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

Incidents per State

State Total
84,042
AK1,755
AL5,946
AR3,860
AS44
AZ14,180
CA62,867
CO11,836
CT8,507
DC1,710
DE1,814
FL40,229
FM3
GA14,868
GU90
HI2,387
IA4,636
ID2,657
IL20,908
IN23,355
KS4,628
KY7,968
LA5,162
MA14,931
MD12,804
ME3,203
MH8
MI19,536
MN12,412
MO9,780
MP30
MS2,961
MT2,311
NC16,852
ND1,406
NE2,962
NH3,064
NJ18,939
NM4,002
NV4,480
NY35,443
OH19,578
OK6,354
OR8,648
PA24,366
PR2,354
QM2
RI2,044
SC6,720
SD1,204
TN9,638
TX37,465
UT4,348
VA15,043
VI57
VT1,756
WA15,027
WI11,245
WV2,377
WY875
XB5
XL1
XV2

ID: 1567410
Sex: F
Age: 78
State: TX

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

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Symptom List:

Symptoms: Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. No Medical History information was reported. On 06-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 ERYTHEMA (Redness). At the time of the report, ERYTHEMA (Redness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were provided. No concomitant medications were provided. This case was linked to MOD-2021-131302 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received contains no new information regarding dose 1 of mRNA-1273.

Other Meds:

Current Illness:

ID: 1567411
Sex: F
Age: 57
State: CT

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

Vax Type:
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Symptom List:

Symptoms: dizziness /felt lightheaded; Low grade fever; nonstop headache; typical soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (typical soreness in the arm), DIZZINESS (dizziness /felt lightheaded), PYREXIA (Low grade fever) and HEADACHE (nonstop headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) 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) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (typical soreness in the arm) and HEADACHE (nonstop headache). On an unknown date, the patient experienced DIZZINESS (dizziness /felt lightheaded) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at a dose of 1 dosage form and NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (typical soreness in the arm), DIZZINESS (dizziness /felt lightheaded), PYREXIA (Low grade fever) and HEADACHE (nonstop headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow-up received does not contains non significant information (contact information updated)

Other Meds:

Current Illness:

ID: 1567412
Sex: M
Age:
State: FL

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

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Symptoms: flu shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WRONG PRODUCT ADMINISTERED (flu shot) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: influenza on 15-Mar-2021. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (flu shot). At the time of the report, WRONG PRODUCT ADMINISTERED (flu shot) outcome was unknown. 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. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: TCR attached - NNI

Other Meds:

Current Illness:

ID: 1567413
Sex: F
Age: 16
State: TX

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

Vax Type:
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Symptoms: Inquired about administering the second dose to a patient who is 16 years old; 16 years old patient received the first dose of the Moderna vaccine/inquired about administering the second dose to a patient who was 16 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient received the first dose of the Moderna vaccine/inquired about administering the second dose to a patient who was 16 years old) and OFF LABEL USE (Inquired about administering the second dose to a patient who is 16 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient received the first dose of the Moderna vaccine/inquired about administering the second dose to a patient who was 16 years old). On 16-Mar-2021, the patient experienced OFF LABEL USE (Inquired about administering the second dose to a patient who is 16 years old). On 03-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient received the first dose of the Moderna vaccine/inquired about administering the second dose to a patient who was 16 years old) had resolved. At the time of the report, OFF LABEL USE (Inquired about administering the second dose to a patient who is 16 years old) 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. The reporter was a registered Nurse who was helping to administer vaccine in the clinic, and inquired about administering the second dose to a patient who was 16 years old and has received already the first dose of the Moderna vaccine 41 days ago, on 03-Feb-2021. No Concomitant product use was reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1567414
Sex: F
Age:
State: MI

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

Vax Type:
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Symptom List:

Symptoms: chronic migraines few did not follow her typical migraine pattern; Itchy Injection Site; Sore Injection Site; Swollen Injection Site; Red Injection Site; Muscle Ache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (chronic migraines few did not follow her typical migraine pattern), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE ERYTHEMA (Red Injection Site) in a 59-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. The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Chronic migraine. 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 VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and MYALGIA (Muscle Ache). On an unknown date, the patient experienced MIGRAINE (chronic migraines few did not follow her typical migraine pattern). On 15-Mar-2021, VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and MYALGIA (Muscle Ache) had resolved. At the time of the report, MIGRAINE (chronic migraines few did not follow her typical migraine pattern) outcome was unknown and VACCINATION SITE PRURITUS (Itchy Injection Site) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 90 (Low) 90 Percent. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Reporter details, Patient's medical history, lab data and event data has been updated.

Other Meds:

Current Illness: Chronic migraine

ID: 1567415
Sex: F
Age: 87
State: MD

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
Hospital:

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Symptom List:

Symptoms: Localized inflammation; Elevated temperature of 102; Itchiness in the injection site; Swelling/ Injection site is slightly raised; Redness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Localized inflammation), VACCINATION SITE PRURITUS (Itchiness in the injection site), VACCINATION SITE SWELLING (Swelling/ Injection site is slightly raised), VACCINATION SITE ERYTHEMA (Redness in the injection site) and PYREXIA (Elevated temperature of 102) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination. The patient's past medical history included Bone marrow disorder and Chemotherapy (8 years ago). Concurrent medical conditions included Blood pressure abnormal. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication. 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 VACCINATION SITE PRURITUS (Itchiness in the injection site), VACCINATION SITE SWELLING (Swelling/ Injection site is slightly raised) and VACCINATION SITE ERYTHEMA (Redness in the injection site). On an unknown date, the patient experienced INFLAMMATION (Localized inflammation) and PYREXIA (Elevated temperature of 102). The patient was treated with CORTISONE at a dose of UNK dosage form. On 23-Mar-2021, VACCINATION SITE PRURITUS (Itchiness in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) had resolved. At the time of the report, INFLAMMATION (Localized inflammation), VACCINATION SITE SWELLING (Swelling/ Injection site is slightly raised) and PYREXIA (Elevated temperature of 102) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant medication use included unspecified blood pressure medication. Patient stated that she has a complex history as she had chemotherapy eight years ago for a bone marrow disorder but that she sees a hematologist and oncologist and that everything was stable. This case was linked to MOD-2021-069888 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up received included past medical history, suspect product details, concomitant medication details and outcome. On 06-Jul-2021: additional event and contact info added

Other Meds: MULTIVITAMINS [VITAMINS NOS]; VITAMIN D [VITAMIN D NOS]

Current Illness: Blood pressure abnormal

ID: 1567416
Sex: F
Age:
State: CA

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

Vax Type:
Manufacturer:
Vax Name:
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Symptoms: Patient was very sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient was very sleepy) in a 74-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced SOMNOLENCE (Patient was very sleepy). At the time of the report, SOMNOLENCE (Patient was very sleepy) outcome was unknown. No Concomitant and treatment medications were provided. Action taken with mRNA-1273 in response to the event was not applicable. . Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: TCR: nonsafety info

Other Meds:

Current Illness:

ID: 1567417
Sex: F
Age: 52
State: GA

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
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Lot:
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Lab Data:

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Symptom List:

Symptoms: could not move and she could not bend when she got up; she could not sleep or lay down as she normally does; Dizziness; head spinning/ vertigo; Nausea; pain in her arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), DIZZINESS (Dizziness), VERTIGO (head spinning/ vertigo), HYPOKINESIA (could not move and she could not bend when she got up) and INSOMNIA (she could not sleep or lay down as she normally does) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE ER) and OXCARBAMAZEPINE for an unknown indication. 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 PAIN IN EXTREMITY (pain in her arm) and CHILLS (Chills). On 14-Mar-2021, the patient experienced DIZZINESS (Dizziness), VERTIGO (head spinning/ vertigo) and NAUSEA (Nausea). On an unknown date, the patient experienced HYPOKINESIA (could not move and she could not bend when she got up) and INSOMNIA (she could not sleep or lay down as she normally does). At the time of the report, PAIN IN EXTREMITY (pain in her arm), DIZZINESS (Dizziness), VERTIGO (head spinning/ vertigo), HYPOKINESIA (could not move and she could not bend when she got up), INSOMNIA (she could not sleep or lay down as she normally does), CHILLS (Chills) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided.

Other Meds: DEPAKOTE ER; OXCARBAMAZEPINE

Current Illness:

ID: 1567418
Sex: F
Age:
State: IN

Vax Date: 03/09/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Injection site pain; injection site redness; Injection site swelling; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy. 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 VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) 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 considered VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) to be related. Concomitant product use was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Initial additional included patient demographic details, allergy history, route of vaccine administration and event outcome.

Other Meds:

Current Illness: Penicillin allergy

ID: 1567419
Sex: F
Age:
State: CT

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: 17 year old female who received her first dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female who received her first dose of the Moderna COVID19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (Medical history not provided.). On 16-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female who received her first dose of the Moderna COVID19 vaccine). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female who received her first dose of the Moderna COVID19 vaccine) 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. This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # 006B21A with no associated AEs.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # 006B21A with no associated AEs.

Other Meds:

Current Illness:

ID: 1567420
Sex: F
Age:
State: CT

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Nervous (Before taking the vaccine) and Anxiety attack (Before taking the vaccine). On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PALPITATIONS (Heart palpitations). At the time of the report, PALPITATIONS (Heart palpitations) had not resolved. 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/unknown.

Other Meds:

Current Illness:

ID: 1567421
Sex: F
Age:
State: CA

Vax Date: 03/13/2021
Onset Date: 03/14/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: vertigo; dizziness; nausea; vomiting; Headache; Vaccination site erythema; Vaccination site swelling; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm ), VERTIGO (vertigo), DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Vertigo (doctor told her that it?s on her mid ear). Concomitant products included VITAMIN C [ASCORBIC ACID] and ZINC 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 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm ). On 15-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling). On 16-Mar-2021, the patient experienced VERTIGO (vertigo), DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm ), VERTIGO (vertigo), DIZZINESS (dizziness), VACCINATION SITE SWELLING (Vaccination site swelling), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (Headache) outcome was unknown and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications were discontinued last week. The patient's second dose was scheduled on 10-Apr-2021. The patient's redness disappeared. Reportedly, the vertigo is 50% more intense. No treatment information was provided by the reporter.

Other Meds: VITAMIN C [ASCORBIC ACID]; ZINC

Current Illness:

ID: 1567422
Sex: F
Age: 32
State: IN

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Itching at the injection site/Injection site pain/swelling/redness/itchy; pain at the injection site/Injection site pain/swelling/redness/itchy; Swelling at the injection site/Injection site pain/swelling/redness/itchy; Redness at the injection site/Injection site pain/swelling/redness/itchy; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site/Injection site pain/swelling/redness/itchy), VACCINATION SITE PAIN (pain at the injection site/Injection site pain/swelling/redness/itchy), VACCINATION SITE SWELLING (Swelling at the injection site/Injection site pain/swelling/redness/itchy) and VACCINATION SITE ERYTHEMA (Redness at the injection site/Injection site pain/swelling/redness/itchy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site/Injection site pain/swelling/redness/itchy), VACCINATION SITE PAIN (pain at the injection site/Injection site pain/swelling/redness/itchy), VACCINATION SITE SWELLING (Swelling at the injection site/Injection site pain/swelling/redness/itchy) and VACCINATION SITE ERYTHEMA (Redness at the injection site/Injection site pain/swelling/redness/itchy). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site/Injection site pain/swelling/redness/itchy), VACCINATION SITE PAIN (pain at the injection site/Injection site pain/swelling/redness/itchy), VACCINATION SITE SWELLING (Swelling at the injection site/Injection site pain/swelling/redness/itchy) and VACCINATION SITE ERYTHEMA (Redness at the injection site/Injection site pain/swelling/redness/itchy) 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 drugs were not provided concomitant drugs were not provided Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Completed ADR Form

Other Meds:

Current Illness:

ID: 1567423
Sex: F
Age: 54
State: MI

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

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Symptom List:

Symptoms: Red blotch at site of injection; Itchy at site of injection; Raised area (bigger than a half-dollar) at site of injection; Burning sensation at site of injection; Raised area (bigger than a half-dollar) at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotch at site of injection), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE SWELLING (Raised area (bigger than a half-dollar) at site of injection), VACCINATION SITE PAIN (Burning sensation at site of injection) and VACCINATION SITE RASH (Raised area (bigger than a half-dollar) at site of injection) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. Concurrent medical conditions included Poison ivy rash. 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 RASH MACULAR (Red blotch at site of injection), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE SWELLING (Raised area (bigger than a half-dollar) at site of injection), VACCINATION SITE PAIN (Burning sensation at site of injection) and VACCINATION SITE RASH (Raised area (bigger than a half-dollar) at site of injection). The patient was treated with HYDROCORTISONE for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Red blotch at site of injection), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE SWELLING (Raised area (bigger than a half-dollar) at site of injection), VACCINATION SITE PAIN (Burning sensation at site of injection) and VACCINATION SITE RASH (Raised area (bigger than a half-dollar) at site of injection) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. On 09-Mar-2021, the patient developed a red blotch, raised (bigger than half-dollar) area, burning sensation, itchy. On 11-Mar-2021, symptoms disappeared. On 16-Mar-2021, developed another red blotch (more red than previous reaction), raised area, itchy, all at site of injection. Treatment with hydrocortisone cream was given and some symptoms resolved. On 17-Mar-2021 symptoms still persist. This case was linked to MOD-2021-109664 (Patient Link).

Other Meds:

Current Illness: Poison ivy rash

ID: 1567424
Sex: M
Age:
State: IN

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
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Symptoms: swollen lymph nodes in his neck; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes in his neck) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021 at 2:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021 at 8:00 PM, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in his neck). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes in his neck) 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 reported by investigator No treatment medications provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional document received on 24 May 2021. Reporter contact details updated, patient demographics updated and route of administration of vaccine added.

Other Meds:

Current Illness:

ID: 1567425
Sex: F
Age:
State:

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Vaccination site burning; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site burning). At the time of the report, VACCINATION SITE PAIN (Vaccination site burning) outcome was unknown. The concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1567426
Sex: F
Age:
State: IN

Vax Date: 03/03/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
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Symptoms: Pain, redness and swelling at the injection site; Pain, redness and swelling at the injection site; Pain, redness and swelling at the injection site; Muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Pain, redness and swelling at the injection site), VACCINATION SITE ERYTHEMA (Pain, redness and swelling at the injection site), VACCINATION SITE SWELLING (Pain, redness and swelling at the injection site) and MYALGIA (Muscle pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain, redness and swelling at the injection site), VACCINATION SITE ERYTHEMA (Pain, redness and swelling at the injection site), VACCINATION SITE SWELLING (Pain, redness and swelling at the injection site) and MYALGIA (Muscle pain). At the time of the report, VACCINATION SITE PAIN (Pain, redness and swelling at the injection site), VACCINATION SITE ERYTHEMA (Pain, redness and swelling at the injection site), VACCINATION SITE SWELLING (Pain, redness and swelling at the injection site) and MYALGIA (Muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was mentioned.

Other Meds:

Current Illness:

ID: 1567427
Sex: M
Age: 62
State: VA

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
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Symptoms: dose of the vaccine in his left arm 6 hours after first vial puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the vaccine in his left arm 6 hours after first vial puncture) in a 62-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 16-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 EXPIRED PRODUCT ADMINISTERED (dose of the vaccine in his left arm 6 hours after first vial puncture). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (dose of the vaccine in his left arm 6 hours after first vial puncture) 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 by the reporter.

Other Meds:

Current Illness:

ID: 1567428
Sex: M
Age:
State: WI

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/15/2021
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Symptoms: administration high in his left arm, right in joint between arm and shoulder; no able to sleep at night; Hurts like hell; touch is hurting; This spontaneous case was reported by a consumer and describes the occurrence of DOSE CALCULATION ERROR (administration high in his left arm, right in joint between arm and shoulder), INSOMNIA (no able to sleep at night), PAIN (Hurts like hell) and PAIN (touch is hurting) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced DOSE CALCULATION ERROR (administration high in his left arm, right in joint between arm and shoulder), INSOMNIA (no able to sleep at night), PAIN (Hurts like hell) and PAIN (touch is hurting). At the time of the report, DOSE CALCULATION ERROR (administration high in his left arm, right in joint between arm and shoulder) had resolved and INSOMNIA (no able to sleep at night), PAIN (Hurts like hell) and PAIN (touch is hurting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided No treatment medications were provided

Other Meds:

Current Illness:

ID: 1567429
Sex: F
Age: 69
State: FL

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: This spontaneous case reported by a consumer, describes the occurrence of urinary tract infection (UTI) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 015M20A) for COVID-19 immunization. The patient's past medical history included UTI (a week before first dose had a UTI). Concomitant products included ciprofloxacin for UTI, Synthroid (levothyroxine sodium) for an unknown indication. On Feb 18, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced urinary tract infection (UTI). At the time of the report, urinary tract infection (UTI) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Reportedly, patient is taking a strong medication (unspecified) for UTI.

Other Meds: Ciprofloxacin; Synthroid

Current Illness: UTI (a week before first dose had a UTI)

ID: 1567430
Sex: F
Age: 62
State: CO

Vax Date: 03/08/2021
Onset Date: 03/14/2021
Rec V Date: 08/15/2021
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Symptoms: red at the injection site; puffed out a little bit; itchy; back red at the injection site; like a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red at the injection site), VACCINATION SITE RASH (like a rash), VACCINATION SITE SWELLING (puffed out a little bit) and VACCINATION SITE ERYTHEMA (back red at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. No medical history information was reported. Concomitant products included ATORVASTATIN for an unknown indication. On 08-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 RASH (like a rash) and VACCINATION SITE ERYTHEMA (back red at the injection site). On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE SWELLING (puffed out a little bit). At the time of the report, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red at the injection site), VACCINATION SITE RASH (like a rash) and VACCINATION SITE SWELLING (puffed out a little bit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient reported, it was red for a few days after the shot, but then it went away. On 14-Mar-2021, it was back, red at the injection site. It is like a rash, it is puffed out a little bit. On 15-Mar-2021, it was a little bit bigger, and then it started to get itchy, It was also bigger since then.

Other Meds: ATORVASTATIN

Current Illness:

ID: 1567431
Sex: F
Age: 36
State: PA

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 08/15/2021
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Symptoms: Drippage that causes sore throat; Fatigue; Running/runny nose; This spontaneous case was reported by a health care professional and describes the occurrence of RHINORRHOEA (Running/runny nose), UPPER-AIRWAY COUGH SYNDROME (Drippage that causes sore throat) and FATIGUE (Fatigue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The patient's past medical history included Stroke (Stroke x2) on 30-May-2016. Previously administered products included for an unreported indication: FLU in October 2020. Family history included Cancer (Mother), Diabetes (Father) and Blood pressure high (Father). Concurrent medical conditions included Seasonal allergy since 01-Jan-2012. Concomitant products included CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Anxiety, TOPIRAMATE (TOPAMAX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Stroke. On 15-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced RHINORRHOEA (Running/runny nose). On an unknown date, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Drippage that causes sore throat). an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, RHINORRHOEA (Running/runny nose) and UPPER-AIRWAY COUGH SYNDROME (Drippage that causes sore throat) had not resolved and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2016, Magnetic resonance imaging: stroke (Inconclusive) MRI around "my strokes" and every year after. 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. A self-report from a female health care professional was forwarded by Pfizer regarding the following reported events: Running nose (day after shot, also reported as 24-Jan-2021), drippage that caused sore throat (starting 2-3 days after vaccination) and fatigue. The patient reported that she went to Urgent Care and "believed it was a viral infection". Treatment information was not provided. The patient reported that her next dose of the Moderna vaccine was scheduled for 12-Feb-2021.

Other Meds: CELEXA [CITALOPRAM HYDROBROMIDE]; TOPAMAX; BABY ASPIRIN

Current Illness: Seasonal allergy

ID: 1567432
Sex: F
Age:
State:

Vax Date:
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Rec V Date: 08/15/2021
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Symptoms: nauseated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of NAUSEA (nauseated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (nauseated). At the time of the report, NAUSEA (nauseated) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator No treatment medications provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1567433
Sex: F
Age:
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Rec V Date: 08/15/2021
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Symptoms: Pain in the back of neck; Pain in lower back; Pain in forehead; This spontaneous case was reported by an other and describes the occurrence of NECK PAIN (Pain in the back of neck), BACK PAIN (Pain in lower back) and HEADACHE (Pain in forehead) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 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 NECK PAIN (Pain in the back of neck), BACK PAIN (Pain in lower back) and HEADACHE (Pain in forehead). The patient was treated with SEMAGLUTIDE (OZEMPIC) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Pain in the back of neck), BACK PAIN (Pain in lower back) and HEADACHE (Pain in forehead) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1567434
Sex: U
Age:
State:

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Severe sore arm pain; Loss of appetite; Fatigue, dizziness, tiredness and chills; Fatigue, dizziness, tiredness and chills; Fatigue, dizziness, tiredness and chills; Nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe sore arm pain), DECREASED APPETITE (Loss of appetite), DIZZINESS (Fatigue, dizziness, tiredness and chills), FATIGUE (Fatigue, dizziness, tiredness and chills) and CHILLS (Fatigue, dizziness, tiredness and chills) in a patient of an unknown age and gender 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 Diabetes. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe sore arm pain), DECREASED APPETITE (Loss of appetite), DIZZINESS (Fatigue, dizziness, tiredness and chills), FATIGUE (Fatigue, dizziness, tiredness and chills), CHILLS (Fatigue, dizziness, tiredness and chills) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Severe sore arm pain), DECREASED APPETITE (Loss of appetite), DIZZINESS (Fatigue, dizziness, tiredness and chills), FATIGUE (Fatigue, dizziness, tiredness and chills), CHILLS (Fatigue, dizziness, tiredness and chills) and NAUSEA (Nausea) had not resolved. Reporter did not allow further contact

Other Meds:

Current Illness: Diabetes

ID: 1567435
Sex: F
Age:
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Rec V Date: 08/15/2021
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Symptoms: This spontaneous case reported by an other healthcare professional, describes the occurrence of back pain, vaccination complication (drug side effect) and chills in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Co-suspect product included adalimumab injection for psoriatic arthritis. No medical history reported. On an unknown date, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form and adalimumab (unknown route) 1 dosage form. On an unknown date, patient experienced back pain, vaccination complication (drug side effect) and chills. At the time of the report, back pain and vaccination complication (drug side effect): not resolved and chills outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment information provided. Most recent follow-up information incorporated above includes: On May 3, 2021: No new information provided.

Other Meds:

Current Illness:

ID: 1567436
Sex: M
Age: 69
State: IL

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/15/2021
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Symptoms: Left arm was sore; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Left arm was sore) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced PAIN IN EXTREMITY (Left arm was sore). In February 2021, PAIN IN EXTREMITY (Left arm was sore) 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: HUMIRA

Current Illness:

ID: 1567437
Sex: F
Age:
State:

Vax Date:
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Rec V Date: 08/15/2021
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Symptoms: occasional headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (occasional headaches) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product TREPROSTINIL SODIUM for Pulmonary arterial hypertension. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. 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. and TREPROSTINIL SODIUM (IV drip) .165 microgram/kilogram. On an unknown date, the patient experienced HEADACHE (occasional headaches). At the time of the report, HEADACHE (occasional headaches) outcome was unknown. No treatment medication was reported. Reporter did not allow further contact

Other Meds: ELIQUIS

Current Illness: Pulmonary arterial hypertension

ID: 1567438
Sex: F
Age: 70
State: IL

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/15/2021
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Symptoms: Fatigue; Vaccination site pain; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037KZ0A) for COVID-19 vaccination. The patient's past medical history included Cyst ovary from April 2020 to September 2020, Appendicitis in January 2015, General physical condition abnormal in 2012, Weight gain in 2012, Diabetes since 2016, Fatty liver, Elevated liver enzymes in 2017, Psoriasis in 2016, Shingles from November 2020 to December 2020 and Alcohol use (Abstain from alcohol). Concurrent medical conditions included Drug allergy (Sulfa drug allergy associated with manifestations of itching and burning skin.). Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease, METHOTREXATE for Psoriasis, LIDOCAINE and DOXYCYCLINE for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and METFORMIN at an unspecified dose and frequency. On 03-Jan-2021, FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2012, Weight: inconclusive (Inconclusive) Inconclusive. In January 2015, Abdominal X-ray: inconclusive (Inconclusive) Inconclusive. In January 2015, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. In 2016, Glycosylated haemoglobin: inconclusive (Inconclusive) Inconclusive. On 13-Nov-2020, Ultrasound liver: inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment for the event included TYLENOL, METFORMIN and BYDUREON BCISE. 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-2021-047583 (Patient Link).

Other Meds: HUMIRA; METHOTREXATE; LIDOCAINE; DOXYCYCLINE

Current Illness: Diabetes; Drug allergy (Sulfa drug allergy associated with manifestations of itching and burning skin.)

ID: 1567439
Sex: F
Age: 70
State:

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 08/15/2021
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Symptoms: Fever blister; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Fever blister) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis relapse. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication. On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced ORAL HERPES (Fever blister). At the time of the report, ORAL HERPES (Fever blister) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided by the reporter.

Other Meds: OCREVUS

Current Illness: Multiple sclerosis relapse

ID: 1567440
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (violently sick), INJECTION SITE MASS (golfball sized lump on her arm at the injection site) and HYPERSENSITIVITY (allergic reaction) 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 MALAISE (violently sick), INJECTION SITE MASS (golfball sized lump on her arm at the injection site) and HYPERSENSITIVITY (allergic reaction). At the time of the report, MALAISE (violently sick), INJECTION SITE MASS (golfball sized lump on her arm at the injection site) and HYPERSENSITIVITY (allergic reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medicines were not reported

Other Meds:

Current Illness:

ID: 1567441
Sex: F
Age: 64
State: AZ

Vax Date: 03/07/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
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Symptoms: warm at the injection site; fever blister; rash at the injection site; red circle at the injection site,redness at the injection; 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 17-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (fever blister), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red circle at the injection site,redness at the injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No reported medical history. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYDROCHLOROTHIAZIDE + LOSARTAN) and LEVOTHYROXINE for an unknown indication. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red circle at the injection site,redness at the injection). On 12-Mar-2021, the patient experienced ORAL HERPES (fever blister). On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm at the injection site). At the time of the report, ORAL HERPES (fever blister), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red circle at the injection site,redness at the injection) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information in response to events was not provided.

Other Meds: HYDROCHLOROTHIAZIDE + LOSARTAN; LEVOTHYROXINE

Current Illness:

ID: 1567442
Sex: M
Age:
State: FL

Vax Date: 03/16/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
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Symptoms: tingling on his back; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling on his back) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PARAESTHESIA (tingling on his back). At the time of the report, PARAESTHESIA (tingling on his back) 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 Treatment medications were provided No Concomitant medications were provided; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1567443
Sex: M
Age: 76
State: TX

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: blood sugar fluctuated and became unmanageable; flu like symptoms; headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE FLUCTUATION (blood sugar fluctuated and became unmanageable), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31A21A) for COVID-19 vaccination. Co-suspect product included non-company product OXYCODONE for an unknown indication. Concurrent medical conditions included Diabetes mellitus. Concomitant products included INSULIN for Blood sugar level fluctuation. On 12-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 started OXYCODONE (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE FLUCTUATION (blood sugar fluctuated and became unmanageable), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache). The patient was treated with IBUPROFEN for Headache, at a dose of 1 dosage form. At the time of the report, BLOOD GLUCOSE FLUCTUATION (blood sugar fluctuated and became unmanageable), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache) 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. .

Other Meds: INSULIN, OXYCODONE

Current Illness: Diabetes mellitus

ID: 1567444
Sex: F
Age:
State: MA

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
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Symptoms: Feeling tired and fatigued in the evening after receiving 1st dose; Fever; Headache; Reporting joint pain in her whole body that is unusual and started next day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling tired and fatigued in the evening after receiving 1st dose), PYREXIA (Fever), HEADACHE (Headache) and ARTHRALGIA (Reporting joint pain in her whole body that is unusual and started next day) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. Concurrent medical conditions included Pre-diabetes. On 16-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 FATIGUE (Feeling tired and fatigued in the evening after receiving 1st dose), PYREXIA (Fever), HEADACHE (Headache) and ARTHRALGIA (Reporting joint pain in her whole body that is unusual and started next day). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, FATIGUE (Feeling tired and fatigued in the evening after receiving 1st dose), PYREXIA (Fever), HEADACHE (Headache) and ARTHRALGIA (Reporting joint pain in her whole body that is unusual and started next day) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications include pre-diabetes medications.

Other Meds:

Current Illness: Pre-diabetes

ID: 1567445
Sex: F
Age:
State: MN

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
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Symptoms: This spontaneous case reported by a consumer, describes the occurrence of nasal congestion (stuffy nose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included seasonal allergy. Concomitant products included desmopressin for an unknown indication. On Mar 17, 2021, patient received second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; dosage 1 dosage form. On an unknown date, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 17, 2021, patient experienced nasal congestion (stuffy nose). The patient was treated with Flonase (fluticasone propionate) for nasal stuffiness, at an unspecified dose and frequency. At the time of the report, nasal congestion (stuffy nose) outcome: unknown. Patient did not get a stuffy nose from the use of Moderna. However, as per initial document, patient had it before the 2nd dose which confirms that patient had it after the 1st dose. Action taken with the product mRNA-1273 not applicable. Most recent follow-up information incorporated above includes: On May 7, 2021: medical history and clinical information updated.

Other Meds: Desmopressin

Current Illness: Seasonal allergy

ID: 1567446
Sex: F
Age: 57
State:

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over the body with itching), VACCINATION SITE SWELLING (swollen arm left arm) and VACCINATION SITE PRURITUS (rash witn itching left arm) in a 56-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 04-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 RASH (Rash all over the body with itching), VACCINATION SITE SWELLING (swollen arm left arm) and VACCINATION SITE PRURITUS (rash witn itching left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash all over the body with itching), VACCINATION SITE SWELLING (swollen arm left arm) and VACCINATION SITE PRURITUS (rash witn itching left arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information in response to events was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1567447
Sex: F
Age: 87
State: CA

Vax Date: 03/10/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
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Symptoms: dizziness; headache; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) in an 87-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 10-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 (headache), FATIGUE (fatigue) and NAUSEA (nausea). On 17-Mar-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with MARIJUANA for Headache, at a dose of Marijuana candy bar. At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) had resolved. No Concomitant medication was received by the patient The patient took a marijuana candy bar to help with her headaches. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Outcome of the events was updated to resolved.

Other Meds:

Current Illness:

ID: 1567448
Sex: F
Age:
State: ID

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
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Symptoms: Red welt at the site of injection; Fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red welt at the site of injection) in a 40-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 (No medical history reported.). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Sore arm). On 17-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red welt at the site of injection). At the time of the report, PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red welt at the site of injection) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided.

Other Meds:

Current Illness:

ID: 1567449
Sex: F
Age:
State:

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
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Symptoms: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) 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 15-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 15-Mar-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided Concomitant medications were not reported. Treatment information in response to events was not provided.

Other Meds:

Current Illness:

ID: 1567450
Sex: F
Age: 30
State: MA

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: fever; Is very tired; Sore Arm; Feels Dirty; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), FATIGUE (Is very tired), PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Feels Dirty) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. Concomitant products included LITHIUM, CLOZAPINE, TRAZODONE, PALIPERIDONE (INVEGA [PALIPERIDONE]), PALIPERIDONE (INVEGA [PALIPERIDONE]) and PARACETAMOL (TYLENOL) for an unknown indication. On 16-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 PYREXIA (fever), FATIGUE (Is very tired), PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Feels Dirty) and FATIGUE (Fatigue). At the time of the report, PYREXIA (fever), FATIGUE (Is very tired), PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Feels Dirty) and FATIGUE (Fatigue) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were provided Reporter did not allow further contact

Other Meds: LITHIUM; CLOZAPINE; TRAZODONE; INVEGA [PALIPERIDONE]; INVEGA [PALIPERIDONE]; TYLENOL

Current Illness:

ID: 1567451
Sex: F
Age: 80
State: CA

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
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Symptoms: Subcutaneous tissue of left arm; Pain at injection site (left arm); This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous tissue of left arm) and VACCINATION SITE PAIN (Pain at injection site (left arm)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07M20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 16-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous tissue of left arm) and VACCINATION SITE PAIN (Pain at injection site (left arm)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of one dose. On 16-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous tissue of left arm) had resolved. On 19-Feb-2021, VACCINATION SITE PAIN (Pain at injection site (left arm)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown. No concomitant medication were provided This case was linked to MOD-2021-047696 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29-Jul-2021 contain non-significant information

Other Meds:

Current Illness:

ID: 1567452
Sex: M
Age: 67
State: ID

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 08/15/2021
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Symptoms: swelling/numbness left side of face; sob; severe sweating; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (swelling/numbness left side of face), DYSPNOEA (sob), HYPERHIDROSIS (severe sweating) and FATIGUE (fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HYPOAESTHESIA (swelling/numbness left side of face), DYSPNOEA (sob), HYPERHIDROSIS (severe sweating) and FATIGUE (fatigue). The patient was treated with SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (swelling/numbness left side of face), DYSPNOEA (sob), HYPERHIDROSIS (severe sweating) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1567453
Sex: F
Age: 73
State: PA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/15/2021
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Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling lousy/yucky), MALAISE (Not feeling well), DIARRHOEA (Loose Bowels), NASOPHARYNGITIS (Cold symptoms) and PAIN IN EXTREMITY (Sore arm) in a 73-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. The patient's past medical history included No adverse event (No medical history reported). On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling lousy/yucky), MALAISE (Not feeling well), DIARRHOEA (Loose Bowels), NASOPHARYNGITIS (Cold symptoms) and MYALGIA (Feeling achy). At the time of the report, FEELING ABNORMAL (Feeling lousy/yucky), MALAISE (Not feeling well), DIARRHOEA (Loose Bowels), NASOPHARYNGITIS (Cold symptoms) and MYALGIA (Feeling achy) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Description: The patient mentioned that they were not feeling well despite being scheduled for the second dose of their Moderna COVID-19 vaccine on 17 Mar 2021. She stated she was not feeling well, had loose bowels, was feeling achy, lousy, yucky and had cold symptoms.She mentioned at that time she received first dose she had a little bit of the sore arm symptom. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1567454
Sex: F
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Mixed mRNA vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed mRNA vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No adverse event 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 INTERCHANGE OF VACCINE PRODUCTS (Mixed mRNA vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed mRNA vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: This report refers to a case of (Product storage error ? Product administration error for mRNA-1273, lot # with no associated Adverse Events.

Other Meds:

Current Illness:

ID: 1567455
Sex: F
Age: 62
State: TX

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

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Symptom List:

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflammation), VACCINATION SITE MASS (little bumps at injection site), VACCINATION SITE WARMTH (warm to the touch at injection site), LYMPH NODE PAIN (painful lymph nodes of neck on right side) and VACCINATION SITE PRURITUS (itching at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ESTRADIOL and LOSARTAN POTASSIUM for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (inflammation) and VACCINATION SITE PAIN (tenderness at injection site). On 16-Mar-2021, the patient experienced VACCINATION SITE MASS (little bumps at injection site), VACCINATION SITE WARMTH (warm to the touch at injection site), VACCINATION SITE PRURITUS (itching at injection site) and PYREXIA (slight fever). On 17-Mar-2021, the patient experienced LYMPH NODE PAIN (painful lymph nodes of neck on right side) and LYMPHADENOPATHY (swollen lymph nodes of neck on right side). At the time of the report, VACCINATION SITE INFLAMMATION (inflammation), VACCINATION SITE MASS (little bumps at injection site), VACCINATION SITE WARMTH (warm to the touch at injection site), LYMPH NODE PAIN (painful lymph nodes of neck on right side), VACCINATION SITE PRURITUS (itching at injection site), LYMPHADENOPATHY (swollen lymph nodes of neck on right side), VACCINATION SITE PAIN (tenderness at injection site) and PYREXIA (slight fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not reported. Patient did not treated the symptoms.

Other Meds: LIPITOR; ESTRADIOL; LOSARTAN POTASSIUM

Current Illness:

ID: 1567456
Sex: F
Age: 79
State: FL

Vax Date: 03/13/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
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Symptoms: achy; under arm it was rough and burning; rash in her back, rash in back and chest, left arm and elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), SKIN BURNING SENSATION (under arm it was rough and burning) and RASH (rash in her back, rash in back and chest, left arm and elbow) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR), ATORVASTATIN CALCIUM (LIPITOR), PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), FUROSEMIDE, ACETYLSALICYLIC ACID (ASPRIN), APPLE CIDER VINEGAR, ZINC, MULTIVITAMIN [VITAMINS NOS], ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and VITAMIN B12 NOS for an unknown indication, NIFEDIPINE (ADALAT). On 13-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 PAIN (achy), SKIN BURNING SENSATION (under arm it was rough and burning) and RASH (rash in her back, rash in back and chest, left arm and elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (achy), SKIN BURNING SENSATION (under arm it was rough and burning) and RASH (rash in her back, rash in back and chest, left arm and elbow) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The other concomitant medication include electrozole 2.5mg .

Other Meds: ADALAT; HYZAAR; LIPITOR; PAXIL [PAROXETINE HYDROCHLORIDE]; FUROSEMIDE; ASPRIN; APPLE CIDER VINEGAR; ZINC; MULTIVITAMIN [VITAMINS NOS]; VITAMIN C & ROSEHIP; VITAMIN B12 NOS

Current Illness:

ID: 1567457
Sex: M
Age: 62
State: CA

Vax Date: 03/15/2021
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Rec V Date: 08/15/2021
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Symptoms: fever; bone pain; very strong reaction; temperature goes down but at times it shoots up strongly; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), BONE PAIN (bone pain), ADVERSE EVENT (very strong reaction) and BODY TEMPERATURE FLUCTUATION (temperature goes down but at times it shoots up strongly) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. No medical history was provided by reporter. No concomitant medication reported. On 15-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 PYREXIA (fever), BONE PAIN (bone pain), ADVERSE EVENT (very strong reaction) and BODY TEMPERATURE FLUCTUATION (temperature goes down but at times it shoots up strongly). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram every four hours. At the time of the report, PYREXIA (fever), BONE PAIN (bone pain), ADVERSE EVENT (very strong reaction) and BODY TEMPERATURE FLUCTUATION (temperature goes down but at times it shoots up strongly) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product was provided.

Other Meds:

Current Illness:

ID: 1567458
Sex: F
Age: 69
State: FL

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
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Symptoms: warm to touch at the injection site; slightly raised at the injection site; 6 inch diameter red area at the injection site; arm was achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was achy), VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE SWELLING (slightly raised at the injection site) and VACCINATION SITE ERYTHEMA (6 inch diameter red area at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was achy). On 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE SWELLING (slightly raised at the injection site) and VACCINATION SITE ERYTHEMA (6 inch diameter red area at the injection site). On 09-Mar-2021, PAIN IN EXTREMITY (arm was achy) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE SWELLING (slightly raised at the injection site) and VACCINATION SITE ERYTHEMA (6 inch diameter red area at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment information was provided. No concomitant product was reported.

Other Meds:

Current Illness:

ID: 1567459
Sex: U
Age:
State: TX

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Rec V Date: 08/15/2021
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Symptoms: Heart Beat Rising; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart Beat Rising) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Heart Beat Rising). At the time of the report, HEART RATE INCREASED (Heart Beat Rising) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Upon in internal review on 24 May 2021, the age was corrected to unknown age. No treatment information was provided. No concomitant products were reported. This case was linked to MOD21-055836 (Patient Link).

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Current Illness:

Total 2021 VAERS Injuries: 657,908

Page last modified: 03 October 2021 5:28pm