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: 1570272
Sex: F
Age: 62
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 62-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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) was resolving. 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.

Other Meds:

Current Illness:

ID: 1570273
Sex: F
Age:
State: NC

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Slept for three to four days after second shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for three to four days after second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Slept for three to four days after second shot). At the time of the report, HYPERSOMNIA (Slept for three to four days after second shot) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1570274
Sex: M
Age: 81
State: PA

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

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

Lab Data:

Allergies:

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

Symptoms: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 012M20A.) 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) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown. Not Provided Concomitant medications were not reported. Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments This case was linked to MOD21-059005 (Patient Link).

Other Meds:

Current Illness:

ID: 1570275
Sex: M
Age:
State: TX

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: discomfort while sleeping; pain - pain level 3 on a pain scale of 1-10; small bump on his head; swelling of the lymph node on the right side of the head/swelling of the lymph node all the way back to the top of the right ear; arm is sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (discomfort while sleeping), PAIN (pain - pain level 3 on a pain scale of 1-10), SWELLING (small bump on his head), VACCINATION SITE PAIN (arm is sore at the injection site) and LYMPHADENOPATHY (swelling of the lymph node on the right side of the head/swelling of the lymph node all the way back to the top of the right ear) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is sore at the injection site). On 21-Mar-2021, the patient experienced INSOMNIA (discomfort while sleeping), PAIN (pain - pain level 3 on a pain scale of 1-10), SWELLING (small bump on his head) and LYMPHADENOPATHY (swelling of the lymph node on the right side of the head/swelling of the lymph node all the way back to the top of the right ear). At the time of the report, INSOMNIA (discomfort while sleeping), PAIN (pain - pain level 3 on a pain scale of 1-10), SWELLING (small bump on his head), VACCINATION SITE PAIN (arm is sore at the injection site) and LYMPHADENOPATHY (swelling of the lymph node on the right side of the head/swelling of the lymph node all the way back to the top of the right ear) 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 and treatment medication information was reported.

Other Meds:

Current Illness:

ID: 1570276
Sex: F
Age: 71
State: MI

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
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: hard and red spot on her arm around the site of injection; only achy the first night after receiving the injection but not anymore.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (hard and red spot on her arm around the site of injection) and VACCINATION SITE PAIN (only achy the first night after receiving the injection but not anymore.) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (only achy the first night after receiving the injection but not anymore.). On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (hard and red spot on her arm around the site of injection). On 12-Mar-2021, VACCINATION SITE PAIN (only achy the first night after receiving the injection but not anymore.) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (hard and red spot on her arm around the site of injection) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1570277
Sex: F
Age: 67
State: NY

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

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: temperature that went up to 102; headaches; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), FATIGUE (very fatigued) and PYREXIA (temperature that went up to 102) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. No Medical History information was reported. On 17-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches), FATIGUE (very fatigued) and PYREXIA (temperature that went up to 102). At the time of the report, HEADACHE (headaches), FATIGUE (very fatigued) and PYREXIA (temperature that went up to 102) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Temperature went up to 102. No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: updated contact information (mail, address)and new event

Other Meds:

Current Illness:

ID: 1570278
Sex: F
Age: 59
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Rash on her face / Rash on her neck; Lot of chills; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), RASH (Rash on her face / Rash on her neck) and CHILLS (Lot of chills) in a 59-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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (Pain). On 20-Mar-2021, the patient experienced CHILLS (Lot of chills). On 21-Mar-2021, the patient experienced RASH (Rash on her face / Rash on her neck). At the time of the report, PAIN (Pain), RASH (Rash on her face / Rash on her neck) and CHILLS (Lot of chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-053016 (Patient Link).

Other Meds:

Current Illness:

ID: 1570279
Sex: F
Age: 78
State: MO

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Later experienced shortness; Swollen face; Swollen arms; Teeth ache; Burning eyes; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Later experienced shortness), SWELLING FACE (Swollen face), PERIPHERAL SWELLING (Swollen arms), TOOTHACHE (Teeth ache) and EYE IRRITATION (Burning eyes) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (Later experienced shortness), SWELLING FACE (Swollen face), PERIPHERAL SWELLING (Swollen arms), TOOTHACHE (Teeth ache), EYE IRRITATION (Burning eyes) and HEADACHE (Headache). At the time of the report, DYSPNOEA (Later experienced shortness), SWELLING FACE (Swollen face), PERIPHERAL SWELLING (Swollen arms), TOOTHACHE (Teeth ache), EYE IRRITATION (Burning eyes) and HEADACHE (Headache) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant drug was not administered. Treatment for the event was not taken.

Other Meds:

Current Illness:

ID: 1570280
Sex: F
Age: 52
State: NJ

Vax Date: 01/11/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Patient stated that she has experienced the vaccine working from her upper arm, into her face,; patient said that she can taste the vaccine; Having issues with feeling in face; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Patient stated that she has experienced the vaccine working from her upper arm, into her face,), TASTE DISORDER (patient said that she can taste the vaccine) and HYPOAESTHESIA (Having issues with feeling in face) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Patient stated that she has experienced the vaccine working from her upper arm, into her face,), TASTE DISORDER (patient said that she can taste the vaccine) and HYPOAESTHESIA (Having issues with feeling in face). At the time of the report, FEELING ABNORMAL (Patient stated that she has experienced the vaccine working from her upper arm, into her face,) and TASTE DISORDER (patient said that she can taste the vaccine) outcome was unknown and HYPOAESTHESIA (Having issues with feeling in face) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient reported that she has not received any treatment. This case was linked to US-MODERNATX, INC.-MOD-2021-053108 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-053108:Crosslinked for Dose 2

Other Meds:

Current Illness:

ID: 1570281
Sex: F
Age: 98
State:

Vax Date: 02/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A) for COVID-19 vaccination. The patient's past medical history included Congestive heart failure. Concomitant products included DIGOXIN and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown. No treatment medications were provided. The patient experienced dizziness, she states the whole room spins only when she is going to bed at night, but the dizziness is not there in the morning. The action taken with mRNA-1273 in response to the event was not applicable.

Other Meds: DIGOXIN; ALDACTONE [SPIRONOLACTONE]

Current Illness:

ID: 1570282
Sex: F
Age: 64
State: CT

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

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

Lab Data:

Allergies:

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

Symptoms: blotchy now going down to her wrist; Arm was warm at injection site; Circled her arm above elbow going down; hard at the injection site; Arm was itchy at injection site; arm was red at injection site; arm hurt at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (blotchy now going down to her wrist), VACCINATION SITE WARMTH (Arm was warm at injection site), VACCINATION SITE REACTION (Circled her arm above elbow going down), VACCINATION SITE INDURATION (hard at the injection site) and VACCINATION SITE PRURITUS (Arm was itchy at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR) and ATORVASTATIN for an unknown indication. On 05-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) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm hurt at injection site). On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm was warm at injection site), VACCINATION SITE REACTION (Circled her arm above elbow going down), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE PRURITUS (Arm was itchy at injection site) and VACCINATION SITE ERYTHEMA (arm was red at injection site). On 22-Mar-2021, the patient experienced RASH MACULAR (blotchy now going down to her wrist). At the time of the report, RASH MACULAR (blotchy now going down to her wrist), VACCINATION SITE WARMTH (Arm was warm at injection site), VACCINATION SITE REACTION (Circled her arm above elbow going down), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE PRURITUS (Arm was itchy at injection site), VACCINATION SITE PAIN (arm hurt at injection site) and VACCINATION SITE ERYTHEMA (arm was red at injection site) had resolved. Concomitant product also included Iron supplement. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Event outcome updated

Other Meds: METFORMIN; LIPITOR; ATORVASTATIN

Current Illness:

ID: 1570283
Sex: F
Age:
State: NJ

Vax Date: 02/21/2021
Onset Date: 02/21/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Not feeling well; sinus or seasonal allergies; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), HYPERSENSITIVITY (sinus or seasonal allergies) and HEADACHE (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 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced HEADACHE (Headache). On 22-Mar-2021, the patient experienced MALAISE (Not feeling well) and HYPERSENSITIVITY (sinus or seasonal allergies). On 24-Feb-2021, HEADACHE (Headache) had resolved. At the time of the report, MALAISE (Not feeling well) and HYPERSENSITIVITY (sinus or seasonal allergies) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: other (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications and treatment details were not provided. Treatment information was not provided

Other Meds:

Current Illness:

ID: 1570284
Sex: F
Age: 69
State: OH

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

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

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Fluid in the ear; Soreness in the arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIDDLE EAR EFFUSION (Fluid in the ear), VACCINATION SITE PAIN (Soreness in the arm) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No relevant Medical history Reported. Concurrent medical conditions included Fluid in middle ear. Concomitant products included LISINOPRIL, CHLORTHALIDONE and SIMVASTATIN for an unknown indication. On 01-Mar-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 MIDDLE EAR EFFUSION (Fluid in the ear), VACCINATION SITE PAIN (Soreness in the arm) and HEADACHE (Headache). At the time of the report, MIDDLE EAR EFFUSION (Fluid in the ear) had not resolved and VACCINATION SITE PAIN (Soreness in the arm) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: LISINOPRIL; CHLORTHALIDONE; SIMVASTATIN

Current Illness: Fluid in middle ear

ID: 1570285
Sex: M
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Dental disorder NOS. On 19-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 PYREXIA (Low grade fever). At the time of the report, PYREXIA (Low grade fever) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment Medication were provided. The patient enquired that if he could take Antibiotic for his dental treatment.

Other Meds:

Current Illness: Dental disorder NOS

ID: 1570286
Sex: F
Age: 69
State: OH

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the deadline for her second dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ATORVASTATIN, METOPROLOL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LISINOPRIL, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ANASTROZOLE for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the deadline for her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the deadline for her second dose) had 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 treatment information was provided. This case was linked to MOD-2021-053134.

Other Meds: PLAVIX; ATORVASTATIN; METOPROLOL; PROTONIX [OMEPRAZOLE]; LISINOPRIL; CYMBALTA; ANASTROZOLE

Current Illness:

ID: 1570287
Sex: F
Age: 56
State: FL

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Didn't get the second dose before the 37 day mark; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Didn't get the second dose before the 37 day mark) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Didn't get the second dose before the 37 day mark). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Didn't get the second dose before the 37 day mark) 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 treatment Medications and concomitant medications were provided. The patient got an email from the health department stating that they scheduled her for the Pfizer vaccine.

Other Meds:

Current Illness:

ID: 1570288
Sex: F
Age: 79
State: NY

Vax Date: 02/13/2021
Onset Date: 03/22/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Swelling behand the ear; Swelling of the neck; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (Swelling behand the ear) and SWELLING (Swelling of the neck) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) 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 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced EAR SWELLING (Swelling behand the ear) and SWELLING (Swelling of the neck). At the time of the report, EAR SWELLING (Swelling behand the ear) and SWELLING (Swelling of the neck) had not resolved. No concomitant medication details were provided. No Treatment Medication was available. The action taken with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1570289
Sex: M
Age: 66
State: NJ

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

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant Medication was reported. treatment Medication was notreported.

Other Meds:

Current Illness:

ID: 1570290
Sex: M
Age:
State: NY

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Sleepy; Fatigued; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), FATIGUE (Fatigued), HEADACHE (Headache) and NAUSEA (Nausea) 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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 20-Mar-2021, the patient experienced SOMNOLENCE (Sleepy), FATIGUE (Fatigued), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, SOMNOLENCE (Sleepy), FATIGUE (Fatigued), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication and treatment details were not provided.

Other Meds:

Current Illness:

ID: 1570291
Sex: F
Age:
State:

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

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Body ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body ache). At the time of the report, MYALGIA (Body ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use were not provided by the reporter. Treatment medication was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1570292
Sex: F
Age: 52
State: NJ

Vax Date: 01/11/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Facial numbness/Ongoing issues of her Left side of her face; from the ear to the cheek and jawbone all feels numb; Tingling in face; Joint pain in the right arm/pain in both thumbs; feels weak some time when I try to use them; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Facial numbness/Ongoing issues of her Left side of her face; from the ear to the cheek and jawbone all feels numb), PARAESTHESIA (Tingling in face), PAIN IN EXTREMITY (Joint pain in the right arm/pain in both thumbs) and ASTHENIA (feels weak some time when I try to use them) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Facial numbness/Ongoing issues of her Left side of her face; from the ear to the cheek and jawbone all feels numb), PARAESTHESIA (Tingling in face), PAIN IN EXTREMITY (Joint pain in the right arm/pain in both thumbs) and ASTHENIA (feels weak some time when I try to use them). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (Facial numbness/Ongoing issues of her Left side of her face; from the ear to the cheek and jawbone all feels numb), PARAESTHESIA (Tingling in face) and ASTHENIA (feels weak some time when I try to use them) outcome was unknown and PAIN IN EXTREMITY (Joint pain in the right arm/pain in both thumbs) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. The patient stated Patient said that she thought in face it almost like having facial numbness and she advised the facility what took place after receiving her 1st dose; and on her 2nd dose she said that she was given liquid Benadryl, because her previous side effects of facial numinous and being able to taste the vaccine. They waited 15 minutes before giving her the vaccine. She still had the same side effect of numinous in the face and taste of the vaccine. She said on the call she still has taste issue. There were still ongoing issues of her Left side of her face; from the ear to the cheek and jawbone all feels numb. Patient stated that she has been experiencing joint pain in the right arm, pain in both thumbs (left and right hand). It still hurts in her hands and arm; and it feels weak some time when I try to use them. She will be making an appointment to see a neurologist; she did talk to her gynecologist, who suggested that she speak with a neurologist to help with nervure pain. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-053094.

Other Meds:

Current Illness:

ID: 1570293
Sex: F
Age:
State: FL

Vax Date: 03/10/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Broke out with blisters; Shingles; Pain in her back; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Pain in her back), BLISTER (Broke out with blisters) and HERPES ZOSTER (Shingles) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BACK PAIN (Pain in her back). On 16-Mar-2021, the patient experienced BLISTER (Broke out with blisters) and HERPES ZOSTER (Shingles). The patient was treated with PREDNISONE at an unspecified dose and frequency; TRAMADOL at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Pain in her back), BLISTER (Broke out with blisters) and HERPES ZOSTER (Shingles) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 19-Mar-2021, she went to a walk-in clinic and received an unspecified injection and was prescribed Prednisone and Tramadol. She also applied Calamine lotion. She continues to have blisters however they have stopped spreading. The patient was taking medicine for blood pressure.

Other Meds:

Current Illness: Hypertension

ID: 1570294
Sex: F
Age: 65
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: Sensation of something getting stuck in the chest; Headache; Labored Breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Labored Breathing), CHEST DISCOMFORT (Sensation of something getting stuck in the chest) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DYSPNOEA (Labored Breathing) and HEADACHE (Headache). On 12-Mar-2021, the patient experienced CHEST DISCOMFORT (Sensation of something getting stuck in the chest). At the time of the report, DYSPNOEA (Labored Breathing), CHEST DISCOMFORT (Sensation of something getting stuck in the chest) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication list was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1570295
Sex: M
Age: 41
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Vomiting; Fever 101.6F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.6F) and VOMITING (Vomiting) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Fever 101.6F). On 21-Mar-2021, the patient experienced VOMITING (Vomiting). At the time of the report, PYREXIA (Fever 101.6F) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.6 f (High) 101.6 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported No treatment drugs were reported Statements

Other Meds:

Current Illness:

ID: 1570296
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: UTI; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI), MYALGIA (Body aches) 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 19-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 19-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, URINARY TRACT INFECTION (UTI), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown. No concomitant medications were provided. Treatment medications were unknown. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable. This case was linked to MOD-2021-053107 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1570297
Sex: F
Age: 67
State: CO

Vax Date: 02/12/2021
Onset Date: 02/19/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided concomitant medication were not provided

Other Meds:

Current Illness:

ID: 1570298
Sex: F
Age: 73
State: OH

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: got one dose and hasn't gotten second dose, past 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got one dose and hasn't gotten second dose, past 42 days) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got one dose and hasn't gotten second dose, past 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got one dose and hasn't gotten second dose, past 42 days) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment information was not provided.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 007M20A) with no associated AEs.

Other Meds:

Current Illness:

ID: 1570299
Sex: F
Age: 51
State: CA

Vax Date: 03/20/2021
Onset Date: 03/21/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Chills; Fever; Headache; Sick; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomited) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in December 2020. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced ILLNESS (Sick) and VOMITING (Vomited). On 21-Mar-2021 at 3:00 AM, the patient experienced HEADACHE (Headache). On 21-Mar-2021 at 10:00 AM, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Mar-2021, ILLNESS (Sick) and VOMITING (Vomited) had resolved. On 21-Mar-2021 at 1:00 PM, CHILLS (Chills) and PYREXIA (Fever) had resolved. On 22-Mar-2021, HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications included unspecified Statins for cholesterol.

Other Meds:

Current Illness:

ID: 1570300
Sex: F
Age: 83
State: NJ

Vax Date: 03/05/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Redover elbow of arm of injection site; itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and VACCINATION SITE ERYTHEMA (Redover elbow of arm of injection site) in an 83-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (itching). On 17-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redover elbow of arm of injection site). At the time of the report, PRURITUS (itching) and VACCINATION SITE ERYTHEMA (Redover elbow of arm of injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1570301
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Swollen arm; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE PAIN (injection site pain) 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. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE PAIN (injection site pain). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE PAIN (injection site pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications and treatment details were not provided.

Other Meds:

Current Illness:

ID: 1570302
Sex: F
Age:
State: KY

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: COVID-19; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and FEELING ABNORMAL (Feeling bad) 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-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 COVID-19 (COVID-19) and FEELING ABNORMAL (Feeling bad). At the time of the report, COVID-19 (COVID-19) and FEELING ABNORMAL (Feeling bad) 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. The patient had body aches, headaches, tired, feeling bad, no smell which are included as the COVID-19 symptoms. Concomitant medication information was not reported No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Updated reporter's address

Other Meds:

Current Illness:

ID: 1570303
Sex: F
Age:
State: MI

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
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: Fever; Constant headache; Nauseous; Cannot sleep; Cannot eat or drink anything cannot eat or drink anything only little sips of water; Very very sick; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Cannot sleep), FEEDING DISORDER (Cannot eat or drink anything cannot eat or drink anything only little sips of water), MALAISE (Very very sick), PYREXIA (Fever) and HEADACHE (Constant headache) 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. Concurrent medical conditions included Migraine. On 19-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 19-Mar-2021, the patient experienced INSOMNIA (Cannot sleep), FEEDING DISORDER (Cannot eat or drink anything cannot eat or drink anything only little sips of water), HEADACHE (Constant headache) and NAUSEA (Nauseous). 19-Mar-2021, the patient experienced MALAISE (Very very sick). On 20-Mar-2021, the patient experienced PYREXIA (Fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 20-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, INSOMNIA (Cannot sleep), FEEDING DISORDER (Cannot eat or drink anything cannot eat or drink anything only little sips of water), MALAISE (Very very sick), HEADACHE (Constant headache) and NAUSEA (Nauseous) outcome was unknown. Patient had Ice for treatment along with the treatment medication. No concomitant product was reported. Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Non-Significant follow-up received and reporter details were added.

Other Meds:

Current Illness: Migraine

ID: 1570304
Sex: M
Age: 69
State: OH

Vax Date: 02/28/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in legs) and VACCINATION SITE PAIN (Injection site pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in legs) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in legs) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use was not provided. Treatment information included was not provided.

Other Meds:

Current Illness:

ID: 1570305
Sex: M
Age: 73
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: arm swelled up; sensitive to touch; extremely sore; lethargic; blood sugar not in control; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (lethargic), PARAESTHESIA (sensitive to touch), BLOOD GLUCOSE ABNORMAL (blood sugar not in control), VACCINATION SITE PAIN (extremely sore) and VACCINATION SITE SWELLING (arm swelled up) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 15-Mar-2021, the patient experienced LETHARGY (lethargic) and BLOOD GLUCOSE ABNORMAL (blood sugar not in control). On 19-Mar-2021, the patient experienced PARAESTHESIA (sensitive to touch) and VACCINATION SITE PAIN (extremely sore). On an unknown date, the patient experienced VACCINATION SITE SWELLING (arm swelled up). At the time of the report, LETHARGY (lethargic), PARAESTHESIA (sensitive to touch), BLOOD GLUCOSE ABNORMAL (blood sugar not in control), VACCINATION SITE PAIN (extremely sore) and VACCINATION SITE SWELLING (arm swelled up) outcome was unknown. Not Provided patient applied ice using Tylenol and Benadryl. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1570306
Sex: F
Age: 93
State: MI

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: solid cramps on both her legs to the point of not being able to walk; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (solid cramps on both her legs to the point of not being able to walk) in a 93-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 27-Feb-2021, the patient experienced MUSCLE SPASMS (solid cramps on both her legs to the point of not being able to walk). At the time of the report, MUSCLE SPASMS (solid cramps on both her legs to the point of not being able to walk) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1570307
Sex: F
Age: 46
State: NH

Vax Date: 02/19/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Possible partial first dose of 0.3 mL; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Possible partial first dose of 0.3 mL) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunisation. No Medical History information was reported. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .3 ml. On 19-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Possible partial first dose of 0.3 mL). On 19-Mar-2021, INCORRECT DOSE ADMINISTERED (Possible partial first dose of 0.3 mL) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication and treatment drug were not reported. This case was linked to MOD21-059986 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: No adverse event deleted as relevant medical history. Lower level term updated from Accidental underdose to Inappropriate dose of vaccine administered.; Sender's Comments: MOD21-059986:cross-linked case

Other Meds:

Current Illness:

ID: 1570308
Sex: M
Age: 66
State: WI

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

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

Lab Data:

Allergies:

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

Symptoms: Incorrect site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect site of injection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-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 PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect site of injection). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect site of injection) outcome was unknown. Not Provided 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 information was reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1570309
Sex: F
Age: 46
State: IN

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Euphoria; Some soreness at injection site; Excess amount of energy; Excessive energy has slowly decreased.; This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (Excess amount of energy), ASTHENIA (Excessive energy has slowly decreased.), EUPHORIC MOOD (Euphoria) and VACCINATION SITE PAIN (Some soreness at injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008AMA) for COVID-19 vaccination. Concurrent medical conditions included Polycystic ovarian syndrome (No recent changes occurred in the status of chronic condition) since 06-Jan-2003. Concomitant products included TRAZODONE, METFORMIN HYDROCHLORIDE (METFORMIN ER) and ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (JUNEL FE) for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ENERGY INCREASED (Excess amount of energy), ASTHENIA (Excessive energy has slowly decreased.) and VACCINATION SITE PAIN (Some soreness at injection site). On an unknown date, the patient experienced EUPHORIC MOOD (Euphoria). On 23-Mar-2021, ENERGY INCREASED (Excess amount of energy) had resolved. At the time of the report, ASTHENIA (Excessive energy has slowly decreased.), EUPHORIC MOOD (Euphoria) and VACCINATION SITE PAIN (Some soreness at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information were reported.Patient's heart rate stayed normal as did blood pressure and no insomnia experienced. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10 May 2021.Added patient demographics, medical history,concomitant medication's dosage details and new event. Updated outcome of event, excess energy from unknown to resolved,updated re-challenge and de-challenge.

Other Meds: TRAZODONE; METFORMIN ER; JUNEL FE

Current Illness: Polycystic ovarian syndrome (No recent changes occurred in the status of chronic condition)

ID: 1570310
Sex: F
Age: 82
State: CT

Vax Date: 02/24/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: felt sick after opening the bleach; rapid heartbeat/Fast heart rate feels different than her a-fib; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heartbeat), HEART RATE INCREASED (Fast heart rate feels different than her a-fib) and ALLERGY TO CHEMICALS (thinks she now has allergies to bleach) in an 82-year-old female elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the parent received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2. Last menstrual period and estimated date of delivery were not provided. On 27-Feb-2021, the elderly was diagnosed with HEART RATE INCREASED (rapid heartbeat). 27-Feb-2021, the elderly experienced HEART RATE INCREASED (Fast heart rate feels different than her a-fib). On 15-Mar-2021, the elderly was diagnosed with ALLERGY TO CHEMICALS (thinks she now has allergies to bleach). The Elderly was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. Not Provided Treatment Medications include natural supplements to thin out blood, concomitant medicines were not included Action taken with mRNA-1273 in response to the event was not applicable. Reporter did not allow further contact

Other Meds:

Current Illness: Atrial fibrillation

ID: 1570311
Sex: F
Age:
State: MI

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: colds; on and off fever; chills; swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (colds), LYMPHADENOPATHY (swollen lymph nodes), PYREXIA (on and off fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). On 12-Mar-2021, the patient experienced NASOPHARYNGITIS (colds), PYREXIA (on and off fever) and CHILLS (chills). At the time of the report, NASOPHARYNGITIS (colds), LYMPHADENOPATHY (swollen lymph nodes), PYREXIA (on and off fever) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, SARS-CoV-2 test positive: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1570312
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (fast heart rate), DYSPNOEA (difficulty breathing) and SWELLING (swelling of her face and throat) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced HEART RATE INCREASED (fast heart rate), DYSPNOEA (difficulty breathing) and SWELLING (swelling of her face and throat). At the time of the report, HEART RATE INCREASED (fast heart rate), DYSPNOEA (difficulty breathing) and SWELLING (swelling of her face and throat) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medical provided by the reporter. No treatment medication provided by the reporter.

Other Meds:

Current Illness:

ID: 1570313
Sex: M
Age:
State: AZ

Vax Date: 03/21/2021
Onset Date: 03/21/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: can not raise his shoulder/his shoulder locks right up on him; can not tie his shoe; ache/couldn't sleep on his left side; couldn't raise his hand above his head; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (ache/couldn't sleep on his left side), LIMB DISCOMFORT (couldn't raise his hand above his head), JOINT RANGE OF MOTION DECREASED (can not raise his shoulder/his shoulder locks right up on him) and MOVEMENT DISORDER (can not tie his shoe) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included GLIMEPIRIDE, TAMSULOSIN, LISINOPRIL, METOPROLOL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN (ache/couldn't sleep on his left side) and LIMB DISCOMFORT (couldn't raise his hand above his head). On 22-Mar-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (can not raise his shoulder/his shoulder locks right up on him) and MOVEMENT DISORDER (can not tie his shoe). At the time of the report, PAIN (ache/couldn't sleep on his left side), LIMB DISCOMFORT (couldn't raise his hand above his head), JOINT RANGE OF MOTION DECREASED (can not raise his shoulder/his shoulder locks right up on him) and MOVEMENT DISORDER (can not tie his shoe) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Lab details were not provided.

Other Meds: GLIMEPIRIDE; TAMSULOSIN; LISINOPRIL; METOPROLOL; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1570314
Sex: F
Age: 62
State: FL

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headache; dizzy; muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), MYALGIA (muscle pain), CHILLS (chills) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. Concomitant products included SITAGLIPTIN (JANUVIA [SITAGLIPTIN]), ROSUVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 20-Mar-2021, the patient experienced DIZZINESS (dizzy), MYALGIA (muscle pain) and CHILLS (chills). On 22-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with MECLIZINE HYDROCHLORIDE ongoing since an unknown date at a dose of UNK dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, DIZZINESS (dizzy), MYALGIA (muscle pain) and CHILLS (chills) had not resolved and HEADACHE (headache) 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 details not provided.

Other Meds: JANUVIA [SITAGLIPTIN]; ROSUVASTATIN; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1570315
Sex: M
Age: 71
State: OH

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: patient has not received second dose of Moderna Covid-19 vaccine; A spontaneous report was received from a healthcare facility staff member concerning her husband, a 71-year-old male patient who received Moderna (mRNA-1273) vaccine and has not received second dose of Moderna Covid-19 vaccine/Product dose omission issue. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included lisinopril, simvastatin, acetylsalicylic acid, omeprazole, and metoprolol for unknown indications. On 6 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. At the time of this report, the patient has not received the second dose of Moderna Covid-19 vaccine. Treatment information was unknown. Action taken with mRNA-1273 in response to the event(s) was not reported. The outcome of the event, not received second dose of Moderna Covid-19 vaccine was resolved at the time of this report.

Other Meds: LISINOPRIL; SIMVASTATIN; BABY ASPIRIN; OMEPRAZOLE; METOPROLOL

Current Illness:

ID: 1570316
Sex: F
Age: 71
State: ME

Vax Date: 02/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: injection site puffy; injection site arm red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site puffy) and VACCINATION SITE ERYTHEMA (injection site arm red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 023M20A) for COVID-19 vaccination. 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 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE INDURATION (injection site puffy) and VACCINATION SITE ERYTHEMA (injection site arm red). At the time of the report, VACCINATION SITE INDURATION (injection site puffy) and VACCINATION SITE ERYTHEMA (injection site arm red) outcome was unknown. No concomitant medication was reported No treatment medication was reported Action taken with the mRNA-1273 vaccine in response to the events was not applicable

Other Meds:

Current Illness:

ID: 1570317
Sex: F
Age: 70
State: NY

Vax Date: 03/06/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt like my arm hurt and arm soreness), NERVOUSNESS (little edgy and nervous last night), VACCINATION SITE RASH (injection site rash and redness and itching), VACCINATION SITE ERYTHEMA (injection site rash and redness and itching) and VACCINATION SITE PRURITUS (injection site rash and redness and itching) in a 70-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. No medical history was Provided by the reporter. Concomitant products included ATORVASTATIN, LOSARTAN POTASSIUM, VITAMINS NOS (MTV), CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), AZELASTINE HYDROCHLORIDE (ASTEPRO) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (felt like my arm hurt and arm soreness). On 21-Mar-2021, the patient experienced NERVOUSNESS (little edgy and nervous last night), VACCINATION SITE RASH (injection site rash and redness and itching), VACCINATION SITE ERYTHEMA (injection site rash and redness and itching) and VACCINATION SITE PRURITUS (injection site rash and redness and itching). On an unknown date, the patient experienced MYALGIA (achiness) and FATIGUE (fatigue, described as feeling weak). At the time of the report, PAIN IN EXTREMITY (felt like my arm hurt and arm soreness), NERVOUSNESS (little edgy and nervous last night), VACCINATION SITE RASH (injection site rash and redness and itching), VACCINATION SITE ERYTHEMA (injection site rash and redness and itching), VACCINATION SITE PRURITUS (injection site rash and redness and itching), MYALGIA (achiness) and FATIGUE (fatigue, described as feeling weak) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. Follow-up received on 04-JUN-2021 date included no new information. Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Follow up received on 02-may-2021: Second dose vaccine details and events updated(created separate case for dose two) On 04-Jun-2021: Follow up received: 4 Jun 2021 No significant information updated

Other Meds: ATORVASTATIN; LOSARTAN POTASSIUM; MTV; CALCIUM; VITAMIN D 2000; VITAMIN C & ROSEHIP; ASTEPRO; PRILOSEC [OMEPRAZOLE]

Current Illness:

ID: 1570318
Sex: F
Age: 78
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: swelling on left arm from the elbow to the shoulder; Hot at injection site; itchy at injection site; red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on left arm from the elbow to the shoulder), VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling on left arm from the elbow to the shoulder), VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. On 22-Mar-2021, VACCINATION SITE ERYTHEMA (red at injection site) was resolving. At the time of the report, PERIPHERAL SWELLING (swelling on left arm from the elbow to the shoulder), VACCINATION SITE WARMTH (Hot at injection site) and VACCINATION SITE PRURITUS (itchy at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1570319
Sex: M
Age: 72
State: MI

Vax Date: 03/04/2021
Onset Date: 03/14/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Red circle (2-3 inches) at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red circle (2-3 inches) at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circle (2-3 inches) at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red circle (2-3 inches) at injection site) 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 assessment. Concomitant product use was not provided by the reporter. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1570320
Sex: F
Age:
State: PA

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Experiencing cough after receiving the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Experiencing cough after receiving the Moderna vaccine). At the time of the report, COUGH (Experiencing cough after receiving the Moderna vaccine) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received on 10-Aug-2021 and included No new information.

Other Meds:

Current Illness:

ID: 1570321
Sex: F
Age:
State: TX

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rapid heart rate, immediately; Body warmed up immediately; This spontaneous case was reported by a health care professional and describes the occurrence of HEART RATE INCREASED (Rapid heart rate, immediately) and FEELING HOT (Body warmed up immediately) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A021A) for COVID-19 vaccination. Concomitant products included VITAMIN D NOS and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid heart rate, immediately) and FEELING HOT (Body warmed up immediately). At the time of the report, HEART RATE INCREASED (Rapid heart rate, immediately) and FEELING HOT (Body warmed up immediately) had 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. Concomitant medication also includes Antihyperlipidemic and Eye drops

Other Meds: VITAMIN D NOS; VITAMIN C ACID

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm