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: 1568960
Sex: F
Age: 58
State: OK

Vax Date: 03/01/2021
Onset Date: 03/12/2021
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: rash; shingles on her left leg; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles on her left leg) and RASH (rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D14M20A) for COVID-19 vaccination. No medical reported history provided by the reporter. Concomitant products included LIDOCAINE for Pain, NAPROXEN for an unknown indication. On 01-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 HERPES ZOSTER (shingles on her left leg). On an unknown date, the patient experienced RASH (rash). At the time of the report, HERPES ZOSTER (shingles on her left leg) and RASH (rash) 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. Patient was given Antiviral (doctor gave her for the shingles). Patient had shingles before. And before the reaction she was taking lexeril first and then tramadol, stopped taking it after the reaction.

Other Meds: LIDOCAINE; NAPROXEN

Current Illness:

ID: 1568961
Sex: F
Age: 75
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: a dot of blood seen through bandage at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (a dot of blood seen through bandage at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The patient's past medical history included Tremor. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (a dot of blood seen through bandage at injection site). At the time of the report, VACCINATION SITE HAEMORRHAGE (a dot of blood seen through bandage at injection 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. Concomitant drugs were not provided. Treatment drugs were not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1568962
Sex: M
Age: 68
State: NJ

Vax Date: 01/07/2021
Onset Date: 01/09/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Developed illness; Tested positive for COVID19 Virus; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Developed illness) and COVID-19 (Tested positive for COVID19 Virus) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and Hypertension. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced ILLNESS (Developed illness) and COVID-19 (Tested positive for COVID19 Virus). On 30-Jan-2021, COVID-19 (Tested positive for COVID19 Virus) had resolved. At the time of the report, ILLNESS (Developed illness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 and recovered on 30 JAN 2021. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included Diabetic medications and High Blood Pressure medication. No treatment information was provided.

Other Meds:

Current Illness: Diabetes; Hypertension

ID: 1568963
Sex: F
Age: 59
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: shortness of breath/difficulty breathing; dizziness; rapid heartbeat; as if someone was sawing my arm off; pain in her injection arm all the way down to her fingers; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/difficulty breathing), DIZZINESS (dizziness), VACCINATION SITE PAIN (pain in her injection arm all the way down to her fingers), HEART RATE INCREASED (rapid heartbeat) and FEELING ABNORMAL (as if someone was sawing my arm off) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M049(?)) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (shortness of breath/difficulty breathing), DIZZINESS (dizziness), VACCINATION SITE PAIN (pain in her injection arm all the way down to her fingers), HEART RATE INCREASED (rapid heartbeat) and FEELING ABNORMAL (as if someone was sawing my arm off). At the time of the report, DYSPNOEA (shortness of breath/difficulty breathing), DIZZINESS (dizziness), VACCINATION SITE PAIN (pain in her injection arm all the way down to her fingers), HEART RATE INCREASED (rapid heartbeat) and FEELING ABNORMAL (as if someone was sawing my arm off) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) 120. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided no treatment information provided

Other Meds:

Current Illness:

ID: 1568964
Sex: F
Age: 79
State: TN

Vax Date: 03/12/2021
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: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Warm around shot site after 2nd dose; Red area around shot site after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm around shot site after 2nd dose) and VACCINATION SITE ERYTHEMA (Red area around shot site after 2nd dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 12-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 VACCINATION SITE WARMTH (Warm around shot site after 2nd dose) and VACCINATION SITE ERYTHEMA (Red area around shot site after 2nd dose). At the time of the report, VACCINATION SITE WARMTH (Warm around shot site after 2nd dose) and VACCINATION SITE ERYTHEMA (Red area around shot site after 2nd dose) outcome was unknown. Other relevant medication history included thyroid medication. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1568965
Sex: M
Age: 52
State: IL

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

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

Lab Data:

Allergies:

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

Symptoms: Itchy; Right arm feel slightly weaker; Soreness in the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), MUSCULAR WEAKNESS (Right arm feel slightly weaker) and VACCINATION SITE PAIN (Soreness in the arm of injection) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (MULTIVITAMINS [VITAMINS NOS]) for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PRURITUS (Itchy), MUSCULAR WEAKNESS (Right arm feel slightly weaker) and VACCINATION SITE PAIN (Soreness in the arm of injection). At the time of the report, PRURITUS (Itchy), MUSCULAR WEAKNESS (Right arm feel slightly weaker) and VACCINATION SITE PAIN (Soreness in the arm of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1568966
Sex: F
Age: 67
State: CO

Vax Date: 03/01/2021
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: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: blister on her cheek; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blister on her cheek), PYREXIA (fever) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-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 PYREXIA (fever) and FATIGUE (fatigue). On 10-Mar-2021, the patient experienced BLISTER (blister on her cheek). At the time of the report, BLISTER (blister on her cheek), PYREXIA (fever) and FATIGUE (fatigue) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product was reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1568967
Sex: F
Age:
State: OR

Vax Date: 03/02/2021
Onset Date: 03/07/2021
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: Hives; Rash on back, sides, butt, stomach.; Itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash on back, sides, butt, stomach.), PRURITUS (Itchy) and URTICARIA (Hives) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 07-Mar-2021, the patient experienced RASH (Rash on back, sides, butt, stomach.) and PRURITUS (Itchy). On an unknown date, the patient experienced URTICARIA (Hives). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash on back, sides, butt, stomach.), PRURITUS (Itchy) and URTICARIA (Hives) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medication were reported.

Other Meds:

Current Illness:

ID: 1568968
Sex: M
Age: 68
State: PA

Vax Date: 03/04/2021
Onset Date: 03/04/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: sore; Being achy in joints; being achy in joints and some muscles; fever spike to 103.4F; headache; No appetite; mild coughing; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), COUGH (mild coughing), PAIN IN EXTREMITY (Sore arm), PAIN (sore) and ARTHRALGIA (Being achy in joints) in a 68-year-old male 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 reported by reporter. Concurrent medical conditions included Hypothyroidism since 23-Jan-2015. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 23-Jan-2015 to an unknown date for Hypothyroidism, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ZINC 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 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Mar-2021, the patient experienced DECREASED APPETITE (No appetite), COUGH (mild coughing), PAIN (sore), ARTHRALGIA (Being achy in joints), MYALGIA (being achy in joints and some muscles), PYREXIA (fever spike to 103.4F) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) on 16-Mar-2021 at a dose of 2 dosage form in total. On 05-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, DECREASED APPETITE (No appetite), COUGH (mild coughing), PAIN (sore), ARTHRALGIA (Being achy in joints), MYALGIA (being achy in joints and some muscles), PYREXIA (fever spike to 103.4F) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood immunoglobulin G: unknown (Positive) IgG positive. On 16-Mar-2021, Body temperature: 103.4 (High) 103.4 F. On 16-Mar-2021, COVID-19: unknown (Negative) COVID-19 negative. On 16-Mar-2021, Influenza virus test: unknown (Negative) Flu test negative. On 16-Mar-2021, Polymerase chain reaction: unknown (Negative) PCR negative. 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. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26MAY2021, included patient demographic details, lab data and medical history details.

Other Meds: SYNTHROID; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; ZINC

Current Illness: Hypothyroidism

ID: 1568969
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: She was weak; Fever; Chills; She vomited; Rashes around injection site; Itchiness around injection site; Redness around injection site; So tired; She felt like vomiting; Elevated blood sugar at 365; Felt sick; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Elevated blood sugar at 365), ILLNESS (Felt sick), ASTHENIA (She was weak), VACCINATION SITE PRURITUS (Itchiness around injection site) and VOMITING (She felt like vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ATORVASTATIN and LISINOPRIL for an unknown indication. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Elevated blood sugar at 365), ILLNESS (Felt sick), VOMITING (She felt like vomiting) and FATIGUE (So tired). On 22-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE RASH (Rashes around injection site). On 14-Mar-2021, the patient experienced ASTHENIA (She was weak), PYREXIA (Fever), CHILLS (Chills) and VOMITING (She vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE INCREASED (Elevated blood sugar at 365), ILLNESS (Felt sick), ASTHENIA (She was weak), VACCINATION SITE PRURITUS (Itchiness around injection site), VOMITING (She felt like vomiting), VACCINATION SITE ERYTHEMA (Redness around injection site), FATIGUE (So tired), PYREXIA (Fever), CHILLS (Chills), VOMITING (She vomited) and VACCINATION SITE RASH (Rashes around injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ATORVASTATIN; LISINOPRIL

Current Illness:

ID: 1568970
Sex: M
Age: 63
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: headache; fatigue; Myalgia; muscle pain; Diarrhea; shortness of breath; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), VACCINATION SITE RASH (rash at the injection site), HEADACHE (headache) and FATIGUE (fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type 2 diabetes mellitus. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). On 15-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (Myalgia) and MYALGIA (muscle pain). At the time of the report, DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), VACCINATION SITE RASH (rash at the injection site), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (Myalgia) and MYALGIA (muscle pain) outcome was unknown. Treatment drugs were not provided concomitant drugs were not provided

Other Meds:

Current Illness: Type 2 diabetes mellitus

ID: 1568971
Sex: M
Age: 24
State:

Vax Date: 03/09/2021
Onset Date:
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: feeling strange; tightness in back of his throat; stuffy nose; soreness in his lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling strange), THROAT TIGHTNESS (tightness in back of his throat), NASAL CONGESTION (stuffy nose) and LYMPH NODE PAIN (soreness in his lymph nodes) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0034211A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling strange), THROAT TIGHTNESS (tightness in back of his throat), NASAL CONGESTION (stuffy nose) and LYMPH NODE PAIN (soreness in his lymph nodes). At the time of the report, FEELING ABNORMAL (feeling strange), THROAT TIGHTNESS (tightness in back of his throat), NASAL CONGESTION (stuffy nose) and LYMPH NODE PAIN (soreness in his lymph nodes) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Not specified

Other Meds:

Current Illness:

ID: 1568972
Sex: F
Age: 70
State: MN

Vax Date: 02/18/2021
Onset Date: 03/17/2021
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: flu-like symptoms; runny nose; achy; fatigue; chills; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), PAIN (achy), FATIGUE (fatigue) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced RHINORRHOEA (runny nose), PAIN (achy), FATIGUE (fatigue) and CHILLS (chills). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), PAIN (achy), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications information was reported. No treatment medications were provided. . Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received: Contain Non significant information

Other Meds:

Current Illness:

ID: 1568973
Sex: F
Age: 61
State: NY

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Little sores in her mouth including her palate; Mouth is "burning"; Throat "was not feeling right"; Felt that her face was sunburnt; Dry lips; This spontaneous case was reported by a consumer and describes the occurrence of SUNBURN (Felt that her face was sunburnt), LIP DRY (Dry lips), OROPHARYNGEAL DISCOMFORT (Throat "was not feeling right"), ORAL PAIN (Little sores in her mouth including her palate) and ORAL DISCOMFORT (Mouth is "burning") in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The patient's past medical history included Oral disorder (For which the patient was prescribed with a low dose antibiotic.) from October 2020 to January 2021. On 10-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 SUNBURN (Felt that her face was sunburnt) and LIP DRY (Dry lips). On 13-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat "was not feeling right"). On 17-Mar-2021, the patient experienced ORAL PAIN (Little sores in her mouth including her palate) and ORAL DISCOMFORT (Mouth is "burning"). The patient was treated with AMOXICILLIN at a dose of 1 dosage form. On 12-Mar-2021, SUNBURN (Felt that her face was sunburnt) had resolved. At the time of the report, LIP DRY (Dry lips), OROPHARYNGEAL DISCOMFORT (Throat "was not feeling right"), ORAL PAIN (Little sores in her mouth including her palate) and ORAL DISCOMFORT (Mouth is "burning") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1568974
Sex: F
Age: 75
State: PA

Vax Date: 03/16/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dry heaves really bad; Dizziness; headache; i'm tired; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (Dry heaves really bad), DIZZINESS (Dizziness), HEADACHE (headache) and FATIGUE (i'm tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced RETCHING (Dry heaves really bad), DIZZINESS (Dizziness), HEADACHE (headache) and FATIGUE (i'm tired). At the time of the report, RETCHING (Dry heaves really bad), DIZZINESS (Dizziness), HEADACHE (headache) and FATIGUE (i'm tired) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitants were not provided. Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: NNI-Reporter stated she does not have an email address or a faxnumber.

Other Meds:

Current Illness:

ID: 1568975
Sex: F
Age: 72
State: PR

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

Lab Data:

Allergies:

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

Symptoms: a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a slight headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE, METOPROLOL, MONTELUKAST and LOSARTAN for an unknown indication. On 12-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 12-Mar-2021, the patient experienced HEADACHE (a slight headache). On 12-Mar-2021, HEADACHE (a slight headache) had resolved. Asthma Inhaler used as a Concomitant medication. Tylenol used as a Treatment Medication. Action taken with mRNA-1273 in response to the event was not applicable. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.

Other Meds: LEVOTHYROXINE; METOPROLOL; MONTELUKAST; LOSARTAN

Current Illness:

ID: 1568976
Sex: M
Age: 63
State: FL

Vax Date: 02/15/2021
Onset Date: 03/15/2021
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: shortness of breath on exertion; diarrhea; body aches; muscle ache; rash at the injection site; felt tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath on exertion), DIARRHOEA (diarrhea), PAIN (body aches), MYALGIA (muscle ache) and VACCINATION SITE RASH (rash at the injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic (Type-2 diabetes). On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DYSPNOEA (shortness of breath on exertion), DIARRHOEA (diarrhea), PAIN (body aches), MYALGIA (muscle ache), VACCINATION SITE RASH (rash at the injection site), FATIGUE (felt tired) and HEADACHE (headache). At the time of the report, DYSPNOEA (shortness of breath on exertion), DIARRHOEA (diarrhea), PAIN (body aches), MYALGIA (muscle ache), VACCINATION SITE RASH (rash at the injection site), FATIGUE (felt tired) and HEADACHE (headache) outcome was unknown. the action taken with response to drug is not applicable

Other Meds:

Current Illness: Diabetic (Type-2 diabetes)

ID: 1568977
Sex: F
Age: 96
State: TX

Vax Date: 03/09/2021
Onset Date: 03/16/2021
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: still kind of hot felt hot; red spot (injection site); little swollen; very very itching/felt like scratching around the area; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (still kind of hot felt hot), VACCINATION SITE ERYTHEMA (red spot (injection site)), VACCINATION SITE SWELLING (little swollen) and VACCINATION SITE PRURITUS (very very itching/felt like scratching around the area) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Hypertension. On 09-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 FEELING HOT (still kind of hot felt hot), VACCINATION SITE ERYTHEMA (red spot (injection site)), VACCINATION SITE SWELLING (little swollen) and VACCINATION SITE PRURITUS (very very itching/felt like scratching around the area). At the time of the report, FEELING HOT (still kind of hot felt hot), VACCINATION SITE ERYTHEMA (red spot (injection site)) and VACCINATION SITE SWELLING (little swollen) had not resolved and VACCINATION SITE PRURITUS (very very itching/felt like scratching around the area) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other medications include high blood pressure medicine. Treatment information not provided.

Other Meds:

Current Illness:

ID: 1568978
Sex: F
Age: 69
State: NJ

Vax Date: 03/12/2021
Onset Date: 03/12/2021
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: Pain in the lower pelvic area; Fatigue; Pain on right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on right arm), PELVIC PAIN (Pain in the lower pelvic area) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. Concurrent medical conditions included Lymph node disorder. On 12-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 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain on right arm) and FATIGUE (Fatigue). On 17-Mar-2021, the patient experienced PELVIC PAIN (Pain in the lower pelvic area). On 13-Mar-2021, PAIN IN EXTREMITY (Pain on right arm) and FATIGUE (Fatigue) had resolved. At the time of the report, PELVIC PAIN (Pain in the lower pelvic area) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant product use was not provided by the reporter. No treatment information were reported. .

Other Meds:

Current Illness:

ID: 1568979
Sex: F
Age: 60
State: WI

Vax Date: 03/05/2021
Onset Date: 03/06/2021
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: Arm Pain - Near Injection Site; Swelling - Near Injection Site; Redness - Near Injection Site; Rash - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. Concurrent medical conditions included Cholesterol and Diabetes. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Cholesterol, METFORMIN and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes. 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 VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site). The patient was treated with IBUPROFEN ongoing from 06-Mar-2021 for Pain management, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection 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. Other concomitant medication included thyroid medication. ibuprofen is used as treatment medication.

Other Meds: BABY ASPIRIN; METFORMIN; FARXIGA

Current Illness: Cholesterol; Diabetes

ID: 1568980
Sex: F
Age: 41
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: Injection site had leakage after fluid injection in right arm about two drops of vaccine; Injection site had leakage after fluid injection in right arm about two drops of vaccine; a localized red rash was observed at the site; a localized red rash was observed at the site; a localized red rash was observed at the site for several days following the injection accompanied with mild soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Injection site had leakage after fluid injection in right arm about two drops of vaccine), DEVICE CONNECTION ISSUE (Injection site had leakage after fluid injection in right arm about two drops of vaccine), VACCINATION SITE ERYTHEMA (a localized red rash was observed at the site), VACCINATION SITE RASH (a localized red rash was observed at the site) and VACCINATION SITE PAIN (a localized red rash was observed at the site for several days following the injection accompanied with mild soreness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The patient's past medical history included Acute bronchitis from 20-Jan-2021 to 01-Mar-2021 and Hashimoto's disease on 01-Aug-1998. Concomitant products included LEVOTHYROXINE and LIOTHYRONINE for Hypothyroidism. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced UNDERDOSE (Injection site had leakage after fluid injection in right arm about two drops of vaccine), DEVICE CONNECTION ISSUE (Injection site had leakage after fluid injection in right arm about two drops of vaccine), VACCINATION SITE ERYTHEMA (a localized red rash was observed at the site), VACCINATION SITE RASH (a localized red rash was observed at the site) and VACCINATION SITE PAIN (a localized red rash was observed at the site for several days following the injection accompanied with mild soreness). On 17-Mar-2021, UNDERDOSE (Injection site had leakage after fluid injection in right arm about two drops of vaccine) had resolved. At the time of the report, DEVICE CONNECTION ISSUE (Injection site had leakage after fluid injection in right arm about two drops of vaccine), VACCINATION SITE ERYTHEMA (a localized red rash was observed at the site), VACCINATION SITE RASH (a localized red rash was observed at the site) and VACCINATION SITE PAIN (a localized red rash was observed at the site for several days following the injection accompanied with mild soreness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient taken oral NSAIDS for her events. No relevant concomitant medication was reported. . Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Patient demographics, vaccine facility information ,medical history, concomitant medication and new events were added.

Other Meds: LEVOTHYROXINE; LIOTHYRONINE

Current Illness:

ID: 1568981
Sex: M
Age: 66
State: ID

Vax Date: 03/16/2021
Onset Date: 03/17/2021
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: Chills/shakes; Chills/shakes; A mild fever at 100F; Tenderness at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Chills/shakes), CHILLS (Chills/shakes), PYREXIA (A mild fever at 100F), VACCINATION SITE PAIN (Tenderness at the injection site) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TREMOR (Chills/shakes), CHILLS (Chills/shakes), PYREXIA (A mild fever at 100F), VACCINATION SITE PAIN (Tenderness at the injection site) and HEADACHE (Headache). At the time of the report, TREMOR (Chills/shakes), CHILLS (Chills/shakes), PYREXIA (A mild fever at 100F), VACCINATION SITE PAIN (Tenderness at the injection site) and HEADACHE (Headache) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 100 (High) 100F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not given. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1568982
Sex: F
Age:
State:

Vax Date:
Onset Date:
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: Sleeplessness night; itchy area at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeplessness night) and PRURITUS (itchy area at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 INSOMNIA (Sleeplessness night) and PRURITUS (itchy area at injection site). At the time of the report, INSOMNIA (Sleeplessness night) and PRURITUS (itchy area at injection site) outcome was unknown. Not Provided No relevant concomitant medication was reported. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1568983
Sex: F
Age: 44
State: LA

Vax Date: 03/12/2021
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: Patient received second dose 6 days after first dose; A spontaneous report was received from other health care professional concerning a 44-years-old, female patient who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) 6 days after first dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012A21A) on right arm for prophylaxis of COVID-19 infection. On 18 Mar 2021, 6 days after vaccination, the patient received their second dose of mRNA-1273 (Batch Number: 029A21A) on left arm for prophylaxis of COVID-19 infection. On 18 Mar 2021, the patient received second dose 6 days after first dose. No treatment information was provided. The patient received both the doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the event, patient received second dose 6 days after first dose was considered as resolved on 18 Mar 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 029A21A for second dose) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1568984
Sex: M
Age:
State: TN

Vax Date: 03/16/2021
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: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 16-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 NASOPHARYNGITIS (cold). At the time of the report, NASOPHARYNGITIS (cold) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No Treatment information was provided.

Other Meds:

Current Illness:

ID: 1568985
Sex: F
Age:
State:

Vax Date: 03/15/2021
Onset Date: 03/16/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Throat still sounds froggy), ILLNESS (Sound slightly sick), COUGH (bit of a cough), URTICARIA (breaking out in hives) and RASH (rash all over her body) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for an unknown indication. On 15-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 16-Mar-2021, the patient experienced COUGH (bit of a cough), CHILLS (Chills) and PYREXIA (fever). On 17-Mar-2021, the patient experienced URTICARIA (breaking out in hives) and RASH (rash all over her body). On 18-Mar-2021, the patient experienced DYSPHONIA (Throat still sounds froggy) and ILLNESS (Sound slightly sick). At the time of the report, DYSPHONIA (Throat still sounds froggy), ILLNESS (Sound slightly sick), COUGH (bit of a cough), URTICARIA (breaking out in hives), RASH (rash all over her body), CHILLS (Chills) and PYREXIA (fever) had not resolved.

Other Meds: BENADRYL N

Current Illness:

ID: 1568986
Sex: F
Age: 63
State: LA

Vax Date: 02/17/2021
Onset Date:
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 012M20A) for COVID-19 vaccination. Concomitant products included INSULIN and METFORMIN for Diabetes, WARFARIN for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-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 (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Concomitant medication includes blood pressure pills. treatment information not provided

Other Meds: INSULIN; WARFARIN; METFORMIN

Current Illness:

ID: 1568987
Sex: F
Age: 65
State: FL

Vax Date: 03/09/2021
Onset Date: 03/17/2021
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: red; itchy; sensitive; rash at the injection site; a little bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red), RASH PRURITIC (itchy), VACCINATION SITE PAIN (sensitive), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red), RASH PRURITIC (itchy), VACCINATION SITE PAIN (sensitive), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit swollen). At the time of the report, RASH ERYTHEMATOUS (red), RASH PRURITIC (itchy), VACCINATION SITE PAIN (sensitive), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1568988
Sex: F
Age: 70
State: MO

Vax Date: 03/08/2021
Onset Date:
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: left arm is itchy; red spot bigger than a golf ball; barely tender; hard knot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (left arm is itchy), ERYTHEMA (red spot bigger than a golf ball), TENDERNESS (barely tender) and VACCINATION SITE INDURATION (hard knot at injection site) in a 70-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (left arm is itchy), ERYTHEMA (red spot bigger than a golf ball), TENDERNESS (barely tender) and VACCINATION SITE INDURATION (hard knot at injection site). At the time of the report, PRURITUS (left arm is itchy), ERYTHEMA (red spot bigger than a golf ball), TENDERNESS (barely tender) and VACCINATION SITE INDURATION (hard knot at injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant and treatment medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1568989
Sex: F
Age:
State: NM

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Bruise after receiving 1st dose; sore left arm after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise after receiving 1st dose) and PAIN IN EXTREMITY (sore left arm after receiving 1st dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included VITAMINS NOS for an unknown indication. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Feb-2021, the patient experienced CONTUSION (Bruise after receiving 1st dose) and PAIN IN EXTREMITY (sore left arm after receiving 1st dose). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 27-Feb-2021, CONTUSION (Bruise after receiving 1st dose) and PAIN IN EXTREMITY (sore left arm after receiving 1st dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1568990
Sex: F
Age:
State: NH

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Dizziness; Chest pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 18-Mar-2021. This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness) and CHEST PAIN (Chest pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Allergy to plants (trees and grass) and Food allergy (fruits, lemons, melons, certain spices such as coriander, thyme, and pepper). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Dizziness) and CHEST PAIN (Chest pain). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Dizziness and Chest pain, at a dose of 1 dosage form. On 22-Feb-2021, DIZZINESS (Dizziness) and CHEST PAIN (Chest pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: NEXIUM [ESOMEPRAZOLE SODIUM]; CRESTOR

Current Illness: Allergy to plants (trees and grass); Food allergy (fruits, lemons, melons, certain spices such as coriander, thyme, and pepper)

ID: 1568991
Sex: F
Age: 39
State: TX

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 023M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. The patient's last menstrual period was on 08-Jan-2021 and the estimated date of delivery was 15-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fourth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown. Not Provided Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1568992
Sex: F
Age: 31
State: MD

Vax Date: 03/03/2021
Onset Date: 03/03/2021
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: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 019B21A) for COVID-19 vaccination. Concurrent medical conditions included Alcohol use (socially - 3 drinks per week). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 14-Feb-2021 to an unknown date for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 16-Jan-2021 and the estimated date of delivery was 23-Oct-2021. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the sixth week of the pregnancy. On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Pregnancy test: positive (Positive) positive. On 14-Apr-2021, Glucose tolerance test: april 12, 2021: negative (within normal range) (normal) April 12, 2021: negative (within normal range). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Estimated date of conception on 30 Jan 2021 In Apr 2021, MaterniT21 PLUS Core+ESS+SCA was performed resulted in to April 12, 2021: negative screenings for chromosomal disorders (Trisomy 23, 18, 13). On 14 May 2021, AFP was performed and resulted into May 07, 2021: Screen Negative for Open Spina Bifida. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: completed Pregnancy Report Form.

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

Current Illness:

ID: 1568993
Sex: M
Age: 60
State: NY

Vax Date: 03/12/2021
Onset Date: 03/13/2021
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: Fever; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and ARTHRALGIA (Shoulder pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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 13-Mar-2021, the patient experienced PYREXIA (Fever) and ARTHRALGIA (Shoulder pain). At the time of the report, PYREXIA (Fever) and ARTHRALGIA (Shoulder pain) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported No treatment information was provided.

Other Meds:

Current Illness:

ID: 1568994
Sex: F
Age: 88
State: FL

Vax Date: 03/04/2021
Onset Date: 03/15/2021
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: shortness of breath; sweating more than normal; more tired than usual; nausea/vomiting; nausea/vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), HYPERHIDROSIS (sweating more than normal), FATIGUE (more tired than usual), NAUSEA (nausea/vomiting) and VOMITING (nausea/vomiting) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), HYPERHIDROSIS (sweating more than normal), FATIGUE (more tired than usual), NAUSEA (nausea/vomiting) and VOMITING (nausea/vomiting). On 17-Mar-2021, DYSPNOEA (shortness of breath), HYPERHIDROSIS (sweating more than normal), FATIGUE (more tired than usual), NAUSEA (nausea/vomiting) and VOMITING (nausea/vomiting) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter Treatment information was not provided

Other Meds:

Current Illness:

ID: 1568995
Sex: M
Age: 27
State: IN

Vax Date: 03/09/2021
Onset Date: 03/09/2021
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: Severe Chills; Achy joints; fever; headache; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (Severe Chills), ARTHRALGIA (Achy joints), PYREXIA (fever) and HEADACHE (headache) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (Severe Chills), ARTHRALGIA (Achy joints), PYREXIA (fever) and HEADACHE (headache). At the time of the report, CHILLS (Severe Chills), ARTHRALGIA (Achy joints), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications and treatment details were not provided.

Other Meds:

Current Illness:

ID: 1568996
Sex: F
Age: 62
State:

Vax Date: 03/13/2021
Onset Date: 03/13/2021
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: Tightness in chest; Burning in throat; Legs felt weird; Congestion in ears; Sore Throat; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in chest), THROAT IRRITATION (Burning in throat), FEELING ABNORMAL (Legs felt weird), EAR CONGESTION (Congestion in ears) and OROPHARYNGEAL PAIN (Sore Throat) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's past medical history included Fatty liver since an unknown date and Arm injury. Concurrent medical conditions included Diabetes mellitus, Chronic kidney disease (stage 3 kidney disease.) and Addison's disease. Concomitant products included HYDROCORTISONE ACETATE (CORTES) for Addison's disease, INSULIN for an unknown indication. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced CHEST DISCOMFORT (Tightness in chest), THROAT IRRITATION (Burning in throat), FEELING ABNORMAL (Legs felt weird), EAR CONGESTION (Congestion in ears) and OROPHARYNGEAL PAIN (Sore Throat). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Tightness in chest), THROAT IRRITATION (Burning in throat), FEELING ABNORMAL (Legs felt weird), EAR CONGESTION (Congestion in ears) and OROPHARYNGEAL PAIN (Sore Throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was also taking cholesterol medicine. She was treated with Z-pac and Allerga. Treatment medicines were not reported.

Other Meds: CORTES; INSULIN

Current Illness: Addison's disease; Chronic kidney disease (stage 3 kidney disease.); Diabetes mellitus; Fatty liver

ID: 1568997
Sex: M
Age: 74
State: NC

Vax Date: 02/10/2021
Onset Date: 03/17/2021
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: Swollen left arm but not at injection site, in muscle; Itches in left arm but not at injection site; chills; aches/pain; Lightheaded/dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen left arm but not at injection site, in muscle), PAIN (aches/pain), DIZZINESS (Lightheaded/dizziness), PRURITUS (Itches in left arm but not at injection site) and CHILLS (chills) in a 74-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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (aches/pain), DIZZINESS (Lightheaded/dizziness) and CHILLS (chills). On 18-Mar-2021, the patient experienced PRURITUS (Itches in left arm but not at injection site). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen left arm but not at injection site, in muscle). At the time of the report, PERIPHERAL SWELLING (Swollen left arm but not at injection site, in muscle), PAIN (aches/pain), DIZZINESS (Lightheaded/dizziness), PRURITUS (Itches in left arm but not at injection site) and CHILLS (chills) outcome was unknown. patient is taking medicine for high blood pressure, heart, diabetes (pills) patient has a surgery tomorrow and don't know if he should go or not.

Other Meds:

Current Illness:

ID: 1568998
Sex: F
Age: 87
State: PA

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 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 a little bit weird the night after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little bit weird the night after the first dose) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030120A and 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-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 FEELING ABNORMAL (felt a little bit weird the night after the first dose). At the time of the report, FEELING ABNORMAL (felt a little bit weird the night after the first dose) outcome was unknown. Concomitant product use was not provided. No treatment reported. This case was linked to US-MODERNATX, INC.-MOD-2021-049863 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: patient said she is fine now.TCR document attached.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-049863:crosslink

Other Meds:

Current Illness:

ID: 1568999
Sex: M
Age: 71
State: MN

Vax Date: 02/26/2021
Onset Date:
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: sore arm where the needle went in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm where the needle went in) in a 71-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 26-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 VACCINATION SITE PAIN (sore arm where the needle went in). At the time of the report, VACCINATION SITE PAIN (sore arm where the needle went in) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment medications were not reported This case was linked to MOD21-056973, MOD21-057016 (E2B Linked Report).; Sender's Comments: MOD21-056973:Crosslinked case MOD21-057016:Crosslinked case

Other Meds:

Current Illness:

ID: 1569000
Sex: F
Age:
State: NM

Vax Date:
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: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Caller's friend had a sore arm; Caller's friend had intense headache after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Caller's friend had a sore arm) and HEADACHE (Caller's friend had intense headache after receiving vaccine) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Caller's friend had a sore arm) and HEADACHE (Caller's friend had intense headache after receiving vaccine). At the time of the report, PAIN IN EXTREMITY (Caller's friend had a sore arm) and HEADACHE (Caller's friend had intense headache after receiving vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1569001
Sex: F
Age: 82
State: FL

Vax Date: 02/12/2021
Onset Date: 03/12/2021
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: Blood sugar went "way high; Sunburn to left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Blood sugar went "way high) and SUNBURN (Sunburn to left arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HYPERGLYCAEMIA (Blood sugar went "way high) and SUNBURN (Sunburn to left arm). On 13-Mar-2021, HYPERGLYCAEMIA (Blood sugar went "way high) had resolved. At the time of the report, SUNBURN (Sunburn to left arm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood glucose: high (High) High. No concomitant medication was reported. No treatment information was reported. This case was linked to MOD-2021-065348 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received : Updated outcome of event (sun burn) from unknown to resolved.

Other Meds:

Current Illness:

ID: 1569002
Sex: F
Age: 61
State: PA

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

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

Lab Data:

Allergies:

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

Symptoms: site of injection was stiff; discomfort at the site; eyes felt so gritty; left eye very painful; beyond normal dry eyes both eyes; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOMFORT (discomfort at the site), FOREIGN BODY SENSATION IN EYES (eyes felt so gritty), EYE PAIN (left eye very painful), DRY EYE (beyond normal dry eyes both eyes) and INJECTION SITE INDURATION (site of injection was stiff) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE DISCOMFORT (discomfort at the site), FOREIGN BODY SENSATION IN EYES (eyes felt so gritty), EYE PAIN (left eye very painful) and DRY EYE (beyond normal dry eyes both eyes). On 18-Mar-2021, the patient experienced INJECTION SITE INDURATION (site of injection was stiff). The patient was treated with MACROGOL 400, PROPYLENE GLYCOL (SYSTANE LUBRICANT) (ophthalmic) at an unspecified dose and frequency. At the time of the report, INJECTION SITE DISCOMFORT (discomfort at the site), FOREIGN BODY SENSATION IN EYES (eyes felt so gritty), EYE PAIN (left eye very painful), DRY EYE (beyond normal dry eyes both eyes) and INJECTION SITE INDURATION (site of injection was stiff) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1569003
Sex: F
Age:
State: NC

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: body ache; bone ache; chills; headache; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), BONE PAIN (bone ache), CHILLS (chills), HEADACHE (headache) and PYREXIA (high temperature) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. No Medical History information was reported. On 17-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 PAIN (body ache), BONE PAIN (bone ache), CHILLS (chills), HEADACHE (headache) and PYREXIA (high temperature). At the time of the report, PAIN (body ache), BONE PAIN (bone ache), CHILLS (chills), HEADACHE (headache) and PYREXIA (high temperature) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1569004
Sex: F
Age: 63
State: LA

Vax Date: 03/17/2021
Onset Date:
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: a little bit more soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit more soreness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Blood pressure high and Knee pain. Concomitant products included METFORMIN for Diabetes, INSULIN and WARFARIN for an unknown indication. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little bit more soreness). At the time of the report, PAIN IN EXTREMITY (a little bit more soreness) outcome was unknown. Patient's concomitant medications include blood pressure pills. (unspecified) No treatment information was reported. This case was linked to MOD-2021-049827 (Patient Link).

Other Meds: INSULIN; WARFARIN; METFORMIN

Current Illness: Blood pressure high; Diabetes; Knee pain

ID: 1569005
Sex: F
Age: 78
State: IN

Vax Date: 01/27/2021
Onset Date: 02/27/2021
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: Trouble extending arm due to pain deep located between shoulder and elbow of left arm; looks swollen; Hardly lift her arm; Pain while lifting/Trouble extending arm due to pain; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), PERIPHERAL SWELLING (looks swollen), LIMB DISCOMFORT (Hardly lift her arm), PAIN IN EXTREMITY (Pain while lifting/Trouble extending arm due to pain) and ARTHRALGIA (Trouble extending arm due to pain deep located between shoulder and elbow of left arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetic and Blood pressure high. On 27-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) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 18-Mar-2021, the patient experienced PERIPHERAL SWELLING (looks swollen), LIMB DISCOMFORT (Hardly lift her arm) and PAIN IN EXTREMITY (Pain while lifting/Trouble extending arm due to pain). On 11-May-2021, the patient experienced ARTHRALGIA (Trouble extending arm due to pain deep located between shoulder and elbow of left arm). At the time of the report, VACCINATION SITE PAIN (Sore arm), PERIPHERAL SWELLING (looks swollen), LIMB DISCOMFORT (Hardly lift her arm), PAIN IN EXTREMITY (Pain while lifting/Trouble extending arm due to pain) and ARTHRALGIA (Trouble extending arm due to pain deep located between shoulder and elbow of left arm) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided This case was linked to US-MODERNATX, INC.-MOD-2021-049843 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow-up added on 11May2021 includes new events were added; Sender's Comments: US-MODERNATX, INC.-MOD-2021-049843:First dose

Other Meds:

Current Illness: Blood pressure high; Diabetic

ID: 1569006
Sex: F
Age: 0
State: VA

Vax Date: 12/17/1980
Onset Date:
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: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). On 17-Dec-1980, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 20-Oct-2020 and the estimated date of delivery was 27-Jul-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medicines were reported. No treatment information were reported. On 20 Nov 2020 she had a positive pregnancy test.

Other Meds:

Current Illness:

ID: 1569007
Sex: F
Age: 87
State: PA

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: decreased appetite; dizziness; disorientation; felt out of it; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (decreased appetite), DIZZINESS (dizziness), DISORIENTATION (disorientation), FEELING ABNORMAL (felt out of it) and NAUSEA (nausea) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030120A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-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 DECREASED APPETITE (decreased appetite), DIZZINESS (dizziness), DISORIENTATION (disorientation), FEELING ABNORMAL (felt out of it), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, DECREASED APPETITE (decreased appetite), DIZZINESS (dizziness), DISORIENTATION (disorientation), FEELING ABNORMAL (felt out of it), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown. No concomitant medicines were included. treatment drugs were not provided. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-049844 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: TCR attached. Patient said she is fine now; Sender's Comments: US-MODERNATX, INC.-MOD-2021-049844:First dose case

Other Meds:

Current Illness:

ID: 1569008
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: She couldn't sleep at night because of aches and pain; She had pain in her head and some chills on next day; Patient reports that she felt dizzy after 3-4 hours of receiving 2nd dose; She had pain in her head and some chills on next day; She couldn't sleep at night because of aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Patient reports that she felt dizzy after 3-4 hours of receiving 2nd dose), INSOMNIA (She couldn't sleep at night because of aches and pain), PAIN (She couldn't sleep at night because of aches and pain), HEADACHE (She had pain in her head and some chills on next day) and CHILLS (She had pain in her head and some chills on next day) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included VITAMINS NOS for an unknown indication. On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Mar-2021, the patient experienced INSOMNIA (She couldn't sleep at night because of aches and pain). On 16-Mar-2021, the patient experienced CHILLS (She had pain in her head and some chills on next day). On 18-Mar-2021, the patient experienced DIZZINESS (Patient reports that she felt dizzy after 3-4 hours of receiving 2nd dose). On an unknown date, the patient experienced PAIN (She couldn't sleep at night because of aches and pain) and HEADACHE (She had pain in her head and some chills on next day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Patient reports that she felt dizzy after 3-4 hours of receiving 2nd dose), INSOMNIA (She couldn't sleep at night because of aches and pain), PAIN (She couldn't sleep at night because of aches and pain), HEADACHE (She had pain in her head and some chills on next day) and CHILLS (She had pain in her head and some chills on next day) outcome was unknown. Not Provided Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1569009
Sex: M
Age: 68
State: CA

Vax Date: 01/27/2021
Onset Date: 03/17/2021
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: Patient accidentally received third moderna vaccine; Palpitation; Chest heaviness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL OVERDOSE (Patient accidentally received third moderna vaccine), PALPITATIONS (Palpitation) and CHEST DISCOMFORT (Chest heaviness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 042L20A and 042L20A) for COVID-19 vaccination. The patient's past medical history included Hypertension, Brain disorder NOS, Benign prostatic hyperplasia and Cocaine abuse. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient accidentally received third moderna vaccine), PALPITATIONS (Palpitation) and CHEST DISCOMFORT (Chest heaviness). On 17-Mar-2021, ACCIDENTAL OVERDOSE (Patient accidentally received third moderna vaccine), PALPITATIONS (Palpitation) and CHEST DISCOMFORT (Chest heaviness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information given. As patient has taken 2 scheduled doses of the vaccine (3rd being a mistake) the action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information received on 01-JUN-2021 contains significant information. ADR form received, updated weight of the patient and new events.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm