VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.






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: 1543425
Sex: F
Age: 51
State: WA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/11/2021
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: couldn't swallow; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPHAGIA (couldn't swallow) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DYSPHAGIA (couldn't swallow). At the time of the report, DYSPHAGIA (couldn't swallow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided No treatment information provided

Other Meds:

Current Illness:

ID: 1543426
Sex: M
Age: 81
State: NC

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
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: joint pain in my shoulders, hands, and wrist/Joint Pain From Shoulder to Hands on Both Arms (After the First Vaccine); The joints all have severe swelling; Both Hands swelled up/hands still swell up like grapefruits; Hands tingle under fingernails like its falling asleep; Not Able to Use Hands (After the First Vaccine); Muscle Pain From Shoulder to Hands on Both Arms (After the First Vaccine); This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (The joints all have severe swelling), PERIPHERAL SWELLING (Both Hands swelled up/hands still swell up like grapefruits), PARAESTHESIA (Hands tingle under fingernails like its falling asleep), MOBILITY DECREASED (Not Able to Use Hands (After the First Vaccine)) and MYALGIA (Muscle Pain From Shoulder to Hands on Both Arms (After the First Vaccine)) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis and Hypertension. Concomitant products included ALFUZOSIN for Benign prostatic hypertrophy, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced JOINT SWELLING (The joints all have severe swelling), PERIPHERAL SWELLING (Both Hands swelled up/hands still swell up like grapefruits), PARAESTHESIA (Hands tingle under fingernails like its falling asleep), MOBILITY DECREASED (Not Able to Use Hands (After the First Vaccine)) and MYALGIA (Muscle Pain From Shoulder to Hands on Both Arms (After the First Vaccine)). The patient was treated with MELOXICAM at a dose of unknown; PREDNISONE at a dose of unknown and PARACETAMOL (TYLENOL) at a dose of unknown. At the time of the report, JOINT SWELLING (The joints all have severe swelling), PERIPHERAL SWELLING (Both Hands swelled up/hands still swell up like grapefruits), PARAESTHESIA (Hands tingle under fingernails like its falling asleep), MOBILITY DECREASED (Not Able to Use Hands (After the First Vaccine)) and MYALGIA (Muscle Pain From Shoulder to Hands on Both Arms (After the First Vaccine)) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Significant follow up-New events are added On 01-Jun-2021: Non-Significant F/U Case On 23-Jul-2021: Significant Follow-up received-Events and outcome of the events updated.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; ALFUZOSIN

Current Illness: Arthritis; Hypertension

ID: 1543427
Sex: F
Age:
State:

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 08/11/2021
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: muscles are hurting; extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscles are hurting) and FATIGUE (extremely fatigued) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscles are hurting) and FATIGUE (extremely fatigued). At the time of the report, MYALGIA (muscles are hurting) and FATIGUE (extremely fatigued) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided No treatment information provided

Other Meds:

Current Illness:

ID: 1543428
Sex: M
Age:
State:

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 08/11/2021
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: Some soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Some soreness at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Some soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Some soreness at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided

Other Meds:

Current Illness:

ID: 1543429
Sex: F
Age: 33
State: TX

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 08/11/2021
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: received the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received the vaccine while pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication, THYROID (ARMOUR THYROID). On 08-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 an unknown date and the estimated date of delivery was 09-Oct-2021. On 08-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (received the vaccine while pregnant). On 08-Feb-2021, EXPOSURE DURING PREGNANCY (received the vaccine while pregnant) 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. No treatment information provided

Other Meds: SYMBICORT; ARMOUR THYROID

Current Illness:

ID: 1543430
Sex: F
Age: 37
State: WV

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
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: Red knot at the injection site; red at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Red knot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history was reported). On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 21-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Red knot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site). On 16-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE INDURATION (Red knot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided No treatment information provided Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Email added

Other Meds:

Current Illness:

ID: 1543431
Sex: M
Age:
State: FL

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 08/11/2021
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: experiencing an adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (experiencing an adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced ADVERSE EVENT (experiencing an adverse event). At the time of the report, ADVERSE EVENT (experiencing an adverse event) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided No treatment information provided

Other Meds:

Current Illness:

ID: 1543432
Sex: F
Age: 72
State: MO

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/11/2021
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: Had a terrible time breathing; Had to use her oxygen more often; A spontaneous report was received from a consumer, concerning herself, a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a terrible time breathing and had to use her oxygen more often. The patient's medical history reported included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided by the reporter. On 02 FEB 2021, prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (lot number: unknown) in the left arm for prophylaxis of COVID-19 infection. On 02 FEB 2021, since patient took vaccine, she had started to have a terrible time in breathing and has had to use her oxygen more often. Treatments of these events included oxygen. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events had a terrible time breathing and had to use her oxygen more often were considered unknown at the time of this report.; Reporter's Comments: This report concerns a 72-year old female patient with medical history COPD who experienced non-serious events of dyspnea and increased use of oxygen within 2 days of his receiving the mRNA-1273 (Lot # 039K20-2A). Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidity

Other Meds:

Current Illness:

ID: 1543433
Sex: F
Age:
State:

Vax Date: 01/09/2021
Onset Date:
Rec V Date: 08/11/2021
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: back pain; knee swollen; body ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), JOINT SWELLING (knee swollen) and MYALGIA (body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain), JOINT SWELLING (knee swollen) and MYALGIA (body ache). At the time of the report, BACK PAIN (back pain), JOINT SWELLING (knee swollen) and MYALGIA (body ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: adverse events obtained via follow-up call

Other Meds:

Current Illness:

ID: 1543434
Sex: F
Age: 68
State: WA

Vax Date: 01/26/2021
Onset Date: 02/03/2021
Rec V Date: 08/11/2021
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: upper part of her arm started getting itchy; upper part of her arm started getting red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (upper part of her arm started getting itchy) and VACCINATION SITE ERYTHEMA (upper part of her arm started getting red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy and Bee sting hypersensitivity. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (upper part of her arm started getting itchy) and VACCINATION SITE ERYTHEMA (upper part of her arm started getting red). At the time of the report, VACCINATION SITE PRURITUS (upper part of her arm started getting itchy) and VACCINATION SITE ERYTHEMA (upper part of her arm started getting red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided No treatment information provided

Other Meds:

Current Illness: Bee sting hypersensitivity; Penicillin allergy

ID: 1543435
Sex: F
Age: 31
State: OH

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/11/2021
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: received the 1st Moderna vaccine 29Dec2020 and the 2nd vaccine on 27Jan2021 and is Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine 29Dec2020 and the 2nd vaccine on 27Jan2021 and is Pregnant) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20-2A and 039K20-2A) for COVID-19 vaccination. The patient's past medical history included Factor V Leiden carrier since 2012. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ACETYLSALICYLIC ACID (BABY ASPIRIN), DOXYLAMINE and PYRIDOXINE HYDROCHLORIDE (VIT B6) for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 12-Nov-2020 and the estimated date of delivery was 19-Aug-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine 29Dec2020 and the 2nd vaccine on 27Jan2021 and is Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the sixth week of the pregnancy. On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine 29Dec2020 and the 2nd vaccine on 27Jan2021 and is Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2020, Pregnancy test: positive (Positive) Positive. The date of positive pregnancy test was 08-Dec-2020. The patient has an established prenatal care. No treatment information provided.

Other Meds: BABY ASPIRIN; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; DOXYLAMINE; VIT B6

Current Illness: Factor V Leiden carrier

ID: 1543436
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
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: Redness Beneath the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness Beneath the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history.). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness Beneath the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness Beneath the injection site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided No treatment information provided

Other Meds:

Current Illness:

ID: 1543437
Sex: F
Age: 65
State: CO

Vax Date: 01/14/2021
Onset Date: 01/16/2021
Rec V Date: 08/11/2021
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: chills; fever; nausea; throwing up vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and VOMITING (throwing up vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and VOMITING (throwing up vomiting). On 20-Jan-2021, CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and VOMITING (throwing up vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test positive: positive Tested positive for COVID 19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided No treatment information provided

Other Meds:

Current Illness:

ID: 1543438
Sex: F
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
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: arthritis flare up; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis flare up) and FATIGUE (tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Arthritis. 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 ARTHRITIS (arthritis flare up) and FATIGUE (tiredness). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, ARTHRITIS (arthritis flare up) and FATIGUE (tiredness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication include on 8-Feb-2021; 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:

ID: 1543439
Sex: F
Age: 34
State: TX

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 7, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1ZM20A) for COVID-19 vaccination. The patient's past medical history included Spontaneous abortion (x5) and Pregnancy (live-full term birth). Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Allergy (Allergy to bees) and Illness (Not feeling well due to pregnancy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, PROGESTERONE for an unknown indication. On 13-Jan-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 29-Nov-2020 and the estimated date of delivery was 12-Sep-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the sixth week of the pregnancy. On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound foetal: normal (normal) normal. 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. 07-Jan-2021: pregnancy test results positive She had to do IVS and had 5 miscarriages, unexplained where it was natural. Company Comment : This case involves a 34 year old pregnant female with LMP of 19 Nov 2021 and EDC of 13 Sep 2021 who received the mRNA-1273 on 13 Jan 2021. The causality for the event Maternal exposure during pregnancy is Not applicable. Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Internal review on 29-Jul-2021 resulted to updated number of pregnancy, medical history, birth type and fetal outcome, event dates and outcome, new event and narrative.; Sender's Comments: This case involves a 34 year old pregnant female with LMP of 19 Nov 2021 and EDC of 13 Sep 2021 who received the mRNA-1273 on 13 Jan 2021. The causality for the event Maternal exposure during pregnancy is Not applicable.

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

Current Illness: Allergy (Allergy to bees); Illness (Not feeling well due to pregnancy); Sulfonamide allergy (Sulfa drugs allergy)

ID: 1543440
Sex: F
Age:
State:

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
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: injection site warmth; injection site hard; The area at the injection site on my arm there is a 2" circular swelling which is hard and on the warm side; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site warmth), INJECTION SITE INDURATION (injection site hard), VACCINATION SITE SWELLING (The area at the injection site on my arm there is a 2" circular swelling which is hard and on the warm side) and INJECTION SITE ERYTHEMA (injection site red) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20-2A and 038K20A) 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) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site warmth), INJECTION SITE INDURATION (injection site hard), VACCINATION SITE SWELLING (The area at the injection site on my arm there is a 2" circular swelling which is hard and on the warm side) and INJECTION SITE ERYTHEMA (injection site red). At the time of the report, INJECTION SITE WARMTH (injection site warmth), INJECTION SITE INDURATION (injection site hard) and VACCINATION SITE SWELLING (The area at the injection site on my arm there is a 2" circular swelling which is hard and on the warm side) had resolved and INJECTION SITE ERYTHEMA (injection site red) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medications were provided. No treatment information provided Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Additional info. VAERS

Other Meds:

Current Illness:

ID: 1543441
Sex: F
Age: 64
State: CA

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 08/11/2021
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: tender hardness on the injection site the size of a silver dollar; tender hardness on the injection site the size of a silver dollar; freezing to death;feels very cold; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tender hardness on the injection site the size of a silver dollar), VACCINATION SITE MASS (tender hardness on the injection site the size of a silver dollar) and FEELING COLD (freezing to death;feels very cold) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (tender hardness on the injection site the size of a silver dollar), VACCINATION SITE MASS (tender hardness on the injection site the size of a silver dollar) and FEELING COLD (freezing to death;feels very cold). At the time of the report, VACCINATION SITE PAIN (tender hardness on the injection site the size of a silver dollar), VACCINATION SITE MASS (tender hardness on the injection site the size of a silver dollar) and FEELING COLD (freezing to death;feels very cold) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment and concomitant medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1543442
Sex: F
Age:
State:

Vax Date: 01/12/2021
Onset Date: 01/21/2021
Rec V Date: 08/11/2021
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: Reaction at the injection site; Occasional itching over the whole body; Arm itchy; Arm swollen; Little bit of nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NAUSEA (Little bit of nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-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 NAUSEA (Little bit of nausea). At the time of the report, NAUSEA (Little bit of nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator No treatment medications 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:

ID: 1543443
Sex: F
Age: 40
State: CA

Vax Date: 02/04/2021
Onset Date: 02/01/2021
Rec V Date: 08/11/2021
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: pregnancy; pain at the site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) and VACCINATION SITE PAIN (pain at the site) in a 40-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Gestational diabetes. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Pre-eclampsia, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, LEVOTHYROXINE for Thyroiditis NOS, CALCIUM, DOCOSAHEXAENOIC ACID (DHA), VITAMIN D NOS and MAGNESIUM for an unknown indication. On 04-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 an unknown date and the estimated date of delivery was 04-Apr-2021. On 04-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). In February 2021, the patient experienced VACCINATION SITE PAIN (pain at the site). On 04-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (pain at the site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: (normal) At 12 weeks; normal, (normal) At 20 weeks ; normal and (normal) At 31 weeks; normal. 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. Patient previously had live full-term child birth on 19JUL2016 and 21 AUG2018. Treatment medications were not provided by reporter.

Other Meds: LEVOTHYROXINE; ASPIRIN (E.C.); CALCIUM; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; DHA; VITAMIN D NOS; MAGNESIUM

Current Illness: Gestational diabetes

ID: 1543444
Sex: F
Age: 33
State: TX

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/11/2021
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: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination. No medical history provided by Reporter. The patient's past medical history included Pregnancy (Live, full-term birth) on 11-May-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Jun-2020 and the estimated date of delivery was 31-Mar-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the thirty-second week of the pregnancy. On 08-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Pregnancy test: positive (Positive) Positive. The date of positive pregnancy test was Oct-2020. The patient has an established prenatal care. Treatment medications were not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Internal review on 23-Jul-2021 resulted in updates to the pregnancy test, birth type and fetal outcome.

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

Current Illness:

ID: 1543445
Sex: F
Age: 77
State: NC

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 08/11/2021
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: INJECTION SITE SWELLING; Its Red,Redness is getting bigger and bigger and bigger; Its itchy; Its getting hard; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (INJECTION SITE SWELLING), VACCINATION SITE ERYTHEMA (Its Red,Redness is getting bigger and bigger and bigger), VACCINATION SITE PRURITUS (Its itchy) and VACCINATION SITE INDURATION (Its getting hard) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history is reported.). On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE SWELLING (INJECTION SITE SWELLING), VACCINATION SITE ERYTHEMA (Its Red,Redness is getting bigger and bigger and bigger), VACCINATION SITE PRURITUS (Its itchy) and VACCINATION SITE INDURATION (Its getting hard). At the time of the report, VACCINATION SITE SWELLING (INJECTION SITE SWELLING), VACCINATION SITE ERYTHEMA (Its Red,Redness is getting bigger and bigger and bigger), VACCINATION SITE PRURITUS (Its itchy) and VACCINATION SITE INDURATION (Its getting hard) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment and concomitant medications were not provided by reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1543446
Sex: F
Age: 72
State: WY

Vax Date: 01/26/2021
Onset Date: 01/30/2021
Rec V Date: 08/11/2021
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: Cellulitis at her injection site; Arm was inflamed and red; Arm was sore and even under armpit; A lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE CELLULITIS (Cellulitis at her injection site), VACCINATION SITE ERYTHEMA (Arm was inflamed and red) and AXILLARY PAIN (Arm was sore and even under armpit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Accident (She crushed her right arm in May 2020 with 18 screws in place.) in May 2020, Tumor (Stomach Tumor which was operated on at an unmentioned date.) in 2019 and Staphylococcal infection (Staph infection from the stomach tumor surgery.) in 2019. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced INJECTION SITE CELLULITIS (Cellulitis at her injection site), VACCINATION SITE ERYTHEMA (Arm was inflamed and red) and AXILLARY PAIN (Arm was sore and even under armpit). The patient was treated with CEFIXIME (ANCEF O) ongoing from 02-Feb-2021 at a dose of 1 dosage form and CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, INJECTION SITE CELLULITIS (Cellulitis at her injection site), VACCINATION SITE ERYTHEMA (Arm was inflamed and red) and AXILLARY PAIN (Arm was sore and even under armpit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medications included 2G IV Ancef with 2 doses total on 02FEB2021and 03FEB2021 and 10 days of Keflex 500mg/280mg. No concomitant medications were provided by reporter.

Other Meds:

Current Illness:

ID: 1543447
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
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: delayed subcutaneous hypersensitivity/Covid arm- delayed; lump on my pinky joint; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (delayed subcutaneous hypersensitivity/Covid arm- delayed) and JOINT SWELLING (lump on my pinky joint) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Lymph node dissection (Lymph node removed in the second arm.(right or left not specified).). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (delayed subcutaneous hypersensitivity/Covid arm- delayed) and JOINT SWELLING (lump on my pinky joint). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (delayed subcutaneous hypersensitivity/Covid arm- delayed) and JOINT SWELLING (lump on my pinky joint) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment and concomitant medications were not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Follow up attached on 08 Feb 2021 and contains information

Other Meds:

Current Illness:

ID: 1543448
Sex: F
Age: 27
State: WA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/11/2021
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: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-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 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Pregnancy test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient had first dose of the vaccine on 21-Jan-2021 and later discovered on 01-Feb-2021 that she was pregnant. she wanted to know if she can still go ahead with the second dose

Other Meds:

Current Illness:

ID: 1543449
Sex: F
Age: 75
State: GA

Vax Date: 01/09/2021
Onset Date:
Rec V Date: 08/11/2021
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: Soreness red and hot around the injection site, bumps size of half a dollar on injection arm; bumps size of half a dollar on injection arm; Soreness red and hot around the injection site, bumps size of half a dollar on injection arm; Soreness red and hot around the injection site, bumps size of half a dollar on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm), VACCINATION SITE INDURATION (bumps size of half a dollar on injection arm), VACCINATION SITE ERYTHEMA (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) and VACCINATION SITE PAIN (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm), VACCINATION SITE INDURATION (bumps size of half a dollar on injection arm), VACCINATION SITE ERYTHEMA (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) and VACCINATION SITE PAIN (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm). At the time of the report, VACCINATION SITE WARMTH (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm), VACCINATION SITE INDURATION (bumps size of half a dollar on injection arm), VACCINATION SITE ERYTHEMA (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) and VACCINATION SITE PAIN (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment for the event was not provided.

Other Meds:

Current Illness:

ID: 1543450
Sex: F
Age:
State: NC

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 08/11/2021
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: barely any soreness at the injection site; A spontaneous case was received from a consumer concerning from social media concerning an unknown age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced barely any soreness at the injection site/injection site pain. No medical history was reported. No relevant concomitant medications were reported. On 31 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-24) intramuscularly for prophylaxis of COVID-19 infection. On 31 Dec 2020 a few hours later, the patient experienced barely any soreness at the injection site. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1543451
Sex: M
Age: 80
State: FL

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 08/11/2021
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: light pink color developed over the vaccine site; soreness in the arm; bump in the arm; A Spontaneous report was received from consumer concerning a male patient of 80 age who received Moderna COVID-19 vaccine (m-RNA-1273) and experienced Vaccination site pain, Vaccination site mass, Vaccination site erythema . The patient has no medical history. relevant concomitant medications are Vytorin, Atenolol, Pantoprazole, Xanax, Mirtazapine, V-C Forte, Aspirin, Coenzyme, Selenium, Vitamin C, Colace, Calcium, Metamucil, Turmeric Hydrocortisone. On 06-Jan-2021, prior to the onset of the events the patient received their dose of mRNA1273(batch no. unknown) and the route of administration is unknown for prophylaxis of COVID-19 infection. Treatment information was not provided. The events Vaccination site pain, Vaccination site mass, Vaccination site erythema . were recovered on 20 Jan 2021. The outcome of the events is unknown. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.

Other Meds: VYTORIN; ATENOLOL; PANTOPRAZOLE; ALPRAZOLAM; MIRTAZAPINE; MULTIVITAMIN [VITAMINS NOS]; ASPIRIN 81; COENZYME Q10+; SELENIUM; VITAMIN C ACID; COLACE; CALCIUM; METAMUCIL REGULAR; TURMERIC [CURCUMA LONGA RHIZOME]; HYDROCORTISONE

Current Illness:

ID: 1543452
Sex: F
Age:
State: NY

Vax Date: 01/06/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
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: Headache; Sore at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1543453
Sex: F
Age: 66
State: TX

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
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: Hot arm; Diarrhea; Arm swollen; Red arm; Threw up; High fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot arm), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE ERYTHEMA (Red arm) and VOMITING (Threw up) in a 66-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 information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot arm), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE ERYTHEMA (Red arm), VOMITING (Threw up), PYREXIA (High fever) and CHILLS (Chills). At the time of the report, VACCINATION SITE WARMTH (Hot arm), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE ERYTHEMA (Red arm), VOMITING (Threw up), PYREXIA (High fever) and CHILLS (Chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment and concomitant medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1543454
Sex: F
Age: 74
State: VA

Vax Date: 01/12/2021
Onset Date: 01/20/2021
Rec V Date: 08/11/2021
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: Injection site was welty; the injection site was welty but now it's flat and warm to the touch; Arm got red; It hurts a little bit; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (the injection site was welty but now it's flat and warm to the touch), VACCINATION SITE ERYTHEMA (Arm got red), VACCINATION SITE PAIN (It hurts a little bit) and VACCINATION SITE URTICARIA (Injection site was welty) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE WARMTH (the injection site was welty but now it's flat and warm to the touch), VACCINATION SITE ERYTHEMA (Arm got red) and VACCINATION SITE PAIN (It hurts a little bit). On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Injection site was welty). On 20-Jan-2021, VACCINATION SITE URTICARIA (Injection site was welty) had resolved. At the time of the report, VACCINATION SITE WARMTH (the injection site was welty but now it's flat and warm to the touch), VACCINATION SITE ERYTHEMA (Arm got red) and VACCINATION SITE PAIN (It hurts a little bit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment and concomitant medications were not provided by reporter. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up received on 14-Apr-2021 included no new information. The patient denied consent for further follow-up.

Other Meds:

Current Illness:

ID: 1543455
Sex: F
Age: 61
State: MO

Vax Date: 02/12/2021
Onset Date: 02/21/2021
Rec V Date: 08/11/2021
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: Itchiness; Redness as well as bruise at injection site; It is inflamed, 1 1/2 inch below the shot; Redness as well as bruise at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS (It is inflamed, 1 1/2 inch below the shot), VACCINATION SITE BRUISING (Redness as well as bruise at the injection site), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Redness as well as bruise at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The patient's past medical history included Eczema. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), VITAMINS NOS and WHITE SOFT PARAFFIN (AQUAPHOR [WHITE SOFT PARAFFIN]) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced DERMATITIS (It is inflamed, 1 1/2 inch below the shot), VACCINATION SITE BRUISING (Redness as well as bruise at the injection site) and VACCINATION SITE ERYTHEMA (Redness as well as bruise at injection site). On 21-Feb-2021 at 2:00 AM, the patient experienced VACCINATION SITE PRURITUS (Itchiness). The patient was treated with HYDROCORTISONE (CORTAID [HYDROCORTISONE]) in February 2021 at an unspecified dose and frequency. At the time of the report, DERMATITIS (It is inflamed, 1 1/2 inch below the shot), VACCINATION SITE BRUISING (Redness as well as bruise at the injection site), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Redness as well as bruise at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products included Lubber derma for an unknown indication.

Other Meds: PEPCID [FAMOTIDINE]; VITAMINS NOS; AQUAPHOR [WHITE SOFT PARAFFIN]

Current Illness:

ID: 1543456
Sex: F
Age: 85
State:

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
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: coughing; tender arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (tender arm) and COUGH (coughing) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), OMEPRAZOLE, LEVOTHYROXINE SODIUM (LEVOTIROXIN), TOLTERODINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (tender arm). On 14-Feb-2021, the patient experienced COUGH (coughing). At the time of the report, PAIN IN EXTREMITY (tender arm) and COUGH (coughing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: positive (Positive) positive. On 27-Feb-2021, SARS-CoV-2 antibody test: negative (Negative) negative- she had no immunity. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 21Jan2021 the patient tested positive to COVID-19. On 25Jan2021 the patient was in ER, she was eligible for antibodies and got them on 27Feb2021. She received the clearance from a doctor to discontinue the isolation. Tx: Antibodies On 18Feb2021 the patient went to take her second shot which was denied as "she had no immunity" and that she "had to wait 90 days from the antibodies. It was reported that patient had a schedule for a stomach procedure. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: email address updated

Other Meds: LIPITOR; BABY ASPIRIN; OMEPRAZOLE; LEVOTIROXIN; TOLTERODINE; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1543457
Sex: F
Age: 67
State: CA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/11/2021
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: sore arm; injection site started to get rash; Redness; Bumpy; Mild headache; It was sore for 1st 2 days of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE RASH (injection site started to get rash), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Bumpy) and VACCINATION SITE PAIN (It was sore for 1st 2 days of injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (It was sore for 1st 2 days of injection). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE RASH (injection site started to get rash), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Bumpy) and HEADACHE (Mild headache). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE RASH (injection site started to get rash), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Bumpy), VACCINATION SITE PAIN (It was sore for 1st 2 days of injection) and HEADACHE (Mild headache) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No relevant concomitant medications were provided. Reportedly, it was sore (at injection site) for first 2 days of injection as well but then again it started getting red, bumpy, mild headache, sore from 19-Feb-2021. No treatment was taken by the patient for the symptoms. The patient's 2nd shot scheduled on 05 Mar 2021. Lot number: 012M20A.

Other Meds:

Current Illness:

ID: 1543458
Sex: M
Age: 69
State: VA

Vax Date: 02/10/2021
Onset Date: 02/17/2021
Rec V Date: 08/11/2021
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: Red Circle around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red Circle around the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red Circle around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red Circle around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment and concomitant medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1543459
Sex: F
Age:
State: FL

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/11/2021
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: Left arm became itchy/arm itches like crazy; left arm bright red; swollen at the injection site; vaccination site warmth; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE PRURITUS (Left arm became itchy/arm itches like crazy), VACCINATION SITE ERYTHEMA (left arm bright red), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE WARMTH (vaccination site warmth) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient's past medical history included Hypertension. Concomitant products included SPIRONOLACTONE (SPIRONOLACTONE A L), OLMESARTAN MEDOXOMIL (OLMESARTAN [OLMESARTAN MEDOXOMIL]) and BUPROPION HYDROCHLORIDE (BUPROPION BETA) for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Left arm became itchy/arm itches like crazy), VACCINATION SITE ERYTHEMA (left arm bright red), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE WARMTH (vaccination site warmth). At the time of the report, VACCINATION SITE PAIN (sore arm) had resolved and VACCINATION SITE PRURITUS (Left arm became itchy/arm itches like crazy), VACCINATION SITE ERYTHEMA (left arm bright red), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE WARMTH (vaccination site warmth) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not provided by reporter. Reporter did not allow further contact

Other Meds: SPIRONOLACTONE A L; OLMESARTAN [OLMESARTAN MEDOXOMIL]; BUPROPION BETA

Current Illness:

ID: 1543460
Sex: M
Age: 31
State:

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 08/11/2021
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: cough; Nausea; Headache; Fatigue; Sore throat; A spontaneous report, was received from a health care professional concerning a 33Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events list. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21/01/2020, prior to the onset of the events, the patient received their first dose of mRNA-1273 intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 21/01/2020, The patient experienced the events list nausea, headache with non-serious. on 22/01/2020, the patient experienced the events like sore throat, cough, fatigue, body ache but not too much with are non serious. no treatment provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was not provided.

Other Meds:

Current Illness:

ID: 1543461
Sex: F
Age: 78
State: FL

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
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: Leg pain; nerve pain on the left foot; A spontaneous report was received from a consumer concerning a female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced leg pain and nerve pain on the left foot. The patient's medical history was reported as history of Lyme disease. Patient is also asthmatic and has COPD. No relevant concomitant medications were reported. On 12-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 13-JAN-2021, one day after the dose of injection, the patient experienced leg pain and nerve pain on the left foot. No Laboratory details provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events leg pain and nerve pain on the left foot was Unknown.

Other Meds:

Current Illness:

ID: 1543462
Sex: F
Age: 89
State: CT

Vax Date: 01/20/2021
Onset Date: 01/22/2021
Rec V Date: 08/11/2021
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: Stomach pain / sharp pain in the stomach; A spontaneous report was received from a consumer concerning a 89-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stomach pain / sharp pain in the stomach. The patient medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273, intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient experienced Stomach pain/sharp pain in the stomach. Treatment for the event included Stomach-Aid. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event stomach pain/sharp pain in the stomach was not resolved.; Reporter's Comments: This case concerns a 89 year old female patient, who experienced a unexpected event of stomach pain, 4 days after receiving first dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1543463
Sex: M
Age: 73
State: TX

Vax Date: 01/09/2021
Onset Date: 01/10/2021
Rec V Date: 08/11/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included Heart disease, unspecified. Concurrent medical conditions included Diabetes. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided No Treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1543464
Sex: M
Age: 67
State: FL

Vax Date: 01/16/2021
Onset Date: 01/17/2021
Rec V Date: 08/11/2021
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: abdominal cramping; pain radiating to lower back; constipation; soreness at the injection; A spontaneous report was received from a consumer concerning that 67 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced abdominal cramping and pain radiating to lower back and has constipation, soreness at the injection site. The patient's past medical history as provided by the reporter includes Knee surgery and shoulder surgery and does not have any allergies and concomitant medication. On 16 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch No- 0273-99) intramuscularly on the left upper arm for prophylaxis of COVID-19 infection. On 17 Jan 2021, patient experienced abdominal cramping and pain radiating to lower back. Has constipation. Has soreness at the injection site and no treatment taken for events. No laboratory details provided. Action taken with mRNA-1273 in response to the events was not reported. Outcome of the events are unknown.; 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:

ID: 1543465
Sex: M
Age: 73
State: TX

Vax Date: 01/09/2021
Onset Date: 01/10/2021
Rec V Date: 08/11/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. Concurrent medical conditions included Heart disease, unspecified and Diabetes. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Treatment medication was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Diabetes; Heart disease, unspecified

ID: 1543466
Sex: F
Age: 76
State: CT

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/11/2021
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: little soreness at the injection site; little swelling like a little knot that went little down; A spontaneous report was received from a consumer ? female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash . Patient stated that she got Moderna Covid-19 vaccine yesterday. She got little soreness and little swelling like a little knot that went little down. She took Tylenol after getting the vaccine this morning. She experienced symptoms events soreness at the vaccine site. The patient's medical history and concominant medication was not provided,. Action taken with mRNA-1273 in response to the events was not reported.

Other Meds:

Current Illness:

ID: 1543467
Sex: F
Age: 44
State: CT

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 08/11/2021
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: Injection site on my left deltoid region is red; Injection site circular with defined borders; injection site painful; A spontaneous report was received from a consumer/physician/nurse/pharmacist/healthcare facility staff member/literature article concerning a 44 years old, female patient who experienced injection site redness (vaccination site erythema), Injection site circular with defined borders (injection site urticaria), injection site painful(vaccination site painful). The patient's medical history included rheumatoid arthritis. Products known to have been used by the patient, within two weeks prior to the event, included biologic. The patient's medication allergies included doxycycline and bactrim. On 08-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09-Jan-2021, patients experienced injection site redness, Injection site circular with defined borders, injection site painful. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the events were considered not resolve/not recovered.

Other Meds:

Current Illness: Drug allergy

ID: 1543468
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
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: brain fog; lethargy; nausea; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), LETHARGY (lethargy), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Pt was hospitalized for COVID in October of 2020.) in October 2020. 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 FEELING ABNORMAL (brain fog), LETHARGY (lethargy), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (brain fog), LETHARGY (lethargy), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications was reported No treatment information was provided Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: TCR Was received on 21-JUL-2021 Does not contains any new information

Other Meds:

Current Illness:

ID: 1543469
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
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: tingling in arm; Falling sleep; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in arm) and SOMNOLENCE (Falling sleep) 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 PARAESTHESIA (tingling in arm) and SOMNOLENCE (Falling sleep). At the time of the report, PARAESTHESIA (tingling in arm) and SOMNOLENCE (Falling sleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. The reporter did not allow further contact.

Other Meds:

Current Illness:

ID: 1543470
Sex: F
Age: 69
State: MD

Vax Date: 01/04/2021
Onset Date: 01/09/2021
Rec V Date: 08/11/2021
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: local reaction; one and a half by two inches, raised; erythematous/arm is still red where delayed reaction occurred; intensely pruritic; painful, tender; palpable; started to feel the axillary node on the injection side; A spontaneous report was received from a physician concerning a 69 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic. Medical history was not provided. Concomitant medication was not provided. On 04-Jan-2021, prior to the onset of the events started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 300042721) via intramuscular route in left arm for prophylaxis of COVID-19 infection. On 09-Jan-2021, the patient experienced started to feel the axillary node on the injection side, painful and on 10-Jan-2021 experienced painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic. Laboratory details was not reported. Treatment medication included Benadryl and hydrocortisone at an unknown dose and frequency via an unknown route. Action taken with mRNA-1273 in response to the events started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic was not provided. The outcome of the events started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, , intensely pruritic was recovered on 16-Feb-2021 and the outcome of the event erythematous/arm is still red where delayed reaction occurred was not recovered. The reporter did not provide the assessment of the events started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic to study drug.

Other Meds:

Current Illness:

ID: 1543471
Sex: F
Age: 66
State:

Vax Date: 01/16/2021
Onset Date:
Rec V Date: 08/11/2021
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: Back pain; Legs pain; Swelling of the lymph nodes through all her body; Extremely exhausted; Headache; Dizzy; Nausea; Felt really sick; Teeth hurts; Face swelling; Fast heartbeat rate; Freaking out; A spontaneous report was received from a consumer concerning a 67 years of age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and patient experienced extremely exhausted, very tired, headache, dizzy, nausea and couldn't open her eyes after sleep, lymph nodes swelling everywhere and felt her nodes with her hand, Arm pain, tenderness not terrific, extraordinary pain in back and in legs. Teeth hurts, fast heartbeat rate, face swelling. The patient's medical history were not provided. Concomitant medications Tylenol for symptoms were reported. On 16 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection. On unknown date , prior to receiving mRNA-1273, the patient experienced extremely exhausted, very tired, headache and dizzy, nausea two hours after received vaccine. Patient slept for about 2 hours and then she couldn't open her eyes and had lymph nodes were swelling every where. The patient felt really sick. She had arm pain, tenderness not terrific. That night patient tried to sleep but she has an extraordinary pain in her back and legs. Patient could feel her nodes with the hand, teeth hurts, face swelling and fast heartbeat rate. For 3 days she was freaking out. No Treatment for the events were reported. No Laboratory details were provided. Action taken with mRNA-1273 in response to the events was not reported. The events, extremely exhausted, very tired, headache, dizzy, nausea and couldn't open her eyes after sleep, lymph nodes swelling everywhere and felt her nodes with her hand, Arm pain, tenderness not terrific, extraordinary pain in back and in legs. Teeth hurts, fast heartbeat rate, face swelling were considered as unknown.; 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:

Current Illness:

ID: 1543472
Sex: F
Age: 61
State:

Vax Date: 01/07/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
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: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (hot extremely itchy), VACCINATION SITE PRURITUS (red, hot, raised, extremely itchy red "spot/circle" at the injection site), VACCINATION SITE SWELLING (puffy and swollen) and VACCINATION SITE ERYTHEMA (Red mark on right arm, red, hot, raised, extremely itchy red "spot/circle" at the injection site.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The patient's past medical history included Skin rash. Concurrent medical conditions included Drug allergy (Sulfur medications) and Seasonal allergy (Hay fever allergies). Concomitant products included MULTIVITAMINS [VITAMINS NOS], ASPIRIN [ACETYLSALICYLIC ACID] and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM SUPPLEMENT WITH VITAMIN D) for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot extremely itchy), VACCINATION SITE PRURITUS (red, hot, raised, extremely itchy red "spot/circle" at the injection site) and VACCINATION SITE ERYTHEMA (Red mark on right arm, red, hot, raised, extremely itchy red "spot/circle" at the injection site.). On 17-Jan-2021, the patient experienced VACCINATION SITE SWELLING (puffy and swollen). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot extremely itchy), VACCINATION SITE PRURITUS (red, hot, raised, extremely itchy red "spot/circle" at the injection site), VACCINATION SITE SWELLING (puffy and swollen) and VACCINATION SITE ERYTHEMA (Red mark on right arm, red, hot, raised, extremely itchy red "spot/circle" at the injection site.) had resolved. Second event after second shot: 3 days later woke up with red, hot, reased and not as itchy red "spot" not as defined a circle as the first one. Took Bendaryl and iced it as needed for about 3 days. It eventually went away in about 2 weeks. (could still see a shadow of the "spot" wasn't hot, or raised or itchy. This case was linked to MOD-2021-089784 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Event details updated, patient details updated, concomitant medication list updated. On 28-Apr-2021: patient date of birth and phone number details was provided in TCR.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; ASPIRIN [ACETYLSALICYLIC ACID]; CALCIUM SUPPLEMENT WITH VITAMIN D

Current Illness: Drug allergy (Sulfur medications); Seasonal allergy (Hay fever allergies)

ID: 1543473
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
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: he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID; he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) and ADVERSE EVENT FOLLOWING IMMUNISATION (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included SARS-CoV-2 infection. 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 COVID-19 (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) and ADVERSE EVENT FOLLOWING IMMUNISATION (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID). At the time of the report, COVID-19 (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) and ADVERSE EVENT FOLLOWING IMMUNISATION (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided No Treatment information provided; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1543474
Sex: F
Age:
State: NY

Vax Date: 12/30/2020
Onset Date: 01/05/2021
Rec V Date: 08/11/2021
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: mild delayed inflammatory response; lumps in lips; A spontaneous report was received from other health care professional, via letter, concerning an unknown age female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced delayed inflammatory response (inflammation) and lumps on lips (lip swelling). The patient's medical history was not provided. History of application of lip filler (1 milliliter of Restylane kysse) to upper and lower lips on 08-Dec-2020. No relevant concomitant medications were reported. On 30-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly on left arm for prophylaxis of COVID-19 infection. On 05-Jan-2021, 6 days post vaccination, per HCP the patient had mild delayed inflammatory response and lumps in lips. Treatment included Medrol pack and antihistamine for the reported events. No laboratory data was provided. Action taken with mRNA-1273 in response to the event delayed inflammatory response (inflammation) and lumps on lips (lip swelling) was not provided. The outcome of the delayed inflammatory response (inflammation) and lumps on lips (lip swelling) was not recovered/not resolved. No concomitant medications were reported. No treatment related information has been reported.

Other Meds: RESTYLANE

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm