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: 1564892
Sex: F
Age: 50
State: MN

Vax Date: 02/27/2021
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: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: swelling in ankle; Swelling in wrist; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling in ankle ) and JOINT SWELLING (Swelling in wrist) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 27-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 JOINT SWELLING (swelling in ankle ) and JOINT SWELLING (Swelling in wrist). At the time of the report, JOINT SWELLING (swelling in ankle ) and JOINT SWELLING (Swelling in wrist) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product used was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1564893
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: trouble breathing; felt bad; Vomit; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (trouble breathing), FEELING ABNORMAL (felt bad) and VOMITING (Vomit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (trouble breathing), FEELING ABNORMAL (felt bad) and VOMITING (Vomit). At the time of the report, DYSPNOEA (trouble breathing), FEELING ABNORMAL (felt bad) and VOMITING (Vomit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment information was not provided.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected at this time as patient didn't give consent for follow up

Other Meds:

Current Illness:

ID: 1564894
Sex: F
Age: 67
State: CT

Vax Date: 03/09/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Head feels heavy; Dizziness; Arm is sore to touch; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head feels heavy), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore to touch) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEAD DISCOMFORT (Head feels heavy), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore to touch) and NAUSEA (Nausea). At the time of the report, HEAD DISCOMFORT (Head feels heavy), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore to touch) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product used was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1564895
Sex: F
Age:
State: TX

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: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's past medical history included Hepatitis B (No changes) in 2018 and Alcohol use (social 1-2 drinks/week). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy. On 09-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 09-Sep-2021. On 09-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 09-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Prenatal screening test: negative (Negative) Negative. In 2021, Ultrasound foetal: normal (normal) No abnormalities. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up received on 12-JUL-2021 Contains no new information.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1564896
Sex: F
Age:
State: OH

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: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported. Treatment details was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1564897
Sex: M
Age: 75
State: CA

Vax Date: 02/10/2021
Onset Date: 02/11/2021
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: Rash which increased in size up to 1 x 6 in below the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash which increased in size up to 1 x 6 in below the injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L204) 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 11-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash which increased in size up to 1 x 6 in below the injection site). The patient was treated with CEFALEXIN (CEPHALEXINE) for Vaccination site rash, at a dose of UNK dosage form. On 25-Feb-2021, VACCINATION SITE RASH (Rash which increased in size up to 1 x 6 in below the injection site) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product used was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1564898
Sex: F
Age: 55
State: MS

Vax Date: 03/09/2021
Onset Date: 03/10/2021
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: aching all over the body; very tired/sleepy; head ache; sore arm at injection sit e; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching all over the body), FATIGUE (very tired/sleepy), HEADACHE (head ache) and VACCINATION SITE PAIN (sore arm at injection sit e) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 PAIN (aching all over the body), FATIGUE (very tired/sleepy), HEADACHE (head ache) and VACCINATION SITE PAIN (sore arm at injection sit e). At the time of the report, PAIN (aching all over the body), FATIGUE (very tired/sleepy), HEADACHE (head ache) and VACCINATION SITE PAIN (sore arm at injection sit e) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No Treatments were reported.

Other Meds:

Current Illness:

ID: 1564899
Sex: F
Age:
State:

Vax Date: 01/26/2021
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: side effects after my two shots; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after my two shots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Fibromyalgia and Asthma. On 26-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after my two shots). At the time of the report, VACCINATION COMPLICATION (side effects after my two shots) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) tested twice with negative results. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information was not provided for the second dose.

Other Meds:

Current Illness: Asthma; Fibromyalgia

ID: 1564900
Sex: F
Age: 84
State: IA

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Arm started hurting; Arm is red; Arm hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), ERYTHEMA (Arm is red) and SKIN WARM (Arm hot to touch) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Arthritis, ZOLPIDEM TARTRATE (AMBIEN), VITAMINS NOS and CALCIUM 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 an unknown date, the patient experienced PAIN IN EXTREMITY (Arm started hurting), ERYTHEMA (Arm is red) and SKIN WARM (Arm hot to touch). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Painful arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm started hurting), ERYTHEMA (Arm is red) and SKIN WARM (Arm hot to touch) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product used included an unspecified antidepressant. Treatment included ibuprofen (ADVIL), which she already takes for arthritis, but it did not help. The patient consulted a doctor, but she cannot remember what he recommended. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Event outcomes updated.

Other Meds: ADVIL [IBUPROFEN]; AMBIEN; VITAMINS NOS; CALCIUM

Current Illness: Arthritis

ID: 1564901
Sex: F
Age: 65
State: CT

Vax Date: 02/26/2021
Onset Date: 02/26/2021
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: This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAPULE (Progressively worsened into "red bump" and "hives"), VACCINATION SITE PRURITUS (Itching initially at the site of the injection), VACCINATION SITE URTICARIA (Progressively worsened into "red bump" and "hives") and VACCINATION SITE ERYTHEMA (Redness initially at the site of the injection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history provided by reporter. Concurrent medical conditions included Allergy to antibiotic (Allergies to Amoxicillin), Drug allergy (Allergies to Statins) and Drug allergy (Allergies to percocet). 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 VACCINATION SITE PRURITUS (Itching initially at the site of the injection) and VACCINATION SITE ERYTHEMA (Redness initially at the site of the injection). On 07-Mar-2021, the patient experienced VACCINATION SITE PAPULE (Progressively worsened into "red bump" and "hives") and VACCINATION SITE URTICARIA (Progressively worsened into "red bump" and "hives"). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Antihistamine therapy, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Antihistamine therapy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAPULE (Progressively worsened into "red bump" and "hives"), VACCINATION SITE PRURITUS (Itching initially at the site of the injection), VACCINATION SITE URTICARIA (Progressively worsened into "red bump" and "hives") and VACCINATION SITE ERYTHEMA (Redness initially at the site of the injection) 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 used was not provided by the reporter.; 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:

Current Illness: Allergy to antibiotic (Allergies to Amoxicillin); Drug allergy (Allergies to Statins); Drug allergy (Allergies to percocet)

ID: 1564902
Sex: M
Age:
State:

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: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: the appointment the patient had gotten for her second dose was 47 days after the first shot; A spontaneous report was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and got the appointment for his second dose 47 days after the first shot (inappropriate schedule of product administration). The patient's medical history was not reported. Concomitant product use was not reported. On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection and had gotten the appointment for his second dose 47 days after the first shot on 30 Mar 2021. Treatment information was also not provided . Action taken with mRNA-1273 in response to the event was not reported. The outcome of event was considered as unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-034913:Wife's case

Other Meds:

Current Illness:

ID: 1564903
Sex: F
Age: 74
State: NC

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Red; Hot to touch; Itchy; raise in temperature; Large bump on injection site a size of tennis ball; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Large bump on injection site a size of tennis ball), ERYTHEMA (Red), SKIN WARM (Hot to touch), PRURITUS (Itchy) and PYREXIA (raise in temperature) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE MASS (Large bump on injection site a size of tennis ball). On 26-Feb-2021, the patient experienced ERYTHEMA (Red), SKIN WARM (Hot to touch), PRURITUS (Itchy) and PYREXIA (raise in temperature). At the time of the report, INJECTION SITE MASS (Large bump on injection site a size of tennis ball), ERYTHEMA (Red), SKIN WARM (Hot to touch), PRURITUS (Itchy) and PYREXIA (raise in temperature) had not resolved. No concomitant medications reported by investigator o No treatment medications provided by the reporter. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable

Other Meds:

Current Illness:

ID: 1564904
Sex: F
Age: 58
State: KY

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:
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: This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE INDURATION, the second episode of VACCINATION SITE INDURATION, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA and VACCINATION SITE SWELLING in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chronic fatigue (symptoms worse after the vaccine) in 1990 and Epstein-Barr virus infection in 1990. Concomitant products included SERTRALINE, DOXYCYCLINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced the first episode of VACCINATION SITE INDURATION, VACCINATION SITE PAIN and VACCINATION SITE ERYTHEMA. On 10-Mar-2021, the patient experienced the second episode of VACCINATION SITE INDURATION, VACCINATION SITE SWELLING and VACCINATION SITE PAIN. On 25-Feb-2021, VACCINATION SITE PAIN and VACCINATION SITE ERYTHEMA had resolved. On 14-Mar-2021, last episode of VACCINATION SITE INDURATION, VACCINATION SITE SWELLING and VACCINATION SITE PAIN had resolved. ON 10mar2021, post vaccination, the patient reported that she experienced pain, swelling, redness at the injection site. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes on 11-May-2021: Follow-up information received on 11-May-2021 will be processed with initial report. Follow-up updated patient demographics, concomitant medications, adverse events start/stop dates and outcome. On 14-Jun-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1564905
Sex: F
Age: 74
State: NC

Vax Date: 02/25/2021
Onset Date: 02/26/2021
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: no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.; no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.; no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.; no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE JOINT WARMTH (no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.), INJECTION SITE PRURITUS (no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.), INJECTION SITE SWELLING (no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.) and INJECTION SITE ERYTHEMA (no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 26-Feb-2021, the patient experienced INJECTION SITE JOINT WARMTH (no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.), INJECTION SITE PRURITUS (no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.), INJECTION SITE SWELLING (no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.) and INJECTION SITE ERYTHEMA (no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.). At the time of the report, INJECTION SITE JOINT WARMTH (no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.), INJECTION SITE PRURITUS (no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.), INJECTION SITE SWELLING (no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.) and INJECTION SITE ERYTHEMA (no side effects that day except raise in temperature. Next day, 26Feb2021 she got a large bump on injection site a size of tennis ball, red, hot to touch and itchy.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: raised raised. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1564906
Sex: M
Age: 78
State: CO

Vax Date: 02/15/2021
Onset Date: 02/15/2021
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: Always sleepy; Lethargy; Body aches; Fever to 102.4 F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Always sleepy), LETHARGY (Lethargy), MYALGIA (Body aches), PYREXIA (Fever to 102.4 F) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation (Occasional atrial fibrillation; No recent change in status of chronic condition) since 1999. Concomitant products included METOPROLOL for Atrial fibrillation, APIXABAN (ELIQUIS) for Atrial fibrillation and Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol high, VITAMIN C [ASCORBIC ACID], VITAMIN D3 and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for Prevention, LISINOPRIL and PARACETAMOL (TYLENOL) for an unknown indication. On 15-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced SOMNOLENCE (Always sleepy), LETHARGY (Lethargy) and MYALGIA (Body aches). 15-Feb-2021, the patient experienced PYREXIA (Fever to 102.4 F) and CHILLS (Chills). At the time of the report, SOMNOLENCE (Always sleepy), LETHARGY (Lethargy), MYALGIA (Body aches) and CHILLS (Chills) had not resolved and PYREXIA (Fever to 102.4 F) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 102.4 (High) increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included paracetamol. This case was linked to MOD-2021-060090 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated contact information, patient information, medical history, lab data,concomitant medications, rechallenge results; Added event (FEVER).

Other Meds: ELIQUIS; METOPROLOL; LISINOPRIL; CRESTOR; TYLENOL; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]

Current Illness: Atrial fibrillation (Occasional atrial fibrillation; No recent change in status of chronic condition)

ID: 1564907
Sex: M
Age: 62
State: PR

Vax Date: 01/01/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Allergic reaction / allergy on his scalp; Felt like it burned; This spontaneous case was reported by a physician and describes the occurrence of DERMATITIS ALLERGIC (Allergic reaction / allergy on his scalp) and SKIN BURNING SENSATION (Felt like it burned) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. Concomitant products included METFORMIN, ISOSORBIDE, LISINOPRIL and SERTRALINE for an unknown indication. In January 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DERMATITIS ALLERGIC (Allergic reaction / allergy on his scalp) and SKIN BURNING SENSATION (Felt like it burned). At the time of the report, DERMATITIS ALLERGIC (Allergic reaction / allergy on his scalp) and SKIN BURNING SENSATION (Felt like it burned) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided

Other Meds: METFORMIN; ISOSORBIDE; LISINOPRIL; SERTRALINE

Current Illness:

ID: 1564908
Sex: M
Age: 36
State: NJ

Vax Date: 02/08/2021
Onset Date: 03/09/2021
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: missed day of work; feeling sluggish or tired; left arm hurting; lower back tightness; sweating a lot; feeling spacey; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left arm hurting), MUSCLE TIGHTNESS (lower back tightness), HYPERHIDROSIS (sweating a lot), FEELING ABNORMAL (feeling spacey) and IMPAIRED WORK ABILITY (missed day of work) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) for an unknown indication. The patient's past medical history included Anxiety. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-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 started ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm hurting), MUSCLE TIGHTNESS (lower back tightness), HYPERHIDROSIS (sweating a lot) and FEELING ABNORMAL (feeling spacey). 09-Mar-2021, the patient experienced FATIGUE (feeling sluggish or tired). On 10-Mar-2021, the patient experienced IMPAIRED WORK ABILITY (missed day of work). On 09-Mar-2021, HYPERHIDROSIS (sweating a lot) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (left arm hurting), MUSCLE TIGHTNESS (lower back tightness), FEELING ABNORMAL (feeling spacey), IMPAIRED WORK ABILITY (missed day of work) and FATIGUE (feeling sluggish or tired) outcome was unknown. Not Provided Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided. This case was linked to MOD-2021-136100, MOD-2021-136100 (Patient Link).

Other Meds:

Current Illness:

ID: 1564909
Sex: F
Age: 33
State: TX

Vax Date: 02/27/2021
Onset Date: 02/26/2021
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: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A211A) for COVID-19 vaccination. The patient's past medical history included Alcohol use (1-2 glasses/week) on 12-Jul-2020. Concurrent medical conditions included Subfertility. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-May-2020 to an unknown date, VITAMIN D [VITAMIN D NOS], IRON and OMEGA-3 [OMEGA-3 NOS] for an unknown indication. On 27-Feb-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 21-Jun-2020 and the estimated date of delivery was 21-Mar-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the thirty-fifth week of the pregnancy. On 26-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2020, Pregnancy test: positive (Positive) Positive. On 07-Jan-2021, Glucose tolerance test: no findings (normal) No findings. On 03-Nov-2021, Ultrasound scan: no findings (normal) No findings. 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 treatment information was provided by the reporter. Estimated date of conception was reported as 08-Jul-2021. The number of fetus was reported as 1 and prenatal care was established. There was no complications or acute illness during the pregnancy.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; VITAMIN D [VITAMIN D NOS]; IRON; OMEGA-3 [OMEGA-3 NOS]

Current Illness: Subfertility

ID: 1564910
Sex: F
Age: 63
State: CO

Vax Date: 03/09/2021
Onset Date: 03/10/2021
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: Swelling at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Swelling at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. Concomitant products included METFORMIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), ENALAPRIL, HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication. 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 VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication include topical gel for arthritis. Treatment information was not provided

Other Meds: METFORMIN; FARXIGA; ENALAPRIL; HYDROCHLOROTHIAZIDE; ATORVASTATIN

Current Illness:

ID: 1564911
Sex: F
Age:
State: WI

Vax Date:
Onset Date:
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: Dizziness; Sleepy; Not feeling myself; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), SOMNOLENCE (Sleepy) and MALAISE (Not feeling myself) in an 86-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), SOMNOLENCE (Sleepy) and MALAISE (Not feeling myself). At the time of the report, DIZZINESS (Dizziness), SOMNOLENCE (Sleepy) and MALAISE (Not feeling myself) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided. Patient did not want to take the 2nd dose because of the reaction she had after receiving the 1st dose Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Additional document attached and does not contain any new information

Other Meds:

Current Illness:

ID: 1564912
Sex: F
Age: 75
State: GA

Vax Date: 03/10/2021
Onset Date: 03/10/2021
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: Blurred vision; This spontaneous case was reported by a patient and describes the occurrence of VISION BLURRED (Blurred vision) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Glaucoma. Concomitant products included DORZOLAMIDE HCL for Eye drop instillation, LATANOPROST for an unknown indication. On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VISION BLURRED (Blurred vision). At the time of the report, VISION BLURRED (Blurred vision) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided.

Other Meds: DORZOLAMIDE HCL; LATANOPROST

Current Illness: Glaucoma

ID: 1564913
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:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Site effect of moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE DRUG REACTION (Site effect of moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Site effect of moderna vaccine). At the time of the report, ADVERSE DRUG REACTION (Site effect of moderna vaccine) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported Treatment information was not provided Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1564914
Sex: F
Age: 65
State: DC

Vax Date: 01/19/2021
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Chills; Mild ar m soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild ar m soreness) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 020L20A) for COVID-19 vaccination. Concomitant products included ATORVASTATIN for Hyperlipidemia, LISINOPRIL for Hypertension, LEVOTHYROXINE for Parathyroid tumor malignant. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Mild ar m soreness). On 17-Feb-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Mild ar m soreness) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-020736 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up recieved on 28-APR-2021 included added patient birth date demographics, stop date of event chills secondary reporter contact information

Other Meds: LEVOTHYROXINE; LISINOPRIL; ATORVASTATIN

Current Illness:

ID: 1564915
Sex: F
Age:
State: AK

Vax Date: 02/18/2021
Onset Date: 02/18/2021
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: tiny rash; little pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (tiny rash) and PAIN (little pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RASH (tiny rash) and PAIN (little pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] ongoing since an unknown date at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (tiny rash) and PAIN (little pain) outcome was unknown. no concomitant medications reported. This case was linked to MOD-2021-016861 (Parent-Child Link). See case MOD-2021-016861 for details regarding the child case.

Other Meds:

Current Illness:

ID: 1564916
Sex: F
Age: 79
State:

Vax Date: 02/02/2021
Onset Date: 03/02/2020
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: Swollen lip; Swollen tongue; Swollen throat; swollen inside part of the right cheeck / swollen right cheeck; Swollen right arm/ Swollen right hand; Vaccine is making her sick; all joints on the right side of my body are swollen and stiff,; Swollen right wrist; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lip), SWOLLEN TONGUE (Swollen tongue), PHARYNGEAL SWELLING (Swollen throat), SWELLING FACE (swollen inside part of the right cheeck / swollen right cheeck) and PERIPHERAL SWELLING (Swollen right arm/ Swollen right hand) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0U1AZIA and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2020, the patient experienced OEDEMA PERIPHERAL (Swollen right wrist). On 02-Mar-2021, the patient experienced LIP SWELLING (Swollen lip), SWOLLEN TONGUE (Swollen tongue), PHARYNGEAL SWELLING (Swollen throat), SWELLING FACE (swollen inside part of the right cheeck / swollen right cheeck), PERIPHERAL SWELLING (Swollen right arm/ Swollen right hand), ILLNESS (Vaccine is making her sick) and JOINT SWELLING (all joints on the right side of my body are swollen and stiff,). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swollen lip), SWOLLEN TONGUE (Swollen tongue), PHARYNGEAL SWELLING (Swollen throat), SWELLING FACE (swollen inside part of the right cheeck / swollen right cheeck), PERIPHERAL SWELLING (Swollen right arm/ Swollen right hand), OEDEMA PERIPHERAL (Swollen right wrist), ILLNESS (Vaccine is making her sick) and JOINT SWELLING (all joints on the right side of my body are swollen and stiff,) had not resolved. Treatment drug as reported is Certax On 01-JUN-2021, Patient provided follow-up information in stating that the patient's condition remains unchanged. In addition to the swollen limbs previously reported, the patient states that the patient's right foot is also swollen. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: follow-up added,

Other Meds:

Current Illness:

ID: 1564917
Sex: F
Age:
State: NM

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: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (Sleepiness) in a 78-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 PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (Sleepiness). At the time of the report, PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (Sleepiness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-015824.

Other Meds:

Current Illness:

ID: 1564918
Sex: F
Age: 60
State: CT

Vax Date: 03/09/2021
Onset Date: 03/09/2021
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: soreness in arm so great and right after the shot was heavy and now upper arm still very sore; pain; fatigue but unsure if from vaccine since she suffers from migraines; Feels like the muscle is damaged,more than muscle being effected to where she couldn't lay on that arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm so great and right after the shot was heavy and now upper arm still very sore), PAIN (pain), FATIGUE (fatigue but unsure if from vaccine since she suffers from migraines) and MYALGIA (Feels like the muscle is damaged,more than muscle being effected to where she couldn't lay on that arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The patient's past medical history included Migraine. Concomitant products included MELATONIN for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm so great and right after the shot was heavy and now upper arm still very sore), PAIN (pain), FATIGUE (fatigue but unsure if from vaccine since she suffers from migraines) and MYALGIA (Feels like the muscle is damaged,more than muscle being effected to where she couldn't lay on that arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm so great and right after the shot was heavy and now upper arm still very sore) had not resolved and PAIN (pain), FATIGUE (fatigue but unsure if from vaccine since she suffers from migraines) and MYALGIA (Feels like the muscle is damaged,more than muscle being effected to where she couldn't lay on that arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatments were reported. Patient was planned to reach out to HCP on 11-MAR-2021.

Other Meds: MELATONIN

Current Illness:

ID: 1564919
Sex: M
Age: 66
State: NV

Vax Date: 02/27/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: I've lost so much sleep,I can barely sleep; a lot of coughing every now and then; a lot of phlegm; soreness in my arm; chills; fever; tiredness; headaches daily; Muscle pain; Joint pain; nausea; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (I've lost so much sleep,I can barely sleep), COUGH (a lot of coughing every now and then), PRODUCTIVE COUGH (a lot of phlegm), PAIN IN EXTREMITY (soreness in my arm) and CHILLS (chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included INSULIN HUMAN (NOVOLIN R), INSULIN GLARGINE (LANTUS), ACETYLSALICYLIC ACID (BABY ASPIRIN), FINASTERIDE, ATORVASTATIN, TAMSULOSIN, METFORMIN HCL and MONTELUKAST for an unknown indication. On 27-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 INSOMNIA (I've lost so much sleep,I can barely sleep), COUGH (a lot of coughing every now and then), PRODUCTIVE COUGH (a lot of phlegm), PAIN IN EXTREMITY (soreness in my arm), CHILLS (chills), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headaches daily), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and NAUSEA (nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (I've lost so much sleep,I can barely sleep), COUGH (a lot of coughing every now and then), PRODUCTIVE COUGH (a lot of phlegm), PAIN IN EXTREMITY (soreness in my arm), CHILLS (chills), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headaches daily), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and NAUSEA (nausea) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds: NOVOLIN R; LANTUS; BABY ASPIRIN; FINASTERIDE; ATORVASTATIN; TAMSULOSIN; METFORMIN HCL; MONTELUKAST

Current Illness: Blood pressure high; Diabetes

ID: 1564920
Sex: F
Age: 64
State: TX

Vax Date: 02/08/2021
Onset Date: 02/08/2021
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: Pain around injection site; Swelling around injection site; rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain around injection site), VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE RASH (rash around injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain around injection site), VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE RASH (rash around injection site). On 11-Feb-2021, VACCINATION SITE PAIN (Pain around injection site), VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE RASH (rash around injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-207669 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR form received on 04-MAY-2021 and does not contain any new information.

Other Meds:

Current Illness:

ID: 1564921
Sex: F
Age: 65
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: scheduled for second dose 18 Feb 2021 but delayed due to snow storm; new appointment is now 12 Mar 2021, past the 36 day mark; headache; nausea; myalgia; chills; injection site pain; severe stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach pain), PRODUCT AVAILABILITY ISSUE (scheduled for second dose 18 Feb 2021 but delayed due to snow storm), PRODUCT ADMINISTRATION INTERRUPTED (new appointment is now 12 Mar 2021, past the 36 day mark), HEADACHE (headache) and NAUSEA (nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history is provided. concomitant is provided. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (severe stomach pain), HEADACHE (headache), NAUSEA (nausea), MYALGIA (myalgia), CHILLS (chills) and INJECTION SITE PAIN (injection site pain). On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (scheduled for second dose 18 Feb 2021 but delayed due to snow storm) and PRODUCT ADMINISTRATION INTERRUPTED (new appointment is now 12 Mar 2021, past the 36 day mark). At the time of the report, ABDOMINAL PAIN UPPER (severe stomach pain), PRODUCT AVAILABILITY ISSUE (scheduled for second dose 18 Feb 2021 but delayed due to snow storm), PRODUCT ADMINISTRATION INTERRUPTED (new appointment is now 12 Mar 2021, past the 36 day mark), HEADACHE (headache), NAUSEA (nausea), MYALGIA (myalgia), CHILLS (chills) and INJECTION SITE PAIN (injection site pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient received no treatment for the events.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds: ADDERALL

Current Illness:

ID: 1564922
Sex: M
Age: 70
State:

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:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and ARTHRALGIA (joint pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination. The patient's past medical history included Sickle cell disease. On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headache) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (Headache) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided No concomitant medications were reported. No Treatments were reported. Action taken with mRNA-1273 in response to the events was not Applicable.

Other Meds:

Current Illness:

ID: 1564923
Sex: F
Age: 48
State: FL

Vax Date: 03/09/2021
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: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Soreness; Pretty bad headache; Extremely Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), HEADACHE (Pretty bad headache) and FATIGUE (Extremely Tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 11-Mar-2021, the patient experienced PAIN (Soreness) and HEADACHE (Pretty bad headache). 11-Mar-2021, the patient experienced FATIGUE (Extremely Tired). At the time of the report, PAIN (Soreness), HEADACHE (Pretty bad headache) and FATIGUE (Extremely Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications provided by the reporter. No concomitant medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1564924
Sex: M
Age: 81
State: TX

Vax Date: 01/13/2021
Onset Date: 02/12/2021
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: on and off pain especially on quad muscle; pain in right leg; pain in right side of body,pain all over body,soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in right leg), PAIN (pain in right side of body,pain all over body,soreness) and MYALGIA (on and off pain especially on quad muscle) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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 PAIN IN EXTREMITY (pain in right leg) and PAIN (pain in right side of body,pain all over body,soreness). On 11-Mar-2021, the patient experienced MYALGIA (on and off pain especially on quad muscle). At the time of the report, PAIN IN EXTREMITY (pain in right leg), PAIN (pain in right side of body,pain all over body,soreness) and MYALGIA (on and off pain especially on quad muscle) outcome was unknown. No concomitant medications were reported. Treatment included Pain medications. Action taken with mRNA-1273 in response to the events was not Applicable

Other Meds:

Current Illness:

ID: 1564925
Sex: F
Age: 73
State:

Vax Date: 02/08/2021
Onset Date: 03/09/2021
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: kidney stone problem really bad; low fever; running in temperature; This spontaneous case was reported by a consumer and describes the occurrence of RENAL COLIC (kidney stone problem really bad), PYREXIA (running in temperature) and PYREXIA (low fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 010M20A) for COVID-19 vaccination. The patient's past medical history included Kidney stone (she had 2 kidney stone 15 years ago reported.). Concurrent medical conditions included Drug allergy (Allergic to a lot of drugs, Vitamins Reported.). On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (running in temperature). On 10-Mar-2021, the patient experienced RENAL COLIC (kidney stone problem really bad) and PYREXIA (low fever). At the time of the report, RENAL COLIC (kidney stone problem really bad), PYREXIA (running in temperature) and PYREXIA (low fever) outcome was unknown. No Concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not Applicable

Other Meds:

Current Illness: Drug allergy (Allergic to a lot of drugs, Vitamins Reported.)

ID: 1564926
Sex: F
Age:
State: MA

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: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Fever of 99.8F; Chills; Sore at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 99.8F), CHILLS (Chills) and INJECTION SITE PAIN (Sore at injection arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included AMOXYCILLIN [AMOXICILLIN] for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore at injection arm). On 20-Feb-2021, the patient experienced PYREXIA (Fever of 99.8F) and CHILLS (Chills). At the time of the report, PYREXIA (Fever of 99.8F), CHILLS (Chills) and INJECTION SITE PAIN (Sore at injection arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Pyrexia: inconclusive (Inconclusive) 99.8F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatments were reported.

Other Meds: AMOXYCILLIN [AMOXICILLIN]

Current Illness:

ID: 1564927
Sex: F
Age: 32
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient was pregnant while on the Moderna vaccine) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. No Medical History information was reported. On 10-Mar-2021, 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 10-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient was pregnant while on the Moderna vaccine). On 10-Mar-2021, EXPOSURE DURING PREGNANCY (Patient was pregnant while on the Moderna vaccine) had resolved. Not Provided. 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: 1564928
Sex: M
Age: 65
State:

Vax Date: 03/03/2021
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: sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal, Parkinson's disease, Nerve pain and Cardiac disorder NOS. On 03-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 SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications sleep pill and medications for the indications for blood pressure, parkinson's disease, nerve pain, heart conditions. No treatment medications were reported

Other Meds:

Current Illness: Blood pressure abnormal; Cardiac disorder NOS; Nerve pain; Parkinson's disease

ID: 1564929
Sex: F
Age:
State: MD

Vax Date: 02/22/2021
Onset Date: 02/01/2021
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: Head was killing me/ Headache; wasn't feeling that great on that night; It hurts all day since 2 weeks especially my eyes; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (wasn't feeling that great on that night), EYE PAIN (It hurts all day since 2 weeks especially my eyes) and HEADACHE (Head was killing me/ Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. No Medical History information was reported. On 22-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) at an unspecified dose. In February 2021, the patient experienced EYE PAIN (It hurts all day since 2 weeks especially my eyes). On 22-Feb-2021, the patient experienced FEELING ABNORMAL (wasn't feeling that great on that night). On 23-Feb-2021, the patient experienced HEADACHE (Head was killing me/ Headache). At the time of the report, FEELING ABNORMAL (wasn't feeling that great on that night) outcome was unknown, EYE PAIN (It hurts all day since 2 weeks especially my eyes) had not resolved and HEADACHE (Head was killing me/ Headache) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1564930
Sex: F
Age: 57
State:

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: 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: Body ache; Feeling ache in neck as well as shoulder; Nausea; headache; fatigue; Fever; Feeling ache in neck as well as shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), NECK PAIN (Feeling ache in neck as well as shoulder), NAUSEA (Nausea), HEADACHE (headache) and FATIGUE (fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036AL1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (Body ache), NECK PAIN (Feeling ache in neck as well as shoulder), NAUSEA (Nausea), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (Fever) and ARTHRALGIA (Feeling ache in neck as well as shoulder). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of UNK dosage form. In March 2021, NAUSEA (Nausea) and HEADACHE (headache) had resolved. At the time of the report, PAIN (Body ache), NECK PAIN (Feeling ache in neck as well as shoulder), FATIGUE (fatigue) and ARTHRALGIA (Feeling ache in neck as well as shoulder) had not resolved and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1564931
Sex: F
Age: 72
State: MO

Vax Date: 02/24/2021
Onset Date: 02/24/2021
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: Itches; Still a little red; Arm was swollen; Itchy spot; Large red sore; Arm was red; Sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was red), PAIN (Sore), RASH MACULAR (Large red sore), PRURITUS (Itches) and RASH ERYTHEMATOUS (Still a little red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Drug allergy (Clindamycin). On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced ERYTHEMA (Arm was red) and PAIN (Sore). On 03-Mar-2021, the patient experienced RASH MACULAR (Large red sore) and VACCINATION SITE PRURITUS (Itchy spot). On an unknown date, the patient experienced PRURITUS (Itches), RASH ERYTHEMATOUS (Still a little red) and PERIPHERAL SWELLING (Arm was swollen). The patient was treated with HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Arm was red), PAIN (Sore), RASH MACULAR (Large red sore), PRURITUS (Itches), RASH ERYTHEMATOUS (Still a little red), PERIPHERAL SWELLING (Arm was swollen) and VACCINATION SITE PRURITUS (Itchy spot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to US-MODERNATX, INC.-MOD-2021-131181 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: added dosage form, added event. added patient demographic, added historical condition; Sender's Comments: US-MODERNATX, INC.-MOD-2021-131181:2nd dose

Other Meds:

Current Illness: Drug allergy (Clindamycin); Penicillin allergy; Sulfonamide allergy

ID: 1564932
Sex: M
Age:
State:

Vax Date: 03/09/2021
Onset Date: 03/10/2021
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: experiencing inflammation under the ribcage; Hardness under the skin; a lump below the injection site, under the vaccination site there is a hard lump; as if the fluid had dropped and made a bump and it is the size of an olive; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a lump below the injection site, under the vaccination site there is a hard lump), SWELLING (as if the fluid had dropped and made a bump and it is the size of an olive), INFLAMMATION (experiencing inflammation under the ribcage) and VACCINATION SITE INDURATION (Hardness under the skin) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. No medical history reported. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), LOSARTAN and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. 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 VACCINATION SITE MASS (a lump below the injection site, under the vaccination site there is a hard lump), SWELLING (as if the fluid had dropped and made a bump and it is the size of an olive) and VACCINATION SITE INDURATION (Hardness under the skin). On an unknown date, the patient experienced INFLAMMATION (experiencing inflammation under the ribcage). At the time of the report, VACCINATION SITE MASS (a lump below the injection site, under the vaccination site there is a hard lump), SWELLING (as if the fluid had dropped and made a bump and it is the size of an olive) and VACCINATION SITE INDURATION (Hardness under the skin) had resolved and INFLAMMATION (experiencing inflammation under the ribcage) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-Jun-2021 contains significant information including updated previous events outcome to recovered/resolved and added a new event.

Other Meds: PLAVIX; LOSARTAN; LIPITOR

Current Illness:

ID: 1564933
Sex: F
Age: 40
State: CA

Vax Date: 03/09/2021
Onset Date: 03/09/2021
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: Nausea/she feels like she may vomit; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) and NAUSEA (Nausea/she feels like she may vomit) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (Severe headache). On 11-Mar-2021, the patient experienced NAUSEA (Nausea/she feels like she may vomit). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form, q4h. On 11-Mar-2021, HEADACHE (Severe headache) had resolved. At the time of the report, NAUSEA (Nausea/she feels like she may vomit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1564934
Sex: F
Age: 41
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: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Soon after the vaccination her arm is Red and hot; Soon after the vaccination her arm is Red and hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Soon after the vaccination her arm is Red and hot) and VACCINATION SITE ERYTHEMA (Soon after the vaccination her arm is Red and hot) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. Concurrent medical conditions included Allergy (getting allergy shot every week). 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 VACCINATION SITE WARMTH (Soon after the vaccination her arm is Red and hot) and VACCINATION SITE ERYTHEMA (Soon after the vaccination her arm is Red and hot). At the time of the report, VACCINATION SITE WARMTH (Soon after the vaccination her arm is Red and hot) and VACCINATION SITE ERYTHEMA (Soon after the vaccination her arm is Red and hot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1564935
Sex: F
Age: 83
State: CO

Vax Date: 02/26/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. Concurrent medical conditions included Cancer. Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) for Cancer. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. The patient was given a topical ointment but it was still looking a little red and visited an acupuncturist.

Other Meds: TAGRISSO

Current Illness: Cancer

ID: 1564936
Sex: F
Age: 33
State: NJ

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: Lump the size of a baseball near injection site; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump the size of a baseball near injection site) and VACCINATION SITE PAIN (Soreness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump the size of a baseball near injection site) and VACCINATION SITE PAIN (Soreness). At the time of the report, VACCINATION SITE MASS (Lump the size of a baseball near injection site) and VACCINATION SITE PAIN (Soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1564937
Sex: F
Age: 64
State: TN

Vax Date: 02/25/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Redness around injection site (left arm); It itches around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around injection site (left arm)) and VACCINATION SITE PRURITUS (It itches around injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 036AZ1A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Aspirin) and Drug allergy (Daypro). On 25-Feb-2021 at 7:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021 at 7:25 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021 at 7:00 AM, the patient experienced VACCINATION SITE ERYTHEMA (Redness around injection site (left arm)) and VACCINATION SITE PRURITUS (It itches around injection site). On 06-Mar-2021, VACCINATION SITE ERYTHEMA (Redness around injection site (left arm)) had resolved. On 28-Mar-2021, VACCINATION SITE PRURITUS (It itches around injection site) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE ERYTHEMA (Redness around injection site (left arm)) and VACCINATION SITE PRURITUS (It itches around injection site) to be related. Treatment details included Benadryl cream. This case was linked to MOD-2021-105088 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Patient demographics, event start date and time, event stop date, event outcome, allergies and causality updated

Other Meds:

Current Illness: Drug allergy (Daypro); Drug allergy (Aspirin)

ID: 1564938
Sex: F
Age: 85
State: NV

Vax Date: 03/05/2021
Onset Date: 03/11/2021
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: Lump in arm; Arm purple and blue; Lump turned itchy; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE MASS (Lump in arm), VACCINATION SITE BRUISING (Arm purple and blue) and VACCINATION SITE PRURITUS (Lump turned itchy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination. No Medical History information was reported. On 05-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 VACCINATION SITE MASS (Lump in arm), VACCINATION SITE BRUISING (Arm purple and blue) and VACCINATION SITE PRURITUS (Lump turned itchy). At the time of the report, VACCINATION SITE MASS (Lump in arm), VACCINATION SITE BRUISING (Arm purple and blue) and VACCINATION SITE PRURITUS (Lump turned itchy) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1564939
Sex: M
Age: 57
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: headache; soreness in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and VACCINATION SITE PAIN (soreness in the arm of the injection) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and VACCINATION SITE PAIN (soreness in the arm of the injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and VACCINATION SITE PAIN (soreness in the arm of the injection) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1564940
Sex: M
Age:
State: UT

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:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Extreme vertigo; Dizziness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VERTIGO (Extreme vertigo) and DIZZINESS (Dizziness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included VITAMIN D NOS for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-Mar-2021, the patient experienced VERTIGO (Extreme vertigo) and DIZZINESS (Dizziness). At the time of the report, PAIN IN EXTREMITY (Sore arm), VERTIGO (Extreme vertigo) and DIZZINESS (Dizziness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported.

Other Meds: VITAMIN D NOS

Current Illness:

ID: 1564941
Sex: F
Age: 77
State: GA

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

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Headache, nausea, extreme pain across her shoulder blade, and fever; Headache, nausea, extreme pain across her shoulder blade, and fever; Symptoms seem to occur in cycles where she feels good for a bit and then she "crashes."; Headache, nausea, extreme pain across her shoulder blade, and fever; Headache, nausea, extreme pain across her shoulder blade, and fever; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Symptoms seem to occur in cycles where she feels good for a bit and then she "crashes."), HEADACHE (Headache, nausea, extreme pain across her shoulder blade, and fever), NAUSEA (Headache, nausea, extreme pain across her shoulder blade, and fever), ARTHRALGIA (Headache, nausea, extreme pain across her shoulder blade, and fever) and PYREXIA (Headache, nausea, extreme pain across her shoulder blade, and fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-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 CONDITION AGGRAVATED (Symptoms seem to occur in cycles where she feels good for a bit and then she "crashes."), HEADACHE (Headache, nausea, extreme pain across her shoulder blade, and fever), NAUSEA (Headache, nausea, extreme pain across her shoulder blade, and fever) and PYREXIA (Headache, nausea, extreme pain across her shoulder blade, and fever). On 11-Mar-2021, the patient experienced ARTHRALGIA (Headache, nausea, extreme pain across her shoulder blade, and fever). At the time of the report, CONDITION AGGRAVATED (Symptoms seem to occur in cycles where she feels good for a bit and then she "crashes."), HEADACHE (Headache, nausea, extreme pain across her shoulder blade, and fever), NAUSEA (Headache, nausea, extreme pain across her shoulder blade, and fever), ARTHRALGIA (Headache, nausea, extreme pain across her shoulder blade, and fever) and PYREXIA (Headache, nausea, extreme pain across her shoulder blade, and fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm