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: 1596989
Sex: F
Age:
State: WI

Vax Date: 02/24/2021
Onset Date: 03/08/2021
Rec V Date: 08/21/2021
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: pain in her right leg starting with knee and passed through the ankle; arm pain; she hasn't received the 2nd shot yet; swollen injection site; whole arm hurt (site of injection); arm has a red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (arm has a red rash), PAIN IN EXTREMITY (pain in her right leg starting with knee and passed through the ankle), PAIN IN EXTREMITY (arm pain), PRODUCT DOSE OMISSION ISSUE (she hasn't received the 2nd shot yet) and VACCINATION SITE SWELLING (swollen injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced RASH ERYTHEMATOUS (arm has a red rash), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE PAIN (whole arm hurt (site of injection)). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her right leg starting with knee and passed through the ankle), PAIN IN EXTREMITY (arm pain) and PRODUCT DOSE OMISSION ISSUE (she hasn't received the 2nd shot yet). At the time of the report, RASH ERYTHEMATOUS (arm has a red rash), PAIN IN EXTREMITY (pain in her right leg starting with knee and passed through the ankle), PAIN IN EXTREMITY (arm pain), PRODUCT DOSE OMISSION ISSUE (she hasn't received the 2nd shot yet), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE PAIN (whole arm hurt (site of injection)) 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 03-May-2021: The Significant follow up case was received on 03-MAY-2021. Events were updated.

Other Meds:

Current Illness:

ID: 1596990
Sex: F
Age: 75
State: AR

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 08/21/2021
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: Low grade fever 99.1-99.4; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever 99.1-99.4) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L208) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (Low grade fever 99.1-99.4). At the time of the report, PYREXIA (Low grade fever 99.1-99.4) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1-99.4 High. No concomitant medications were reported. No treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1596991
Sex: M
Age: 85
State: FL

Vax Date: 01/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/21/2021
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: experiencing fever continued the fever for 6-7 days and measured always between 99-100 degree; "horrible, weak and hardly able to walk; felt "horrible, weak; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY ("horrible, weak and hardly able to walk), ASTHENIA (felt "horrible, weak) and PYREXIA (experiencing fever continued the fever for 6-7 days and measured always between 99-100 degree) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Neck surgery (plate put in) on 15-Jan-2021. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced GAIT INABILITY ("horrible, weak and hardly able to walk) and ASTHENIA (felt "horrible, weak). On 27-Feb-2021, the patient experienced PYREXIA (experiencing fever continued the fever for 6-7 days and measured always between 99-100 degree). On 05-Mar-2021, PYREXIA (experiencing fever continued the fever for 6-7 days and measured always between 99-100 degree) had resolved. At the time of the report, GAIT INABILITY ("horrible, weak and hardly able to walk) and ASTHENIA (felt "horrible, weak) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-100 (High) 99-100. 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 events was not Applicable.

Other Meds: STATIN [ATORVASTATIN CALCIUM]; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Blood pressure abnormal

ID: 1596992
Sex: F
Age:
State: NY

Vax Date: 02/27/2019
Onset Date: 02/28/2021
Rec V Date: 08/21/2021
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: it was very sore; there was a rash there; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (it was very sore) and VACCINATION SITE RASH (there was a rash there) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included SULFASALAZINE for an unknown indication. On 27-Feb-2019, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (it was very sore) and VACCINATION SITE RASH (there was a rash there). At the time of the report, VACCINATION SITE PAIN (it was very sore) and VACCINATION SITE RASH (there was a rash there) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Treatment details include paracetamol. Concomitant medications include Sulfasalazine, Hormonal medicine and cholesterol medicine.

Other Meds: SULFASALAZINE

Current Illness:

ID: 1596993
Sex: M
Age: 71
State: TX

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 08/21/2021
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: diarrhea; pain in the shoulder; felt like strained muscle; aching and throbbing in the shoulder; can not raise arm above shoulder height; feels like loss of muscle control; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ARTHRALGIA (pain in the shoulder), MUSCLE STRAIN (felt like strained muscle), PAIN (aching and throbbing in the shoulder) and VACCINATION SITE MOVEMENT IMPAIRMENT (can not raise arm above shoulder height) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), ARTHRALGIA (pain in the shoulder), MUSCLE STRAIN (felt like strained muscle), PAIN (aching and throbbing in the shoulder), VACCINATION SITE MOVEMENT IMPAIRMENT (can not raise arm above shoulder height) and MUSCULAR WEAKNESS (feels like loss of muscle control). At the time of the report, DIARRHOEA (diarrhea), ARTHRALGIA (pain in the shoulder), MUSCLE STRAIN (felt like strained muscle), PAIN (aching and throbbing in the shoulder), VACCINATION SITE MOVEMENT IMPAIRMENT (can not raise arm above shoulder height) and MUSCULAR WEAKNESS (feels like loss of muscle control) 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: 1596994
Sex: M
Age:
State: AZ

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 08/21/2021
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: left lymph nodes swelling at left armpit; swelling in both left and right ankle; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling in both left and right ankle), VACCINATION SITE PAIN (soreness at the injection site) and LYMPHADENOPATHY (left lymph nodes swelling at left armpit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Hypertension (He takes medication for his hypertension and high cholesterol) and Cholesterol. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 01-Mar-2021, the patient experienced JOINT SWELLING (swelling in both left and right ankle). On 07-Mar-2021, the patient experienced LYMPHADENOPATHY (left lymph nodes swelling at left armpit). On 09-Mar-2021, LYMPHADENOPATHY (left lymph nodes swelling at left armpit) had resolved. At the time of the report, JOINT SWELLING (swelling in both left and right ankle) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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 medication were provided that icing and elevating

Other Meds:

Current Illness: Cholesterol; Hypertension (He takes medication for his hypertension and high cholesterol)

ID: 1596995
Sex: F
Age: 88
State: FL

Vax Date: 02/26/2021
Onset Date: 02/01/2021
Rec V Date: 08/21/2021
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: slight itch lower extremeties; Hives; stomach cramping; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives), ABDOMINAL PAIN UPPER (stomach cramping) and VACCINATION SITE PRURITUS (slight itch lower extremeties) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L2) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced URTICARIA (Hives) and ABDOMINAL PAIN UPPER (stomach cramping). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (slight itch lower extremeties). The patient was treated with TRIAMCINOLONE at a dose of UNK,0.1% topical cream and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 04-Mar-2021, URTICARIA (Hives) and ABDOMINAL PAIN UPPER (stomach cramping) had resolved. At the time of the report, VACCINATION SITE PRURITUS (slight itch lower extremeties) outcome was unknown. No concomitant medicines reported by reporter. Treatment medication includes shot of some sort of steroid(name unknown).

Other Meds:

Current Illness:

ID: 1596996
Sex: M
Age: 64
State: ME

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 08/21/2021
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: bright red itchy rash on chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (bright red itchy rash on chest) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included FLUOXETINE and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (bright red itchy rash on chest). At the time of the report, RASH (bright red itchy rash on chest) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Patient was also taking clonidine 1.5mg hs concomitantly

Other Meds: FLUOXETINE; ADVAIR

Current Illness:

ID: 1596997
Sex: F
Age: 80
State: FL

Vax Date: 02/07/2021
Onset Date: 03/08/2021
Rec V Date: 08/21/2021
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: Diarrhea; Nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (vomiting) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O31L20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (vomiting). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 09-Mar-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, NAUSEA (Nausea) and VOMITING (vomiting) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was unknown by the reporter,Expiration date is not provided. He did not provide any information for her health care provider. He consented for follow up with safety. He agreed on follow up with her Health Care Provider. Treatment medication include Imodium, Ibuprofen

Other Meds:

Current Illness:

ID: 1596998
Sex: F
Age: 66
State: TX

Vax Date: 02/22/2021
Onset Date:
Rec V Date: 08/21/2021
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: big lump on the left side by her rib cage; muscles in her legs hurt every time she walks; It feels like a hurt rib cage; is sore to the touch; They feel weak; the muscles are tight; This spontaneous case was reported by a consumer and describes the occurrence of MASS (big lump on the left side by her rib cage), MYALGIA (muscles in her legs hurt every time she walks), MUSCULOSKELETAL CHEST PAIN (It feels like a hurt rib cage), PAIN IN EXTREMITY (is sore to the touch) and MUSCULAR WEAKNESS (They feel weak) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (product used for unknown indication). On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MASS (big lump on the left side by her rib cage), MYALGIA (muscles in her legs hurt every time she walks), MUSCULOSKELETAL CHEST PAIN (It feels like a hurt rib cage), PAIN IN EXTREMITY (is sore to the touch), MUSCULAR WEAKNESS (They feel weak) and MUSCLE TIGHTNESS (the muscles are tight). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia and Muscle tightness, at an unspecified dose and frequency and TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) for Myalgia and Pain, at an unspecified dose and frequency. At the time of the report, MASS (big lump on the left side by her rib cage), MYALGIA (muscles in her legs hurt every time she walks), MUSCULOSKELETAL CHEST PAIN (It feels like a hurt rib cage), PAIN IN EXTREMITY (is sore to the touch), MUSCULAR WEAKNESS (They feel weak) and MUSCLE TIGHTNESS (the muscles are tight) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided

Other Meds:

Current Illness:

ID: 1596999
Sex: F
Age: 72
State: WA

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 08/21/2021
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: Rash on back of the neck after the vaccine about 3-4 hours afterwards and spread to should and ches; Slight headache; arm discomfort; Getting dizzy off and on not sure if its from Zyrtec or vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back of the neck after the vaccine about 3-4 hours afterwards and spread to should and ches), HEADACHE (Slight headache), LIMB DISCOMFORT (arm discomfort) and DIZZINESS (Getting dizzy off and on not sure if its from Zyrtec or vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced RASH (Rash on back of the neck after the vaccine about 3-4 hours afterwards and spread to should and ches), HEADACHE (Slight headache), LIMB DISCOMFORT (arm discomfort) and DIZZINESS (Getting dizzy off and on not sure if its from Zyrtec or vaccine). At the time of the report, RASH (Rash on back of the neck after the vaccine about 3-4 hours afterwards and spread to should and ches), HEADACHE (Slight headache), LIMB DISCOMFORT (arm discomfort) and DIZZINESS (Getting dizzy off and on not sure if its from Zyrtec or vaccine) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drug was taken. No treatment drug was taken.

Other Meds:

Current Illness:

ID: 1597000
Sex: F
Age: 40
State: TN

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/21/2021
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: Increased heartbeat; quirky feeling in throat; Vomiting; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heartbeat), OROPHARYNGEAL DISCOMFORT (quirky feeling in throat), VOMITING (Vomiting) and DIARRHOEA (diarrhea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE for an unknown indication. On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced HEART RATE INCREASED (Increased heartbeat), OROPHARYNGEAL DISCOMFORT (quirky feeling in throat), VOMITING (Vomiting) and DIARRHOEA (diarrhea). At the time of the report, HEART RATE INCREASED (Increased heartbeat), OROPHARYNGEAL DISCOMFORT (quirky feeling in throat), VOMITING (Vomiting) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Heart rate: 120 beats/min (High) developed an increase in heart rate upto 120 beats/ mnt. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE for an unknown indication. Patient gave consent for safety team to follow up with them Reporter did not allow further contact

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1597001
Sex: F
Age: 81
State: PA

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/21/2021
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: headache; threw up; really sick; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), ILLNESS (really sick), HEADACHE (headache) and VOMITING (threw up) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 101A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach). On 04-Mar-2021, the patient experienced ILLNESS (really sick) and VOMITING (threw up). On an unknown date, the patient experienced HEADACHE (headache). On 05-Mar-2021, ILLNESS (really sick) and VOMITING (threw up) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) had not resolved and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication nor treatment provided

Other Meds:

Current Illness:

ID: 1597002
Sex: F
Age: 68
State: NC

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/21/2021
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: Started like a little red bump; Red Bump itched; Left arm has a rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Started like a little red bump), PRURITUS (Red Bump itched) and RASH (Left arm has a rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 98162) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure and Allergy. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Started like a little red bump), PRURITUS (Red Bump itched) and RASH (Left arm has a rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Started like a little red bump), PRURITUS (Red Bump itched) and RASH (Left arm has a rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications also included medications for blood pressure and allergy.

Other Meds:

Current Illness: Allergy; Blood pressure

ID: 1597003
Sex: F
Age: 61
State: CA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/21/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 015M20A) 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) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-059975.

Other Meds:

Current Illness:

ID: 1597004
Sex: F
Age: 70
State: KS

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/21/2021
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: pain at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) 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 02-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the site). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain at the site) 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 information was not included.

Other Meds:

Current Illness:

ID: 1597005
Sex: F
Age: 68
State: AZ

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 08/21/2021
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: This spontaneous case reported by a consumer, describes the occurrence of ear pain (sore arm, chills, earache), pain in extremity (sore arm, chills, earache), headache and chills (Sore arm, chills, earache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 01314209) for COVID-19 immunization. No medical history reported. On Mar 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 9, 2021, patient experienced ear pain (sore arm, chills, earache), pain in extremity (sore arm, chills, earache), headache and chills (sore arm, chills, earache). At the time of the report, ear pain (sore arm, chills, earache), pain in extremity (sore arm, chills, earache), headache and chills (sore arm, chills, earache) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.

Other Meds:

Current Illness:

ID: 1597006
Sex: M
Age: 72
State: IN

Vax Date: 01/28/2021
Onset Date: 02/26/2021
Rec V Date: 08/21/2021
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: Sore and tender arm; Sore and tender arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore and tender arm) and TENDERNESS (Sore and tender arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030L20A) for COVID-19 vaccination. Concomitant products included RAMIPRIL for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Sore and tender arm) and TENDERNESS (Sore and tender arm). On 27-Feb-2021, MYALGIA (Sore and tender arm) and TENDERNESS (Sore and tender arm) had resolved. No treatment medication were provided. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up information received on 30-JUN-2021 contains no new information.

Other Meds: RAMIPRIL

Current Illness:

ID: 1597007
Sex: M
Age:
State: MA

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/21/2021
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: Warm in the chest; Warm in the shoulder; warm in the abdomen; warm in the head; Sensation inside the head felt like was was going to faint; Knuckle started to hurt; This case was received via an unknown source (no reference has been entered for a health authority) on 09-Mar-2021 and was forwarded to Moderna on 09-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, ABDOMINAL DISCOMFORT, HEAD DISCOMFORT, and DIZZINESS in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse events (No reported medical history.). On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CHEST DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, ABDOMINAL DISCOMFORT, HEAD DISCOMFORT, DIZZINESS, and ARTHRALGIA. At the time of the report, CHEST DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, ABDOMINAL DISCOMFORT, DIZZINESS, and ARTHRALGIA outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 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. Reporter did not allow further contact. 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: 1597008
Sex: F
Age: 81
State: TN

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/21/2021
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: Rapid heart beat; Sensation of fluid moving around her body; Brain spin; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), FEELING ABNORMAL (Sensation of fluid moving around her body) and DIZZINESS (Brain spin) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat), FEELING ABNORMAL (Sensation of fluid moving around her body) and DIZZINESS (Brain spin). At the time of the report, HEART RATE INCREASED (Rapid heart beat), FEELING ABNORMAL (Sensation of fluid moving around her body) and DIZZINESS (Brain spin) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported. Concomitant product use was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1597009
Sex: M
Age: 32
State:

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/21/2021
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: Severe chills; disoriented; confused; haze over words; couldn't remember what people told him; mental lag; confusion; temperature; This spontaneous case was reported by a patient and describes the occurrence of BODY TEMPERATURE INCREASED (temperature), CHILLS (Severe chills), DISORIENTATION (disoriented), CONFUSIONAL STATE (confused) and SPEECH DISORDER (haze over words) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature). On 06-Mar-2021, the patient experienced CHILLS (Severe chills), DISORIENTATION (disoriented), CONFUSIONAL STATE (confused), SPEECH DISORDER (haze over words), MEMORY IMPAIRMENT (couldn't remember what people told him), DISTURBANCE IN ATTENTION (mental lag) and CONFUSIONAL STATE (confusion). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 06-Mar-2021, BODY TEMPERATURE INCREASED (temperature) had resolved. At the time of the report, CHILLS (Severe chills), DISORIENTATION (disoriented), CONFUSIONAL STATE (confused), SPEECH DISORDER (haze over words), MEMORY IMPAIRMENT (couldn't remember what people told him), DISTURBANCE IN ATTENTION (mental lag) and CONFUSIONAL STATE (confusion) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Lab data: Temperature 101.6 Concomitant product use was not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1597010
Sex: F
Age: 17
State: CA

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/21/2021
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: Vaccinated 17 year old; A spontaneous report was received from a healthcare professional concerning a 17-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 04 Mar 2021, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: 013A21A) for prophylaxis of COVID-19 infection. The patient was vaccinated at 17 years old. No Treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The event vaccinated at 17 years old was considered resolved on 04 mar 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 01321A) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1597011
Sex: F
Age:
State:

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/21/2021
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: eyes were burning, eyelids swollen; eyes were burning, eyelids swollen; heart rate went from resting to 116.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (eyes were burning, eyelids swollen), EYE IRRITATION (eyes were burning, eyelids swollen) and HEART RATE INCREASED (heart rate went from resting to 116.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced EYE SWELLING (eyes were burning, eyelids swollen), EYE IRRITATION (eyes were burning, eyelids swollen) and HEART RATE INCREASED (heart rate went from resting to 116.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (eyes were burning, eyelids swollen), EYE IRRITATION (eyes were burning, eyelids swollen) and HEART RATE INCREASED (heart rate went from resting to 116.) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported.

Other Meds:

Current Illness:

ID: 1597012
Sex: F
Age: 76
State: NC

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 08/21/2021
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: Outside 37 day dosing interval/05Mar2021 and still has not gotten the second dose/Patient has not got second dose yet/ has not received the second dose she is 88 days out; headache; She was feeling shaky; Diarrhoea; Sore arm; nervous; pain at injection site; This case was initially received via the Regulatory Authority (Reference number: 128020 ) on 09-Mar-2021. The most recent information was received on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (She was feeling shaky), DIARRHEA (Diarrhea), VACCINATION SITE PAIN (Sore arm), NERVOUSNESS (nervous) and PRODUCT DOSE OMISSION ISSUE (Outside 37 day dosing interval/05Mar2021 and still has not gotten the second dose/Patient has not got second dose yet/ has not received the second dose she is 88 days out) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anxiety. Concurrent medical conditions included Atrial fibrillation. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, DRONEDARONE HYDROCHLORIDE (MULTAQ), ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D NOS, ROSUVASTATIN and ALPRAZOLAM for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm), NERVOUSNESS (nervous) and VACCINATION SITE PAIN (pain at injection site). On 20-Mar-2021, the patient experienced TREMOR (She was feeling shaky), DIARRHEA (Diarrhea) and HEADACHE (headache). On 01-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Outside 37 day dosing interval/05Mar2021 and still has not gotten the second dose/Patient has not got second dose yet/ has not received the second dose she is 88 days out). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 07-Mar-2021, VACCINATION SITE PAIN (pain at injection site) had resolved. On 08-Mar-2021, VACCINATION SITE PAIN (Sore arm) and NERVOUSNESS (nervous) had resolved. On 23-Mar-2021, TREMOR (She was feeling shaky), DIARRHEA (Diarrhea) and HEADACHE (headache) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Outside 37 day dosing interval/05Mar2021 and still has not gotten the second dose/Patient has not got second dose yet/ has not received the second dose she is 88 days out) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Drug specific antibody: 68 (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. Recieved first dose of the Modena vaccine on 05Mar2021 and still has not gotten the second dose. Patient states that in July2021 they had their antibodies tested and had a positive result of 68. Patient took CENTRUM JUNIOR as concomitant product. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non significant follow up On 09-Aug-2021: Follow up information was received wherein in vaccine start date was changed from 05 Mar 2021 to 06 Mar 2021 and the outcome for the event missed dose was updated.

Other Meds: MULTAQ; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D NOS; ROSUVASTATIN; ALPRAZOLAM; CRESTOR

Current Illness:

ID: 1597013
Sex: F
Age: 69
State: MA

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 08/21/2021
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: Noticed pocket of fluid out of left breast; Swelling on left breast; Slight redness of left breast; A lot of swelling on left armpit; Redness on injection site of left arm; Period of chills; Slight elevation of temperature measured 99.4 F; Hot flashes; Had a diarrhea; Pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BREAST INFLAMMATION (Swelling on left breast), ERYTHEMA (Slight redness of left breast), BREAST DISCHARGE (Noticed pocket of fluid out of left breast), BODY TEMPERATURE INCREASED (Slight elevation of temperature measured 99.4 F) and HOT FLUSH (Hot flashes) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer in 2012. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain on the injection site). On 04-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (Slight elevation of temperature measured 99.4 F), HOT FLUSH (Hot flashes), DIARRHOEA (Had a diarrhea) and CHILLS (Period of chills). On 05-Mar-2021, the patient experienced BREAST INFLAMMATION (Swelling on left breast), ERYTHEMA (Slight redness of left breast), PERIPHERAL SWELLING (A lot of swelling on left armpit) and INJECTION SITE ERYTHEMA (Redness on injection site of left arm). On 06-Mar-2021, the patient experienced BREAST DISCHARGE (Noticed pocket of fluid out of left breast). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, BODY TEMPERATURE INCREASED (Slight elevation of temperature measured 99.4 F), HOT FLUSH (Hot flashes), DIARRHOEA (Had a diarrhea) and CHILLS (Period of chills) had resolved. On 05-Mar-2021, VACCINATION SITE PAIN (Pain on the injection site) had resolved. At the time of the report, BREAST INFLAMMATION (Swelling on left breast), ERYTHEMA (Slight redness of left breast), BREAST DISCHARGE (Noticed pocket of fluid out of left breast) and INJECTION SITE ERYTHEMA (Redness on injection site of left arm) outcome was unknown and PERIPHERAL SWELLING (A lot of swelling on left armpit) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, SARS-CoV-2 test: positive (Positive) positive. On 04-Mar-2021, Body temperature: 99.4 (Inconclusive) 99.4 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1597014
Sex: F
Age:
State: CA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/21/2021
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: Redness/Elbows were red; Throat issues; Skin was burning; All around her neck and in the front of where her clavicle bone is - red and burning, back was burning; Anxiety attack; Rash; Felt a little tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Redness/Elbows were red), OROPHARYNGEAL DISCOMFORT (Throat issues), SKIN BURNING SENSATION (Skin was burning), BURNING SENSATION (All around her neck and in the front of where her clavicle bone is - red and burning, back was burning) and ANXIETY (Anxiety attack) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anxiety. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ERYTHEMA (Redness/Elbows were red), OROPHARYNGEAL DISCOMFORT (Throat issues), SKIN BURNING SENSATION (Skin was burning), BURNING SENSATION (All around her neck and in the front of where her clavicle bone is - red and burning, back was burning), ANXIETY (Anxiety attack), RASH (Rash) and FATIGUE (Felt a little tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 mg three times a day. On 07-Mar-2021, ERYTHEMA (Redness/Elbows were red), OROPHARYNGEAL DISCOMFORT (Throat issues), SKIN BURNING SENSATION (Skin was burning), BURNING SENSATION (All around her neck and in the front of where her clavicle bone is - red and burning, back was burning), ANXIETY (Anxiety attack), RASH (Rash) and FATIGUE (Felt a little tired) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported that it was allergy season all day long where she lives. The patient had been using Aloe vera on her skin to help with the skin rash and back burning

Other Meds: CLARITIN [LORATADINE]

Current Illness: Anxiety

ID: 1597015
Sex: F
Age:
State: MI

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 08/21/2021
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: Feels terrible; Sinus congestion; Dizziness; Sore arm; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels terrible), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feels terrible), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, FEELING ABNORMAL (Feels terrible), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1597016
Sex: F
Age:
State: MI

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 08/21/2021
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: nerves are shot; fever of 99.1 F.; her arm was "more sore"; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (nerves are shot), PAIN (her arm was "more sore") and PYREXIA (fever of 99.1 F.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (her arm was "more sore"). On 09-Mar-2021, the patient experienced NERVOUS SYSTEM DISORDER (nerves are shot) and PYREXIA (fever of 99.1 F.). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, NERVOUS SYSTEM DISORDER (nerves are shot) and PAIN (her arm was "more sore") outcome was unknown and PYREXIA (fever of 99.1 F.) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 99.1 (Inconclusive) 99.1. Concomitant medications on use were not provided. Action taken with mRNA-1273 was not applicable. This case was linked to MOD-2021-038084, MOD-2021-038078 (Patient Link).

Other Meds:

Current Illness:

ID: 1597017
Sex: F
Age: 86
State: FL

Vax Date: 02/27/2021
Onset Date: 02/28/2021
Rec V Date: 08/21/2021
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: nausea; site was red and very large, round and hard; stomach cramp and felt like throwing up; itchiness around the site; red around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red around the site), NAUSEA (nausea), VACCINATION SITE INDURATION (site was red and very large, round and hard), ABDOMINAL PAIN UPPER (stomach cramp and felt like throwing up) and VACCINATION SITE PRURITUS (itchiness around the site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), AZELASTINE, MONTELUKAST SODIUM and BUDESONIDE (PULMICORT) for an unknown indication. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red around the site), VACCINATION SITE INDURATION (site was red and very large, round and hard), ABDOMINAL PAIN UPPER (stomach cramp and felt like throwing up) and VACCINATION SITE PRURITUS (itchiness around the site). On 03-Mar-2021, the patient experienced NAUSEA (nausea). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) for Adverse event, at a dose of 0.025 %. At the time of the report, VACCINATION SITE ERYTHEMA (red around the site), NAUSEA (nausea), VACCINATION SITE INDURATION (site was red and very large, round and hard), ABDOMINAL PAIN UPPER (stomach cramp and felt like throwing up) and VACCINATION SITE PRURITUS (itchiness around the site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ALLEGRA; AZELASTINE; MONTELUKAST SODIUM; PULMICORT

Current Illness:

ID: 1597018
Sex: F
Age: 65
State: TN

Vax Date: 02/25/2021
Onset Date: 03/08/2021
Rec V Date: 08/21/2021
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: Small rash at Injection site; Rash is burning and stinging; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Small rash at Injection site) and VACCINATION SITE PAIN (Rash is burning and stinging) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 immunisation. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INJECTION SITE RASH (Small rash at Injection site) and VACCINATION SITE PAIN (Rash is burning and stinging). At the time of the report, INJECTION SITE RASH (Small rash at Injection site) and VACCINATION SITE PAIN (Rash is burning and stinging) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications or treatment details reported.

Other Meds:

Current Illness:

ID: 1597019
Sex: F
Age: 62
State: KY

Vax Date: 02/25/2021
Onset Date: 03/04/2021
Rec V Date: 08/21/2021
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: rash appeared at the injection site, rash was oblong (5" long and 3" wide) in shape; injection site became warm, red, and caky/warm to touch; injection site became warm, red, and caky; injection site became warm, red, and caky; bad firey red sore throat/very odd sore throat; bad firey red sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (bad firey red sore throat/very odd sore throat), PHARYNGEAL ERYTHEMA (bad firey red sore throat), VACCINATION SITE WARMTH (injection site became warm, red, and caky), VACCINATION SITE ERYTHEMA (injection site became warm, red, and caky) and VACCINATION SITE SWELLING (injection site became warm, red, and caky) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic (Bactrim.). Concomitant products included MONTELUKAST for Allergy, ROSUVASTATIN for Cholesterol, VITAMIN D NOS for Osteoporosis. On 25-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (bad firey red sore throat/very odd sore throat) and PHARYNGEAL ERYTHEMA (bad firey red sore throat). On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site became warm, red, and caky), VACCINATION SITE ERYTHEMA (injection site became warm, red, and caky) and VACCINATION SITE SWELLING (injection site became warm, red, and caky). On an unknown date, the patient experienced VACCINATION SITE RASH (rash appeared at the injection site, rash was oblong (5" long and 3" wide) in shape). On 07-Mar-2021, OROPHARYNGEAL PAIN (bad firey red sore throat/very odd sore throat) and PHARYNGEAL ERYTHEMA (bad firey red sore throat) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site became warm, red, and caky), VACCINATION SITE ERYTHEMA (injection site became warm, red, and caky), VACCINATION SITE SWELLING (injection site became warm, red, and caky) and VACCINATION SITE RASH (rash appeared at the injection site, rash was oblong (5" long and 3" wide) in shape) had resolved. Treatment details included antibiotics was prescribed but didn't took those medications. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI On 23-Jun-2021: Added patient demographics, added medical history, added concomitant medication

Other Meds: MONTELUKAST; VITAMIN D NOS; ROSUVASTATIN

Current Illness: Allergy to antibiotic (Bactrim.)

ID: 1597020
Sex: F
Age: 56
State: NY

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 08/21/2021
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: This spontaneous case reported by a consumer, describes the occurrence of back pain (low-back pain), fatigue and myalgia (muscle pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 036A21A) for COVID-19 immunization. No medical history reported. On Mar 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 9, 2021, patient experienced back pain (low-back pain), fatigue and myalgia (muscle pain). At the time of the report, back pain (low-back pain), fatigue and myalgia (muscle pain): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.

Other Meds:

Current Illness:

ID: 1597021
Sex: F
Age:
State: NJ

Vax Date: 02/28/2021
Onset Date: 03/01/2021
Rec V Date: 08/21/2021
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: started itching everywhere legs, arm, back.; a little red; her arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started itching everywhere legs, arm, back.), ERYTHEMA (a little red) and VACCINATION SITE PAIN (her arm hurt a little) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. Concomitant products included DICLOFENAC for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (her arm hurt a little). On an unknown date, the patient experienced PRURITUS (started itching everywhere legs, arm, back.) and ERYTHEMA (a little red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRURITUS (started itching everywhere legs, arm, back.), ERYTHEMA (a little red) and VACCINATION SITE PAIN (her arm hurt a little) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication include Tylenol.

Other Meds: DICLOFENAC

Current Illness:

ID: 1597022
Sex: F
Age:
State:

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 08/21/2021
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: weak; Breathing is labored; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak) and DYSPNOEA (Breathing is labored) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 09-Mar-2021, the patient experienced ASTHENIA (weak) and DYSPNOEA (Breathing is labored). At the time of the report, ASTHENIA (weak) and DYSPNOEA (Breathing is labored) outcome was unknown. Treatment information was not provided. Concomitant medication was not provided.

Other Meds:

Current Illness:

ID: 1597023
Sex: F
Age: 63
State: MI

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 08/21/2021
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: increased heart rate; blood pressure increased; fatigue; headahe; muscle pain; vomiting; chills; nausea; Dizziness; weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increased heart rate), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (fatigue), HEADACHE (headahe) and MYALGIA (muscle pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Mar-2021, the patient experienced HEART RATE INCREASED (increased heart rate), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (fatigue), HEADACHE (headahe), MYALGIA (muscle pain), VOMITING (vomiting), CHILLS (chills), NAUSEA (nausea), DIZZINESS (Dizziness) and ASTHENIA (weakness). At the time of the report, HEART RATE INCREASED (increased heart rate), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (fatigue), HEADACHE (headahe), MYALGIA (muscle pain), VOMITING (vomiting), CHILLS (chills), NAUSEA (nausea), DIZZINESS (Dizziness) and ASTHENIA (weakness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Pepto-Bismol Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1597024
Sex: M
Age: 40
State: MD

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/21/2021
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: muscle pain on my right side, like an extreme muscle pain; fever; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (muscle pain on my right side, like an extreme muscle pain) and PYREXIA (fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse reaction. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced MYALGIA (muscle pain on my right side, like an extreme muscle pain) and PYREXIA (fever). At the time of the report, MYALGIA (muscle pain on my right side, like an extreme muscle pain) and PYREXIA (fever) 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. Treatment- Muscle relaxant

Other Meds:

Current Illness:

ID: 1597025
Sex: F
Age:
State: NC

Vax Date: 02/26/2021
Onset Date: 03/02/2021
Rec V Date: 08/21/2021
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: redness around the injection site; itchiness around the injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE PRURITUS (itchiness around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included OMEPRAZOLE for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE PRURITUS (itchiness around the injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE PRURITUS (itchiness around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment information was reported.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 1597026
Sex: F
Age:
State: KY

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/21/2021
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: Below the site of injection was hot; Below the site of injection was puffy; Belowthe site of injection was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Below the site of injection was hot), VACCINATION SITE SWELLING (Below the site of injection was puffy) and VACCINATION SITE ERYTHEMA (Belowthe site of injection was red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Below the site of injection was hot), VACCINATION SITE SWELLING (Below the site of injection was puffy) and VACCINATION SITE ERYTHEMA (Belowthe site of injection was red). At the time of the report, VACCINATION SITE WARMTH (Below the site of injection was hot), VACCINATION SITE SWELLING (Below the site of injection was puffy) and VACCINATION SITE ERYTHEMA (Belowthe site of injection was red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment details was not provided.

Other Meds:

Current Illness:

ID: 1597027
Sex: F
Age:
State: CA

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 08/21/2021
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: itching that keep you up at night and little soreness at the injection site; little soreness - left arm; rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching that keep you up at night and little soreness at the injection site), PAIN IN EXTREMITY (little soreness - left arm) and RASH (rash on the arm) 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 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching that keep you up at night and little soreness at the injection site), PAIN IN EXTREMITY (little soreness - left arm) and RASH (rash on the arm). At the time of the report, PRURITUS (itching that keep you up at night and little soreness at the injection site), PAIN IN EXTREMITY (little soreness - left arm) and RASH (rash on the arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided by the reporter. Treatment drugs include creams for an unknown indication. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1597028
Sex: M
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: Covid after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid after first dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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 after first dose). At the time of the report, COVID-19 (Covid after first dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1597029
Sex: F
Age:
State: FL

Vax Date: 03/05/2021
Onset Date: 03/06/2021
Rec V Date: 08/21/2021
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: Severe lower back pain; I couldn't walk; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe lower back pain) and GAIT INABILITY (I couldn't walk) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced BACK PAIN (Severe lower back pain) and GAIT INABILITY (I couldn't walk). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (Severe lower back pain) and GAIT INABILITY (I couldn't walk) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1597030
Sex: M
Age:
State: NY

Vax Date: 03/04/2021
Onset Date: 03/09/2021
Rec V Date: 08/21/2021
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: Injection site rash (7inches by 5 inches) 4 days after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash (7inches by 5 inches) 4 days after vaccination) 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-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE RASH (Injection site rash (7inches by 5 inches) 4 days after vaccination). At the time of the report, VACCINATION SITE RASH (Injection site rash (7inches by 5 inches) 4 days after vaccination) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1597031
Sex: F
Age: 70
State: TN

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 08/21/2021
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: coughing; Issues breathing; Couldn't sleep; terrible wheezing; "had a bad reaction"; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), DYSPNOEA (Issues breathing), POOR QUALITY SLEEP (Couldn't sleep), WHEEZING (terrible wheezing) and ADVERSE REACTION ("had a bad reaction") in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Food allergy (MSG and red dye #40 (carries epi pen)). On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced COUGH (coughing), DYSPNOEA (Issues breathing), POOR QUALITY SLEEP (Couldn't sleep), WHEEZING (terrible wheezing) and ADVERSE REACTION ("had a bad reaction"). At the time of the report, COUGH (coughing), POOR QUALITY SLEEP (Couldn't sleep), WHEEZING (terrible wheezing) and ADVERSE REACTION ("had a bad reaction") outcome was unknown and DYSPNOEA (Issues breathing) had resolved. Unknown The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use was not provided. Treatment information was not provided Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-06-2021 contains No significant information

Other Meds:

Current Illness: Food allergy (MSG and red dye #40 (carries epi pen))

ID: 1597032
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: Got vaccine from a already thawed vial.; A spontaneous report was received from a health care professional concerning a unspecified years old, male patient who experienced got vaccine from a already thawed vial/PT: wrong product administered. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date in 2021, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. The patient experienced got vaccine from a already thawed vial on an unknown date in 2021. The reported event was considered medication error. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of event got vaccine from a already thawed vial was considered resolved.; Reporter's Comments: This report refers to a case of wrong product administered for mRNA-1273, with no associated AEs.

Other Meds:

Current Illness:

ID: 1597033
Sex: F
Age: 72
State: WI

Vax Date: 02/22/2021
Onset Date: 02/24/2021
Rec V Date: 08/21/2021
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: itchiness; hard a circumference of a golf ball; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), INDURATION (hard a circumference of a golf ball) and ERYTHEMA (Redness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (itchiness), INDURATION (hard a circumference of a golf ball) and ERYTHEMA (Redness). At the time of the report, PRURITUS (itchiness), INDURATION (hard a circumference of a golf ball) and ERYTHEMA (Redness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications include Benadryl cream for an unknown indication. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1597034
Sex: F
Age: 69
State: MN

Vax Date: 02/05/2021
Onset Date: 03/06/2021
Rec V Date: 08/21/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 036A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included TAMOXIFEN and clindamycin as needed for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (extreme fatigue). At the time of the report, FATIGUE (extreme fatigue) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: Tamoxifen; Clindamycin as needed

Current Illness:

ID: 1597035
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date: 03/01/2021
Rec V Date: 08/21/2021
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 positive; sore neck; sore tongue; feel sick; Some low fever also (99.5?F); This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid positive), NECK PAIN (sore neck), GLOSSODYNIA (sore tongue), MALAISE (feel sick) and PYREXIA (Some low fever also (99.5?F)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (sore neck), GLOSSODYNIA (sore tongue), MALAISE (feel sick) and PYREXIA (Some low fever also (99.5?F)). On 04-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid positive), NECK PAIN (sore neck), GLOSSODYNIA (sore tongue), MALAISE (feel sick) and PYREXIA (Some low fever also (99.5?F)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, COVID-19: Positive. No Concomitant medications were provided. No Treatment History was provided.

Other Meds:

Current Illness:

ID: 1597036
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: worse side effects after the second shot; 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 ADVERSE DRUG REACTION (worse side effects after the second shot) 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. 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 ADVERSE DRUG REACTION (worse side effects after the second shot). At the time of the report, ADVERSE DRUG REACTION (worse side effects after the second shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1597037
Sex: F
Age: 80
State: CA

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 08/21/2021
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: pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032G20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1597038
Sex: F
Age:
State: WA

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 08/21/2021
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: sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Mar-2021 and was forwarded to Moderna on 09-Mar-2021. A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm/pain in extremity. The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) sore arm. Treatment details included Aleve. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), sore arm was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm