VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

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

Incidents per State

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

ID: 1544276
Sex: F
Age: 55
State: CT

Vax Date: 01/15/2021
Onset Date: 01/15/2021
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: Headache, feel stabbing pains in my head; Pressure and burning in head; Pressure and burning in head; feels like my brain has the chills; my brain feels like it's shaking in my head; Arm sore at injection site; Termperature 99.9 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Pressure and burning in head), BURNING SENSATION (Pressure and burning in head), COLD-STIMULUS HEADACHE (feels like my brain has the chills), NERVOUSNESS (my brain feels like it's shaking in my head) and VACCINATION SITE PAIN (Arm sore at injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0132L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HEAD DISCOMFORT (Pressure and burning in head), BURNING SENSATION (Pressure and burning in head), COLD-STIMULUS HEADACHE (feels like my brain has the chills), NERVOUSNESS (my brain feels like it's shaking in my head), VACCINATION SITE PAIN (Arm sore at injection site) and PYREXIA (Termperature 99.9 degrees F). On 16-Jan-2021, the patient experienced HEADACHE (Headache, feel stabbing pains in my head). At the time of the report, HEAD DISCOMFORT (Pressure and burning in head), BURNING SENSATION (Pressure and burning in head), COLD-STIMULUS HEADACHE (feels like my brain has the chills), NERVOUSNESS (my brain feels like it's shaking in my head), VACCINATION SITE PAIN (Arm sore at injection site), PYREXIA (Termperature 99.9 degrees F) and HEADACHE (Headache, feel stabbing pains in my head) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: other (High) 99.9 degree Fahrenheit. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1544277
Sex: F
Age: 19
State: MI

Vax Date: 01/25/2021
Onset Date: 02/01/2021
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: itchiness; rashes on both arms and Palms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and RASH (rashes on both arms and Palms) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced RASH (rashes on both arms and Palms). On an unknown date, the patient experienced PRURITUS (itchiness). At the time of the report, PRURITUS (itchiness) had not resolved and RASH (rashes on both arms and Palms) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: LEVOTHYROXINE

Current Illness: Hypothyroidism

ID: 1544278
Sex: M
Age: 50
State: NY

Vax Date: 01/23/2021
Onset Date: 01/23/2021
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: Shortness of breath; Felt like someone was choking his throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and CHOKING SENSATION (Felt like someone was choking his throat) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath) and CHOKING SENSATION (Felt like someone was choking his throat). On 23-Jan-2021, DYSPNOEA (Shortness of breath) and CHOKING SENSATION (Felt like someone was choking his throat) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1544279
Sex: F
Age: 57
State: NC

Vax Date: 12/30/2020
Onset Date: 12/31/2020
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: scarring from hives; still has a raised welt on her right cheek; fatigue returned; have the J&J vaccine; Spot on her face, rash on the face; Face hot to the touch; Hives on the right side of her face; swelling under eyes; itching on the face; asthma flare ups; rash on the face; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on the right side of her face), PERIORBITAL SWELLING (swelling under eyes), PRURITUS (itching on the face), ASTHMA (asthma flare ups) and RASH (Spot on her face, rash on the face) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hashimoto's disease and Thyroiditis. Concurrent medical conditions included Asthma. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced FATIGUE (fatigue). On 03-Jan-2021, the patient experienced URTICARIA (Hives on the right side of her face), PERIORBITAL SWELLING (swelling under eyes), PRURITUS (itching on the face), ASTHMA (asthma flare ups) and RASH (rash on the face). On 10-Jan-2021, the patient experienced RASH (Spot on her face, rash on the face) and SKIN WARM (Face hot to the touch). On 09-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (have the J&J vaccine). On an unknown date, the patient experienced SCAR (scarring from hives), URTICARIA (still has a raised welt on her right cheek) and FATIGUE (fatigue returned). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) on 03-Jan-2021 at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL PM) on 03-Jan-2021 at an unspecified dose and frequency and LORATADINE (Claritin AM) on 03-Jan-2021 at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on the right side of her face), PERIORBITAL SWELLING (swelling under eyes), PRURITUS (itching on the face), ASTHMA (asthma flare ups), RASH (Spot on her face, rash on the face), SKIN WARM (Face hot to the touch), SCAR (scarring from hives), RASH (rash on the face), FATIGUE (fatigue returned) and FATIGUE (fatigue) had resolved, INTERCHANGE OF VACCINE PRODUCTS (have the J&J vaccine) outcome was unknown and URTICARIA (still has a raised welt on her right cheek) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No relevant concomitant medications were reported. The patient on 03JAN2021 the patient had started to experience hives on the right side of her face and swelling under the eyes, rash on the face, itching of the face, and Asthma flares ups. On 03JAN2021 the doctor gave her a Steroid shot, and prescription for Medrol Dose pack, Benadryl PM and Claritin AM. A week later on 10JAN2021 (after finishing Medrol Dose Pack) she had another flare of hives on both sides of the face, Rash on face hot to the touch and Asthma got worst. The doctor told her not to get the second shot. She still had Fatigue and a spot on her face. Patient has never used dermatological fillers. On 19-APR-2021, the patient reported that she had raised welt on her right cheek (it is not red). She also had some scarring from the hives. Her asthma is now back to baseline. The reaction with her face had resolved. The fatigue occurred right after the shot, went away, when she had the second reaction and went through the second dose of steroids, she had the fatigue return, but the fatigue resolved. She did have the J&J vaccine on 09/APR/2021 Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: adverse event and narrative information was updated.

Other Meds:

Current Illness: Asthma

ID: 1544280
Sex: F
Age: 78
State: PA

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: 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: her upper lip, mouth, tongue and throat got swollen; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA MOUTH (her upper lip, mouth, tongue and throat got swollen) and PERIPHERAL SWELLING (Swollen arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028120A) for COVID-19 vaccination. Concurrent medical conditions included Allergy. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced OEDEMA MOUTH (her upper lip, mouth, tongue and throat got swollen) and PERIPHERAL SWELLING (Swollen arm). On 04-Feb-2021, PERIPHERAL SWELLING (Swollen arm) had resolved. At the time of the report, OEDEMA MOUTH (her upper lip, mouth, tongue and throat got swollen) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by reporter No treatment medications provided by the reporter Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No specific follow-up information recorded.

Other Meds:

Current Illness: Allergy

ID: 1544281
Sex: M
Age: 77
State: LA

Vax Date: 01/22/2021
Onset Date: 02/11/2021
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: Heart was racing /pounding; Heart rate when up; WEAK; warm to touch; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was racing /pounding), HEART RATE INCREASED (Heart rate when up), ASTHENIA (WEAK), SKIN WARM (warm to touch) and CHILLS (Chills) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PALPITATIONS (Heart was racing /pounding), HEART RATE INCREASED (Heart rate when up), ASTHENIA (WEAK), SKIN WARM (warm to touch) and CHILLS (Chills). At the time of the report, PALPITATIONS (Heart was racing /pounding), HEART RATE INCREASED (Heart rate when up), ASTHENIA (WEAK), SKIN WARM (warm to touch) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood pressure measurement: 160 (Inconclusive) 160. On 22-Jan-2021, Heart rate: 118 (Inconclusive) 118. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included enlarged prostate, eyedrops for glaucoma and aspirin. Treatment details not reported by the reported.

Other Meds: ASPIRIN (E.C.)

Current Illness:

ID: 1544282
Sex: U
Age:
State: CA

Vax Date: 02/12/2021
Onset Date: 02/12/2021
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: Doses were administered from a vial with slight solid particles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT CONTAMINATION PHYSICAL (Doses were administered from a vial with slight solid particles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021 at 9:07 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRODUCT CONTAMINATION PHYSICAL (Doses were administered from a vial with slight solid particles). On 21-Feb-2021, PRODUCT CONTAMINATION PHYSICAL (Doses were administered from a vial with slight solid particles) 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. On 12 Feb 2021, six doses were administered from a vial with slight solid particulates was noted clinging to the side of the vial. Dosage administration was suspended from this vial and after the vial was rested for 20 minutes at room temperature, the particulate disappeared. No concomitant medication were provided. No treatment information were provided. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-Jul-2021 appended to AER, new reporter added, batch number and clinical course of the narrative was updated.

Other Meds:

Current Illness:

ID: 1544283
Sex: F
Age: 62
State: WA

Vax Date: 02/03/2021
Onset Date: 02/10/2021
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: Hives; Itchy; Raised; Red; Slouchy; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives), ASTHENIA (Slouchy), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Raised) and VACCINATION SITE ERYTHEMA (Red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Concomitant products included LOSARTAN for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Raised) and VACCINATION SITE ERYTHEMA (Red). On 11-Feb-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced ASTHENIA (Slouchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), ASTHENIA (Slouchy), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Raised) and VACCINATION SITE ERYTHEMA (Red) 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. Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No new information

Other Meds: LOSARTAN

Current Illness:

ID: 1544284
Sex: U
Age:
State:

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: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Pain spread down side of arm to elbow; Pain in up side of neck; Arm starting hurting focalized at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain spread down side of arm to elbow), NECK PAIN (Pain in up side of neck) and VACCINATION SITE PAIN (Arm starting hurting focalized at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No relevant medical history provided). 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 PAIN IN EXTREMITY (Pain spread down side of arm to elbow), NECK PAIN (Pain in up side of neck) and VACCINATION SITE PAIN (Arm starting hurting focalized at injection site). At the time of the report, PAIN IN EXTREMITY (Pain spread down side of arm to elbow), NECK PAIN (Pain in up side of neck) and VACCINATION SITE PAIN (Arm starting hurting focalized at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication details were not reported by the reporter. Treatment included ice and ibuprofen.

Other Meds:

Current Illness:

ID: 1544285
Sex: F
Age:
State:

Vax Date: 02/13/2021
Onset Date: 02/14/2021
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: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication details were not reported by the reporter. No treatment information provided.

Other Meds:

Current Illness:

ID: 1544286
Sex: F
Age: 64
State:

Vax Date: 02/12/2021
Onset Date: 02/12/2021
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: Could not hold urine; Lost 7 pounds; Vomited; Headache; felt fatigued; Chills; Muscle and joint pain; Muscle and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Could not hold urine), ABNORMAL LOSS OF WEIGHT (Lost 7 pounds), VOMITING (Vomited), HEADACHE (Headache) and FATIGUE (felt fatigued) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Acid reflux (esophageal) and Hypertension. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), CELECOXIB (CELEBREX), ATORVASTATIN, LOSARTAN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced URINARY INCONTINENCE (Could not hold urine), ABNORMAL LOSS OF WEIGHT (Lost 7 pounds), VOMITING (Vomited), HEADACHE (Headache), FATIGUE (felt fatigued), CHILLS (Chills), MYALGIA (Muscle and joint pain) and ARTHRALGIA (Muscle and joint pain). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 3 tablets every 3-4 hours. At the time of the report, URINARY INCONTINENCE (Could not hold urine), ABNORMAL LOSS OF WEIGHT (Lost 7 pounds), VOMITING (Vomited), HEADACHE (Headache), FATIGUE (felt fatigued), CHILLS (Chills), MYALGIA (Muscle and joint pain) and ARTHRALGIA (Muscle and joint pain) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds: OMEPRAZOLE; CELEBREX; ATORVASTATIN; LOSARTAN; ASPIRIN (E.C.)

Current Illness: Acid reflux (esophageal); Hypertension

ID: 1544287
Sex: F
Age: 76
State:

Vax Date: 02/05/2021
Onset Date: 02/13/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Sore throat; Intermittent Cough; Rash on injection site (the size of a half dollar); This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (Intermittent Cough) and INJECTION SITE RASH (Rash on injection site (the size of a half dollar)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. 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 13-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), COUGH (Intermittent Cough) and INJECTION SITE RASH (Rash on injection site (the size of a half dollar)). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), COUGH (Intermittent Cough) and INJECTION SITE RASH (Rash on injection site (the size of a half dollar)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1544288
Sex: U
Age:
State:

Vax Date: 01/07/2021
Onset Date: 01/07/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1544289
Sex: F
Age:
State: AZ

Vax Date: 02/09/2021
Onset Date: 02/09/2021
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: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Trouble breathing feels like crack ribs; Fever above 102; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing feels like crack ribs) and PYREXIA (Fever above 102) 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 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (Fever above 102). On an unknown date, the patient experienced DYSPNOEA (Trouble breathing feels like crack ribs). The patient was treated with PARACETAMOL (TYNELOL) ongoing from 09-Feb-2021 at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Trouble breathing feels like crack ribs) and PYREXIA (Fever above 102) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication details were not reported by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1544290
Sex: F
Age:
State: MD

Vax Date: 02/11/2021
Onset Date: 02/13/2021
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: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included BISACODYL (LAXATIVE [BISACODYL]) for Bowel movement irregularity. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details not reported by the reporter.

Other Meds: LAXATIVE [BISACODYL]

Current Illness:

ID: 1544291
Sex: F
Age: 76
State: CA

Vax Date: 01/26/2021
Onset Date: 01/28/2021
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: Sore throat; Face feels swollen and hot; face feels hot; Feverish and felt hot; so sick; very tired; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face feels swollen and hot), FEELING HOT (face feels hot), ILLNESS (so sick) and FATIGUE (very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ILLNESS (so sick) and FATIGUE (very tired). On 30-Jan-2021, the patient experienced SWELLING FACE (Face feels swollen and hot), FEELING HOT (face feels hot) and PYREXIA (Feverish and felt hot). On 31-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face feels swollen and hot), FEELING HOT (face feels hot) and PYREXIA (Feverish and felt hot) had not resolved and ILLNESS (so sick) and FATIGUE (very tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Body temperature: 98.4 normal. In February 2021, SARS-CoV-2 test: (Positive) one week later after vaccination got tested positive.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Caucasian is the race of the patient. No concomitant medications were reported No treatment drugs were reported Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: Additional initial document received on 17-FEB-2021 had added events like lab data

Other Meds:

Current Illness:

ID: 1544292
Sex: F
Age:
State:

Vax Date:
Onset Date:
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: Coworker experienced migraines; This spontaneous case was reported by a health care professional and describes the occurrence of MIGRAINE (Coworker experienced migraines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported by the reporter. 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 MIGRAINE (Coworker experienced migraines). At the time of the report, MIGRAINE (Coworker experienced migraines) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatments were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: TCR received and included information to confirm that reporter did not receive the Moderna vaccine and had only mentioned a coworker that received Moderna with an AE of migraine. Case updated to reflect this information.

Other Meds:

Current Illness:

ID: 1544293
Sex: M
Age: 62
State: PA

Vax Date: 01/20/2021
Onset Date: 01/22/2021
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: Was 200 lbs, but he went down to 181 lbs after getting covid; He got much sicker; This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (He got much sicker) and WEIGHT DECREASED (Was 200 lbs, but he went down to 181 lbs after getting covid) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced ILLNESS (He got much sicker). On an unknown date, the patient experienced WEIGHT DECREASED (Was 200 lbs, but he went down to 181 lbs after getting covid). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, ILLNESS (He got much sicker) had not resolved and WEIGHT DECREASED (Was 200 lbs, but he went down to 181 lbs after getting covid) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, COVID-19: positive (Positive) tested positive for covid. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. This case was linked to MOD-2021-014947 (Patient Link).

Other Meds:

Current Illness:

ID: 1544294
Sex: F
Age:
State: MO

Vax Date: 02/03/2021
Onset Date: 02/03/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red and swollen area at injection site) and VACCINATION SITE SWELLING (Red and swollen area at injection site) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red and swollen area at injection site) and VACCINATION SITE SWELLING (Red and swollen area at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red and swollen area at injection site) and VACCINATION SITE SWELLING (Red and swollen area at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication details were not reported by the reported. Treatment details not reported by the reporter.

Other Meds:

Current Illness:

ID: 1544295
Sex: F
Age: 29
State: NE

Vax Date: 01/07/2021
Onset Date:
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: 1 week pregnant/ 5 weeks pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (1 week pregnant/ 5 weeks pregnant) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination. The patient's past medical history included Alcohol use (Prior history of alcohol use ocassionally). Concomitant products included PARACETAMOL (TYLENOL) for Pain, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 29-Dec-2020 and the estimated date of delivery was 05-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (1 week pregnant/ 5 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fifth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (1 week pregnant/ 5 weeks pregnant) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Ultrasound scan: (normal) Normal Pregnancy. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment details was not reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Pregnancy details updated.

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

Current Illness:

ID: 1544296
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
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: swollen eye; fever; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (swollen eye) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 EYE SWELLING (swollen eye) and PYREXIA (fever). At the time of the report, EYE SWELLING (swollen eye) and PYREXIA (fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not provided. As per source document, a follow-up conducted with consumer on 06-Jul-21, the outcome of all adverse events reported had been resolved. Reporter did not allow further contact: Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant information received, outcome of the events updated and patient denied for further follow up.

Other Meds:

Current Illness:

ID: 1544297
Sex: F
Age:
State: CA

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: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitants products were reported. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: TCR- received on 24-apr-2021. Outcome of the event updated from unknown to not recovered/not resolved.

Other Meds:

Current Illness:

ID: 1544298
Sex: U
Age:
State: PR

Vax Date: 01/15/2021
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: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: cough; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and NASAL CONGESTION (nasal congestion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030620A) for COVID-19 vaccination. No Medical History information was reported. On 15-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 COUGH (cough) and NASAL CONGESTION (nasal congestion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 26-Jan-2021, COUGH (cough) and NASAL CONGESTION (nasal congestion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, COVID-19: Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment details included Acetamide Fen, Tylenol, Advil Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1544299
Sex: F
Age:
State: NY

Vax Date: 01/20/2021
Onset Date: 01/20/2021
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: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. The patient's last menstrual period was on 05-Jan-2021 and the estimated date of delivery was 06-Oct-2021. On 20-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the second week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1544300
Sex: F
Age: 70
State: GA

Vax Date: 01/18/2021
Onset Date: 01/19/2021
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: felt like she was "going to pass-out"; heart palpitations; nauseous; fever (about 100 degrees); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt like she was "going to pass-out"), PALPITATIONS (heart palpitations), NAUSEA (nauseous) and PYREXIA (fever (about 100 degrees)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Macular degeneration. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced DIZZINESS (felt like she was "going to pass-out"), PALPITATIONS (heart palpitations), NAUSEA (nauseous) and PYREXIA (fever (about 100 degrees)). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (felt like she was "going to pass-out"), PALPITATIONS (heart palpitations), NAUSEA (nauseous) and PYREXIA (fever (about 100 degrees)) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness: Macular degeneration

ID: 1544301
Sex: F
Age: 33
State: CA

Vax Date: 12/23/2020
Onset Date: 01/01/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Covid-19; shortness of breath; headache; flu-like symptoms; body aches; fever of 101; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DYSPNOEA (shortness of breath), COVID-19 (Covid-19), MYALGIA (body aches) and PYREXIA (fever of 101) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (body aches), PYREXIA (fever of 101) and CHILLS (chills). On 10-Feb-2021, the patient experienced DYSPNOEA (shortness of breath) and HEADACHE (headache). On 11-Feb-2021, the patient experienced COVID-19 (Covid-19). On 02-Jan-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (body aches), PYREXIA (fever of 101) and CHILLS (chills) had resolved. At the time of the report, DYSPNOEA (shortness of breath), COVID-19 (Covid-19) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medication reported. Patient took Tylenol and Ibuprofen for treatment.

Other Meds:

Current Illness:

ID: 1544302
Sex: F
Age: 61
State: NH

Vax Date: 12/29/2020
Onset Date: 12/30/2020
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: hot flashes; palpitations; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations) and HOT FLUSH (hot flashes) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039KorR0A and 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Sulfa), Drug allergy (TRAZADONE), Food allergy (GLUTEN & DAIRY SENSITIVE) and Allergy to animal (CATS). Concomitant products included CALCIUM for Osteopenia, VITAMIN D [VITAMIN D NOS], VITAMIN E [VITAMIN E NOS], MULTIVITAMIN [VITAMINS NOS] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced PALPITATIONS (palpitations). On an unknown date, the patient experienced HOT FLUSH (hot flashes). At the time of the report, PALPITATIONS (palpitations) and HOT FLUSH (hot flashes) had not resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test negative: negative (Negative) Covid-19 test-Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had post menopausal for over 17 years. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Moderna ADR form

Other Meds: CALCIUM; VITAMIN D [VITAMIN D NOS]; VITAMIN E [VITAMIN E NOS]; MULTIVITAMIN [VITAMINS NOS]; BABY ASPIRIN

Current Illness: Allergy to animal (CATS); Drug allergy (TRAZADONE); Drug allergy (Sulfa); Food allergy (GLUTEN & DAIRY SENSITIVE)

ID: 1544303
Sex: F
Age: 67
State: FL

Vax Date: 02/14/2021
Onset Date: 02/14/2021
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: back pain; pain at injection site; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), INJECTION SITE PAIN (pain at injection site) and HEADACHE (slight headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Allergy to diclofenac reported.). On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced BACK PAIN (back pain), INJECTION SITE PAIN (pain at injection site) and HEADACHE (slight headache). At the time of the report, BACK PAIN (back pain), INJECTION SITE PAIN (pain at injection site) and HEADACHE (slight headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatments were reported. This case was linked to MOD-2021-068634 (Patient Link).

Other Meds:

Current Illness: Drug allergy (Allergy to diclofenac reported.)

ID: 1544304
Sex: F
Age: 32
State: FL

Vax Date: 02/09/2021
Onset Date: 02/10/2021
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: Generalize itching (face and scalp); anorexia; nausea; mild headache; fatigue; insomnia; numbness on legs; Throat swollen up; This spontaneous case was reported by a physician and describes the occurrence of PHARYNGEAL SWELLING (Throat swollen up), PRURITUS (Generalize itching (face and scalp)), DECREASED APPETITE (anorexia), NAUSEA (nausea) and HEADACHE (mild headache) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHARYNGEAL SWELLING (Throat swollen up). On 11-Feb-2021, the patient experienced DECREASED APPETITE (anorexia), NAUSEA (nausea), HEADACHE (mild headache), FATIGUE (fatigue), INSOMNIA (insomnia) and HYPOAESTHESIA (numbness on legs). On 15-Feb-2021, the patient experienced PRURITUS (Generalize itching (face and scalp)). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form; PEPTIDE LOPHE at a dose of UNK dosage form and MULTIVITAMINS & MINERALS PLUS LUTEIN at a dose of UNK dosage form. At the time of the report, PHARYNGEAL SWELLING (Throat swollen up), PRURITUS (Generalize itching (face and scalp)), DECREASED APPETITE (anorexia), NAUSEA (nausea), HEADACHE (mild headache), FATIGUE (fatigue), INSOMNIA (insomnia) and HYPOAESTHESIA (numbness on legs) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1544305
Sex: F
Age: 58
State: CA

Vax Date: 02/11/2021
Onset Date: 02/11/2021
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: fever; Lips like has botox/both lips/Swollen lips; Little headache; Little pain in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Little pain in the arm), LIP SWELLING (Lips like has botox/both lips/Swollen lips), HEADACHE (Little headache) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Allergy to tetracycline.). On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Little pain in the arm) and HEADACHE (Little headache). On 13-Feb-2021, the patient experienced LIP SWELLING (Lips like has botox/both lips like Miss Pinky/Swollen lips). On 14-Feb-2021, the patient experienced PYREXIA (fever). The patient was treated with ACETAMINOPHEN for Fever, at a dose of UNK dosage form; LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date at a dose of UNK, q12h and ACETAMINOPHEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Little pain in the arm), HEADACHE (Little headache) and PYREXIA (fever) outcome was unknown and LIP SWELLING (Lips like has botox/both lips like Miss Pinky/Swollen lips) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 102.4 (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication include Vitamins. Treatment information included popsicles.

Other Meds:

Current Illness: Allergy to antibiotic (Allergy to tetracycline.)

ID: 1544306
Sex: F
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/22/2021
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: didn't feel good; felt run down - feels tired, need to take nap; Headache; Achy; had low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel good), FATIGUE (felt run down - feels tired, need to take nap), PYREXIA (had low grade fever), HEADACHE (Headache) and MYALGIA (Achy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Thyroid operation (She undergone procedure 4 months ago, still having thyroid problems and taking medication for it.). On 22-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 PYREXIA (had low grade fever). On an unknown date, the patient experienced MALAISE (didn't feel good), FATIGUE (felt run down - feels tired, need to take nap), HEADACHE (Headache) and MYALGIA (Achy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 26-Jan-2021, PYREXIA (had low grade fever) had resolved. At the time of the report, MALAISE (didn't feel good), FATIGUE (felt run down - feels tired, need to take nap), HEADACHE (Headache) and MYALGIA (Achy) 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. No concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up information received on 12-JUN-2021 and contains no new information.

Other Meds:

Current Illness:

ID: 1544307
Sex: F
Age: 35
State: KS

Vax Date: 01/20/2021
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: LA

Lab Data:

Allergies:

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

Symptoms: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 030L20A) for COVID-19 vaccination. The patient's past medical history included Spontaneous abortion on 02-Jan-2017, Spontaneous abortion on 12-Jun-2017 and Pregnancy on 12-Jun-2018. Concurrent medical conditions included Drug allergy (Morphine). On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 15-May-2020 and the estimated date of delivery was 06-Mar-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the thirty-ninth week of the pregnancy. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2020, Pregnancy test: positive (Positive) Positive. On 10-Jul-2020, Ultrasound scan: normal (normal) normal. On 10-Oct-2020, Ultrasound scan: normal (normal) normal. On 02-Feb-2021, Ultrasound scan: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications reported. No treatment information was provided. Action taken with mRNA-123 is not applicable. The patient's estimated date of conception was reported as 01-JUN-2020.

Other Meds:

Current Illness: Drug allergy (Morphine)

ID: 1544308
Sex: F
Age: 81
State: NY

Vax Date: 01/11/2021
Onset Date: 01/16/2021
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: arm got red, had a little heat; arm got red, had a little heat; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (arm got red, had a little heat) and INJECTION SITE WARMTH (arm got red, had a little heat) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient's past medical history included Breast cancer (history of breast cancer 20 years ago) and Lymph node excision (lymph nodes removed 20 years ago). On 11-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 INJECTION SITE ERYTHEMA (arm got red, had a little heat) and INJECTION SITE WARMTH (arm got red, had a little heat). At the time of the report, INJECTION SITE ERYTHEMA (arm got red, had a little heat) and INJECTION SITE WARMTH (arm got red, had a little heat) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1544309
Sex: M
Age:
State: NJ

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: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: COVID-19; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (CITRAMAX FORTE) for COVID-19, at a dose of UNK dosage form; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for COVID-19, at a dose of UNK dosage form and ANTIBIOTICS for COVID-19, at a dose of UNK dosage form. At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications reported. Patient was treated with isolation as well. This case was linked to US-MODERNATX, INC.-MOD-2021-065849, US-MODERNATX, INC.-MOD-2021-014845 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-065849:Reporter's co-worker wife case (female patient) US-MODERNATX, INC.-MOD-2021-014845:Reporter's case, female patient

Other Meds:

Current Illness:

ID: 1544310
Sex: M
Age:
State: AL

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: Erythema, Pruritus

Symptoms: extreme fatigue; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (extreme fatigue) and HEADACHE (headache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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 FATIGUE (extreme fatigue) and HEADACHE (headache). At the time of the report, FATIGUE (extreme fatigue) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. The patient spoke to the physician and everything was fine and it was taken care of. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information

Other Meds:

Current Illness:

ID: 1544311
Sex: F
Age: 53
State: FL

Vax Date: 01/26/2021
Onset Date: 01/27/2021
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: facial redness; injection site warmth; tenderness; swelling; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (facial redness), INJECTION SITE WARMTH (injection site warmth), INJECTION SITE PAIN (tenderness) and INJECTION SITE SWELLING (swelling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included HYALURONIC ACID, LIDOCAINE (RESTYLANE L) from 11-Jan-2021 to an unknown date for Skin cosmetic procedure. On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ERYTHEMA (facial redness). 27-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site warmth), INJECTION SITE PAIN (tenderness) and INJECTION SITE SWELLING (swelling). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency. On 01-Feb-2021, ERYTHEMA (facial redness), INJECTION SITE WARMTH (injection site warmth), INJECTION SITE PAIN (tenderness) and INJECTION SITE SWELLING (swelling) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds: RESTYLANE L

Current Illness:

ID: 1544312
Sex: F
Age: 67
State: NY

Vax Date: 01/15/2021
Onset Date: 01/16/2021
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: stomach sick; nausea; left arm hurting; corporal temperature of 99.6F; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurting), BODY TEMPERATURE INCREASED (corporal temperature of 99.6F), ABDOMINAL DISCOMFORT (stomach sick) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L2OA) for COVID-19 vaccination. No Medical History information was reported. On 15-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 PAIN IN EXTREMITY (left arm hurting) and BODY TEMPERATURE INCREASED (corporal temperature of 99.6F). On 17-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach sick) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) 16-Jan-2021 at a dose of UNK dosage form. On 17-Jan-2021, BODY TEMPERATURE INCREASED (corporal temperature of 99.6F) had resolved. On 18-Jan-2021, PAIN IN EXTREMITY (left arm hurting), ABDOMINAL DISCOMFORT (stomach sick) and NAUSEA (nausea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient takes blood pressure medication regularly.

Other Meds:

Current Illness:

ID: 1544313
Sex: F
Age: 72
State: MI

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: itchy rash at her lower legs; small patches at the bottom of both of her legs round her ankles; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash at her lower legs) and RASH (small patches at the bottom of both of her legs round her ankles) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and CALAMINE for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH PRURITIC (itchy rash at her lower legs) and RASH (small patches at the bottom of both of her legs round her ankles). At the time of the report, RASH PRURITIC (itchy rash at her lower legs) and RASH (small patches at the bottom of both of her legs round her ankles) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. The patient took Benadryl 2(diphenhydramine) 5mg, calamine topical to alleviate the symptoms.

Other Meds: BENADRYL 24 D; CALAMINE

Current Illness:

ID: 1544314
Sex: F
Age: 25
State: TX

Vax Date: 01/28/2021
Onset Date: 01/28/2021
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: sweating; Pain; Chills; Body ache; head ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PAIN (Pain), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (head ache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HYPERHIDROSIS (sweating), PAIN (Pain), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (head ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating), PAIN (Pain), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (head ache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: follow up received on 02-Mar-2021 included vaccine details has been updated.

Other Meds:

Current Illness:

ID: 1544315
Sex: F
Age: 55
State: TX

Vax Date: 12/30/2020
Onset Date:
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: Pain; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHILLS (Chills) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN (Pain), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. No treatment information for the events was provided. This case was linked to MOD21-13175, MOD21-13172 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: MOD21-13175:Crosslinked: Same reporter MOD21-13172:Crosslinked: Same reporter

Other Meds:

Current Illness:

ID: 1544316
Sex: F
Age: 77
State: AL

Vax Date: 01/28/2021
Onset Date: 01/28/2021
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: shaking all over; sick on stomach; arm extremely sore; chills; headache; so tired; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking all over), ABDOMINAL DISCOMFORT (sick on stomach), PAIN IN EXTREMITY (arm extremely sore), CHILLS (chills) and HEADACHE (headache) in a 77-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. The patient's past medical history included Blood pressure high and COVID-19. Concomitant products included POTASSIUM, CARVEDILOL, FUROSEMIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TELMISARTAN, DOXAZOSIN MESYLATE, CLONIDINE HCL, SIMVASTATIN, ASCORBIC ACID, ZINC SULFATE (VITAMIN C & ZINK) and VITAMIN D2 for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced TREMOR (shaking all over), ABDOMINAL DISCOMFORT (sick on stomach), PAIN IN EXTREMITY (arm extremely sore), CHILLS (chills), HEADACHE (headache), FATIGUE (so tired) and NAUSEA (nausea). At the time of the report, TREMOR (shaking all over), ABDOMINAL DISCOMFORT (sick on stomach), PAIN IN EXTREMITY (arm extremely sore), CHILLS (chills), HEADACHE (headache), FATIGUE (so tired) and NAUSEA (nausea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds: POTASSIUM; CARVEDILOL; FUROSEMIDE; ASPIRIN (E.C.); TELMISARTAN; DOXAZOSIN MESYLATE; CLONIDINE HCL; SIMVASTATIN; VITAMIN C & ZINK; VITAMIN D2

Current Illness:

ID: 1544317
Sex: F
Age: 80
State: PA

Vax Date: 01/13/2021
Onset Date: 01/23/2021
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: Redness at injection site; tenderness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (tenderness at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. Concomitant products included CANDESARTAN CILEXETIL (ATACAND), ATORVASTATIN CALCIUM (LIPITOR), NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PARACETAMOL (TYLENOL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (tenderness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved and VACCINATION SITE PAIN (tenderness at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided.

Other Meds: ATACAND; LIPITOR; EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]; ASPIRIN (E.C.); TYLENOL; SYNTHROID

Current Illness:

ID: 1544318
Sex: M
Age:
State: TX

Vax Date: 12/29/2020
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: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to MOD21-13007, MOD21-13175 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No specific follow-up information recorded.; Sender's Comments: MOD21-13007:Crosslinked: Same reporter MOD21-13175:Crosslinked: Same reporter

Other Meds:

Current Illness:

ID: 1544319
Sex: M
Age: 83
State: TX

Vax Date: 12/29/2020
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: Sore Arm; Rash; "His arm hurts a lot"; Potential Adverse Event because is a Special Population (Geriatric); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm), RASH (Rash), PAIN IN EXTREMITY ("His arm hurts a lot") and GERIATRIC ASSESSMENT (Potential Adverse Event because is a Special Population (Geriatric)) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Arm), RASH (Rash), PAIN IN EXTREMITY ("His arm hurts a lot") and GERIATRIC ASSESSMENT (Potential Adverse Event because is a Special Population (Geriatric)). At the time of the report, VACCINATION SITE PAIN (Sore Arm), RASH (Rash), PAIN IN EXTREMITY ("His arm hurts a lot") and GERIATRIC ASSESSMENT (Potential Adverse Event because is a Special Population (Geriatric)) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD21-13007, MOD21-13172 (E2B Linked Report).; Sender's Comments: MOD21-13007:Crosslinked: Same reporter MOD21-13172:Crosslinked: Same reporter

Other Meds:

Current Illness:

ID: 1544320
Sex: F
Age:
State: TN

Vax Date: 01/16/2021
Onset Date: 01/16/2021
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: severe headache; terrible stomach pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (terrible stomach pain), NAUSEA (nausea) and HEADACHE (severe headache) 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 16-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 ABDOMINAL PAIN UPPER (terrible stomach pain) and NAUSEA (nausea). On 17-Jan-2021, the patient experienced HEADACHE (severe headache). At the time of the report, ABDOMINAL PAIN UPPER (terrible stomach pain), NAUSEA (nausea) and HEADACHE (severe headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1544321
Sex: F
Age: 55
State:

Vax Date: 01/24/2021
Onset Date: 01/24/2021
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: not feeling myself; sore arm; bad headache; nausea; chills; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (bad headache), NAUSEA (nausea), CHILLS (chills) and PYREXIA (low grade fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (bad headache), NAUSEA (nausea), CHILLS (chills) and PYREXIA (low grade fever). On 26-Jan-2021, the patient experienced FEELING ABNORMAL (not feeling myself). On 26-Jan-2021, PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), CHILLS (chills) and PYREXIA (low grade fever) had resolved. At the time of the report, HEADACHE (bad headache) had not resolved and FEELING ABNORMAL (not feeling myself) 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 medication included Tylenol. But it was not working..

Other Meds:

Current Illness:

ID: 1544322
Sex: F
Age: 65
State: FL

Vax Date: 01/06/2021
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: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 036B21A) for COVID-19 vaccination. Concurrent medical conditions included Cholesterol and Hypertension since 2010. Concomitant products included CHLORTHALIDONE for Blood pressure, EZETIMIBE for Cholesterol, OMEPRAZOLE for Indigestion, VITAMIN D3 and CYANOCOBALAMIN (B12-VITAMIN) for an unknown indication. On 06-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Follow-up was received included Medical History was updated and Concomitant Medicines were added.information regarding dose 2 has been added

Other Meds: OMEPRAZOLE; CHLORTHALIDONE; EZETIMIBE; VITAMIN D3; B12-VITAMIN

Current Illness: Hypertension

ID: 1544323
Sex: F
Age:
State: MA

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: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: improved to normal soreness; fatigued; numb like pins and needles; tingly all day; migraine; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numb like pins and needles), PARAESTHESIA (tingly all day), MIGRAINE (migraine), MYALGIA (improved to normal soreness) and FATIGUE (fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 HYPOAESTHESIA (numb like pins and needles), PARAESTHESIA (tingly all day), MIGRAINE (migraine) and FATIGUE (fatigued). On 05-Jan-2021, the patient experienced MYALGIA (improved to normal soreness). On 05-Jan-2021, HYPOAESTHESIA (numb like pins and needles) and PARAESTHESIA (tingly all day) had resolved, MIGRAINE (migraine) and FATIGUE (fatigued) outcome was unknown. At the time of the report, MYALGIA (improved to normal soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was 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: 1544324
Sex: F
Age:
State:

Vax Date: 01/11/2021
Onset Date: 01/11/2021
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: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Exposure via breast milk) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the mother 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 11-Jan-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (Exposure via breast milk) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were provided by reporter. No treatment was reported.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs

Other Meds:

Current Illness:

ID: 1544325
Sex: F
Age:
State:

Vax Date: 01/04/2021
Onset Date:
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: decent skin reaction at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (decent skin reaction at site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (decent skin reaction at site of injection). At the time of the report, VACCINATION SITE REACTION (decent skin reaction at site of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm