]) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/whole shoulder is sore). On 18-Mar-2021, the patient experienced SWELLING (boil is coming up under her arm), MOVEMENT DISORDER (can not raise my arm up and down/hard to move it around), PAIN (throbbing pain), INJECTION SITE PAIN (severe pain) and ARTHRALGIA (She has swollen under her armpit). At the time of the report, PAIN IN EXTREMITY (sore arm/whole shoulder is sore), SWELLING (boil is coming up under her arm), MOVEMENT DISORDER (can not raise my arm up and down/hard to move it around), PAIN (throbbing pain), INJECTION SITE PAIN (severe pain) and ARTHRALGIA (She has swollen under her armpit) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Vicodin used for treatment.

Other Meds: VICODIN; ZOFRAN [ONDANSETRON]; METOPROLOL

Current Illness: Fibromyalgia; Rheumatoid arthritis.

ID: 1569816
Sex: M
Age:
State: MI

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Chills; Shivers; Headache; Fatigue; A spontaneous report was received from a consumer concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, shivers, headache, fatigue. The patient's medical history was not provided. No relevant concomitant medications were reported. On 9 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 002B21A) via unknown route for prophylaxis of COVID-19 infection. On 9 Mar 2021, the patient experienced the event(s) chills, shivers, headache, fatigue. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), chills, shivers, headache, fatigue was unknown.

Other Meds:

Current Illness:

ID: 1569817
Sex: F
Age: 70
State: MD

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: itchy at site of injection; big red circle around the arm and arm was swollen at site of injection and itchy; big red circle around the arm and arm was swollen at site of injection and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy at site of injection), VACCINATION SITE ERYTHEMA (big red circle around the arm and arm was swollen at site of injection and itchy) and VACCINATION SITE SWELLING (big red circle around the arm and arm was swollen at site of injection and itchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for an unknown indication. The patient's past medical history included Allergy. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy at site of injection), VACCINATION SITE ERYTHEMA (big red circle around the arm and arm was swollen at site of injection and itchy) and VACCINATION SITE SWELLING (big red circle around the arm and arm was swollen at site of injection and itchy). At the time of the report, VACCINATION SITE PRURITUS (itchy at site of injection), VACCINATION SITE ERYTHEMA (big red circle around the arm and arm was swollen at site of injection and itchy) and VACCINATION SITE SWELLING (big red circle around the arm and arm was swollen at site of injection and itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1569818
Sex: F
Age:
State: NE

Vax Date: 02/26/2021
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:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: runny nose; swollen nasal passage; sore and tender inside of the nose; aches and pain in body; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), NASAL CONGESTION (swollen nasal passage), TENDERNESS (sore and tender inside of the nose), MYALGIA (aches and pain in body) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 919) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced RHINORRHOEA (runny nose), NASAL CONGESTION (swollen nasal passage), TENDERNESS (sore and tender inside of the nose), MYALGIA (aches and pain in body) and FATIGUE (fatigue). At the time of the report, RHINORRHOEA (runny nose), NASAL CONGESTION (swollen nasal passage), TENDERNESS (sore and tender inside of the nose), MYALGIA (aches and pain in body) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. The patient did not take any treatment medication.

Other Meds:

Current Illness:

ID: 1569819
Sex: F
Age: 50
State:

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Tongue swelling; This spontaneous case was reported by a pharmacist and describes the occurrence of SWOLLEN TONGUE (Tongue swelling) in a 50-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 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced SWOLLEN TONGUE (Tongue swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Tongue swelling non-specific, at a dose of 25 mg four times per day. At the time of the report, SWOLLEN TONGUE (Tongue swelling) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1569820
Sex: F
Age: 70
State: CT

Vax Date: 02/12/2021
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: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: inflammation; HEADACHE/Daily headache; RED AT INJECTION SITE; SORENESS IN ARM; SWELLING ON ARM IS NOW THE SIZE OF A GRAPEFRUIT; SWOLLEN ARM THE SIZE OR A GOFL BALL; HIVES ON ARM; COULDN'T GET OFF THE COUCH; blood pressure 160/140; muscular pain in legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure 160/140), PERIPHERAL SWELLING (SWOLLEN ARM THE SIZE OR A GOFL BALL), URTICARIA (HIVES ON ARM), HYPOKINESIA (COULDN'T GET OFF THE COUCH) and INFLAMMATION (inflammation) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20N and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. The patient's past medical history included Chronic heart failure in 2004, Diabetes in 2008 and Hyperlipidemia in 2008. Concurrent medical conditions included Blood pressure since 2008, Acute otitis media with effusion since 1959 and Drug allergy (PCN, Sulfa, beta blockers, ARBs). Concomitant products included CANDESARTAN for Blood pressure, LEVOFLOXACIN and CLINDAMYCIN for Ear infection, CARVEDILOL, LEVOTHYROXINE, METFORMIN, PANTOPRAZOLE, FOLIC ACID, EZETIMIBE, SIMVASTATIN (EZETIMIBE & SIMVASTATIN), POTASSIUM CHLORIDE (KLOR-CON), VITAMIN B12 (CYANOCOBALAMIN AND ANALOGUES), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and VITAMIN D3 for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (SWOLLEN ARM THE SIZE OR A GOFL BALL), URTICARIA (HIVES ON ARM), HYPOKINESIA (COULDN'T GET OFF THE COUCH), HEADACHE (HEADACHE/Daily headache), VACCINATION SITE ERYTHEMA (RED AT INJECTION SITE), VACCINATION SITE PAIN (SORENESS IN ARM) and VACCINATION SITE SWELLING (SWELLING ON ARM IS NOW THE SIZE OF A GRAPEFRUIT). In March 2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure 160/140) and MYALGIA (muscular pain in legs). On an unknown date, the patient experienced INFLAMMATION (inflammation). The patient was treated with CANDESARTAN (oral) for Blood pressure, at an unspecified dose and frequency. In April 2021, BLOOD PRESSURE INCREASED (blood pressure 160/140) had resolved. At the time of the report, PERIPHERAL SWELLING (SWOLLEN ARM THE SIZE OR A GOFL BALL), URTICARIA (HIVES ON ARM), HYPOKINESIA (COULDN'T GET OFF THE COUCH), INFLAMMATION (inflammation), HEADACHE (HEADACHE/Daily headache), VACCINATION SITE ERYTHEMA (RED AT INJECTION SITE), VACCINATION SITE PAIN (SORENESS IN ARM) and VACCINATION SITE SWELLING (SWELLING ON ARM IS NOW THE SIZE OF A GRAPEFRUIT) outcome was unknown and MYALGIA (muscular pain in legs) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: 160/140 (High) 160/140. In March 2021, C-reactive protein: 60 (High) 60. Patient went to Cardiologist for blood pressure. This case was linked to US-MODERNATX, INC.-MOD-2021-126158 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporter and Patient information updated, Medical history, allergies, concomitant drugs , new events, lab test, treatment information and vaccine information updated; Sender's Comments: US-MODERNATX, INC.-MOD-2021-126158:First dose

Other Meds: CANDESARTAN; CARVEDILOL; LEVOTHYROXINE; METFORMIN; PANTOPRAZOLE; FOLIC ACID; EZETIMIBE & SIMVASTATIN; KLOR-CON; VITAMIN B12 (CYANOCOBALAMIN AND ANALOGUES); FLONASE ALLERGY RELIEF; VITAMIN D3; LEVOFLOXACIN; CLINDAMYCIN

Current Illness: Acute otitis media with effusion; Blood pressure; Drug allergy (PCN, Sulfa, beta blockers, ARBs)

ID: 1569821
Sex: F
Age: 30
State: CT

Vax Date: 03/06/2021
Onset Date: 03/07/2021
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: Extreme body ache; Pain from shoulder to knee on the left arm; extreme fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme body ache), PAIN IN EXTREMITY (Pain from shoulder to knee on the left arm), FATIGUE (extreme fatigue) and HEADACHE (Headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (extreme fatigue) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN (Extreme body ache) and PAIN IN EXTREMITY (Pain from shoulder to knee on the left arm). On 08-Mar-2021, FATIGUE (extreme fatigue) and HEADACHE (Headache) had resolved. At the time of the report, PAIN (Extreme body ache) and PAIN IN EXTREMITY (Pain from shoulder to knee on the left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that the patient had pain in both arms especially (left arm pain from shoulder to knee) and want to know if the given vaccine related as it was a delayed reaction. No concomitant medication was reported. It was not reported if the patient was received any corrective treatment for the event.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm